protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Coma",
"Brain Injuries, Traumatic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hefei",
"contacts": [
{
"email": null,
"name": "Yongming Zhang, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Anhui No.2 Provincial People's Hospital",
"geoPoint": {
"lat": 31.86389,
"lon": 117.28083
},
"state": "Anhui",
"status": null,
"zip": null
},
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Guoyi Gao, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Tiantan Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": null
},
{
"city": "Changsha",
"contacts": [
{
"email": null,
"name": "Jinfang Liu, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xiangya Hospital, Central South University",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan",
"status": null,
"zip": null
},
{
"city": "Nanjing",
"contacts": [
{
"email": null,
"name": "Chiyuan Ma, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The General Hospital of Eastern Theater Command",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": null,
"zip": null
},
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Junfeng Feng",
"phone": "+8613611860825",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "201114"
}
]
},
"descriptionModule": {
"briefSummary": "Development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. We aim to conduct multicenter prospective observational study and non-invasively collect EEG from patients with traumatic coma to analyze the sequential characteristics of EEG power spectrum, and explore their prognostic value for consciousness recovery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 210,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EPIC",
"briefTitle": "Evaluation of EEG Power Spectrum in Patients With Traumatic Coma",
"nctId": "NCT06321146",
"orgStudyIdInfo": {
"id": "LY2024-029-B",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "EEG power spectrum"
}
],
"secondaryOutcomes": [
{
"measure": "Coma Recovery Scale-Revised (CRS-R)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Beijing Tiantan Hospital"
},
{
"name": "Xiangya Hospital of Central South University"
},
{
"name": "The General Hospital of Eastern Theater Command"
},
{
"name": "Anhui No.2 Provincial People's Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "RenJi Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High flow nasal cannula immediate ending"
},
{
"name": "High flow nasal cannula weaning"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Bronchiolitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Joensuu",
"contacts": [
{
"email": "[email protected]",
"name": "Paula Widgren, MD, PhD",
"phone": "0045813 330 8285",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Finland",
"facility": "Siun Sote",
"geoPoint": {
"lat": 62.60118,
"lon": 29.76316
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Jyväskylä",
"contacts": [
{
"email": "[email protected]",
"name": "Milla Pitkänen, MD",
"phone": "0035814 2691811",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Finland",
"facility": "Central Finland Hospital District",
"geoPoint": {
"lat": 62.24147,
"lon": 25.72088
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Kuopio",
"contacts": [
{
"email": "[email protected]",
"name": "Ilari Kuitunen, MD, PhD",
"phone": "+358447174910",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marjo Renko, Professor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Katri Backman, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Miika Arvonen, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Finland",
"facility": "Kuopio University Hospital",
"geoPoint": {
"lat": 62.89238,
"lon": 27.67703
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Mikkeli",
"contacts": [
{
"email": "[email protected]",
"name": "Nicole Weisshoff, MD",
"phone": "0035815 3511",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Finland",
"facility": "Mikkeli Central Hospital",
"geoPoint": {
"lat": 61.68857,
"lon": 27.27227
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Months",
"minimumAge": "0 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High Flow Nasal Cannula Weaning in Acute Bronchiolitis",
"nctId": "NCT06321133",
"orgStudyIdInfo": {
"id": "5402589",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hospitalization time from randomization"
}
],
"secondaryOutcomes": [
{
"measure": "Treatment failures"
},
{
"measure": "Readmission rate"
},
{
"measure": "Overall hospitalization time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Central Finland Hospital District"
},
{
"name": "Mikkeli Central Hospital"
},
{
"name": "Siun sote"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kuopio University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "variability-based lenvatinib regimen"
}
]
},
"conditionsModule": {
"conditions": [
"Lenvatinib Treatment"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jerusalem",
"contacts": [
{
"email": "[email protected]",
"name": "Hadas Lemberg, PhD",
"phone": "+97226777572",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Israel",
"facility": "Hadassah Medical Organization",
"geoPoint": {
"lat": 31.76904,
"lon": 35.21633
},
"state": null,
"status": "RECRUITING",
"zip": "91120"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this proof-of-concept clinical trial is to assess the efficacy and safety of chronobiology implementation into lenvatinib treatment regimens of thyroid cancer patients, via a mobile application.Participants will use a mobile application to follow variability-based physician approved drug administration schedules."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "An open-labeled, prospective, single-center proof-of-concept clinical trial lasting 14 weeks was conducted to investigate the impact of an algorithm-based regimen on enhancing lenvatinib effectiveness.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Using Chronobiology to Improve Lenvatinib Efficacy",
"nctId": "NCT06321120",
"orgStudyIdInfo": {
"id": "0749-21-HMO-CTIL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "disease progression/ tumor response"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse effects occurrence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hadassah Medical Organization"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Infertility"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": null,
"country": "China",
"facility": "The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the safety of a single injection of GenSci094 during Controlled Ovarian Stimulation up to 1 year old of the infants from previous studies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 158,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "39 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference",
"nctId": "NCT06321107",
"orgStudyIdInfo": {
"id": "GenSci094-304",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Summary of Pregnancy Outcome"
}
],
"secondaryOutcomes": [
{
"measure": "neonatal birth outcomes"
},
{
"measure": "Infant development"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Sixth Affiliated Hospital, Sun Yat-sen University"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Changchun GeneScience Pharmaceutical Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vericiguat"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Coronary Syndrome",
"Heart Failure With Reduced Ejection Fraction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": "[email protected]",
"name": "Liansheng Wang, Doctor",
"phone": "85 25 68303830",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "the First Affiliated Hospital of Nanjing Medical University",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection \\<45% between participants who take vericiguat regularly and those who donot."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Vericiguat on Endpoint Events in Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45%",
"nctId": "NCT06321094",
"orgStudyIdInfo": {
"id": "VERI-ACS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "a composite of death from cardiovascular causes or first hospitalization for heart failure"
}
],
"secondaryOutcomes": [
{
"measure": "results of echocardiogram"
},
{
"measure": "the numerical value of NT-proBNP"
},
{
"measure": "level of procalcitonin"
},
{
"measure": "interleukin-6 level"
},
{
"measure": "life quality score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital with Nanjing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "irinotecan, cetuximab, envafolimab"
}
]
},
"conditionsModule": {
"conditions": [
"RAS Mutation",
"Metastatic Colorectal Cancer",
"MSS"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Yingying Huang",
"phone": "86-10-85136715",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100730"
}
]
},
"descriptionModule": {
"briefSummary": "This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC",
"nctId": "NCT06321081",
"orgStudyIdInfo": {
"id": "2023BJYYEC-428-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "progression free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overal survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bethune Charitable Foundation"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Beijing Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "carboplatin"
},
{
"name": "Paclitaxel"
},
{
"name": "Recombinant humanized anti-PD-1 monoclonal antibody injection"
}
]
},
"conditionsModule": {
"conditions": [
"Endometrial Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": [
{
"email": "[email protected]",
"name": "Qi Zhou",
"phone": "86-13708384529",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Affiliated Cancer Hospital of Chongqing University",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": "Chongqing",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR) endometrial carcinoma"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer",
"nctId": "NCT06321068",
"orgStudyIdInfo": {
"id": "BAT-1308-003-CR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "vital signs"
},
{
