{"source":"clinicaltrials","name":"ClinicalTrials.gov","kind":"lookup","result":{"query":{"q":"","status":""},"via":"native","studies":[{"protocolSection":{"identificationModule":{"nctId":"NCT05077735","orgStudyIdInfo":{"id":"GMROR2162"},"secondaryIdInfos":[{"id":"21-000069","type":"OTHER","domain":"Mayo Clinic Institutional Review Board"}],"organization":{"fullName":"Mayo Clinic","class":"OTHER"},"briefTitle":"Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Trial","officialTitle":"Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)"},"statusModule":{"statusVerifiedDate":"2026-07","overallStatus":"RECRUITING","startDateStruct":{"date":"2021-10-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2027-10-15","type":"ESTIMATED"},"completionDateStruct":{"date":"2027-10-15","type":"ESTIMATED"},"studyFirstSubmitDate":"2021-10-01","studyFirstSubmitQcDate":"2021-10-01","studyFirstPostDateStruct":{"date":"2021-10-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-07-10","lastUpdatePostDateStruct":{"date":"2026-07-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Mayo Clinic","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas. This study aims to change the way radiation is delivered, from giving 6 weeks of radiation all at once to giving 2 weeks of radiation. This may determine if there is a difference in the outcome of the treatment, and most importantly, the patients' quality of life.","detailedDescription":"PRIMARY OBJECTIVE:\n\nI. To determine that 10-month overall survival (OS) rate for the hypofractionated radiation course of 25 Gy in 10 fractions in patients with diffuse midline glioma of the pons is superior to the low-end historical control (Survival rate of 40% at 10 months when calculating from time of enrollment) based on the current standard of care (54 GY in 30 fractions).\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the quality of life outcomes for patients with diffuse midline gliomas of the pons.\n\nII. To estimate the time to progression after the second hypofractionated radiation course of 25 Gy in 10 fractions, calculated from date of registration and separately from primary tumor diagnosis date.\n\nIII. To estimate progression free survival intervals for patients after each hypofractionated radiation treatment course.\n\nIV. To evaluate the quality of life outcomes for parents of patients =\\< 18 years with the Functional Assessment of Cancer Therapy General (FACT-G) Family/Caregiver Questionnaire.\n\nV. To estimate the overall survival from date of enrollment to death and from primary tumor diagnosis date to death.\n\nVI. To report toxicities associated with hypofractionated, planned, multi-course radiation treatment for diffuse midline glioma of the pons.\n\nOUTLINE:\n\nPatients undergo hypofractionated radiation therapy (RT) over 10 fractions. Patients who experience progression undergo up to 2 retreatment courses. Patients undergo magnetic resonance imaging (MRI) and computed tomography (CT) scan throughout the study.\n\nAfter completion of study treatment, patients are followed up at 1 month, every 2 months for year 1, every 3 months for year 2, then every 6 months for year 3."},"conditionsModule":{"conditions":["Diffuse Midline Glioma, H3 K27M-Mutant"],"keywords":["DIPG","H3K27M","DMG","Diffuse Midline Glioma"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":32,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Treatment (hypofractionated RT)","type":"EXPERIMENTAL","description":"Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and CT scan throughout the study.","interventionNames":["Radiation: Hypofractionated Radiation Therapy","Other: Questionnaire Administration","Procedure: Magnetic Resonance Imaging","Procedure: Computed Tomography Scan"]}],"interventions":[{"type":"RADIATION","name":"Hypofractionated Radiation Therapy","description":"Undergo hypofractionated radiation therapy","armGroupLabels":["Treatment (hypofractionated RT)"],"otherNames":["Hypofractionated","Hypofractionated Radiotherapy","hypofractionation","Radiation, Hypofractionated"]},{"type":"OTHER","name":"Questionnaire Administration","description":"Ancillary studies","armGroupLabels":["Treatment (hypofractionated RT)"]},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging","description":"Undergo MRI","armGroupLabels":["Treatment (hypofractionated RT)"],"otherNames":["Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging","Magnetic Resonance / Nuclear Magnetic Resonance","MR","MRI","MR Imaging","MRI Scan","MRIs","NMR Imaging","NMRI","nuclear magnetic resonance imaging","sMRI","Structural MRI"]},{"type":"PROCEDURE","name":"Computed Tomography Scan","description":"Undergo CT scan","armGroupLabels":["Treatment (hypofractionated RT)"],"otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized Tomography","CT","CT Scan"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to progression","description":"Defined as the time from date of diagnosis to the date of radiographic or clinical progression following second course of hypofractionated radiation therapy.","timeFrame":"At 10 months"},{"measure":"Overall Survival (OS) at 10 months","description":"OS is defined as the time from date of study registration until death due to any cause.","timeFrame":"Up to 6 years"}],"secondaryOutcomes":[{"measure":"Time to second progression","description":"Defined as the time date of registration or primary tumor diagnosis to the date of radiographic, clinical progression, or death following second course of hypofractionated radiation therapy.","timeFrame":"Up to 6 years"},{"measure":"Quality of Life Measurement - PedsQL (children under 18)","description":"Results from Pediatric Quality of Life Inventory (PedsQL) Brain Tumor Module will be used to evaluate the quality of life outcomes in patients up to 18 years old. PedsQL™ assessments include 23 items answered on aLikert response scale (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem) for each item.","timeFrame":"Baseline up to 3 years"},{"measure":"Quality of Life Measurement - NFBrSI-24","description":"The National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT)-Brain Symptom Index-24 (NFBrSI-24) will be used in patients more than 18 years old. Changes in raw score from baseline to each time-point will be assessed in each of the physical and mental health domains. The NFBrSI-24 consists of 24 questions assessing symptoms over the past 7 days. Items are scored on a 5-point Likert type scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much).","timeFrame":"Baseline up to 3 years"},{"measure":"Progression free survival","description":"The average progression free survival interval after each course of RT will be reported in months. Progression free survival is defined as the time from registration date to the earliest date of documentation of progression after each course of radiation therapy (RT) or death due to any cause.","timeFrame":"Up to 3 years"},{"measure":"FACT-General Family/Caregiver Questionnaire (FACT-G)","description":"Changes in raw score from baseline to each time-point will be assessed in each of the physical and mental health domains. The FACT-G contains 27 questions within 4 subscale domains \\[Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being\\] related to health-related quality of life (QOL) in the past 7 days, with higher scoring indicating better QOL.","timeFrame":"Up to 3 years"},{"measure":"Overall survival","description":"Overall survival is defined as the time from registration date to death due to any cause. Patients alive at the date of last contact will be censored.","timeFrame":"Up to 3 years"},{"measure":"Incidence of adverse events","description":"The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.","timeFrame":"Up to 3 years"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age \\>= 1 year(s) old (no maximum age)\n* Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of \\>= 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign)\n\n  * If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy\n  * If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study\n  * If biopsy has already been completed at an outside institution, the outside pathology report will be reviewed ahead of trial enrollment. The pathology specimen will then be sent to Mayo Clinic for further review, but will not delay study enrollment\n* Able to undergo MRI Brain\n* Negative urine pregnancy test completed =\\< 7 days prior to registration, for women of childbearing potential only\n* Primary language of English or Spanish for patients and their caregiver\n* Patient or caregiver willing and able to provide written informed consent\n* Caregiver able to complete questionnaires by themselves or with assistance\n* Willing to return to enrolling institution for follow-up during the active monitoring phase of the study\n\nExclusion Criteria:\n\n* Any patient who has received previous radiation to the brain\n* Any patient who has received previous chemotherapy\n* Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2)\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Women of childbearing potential who are unwilling to employ adequate contraception\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Other active malignancy =\\< 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix\n\n  * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer\n* Patients \\> 16 years with an Eastern Cooperative Oncology Group (ECOG) score \\>= 4 and patients =\\< 16 years with a Lansky play scale =\\< 20\n\n  * NOTE: All novel therapeutic interventions, including but not limited to dordaviprone, are allowed for patients who enroll on the clinical trial","healthyVolunteers":false,"sex":"ALL","minimumAge":"1 Year","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Clinical Trials Referral Office","role":"CONTACT","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"overallOfficials":[{"name":"Roman O. Kowalchuk, MD","affiliation":"Mayo Clinic in Rochester","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Mayo Clinic Hospital in Arizona","status":"RECRUITING","city":"Phoenix","state":"Arizona","zip":"85054","country":"United States","contacts":[{"name":"Clinical Trials Referral Office","role":"CONTACT","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"},{"name":"Safia K. Ahmed, M.D.","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Mayo Clinic in Rochester","status":"RECRUITING","city":"Rochester","state":"Minnesota","zip":"55905","country":"United States","contacts":[{"name":"Clinical Trials Referral Office","role":"CONTACT","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"},{"name":"Roman O. Kowalchuk, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":44.02163,"lon":-92.4699}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Mayo Clinic Clinical Trials","url":"https://www.mayo.edu/research/clinical-trials"}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"interventionBrowseModule":{"meshes":[{"id":"D000069473","term":"Radiation Dose Hypofractionation"},{"id":"D011827","term":"Radiation"},{"id":"D009682","term":"Magnetic Resonance Spectroscopy"},{"id":"D014965","term":"X-Rays"}],"ancestors":[{"id":"D019583","term":"Dose Fractionation, Radiation"},{"id":"D011879","term":"Radiotherapy Dosage"},{"id":"D011878","term":"Radiotherapy"},{"id":"D013812","term":"Therapeutics"},{"id":"D055585","term":"Physical Phenomena"},{"id":"D013057","term":"Spectrum Analysis"},{"id":"D002623","term":"Chemistry Techniques, Analytical"},{"id":"D008919","term":"Investigative Techniques"},{"id":"D060733","term":"Electromagnetic Radiation"},{"id":"D055590","term":"Electromagnetic Phenomena"},{"id":"D060328","term":"Magnetic Phenomena"},{"id":"D011839","term":"Radiation, Ionizing"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT03872635","orgStudyIdInfo":{"id":"FJCAAN01"},"organization":{"fullName":"Fujian Cancer Hospital","class":"OTHER_GOV"},"briefTitle":"Effects of Anesthesia on Tumor Immunity and Insulin Resistance During Perioperative Period","officialTitle":"Effects of Drug or Drink Intervention and Temperature Protectionon for Cervical Cancer Patients on Insulin Resistance and Tumor Immunity"},"statusModule":{"statusVerifiedDate":"2019-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-01-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-12-31","type":"ACTUAL"},"completionDateStruct":{"date":"2018-12-31","type":"ACTUAL"},"studyFirstSubmitDate":"2019-02-23","studyFirstSubmitQcDate":"2019-03-10","studyFirstPostDateStruct":{"date":"2019-03-13","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-03-10","lastUpdatePostDateStruct":{"date":"2019-03-13","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Fujian Cancer Hospital","class":"OTHER_GOV"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"To evaluate the effects of preoperative oral carbohydrate on postoperative insulin resistance and tumor immunity in cervical cancer patients with neoadjuvant chemotherapy.","detailedDescription":"Fifty-one patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery(CHO group) or to fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid)(FAST group).According to inclusion and exclusion standards, twenty-six patients undergoing the same surgery and standard fasting were selected as control group. Baseline and postoperative measurements of insulin sensitivity were assessed in term of fasting plasma glucose(FPG),fastingainsulin(FINS),HOMA-insulinaresistance(HOMA-IR),HOMA-insulin secretion function index(HOMA-IX) , HOMA-beta cell function index(HOMA-β),serum C-peptide and glucagon.Baseline and postoperative measurements of tumor immunity were evaluated using NK cell and T-cell dynamics.VAS score was introduced to assess preoperative comfort."},"conditionsModule":{"conditions":["Anesthesia","Cervical Cancer","Carbohydrate","Tumor Immunity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":80,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"CHO Drinking Grope","type":"EXPERIMENTAL","description":"receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery","interventionNames":["Other: oral carbohydrate liquid"]},{"label":"Traditional fast Grope","type":"NO_INTERVENTION","description":"fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid"}],"interventions":[{"type":"OTHER","name":"oral carbohydrate liquid","description":"patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery","armGroupLabels":["CHO Drinking Grope"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"insulin resistance","description":"The patient's insulin resistance was determined by fasting plasma glucose(FPG),fastingainsulin(FINS), andHOMA-IR=FPG（mmol/L）×FINS（mIU/L）/22.5","timeFrame":"in 24 hrs"}],"secondaryOutcomes":[{"measure":"tumor immunity","description":"The patient's tumor immune level was determined by changes in T cells (CD3+、CD4+、CD8+、CD44+) and NK cells in the patient's blood","timeFrame":"in 24 hrs"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. The patients aged from 18 to 60 years old were ASA level I to II, and the informed consent was signed by the patients, which was approved by the ethics committee of the hospital.\n2. Cervical squamous cell carcinoma was confirmed by cervical biopsy before pathologic surgery. CT showed no distant metastasis. All patients underwent total hysterectomy, bilateral adnexectomy and pelvic lymph node dissection.\n3. Fasting blood glucose was normal without diabetes, impaired glucose tolerance or other metabolic diseases.\n4. no gastric emptying dysfunction.\n\nExclusion Criteria:\n\n1. Dabetes\n2. Patients with obstruction of gastric emptying, such as pyloric obstruction, gastroesophageal reflux, nausea and vomiting, etc\n3. Obese (BMI \\>32) or severely malnourished (BMI\\<18.5)\n4. Distant metastasis, multiple primary cancers and recurrent tumors\n5. Patients with functional disorders of respiratory system, circulatory system, immune system, nervous system, urinary system and other organs\n6. Received blood transfusion and nutritional support within 2 weeks before surgery\n7. The supplement contains the sugar solution, the blood transfusion, the application glucocorticoid, the sympathetic blood vessel activity medicine in the operation.","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Fuqing Zhang","city":"Fuzhou","state":"Fujian","zip":"350014","country":"China","geoPoint":{"lat":26.06139,"lon":119.30611}},{"facility":"Mengxia Yao","city":"Fuzhou","state":"Fujian","zip":"350014","country":"China","geoPoint":{"lat":26.06139,"lon":119.30611}}]},"referencesModule":{"references":[{"pmid":"32309426","type":"DERIVED","citation":"Zhang F, Yao M, Lin Z, Chen Y, Jiang H, Zeng M, Chen W. The Effects of Preoperative Oral Carbohydrate on Frequency of T and NK Cells in Patients with Cervical Cancer Treated Using Neoadjuvant Chemotherapy and Surgery: A Prospective Cohort Study. Biomed Res Int. 2020 Mar 16;2020:2101480. doi: 10.1155/2020/2101480. eCollection 2020."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D002583","term":"Uterine Cervical Neoplasms"}],"ancestors":[{"id":"D014594","term":"Uterine Neoplasms"},{"id":"D005833","term":"Genital Neoplasms, Female"},{"id":"D014565","term":"Urogenital Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D002577","term":"Uterine Cervical Diseases"},{"id":"D014591","term":"Uterine Diseases"},{"id":"D005831","term":"Genital Diseases, Female"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D000091662","term":"Genital Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT05309135","orgStudyIdInfo":{"id":"AB-HCEC-1-004"},"organization":{"fullName":"Aurion Biotech","class":"INDUSTRY"},"briefTitle":"A Safety and Efficacy Study of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy in Subjects With Corneal Edema Secondary to Endothelial Dysfunction","officialTitle":"A Phase 1, Double-Masked, Randomized, Safety and Efficacy, Single Center Clinical Evaluation of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy (HCEC-1) in Adult Subjects With Corneal Edema Secondary to Endothelial Dysfunction","acronym":"Escalon"},"statusModule":{"statusVerifiedDate":"2024-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-03-24","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-03-09","type":"ACTUAL"},"completionDateStruct":{"date":"2023-03-09","type":"ACTUAL"},"studyFirstSubmitDate":"2022-03-16","studyFirstSubmitQcDate":"2022-03-24","studyFirstPostDateStruct":{"date":"2022-04-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-08-16","lastUpdatePostDateStruct":{"date":"2024-08-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Aurion Biotech","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) in patients with corneal edema secondary to endothelial dysfunction."},"conditionsModule":{"conditions":["Corneal Edema"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Within the treated groups, the sponsor, investigator, assessor, and subject will be masked to the assigned dose.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":22,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Low dose Rho kinase inhibitor Y-27632","type":"ACTIVE_COMPARATOR","description":"Low dose Rho kinase inhibitor Y-27632","interventionNames":["Drug: HCEC-1"]},{"label":"Mid dose Rho kinase inhibitor Y-27632","type":"ACTIVE_COMPARATOR","description":"Mid dose Rho kinase inhibitor Y-27632","interventionNames":["Drug: HCEC-1"]},{"label":"High dose Rho kinase inhibitor Y-27632","type":"ACTIVE_COMPARATOR","description":"High dose Rho kinase inhibitor Y-27632","interventionNames":["Drug: HCEC-1"]}],"interventions":[{"type":"DRUG","name":"HCEC-1","description":"HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor","armGroupLabels":["High dose Rho kinase inhibitor Y-27632","Low dose Rho kinase inhibitor Y-27632","Mid dose Rho kinase inhibitor Y-27632"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)","timeFrame":"12 months"},{"measure":"Incidence and severity of non-ocular TEAEs","timeFrame":"12 months"}],"secondaryOutcomes":[{"measure":"Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry","timeFrame":"12 months"},{"measure":"Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score","timeFrame":"12 months"}]},"eligibilityModule":{"eligibilityCriteria":"Key Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated by subject or legal guardian), and any authorizations required by local law and be able to comply with all study requirements\n2. Clinical diagnosis of corneal edema secondary to endothelial dysfunction\n3. Best Corrected Visual Acuity (BCVA) no worse than 20/800 ETDRS (1.6 LogMAR) or better than 20/63 (0.5 LogMAR) in the study eye\n\nKey Exclusion Criteria:\n\n1. Keratoconus or other conditions of corneal thinning/ectasia\n2. Progressive stromal or anterior corneal dystrophies\n3. Pre-operative corneal epithelial, sub-epithelial or stromal staining, scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment with HCEC-1\n4. Prior ophthalmic surgery including cataract surgery except as noted above in Inclusion Criterion #4, corneal transplantation, glaucoma (MIGS, iridectomy, trabeculectomy, valve), or vitreo-retinal surgery, aphakia, anterior chamber-IOL or iris claw IOL, multifocal IOL.\n5. Relative Afferent Pupillary Defect (RAPD) in the study eye\n6. Uncontrolled glaucoma or an IOP greater than 24 mmHg that is not controlled with topical beta blockers alone at the time of the Screening Visit.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Site","city":"San Salvador","country":"El Salvador","geoPoint":{"lat":13.68935,"lon":-89.18718}}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"The study plan and protocol will be shared with the study center and other researchers per request."