"measure": "Physical examination"
},
{
"measure": "Adverse events"
},
{
"measure": "Clinical laboratory tests"
},
{
"measure": "Clinical auxiliary tests"
},
{
"measure": "Dose-limiting toxicity (DLT)"
},
{
"measure": "Progression Free Survival"
}
],
"secondaryOutcomes": [
{
"measure": "Initial efficacy"
},
{
"measure": "Pharmacokinetic"
},
{
"measure": "Pharmacokinetic"
},
{
"measure": "Pharmacokinetic"
},
{
"measure": "Pharmacokinetic"
},
{
"measure": "Immunogenicity"
},
{
"measure": "Immunogenicity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bio-Thera Solutions"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Regorafenib (Stivarga, BAY73-4506)"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Gastrointestinal Stromal Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Whippany",
"contacts": null,
"country": "United States",
"facility": "Bayer",
"geoPoint": {
"lat": 40.82454,
"lon": -74.4171
},
"state": "New Jersey",
"status": null,
"zip": "07981"
}
]
},
"descriptionModule": {
"briefSummary": "This is an observational study in which data already collected from people with advanced gastrointestinal stromal tumors are studied.In this observational study data are collected from participants who have private insurance or Medicare and who had started regorafenib treatment.Gastrointestinal stromal tumor (GIST) is a type of cancer that most commonly originates from the stomach or small intestine. Advanced means that the cancer has spread to other parts of the body.The study drug, regorafenib, is already approved for doctors to prescribe to people with GIST. Regorafenib works by blocking certain proteins that cause the growth of cancer cells. Regorafenib is recommended as the third choice of treatment for patients after imatinib and sunitinib have stopped working or have caused side effects that are too severe to continue the treatment. In addition, it is also the recommended first choice of treatment in people with GIST who had low levels of protein called succinate dehydrogenase (SDH) protein. This condition is called SDHdeficient GIST. However, doctors might sometimes give it in a different order. To better understand the treatment patterns with regorafenib for GIST, more knowledge is needed about its use in the real world.The participants in this study had started treatment with regorafenib as part of their regular care from their doctors.The main purpose of this study is to learn more about the use of regorafenib treatment among people with advanced GIST who have private insurance or Medicare in the United States. To do this, researchers will collect information on:Duration of treatment with regorafenib (also known as duration of therapy)The length of time it took for participants to switch to another GIST treatment after starting regorafenib (also known as time to next therapy)The data will come from the participants' information stored in a database, called Merative MarketScan for people in the United States. Data collected will be from April 2002 to September 2023.Researchers will track the data of people with GIST who started regorafenib and will follow them for at least 28 days.In this study, only available data are collected. No visits or tests are required as part of this study."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 136,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States",
"nctId": "NCT06321055",
"orgStudyIdInfo": {
"id": "22533",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Duration of Therapy (DOT) on regorafenib"
},
{
"measure": "Time to Next Therapy (TTNT) therapy after regorafenib"
}
],
"secondaryOutcomes": [
{
"measure": "Number of the guideline-listed medications other than regorafenib"
},
{
"measure": "Descriptive analysis of baseline demographic"
},
{
"measure": "Descriptive analysis of clinical characteristics"
},
{
"measure": "Number of patients with evidence of any metastasis on or after the index date during the follow-up period."
},
{
"measure": "Number of patients with evidence of surgery on or after the index date during the follow-up period using Current Procedural Terminology (CPT) codes and International Classification of Disease 9/10 Procedure codes (ICD-PC)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bayer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Knee arthroplasty"
}
]
},
"conditionsModule": {
"conditions": [
"Prosthesis Durability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Stefano Zaffagnini, MD",
"phone": "051 6366075",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Stefano Zaffagnini",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": "Italia",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SYMPHO-EM",
"briefTitle": "Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors",
"nctId": "NCT06321042",
"orgStudyIdInfo": {
"id": "SYMPHO-EM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Knee Society Score"
},
{
"measure": "Knee Society Score"
},
{
"measure": "Knee Society Score"
},
{
"measure": "Knee Society Score"
},
{
"measure": "Western Ontario and McMaster Universities Arthritis Index"
},
{
"measure": "Western Ontario and McMaster Universities Arthritis Index"
},
{
"measure": "Western Ontario and McMaster Universities Arthritis Index"
},
{
"measure": "Western Ontario and McMaster Universities Arthritis Index"
},
{
"measure": "Knee injury and Osteoarthritis Outcome Score"
},
{
"measure": "Knee injury and Osteoarthritis Outcome Score"
},
{
"measure": "Knee injury and Osteoarthritis Outcome Score"
},
{
"measure": "Knee injury and Osteoarthritis Outcome Score"
},
{
"measure": "36-Item Short Form Health Survey"
},
{
"measure": "36-Item Short Form Health Survey"
},
{
"measure": "36-Item Short Form Health Survey"
},
{
"measure": "36-Item Short Form Health Survey"
},
{
"measure": "Forgotten joint score"
},
{
"measure": "Forgotten joint score"
},
{
"measure": "Forgotten joint score"
},
{
"measure": "Forgotten joint score"
}
],
"secondaryOutcomes": [
{
"measure": "Radiographic evaluation of prosthetic femoral component positioning"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Ortopedico Rizzoli"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diabetes Tune-Up Group"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2",
"Diabetes Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Indianapolis",
"contacts": [
{
"email": "[email protected]",
"name": "Barb Myers, MS",
"phone": "317-278-7339",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mary de Groot, PhD",
"phone": "317-278-1965",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mary de Groot, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Indiana University School of Medicine",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
},
"state": "Indiana",
"status": "RECRUITING",
"zip": "46202"
}
]
},
"descriptionModule": {
"briefSummary": "The primary aims of this study are:1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction scores) and well-subscribed (intervention attendance rates).2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in diabetes distress and A1c compared to waitlist control. In order to conserve sample size and budget, participants in each intervention group will serve as their own waitlist control.Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 \\& T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (T2-T3 \\& T4). The hypothesis is that both groups will show comparable improvements in diabetes distress and A1c."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Single group waitlist control",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Electronic Diabetes Tune-Up Group (eDTU) for African Americans",
"nctId": "NCT06321029",
"orgStudyIdInfo": {
"id": "4-22-ICTSHD-44",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diabetes Distress Scale-17 (DDS-17)"
},
{
"measure": "HbA1c (A1c)"
},
{
"measure": "Acceptability of intervention (content and delivery modality)"
},
{
"measure": "Feasibility of intervention and delivery modality"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Health Questionnaire-9 (PHQ-9)"
},
{
"measure": "Confidence in Diabetes Self-Care (CDSC)"
},
{
"measure": "Short Form-12 (SF-12)"
},
{
"measure": "Diabetes Therapy-Related Quality of Life Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Indiana University Health"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Indiana University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physical exercise program"
},
{
"name": "Type of the physical exercise program"
}
]
},
"conditionsModule": {
"conditions": [
"Exercise",
"Childhood Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Objective: To assess the feasibility of a supervised, controlled and personalised physical exercise programme and its potential efficacy in improving functional capacity and quality of life in children and adolescents with cancer.Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation.Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 patients each, aged 4-18 years diagnosed with any type of cancer. Variables: clinical and socio-demographic, body composition, physical condition and mobility, quality of life, physical activity and implementation. Intervention: Everyone will receive a physical exercise intervention combining strength and aerobic capacity work. Initially it will be carried out in the hospital setting, and later in streaming supervised by a professional. The intervention will be modelled through a formative evaluation process with the collaboration of all the agents involved, experimenting in each cycle with an increasingly adapted version of the exercise programme.Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to change, which will then be used in phase II and III trials."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "PoziKids",
"briefTitle": "POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer",
"nctId": "NCT06321016",
"orgStudyIdInfo": {
"id": "2023111039",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Quarterly recruitment rates assessed by comparing those who participate with those who do not."
},
{
"measure": "Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol"
},
{
"measure": "Body composition assessed by the Body Mass Index"
},
{
"measure": "Muscle mass"
},
{
"measure": "Bone mineral density"
},
{
"measure": "Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer"
},
{
"measure": "Muscular strength assessed by manual grip test with a dynamometer"
},
{
"measure": "General Quality of life assessed by the PedsQL 4.0 questionnaire"
},
{
"measure": "Specific Quality of life assessed by the PedsQL cancer questionnaire"
},
{
"measure": "Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS)"
},
{
"measure": "Physical activity level assessed by accelerometers"
}
],
"secondaryOutcomes": [
{
"measure": "Security assessment"
},
{
"measure": "Costs associated estimation"
},
{
"measure": "Implementation barriers and facilitators"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Nere Mendizabal"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "OCT (Optical Coherence Tomography)"
}
]
},
"conditionsModule": {
"conditions": [
"Oral Squamous Cell Carcinoma",
"Oral Potentially Malignant Disorder",
"Oral Leukoplakia",
"Proliferative Verrucous Leukoplakia",
"Oral Lichen Planus",
"Oral Lichenoid Lesion",
"Graft-versus-host-disease",
"Oral Erythroplakia",
"Actinic Keratoses",
"Actinic Cheilitis",
"Oral Cancer",
"Oral Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palermo",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": "091 238 93011",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "University of Palermo",
"geoPoint": {
"lat": 38.13205,
"lon": 13.33561
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SYMILIS OCT",
"briefTitle": "SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography",
"nctId": "NCT06321003",
"orgStudyIdInfo": {
"id": "OCT01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Phase I: Standardization of Biopsy and OCT Imaging Techniques"
},
{
"measure": "Phase II: Development of Standardized OCT Patterns, Creation of Comprehensive Image Repository, and Training Algorithms"
},
{
"measure": "Phase III: Development and Large-Scale Validation of Diagnostic OCT Software"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Palermo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tamoxifen 20mg"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Cyst",
"Pancreatic Mucinous Cystic Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Omaha",
"contacts": [
{
"email": "[email protected]",
"name": "Christina Hoy, DNP",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kelsey Klute, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Nebraska Medical Center",
"geoPoint": {
"lat": 41.25626,
"lon": -95.94043
},
"state": "Nebraska",
"status": null,
"zip": "68198"
}
]
},
"descriptionModule": {
"briefSummary": "This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic MCN who will not undergo immediate resection. Up to 15 subjects will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MCN_Tam",
"briefTitle": "Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection",
"nctId": "NCT06320990",
"orgStudyIdInfo": {
"id": "0074-24-CB",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility, by adherence rate"
},
{
"measure": "Feasibility, by retention rate"
}
],
"secondaryOutcomes": [
{
"measure": "Objective response rate (ORR) of pancreatic MCN"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Nebraska"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Static Stretching"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Porto",
"contacts": null,
"country": "Portugal",
"facility": "Escola Superior de Saúde Fernando Pessoa",
"geoPoint": {
"lat": 41.14961,
"lon": -8.61099
},
"state": null,
"status": null,
"zip": "4200-253"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study isto investigate the influence of acute static stretching on the ankle joint position sense of soccer players."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 19,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Influence of Acute Static Stretching on the Ankle Joint-position Sense of Soccer Players",
"nctId": "NCT06320977",
"orgStudyIdInfo": {
"id": "ESS/FSA-397/23-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Absolute angular error"
},
{
"measure": "Relative angular error"
},
{
"measure": "Variable angular error"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Fernando Pessoa"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TARANG"
}
]
},
"conditionsModule": {
"conditions": [
"Feasibility",
"Acceptability",
"Family Planning",
"Unintended Pregnancy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Udaipur",
"contacts": null,
"country": "India",
"facility": "Vikalp Sansthan",
"geoPoint": {
"lat": 24.58584,
"lon": 73.71346
},
"state": "Rajasthan",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The mixed methods pilot study aims to evaluate the acceptability, feasibility, and implementation challenges of the TARANG intervention in villages in rural/tribal Rajasthan to inform the study design and operational details for a larger cluster-randomized controlled trial."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 135,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TARANG Pilot",
"briefTitle": "The TARANG Intervention",
"nctId": "NCT06320964",
"orgStudyIdInfo": {
"id": "R01HD108252_1",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01HD108252",
"link": "https://reporter.nih.gov/quickSearch/R01HD108252",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility of the intervention"
},
{
"measure": "Acceptability"
},
{
"measure": "Usefulness"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Network for Engineering and Economics Research and Management"
},
{
"name": "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)"
},
{
"name": "Vikalp Sansthan"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Francisco"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vericiguat 10 MG"
},
{
"name": "Placebo"
},
{
"name": "Insulin Sensitivity Test"
},
{
"name": "Resting Energy and Exercise Energy Expenditure Assessment"
},
{
"name": "White Adipose Tissue Biopsy"
},
{
"name": "MRI-PET Scan for Brown Adipose Tissue Volume Assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Insulin Sensitivity/Resistance",
"Metabolic Disease",
"Metabolism",
"Energy Expenditure",
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Birmingham",
"contacts": null,
"country": "United States",
"facility": "University of Alabama at Birmingham",
"geoPoint": {
"lat": 33.52066,
"lon": -86.80249
},
"state": "Alabama",
"status": null,
"zip": "35294"
}
]
},
"descriptionModule": {
"briefSummary": "This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Given that this population has been shown to have lower cGMP activity and the association of lower cGMP activity with increased cardiometabolic disease risk, the proposed study hypothesizes that augmenting cGMP activity in obese individuals will improve insulin sensitivity and energy expenditure. This study is a placebo-controlled randomized trial involving 200 Black obese participants with insulin resistance, assessing the effects of vericiguat on insulin sensitivity, resting, and exercise-induced energy expenditure over 12 weeks. Additionally, it will explore changes in brown adipose tissue and gene expression related to energy metabolism in white adipose tissue, aiming to provide insights into how increasing cGMP activity may improve cardiometabolic health in Black obese individuals."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VITAL-IMPACT",
"briefTitle": "VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway",
"nctId": "NCT06320951",
"orgStudyIdInfo": {
"id": "300012681",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Pending",
"id": "Pending",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance."
},
{
"measure": "Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance."
}
],
"secondaryOutcomes": [
{
"measure": "Change in BAT volume after vericiguat in Black obese individuals with insulin resistance."
},
{
"measure": "Change in BAT activity after vericiguat in Black obese individuals with insulin resistance."
},
{
"measure": "Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance."
},
{
"measure": "Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance."
},
{
"measure": "Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance."
},
{
"measure": "Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance."
},
{
"measure": "Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance."