}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D015715","term":"Corneal Edema"}],"ancestors":[{"id":"D003316","term":"Corneal Diseases"},{"id":"D005128","term":"Eye Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01883635","orgStudyIdInfo":{"id":"46413"},"organization":{"fullName":"University of Rochester","class":"OTHER"},"briefTitle":"Exercise Intervention for Cancer Survivors and Caregivers","officialTitle":"Dyadic Exercise Intervention for Cancer Survivors and Caregivers"},"statusModule":{"statusVerifiedDate":"2016-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-05"},"primaryCompletionDateStruct":{"date":"2015-05","type":"ACTUAL"},"completionDateStruct":{"date":"2015-08","type":"ACTUAL"},"studyFirstSubmitDate":"2013-06-05","studyFirstSubmitQcDate":"2013-06-18","studyFirstPostDateStruct":{"date":"2013-06-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-08-24","resultsFirstSubmitQcDate":"2015-10-23","resultsFirstPostDateStruct":{"date":"2015-11-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-01-08","lastUpdatePostDateStruct":{"date":"2016-02-05","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Charles Kamen","investigatorTitle":"Assistant Research Professor","investigatorAffiliation":"University of Rochester"},"leadSponsor":{"name":"University of Rochester","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.","detailedDescription":"This was a pilot feasibility study to refine our methodology before a larger Phase II trial."},"conditionsModule":{"conditions":["Cancer"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":44,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Individual Exercise Intervention","type":"ACTIVE_COMPARATOR","description":"Survivor-only progressive walking and resistance exercise","interventionNames":["Behavioral: Survivor-only progressive walking and resistance exercise"]},{"label":"Dyadic Exercise Intervention","type":"EXPERIMENTAL","description":"Dyadic progressive walking and resistance exercise","interventionNames":["Behavioral: Dyadic progressive walking and resistance exercise"]}],"interventions":[{"type":"BEHAVIORAL","name":"Survivor-only progressive walking and resistance exercise","description":"Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only","armGroupLabels":["Individual Exercise Intervention"],"otherNames":["EXCAP"]},{"type":"BEHAVIORAL","name":"Dyadic progressive walking and resistance exercise","description":"Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad","armGroupLabels":["Dyadic Exercise Intervention"],"otherNames":["EXCAP-PA"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Psychological Distress","description":"Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.","timeFrame":"Baseline to post-intervention (6 weeks later)"}],"secondaryOutcomes":[{"measure":"Immune Biomarkers","description":"We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.","timeFrame":"Baseline to post-intervention (6 weeks later)"}],"otherOutcomes":[{"measure":"Provision of Social Support","description":"Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.","timeFrame":"Baseline to post-intervention (6 weeks later)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria for Cancer Survivors:\n\n* Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.\n* Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments\n* Have a caregiver willing to participate int he study\n* Be able to read English\n* Be 21 years of age or older\n* Give written informed consent\n\nInclusion Criteria for Caregivers:\n\n* Be nominated by a cancer survivor\n* Be able to read English\n* Be 21 years of age or older\n* Give written informed consent\n\nExclusion Criteria:\n\n* have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.\n* For caregivers, be currently undergoing active treatment for cancer","healthyVolunteers":false,"sex":"ALL","minimumAge":"21 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Charles Kamen, PhD","affiliation":"University of Rochester","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Rochester","city":"Rochester","state":"New York","zip":"14642","country":"United States","geoPoint":{"lat":43.15478,"lon":-77.61556}}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Both cancer survivors and their caregivers were screened, consented, and randomized to one of two intervention arms (Individual Exercise or Dyadic Exercise). 22 cancer survivor/caregiver dyads were recruited (44 individuals).","groups":[{"id":"FG000","title":"Individual Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"},{"id":"FG001","title":"Dyadic Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Individual Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"},{"id":"BG001","title":"Dyadic Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"44"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"35"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56.17","spread":"11.05"},{"groupId":"BG001","value":"53.90","spread":"12.59"},{"groupId":"BG002","value":"55.12","spread":"11.71"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"20"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"43"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"44"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"44"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Psychological Distress","description":"Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.","populationDescription":"The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline to post-intervention (6 weeks later)","groups":[{"id":"OG000","title":"Individual Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"},{"id":"OG001","title":"Dyadic Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.25","spread":"14.24"},{"groupId":"OG001","value":"-.65","spread":"9.84"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.14","statisticalMethod":"t-test, 2 sided","statisticalComment":"degrees of freedom=40","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Immune Biomarkers","description":"We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.","populationDescription":"The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"Baseline to post-intervention (6 weeks later)","groups":[{"id":"OG000","title":"Individual Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"},{"id":"OG001","title":"Dyadic Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.17","spread":"1.57"},{"groupId":"OG001","value":"1.42","spread":"1.24"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.65","statisticalMethod":"t-test, 2 sided","statisticalComment":"degrees of freedom=40","ciNumSides":"TWO_SIDED"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Provision of Social Support","description":"Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.","populationDescription":"This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline to post-intervention (6 weeks later)","groups":[{"id":"OG000","title":"Individual Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"},{"id":"OG001","title":"Dyadic Exercise Intervention","description":"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)\n\nProgressive walking and resistance exercise program"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.90","spread":"1.03"},{"groupId":"OG001","value":"-1.90","spread":"1.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.51","statisticalMethod":"t-test, 2 sided","statisticalComment":"degrees of freedom=40","ciNumSides":"TWO_SIDED"}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"2 years, 3 months","eventGroups":[{"id":"EG000","title":"Individual Exercise Intervention - Cancer Survivors","description":"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)","seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":0,"otherNumAtRisk":22},{"id":"EG001","title":"Dyadic Exercise Intervention - Cancer Survivors","description":"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)","seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":1,"otherNumAtRisk":20},{"id":"EG002","title":"Individual Exercise Intervention - Caregivers","description":"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)","seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":0,"otherNumAtRisk":22},{"id":"EG003","title":"Dyadic Exercise Intervention - Caregivers","description":"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)","seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":1,"otherNumAtRisk":20}],"otherEvents":[{"term":"1 mm segment depression in EKG","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 mm ST segment depression in Lead II at the end of treadmill test, therefore it was immediately terminated. He was not feeling any discomfort or pain, but because of known heart disease, the exercise physiologist thought it would be best.","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":22},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":22},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":20}]},{"term":"Back Pain","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"While exercising, exacerbated her back problems. She has since gone to Chiropractor and massage therapist to help ease pain. Was instructed to stop doing any resistance activity. She will no longer be doing any EXCAP exercises.","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":22},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":22},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":20}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"First, this was a pilot, Phase I trial, and hence had a limited sample size. This study was conducted in a single geographic region. Finally, we analyzed only two time points: baseline and post-intervention."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Charles Kamen","organization":"University of Rochester","email":"charles_kamen@urmc.rochester.edu","phone":"585-275-9958"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D009369","term":"Neoplasms"}]}},"hasResults":true},{"protocolSection":{"identificationModule":{"nctId":"NCT02064335","orgStudyIdInfo":{"id":"ML9981"},"organization":{"fullName":"Universitaire Ziekenhuizen KU Leuven","class":"OTHER"},"briefTitle":"Effects of Physical Activity Coaching on Health and Behaviour Parameters in Diabetic Persons","officialTitle":"Short and Long Term Effects of Physical Activity Coaching on Physical Activity, Physical Fitness, Subjective Well Being and Health in Diabetic Persons"},"statusModule":{"statusVerifiedDate":"2016-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-02"},"primaryCompletionDateStruct":{"date":"2015-08","type":"ACTUAL"},"completionDateStruct":{"date":"2015-09","type":"ACTUAL"},"studyFirstSubmitDate":"2014-02-11","studyFirstSubmitQcDate":"2014-02-13","studyFirstPostDateStruct":{"date":"2014-02-17","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-06-03","lastUpdatePostDateStruct":{"date":"2016-06-06","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Prof Filip Boen","investigatorTitle":"Doctor, Professor","investigatorAffiliation":"Universitaire Ziekenhuizen KU Leuven"},"leadSponsor":{"name":"Universitaire Ziekenhuizen KU Leuven","class":"OTHER"},"collaborators":[{"name":"Dutch Health Care Insurance Board","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"In this project the investigators like to develop a methodology to stimulate more physical activity in inactive diabetic persons by an adapted physical activity program. An individually oriented and medically adapted exercise plan will be set up. Participants will be stimulated to be physically active in the long term, even when the coaching has been finished.\n\nIn a randomized controlled trial the health effects of the coaching are studied in the short and long term. This trial, in addition to a process evaluation by all stakeholders, gives more information about the implementation of the project in Flanders.","detailedDescription":"Being physically active on a regular base makes part of a healthy lifestyle. Research has shown several positive effects of physical activity on physical and mental health. This is also the case in diabetic persons, who are more vulnerable for certain diseases (e.g. cardiovascular diseases).\n\nHowever, a lot of people are not interested and motivated to participate in the local exercise activities. The offer often does not satisfy the different needs of those subjects or the barriers for participating are too high. Diabetic persons are also confronted with these problems. However, physical activity is an important part in the treatment of the disease. There is an urgent need for accessible physical activity programs which motivate diabetic persons to adapt a healthy lifestyle, in the short and long term.\n\nA physical activity coach can set up a physical activity plan, individually adapted and according to the medical needs of a diabetic person. This program is created, based on the principles of need supportive coaching.\n\nIn this project the researchers will investigate the effects of an individually adapted physical activity plan on health and behavior in diabetic persons. The focus of this project will be on the tertiary prevention. For the recruitment of the subjects, there will be a collaboration with a health insurance company in Belgium (CM).\n\nCommunication: Possible participants (cfr database CM) will receive a letter with the invitation of an information session. This information session handles about the importance of being physically active enough in diabetic persons and will present the project where participants are guided by a physical activity coach.\n\nInformation session: In the end of the session, participants can register for the physical activity coaching.\n\nScreening: All General Practitioners in the neighborhood were informed about the project, several weeks before the information sessions took place.\n\nBefore starting the physical activity coaching, participants have to visit their General Practitioner. The doctor will perform a screening and will decide if the subject is able to participate. For this screening, a fixed protocol is set up by the investigators.\n\nSet up: This study is a randomized controlled trial. An intervention (60 subjects) - and control (40 subjects) group will be included in the study. CM will recruit these people by looking in the database (only people with type 2 diabetes and intake of oral antidiabetic medications will be included). The control group will operate as a waiting group. It means that in the first 6 months of the project, the subjects of the control group will only be measured and will not receive any intervention.\n\nFollowing measure moments will take place:\n\nIntervention group: pretesting (start), posttest (after 6 weeks), follow up 1 (after 6 months), follow up 2 (after 12 months).\n\nControl group: baseline 1 (start), baseline 2 (after 6 weeks), pretesting (after 6 months), posttest (after 6 months + 6 weeks).\n\nThe intervention and control group receive an intervention (group sessions + physical activity plan) between pretest and posttest."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["physical activity coach, diabetic persons, health, behaviour"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","CARE_PROVIDER"]}},"enrollmentInfo":{"count":48,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Intervention group","type":"EXPERIMENTAL","description":"Physical activity coaching: Participants will be coached by a professional physical activity coach through individual and group sessions.\n\nIntake: This talk (1 hour) is the start of the coaching. A physical activity plan will be set up, according to the needs and possibilities of the participant. Activities in leisure time and daily physical activity will be included.\n\nGroup sessions: During 5 weeks and one time a week, the subjects will take part in the exercise lessons. About 5 subjects will be in one group and all sessions are supervised by a professional physical activity coach. Activities are walking, Nordic walking and conditional fitness.\n\nEvaluation: After the 5 weeks of group sessions, an evaluation moment will take place between each participant and the physical activity coach. The physical activity plan will be refined.","interventionNames":["Behavioral: Physical activity coaching"]},{"label":"Control group","type":"NO_INTERVENTION","description":"The control group will operate as a waiting group. It means that in the first 6 months of the project, the subjects of the control group will only be measured and will not receive any intervention."}],"interventions":[{"type":"BEHAVIORAL","name":"Physical activity coaching","description":"Comparison the effects of physical activity coaching and no coaching on different health parameters in diabetic subjects","armGroupLabels":["Intervention group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Weight","description":"Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write weight","timeFrame":"Change in weight between different time points: pre, post (6 weeks), folluw up (6 months), follow up 2 (12 months)"},{"measure":"Psychological parameters","description":"Psychological parameters are determined by psychological questionnaires. The researchers will investigate motivation, well being, self-efficacy and social support.","timeFrame":"change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)"},{"measure":"Blood pressure","description":"Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write blood pressure","timeFrame":"change in blood pressure between different time points: pre, post (6 weeks), follow-up 1 (6 months), follow-up 2 (12 months)"},{"measure":"HbA1c","description":"Health parameters are evaluated by the General Practitioner. All subjects receive a little notebook where the physician can write down HbA1C value, taken by a blood sample","timeFrame":"change in HbA1c between different time points: pre, post (6 weeks), follow up 1 (6 months), follow up 2 (12 months)"},{"measure":"Sedentary behavior","description":"Subjective sedentary behavior is determined by a questionnaire.","timeFrame":"change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)"},{"measure":"Physical activity","description":"Level of physical activity is determined by means of an objective physical activity monitor which has to be carried on the upper arm for 1 week.","timeFrame":"change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)"},{"measure":"Physical fitness","description":"Physical fitness is determined by means of the 6 minutes walking test.","timeFrame":"change in parameters between different time points: pretest, posttest (6 weeks), follow up (6 months), follow up 2 (12 months)"}]},"eligibilityModule":{"eligibilityCriteria":"In this project, there is a collaboration with a health insurance company in Flanders (CM). CM will use a database of possible participants for the communication of the project.\n\nParticipants have to meet the following inclusion criteria:\n\n* Suffering from diabetes type 2, with minimal 3 months of intake of oral antidiabetics.\n* Member of CM\n* Owner of a Global Medical File\n* Above 18 years of age\n\nExclusion Criteria:\n\nIn this project, we aim for inactive diabetic subjects. Persons who have more than 30 minutes of moderate exercise a day, will be excluded","healthyVolunteers":false,"sex":"ALL","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Filip Boen, Prof","affiliation":"KU Leuven","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"KU Leuven","city":"Leuven","state":"Vlaams Brabant","zip":"3000","country":"Belgium","geoPoint":{"lat":50.87959,"lon":4.70093}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D001519","term":"Behavior"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT01228435","nctIdAliases":["NCT01119495"],"orgStudyIdInfo":{"id":"10-134"},"organization":{"fullName":"Massachusetts General Hospital","class":"OTHER"},"briefTitle":"IPI-504 in NSCLC Patients With ALK Translocations","officialTitle":"A Phase II Study of IPI-204, A Novel Hsp90 Inhibitor in NSCLC Patients With ALK Translocations"},"statusModule":{"statusVerifiedDate":"2017-10","overallStatus":"TERMINATED","whyStopped":"slow accrual","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-10"},"primaryCompletionDateStruct":{"date":"2012-02","type":"ACTUAL"},"completionDateStruct":{"date":"2012-02","type":"ACTUAL"},"studyFirstSubmitDate":"2010-10-25","studyFirstSubmitQcDate":"2010-10-25","studyFirstPostDateStruct":{"date":"2010-10-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-05-28","resultsFirstSubmitQcDate":"2013-08-18","resultsFirstPostDateStruct":{"date":"2013-10-23","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-10-28","lastUpdatePostDateStruct":{"date":"2017-12-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Lecia V. Sequist","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Massachusetts General Hospital"},"leadSponsor":{"name":"Massachusetts General Hospital","class":"OTHER"},"collaborators":[{"name":"Dana-Farber Cancer Institute","class":"OTHER"},{"name":"Infinity Pharmaceuticals, Inc.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"IPI-504 blocks a protein that is in cancer cells and is also in normal cells. This protein is called Heat Shock Protein-90 (Hsp90). Hsp90 helps protect certain other proteins from being destroyed by cells. These proteins can mutate to give off signals that allow cancer cells to keep growing. By blocking the function of Hsp90, we hope that the cancer cell will block the mutated protein and cause the cancer cells to die. This drug have been used in other research studies and in the laboratory and information from those other research studies suggests that thsi drug may help to treat lung cancer with ALK mutations. In this research study, we are looking to see what effects IPI-504 has in patients with lung cancer who have an ALK mutation.","detailedDescription":"* Participants will receive the study drug (IPI-504) twice weekly for two weeks followed by 10 days without study treatment. This 3-week period is called a cycle. Participants will receive a total of 4 doses per cycle. On the days the participant receives study drug, they will come to the clinic and be given the IPI-504 by being. Participants will continue to receive study drug for additional cycles as long as they are benefiting from it and do not experience any severe side effects.\n* Participants will have CT scans to assess the size and location of their tumor. They may also have a PET scan or a combination of PET/CT scans. Imaging will be done at the beginning of treatment and every five to six weeks while on study to assess how the tumor is responding to IPI-504.