},
{
"measure": "Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Alabama at Birmingham"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neuroscience-Based Pain Education Combined with Home Exercise Program"
},
{
"name": "Myofascial Induction Techniques Combined with Home Exercise Program"
},
{
"name": "Home Exercises Group"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Spine Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kahramanmaraş",
"contacts": null,
"country": "Turkey",
"facility": "Türkoğlu Dr. Kemal Beyazıt State Hospital",
"geoPoint": {
"lat": 37.5847,
"lon": 36.92641
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The effectiveness of neuroscience-based pain education, myofascial induction technique, and home exercise programs will be compared in patients with chronic neck pain."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain",
"nctId": "NCT06320938",
"orgStudyIdInfo": {
"id": "2024/18",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Short Form McGill Pain Questionnaire"
},
{
"measure": "Algometric Digital Measurement"
},
{
"measure": "Central Sensitization Inventory"
},
{
"measure": "Head Posture Evaluation"
},
{
"measure": "Neck Disability Index"
},
{
"measure": "Pittsburgh Sleep Quality Index"
},
{
"measure": "36-Item Short Form Health Survey Questionnaire"
},
{
"measure": "Pain Catastrophizing Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Turkoglu Dr. Kemal Beyazit State Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Standard of Care Treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Shoulder Injuries",
"Knee Injuries",
"Hip Injuries"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Phoenix",
"contacts": [
{
"email": "[email protected]",
"name": "Wafa Mohsin",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael Amini, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Musculoskeletal-Orthopedic Research and Education Foundation",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona",
"status": "RECRUITING",
"zip": "85023"
},
{
"city": "Englewood",
"contacts": [
{
"email": "[email protected]",
"name": "Lauren Heylmun",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "James Genuario, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Steadman Hawkins Clinic Denver",
"geoPoint": {
"lat": 39.64777,
"lon": -104.98776
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80112"
},
{
"city": "San Antonio",
"contacts": [
{
"email": "[email protected]",
"name": "Amanda Strickland",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Robert Hartzler, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "TSAOG Orthopaedics & Spine",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78258"
}
]
},
"descriptionModule": {
"briefSummary": "Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "SportsPro: Post-Market Clinical Follow Up Study",
"nctId": "NCT06320925",
"orgStudyIdInfo": {
"id": "SYK-SM-2022-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ASES"
},
{
"measure": "iHOT-12"
},
{
"measure": "mHHS"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Stryker Endoscopy"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The intraparenchymal portal vein covered stent"
},
{
"name": "TIPS Covered Stent System GORE"
}
]
},
"conditionsModule": {
"conditions": [
"Portal Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": null,
"name": "Jianbo Zhao",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Southern Medical University Nanfang Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 258,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications",
"nctId": "NCT06320912",
"orgStudyIdInfo": {
"id": "TIPS01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative Stent Patency Rate"
}
],
"secondaryOutcomes": [
{
"measure": "Immediate Postoperative Technical Success Rate"
},
{
"measure": "Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively"
},
{
"measure": "Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively"
},
{
"measure": "Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively"
},
{
"measure": "All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively"
},
{
"measure": "Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively"
},
{
"measure": "Incidence of Portal Hypertension Rebleeding Confirmed by Endoscopy or Clinical Investigator at 1 Month, 6 Months, and 12 Months Postoperatively (For Original Bleeding Subjects Only)"
},
{
"measure": "Incidence of Ultrasound-Confirmed Recurrence of Grade 2 or Higher Ascites due to Portal Hypertension at 1 Month, 6 Months, and 12 Months Postoperatively (For Subjects with Original Ascites Only)"
},
{
"measure": "Incidence of Adverse Events/Serious Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Shanghai Shenqi Medical Technology Co., Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SpineShape System IV straight rod elastic"
},
{
"name": "SpineShape System IV straight rod medium"
},
{
"name": "SpineShape System IV straight rod stiff"
}
]
},
"conditionsModule": {
"conditions": [
"Degenerative Lumbar Spinal Stenosis",
"Facet Joint Arthrosis",
"Spondylarthritis",
"Discopathy",
"Degenerative Spondylolisthesis",
"Instability Lumbar Spine"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 126,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases",
"nctId": "NCT06320899",
"orgStudyIdInfo": {
"id": "SpineShape_CH_001",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Ethics Committee Bern",
"id": "BASEC 2023-D0092",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "VAS Score lower back pain"
}
],
"secondaryOutcomes": [
{
"measure": "VAS Score leg pain"
},
{
"measure": "walking duration"
},
{
"measure": "medication consumption"
},
{
"measure": "adverse events"
},
{
"measure": "segmental mobility index level"
},
{
"measure": "ability to work/ activity (for retirees)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "SpineSave AG"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2031-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diagnostic Test"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Abdomen",
"In Adults"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sohag",
"contacts": [
{
"email": null,
"name": "Magdy M Amin, Proffesor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Sohag University Hospital",
"geoPoint": {
"lat": 26.55695,
"lon": 31.69478
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to evaluate the role of Ultrasonography in the diagnosis of the cause of acute abdominal pain in 50 adults presenting in the ER at Sohag University Hospital and compares it to the Computed Tomography scan results of the same patients to discover the superiority of both over the other in the diagnosis of different acute abdomen cases."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan",
"nctId": "NCT06320886",
"orgStudyIdInfo": {
"id": "Soh-Med-24-02-05MS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison between the role of Ultrasonography and Computed Tomography in Acute Abdomen diagnosis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sohag University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
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"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "archery respiratory parameters"
}
]
},
"conditionsModule": {
"conditions": [
"Sports Physical Therapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Halic University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Purpose: The physical, physiological, and functional characteristics of archers affect target shooting performance. In our study, we aimed to examine the effect of pulmonary functions and respiratory muscle strength on sports performance in archers.Methods: Our study included 46 (27 female, 19 male) professional archers registered in archery sports clubs. Sociodemographic and physical characteristics were recorded. Pulmonary function test (PFT), respiratory muscle strength, shooting performance test, Moberg-pickup collection test, Nelson hand reaction test, and Fatigue Severity Scale (FSS) were applied to all participants."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
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"whoMasked": null
},
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"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Respiratory on Sports Performance in Archers",
"nctId": "NCT06320873",
"orgStudyIdInfo": {
"id": "zselcuk1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "FEV1 (liter)"
},
{
"measure": "FEV1 (%-percentage)"
},
{
"measure": "FVC (liter)"
},
{
"measure": "FVC (%-percentage)"
},
{
"measure": "FEV1/FVC (percentage)"
},
{
"measure": "Inspiratory muscle test"
},
{
"measure": "Expiratory muscle test"
},
{
"measure": "Shooting performance"
},
{
"measure": "Nelson Hand Reaction Test"
},
{
"measure": "Moberg-pickup collection test"
},
{
"measure": "The Fatigue Severity Scale (FSS)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Halic University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-07-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Kidney Stone Retrieval"
}
]
},
"conditionsModule": {
"conditions": [
"Kidney Calculi"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nashville",
"contacts": null,
"country": "United States",
"facility": "Vanderbilt University Medical Center",
"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee",
"status": null,
"zip": "37203"
}
]
},
"descriptionModule": {
"briefSummary": "This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DEVICE_FEASIBILITY",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "FlexStone Enabled Kidney Stone Retrieval",
"nctId": "NCT06320860",
"orgStudyIdInfo": {
"id": "IRB231189",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Successful retrieval of kidney stones"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Vanderbilt University Medical Center"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "EndoTheia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-09-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "rPPG"
}
]
},
"conditionsModule": {
"conditions": [
"Remote Photoplethysmography , Blood Pressure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Singapore",
"contacts": [
{
"email": "[email protected]",
"name": "Hairil Rizal Abdullah",
"phone": "63265428",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hairil Rizal Abdullah",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Jia Xin Chai",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Singapore",
"facility": "Singapore General Hospital",
"geoPoint": {
"lat": 1.28967,
"lon": 103.85007
},
"state": null,
"status": "RECRUITING",
"zip": "169608"
}
]
},
"descriptionModule": {
"briefSummary": "Significant advancements in the field of medical technologies have resulted in the rise of contact-free methods of haemodynamic monitoring. Remote photoplethysmography (rPPG) is a videobased, contactless form of monitoring that operates through a camera-enabled device. This innovation interprets minute variations in skin colour due to blood flow which, when analysed with complex signal processing algorithms, generates vital sign readings. Currently, Nervotec's rPPG technology allows for the collection of rPPG waveforms, which enables the measurement of heart rate, heart rate variability, respiration rate and blood oxygen saturation (SpO2) level through signal processing techniques. The plethysmography signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and BP can be studied."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Predictive Remote Photoplethysmography Algorithm for Blood Pressure Pressure Assessment and Monitoring",
"nctId": "NCT06320847",
"orgStudyIdInfo": {
"id": "Predictbloodpressure",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To determine the correlation between remote photoplethysmography (rPPG) and blood pressure variations."
},
{
"measure": "To develop a predictive model in using rPPG for determination of blood pressure."
},
{
"measure": "To validate this predictive model by comparing blood pressure readings obtained using rPPG with standard procedures such as contact sensors and automated oscillometry."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Nervotec Pte. Ltd."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Singapore General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": null,
"contactsLocationsModule": null,
"descriptionModule": null,
"designModule": null,
"eligibilityModule": null,
"identificationModule": {
"acronym": null,
"briefTitle": "[Trial of device that is not approved or cleared by the U.S. FDA]",
"nctId": "NCT06320834",
"orgStudyIdInfo": {
"id": "PTL-1000294",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": null,
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": null,
"name": "[Redacted]"
}
},
"statusModule": {
"completionDateStruct": null,
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "WITHHELD",
"primaryCompletionDateStruct": null,
"resultsFirstPostDateStruct": null,
"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Kidney Transplantation",
"Robotic Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Seoul National University Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": null,
"zip": "110-744"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to compare outcomes of robot-assisted kidney transplantation and open kidney transplantation. The main questions are- comprehensively analyze our early experience of robot-assisted kidney transplant patients and compare the results with those of open kidney transplant patients"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "RAKT OUTCOME ANALYSIS",
"nctId": "NCT06320821",
"orgStudyIdInfo": {
"id": "RAKT Version 1.0",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "learning curve"
}
],
"secondaryOutcomes": [
{
"measure": "renal function"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Seoul National University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-08-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "FDA template PMI"
},
{
"name": "Decision Critical PMI"
},
{
"name": "Standard Information"
}
]
},
"conditionsModule": {
"conditions": [
"Knowledge",
"Attitude"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": null,
"country": "United States",
"facility": "Carnegie Mellon University",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15213"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users.The main questions it aims to answer are:How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension?andHow does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information?Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomized to receive either the one-page FDA-template PMI (FDA PMI), a modified template, which added information about drug benefits (Decision Critical PMI), or the existing drug information insert (standard drug information). Participants will complete the same survey questions measuring perceived usefulness and comprehension of the information.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 330,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluating FDA's Proposed Patient Medication Information Handout",
"nctId": "NCT06320808",
"orgStudyIdInfo": {
"id": "STUDY2023_00000449",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Perceived difficulty or ease in reading information"
},
{
"measure": "Perceived usefulness of the medication information guide in making a use decision"
},
{
"measure": "Perceived usefulness of the medication information guide in taking the medication properly"
},
{
"measure": "Comprehension"
}
],
"secondaryOutcomes": [
{
"measure": "Strength of Evidence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Pittsburgh"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Carnegie Mellon University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SOUNDI"
}
]
},
"conditionsModule": {
"conditions": [
"OSA"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": null,
"name": "Carolina Lombardi, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Carolina Lombardi, Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20149"
}
]
},
"descriptionModule": {
"briefSummary": "This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SOUNDI",
"briefTitle": "Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device",
"nctId": "NCT06320795",
"orgStudyIdInfo": {
"id": "IT-MF-000031905",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate the accuracy of the clinical diagnosis of OSA"
},
{
"measure": "To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with SOUNDI and the home sleep study with polysomnography (PSG)"
}
],
"secondaryOutcomes": [
{
"measure": "Patient satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Biocubica srl"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-02-15",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 2928638,
"typeAbbrev": "Prot",
"uploadDate": "2024-03-13T09:06"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Calorie restriction and balanced distribution of macronutrients"
},
{
"name": "Calorie restriction and low-carbohydrate diet"
},
{
"name": "Calorie restriction and low-fat diet"
},
{
"name": "Collective nutritional guidance"
}
]
},
"conditionsModule": {
"conditions": [
"Abdominal Obesity",
"Cardiac Disease",
"Metabolic Disease",
"Cardiometabolic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Recife",
"contacts": null,
"country": "Brazil",
"facility": "Isa Galvao Rodrigues",
"geoPoint": {
"lat": -8.05389,
"lon": -34.88111
},
"state": "PE",
"status": null,
"zip": "51021120"
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to evaluate the impact of different dietary interventions on abdominal fat components and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample was calculated based on data from a study with the Brazilian population, with the sample size calculated as a function of a mean difference (d) in visceral adipose tissue (VAT) after the interventions, standard deviation (s) and a significance level of 5% (z). To correct eventual losses, the number was increased by 20%. Four dietary interventions will be applied in the 6-month period: group with calorie restriction and balanced distribution of macronutrients (group 1); group with calorie restriction and low-carbohydrate diet (group 2); group with calorie restriction and low-fat diet (group 3) and group with collective nutritional guidance (group 4). Patients will be followed up monthly to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines and monitor anthropometric measurements and abdominal adipose tissue. The evaluation of VAT and subcutaneous adipose tissue (SAT) by ultrasonography will be performed at baseline and after 6 months of intervention. The present study is expected to clarify the effects that different dietary interventions produce over 6 months on abdominal fat deposits and cardiometabolic parameters."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "4 interventions distributed in a randomized manner among 4 different groups",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The data analysis and interpretation stage will be carried out by the study coordinator, who will not have knowledge about the allocation of participants among the intervention groups",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Different Dietary Interventions on Abdominal Fat Components and Cardiometabolic Parameters.",
"nctId": "NCT06320782",
"orgStudyIdInfo": {
"id": "4659262",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Thickness, measured in centimeters, of visceral adipose tissue"
},
{
"measure": "Weight loss measured in kilograms"
}
],
"secondaryOutcomes": [
{
"measure": "Serum levels of fasting glucose"
},
{
"measure": "Serum levels of Insulin"
},
{
"measure": "Serum levels Triglycerides"
},
{
"measure": "Serum levels Lipid profile"
},
{
"measure": "Serum levels C-reactive protein (hs-CRP)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universidade Federal de Pernambuco"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pernambuco"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2023-12-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-08-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Plate Technique"
}
]
},
"conditionsModule": {
"conditions": [
"Increased Femoral Anteversion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Tarek Hassan Abdelaziz, Professor",
"phone": "+201222421760",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of Medicine, Ainshams University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": "El-Waily",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Role of Rotational Guided Growth in Management of Increased Femoral Anteversion",
"nctId": "NCT06320769",
"orgStudyIdInfo": {
"id": "24101994",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gait"
}
],
"secondaryOutcomes": [
{
"measure": "Limb length discrepancy"
},
{
"measure": "Angular Deformities"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Wysa in Hindi"
},
{
"name": "Individual and group sessions on topics like motivation, coping, wellbeing"
}
]
},
"conditionsModule": {
"conditions": [
"Mental Health Issue",
"Diabetes Distress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurangabad",
"contacts": [
{
"email": "[email protected]",
"name": "Archana Sarda, M.D",
"phone": "9730792405",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Saumya Sarda, B.A",
"phone": "8698351351",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "India",
"facility": "Udaan",
"geoPoint": {
"lat": 19.87757,
"lon": 75.34226
},
"state": "Maharashtra",
"status": "RECRUITING",
"zip": "431003"
}
]
},
"descriptionModule": {
"briefSummary": "The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: \\>2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized Control Trial with an intervention arm and a control arm.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 204,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Examining the Feasibility of Wysa in Hindi",
"nctId": "NCT06320756",
"orgStudyIdInfo": {
"id": "24-WYSA-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility - Recruitment rate (Proportion of participants who completed consent procedures)"
},
{
"measure": "Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration)"
},
{
"measure": "Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app)"
},
{
"measure": "Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app)"
},
{