\n* The following tests and procedures will be done on the prior to the first dose of IPI-504: physical examination, vital signs, routine blood tests, EKGs, serum or urine pregnancy test (for women of child-bearing potential).\n* After the first dose of IPI-504, the following tests and procedures will be done: EKGs, vital signs (pulse only).\n* For all other visit days throughout the study, the following exams, tests and procedures will be done: physical examination, vital signs, blood tests, tumor imaging assessments, MRI of the brain (if applicable), review of medications and answer questions about any side effects or changes in health.\n* After the final dose of study drug the following tests and procedures will be done within 30 days: physical examination, ECOG Performance status, blood tests, review of medications and answer questions about any side effects of changes in health."},"conditionsModule":{"conditions":["Lung Cancer","Stage IIIb Lung Cancer","Stage IV Lung Cancer"],"keywords":["NSCLC","IPI-504","ALK translocation","Hsp90 inhibitor"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":3,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"ALK-inhibitor naive","type":"EXPERIMENTAL","description":"No prior exposure to ALK-inhibitor","interventionNames":["Drug: IPI-504"]},{"label":"ALK-inhibitor pre-treated","type":"EXPERIMENTAL","description":"Prior exposure to ALK inhibitor","interventionNames":["Drug: IPI-504"]}],"interventions":[{"type":"DRUG","name":"IPI-504","description":"Given intravenously twice weekly for 2 weeks followed by 10 day off treatment","armGroupLabels":["ALK-inhibitor naive","ALK-inhibitor pre-treated"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Response Rate","description":"The response rate was defined as the number of patients achieving a RECIST 1.0 defined response divided by the number of patients treated and was to be calculated separately for each arm. A response by RECIST criteria means that the pre-defined target lesions (sum of the longest diameters) had to decrease by 30% or more and this response needed to be confirmed on a second scan at least 4 weeks later.","timeFrame":"2 years"}],"secondaryOutcomes":[{"measure":"Number of Participants With Treatment-Emergent Adverse Events","description":"Further document the safety of this regimen. Treatment-emergent adverse events will be summarized by MedDRA coding terms and separate tabulations will be produced for treatment-emergent adverse events, treatment-emergent serious adverse events, discontinuations due to adverse events, and treatment-emergent events of at least Grade 3 severity. A treatment-emergent adverse event is defined as an adverse event that was deemed to be related to the study intervention.","timeFrame":"2 years"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients must have pathologically confirmed diagnosis of Stage IIIb (with malignant pleural or pericardial effusion), Stage IV, or recurrent NSCLC.\n* Patients must have demonstrated ALK mutation\n* There is no requirement for a minimum or maximum number of prior therapies, however, patients must have refused, be intolerant to or already received at least on standard systemic therapy for lung cancer\n* Measureable disease by RECIST criteria. If a patient has received radiation therapy then measurable disease must be outside the radiation field.\n* 18 years of age or older\n* Life expectancy of at least 3 months\n* ECOG performance status of 0-2\n* Baseline studies for determining eligibility, except for ALK mutation status, must be completed within 30 days of first study dose.\n* CT scan must be completed within 28 days prior to first study dose\n* Women of child-bearing potential (WBCP) defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months must have a negative serum or urine pregnancy test within 2 weeks of first study dose\n* All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study\n\nExclusion Criteria:\n\n* Treatment for NSCLC with any approved or investigational product within 2 weeks of Cycle 1, Dose 1 for any small molecule therapy; within 4 weeks of Cycle 1, Dose 1 for any biologic or any conventional chemotherapy.\n* Concurrent radiation therapy is not permitted\n* Use of a medication or food that is clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to Cycle 1, Dose 1\n* Laboratory values as outlined in the protocol\n* Baseline QT corrected using Fridericia's correction method (QTcf) \\> 470ms. Patients with left bundle branch block are eligible regardless of QTcf, as long as serum troponin is normal or undetectable\n* Presence of active infection or systemic use of antibiotics within 72 hours of treatment\n* Significant co-morbid condition or disease which in the judgment of the investigator would place the patient at undue risk or interfere with the study\n* Women who are pregnant or lactating\n* Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor\n* Sinus bradycardia secondary to intrinsic conduction system disease. Patients with sinus bradycardia secondary to pharmacologic treatment may enroll if withdrawal of the treatment results in normalization of the resting heart rate to within normal limits\n* Active keratitis or keratoconjunctivitis\n* Alkaline phosphatase \\> 1.5 x ULN. Patients with bone metastases and an alkaline phosphatase level \\> 1/5 x ULN and less than or equal to 3 x ULN are eligible if they meet the criteria outlined in the protocol\n* Prothrombin time (PT) and partial thromboplastin time (PTT) \\> 1.5 x ULN unless the patient is receiving warfarin. If the patient is receiving warfarin, the international normalized ratio must be within therapeutic range\n* Patients with clinically active brain metastasis or an uncontrolled seizure disorder, ongoing spinal cord compression, or carcinomatous meningitis. Patients with clinically stable brain metastasis are eligible.\n* Patients with prior hepatic resection or hepatic-directed therapy","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Lecia V. Sequist, MD, MPH","affiliation":"Massachusetts General Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","zip":"02115","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","zip":"02214","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study was closed to accrual after 3 patients were enrolled over a 1-year period. It was determined that there were too many competing protocols and completion of the study as designed was not feasible.","recruitmentDetails":"Patients were recruited from the oncology clinic at Mass General from 6/10/10 to 9/26/11.","groups":[{"id":"FG000","title":"ALK-inhibitor Naive","description":"Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days."},{"id":"FG001","title":"ALK-inhibitor Pre-treated","description":"Patients in this arm had prior exposure to an ALK inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"ALK-inhibitor Naive","description":"No prior exposure to ALK-inhibitor"},{"id":"BG001","title":"ALK-inhibitor Pre-treated","description":"Prior exposure to ALK inhibitor"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"79"},{"groupId":"BG001","value":"67.5","spread":"14.8"},{"groupId":"BG002","value":"71.3","spread":"12.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Response Rate","description":"The response rate was defined as the number of patients achieving a RECIST 1.0 defined response divided by the number of patients treated and was to be calculated separately for each arm. A response by RECIST criteria means that the pre-defined target lesions (sum of the longest diameters) had to decrease by 30% or more and this response needed to be confirmed on a second scan at least 4 weeks later.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"2 years","groups":[{"id":"OG000","title":"ALK-inhibitor Naive","description":"Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days."},{"id":"OG001","title":"ALK-inhibitor Pre-treated","description":"Patients in this arm had received prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment-Emergent Adverse Events","description":"Further document the safety of this regimen. Treatment-emergent adverse events will be summarized by MedDRA coding terms and separate tabulations will be produced for treatment-emergent adverse events, treatment-emergent serious adverse events, discontinuations due to adverse events, and treatment-emergent events of at least Grade 3 severity. A treatment-emergent adverse event is defined as an adverse event that was deemed to be related to the study intervention.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"2 years","groups":[{"id":"OG000","title":"ALK-inhibitor Naive","description":"Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days."},{"id":"OG001","title":"ALK-inhibitor Pre-treated","description":"Patients in this arm had received prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"classes":[{"title":"Treatment-emergent adverse events","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Treatment-emergent serious adverse events","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"discontinuations due to adverse events","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"treatment-emergent events ≥ grade 3","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"1 Year","eventGroups":[{"id":"EG000","title":"ALK-inhibitor Naive","description":"No prior exposure to ALK-inhibitor","deathsNumAffected":0,"deathsNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"otherNumAffected":1,"otherNumAtRisk":1},{"id":"EG001","title":"ALK-inhibitor Pre-treated","description":"Prior exposure to ALK inhibitor","deathsNumAffected":0,"deathsNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"otherNumAffected":2,"otherNumAtRisk":2}],"otherEvents":[{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2}]},{"term":"Arthralgias","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2}]},{"term":"Elevated AST","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2}]},{"term":"Anemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"The study was unable to accrue sufficient participants due to competing studies. Therefore, the study results are not sufficiently powered to draw any conclusions."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Lecia Sequist","organization":"Massachusetts General Hospital","email":"lvsequist@partners.org","phone":"617-726-7812"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D008175","term":"Lung Neoplasms"}],"ancestors":[{"id":"D012142","term":"Respiratory Tract Neoplasms"},{"id":"D013899","term":"Thoracic Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D008171","term":"Lung Diseases"},{"id":"D012140","term":"Respiratory Tract Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C112765","term":"tanespimycin"}]}},"hasResults":true},{"protocolSection":{"identificationModule":{"nctId":"NCT03400735","orgStudyIdInfo":{"id":"NEU-08.16"},"organization":{"fullName":"Neutec Ar-Ge San ve Tic A.Ş","class":"INDUSTRY"},"briefTitle":"Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults","officialTitle":"Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-acquired Pneumonia (CAP) in Adults"},"statusModule":{"statusVerifiedDate":"2018-01","overallStatus":"UNKNOWN","lastKnownStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-11-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-04-01","type":"ESTIMATED"},"completionDateStruct":{"date":"2018-08-01","type":"ESTIMATED"},"studyFirstSubmitDate":"2016-10-03","studyFirstSubmitQcDate":"2018-01-09","studyFirstPostDateStruct":{"date":"2018-01-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-01-09","lastUpdatePostDateStruct":{"date":"2018-01-17","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Neutec Ar-Ge San ve Tic A.Ş","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients."},"conditionsModule":{"conditions":["Acute Exacerbation of Chronic Bronchitis","Community-Acquired Pneumoniae"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":50,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets","type":"EXPERIMENTAL","interventionNames":["Drug: Cefdinir 300Mg Capsule"]},{"label":"Cefdinir 300 mg Capsules","type":"ACTIVE_COMPARATOR","interventionNames":["Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets"]}],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Cefdinir/clavulanic acide 300/125 mg film-coated tablets","description":"Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.","armGroupLabels":["Cefdinir 300 mg Capsules"],"otherNames":["Fullcef Plus"]},{"type":"DRUG","name":"Cefdinir 300Mg Capsule","description":"Cefdinir is used as comparator","armGroupLabels":["Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"The comparison of clinical success rates according to laboratory parameters","timeFrame":"7-10 days"}],"secondaryOutcomes":[{"measure":"The comparison of remission or relief of inflammation according to laboratory parameters","timeFrame":"7-10 days"},{"measure":"The comparison of patient satisfaction according to satisfaction questionnaire","timeFrame":"7-10 days"},{"measure":"The comparison of adverse events","timeFrame":"7-10 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* The diagnosis of chronic bronchitis\n* The diagnosis of community-acquired pneumoniae\n* FEV1 value = 30-80%\n* The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)\n* Oxygen saturation \\< 90%\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Allergy against to penicillin or cephalosporins\n* Renal impairment\n* Active hepatic disease\n* Antibiotic use except study drugs\n* Immunosuppressive therapy before 6 months of study initiation\n* Use of probenecid like drugs","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Neutec R&D","role":"CONTACT","phone":"00902128505102","email":"iremkaraman@neutecrdc.com"}],"locations":[{"facility":"Erzincan University Mengücek Gazi Training and Research Hospital","status":"RECRUITING","city":"Erzincan","country":"Turkey (Türkiye)","contacts":[{"name":"Edhem Ünver, Assoc Prof","role":"CONTACT"},{"name":"Edhem Ünver, Assoc Prof","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":39.73919,"lon":39.49015}},{"facility":"Yedikule Chest Diseases Training and Research Hospital","status":"RECRUITING","city":"Istanbul","country":"Turkey (Türkiye)","contacts":[{"name":"Sedat Altın, Prof Dr","role":"CONTACT"},{"name":"Sedat Altın, Prof Dr","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Gülşah Günlüoğlu, Assoc Prof","role":"SUB_INVESTIGATOR"},{"name":"Nurdan Kalkan, MD","role":"SUB_INVESTIGATOR"}],"geoPoint":{"lat":41.01384,"lon":28.94966}}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"interventionBrowseModule":{"meshes":[{"id":"D000077525","term":"Cefdinir"}],"ancestors":[{"id":"D002511","term":"Cephalosporins"},{"id":"D047090","term":"beta-Lactams"},{"id":"D007769","term":"Lactams"},{"id":"D000577","term":"Amides"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D013843","term":"Thiazines"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT04991935","orgStudyIdInfo":{"id":"CC-93538-EE-002"},"secondaryIdInfos":[{"id":"2020-004335-24","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Celgene","class":"INDUSTRY"},"briefTitle":"Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis","officialTitle":"A Phase 3, Multicenter, Multinational, Open-Label Extension Study to Evaluate the Long-Term Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis"},"statusModule":{"statusVerifiedDate":"2026-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-08-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-08-14","type":"ACTUAL"},"completionDateStruct":{"date":"2025-08-14","type":"ACTUAL"},"studyFirstSubmitDate":"2021-07-28","studyFirstSubmitQcDate":"2021-07-28","studyFirstPostDateStruct":{"date":"2021-08-05","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-01-07","resultsFirstSubmitQcDate":"2026-03-17","resultsFirstPostDateStruct":{"date":"2026-04-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-03-17","lastUpdatePostDateStruct":{"date":"2026-04-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Celgene","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies."},"conditionsModule":{"conditions":["Eosinophilic Esophagitis"],"keywords":["Eosinophilic Esophagitis","CC-93538","RPC4046","Adult","Adolescent","Gastrointestinal Diseases","Esophagitis","Gastroenteritis","Eosinophils","Eosinophilia","Esophageal Diseases","Allergic Diseases","Antibody, Monoclonal","Hypersensitivity","Immunologic factors","Physiological Effects of Drugs","Cendakimab"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":367,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Administration of CC-93538","type":"EXPERIMENTAL","description":"Participants are administered CC-93538 dose subcutaneously once weekly","interventionNames":["Drug: CC-93538"]}],"interventions":[{"type":"DRUG","name":"CC-93538","description":"CC-93538","armGroupLabels":["Administration of CC-93538"],"otherNames":["BMS-986355","cendakimab"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAE)","description":"An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.","timeFrame":"From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)"},{"measure":"Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters","description":"Blood samples were collected to assess clinical significant shifts in laboratory parameters. \"Normal to High\" means at baseline the value is Normal and maximum post baseline value is High.","timeFrame":"From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)"},{"measure":"Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters","description":"SBP (Systolic blood Pressure) and DBP (Diastolic Blood Pressure) measured in mmHg and Heart rates measured in beats per minute.","timeFrame":"From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)"}],"secondaryOutcomes":[{"measure":"Number of Participants With Incidence of Treatment Emergent Anti-CEN Antibodies","description":"Blood samples were collected to assess Anti-CEN antibodies. Post-Baseline ADA Positive define as 1) at least 1 positive post-baseline given baseline is negative or missing; or 2) at least 1 positive post-baseline with titer \\>= 4-fold baseline titer given positive baseline.","timeFrame":"From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Previously participated in prior clinical study CC-93538-EE-001 and either:\n\n  1. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR\n  2. Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR\n  3. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR\n  4. Subject completed Week 48 of the Maintenance Phase\n* OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments through the end of treatment visit\n* Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies.\n* Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the Investigator.\n* Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.\n\nExclusion Criteria:\n\n* Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.\n* Active Helicobacter pylori infection or esophageal varices.\n* Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.\n* Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study.\n* Received an investigational product, other than that administered in the CC-93538-EE-001 or CC-93538-DDI-001 studies, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). 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We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication"},"pointOfContact":{"title":"Bristol-Myers Squibb Study Director","organization":"Bristol-Myers Squibb","email":"Clinical.Trials@bms.com","phone":"Please email"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2023-06-30","uploadDate":"2025-12-19T01:51","filename":"Prot_SAP_000.pdf","size":4296560}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2026-01-23","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D057765","term":"Eosinophilic Esophagitis"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D004941","term":"Esophagitis"},{"id":"D005759","term":"Gastroenteritis"},{"id":"D004802","term":"Eosinophilia"},{"id":"D004935","term":"Esophageal Diseases"},{"id":"D006967","term":"Hypersensitivity"}],"ancestors":[{"id":"D004066","term":"Digestive System Diseases"},{"id":"D007960","term":"Leukocyte Disorders"},{"id":"D006402","term":"Hematologic Diseases"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"},{"id":"D006969","term":"Hypersensitivity, Immediate"},{"id":"D007154","term":"Immune System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C000625155","term":"cendakimab"}]}},"hasResults":true},{"protocolSection":{"identificationModule":{"nctId":"NCT01045135","orgStudyIdInfo":{"id":"Pelvic floor ultrasound"},"organization":{"fullName":"University Hospital, Akershus","class":"OTHER"},"briefTitle":"The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound","officialTitle":"The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound"},"statusModule":{"statusVerifiedDate":"2019-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-12"},"primaryCompletionDateStruct":{"date":"2012-10","type":"ACTUAL"},"completionDateStruct":{"date":"2013-06","type":"ACTUAL"},"studyFirstSubmitDate":"2010-01-07","studyFirstSubmitQcDate":"2010-01-07","studyFirstPostDateStruct":{"date":"2010-01-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-01-15","resultsFirstSubmitQcDate":"2019-02-14","resultsFirstPostDateStruct":{"date":"2019-02-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-02-14","lastUpdatePostDateStruct":{"date":"2019-02-18","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Marie Ellstrøm Engh","investigatorTitle":"M.D. PhD","investigatorAffiliation":"University Hospital, Akershus"},"leadSponsor":{"name":"University Hospital, Akershus","class":"OTHER"},"collaborators":[{"name":"The Research Council of Norway","class":"OTHER"},{"name":"South-Eastern Norway Regional Health Authority","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. The investigators are therefore in urgent need of better tools to diagnose these injuries. Having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. It also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. The investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery. At the Department of Obstetrics and Gynaecology, Akershus University Hospital there are approximately 4500 deliveries annually and 1500 women are giving birth for the first time.