"measure": "Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app"
},
{
"measure": "Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app"
}
],
"secondaryOutcomes": [
{
"measure": "Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9)"
},
{
"measure": "Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Udaan"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Wysa"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NIRS ,Ventilation parameters"
},
{
"name": "Oxygen concentration"
}
]
},
"conditionsModule": {
"conditions": [
"Child, Only",
"Inhalation; Vapor",
"Anesthesia",
"Cerebral Oxygenation",
"Cerebral Hypoxia",
"Peripheral Oxygenation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Rabia Bayar",
"phone": "5393300403",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ankara Bilkent City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Çankaya",
"status": "RECRUITING",
"zip": "06800"
}
]
},
"descriptionModule": {
"briefSummary": "To investigate the effects of non-invasive cerebral and peripheral NIRS monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral NIRS in paediatric patients. To determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Cerebral NIRS probe will be attached to the right and left frontotemporal region, and a peripheral NIRS probe will be attached to the inner surface of the forearm and the values will be noted.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 56,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric",
"nctId": "NCT06320743",
"orgStudyIdInfo": {
"id": "Low Flow Anaesthesia And NIRS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Near infrared spectroscopy (NIRS)"
}
],
"secondaryOutcomes": [
{
"measure": "Ventilation parameters"
},
{
"measure": "Ventilation parameters"
},
{
"measure": "Ventilation parameters"
},
{
"measure": "Ventilation parameters"
},
{
"measure": "Ventilation parameters"
},
{
"measure": "Ventilation parameters"
},
{
"measure": "Ventilation parameters"
},
{
"measure": "İntraoperative sevoflurane consumption"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Observational study, records of blood glucose level after reperfusion"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Kidney Injury",
"Hyperglycemia",
"Hypoglycemia",
"End Stage Liver Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Jun-Gol Song",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": "Song-pa Gu",
"status": null,
"zip": "05500"
}
]
},
"descriptionModule": {
"briefSummary": "This retrospective cohort study of patients classified by the blood glucose level after reperfusion in liver transplantation repicient. Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE) and mortality were also investigated."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 3790,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation",
"nctId": "NCT06320730",
"orgStudyIdInfo": {
"id": "2020-0675",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "incidence of acute kidney injury"
}
],
"secondaryOutcomes": [
{
"measure": "incidence of severe AKI"
},
{
"measure": "incidence of chronic kidney disease (CKD)"
},
{
"measure": "incidence of Major adverse cardiac event (MACE)"
},
{
"measure": "overall mortality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Asan Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-08-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-08-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood sample"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Ductal Adenocarcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Buffalo",
"contacts": null,
"country": "United States",
"facility": "Roswell Park Comprehensive Cancer Center",
"geoPoint": {
"lat": 42.88645,
"lon": -78.87837
},
"state": "New York",
"status": "RECRUITING",
"zip": "14263"
}
]
},
"descriptionModule": {
"briefSummary": "To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.The information collected will be used to determine if there are any \"biomarkers\" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma",
"nctId": "NCT06320717",
"orgStudyIdInfo": {
"id": "I-3574823",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Retrospective prediction of pCR in resectable patients"
},
{
"measure": "Retrospective prediction of pCR in borderline resectable patients"
}
],
"secondaryOutcomes": [
{
"measure": "Survival status"
},
{
"measure": "RECIST 1.1 response"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Roswell Park Cancer Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Digital occlusal adjustment using Occulosense digital device"
}
]
},
"conditionsModule": {
"conditions": [
"Bone Density"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Shady Elnaggar",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Badr University in Cairo",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": "القاهرة",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Although the number of individuals who are edentulous is declining, a sizable fraction still needs a complete denture for their oral rehabilitation.Tooth loss is an issue in public health that determines quality of life since it is linked to socioeconomic, physiological, and psychological aspects. In patients who are completely edentulous, dental implants have been viewed as a favorable choice for rehabilitation."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "45 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Occlusal Balance Effect on Mandibular Bone Density by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study)",
"nctId": "NCT06320704",
"orgStudyIdInfo": {
"id": "01067485392",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bone Density"
},
{
"measure": "Bone Density"
},
{
"measure": "Bone Density"
},
{
"measure": "Bone Density"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Badr University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Total Hip Arthroplasty"
},
{
"name": "General Anesthesia"
},
{
"name": "Spinal Anesthesia"
}
]
},
"conditionsModule": {
"conditions": [
"Arthroplasty Complications",
"Anesthesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Bezmialem Vakif University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34140"
}
]
},
"descriptionModule": {
"briefSummary": "The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 437,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study",
"nctId": "NCT06320691",
"orgStudyIdInfo": {
"id": "BezmialemVU 1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean intraoperative estimated blood loss"
},
{
"measure": "mean duration of surgery"
},
{
"measure": "length of hospital stay"
},
{
"measure": "stem subsidence"
},
{
"measure": "stem varus/valgus degrees"
},
{
"measure": "acetabular abduction"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Bezmialem Vakif University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2017-05-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2017-01-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2014-01-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nursing Students Education"
}
]
},
"conditionsModule": {
"conditions": [
"Nursing Education"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bilecik",
"contacts": [
{
"email": "[email protected]",
"name": "Aysun Acun, PhD",
"phone": "+905072104506",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Bilecik Şeyh Edebali University",
"geoPoint": {
"lat": 40.14192,
"lon": 29.97932
},
"state": null,
"status": "RECRUITING",
"zip": "11000"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to evaluate the effect of blended self-directed learning with concept mapping on the level of knowledge regarding parenteral drug administration in nursing students. With out-of-class, online, interactive teaching methods, a memorable learning away from complex structure is aimed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "17 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Parenteral Drug Administration Training for Nursing Students",
"nctId": "NCT06320678",
"orgStudyIdInfo": {
"id": "Aysun Acun 5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Students' knowledge level after blended learning method"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Bilecik Seyh Edebali Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Radiographic measurement"
}
]
},
"conditionsModule": {
"conditions": [
"Impacted Third Molar Tooth"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective is to compare the sagittal and vertical skeletal parameters of patients with an impacted third molar.Patients will be analyzed according to their skeletal characteristics: skeletal class (sagittal direction) and facial skeletal typology (vertical direction).The inclusion characteristics of third molars will also be analyzed, to see the links between typology and inclusion. The principal hypothesis is no significant difference in third molar inclusion patterns in relation to skeletal divergence."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of Sagittal and Vertical Pattern in Correlation With Third Molar Inclusion : A 3D CBCT Analysis",
"nctId": "NCT06320665",
"orgStudyIdInfo": {
"id": "2024PI003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Distance between the occlusal plane and the second molar"
},
{
"measure": "Angle of the third molar"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Central Hospital, Nancy, France"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cardiac telerehabilitation (video consultation and home monitoring)"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Rehabilitation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "First, all willing patients who are offered cardiac rehabilitation will comprise the control group. Following a period of implementing the adapted co-created cardiac telerehabilitation intervention. Patients in the control group have access to standard care at the cardiac outpatient clinic program comprising standard center-based cardiac rehabilitation. Patients in the intervention group will, in addition to standard care, be offered an individually tailored family-focused cardiac telerehabilitation developed through a co-creative process.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation",
"nctId": "NCT06320652",
"orgStudyIdInfo": {
"id": "CUHospital",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Health Literacy Questonnaire"
}
],
"secondaryOutcomes": [
{
"measure": "The European Quality of life five dimensions questionnaire"
},
{