\n\nChallenges: The invitation to participate in the study will be given to all women expecting their first child fulfilling inclusion criteria. The biggest challenges in the project will be logistical. To be able to inform, recruit and follow women having their first child is a challenge in it self.\n\nApplications: If it is possible to identify a risk group for pelvic floor injuries before delivery, it might be ethical to recommend a prophylactic caesarean section to avoid disabling incontinence and prolapse later in life."},"conditionsModule":{"conditions":["Obstetric; Injury Pelvic Floor"],"keywords":["Pelvic organ prolapse","Levator hiatus","3 and 4 dimensional ultrasound"]},"designModule":{"studyType":"OBSERVATIONAL","designInfo":{"observationalModel":"COHORT","timePerspective":"PROSPECTIVE"},"enrollmentInfo":{"count":300,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"first time delivery","description":"Women giving birth to their first child"}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37.","description":"3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes","timeFrame":"21 weeks and 37 weeks of gestation"},{"measure":"Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37","description":"3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.","timeFrame":"21 weeks and 37 weeks of gestation"},{"measure":"Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound","description":"3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.","timeFrame":"gestational week 21 and 37"}],"secondaryOutcomes":[{"measure":"Change in Bladder Neck Mobility Measured Via 3D Ultrasound","description":"3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Bladder neck mobility was measured at gestational week 21 and 37, at rest and during Valsalva maneuver . The change in mobility from rest to valsalva was computed between the two different timepoints.","timeFrame":"gestational week 21 and 37"}],"otherOutcomes":[{"measure":"Health Related Complaints","timeFrame":"20 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Women giving birth to their first child at Akershus University Hospital, Norway\n* Must understand spoken and written Norwegian\n\nExclusion Criteria:\n\n* Previous pregnancy of more than 16 weeks\n* Serious illness mother or child\n* Birth before pregnancy week 32","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"50 Years","stdAges":["ADULT"],"studyPopulation":"Women giving birth to their first child at Akershus University Hospital, Norway","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"overallOfficials":[{"name":"Marie E Engh, M.D., PhD","affiliation":"University Hospital, Akershus","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Akershus University Hospital","city":"Lørenskog","state":"Akershus","country":"Norway"}]},"referencesModule":{"references":[{"pmid":"25100734","type":"DERIVED","citation":"Bo K, Hilde G, Staer-Jensen J, Siafarikas F, Tennfjord MK, Engh ME. Does general exercise training before and during pregnancy influence the pelvic floor \"opening\" and delivery outcome? A 3D/4D ultrasound study following nulliparous pregnant women from mid-pregnancy to childbirth. Br J Sports Med. 2015 Feb;49(3):196-9. doi: 10.1136/bjsports-2014-093548. Epub 2014 Aug 6."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"January 2010 - july 2011","groups":[{"id":"FG000","title":"First Time Delivery","description":"Women giving birth to their first child"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"300"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"274"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"First Time Delivery","description":"Women giving birth to their first child"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"300"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"300"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.6","spread":"4.2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"300"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Norway","categories":[{"measurements":[{"groupId":"BG000","value":"300"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Levator Hiatus Area at Rest Measured Via 3-dimensional Ultrasound at Gestational Week 21 and 37.","description":"3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"21 weeks and 37 weeks of gestation","groups":[{"id":"OG000","title":"Primiparous Women Levator Hiatus Area During Valsalva Maneuver","description":"Women giving birth to their first child"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"1.7"}]}]}]},{"type":"PRIMARY","title":"Change in Levator Hiatus Area at Contraction Measured Via 3D Ultrasound at Gestational Week 21 and 37","description":"3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"21 weeks and 37 weeks of gestation","groups":[{"id":"OG000","title":"Primiparous Women Bladder Neck Mobility Rest to Valsalva Maneu","description":"Women giving birth to their first child"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.2","spread":"1.2"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Health Related Complaints","reportingStatus":"NOT_POSTED","timeFrame":"20 months","denomUnitsSelected":"Participants"},{"type":"PRIMARY","title":"Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D Ultrasound","description":"3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 21 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"gestational week 21 and 37","groups":[{"id":"OG000","title":"Primiparous Women Levator Hiatus Area","description":"Women giving birth to their first child"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.3","spread":"3.5"}]}]}]},{"type":"SECONDARY","title":"Change in Bladder Neck Mobility Measured Via 3D Ultrasound","description":"3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Bladder neck mobility was measured at gestational week 21 and 37, at rest and during Valsalva maneuver . The change in mobility from rest to valsalva was computed between the two different timepoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"gestational week 21 and 37","groups":[{"id":"OG000","title":"Primiparous Women Bladder Neck Mobility Rest to Valsalva Maneu","description":"Women giving birth to their first child"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"274"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.11","spread":"0.8"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"Serious and other (non-serious) adverse effects were not collected/assessed, as this was an observational cohort study with no intervention.","eventGroups":[{"id":"EG000","title":"First Time Delivery","description":"Women giving birth to their first child","seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"We did not examine the women before they were pregnant and therefore do not have information about how the pelvic floor was before pregnancy.\n\nIt is therefore possible that we have underestimated the change happening to the levator hiatus."},"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr.Jette Stær-Jensen, Dr. Franziska Siafarikas","organization":"Akershus University Hospital","email":"jett@ahus.no","phone":"+47-6796000"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D056887","term":"Pelvic Organ Prolapse"}],"ancestors":[{"id":"D011391","term":"Prolapse"},{"id":"D020763","term":"Pathological Conditions, Anatomical"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]}},"hasResults":true},{"protocolSection":{"identificationModule":{"nctId":"NCT01262235","orgStudyIdInfo":{"id":"TKM-PLK1-001"},"organization":{"fullName":"Arbutus Biopharma Corporation","class":"INDUSTRY"},"briefTitle":"A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients","officialTitle":"A Phase 1/2 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors"},"statusModule":{"statusVerifiedDate":"2019-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-12"},"primaryCompletionDateStruct":{"date":"2015-07","type":"ACTUAL"},"completionDateStruct":{"date":"2015-08","type":"ACTUAL"},"studyFirstSubmitDate":"2010-12-15","studyFirstSubmitQcDate":"2010-12-16","studyFirstPostDateStruct":{"date":"2010-12-17","type":"ESTIMATED"},"dispFirstSubmitDate":"2019-01-14","dispFirstSubmitQcDate":"2019-01-14","dispFirstPostDateStruct":{"date":"2019-01-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-01-14","lastUpdatePostDateStruct":{"date":"2019-01-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Arbutus Biopharma Corporation","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors."},"conditionsModule":{"conditions":["Cancer","Neuroendocrine Tumors","NET","Adrenocortical Carcinoma","ACC"],"keywords":["Solid tumor","Non-Hodgkin's Lymphoma","Hodgkin's Disease","Neuroendocrine tumors (NET)","Adrenocortical carcinoma (ACC)","Carcinoid"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1","PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":68,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"TKM-080301","type":"EXPERIMENTAL","interventionNames":["Drug: TKM-080301"]}],"interventions":[{"type":"DRUG","name":"TKM-080301","description":"Repeat dose IV infusion.","armGroupLabels":["TKM-080301"],"otherNames":["PLK1 SNALP","TKM-PLK1"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Safety and tolerability of treatment with TKM-080301","timeFrame":"6 months"},{"measure":"Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301","timeFrame":"6 months"}],"secondaryOutcomes":[{"measure":"Characterize the pharmacokinetics of TKM-080301","timeFrame":"2 months"},{"measure":"Assess preliminary evidence of anti-tumor activity","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-Hodgkin's lymphoma or Hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist. For the Neuroendocrine (NET) and adrenocortical carcinoma (ACC) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per RECIST 1.1) NET or ACC tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy.\n* Patient has an ECOG performance status of 0 - 1,\n* Patient has adequate hematologic, hepatic and renal function,\n* Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV),\n* Patients must have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n* Unresolved toxicities (\\> Grade 1) of previous chemotherapy,\n* Patients with primary tumors of the central nervous system (CNS),\n* Prophylactic hematologic growth factors administered \\</= 2 weeks prior to start of therapy,\n* Patient has history of or existing clinically significant cardiovascular disease,\n* Patient has a history of clinically significant asthma or COPD requiring daily medication within the last 6 months,\n* Patient has a seizure disorder not controlled on medication,\n* Patient has a known or suspected viral, parasitic, or fungal infection,\n* Patient has known hypersensitivity or previous severe reactions to oligonucleotide- or lipid-based products, including liposomal drug products and phospholipid-based products,\n* Patient has been treated with any investigational drugs, biologics, or devices within 28 days prior to study treatment.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Mark Kowalski, MD","affiliation":"Tekmira Pharmaceuticals","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Scottsdale Healthcare Research Institute","city":"Scottsdale","state":"Arizona","zip":"85258","country":"United States","geoPoint":{"lat":33.50921,"lon":-111.89903}},{"facility":"Mayo Clinic Arizona","city":"Scottsdale","state":"Arizona","zip":"85259","country":"United States","geoPoint":{"lat":33.50921,"lon":-111.89903}},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","zip":"33612","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"University of Iowa/Holden Comprehensive Cancer Center","city":"Iowa City","state":"Iowa","zip":"52242","country":"United States","geoPoint":{"lat":41.66113,"lon":-91.53017}},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","zip":"02215","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"University of Michigan Comprehensive Cancer Center","city":"Ann Arbor","state":"Michigan","zip":"48109-2800","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","zip":"55905","country":"United States","geoPoint":{"lat":44.02163,"lon":-92.4699}},{"facility":"Westchase Oncology Center","city":"Houston","state":"Texas","zip":"77042","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D009369","term":"Neoplasms"},{"id":"D018358","term":"Neuroendocrine Tumors"},{"id":"D018268","term":"Adrenocortical Carcinoma"},{"id":"D008228","term":"Lymphoma, Non-Hodgkin"},{"id":"D006689","term":"Hodgkin Disease"},{"id":"D002276","term":"Carcinoid Tumor"}],"ancestors":[{"id":"D017599","term":"Neuroectodermal Tumors"},{"id":"D009373","term":"Neoplasms, Germ Cell and Embryonal"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009380","term":"Neoplasms, Nerve Tissue"},{"id":"D000230","term":"Adenocarcinoma"},{"id":"D002277","term":"Carcinoma"},{"id":"D009375","term":"Neoplasms, Glandular and Epithelial"},{"id":"D000306","term":"Adrenal Cortex Neoplasms"},{"id":"D000310","term":"Adrenal Gland Neoplasms"},{"id":"D004701","term":"Endocrine Gland Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D000303","term":"Adrenal Cortex Diseases"},{"id":"D000307","term":"Adrenal Gland Diseases"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D008223","term":"Lymphoma"},{"id":"D008232","term":"Lymphoproliferative Disorders"},{"id":"D008206","term":"Lymphatic Diseases"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"},{"id":"D007160","term":"Immunoproliferative Disorders"},{"id":"D007154","term":"Immune System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"C000708202","term":"TKM-080301"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT05599035","orgStudyIdInfo":{"id":"sleep disorder in parkinson"},"organization":{"fullName":"Assiut University","class":"OTHER"},"briefTitle":"Sleep Disorder in Parkinson Disease and rTMS","officialTitle":"Sleep Disorder in Parkinson Disease and rTMS"},"statusModule":{"statusVerifiedDate":"2024-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-05-02","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-01-05","type":"ACTUAL"},"completionDateStruct":{"date":"2024-02-04","type":"ACTUAL"},"studyFirstSubmitDate":"2022-10-25","studyFirstSubmitQcDate":"2022-10-25","studyFirstPostDateStruct":{"date":"2022-10-31","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-03-31","lastUpdatePostDateStruct":{"date":"2024-04-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Eman M. Khedr","investigatorTitle":"principal investigator","investigatorAffiliation":"Assiut University"},"leadSponsor":{"name":"Assiut University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The crude prevalence rate of Parkinson's disease in Upper Egypt governorates ranging from 557-436/100,000 (Assiut and Qena governorates respectively) which was one of the highest prevalence of PD around the world .Parkinson's disease patients report having complaints of disrupted sleep anywhere from 60 to 98 %. This is one of the most common non-motor symptoms, and it is a substantial contributor to the diminished quality of life associated with Parkinson's disease. PD patients have poor sleep maintenance and fragmentation (Comella 2007, Khedr et al. 2013). Khedr et al (2013) found that; 78.6% out of 112 patients with PD had sleep disturbances with the commonest complaint being difficulty getting to sleep at night or staying asleep (46.4%) followed by vivid nightmares and night terrors (27.7%). In other studies, 80-90% of PD patients have had sleep difficulty with virtually all patients having symptoms at some time in the course of the disease .","detailedDescription":"The pathophysiology of PD sleep problems is unclear. Degeneration of major sleep control centers in the brainstem is a leading factor . In addition to dopaminergic medication, nocturnal akinesia, depression and restless legs syndrome, may contribute to sleep disturbances in Parkinson's disease .Previous studies linked dopaminergic impairment in the hypothalamus to sleep disturbances in PD.\n\nRepetitive transcranial magnetic stimulation (rTMS), non-invasive magnetic stimulation of the cerebral cortex is utilized as non-pharmacological therapy in PD with varying degree of results on the motor symptoms. rTMS has also an impact sleep organization in healthy people both during and before sleep.\n\nThe effects of rTMS on sleep have been studied in PD in two previous studies, both of which applied HF over either the motor or parietal cortex. They reported improvement in sleep by subjective and objective measures. However, one of the studies found that the improvement seen on polysomnographic (PSG), the other study found improvement in actigraphic recordings. One sham-controlled trial of the effect of rTMS on sleep in patients with PD also revealed substantial placebo-related improvement on subjective questionnaires (i.e., Parkinson Disease Sleep Scale, Hamilton Depression Rating Scale, Unified Parkinson Disease Rating Scale), with sleep improvement found equally between active and sham stimulation groups . Interestingly, in this trial rTMS showed no changes recorded in actigraphy parameters.\n\nHuang et al. 2018 examined the effect of LF rTMS over the parietal cortex in patients who had generalized anxiety disorder with comorbid insomnia and assessed Hamilton Rating Scale for Anxiety (HRS-A), and PSQI. In their trial, PSQI improvements were seen in active rTMS but not in sham stimulation, making this the second trial of a sham-controlled trial without pronounced placebo effect. Additionally, a positive correlation was seen between improvement in the HRSA anxiety scores and PSQI scores which could suggest that sleep improvement was associated with anxiety improvement. It was not known whether the improvement seen in insomnia and anxiety was independent, and whether rTMS really had an intrinsic role in sleep (Rosenquist and McCall 2019) In another study, Jiang et al. 2013 evaluated the effect of rTMS versus medication versus cognitive behavioral therapy in chronic insomnia. They performed the assessments with PSG and PSQI. Based on PSG findings, rTMS only showed superior improvement in stage 3 and rapid-eye movement sleep.\n\nAccording to the above mentioned studies rTMS seems to have the ability to improve sleep disorders.\n\nThe literature in this area remains scarce, with few randomized clinical trials on rTMS and insomnia. Available studies have found mixed results, with some studies reporting subjective sleep improvement while objective improvement is less consistent.\n\nDespite the significant prevalence of sleep disturbances in PD patients, rTMS's influence on sleep has not been objectively evaluated. To date, the exact mechanism by which rTMS is thought to influence sleep has yet to be fully explained particulary in PD.\n\nThe present study aimed to analyse the sleep disturbance in PD patients compared with normal volunteers and to objectively evaluate if rTMS has impact on sleep disorders or not in patients with PD."},"conditionsModule":{"conditions":["Sleep Disorder","Parkinson Disease"],"keywords":["sleep disorder Parkinson disease","rTMS"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"This study included 30 PD patients and 20 normal volunteers' age and sex matched that were recruited .The diagnosis of PD was done according to UK Brain bank Criteria for diagnosis of PD. Out of them we selected only patients with sleep disturbance according to Self-reported questionnaire for non-motor symptoms (sleep disturbance section; Question 23, 24, 25, 26 as follow 23-Difficulty getting to sleep at night or staying asleep at night 24. Intense, vivid dreams or frightening dreams. 25. Talking or moving about in your sleep as if you are 'acting out' a dream 26. Unpleasant sensations in your legs at night or while resting, and a feeling that you need to move.,) (NMSQuest) or frightening dreams All patients fulfilled by Parkinson's disease sleep scale (PDSS). Treatment was maintained constant during the trial. Each patient under levodopa (Sinemet 250/25; ½ table 3 times per day) and anticholinergic (cogenitol ½ table 3 times per day).","primaryPurpose":"OTHER","maskingInfo":{"masking":"TRIPLE","maskingDescription":"Out of 45 PD patients, 30 patients had sleep disturbance and 6 out of them refused to be participated in the study . Group allocations (active or vs sham with ratio 2 (16 cases):1(8 cases) were placed in serially numbered closed envelopes.","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1st group received active rTMS,","type":"ACTIVE_COMPARATOR","description":"Active rTMS was applied using a figure-of-8 coil (7-cm diameter loop) positioned over the parietal area for ten sessions (10 trains, with frequency of stimulation 20-Hz, each lasting for 10 seconds with an inter-train interval of 30 seconds. The intensity of stimulation was set at 80% of the RMT for the first dorsal interosseous (FDI) of the contralateral hand with a total 2000 pulses for each hemisphere). Each patient received five sessions /week for two consecutive weeks with ten total sessions over the parietal area. The parietal region was determined according to the 10-20 system for electroencephalographic electrode positioning at P3 and P4, respectively.","interventionNames":["Device: repititive transcranial magnetic stimulation"]},{"label":"2nd group was the sham group","type":"SHAM_COMPARATOR","description":"rTMS was applied using the same parameters, but with the coil edge was applied perpendicular to the scalp in the sagittal plane jut to reproduce the noise of the stimulation","interventionNames":["Device: repititive transcranial magnetic stimulation"]}],"interventions":[{"type":"DEVICE","name":"repititive transcranial magnetic stimulation","description":"a figure-of-8 coil (7-cm diameter loop) positioned over the parietal area for ten sessions (10 trains, with frequency of stimulation 20-Hz, each lasting for 10 seconds with an inter-train interval of 30 seconds. The intensity of stimulation was set at 80% of the RMT for the first dorsal interosseous (FDI) of the contralateral hand with a total 2000 pulses for each parietal area.)","armGroupLabels":["1st group received active rTMS,","2nd group was the sham group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Parkinson's disease sleep scale (PDSS)","description":"The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance overall quality of night's sleep (item 1); • sleep onset and maintenance insomnia (items 2 and 3); • nocturnal restlessness (items 4 and 5); • nocturnal psychosis (items 6 and 7) • nocturia (items 8 and 9); • nocturnal motor symptoms (items 10-13); • sleep refreshment (item 14); • daytime dozing (item 15).","timeFrame":"1 month"},{"measure":"polysomenography","description":"This polysomnography systematically monitored the electroencephalogram (EEG) (C3-A2, C4-A1), electrooculogram (EOG), electromyogram of the chin (EMG), electrocardiogram (EKG), body positions, nasal and oral airflow, thoracic and abdominal effort, limb movements, pulse oximetry, and snoring sound level.","timeFrame":"1 month"}],"secondaryOutcomes":[{"measure":"Beck Depression Inventory","description":"It is a 21-question multiple-choice self-report inventory, one of the most widely used for measurment severity of depression the BDI-II also contains about 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:\n\n0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression","timeFrame":"1 month"},{"measure":"Unified Parkinson's Disease Rating Scale (UPDRS)","description":"it is a rating scale for assessment of motor and non-motor functions in PD. This assessment included in 4 parts: Part I contains mental section consisting of 4 items (intellectual impairment, thought disorder, depression and motivation), part II consists of activities of daily life with the 12 questions covering many activities like hygiene, dressing, writing and freezing during walking, part III consists of the motor clinical assessment with 14 items (speech, facial expression, tremors at rest, action tremor, rigidity, finger taps, hand movement, rapid alternating movements of hands, leg agility, arising from chair, posture, gait, postural stability, bradykinesia), while part IV is addition of drug complications (dyskinesia, clinical fluctuations). We used motor clinical assessment part III in which each item ranked from 0 (normal), 1 (mildly impaired), 2 (moderately impaired), 3 (severely impaired), 4 (can barely perform the task).","timeFrame":"1 month"},{"measure":"Cognitive assessment using Montreal Cognitive assessment","description":"score 0-30","timeFrame":"1 month"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* diagnosis of PD was done according to UK Brain bank Criteria for diagnosis of PD. Out of them we selected only patients with sleep disturbance All patients fulfilled by Parkinson's disease sleep scale (PDSS).\n\nExclusion Criteria:\n\n* Patients with PD with disturbed conscious level, severe cognitive impairment, psychosis, and medical problems such as (Renal failure, Liver cell Failure, Respiratory Failure, and endocrinal impairment), patients with other types of Parkinsonism as (Multisystem atrophy, supranuclear palsy, and encephalitic Parkinsonism) and patients had contraindication of magnetic stimulation (metallic piece, pacemaker, epilepsy) were also excluded from the study","healthyVolunteers":true,"sex":"ALL","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Eman Khedr","city":"Asyut","zip":"11517","country":"Egypt","geoPoint":{"lat":27.18096,"lon":31.18368}}]},"referencesModule":{"references":[{"pmid":"14592234","type":"BACKGROUND","citation":"Oerlemans WG, de Weerd AW. The prevalence of sleep disorders in patients with Parkinson's disease. A self-reported, community-based survey. Sleep Med. 2002 Mar;3(2):147-9. doi: 10.1016/s1389-9457(01)00127-7."},{"pmid":"15987611","type":"BACKGROUND","citation":"Chaudhuri KR, Yates L, Martinez-Martin P. The non-motor symptom complex of Parkinson's disease: a comprehensive assessment is essential. Curr Neurol Neurosci Rep. 2005 Jul;5(4):275-83. doi: 10.1007/s11910-005-0072-6."},{"pmid":"20674489","type":"BACKGROUND","citation":"Arias P, Vivas J, Grieve KL, Cudeiro J. Double-blind, randomized, placebo controlled trial on the effect of 10 days low-frequency rTMS over the vertex on sleep in Parkinson's disease. Sleep Med. 2010 Sep;11(8):759-65. doi: 10.1016/j.sleep.2010.05.003. Epub 2010 Jul 31."},{"pmid":"12940840","type":"BACKGROUND","citation":"Khedr EM, Farweez HM, Islam H. Therapeutic effect of repetitive transcranial magnetic stimulation on motor function in Parkinson's disease patients. Eur J Neurol. 2003 Sep;10(5):567-72. doi: 10.1046/j.1468-1331.2003.00649.x."},{"pmid":"25796953","type":"BACKGROUND","citation":"Khedr EM, Fawi G, Abbas MA, Mohammed TA, El-Fetoh NA, Attar GA, Zaki AF. Prevalence of Parkinsonism and Parkinson's disease in Qena governorate/Egypt: a cross-sectional community-based survey. Neurol Res. 2015 Jul;37(7):607-18. doi: 10.1179/1743132815Y.0000000020. Epub 2015 Mar 23."},{"pmid":"22473384","type":"BACKGROUND","citation":"Khedr EM, Al Attar GS, Kandil MR, Kamel NF, Abo Elfetoh N, Ahmed MA. Epidemiological study and clinical profile of Parkinson's disease in the Assiut Governorate, Egypt: a community-based study. Neuroepidemiology. 2012;38(3):154-63. doi: 10.1159/000335701. Epub 2012 Mar 29."},{"pmid":"22902078","type":"BACKGROUND","citation":"Khedr EM, El Fetoh NA, Khalifa H, Ahmed MA, El Beh KM. Prevalence of non motor features in a cohort of Parkinson's disease patients. Clin Neurol Neurosurg. 2013 Jun;115(6):673-7. doi: 10.1016/j.clineuro.2012.07.032. Epub 2012 Aug 16."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D012893","term":"Sleep Wake Disorders"},{"id":"D010300","term":"Parkinson Disease"}],"ancestors":[{"id":"D009422","term":"Nervous System Diseases"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D001523","term":"Mental Disorders"},{"id":"D020734","term":"Parkinsonian Disorders"},{"id":"D001480","term":"Basal Ganglia Diseases"},{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009069","term":"Movement Disorders"},{"id":"D000080874","term":"Synucleinopathies"},{"id":"D019636","term":"Neurodegenerative Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT06558435","orgStudyIdInfo":{"id":"252023"},"organization":{"fullName":"Centro Hospitalar de Entre o Douro e Vouga","class":"OTHER"},"briefTitle":"Validation of BRACS to European Portuguese","officialTitle":"Translation and Validation of \"The Boston Residue and Clearance Scale\" to European Portuguese"},"statusModule":{"statusVerifiedDate":"2024-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-03-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-03-01","type":"ACTUAL"},"completionDateStruct":{"date":"2023-05-01","type":"ACTUAL"},"studyFirstSubmitDate":"2024-08-14","studyFirstSubmitQcDate":"2024-08-14","studyFirstPostDateStruct":{"date":"2024-08-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-08-19","lastUpdatePostDateStruct":{"date":"2024-08-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Daniela Ferreira","investigatorTitle":"Speech and Language Pathologist Daniela Ferreira","investigatorAffiliation":"Centro Hospitalar de Entre o Douro e Vouga"},"leadSponsor":{"name":"Centro Hospitalar de Entre o Douro e Vouga","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The goal of this observational study is to translate and validate the fiberoptic endoscopic evaluation of swallowing scale \"The Boston Residue and Clearance Scale - BRACS\" to European Portuguese","detailedDescription":"The Boston Residue and Clearance Scale (BRACS) is a multidimensional scale developed and validated to assess the severity of residues observed during fiberoptic endoscopic evaluation of swallowing (FEES).\n\nIt differs from other FEES residue scales, since it considers all aspects related to pharyngolaryngeal residues, specifically, the location, amount and the patient's clearance ability.\n\nThe purpose of this study was to translate and cross-culturally adapt the English version of the BRACS into European Portuguese and to investigate the reliability and validity of the translated version of the scale."},"conditionsModule":{"conditions":["Deglutition Disorders","Swallowing Disorder","Dysphagia, Oropharyngeal"],"keywords":["Swallowing Disorders","Dysphagia","Fiberoptic Endoscopic Evaluation of Swallowing"]},"designModule":{"studyType":"OBSERVATIONAL","patientRegistry":false,"designInfo":{"observationalModel":"OTHER","timePerspective":"RETROSPECTIVE"},"enrollmentInfo":{"count":16,"type":"ACTUAL"}},"armsInterventionsModule":{"interventions":[{"type":"OTHER","name":"FEES","description":"Single group","otherNames":["Fiberoptic Endoscopic Evaluation of Swallowing"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Reliable and validated European Portuguese version of the BRACS","description":"Demonstrating the reliability and validity of the Boston Residue and Clearance Scale in diagnosing dysphagia during fiberoptic endoscopic assessment of swallowing examination. BRACS it's an 11-point ordinal residue classification scale that assesses 3 aspects: the amount and location of pharyngolaryngeal residues, the presence of spontaneous swallowing to clear it and the effectiveness of patient's swallowing.","timeFrame":"patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* FEES recording that allowed good visualisation of the pharynx and larynx.\n* FEES recording of patients after head and neck surgery who had anatomical alterations of the structures, but which did not interfere with good visualisation of the residues.\n* FEES recording of patients with a tracheostomy or under tube feeding.\n\nExclusion Criteria:\n\n* FEES recording of patients under 18 years of age.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"],"studyPopulation":"Patients with neurological or mechanical dysphagia who have undergone a FEES examination and whose test meets the inclusion criteria described above.","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"locations":[{"facility":"Centro Hospitalar de Entre Douro e Vouga","city":"Santa Maria da Feira","zip":"4520-211","country":"Portugal","geoPoint":{"lat":40.92726,"lon":-8.54839}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D003680","term":"Deglutition Disorders"}],"ancestors":[{"id":"D004935","term":"Esophageal Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D010608","term":"Pharyngeal Diseases"},{"id":"D010038","term":"Otorhinolaryngologic Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D005249","term":"Fees and Charges"}],"ancestors":[{"id":"D004467","term":"Economics"},{"id":"D004472","term":"Health Care Economics and Organizations"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT02086435","orgStudyIdInfo":{"id":"SafeMorcellation"},"organization":{"fullName":"University Magna Graecia","class":"OTHER"},"briefTitle":"Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes","officialTitle":"A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes","acronym":"IEME"},"statusModule":{"statusVerifiedDate":"2015-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-03"},"primaryCompletionDateStruct":{"date":"2014-12","type":"ACTUAL"},"completionDateStruct":{"date":"2015-04","type":"ACTUAL"},"studyFirstSubmitDate":"2014-03-09","studyFirstSubmitQcDate":"2014-03-12","studyFirstPostDateStruct":{"date":"2014-03-13","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-04-19","lastUpdatePostDateStruct":{"date":"2015-04-21","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Fulvio Zullo","investigatorTitle":"Full Professor Obstetric Gynecology","investigatorAffiliation":"University Magna Graecia"},"leadSponsor":{"name":"University Magna Graecia","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal \"protected\" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself."},"conditionsModule":{"conditions":["Uterine Myoma"],"keywords":["Myomectomy","Laparoscopic myomectomy","Morcellation","Risk of dissemination","Uterine Sarcoma","Parasitic myoma"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":93,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Extracorporeal morcellation","type":"EXPERIMENTAL","description":"Extracorporeal morcellation in which patients are treated with \"protected\" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself","interventionNames":["Procedure: Extracorporeal morcellation"]},{"label":"Intracorporeal morcellation","type":"ACTIVE_COMPARATOR","description":"Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device","interventionNames":["Procedure: Intracorporeal morcellation"]}],"interventions":[{"type":"PROCEDURE","name":"Extracorporeal morcellation","description":"patients treated with \"protected\" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself","armGroupLabels":["Extracorporeal morcellation"],"otherNames":["protected morcellation","morcellation in endobag"]},{"type":"PROCEDURE","name":"Intracorporeal morcellation","description":"patients treated with standard intracorporeal morcellation, using reusable electronic device","armGroupLabels":["Intracorporeal morcellation"],"otherNames":["Power morcellation","Standard intracorporeal morcellation"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Operative time","description":"calculated from the time, after secured hemostasis of the uterine breach, in which the myoma is clamped and subjected to intracorporeal or added in endobag for extracorporeal morcellation to the moment when the 'last fragment of myoma will be considered removed from the surgical field","timeFrame":"The day of surgery"}],"secondaryOutcomes":[{"measure":"Total operative time","description":"from skin incision to skin closure","timeFrame":"The day of surgery"},{"measure":"Handling of morcellation","description":"expressed on the VAS scale where 1 means very bad handling and 10 excellent handling","timeFrame":"The day of surgery"},{"measure":"Blood loss","description":"Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery","timeFrame":"2 hours after the end of surgery"},{"measure":"Postoperative hospital stay","timeFrame":"The day of patient discharge, average 4 day after surgery"},{"measure":"Postoperative pain","description":"measured on the VAS scale where 1 stands for a little pain and 10 for intense pain","timeFrame":"The day of patient discharge, average 4 day after surgery"},{"measure":"Rate of complications","description":"need of transfusion or laparotomic conversion","timeFrame":"The day of patient discharge, average 4 day after surgery"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications\n* Presence of at least one uterine myoma larger than 4 cm\n* Aged between 18 and 40 years\n\nExclusion Criteria:\n\n* Presence of uterine neoformations suspicious for malignancy\n* Medical major disorders associated\n* Acute or chronic psychiatric disorders\n* Ascertained Premenstrual syndrome\n* Use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment\n* Presence of calcified fibroids ultrasound examination\n* Presence of adnexal lesions\n* Detection of a pattern of endometrial hyperplasia with atypia determined in the course endometrial biopsy performed for abnormal uterine bleeding\n* Abnormal PAP test\n* Positive Pregnancy Test\n* Previous use of laparoscopic surgery increased","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"40 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Fulvio Zullo","affiliation":"Magna Graecia University of Catanzaro","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Chair of Obstetrics and Gynecology - University division - UMG","city":"Catanzaro","state":"CZ","zip":"88100","country":"Italy","geoPoint":{"lat":38.88247,"lon":16.60086}}]},"referencesModule":{"references":[{"pmid":"26801067","type":"DERIVED","citation":"Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D047708","term":"Myofibroma"}],"ancestors":[{"id":"D009372","term":"Neoplasms, Connective Tissue"},{"id":"D018204","term":"Neoplasms, Connective and Soft Tissue"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D009369","term":"Neoplasms"},{"id":"D003240","term":"Connective Tissue Diseases"},{"id":"D017437","term":"Skin and Connective Tissue Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069577","term":"Morcellation"}],"ancestors":[{"id":"D019060","term":"Minimally Invasive Surgical Procedures"},{"id":"D013514","term":"Surgical Procedures, Operative"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT04696835","orgStudyIdInfo":{"id":"2018_73"},"secondaryIdInfos":[{"id":"2019-A02517-50","type":"OTHER","domain":"ID-RCB number,ANSM"}],"organization":{"fullName":"University Hospital, Lille","class":"OTHER"},"briefTitle":"fNIRS in Pediatric Hearing Aids","officialTitle":"Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)","acronym":"FNIRS"},"statusModule":{"statusVerifiedDate":"2025-12","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-09-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2027-09","type":"ESTIMATED"},"completionDateStruct":{"date":"2027-09","type":"ESTIMATED"},"studyFirstSubmitDate":"2021-01-05","studyFirstSubmitQcDate":"2021-01-05","studyFirstPostDateStruct":{"date":"2021-01-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-12-17","lastUpdatePostDateStruct":{"date":"2025-12-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University Hospital, Lille","class":"OTHER"},"collaborators":[{"name":"Fondation William Demant","class":"UNKNOWN"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Pilot phase. Monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fNIRS) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants.\n\nHemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) recorded by the fNIRS.\n\nThe use of the FNIRS in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss."},"conditionsModule":{"conditions":["Hearing Loss"],"keywords":["NIRS","hearing aid","pediatrics","cochlear implant","rehabilitation","neuroimaging"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"DIAGNOSTIC","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":40,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"children with hearing aids","type":"EXPERIMENTAL","interventionNames":["Diagnostic Test: speech audiometry"]},{"label":"control group","type":"SHAM_COMPARATOR","interventionNames":["Diagnostic Test: speech audiometry"]}],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"speech audiometry","description":"65dB, 55dB or 75dB SPL speech audiometry","armGroupLabels":["children with hearing aids","control group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Oxygenated haemoglobin concentration (HbO)","timeFrame":"Baseline (at inclusion)"}],"secondaryOutcomes":[{"measure":"Deoxygenated haemoglobin concentration (HbR)","timeFrame":"Baseline (at inclusion)"},{"measure":"HbO Concentration","description":"Evolution of the variation in HbO concentration in the group of infants fitted with a device.","timeFrame":"At 3 months, 6 months, 12 months and 24 months"},{"measure":"HbR Concentration","description":"Evolution of the variation in HbR concentration in the group of infants fitted with a device.","timeFrame":"At 3 months, 6 months, 12 months and 24 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Group A: Infants and toddlers 3-18 months of age who are normal hearing.\n* Group B: Infants and toddlers aged 3 to 18 months with sensorineural hearing loss fitted with a unilateral or bilateral hearing aid with optimized adjustments by the hearing healthcare professional.\n* Socially insured subject\n* Parents or guardians who have given their consent to participate in the study\n\nExclusion Criteria:\n\n* Medical condition that does not allow for research compliance.","healthyVolunteers":false,"sex":"ALL","minimumAge":"3 Months","maximumAge":"18 Months","stdAges":["CHILD"]},"contactsLocationsModule":{"centralContacts":[{"name":"Christophe VINCENT, PU-PH","role":"CONTACT","phone":"0320445962","phoneExt":"+33","email":"christophe.vincent@chru-lille.Fr"}],"overallOfficials":[{"name":"Christophe VINCENT, PU-PH","affiliation":"University Hospital, Lille","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Hopital Roger Salengro, CHU Lille","status":"RECRUITING","city":"Lille","zip":"59037","country":"France","contacts":[{"role":"CONTACT","phone":"0320445962"}],"geoPoint":{"lat":50.63391,"lon":3.05512}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D034381","term":"Hearing Loss"}],"ancestors":[{"id":"D006311","term":"Hearing Disorders"},{"id":"D004427","term":"Ear Diseases"},{"id":"D010038","term":"Otorhinolaryngologic Diseases"},{"id":"D012678","term":"Sensation Disorders"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D001302","term":"Audiometry, Speech"}],"ancestors":[{"id":"D001299","term":"Audiometry"},{"id":"D006320","term":"Hearing Tests"},{"id":"D003939","term":"Diagnostic Techniques, Otological"},{"id":"D019937","term":"Diagnostic Techniques and Procedures"},{"id":"D003933","term":"Diagnosis"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT06774235","orgStudyIdInfo":{"id":"87RI24_0040 (PLATINIUM)"},"secondaryIdInfos":[{"id":"2024-516780-93-00","type":"CTIS"}],"organization":{"fullName":"University Hospital, Limoges","class":"OTHER"},"briefTitle":"Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression","officialTitle":"Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial","acronym":"PLATINIUM"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2025-07-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2028-10-09","type":"ESTIMATED"},"completionDateStruct":{"date":"2028-10-09","type":"ESTIMATED"},"studyFirstSubmitDate":"2025-01-06","studyFirstSubmitQcDate":"2025-01-13","studyFirstPostDateStruct":{"date":"2025-01-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-19","lastUpdatePostDateStruct":{"date":"2025-11-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University Hospital, Limoges","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. . It will also learn about the safety of Interferon-gamma. The main questions it aims to answer are:\n\nDoes Interferon-gamma:\n\n* reduces the Incidence of secondary infection episodes at three months\n* reduces the ICU mortality and at Day 90\n* reduces the ICU and hospital length of stay\n* induces Biological immune restoration at Day 10\n* has cost-consequence and cost-effectiveness\n\nResearchers will compare Interferon-gamma to a placebo (a look-alike substance that contains no drug) to see if Interferon-gamma works to treat sustained immunosuppression .