"measure": "The Iceland-Family Perceived Support Questionnaire"
},
{
"measure": "The eHealth Literacy Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hvidovre University Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Copenhagen University Hospital, Hvidovre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Neurocognitive Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Villeurbanne",
"contacts": [
{
"email": "[email protected]",
"name": "Marion Giroux, PhD",
"phone": "0472432372",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital des Charpennes",
"geoPoint": {
"lat": 45.76667,
"lon": 4.88333
},
"state": null,
"status": "RECRUITING",
"zip": "69100"
}
]
},
"descriptionModule": {
"briefSummary": "The ageing of the population is leading to an increasing number of older drivers on the roads. At the same time, the proportion of older people with pathological ageing and neurocognitive disorders (NCD) is increasing. In terms of road safety, this raises the question of whether these drivers should continue to drive or not. People with NCDs may not be aware of the presence, extent and progression of their cognitive impairment and the impact it can have on daily life, including driving.Despite their loss of autonomy and medical advice, 22% of people with major NCD continue to drive. In addition, the presence of minor NCD also puts people at a higher risk of road accidents.However, several studies demonstrated that an NCD does not lead to a systematic and immediate impairment of driving ability and abruptly stopping driving leads to health problems, such as the risk of depression and greatly reduces quality of life.It is therefore relevant to focus research on driving with people with NCD in order to have a reliable indicator of the person's abilities and the impact of their cognitive impairment on driving activity. The proposed study seeks to meet this need by studying the performance of people with NCD on a driving station (mini-simulator) while assessing their ability to evaluate their performance.To achieve this goal, people with NCDs will perform tasks on a driving simulator. In addition, after each task on the driving simulator, they will answer questions about how they evaluate their own driving. Two assessors will observe the participants' driving and will estimate their driving performance. By comparing the driver's self-assessment with the assessors' assessment, an \"awareness score of driving ability\" will be calculated to determine whether the driver correctly assessed his or her performance.Another project already underway aims to collect similar data from people without a diagnosis of NCDs (control group).The principal objective of the present study is to compare the driving performance in a simulator and the awareness of driving ability of people with NCDs with those of a control group. Secondary objectives are :1. to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs.2. to analyse driving performance and awareness of driving abilities according to the diagnosis and severity of the disorder (i.e. minor or major neurocognitive disorders).3. to establish a methodology to identify a driver at risk of dangerous driving.It is mainly an exploratory study however some hypotheses can be made :* The driving performance and awareness of driving skills of people with NCDs are poorer compared to those of older, control individuals.* Individuals' driving performance and awareness of driving ability are lower in the presence of major NCDs compared to minor NCDs."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "95 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DRIVS-NCD",
"briefTitle": "DRIVing Simulator and People With NeuroCognitive Disorders",
"nctId": "NCT06320639",
"orgStudyIdInfo": {
"id": "UGustaveEiffel",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Awareness score of driving ability"
},
{
"measure": "Driving performance variables measured by the driving simulator"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hospices Civils de Lyon"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Gustave Eiffel"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Emicizumab - PK-guided dose reduction"
},
{
"name": "Emicizumab - Dosis continuation group"
},
{
"name": "Emicizumab - Dose adjustment group"
}
]
},
"conditionsModule": {
"conditions": [
"Hemophilia A With Inhibitor",
"Hemophilia A Without Inhibitor",
"Hemophilia A, Severe",
"Adolescent",
"Child",
"Adult"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nijmegen",
"contacts": [
{
"email": "[email protected]",
"name": "Saskia Schols, Dr, MD",
"phone": "+310 24 361 8823",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Saskia Schols, Dr, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Radboud University Medical Center",
"geoPoint": {
"lat": 51.8425,
"lon": 5.85278
},
"state": "Gelderland",
"status": "RECRUITING",
"zip": "6525 GA"
},
{
"city": "Maastricht",
"contacts": [
{
"email": "[email protected]",
"name": "Floor Moenen, Dr, MD",
"phone": "+31433876543",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Floor Moenen, Dr, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Maastricht University Medical Center",
"geoPoint": {
"lat": 50.84833,
"lon": 5.68889
},
"state": "Limburg",
"status": "RECRUITING",
"zip": null
},
{
"city": "Amsterdam",
"contacts": [
{
"email": "[email protected]",
"name": "Michiel Coppens, Dr, MD",
"phone": "+31(0)20 566 5964",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michiel Coppens, Dr, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Amsterdam University Medical Center",
"geoPoint": {
"lat": 52.37403,
"lon": 4.88969
},
"state": "Noord-Holland",
"status": "RECRUITING",
"zip": "1105 AZ"
},
{
"city": "Den Haag",
"contacts": [
{
"email": "[email protected]",
"name": "Paula Ypma, MD",
"phone": "+310702102620",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Paula Ypma, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "HagaZiekenhuis",
"geoPoint": {
"lat": 52.07667,
"lon": 4.29861
},
"state": "Zuid-Holland",
"status": "RECRUITING",
"zip": "2545 CH"
},
{
"city": "Leiden",
"contacts": [
{
"email": "[email protected]",
"name": "Paul den Exter, Dr, MD",
"phone": "+31 (0)71 526 1850",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Paul den Exter, Dr, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Leids Universitair Medisch Centrum",
"geoPoint": {
"lat": 52.15833,
"lon": 4.49306
},
"state": "Zuid-Holland",
"status": "RECRUITING",
"zip": "2300 RC"
},
{
"city": "Rotterdam",
"contacts": [
{
"email": "[email protected]",
"name": "Marjon Cnossen, Dr., MD",
"phone": "+31107040113",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marjon Cnossen, Dr. MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Erasmus University Medical Center",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
},
"state": "Zuid-Holland",
"status": "RECRUITING",
"zip": "3000CA"
},
{
"city": "Groningen",
"contacts": [
{
"email": "[email protected]",
"name": "Louise Hooimeijer, MD",
"phone": "+310-503612740",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Louise Hooimeijer, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "University Medical Center Groningen",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null,
"status": "RECRUITING",
"zip": "9700 RB"
},
{
"city": "Utrecht",
"contacts": [
{
"email": "[email protected]",
"name": "Kathelijn Fischer, Dr, MD",
"phone": "+31887558450",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Konrad van der Zwet, MD",
"phone": "+31650124691",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kathelijn Fischer, Dr, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Konrad van der Zwet, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Lize F.D. van Vulpen, Dr, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Roger E.G. Schutgens, Prof, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Paul van der Valk, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Karin P.M. van Galen, Dr, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Nanda Uitslager, Msc",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "University Medical Center Utrecht",
"geoPoint": {
"lat": 52.09083,
"lon": 5.12222
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "* PK-guided dosing - Intervention group (12M): Subjects with emicizumab concentration of ≥ 40 μg/mL will receive individualized PK-guided dose reduction of emicizumab targeted at a Ctrough of 30μg/mL. The validated population PK model is based on published population PK and PK/PD modelling studies. (9,10,15)* PK-Guided dosing - Non-intervention group (12M): Subjects with emicizumab concentration of 25-39 μg/mL will continue on their current dose regimen and will be followed according to the same assessment schedule as the Intervention Group. Only subjects with emicizumab plasma concentration \\< 25 μg/mL will be adjusted in dosing regimen according to local protocol. These subjects will be followed for selective safety data only.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 95,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "1 Year",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DosEmi",
"briefTitle": "Pharmacokinetic-guided Dosing of Emicizumab",
"nctId": "NCT06320626",
"orgStudyIdInfo": {
"id": "22-571",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of patients without treated bleeds"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of patients without treated bleeds"
},
{
"measure": "Proportion of patients without spontaneous joint- or muscle bleeds"
},
{
"measure": "Annualized bleeding rate (ABR) of treated bleeds, including joint bleeds and sport-induced bleeds"
},
{
"measure": "To compare cost-effectiveness between conventional dosing and individualized PK-guided dosing of emicizumab"
},
{
"measure": "To assess the cumulative number of coagulation factor (sc. and/or iv.) of per year."
},
{
"measure": "To assess the performance of the population PK model"
},
{
"measure": "To investigate whether direct joint health remains stable measured by physical examination when switching to lower-dosed emicizumab compared to conventional treatment"
},
{
"measure": "To investigate whether direct joint health remains stable measured by ultrasound when switching to lower-dosed emicizumab compared to conventional treatment"
},
{
"measure": "To investigate if indirect joint health, as measured by biomarkers, remains stable when switching to lower doses of emicizumab compared to conventional treatment."