\n\nParticipants will:\n\n* Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9\n* be monitored evety day until their ICU discharge and at day 30, 60 and 90"},"conditionsModule":{"conditions":["Sustained Immunosuppression"],"keywords":["ICU","Immuno-restauration","Secondary infections","Prevention"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":326,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Interferon-gamma","type":"EXPERIMENTAL","description":"Injections of Interferon gamma-1b are sub-cutaneous and preferably in the deltoid region left or right or on the anterior part of the thigh.\n\n5 injections between day 1 and day 9","interventionNames":["Drug: Interferon Gamma 1-b"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"The comparative treatment will be a placebo, consisting in 0.5 ml of 0.9% sodium chloride solution only (same volume for interferon gamma-1b)","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Interferon Gamma 1-b","description":"injection of interferon gamma 1-b","armGroupLabels":["Interferon-gamma"]},{"type":"DRUG","name":"Placebo","description":"Injection of placebo in the same condition of experimental traitment","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Incidence of secondary infection episodes","description":"Number of episodes divided by the follow-up length, in days, validated by an independent adjudication committee based on the current definitions.","timeFrame":"Day 90"}],"secondaryOutcomes":[{"measure":"Cause of mortality of participant","description":"All-cause ICU mortality and at Day 90","timeFrame":"Day 90"},{"measure":"Length of stay in the ICU and in the hospital","description":"Number of days spent in the ICU and in the hospital at Day 90","timeFrame":"Day 90"},{"measure":"Antibiotic consumption","description":"Name of antibiotics taken at Day 90","timeFrame":"Day 90"},{"measure":"Biological immune restoration","description":"Percentage of biological immune restoration (defined as an HLA-DR \\> 13 500 Ab/c \\[Antibodies bound per cell\\] and an absolute lymphocyte count \\> 1200 mm3) at Day 10","timeFrame":"Day 10"},{"measure":"Healthcare costs","description":"Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance","timeFrame":"Day 90"},{"measure":"Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR)","description":"Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90 according to sponsor causality assessment","timeFrame":"Day 90"},{"measure":"Antifungal consumption","description":"Name of antifungals taken at Day 90","timeFrame":"Day 90"},{"measure":"Antifungal consumption","description":"Dosage of antifungals taken at Day 90","timeFrame":"Day 90"},{"measure":"Antifungal consumption","description":"Duration of antifungals taken at Day 90","timeFrame":"Day 90"},{"measure":"Antibiotic consumption","description":"Dosage of antibiotics taken at Day 90","timeFrame":"Day 90"},{"measure":"Antibiotic consumption","description":"Duration of antibiotics taken at Day 90","timeFrame":"Day 90"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adult patient hospitalized in the ICU for at least 1 week\n* Expected length of stay in the ICU greater than 10 days at screening\n* At least 1 episode of multiple organ failure, defined as a SOFA ≥ 6 (excluding the respiratory component when related to a neurological failure), during the first 1 week of ICU hospitalization\n* Immunosuppression defined as an mHLA-DR \\< 8000 Ab/c and a lymphopenia \\< 1000/mm3 within a 96 hours time window\n* Patient or the legal representative giving consent must be able to understand the trial in its entirety\n* Patient affiliated to the social security system\n* For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90\n* For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90.\n\nExclusion Criteria:\n\n* Uncontrolled secondary infections ongoing at the time of screening\n* Participation in another research clinical trial within 30 days\n* Chemotherapy / radiation therapy within the last 6 weeks\n* Apache II ≥ 30 at screening\n* History of autoimmune disease\n* Organ or bone marrow transplant\n* History of hematologic malignancy\n* History of hepatitis C\n* HIV stage C within the last 12 months\n* Patients under legal protection\n* History of or ongoing tuberculosis\n* Chronic hepatitis B\n* Patients receiving immunosuppressive medications including patient receiving a steroid dose greater than 1mg/kg/day of prednisone equivalent for more than 1 week and patient that have been on corticosteroid for more than 3 months\n* Patient with thrombocytopenia below 50,000/mm3\n* Patient with traumatic brain and spinal injury\n* Pregnancy or breast feeding\n* Subjects with a history hypersensitivity to interferon gamma or excipient (Mannitol, Sodium succinate dibasic hexahydrate, Succinic acid, polysorbate 20), known latex hypersensitivity or other interferon\n* Hepatic cytolysis with AST/ALT \\> 5 times ULN (local laboratory)\n* Suspected acute pancreatitis with lipase or amylase \\> 3 times ULN (local laboratory)\n* Severe chronic renal failure (eGFR\\<10 ml/min/1.73m2 CKP-EPI method)\n* Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)\n* Mental state rendering the person giving consent incapable of understanding the trial\n* Patient deprived of liberty by judicial or administrative decision\n* Patient being the investigator, or any member of the team or relative of the investigator directly involved in the trial, including assistant doctors, pharmacists, nurses, trial coordinators","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Angers university hospial","status":"RECRUITING","city":"Angers","zip":"49100","country":"France","contacts":[{"name":"Pierre ASFAR, MD","role":"CONTACT","phone":"+33241353815","email":"pierre.asfar@univ-angers.fr"},{"name":"Pierre ASFAR, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.47156,"lon":-0.55202}},{"facility":"Argenteuil hospital","status":"RECRUITING","city":"Argenteuil","zip":"95107","country":"France","contacts":[{"name":"Gaetan PLANTEFEVE, MD","role":"CONTACT","phone":"+33134231445","email":"gaetan.plantefeve@ch-argenteuil.fr"},{"name":"gaetan PLANTEFEVE, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.94788,"lon":2.24744}},{"facility":"Franche-comté north Hospital","status":"RECRUITING","city":"Belfort","zip":"90015","country":"France","contacts":[{"name":"Julio BADIE, MD","role":"CONTACT","phone":"+33384981970","email":"Julio.BADIE@hnfc.fr"},{"name":"julio BADIE, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.64218,"lon":6.85385}},{"facility":"Brive Hospital","status":"RECRUITING","city":"Brive-la-Gaillarde","zip":"19100","country":"France","contacts":[{"name":"Nicolas PICHON, MD","role":"CONTACT","phone":"+33555926013","email":"nicolas.pichon@ch-brive.fr"},{"name":"Nicolas PICHON, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":45.1589,"lon":1.53326}},{"facility":"Chalon sur saone Hospital","status":"RECRUITING","city":"Chalon-sur-Saône","zip":"71100","country":"France","contacts":[{"name":"Thomas MALDINEY, MD","role":"CONTACT","phone":"+33385910111","email":"thomas.maldiney@ch-chalon71.fr"},{"name":"Thomas MALDINEY, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":46.78112,"lon":4.85372}},{"facility":"Dijon University Hospital","status":"RECRUITING","city":"Dijon","zip":"21000","country":"France","contacts":[{"name":"Jean-Pierre QUENOT, MD","role":"CONTACT","phone":"+33380293685","email":"jean-pierre.quenot@chu-dijon.fr"},{"name":"Jean-Pierre QUENOT, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.31344,"lon":5.01391}},{"facility":"APHP - Raymond Poincaré","status":"RECRUITING","city":"Garches","zip":"92380","country":"France","contacts":[{"name":"Djillali ANNANE, MD","role":"CONTACT","phone":"+33147107787","email":"djillali.annane@rpc.aphp.fr"},{"name":"Djillali ANNANE, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.84226,"lon":2.18232}},{"facility":"Versailles Hospital","status":"RECRUITING","city":"Le Chesnay","zip":"78157","country":"France","contacts":[{"name":"Stéphane LEGRIEL, MD","role":"CONTACT","phone":"+33139639717","email":"slegriel@ch-versailles.fr"},{"name":"Stéphane LEGRIEL, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.8222,"lon":2.12213}},{"facility":"Le mans Hospital","status":"RECRUITING","city":"Le Mans","zip":"72000","country":"France","contacts":[{"name":"Christophe GUITTON","role":"CONTACT","phone":"MD","email":"cguitton@ch-lemans.fr"},{"name":"Christophe GUITTON, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.0021,"lon":0.20251}},{"facility":"CH de Lens","status":"RECRUITING","city":"Lens","zip":"62300","country":"France","contacts":[{"name":"Nicolas VAN GRUNDEBEECK, MD","role":"CONTACT","phone":"0321691088","phoneExt":"+33","email":"nvangrunderbeeck@ch-lens.fr"},{"name":"Nicolas VAN GRUNDERBEECK, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":50.43302,"lon":2.82791}},{"facility":"Limoges University Hospital","status":"RECRUITING","city":"Limoges","zip":"87042","country":"France","contacts":[{"name":"Bruno FRANCOIS, MD","role":"CONTACT","phone":"0555058841","phoneExt":"+33","email":"bruno.francois@chu-limoges.fr"},{"name":"Bruno Francois, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":45.83362,"lon":1.24759}},{"facility":"Lyon Civils Hospices","status":"NOT_YET_RECRUITING","city":"Lyon","zip":"69002","country":"France","contacts":[{"name":"Anne-Claire LUKASZEWICZ, MD","role":"CONTACT","phone":"+33472111327","email":"anne-claire.lukaszewicz@chu-lyon.fr"},{"name":"Anne-Claire LUKASZEWICH, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":45.74906,"lon":4.84789}},{"facility":"APHM","status":"RECRUITING","city":"Marseille","zip":"13915","country":"France","contacts":[{"name":"Sami HRAIECH, MD","role":"CONTACT","phone":"+33491965836","email":"sami.hraiech@ap-hm.fr"},{"name":"Sami HRAIECH, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":43.29695,"lon":5.38107}},{"facility":"Melun Hospital","status":"RECRUITING","city":"Melun","zip":"77000","country":"France","contacts":[{"name":"Mehran MONCHI, MD","role":"CONTACT","phone":"+33181742258","email":"mehran.monchi@ghsif.fr"},{"name":"Mehran MONCHI, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.5457,"lon":2.65356}},{"facility":"Nancy University Hospital","status":"RECRUITING","city":"Nancy","zip":"54035","country":"France","contacts":[{"name":"Sébastien GIBOT, MD","role":"CONTACT","phone":"+33383852123","email":"s.gibot@chru-nancy.fr"},{"name":"Sébastien GIBOT, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.68439,"lon":6.18496}},{"facility":"Nantes University Hospital","status":"RECRUITING","city":"Nantes","zip":"44000","country":"France","contacts":[{"name":"Antoine ROQUILLY, MD","role":"CONTACT","phone":"+33240582230","email":"antoine.roquilly@chu-nantes.fr"},{"name":"Antoine ROQUILLY, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.21725,"lon":-1.55336}},{"facility":"Orléans Hospital","status":"RECRUITING","city":"Orléans","zip":"45100","country":"France","contacts":[{"name":"François BARBIER, MD","role":"CONTACT","phone":"+33238514446","email":"francois.barbier@chr-orleans.fr"},{"name":"François BARBIER, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.90248,"lon":1.90407}},{"facility":"APHP - Laroiboisière","status":"RECRUITING","city":"Paris","zip":"75010","country":"France","contacts":[{"name":"Nicolas DEYE, MD","role":"CONTACT","phone":"+33149956347","email":"nicolas.deye@lrb.aphp.fr"},{"name":"nicolas DEYE, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.85341,"lon":2.3488}},{"facility":"Aphp - Hegp","status":"RECRUITING","city":"Paris","zip":"75014","country":"France","contacts":[{"name":"Jean-Luc DIEHL, MD","role":"CONTACT","phone":"+33156093204","email":"jean-luc.diehl@aphp.fr"},{"name":"Jean-Lus DIEHL, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.85341,"lon":2.3488}},{"facility":"APHP - Cochin","status":"RECRUITING","city":"Paris","zip":"75015","country":"France","contacts":[{"name":"Jean-Paul MIRA, MD","role":"CONTACT","phone":"+33158412501","email":"jean-paul.mira@aphp.fr"},{"name":"Jean-Paul MIRA, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.85341,"lon":2.3488}},{"facility":"Rennes University Hospital","status":"RECRUITING","city":"Rennes","zip":"35000","country":"France","contacts":[{"name":"Jean-Marc TADIE, MD","role":"CONTACT","phone":"+33299284248","email":"jeanmarc.tadie@chu-rennes.fr"},{"name":"Jean-Marc TADIE, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.11109,"lon":-1.67431}},{"facility":"Strasbourg University Hospital","status":"RECRUITING","city":"Strasbourg","zip":"67091","country":"France","contacts":[{"name":"Louise-Marie JANDEAUX, MD","role":"CONTACT","phone":"+33369551212","email":"Louise-marie.jandeaux@chru-strasbourg.fr"},{"name":"Louise-Marie JANDEAUX, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":48.58392,"lon":7.74553}},{"facility":"Tours University Hospital","status":"RECRUITING","city":"Tours","zip":"37000","country":"France","contacts":[{"name":"Antoine GUILLON, MD","role":"CONTACT","phone":"+33139639717","email":"antoine.guillon@univ-tours.fr"},{"name":"Antoine GUILLON, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":47.39484,"lon":0.70398}}]},"referencesModule":{"references":[{"pmid":"41592843","type":"DERIVED","citation":"Hernandez Padilla AC, Daix T, Hotchkiss RS, Monneret G, Tadie JM, Jeannet R, Plateker O, Vaidie J, Durand-Zaleski I, Magne J, Giraudeau B, Francois B. Prevention of secondary infections by interferon-gamma in ICU-acquired sustained immune suppression in France: study protocol of the PLATINIUM randomised trial. BMJ Open. 2026 Jan 27;16(1):e106790. doi: 10.1136/bmjopen-2025-106790."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D060085","term":"Coinfection"}],"ancestors":[{"id":"D007239","term":"Infections"}]},"interventionBrowseModule":{"meshes":[{"id":"D007371","term":"Interferon-gamma"}],"ancestors":[{"id":"D007372","term":"Interferons"},{"id":"D016207","term":"Cytokines"},{"id":"D036341","term":"Intercellular Signaling Peptides and Proteins"},{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D016215","term":"Macrophage-Activating Factors"},{"id":"D008222","term":"Lymphokines"},{"id":"D011506","term":"Proteins"},{"id":"D001685","term":"Biological Factors"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00142935","orgStudyIdInfo":{"id":"NIDA-18641-1"},"secondaryIdInfos":[{"id":"R01-DA018641-1"},{"id":"DPMC"},{"id":"R01DA018641","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA018641"}],"organization":{"fullName":"The Miriam Hospital","class":"OTHER"},"briefTitle":"Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1","officialTitle":"Opiate Replacement Therapy at Release From Incarceration"},"statusModule":{"statusVerifiedDate":"2009-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-09"},"primaryCompletionDateStruct":{"date":"2009-12","type":"ACTUAL"},"completionDateStruct":{"date":"2009-12","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-01","studyFirstSubmitQcDate":"2005-09-01","studyFirstPostDateStruct":{"date":"2005-09-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-12-05","resultsFirstSubmitQcDate":"2014-05-08","resultsFirstPostDateStruct":{"date":"2014-06-06","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-05-08","lastUpdatePostDateStruct":{"date":"2014-06-06","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"The Miriam Hospital","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to opiates. Many of these individuals pass through a correctional setting each year, creating an opportunity for linkage to substance abuse treatment. The purpose of this study was to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.","detailedDescription":"A substantial proportion of individuals addicted to heroin are incarcerated while addicted and a majority of individuals released from a correctional setting have a history of heroin addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV transmission and other problems, including drug relapse and overdose. Methadone treatment is the most widely used opiate replacement therapy in the United States and has been shown to decrease HIV risk, as well as drug use, addiction relapse, and criminal activity. The purpose of this study was to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.\n\nParticipants in this were randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 initiated methadone opiate replacement therapy about 1 month prior to release from incarceration. They proceeded with a methadone program of their choice upon release and received short-term payment to cover treatment costs. Participants enrolled in Group 2 were referred to a methadone program of their choice and received short-term payment to cover treatment costs. Participants enrolled in Group 3 were referred to a program of choice upon release from incarceration without receiving financial assistance. All participants had the opportunity to partake in existing support programs available at the Rhode Island Department of Corrections while incarcerated and in the community upon release. Follow-up assessments occurred at Months 1.5, 6, and 12. These included interviews and urine specimens for toxicology analysis to verify self-reports."},"conditionsModule":{"conditions":["HIV Prevention","Opioid-Related Disorders"],"keywords":["HIV Prevention","Opioid-Related Disorders","Medication Assisted Treatment","Methadone"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":87,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Pre-Release Initiation MMT","type":"EXPERIMENTAL","description":"Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.","interventionNames":["Behavioral: Pre-release Initiation of MMT"]},{"label":"Post Release Initiation of MMT","type":"EXPERIMENTAL","description":"Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.","interventionNames":["Behavioral: Post Release Initiation of MMT."]},{"label":"Standard of Care Plus","type":"ACTIVE_COMPARATOR","description":"Participants assigned to this arem will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.","interventionNames":["Behavioral: Standard of Care Plus"]}],"interventions":[{"type":"BEHAVIORAL","name":"Pre-release Initiation of MMT","description":"Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.","armGroupLabels":["Pre-Release Initiation MMT"]},{"type":"BEHAVIORAL","name":"Post Release Initiation of MMT.","description":"Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.","armGroupLabels":["Post Release Initiation of MMT"]},{"type":"BEHAVIORAL","name":"Standard of Care Plus","description":"Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.","armGroupLabels":["Standard of Care Plus"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Treatment Engagement","description":"Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.","timeFrame":"within 30 days post release of incarceration"},{"measure":"Time to MMT Initiation Post Release Based on Clinic Chart Review","description":"Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.","timeFrame":"within 30 days post release from incarceration"},{"measure":"HIV Risk Behaviors - Self Report","description":"Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.","timeFrame":"6 month follow-up interviews"}],"secondaryOutcomes":[{"measure":"Drug Use","description":"Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.","timeFrame":"6 month follow-up interviews"},{"measure":"Fatal Overdose","description":"Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.","timeFrame":"Within six months from release of incarceration"},{"measure":"Non-fatal Overdose","description":"Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.","timeFrame":"6 month follow-up interviews"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Currently incarcerated at the Rhode Island Department of Corrections with a scheduled release date at least 28 days after enrollment\n* Incarceration length not to have exceeded two years at the time of enrollment\n* Heroin dependent with self-reported heroin injection in the month prior to incarceration OR enrollment in a methadone treatment program prior to incarceration for heroin addiction with a history of injection drug use\n* Desire to enter methadone treatment upon release and plans to secure funding for methadone treatment after study completion\n* History of prior tolerance to methadone\n* History of at least one drug-related incarceration\n* Speaks English or Spanish\n* Plans to remain in Rhode Island for the duration of the study (24 months)\n* Ability to provide at least two names of individuals who can verify participant information\n\nExclusion Criteria:\n\n* Currently receiving methadone at the Rhode Island Department of Corrections\n* Currently undergoing a non-narcotic detoxification from illicit opiates at the Rhode Island Department of Corrections\n* Plans to leave Rhode Island within the two years following enrollment","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Josiah D Rich, M.P.H., M.D.","affiliation":"The Miriam Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"The Miriam Hospital","city":"Providence","state":"Rhode Island","zip":"02906","country":"United States","geoPoint":{"lat":41.82399,"lon":-71.41283}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"There were no significant events following participant enrollment and prior to group assignment.","recruitmentDetails":"All recruitment occurred at the Rhode Island Department of Corrections. Screening began on 9/15/2006 and the first participant was enrolled on 9/29/2006. The last participant was enrolled on 2/20/2009.","groups":[{"id":"FG000","title":"Pre-release MMT Initiation + Referral Post Release + Payment","description":"Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks."},{"id":"FG001","title":"MMT Referral Post Release + Payment","description":"Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks."},{"id":"FG002","title":"MMT Referral Post Release","description":"Participants assigned to this arm will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with Medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"23"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Other reason","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Pre-release MMT Initiation + Referral Post Release + Payment","description":"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs."},{"id":"BG001","title":"MMT Referral Post Release + Payment","description":"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"BG002","title":"MMT Referral Post Release","description":"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"87"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"87"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"37.3","spread":"8.79"},{"groupId":"BG001","value":"37","spread":"6.69"},{"groupId":"BG002","value":"38.4","spread":"9.25"},{"groupId":"BG003","value":"37.6","spread":"8.27"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"27"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"60"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"87"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Treatment Engagement","description":"Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.","populationDescription":"We assessed community methadone treatment clinic attendance of all enrolled participants based on clinic chart review.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"within 30 days post release of incarceration","groups":[{"id":"OG000","title":"As Assigned: Pre-release MMT + Referral Post Release + Payment","description":"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"OG001","title":"As Assigned: MMT Referral Post Release + Payment","description":"Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"OG002","title":"As Assigned: MMT Referral Post Release","description":"Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"6"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Outcome: engage in treatment post release, yes or no","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Chi-squared, Corrected","ciPctValue":"95"}]},{"type":"PRIMARY","title":"Time to MMT Initiation Post Release Based on Clinic Chart Review","description":"Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.","populationDescription":"Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"within 30 days post release from incarceration","groups":[{"id":"OG000","title":"As Assigned: Pre-release MMT + Referral Post Release + Payment","description":"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"OG001","title":"As Assigned: MMT Referral Post Release + Payment","description":"Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"OG002","title":"As Assigned: MMT Referral Post Release","description":"Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"4.37"},{"groupId":"OG001","value":"9","spread":"9.74"},{"groupId":"OG002","value":"5","spread":"5.16"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".02","statisticalMethod":"Chi-squared, Corrected"}]},{"type":"PRIMARY","title":"HIV Risk Behaviors - Self Report","description":"Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"6 month follow-up interviews","groups":[{"id":"OG000","title":"As Assigned: Pre-release MMT + Referral Post Release + Payment","description":"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs."},{"id":"OG001","title":"As Assigned: MMT Referral Post Release + Payment","description":"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"OG002","title":"As Assigned: MMT Referral Post Release","description":"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".09","statisticalMethod":"Chi-squared, Corrected","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Drug Use","description":"Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"6 month follow-up interviews","groups":[{"id":"OG000","title":"As Assigned: MMT Pre-release + Referral Post Release + Payment","description":"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs."},{"id":"OG001","title":"As Assigned: MMT Referral Post Release + Payment","description":"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"OG002","title":"As Assigned: MMT Referral Post Release","description":"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".09","statisticalMethod":"Chi-squared, Corrected"}]},{"type":"SECONDARY","title":"Fatal Overdose","description":"Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Within six months from release of incarceration","groups":[{"id":"OG000","title":"As Assigned: MMT Pre-release + Referral Post Release + Payment","description":"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs."},{"id":"OG001","title":"As Assigned: MMT Referral Post Release + Payment","description":"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"OG002","title":"As Assigned: MMT Referral Post Release","description":"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]}]},{"type":"SECONDARY","title":"Non-fatal Overdose","description":"Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"6 month follow-up interviews","groups":[{"id":"OG000","title":"As Assigned: MMT Pre-release + Referral Post Release + Payment","description":"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs."},{"id":"OG001","title":"As Assigned: MMT Referral Post Release + Payment","description":"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs."},{"id":"OG002","title":"As Assigned: MMT Referral Post Release","description":"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8","statisticalMethod":"Chi-squared, Corrected"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"12 months","description":"Fatal Overdoses","eventGroups":[{"id":"EG000","title":"As Assigned: Pre-release MMT + Referral Post Release + Payment","description":"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.\n\nFatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews.","seriousNumAffected":0,"seriousNumAtRisk":29,"otherNumAffected":10,"otherNumAtRisk":26},{"id":"EG001","title":"As Assigned: MMT Referral Post Release + Payment","description":"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.\n\nFatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews.","seriousNumAffected":2,"seriousNumAtRisk":28,"otherNumAffected":8,"otherNumAtRisk":20},{"id":"EG002","title":"As Assigned: MMT Referral Post Release","description":"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.\n\nFatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews.","seriousNumAffected":1,"seriousNumAtRisk":30,"otherNumAffected":8,"otherNumAtRisk":23}],"seriousEvents":[{"term":"Fatal Overdose","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":28},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":30}]}],"otherEvents":[{"term":"Non-fatal Overdose","organSystem":"Injury, poisoning and procedural complications","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Any overdose reported by participants in the 12 month post release interview. These were not related to participation in the study.","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":26},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":20},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":23}]},{"term":"ER visits","organSystem":"Injury, poisoning and procedural complications","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Any ER visits that were reported by participants in the 12 month post release interview. These were not related to participation in the study.","stats":[{"groupId":"EG000","numEvents":10,"numAffected":10,"numAtRisk":26},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":20},{"groupId":"EG002","numEvents":7,"numAffected":7,"numAtRisk":23}]},{"term":"Hospitalizations","organSystem":"Injury, poisoning and procedural complications","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Any hospitalizations that were reported by participants in the 12 month post release interview. These were not related to participation in the study.","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":26},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":23}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Josiah D. Rich, MD, MPH","organization":"The Miriam Hospital/Brown University","email":"jrich@lifespan.org","phone":"401-793-4770"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D009293","term":"Opioid-Related Disorders"}],"ancestors":[{"id":"D000079524","term":"Narcotic-Related Disorders"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D059039","term":"Standard of Care"}],"ancestors":[{"id":"D019984","term":"Quality Indicators, Health Care"},{"id":"D011787","term":"Quality of Health Care"},{"id":"D006298","term":"Health Services Administration"},{"id":"D017530","term":"Health Care Quality, Access, and Evaluation"}]}},"hasResults":true},{"protocolSection":{"identificationModule":{"nctId":"NCT05129735","orgStudyIdInfo":{"id":"20227Teatis"},"organization":{"fullName":"Teatis, Inc","class":"INDUSTRY"},"briefTitle":"An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.","officialTitle":"An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake."},"statusModule":{"statusVerifiedDate":"2024-08","overallStatus":"WITHDRAWN","whyStopped":"Sponsor withdrawn","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-09-15","type":"ESTIMATED"},"primaryCompletionDateStruct":{"date":"2022-12-30","type":"ESTIMATED"},"completionDateStruct":{"date":"2022-12-30","type":"ESTIMATED"},"studyFirstSubmitDate":"2021-11-03","studyFirstSubmitQcDate":"2021-11-18","studyFirstPostDateStruct":{"date":"2021-11-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-08-21","lastUpdatePostDateStruct":{"date":"2024-08-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Teatis, Inc","class":"INDUSTRY"},"collaborators":[{"name":"Citruslabs","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","interventionModelDescription":"This is an open-label single-arm observational trial","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":0,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Meal replacement shake","type":"EXPERIMENTAL","description":"Teatis meal replacement shake","interventionNames":["Dietary Supplement: Meal replacement shake"]}],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Meal replacement shake","description":"Each day for the study period (12 weeks), the participants will take one meal-replacement shake per day for breakfast. The breakfast will be replaced by the shake entirely.","armGroupLabels":["Meal replacement shake"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Improvement of quality of life score from baseline to 12-weeks","description":"Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score)","timeFrame":"12 weeks"}],"secondaryOutcomes":[{"measure":"Improvement in a1c levels from baseline to 12-weeks","description":"Change in a1c biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.","timeFrame":"12 weeks"},{"measure":"Improvement in blood glucose from baseline to 12-weeks","description":"Change in blood glucose biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.","timeFrame":"12 weeks"},{"measure":"Improvement in insulin levels from baseline to 12-weeks","description":"Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results.","timeFrame":"12 weeks"},{"measure":"Improvement in total cholesterol levels from baseline to 12-weeks","description":"Change in total cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.","timeFrame":"12 weeks"},{"measure":"Improvement in triglyceride levels from baseline to 12-weeks","description":"Change in triglyceride measured with an at-home blood test after 12 weeks compared to baseline results.","timeFrame":"12 weeks"},{"measure":"Improvement in HDL cholesterol levels from baseline to 12-weeks","description":"Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.","timeFrame":"12 weeks"},{"measure":"Improvement in LDL cholesterol levels from baseline to 12-weeks","description":"Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.","timeFrame":"12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or Female between 18-75 years old\n* Diagnosed with type 2 diabetes for at least 3 months\n* HbA1c of 7.5 to 10% inclusive\n* BMI of 27 to 40 kg/m2\n* If on any medication, treated with a stable dose for at least 90 days\n* Must be in good health (don't report any medical conditions asked in the screening questionnaire)\n* Willing and able to provide written informed consent\n* Must have a Glucometer at home\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes\n* Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months\n* Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study\n* Allergies to any test product ingredients\n* Has any of the following medical conditions:\n* Oncological conditions\n* Psychiatric disease\n* Cardiovascular disease: any hospitalization within the past 3 months\n* Multiple Sclerosis\n* Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.\n* Any other severe chronic disease\n* History of drug or alcohol abuse\n* Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study\n* Participation in a clinical research trial within 30 days prior to screening\n* Participating in an investigational health product research study\n* Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Susanne Mitschke, MSc","affiliation":"Citruslabs","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Citruslabs","city":"Santa Monica","state":"California","zip":"90404","country":"United States","geoPoint":{"lat":34.01949,"lon":-118.49138}}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT02295735","orgStudyIdInfo":{"id":"CRC-PU-A-16"},"organization":{"fullName":"Charite University, Berlin, Germany","class":"OTHER"},"briefTitle":"Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention","officialTitle":"A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings"},"statusModule":{"statusVerifiedDate":"2020-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-06","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-07","type":"ACTUAL"},"completionDateStruct":{"date":"2018-07","type":"ACTUAL"},"studyFirstSubmitDate":"2014-11-10","studyFirstSubmitQcDate":"2014-11-17","studyFirstPostDateStruct":{"date":"2014-11-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-05-11","resultsFirstSubmitQcDate":"2020-06-18","resultsFirstPostDateStruct":{"date":"2020-07-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-06-18","lastUpdatePostDateStruct":{"date":"2020-07-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"PD Dr. Jan Kottner","investigatorTitle":"PD Dr. rer cur","investigatorAffiliation":"Charite University, Berlin, Germany"},"leadSponsor":{"name":"PD Dr. Jan Kottner","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.","detailedDescription":"Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients."},"conditionsModule":{"conditions":["Pressure Ulcer"],"keywords":["Skin, safety, wounds, intensive care"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":475,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Mepilex® Border","type":"EXPERIMENTAL","description":"If a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and Mepilex® Border Heel will be applied onto the respective intact skin areas in addition to standard pressure ulcer prevention","interventionNames":["Device: Mepilex® Border Sacrum and Mepilex® Border Heel"]},{"label":"Control","type":"NO_INTERVENTION","description":"Standard pressure ulcer prevention according to hospital standard"}],"interventions":[{"type":"DEVICE","name":"Mepilex® Border Sacrum and Mepilex® Border Heel","armGroupLabels":["Mepilex® Border"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)","description":"The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"}],"secondaryOutcomes":[{"measure":"Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)","description":"The Incidence density of Pressure Ulcer category II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)","description":"The the cumulative incidence of Pressure ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)","description":"The Incidence density of Pressure Ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention","description":"Number of preventive sacrum dressings used for pressure ulcer prevention","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)","description":"Support surface categories were recorded. Please see the different types in the Outcome measure data table","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum","description":"• Time to Pressure ulcer development in days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention","description":"Number of preventive heel dressings used for pressure ulcer prevention","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum","description":"• Time to Pressure ulcer development in days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)","description":"• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)","description":"• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"},{"measure":"Follow up Period of Included ICU Patients (Days)","description":"Follow up period of included ICU patients in mean (days)","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days"}]},"eligibilityModule":{"eligibilityCriteria":"* Major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal ICU\n* Being at \"high\" or \"very high\" PU risk according to the Charité PU prevention standard:\n\n  \\- Category 3 (= partly care dependent/limited mobility in bed), 4A (= care depended, limited mobility in bed), 4B (= totally immobile) according to the Jones classification modified by Charité\n* Expected minimum length of stay at least three days\n* Informed consent (or by legal representative)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jan Kottner, PhD","affiliation":"Charite University, Berlin, Germany","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Charité-Universitätsmedizin Berlin","city":"Berlin","zip":"10117","country":"Germany","geoPoint":{"lat":52.52437,"lon":13.41053}}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"The study was conducted in a tertiary care hospital from June 2015 to July 2018 at the Charite Universitaetsmedizin Berlin, Germany. Patients were recruited from seven ICUs.\n\nIn total, 7575 ICU patients were screened for eligibility and 475 ICU patients were included.","groups":[{"id":"FG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"FG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"238"},{"groupId":"FG001","numSubjects":"237"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"212"},{"groupId":"FG001","numSubjects":"210"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"27"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"BG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"63.8","spread":"15.6"},{"groupId":"BG001","value":"63.1","spread":"15.2"},{"groupId":"BG002","value":"63.5","spread":"15.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"64"},{"groupId":"BG001","value":"82"},{"groupId":"BG002","value":"146"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"148"},{"groupId":"BG001","value":"128"},{"groupId":"BG002","value":"276"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Germany","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}]}]},{"title":"Body Mass Index","populationDescription":"The analyzed Population differs from the Overall due to missing data","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m²","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"199"},{"groupId":"BG001","value":"202"},{"groupId":"BG002","value":"401"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"26.4","spread":"4.9"},{"groupId":"BG001","value":"26.6","spread":"4.8"},{"groupId":"BG002","value":"26.5","spread":"4.9"}]}]}]},{"title":"Braden scale score","description":"The Braden scale is a standardized six item Pressure ulcer risk assessment instrument with scores ranging from 6 (= high Pressure ulcer risk) to 23 (= no Pressure ulcer risk).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.9","spread":"1.4"},{"groupId":"BG001","value":"9.0","spread":"1.6"},{"groupId":"BG002","value":"8.9","spread":"1.5"}]}]}]},{"title":"High Pressure ulcer risk","description":"According to Hospital Standard","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"39"}]}]}]},{"title":"Very high Pressure ulcer risk","description":"According to Hospital Standard","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"212"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"422"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"192"},{"groupId":"BG001","value":"191"},{"groupId":"BG002","value":"383"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)","description":"The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Pressure ulcer","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"22"}]}]}]},{"type":"SECONDARY","title":"Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)","description":"The Incidence density of Pressure Ulcer category II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Proportion developed / 1000 bed days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.8"},{"groupId":"OG001","value":"30.5"}]}]}]},{"type":"SECONDARY","title":"Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)","description":"The the cumulative incidence of Pressure ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Pressure ulcer","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"28"}]}]}]},{"type":"SECONDARY","title":"Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)","description":"The Incidence density of Pressure Ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Proportion developed / 1000 bed days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.0"},{"groupId":"OG001","value":"37.6"}]}]}]},{"type":"SECONDARY","title":"Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention","description":"Number of preventive sacrum dressings used for pressure ulcer prevention","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Dressings","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1050"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)","description":"Support surface categories were recorded. Please see the different types in the Outcome measure data table","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"number of support surfaces used","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"title":"Total numbers of support surfaces used","categories":[{"measurements":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"209"}]}]},{"title":"non-powered systems","categories":[{"measurements":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"117"}]}]},{"title":"powered - alternating Systems","categories":[{"measurements":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"85"}]}]},{"title":"powered - low-air-loss Systems","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"}]}]},{"title":"other","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}]}]},{"type":"SECONDARY","title":"Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum","description":"• Time to Pressure ulcer development in days","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"10.1"},{"groupId":"OG001","value":"13.5","spread":"13.8"}]}]}]},{"type":"SECONDARY","title":"Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention","description":"Number of preventive heel dressings used for pressure ulcer 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Deep Tissue Injury (DTI) at Heels and/or Sacrum","description":"• Time to Pressure ulcer development in days","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.8","spread":"10.1"},{"groupId":"OG001","value":"13.2","spread":"12.4"}]}]}]},{"type":"SECONDARY","title":"Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)","description":"• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60.7","spread":"4.1"},{"groupId":"OG001","value":"89.0","spread":"9.8"}]}]}]},{"type":"SECONDARY","title":"Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)","description":"• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60.7","spread":"4.1"},{"groupId":"OG001","value":"54.6","spread":"9.1"}]}]}]},{"type":"SECONDARY","title":"Follow up Period of Included ICU Patients (Days)","description":"Follow up period of included ICU patients in mean (days)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"Duration of hospital stay, an average of 12.6 (SD +/-12.7) days","groups":[{"id":"OG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care."},{"id":"OG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"212"},{"groupId":"OG001","value":"210"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.0","spread":"10.3"},{"groupId":"OG001","value":"14.3","spread":"14.6"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0.47","timeFrame":"Adverse events were recorded every day until the Patient was discharged from the Hospital,an average of 12.6 (SD +/-12.7) days","description":"Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device.\n\nNote: This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved. For users or other persons, this definition is restricted to events related to investigational medical devices.","eventGroups":[{"id":"EG000","title":"Intervention Group","description":"For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.","deathsNumAffected":0,"deathsNumAtRisk":212,"seriousNumAffected":0,"seriousNumAtRisk":212,"otherNumAffected":2,"otherNumAtRisk":212},{"id":"EG001","title":"Control Group","description":"Standard pressure ulcer prevention according to hospital standard","deathsNumAffected":0,"deathsNumAtRisk":210,"seriousNumAffected":0,"seriousNumAtRisk":210,"otherNumAffected":0,"otherNumAtRisk":210}],"otherEvents":[{"term":"Burning pain and warm sensation under the sacral dressing","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":212},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":210}]},{"term":"Peeling of the outer layers of the skin under the sacral dressing","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":212},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":210}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"PD Dr. Jan Kottner","organization":"Charité Universitätsmedizin Berlin, Department of Dermatology and Allergy","email":"jan.kottner@charite.de","phone":"+4930450518218"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2015-09-29","uploadDate":"2020-05-11T07:40","filename":"Prot_SAP_000.pdf","size":2683827}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D003668","term":"Pressure Ulcer"},{"id":"D014947","term":"Wounds and Injuries"}],"ancestors":[{"id":"D012883","term":"Skin Ulcer"},{"id":"D012871","term":"Skin Diseases"},{"id":"D017437","term":"Skin and Connective Tissue Diseases"}]}},"hasResults":true},{"protocolSection":{"identificationModule":{"nctId":"NCT06800235","orgStudyIdInfo":{"id":"635"},"organization":{"fullName":"University of Beykent","class":"OTHER"},"briefTitle":"The Effect of Computer-Aided Simulation Training on Aspiration Skills and General Efficacy Beliefs","officialTitle":"The Effect of Computer-Assisted Simulation Education on Aspiration Skills and General Efficacy Beliefs of Nursing Students"},"statusModule":{"statusVerifiedDate":"2025-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2024-11-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-11-20","type":"ACTUAL"},"completionDateStruct":{"date":"2024-12-20","type":"ACTUAL"},"studyFirstSubmitDate":"2025-01-23","studyFirstSubmitQcDate":"2025-01-23","studyFirstPostDateStruct":{"date":"2025-01-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-01-23","lastUpdatePostDateStruct":{"date":"2025-01-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Hamiyet KIZIL","investigatorTitle":"PhD RN Assistant Professor Hamiyet KIZIL","investigatorAffiliation":"University of Beykent"},"leadSponsor":{"name":"University of Beykent","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Purpose This study was conducted to determine the effect of computer-aided simulation education on nursing students' aspiration skills and general competence beliefs.\n\nResearch Hypotheses H1-1: Computer-aided simulation education has an effect on aspiration self-efficacy.\n\nH1-2: Computer-aided simulation education has an effect on nursing students' general competence beliefs.\n\nMethod\n\nResearch Design The research is a randomized controlled experimental study.\n\nPlace of the Research The research was conducted with students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year between November 20 and December 20, 2024.\n\nThe Universe and Sample of the Study The universe of the study consisted of students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year (N=126). The sample consisted of second year students who met the acceptance criteria of the study. Power analysis was performed to determine the number of people to be included in the study. Power analysis was calculated with the G\\*Power 3.1 program in the sample calculation. The effect size was taken as 0.80 as high level according to the difference between independent groups determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; a total of 70 people should be reached, 35 in each group at a significance level of 5% and an effect size of 0.80 (df=68; t=1.668).\n\nThe students were randomly assigned to the control and intervention groups. A randomization table was created using the website http://stattrek.com/statistics/random-number-generator.aspx.","detailedDescription":"Purpose This study was conducted to determine the effect of computer-aided simulation education on nursing students' aspiration skills and general competence beliefs.\n\nResearch Hypotheses H1-1: Computer-aided simulation education has an effect on aspiration self-efficacy.\n\nH1-2: Computer-aided simulation education has an effect on nursing students' general competence beliefs.\n\nMethod\n\nResearch Design The research is a randomized controlled experimental study.\n\nPlace of the Research The research was conducted with students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year between November 20 and December 20, 2024.\n\nThe Universe and Sample of the Study The universe of the study consisted of students studying in the second year of the nursing department of the faculty of health sciences of a state university in the fall semester of the 2024-2025 academic year (N=126). The sample consisted of second year students who met the acceptance criteria of the study. Power analysis was performed to determine the number of people to be included in the study. Power analysis was calculated with the G\\*Power 3.1 program in the sample calculation. The effect size was taken as 0.80 as high level according to the difference between independent groups determined by Cohen (1988). In order to exceed the 95% value in determining the power of the study; a total of 70 people should be reached, 35 in each group at a significance level of 5% and an effect size of 0.80 (df=68; t=1.668).\n\nThe students were randomly assigned to the control and intervention groups. A randomization table was created using the website http://stattrek.com/statistics/random-number-generator.aspx. Inclusion and Exclusion Criteria: Volunteer second-year nursing students were included in the study. Students who were absent from classes in the relevant period, who joined the department through horizontal and vertical transfer, who were unsuccessful in the Fundamentals of Nursing course, who experienced aspiration skill on a real patient, and students who did not volunteer to participate in the study will not be accepted.\n\nDependent, independent variables: The dependent variables of the study were determined as aspiration self-efficacy and general competence belief scale score average. Independent variables are other characteristics obtained in the student identification form (age, gender, etc.) Data Collection Tools Student Identification Form It was prepared by the researchers in line with the literature. It consists of 6 questions that include the introductory characteristics of nursing students and some information about their education (age, gender, academic grade point average, type of high school graduated, status of choosing the nursing department, status of fear of performing nursing practices).\n\nAspiration Skill Self-Assessment Form It was created by the researcher in order to evaluate the students' ability to perform the steps of the procedure related to aspiration application. The first form consisting of 25 items in a 5-point Likert type developed by the researchers for aspiration application skills was presented to a total of 10 experts from the field of nursing. The content validity index (CVI) of the expressions for the created items was calculated. In line with the expert opinions; adjustments were made regarding the items that were stated to be incomprehensible, had similar meanings, contained multiple judgments and would not measure the skill. In addition, the Cronbach Alpha value of the evaluation form for this study was determined as 0.882.\n\nGeneral Competence Belief Scale The scale to be used to measure the general competence belief of nursing students was created by Jerusalem and Schwarzer in 1992. Its adaptation to Turkish was also made by Çelik Kaleli and Çapri (2008) (Çelik Kaleli and Çapri, 2008). The scale has 10 items and a 4-point Likert type. The minimum score that can be obtained from the scale is 10, and the maximum score is 40. An increase in the score obtained by the participant indicates that the level of general competence belief also increases. The Cronbach Alpha value of the scale is 0.92. The Cronbach Alpha value of the scale for this study was obtained as 0.875.\n\nData Collection The data were collected by the researchers between November-December 2024. The study was started after obtaining permission from the ethics committee and the institution. At the beginning of the study, the purpose and process of the study were explained to the students and the \"Informed Voluntary Consent Form\" and \"Student Identification Form\" were filled out. After this consent, other forms were applied to the students as a pre-test. Then, the students were separated into experimental and control groups with a random number table and the education date and information were shared with the students. In the study, the control group was given standard education with a skill model and the experimental group was given education with a computer-aided simulation. The forms were applied again as a post-test after each group.\n\nEthical Aspect of the Study Before starting the study, approval was obtained from the Istanbul Beykent University Non-Interventional Ethics Committee (Date: 18.11.2024 and Number: 72128186/635) and institutional permission was obtained from the Tekirdağ Namık Kemal University Faculty of Health Sciences. The students were informed about the study and written consent was obtained from the students who volunteered to participate in the study. The study was conducted according to the principles of the Helsinki Declaration.\n\nData Evaluation The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods were used in the evaluation of the data: number, percentage, mean, standard deviation. Differences between the rates of categorical variables in independent groups were analyzed with Chi-Square and Fisher exact tests. Independent groups t-test was used to compare quantitative continuous data between two independent groups. Dependent groups t-test was used to compare within-group measurements. The results were evaluated at a 95% confidence interval and significance was at p\\<0.05."},"conditionsModule":{"conditions":["Aspiration Skill Self-assessment","General Competence Belief"],"keywords":["aspiration skill self-assessment","general competence belief","computer-based simulation","nursing practices"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":70,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Control Group (Standard Procedure)","type":"OTHER","description":"Nursing students in the control group were informed about the standard procedure/traditional method. They were also informed about the aspiration skill form and general competency scale.","interventionNames":["Other: Control grup"]},{"label":"Experimental Group","type":"EXPERIMENTAL","description":"Nursing students in the experimental group were informed about computer-based simulation. They were also informed about the aspiration skill form and general competency scale.","interventionNames":["Other: Computer-Assisted Simulation"]}],"interventions":[{"type":"OTHER","name":"Computer-Assisted Simulation","description":"Nursing students in the experimental group were informed about computer-based simulation. They were also informed about the aspiration skill form and general competency scale.","armGroupLabels":["Experimental Group"]},{"type":"OTHER","name":"Control grup","description":"Nursing students in the control group were informed about the standard procedure/traditional method. They were also informed about the aspiration skill form and general competency scale.","armGroupLabels":["Control Group (Standard Procedure)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Aspiration Skill Self-Assessment score average","description":"Nursing students were informed about the Aspiration Skill Self-Assessment Form","timeFrame":"1 month"},{"measure":"General Self-Efficacy Belief Scale score average","description":"Nursing students were informed about the general competency scale.","timeFrame":"1 month"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nParticipants;\n\n* Must be enrolled in a nursing program,\n* Must be a second year student,\n* Must be volunteers for the study.\n\nExclusion Criteria:\n\nParticipants;\n\n* Not registered in the nursing program,\n* Not being a second year student,\n* Having class absences,\n* Joining the department through horizontal or vertical transfer,\n* Not passing the Fundamentals of Nursing course,\n* Not having experienced aspiration skills on a real patient,\n* Not volunteering for the study.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"25 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Hamiyet Kızıl, Phd RN","affiliation":"Istanbul Beykent University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Hamiyet Kızıl","city":"Istanbul","country":"Turkey (Türkiye)","geoPoint":{"lat":41.01384,"lon":28.94966}}]},"referencesModule":{"references":[{"type":"RESULT","citation":"Gülbetekin, E., & Abi, Ö. (2023). Hemşirelik öğrencilerinin mesleki beceri laboratuvarı uygulamaları öncesi ve sonrası stres ve genel yetkinlik inancı düzeyleri: Hemşirelik öğrencilerinin mesleki beceri laboratuvarı uygulamaları. Journal of Infant, Child and Adolescent Health, 3(2), 111-119."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT00664508","orgStudyIdInfo":{"id":"2007-390"},"organization":{"fullName":"Ottawa Hospital Research Institute","class":"OTHER"},"briefTitle":"Mobility Assessment of Patients With Total Hip Arthroplasty","officialTitle":"Mobility Assessment of Patients With Total Hip Arthroplasty: Joint Mechanics and Rehabilitation"},"statusModule":{"statusVerifiedDate":"2024-01","overallStatus":"UNKNOWN","lastKnownStatus":"ACTIVE_NOT_RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-04-28","type":"ESTIMATED"},"completionDateStruct":{"date":"2024-04-28","type":"ESTIMATED"},"studyFirstSubmitDate":"2008-04-21","studyFirstSubmitQcDate":"2008-04-21","studyFirstPostDateStruct":{"date":"2008-04-23","type":"ESTIMATED"},"lastUpdateSubmitDate":"2024-01-02","lastUpdatePostDateStruct":{"date":"2024-01-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Ottawa Hospital Research Institute","class":"OTHER"},"collaborators":[{"name":"Canadian Institutes of Health Research (CIHR)","class":"OTHER_GOV"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to describe the 3D joint biomechanics of the lower extremities of patients having had a total hip replacement or hip resurfacing surgery as compared to a healthy age and weight matched control group during level walking, stair ascent and descent, and entering and exiting the front seat of a car.","detailedDescription":"Much research has shown that patients are generally satisfied with pain relief in the months and years following a total hip replacement (THR) or hip resurfacing procedure. However, many express dissatisfaction with their ability to perform daily activities, a reduced walking ability and long-term lower extremity muscle weakness. Given the general lack of knowledge surrounding joint motion of the lower extremities in the THR population, there is a need to characterize the joint mechanics of people having undergone THR, so that interventions and rehabilitation strategies can be designed to reduce post-operative complications and improve mobility."},"conditionsModule":{"conditions":["Osteoarthritis","Arthroplasty","Hip Replacement"],"keywords":["Arthroplasty","Hip Replacement","motion analysis"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Comparative study with a control group","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":30,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Lateral approach","type":"ACTIVE_COMPARATOR","description":"Lateral approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory","interventionNames":["Procedure: Motion analysis"]},{"label":"Anterior approach","type":"ACTIVE_COMPARATOR","description":"Anterior approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory","interventionNames":["Procedure: Motion analysis"]},{"label":"Posterior approach","type":"ACTIVE_COMPARATOR","description":"Posterior approach Intervention: Motion Analysis. Standard AP/Lateral x-rays of the hips, functional assessment questionnaires and 3D joint mechanic assessment at the Biomechanics Laboratory","interventionNames":["Procedure: Motion analysis"]}],"interventions":[{"type":"PROCEDURE","name":"Motion analysis","description":"Motion analysis will be administered to each of the three groups: Lateral approach, anterior approach and posterior approach","armGroupLabels":["Anterior approach","Lateral approach","Posterior approach"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Joint mechanics of people having undergone total hip replacement","description":"3D joint mechanics of the lower extremities during level walking, stair ascent and descent, and entering and exiting the front seat of the car","timeFrame":"6-18 months post surgery"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 15 patients between the ages of 50 and 75 yrs having undergone a primary total hip replacement or hip resurfacing within 6 to 18 months of the study will participate, as well as an equal number of age, sex, height and weight matched healthy control participants.\n\nExclusion Criteria:\n\n* Potential participants for the control group will be asked if they have had previous lower limb ailments or surgery, and if they have they will be excluded. Moreover, the THR participants cannot have had secondary hip replacement due to infection, revision surgery, or a concomitant surgical procedure (i.e., graft). Participants from both groups cannot have had any medical conditions which could affect physical movement such as a stroke.","healthyVolunteers":true,"sex":"ALL","minimumAge":"50 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Paul E Beaule, MD, FRCSC","affiliation":"University of Ottawa / The Ottawa Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"OHRI","city":"Ottawa","state":"Ontario","zip":"K1Y4E9","country":"Canada","geoPoint":{"lat":45.41117,"lon":-75.69812}}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-07-24"},"conditionBrowseModule":{"meshes":[{"id":"D010003","term":"Osteoarthritis"}],"ancestors":[{"id":"D001168","term":"Arthritis"},{"id":"D007592","term":"Joint Diseases"},{"id":"D009140","term":"Musculoskeletal Diseases"},{"id":"D012216","term":"Rheumatic Diseases"}]}},"hasResults":false}],"nextPageToken":"ZVdj7o2Elu8o3lp3Rcmm4Krumo6Qf5BsZ_Sl1Pg","fetched_at":"2026-07-25T12:29:20.142Z"},"via":"native","generated_at":"2026-07-25T12:29:20.152Z"}