},
{
"measure": "To investigate if indirect joint health, as measured by biomarkers, remains stable when switching to lower doses of emicizumab compared to conventional treatment."
},
{
"measure": "To investigate whether Health Related Quality of Life (HR-QoL) are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab."
},
{
"measure": "To investigate whether Health Related Quality of Life (HR-QoL) are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab."
},
{
"measure": "To investigate whether sports participation are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab."
},
{
"measure": "To investigate whether thrombin generation parameters can be used as a pharmacodynamic (PD) biomarker for emicizumab treatment efficacy."
},
{
"measure": "To assess and monitor pain during emicizumab administration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Erasmus Medical Center"
},
{
"name": "Amsterdam University Medical Center"
},
{
"name": "Leiden University Medical Center"
},
{
"name": "Radboud University Medical Center"
},
{
"name": "Maastricht University Medical Center"
},
{
"name": "University Medical Center Groningen"
},
{
"name": "HagaZiekenhuis"
},
{
"name": "Dutch Society of Haemophilia Patients"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kathelijn Fischer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acupuncture therapy"
},
{
"name": "Ginger Acupuncture Point Patch"
}
]
},
"conditionsModule": {
"conditions": [
"Gastrointestinal Motility",
"Postoperative Nausea and Vomiting"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Weifang",
"contacts": [
{
"email": "[email protected]",
"name": "Lin Cheng, B.S",
"phone": "17667404256",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Lin Cheng",
"geoPoint": {
"lat": 36.71,
"lon": 119.10194
},
"state": "Shandong",
"status": "RECRUITING",
"zip": "261000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to investigate the effect of implementing snap-needle therapy combined with ginger paste during anesthesia recovery on the recovery of gastrointestinal function after gynecological laparoscopy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Implementing Snap-needle Therapy Combined With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy",
"nctId": "NCT06320613",
"orgStudyIdInfo": {
"id": "KYLL20240117-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative nausea and vomiting"
},
{
"measure": "Postoperative nausea and vomiting"
},
{
"measure": "Postoperative nausea and vomiting"
},
{
"measure": "Postoperative nausea and vomiting"
},
{
"measure": "Postoperative nausea and vomiting"
},
{
"measure": "Postoperative nausea and vomiting"
},
{
"measure": "Abdominal distention"
},
{
"measure": "Abdominal distention"
},
{
"measure": "Abdominal distention"
},
{
"measure": "Abdominal distention"
},
{
"measure": "Abdominal distention"
},
{
"measure": "Abdominal distention"
},
{
"measure": "Time to first flatus"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative pain response"
},
{
"measure": "Postoperative pain response"
},
{
"measure": "Postoperative pain response"
},
{
"measure": "Postoperative pain response"
},
{
"measure": "Postoperative pain response"
},
{
"measure": "Postoperative pain response"
},
{
"measure": "Consumption of postoperative analgesic"
},
{
"measure": "Consumption of postoperative rescue antiemetic"
},
{
"measure": "Time to first defecation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Weifang People's Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Weifang Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "no intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Changsha",
"contacts": [
{
"email": "[email protected]",
"name": "Shuting Yang",
"phone": "15200863137",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "the Second Xiangya Hospital",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan",
"status": "RECRUITING",
"zip": "410010"
}
]
},
"descriptionModule": {
"briefSummary": "The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 120000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PDC",
"briefTitle": "Precision Medicine of Diabetes Program in China",
"nctId": "NCT06320600",
"orgStudyIdInfo": {
"id": "PDC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "To establish a model for hypoglycemic therapy"
}
],
"primaryOutcomes": [
{
"measure": "The currency analysis of diabetes classification"
}
],
"secondaryOutcomes": [
{
"measure": "To establish a model for predicting diabetic retinopathy"
},
{
"measure": "To establish a model for predicting diabetic kidney disease"
},
{
"measure": "To establish a model for predicting diabetic neuropathy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Second Xiangya Hospital of Central South University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Kangaroo care practice by both mother and father"
},
{
"name": "Kangaroo care practice only mother"
}
]
},
"conditionsModule": {
"conditions": [
"Kangaroo Care",
"Fathers",
"Mother-Infant Interaction",
"Premature Infant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Gönül Kurt, Assoc.prof.",
"phone": "90(312)304",
"phoneExt": "3934",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Meryem Büşra Borazan",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Meryem Büşra Borazan",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Gönül Kurt, Assoc.prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Ankara Etlik City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": "RECRUITING",
"zip": "06170"
}
]
},
"descriptionModule": {
"briefSummary": "This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "37 Weeks",
"minimumAge": "28 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs",
"nctId": "NCT06320587",
"orgStudyIdInfo": {
"id": "AEŞH-EK1-2023-508",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mother-To-Infant Bonding Scale"
},
{
"measure": "Perceived Mother Parenting Self-Efficacy Scale"
},
{
"measure": "Postnatal Paternal-Infant Attachment Questionnaire"
},
{
"measure": "Perceived Father Parenting Self-Efficacy Form"
},
{
"measure": "Physiological parameters of the premature infant: peak heart rate (BPM)"
},
{
"measure": "Physiological parameters of the premature infant: oxygen saturation (%)"
},
{
"measure": "Physiological parameters of the premature infant: body temperature (°C)"
},
{
"measure": "Physiological parameters of the premature infant:Respiration rate (RPM)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Saglik Bilimleri Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Gastric Content",
"Healthy Volunteers"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is:• how much training is required for surgical nurses to obtain competency in performing gastric ultrasound.Participants will follow a training involving* theoretical background using e-learning, picture library and lecture* practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer* and formative assessments during training sessions scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 8,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SKILLS-1",
"briefTitle": "Nurses' Competence in Gastric Ultrasound",
"nctId": "NCT06320574",
"orgStudyIdInfo": {
"id": "2023-16880",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of required training"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Radboud University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Longitudinal prospective cohort study"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The investigators will use 3D freehand ultrasound to investigate changes in muscle morphology of the paretic m. rectus femoris and m. gastrocnemius medialis during the first 3 months after stroke. Additionally, 2D ultrasound and surface EMG will be synchronized to examine muscle activation and morphological changes resulting from this activation. Clinical tests will be conducted on the same test occasions to objectify lower limb impairment and gait recovery. As such, the investigators will explore the relationship between the muscle specific changes and functional recovery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "StrIMuC12",
"briefTitle": "Muscular Changes in the First 12 Weeks After Stroke.",
"nctId": "NCT06320561",
"orgStudyIdInfo": {
"id": "23485_StrIMuC12",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Functional Ambulation Categories (FAC)-score"
},
{
"measure": "Muscle volume"
},
{
"measure": "Cross-sectional area (CSA)"
},
{
"measure": "Physiological cross-sectional area (pCSA)"
},
{
"measure": "Muscle tickness"
},
{
"measure": "Fascicle length"
},
{
"measure": "Muscle length"
},
{
"measure": "Tendon length"
},
{
"measure": "Pennation angle"
},
{
"measure": "Echo Intensity"
},
{
"measure": "Dynamic muscle morphology"
},
{
"measure": "Change in cross-sectional area"
},
{
"measure": "Change in fascicle length"
},
{
"measure": "Average root mean square (RMS)"
},
{
"measure": "Peak root mean square (RMS)"
},
{
"measure": "Muscle strength"
},
{
"measure": "Spasticity"
},
{
"measure": "Lower limb motor impairment"
},
{
"measure": "Spatiotemporal gait parameters"
},
{
"measure": "Gait quality"
}
],
"secondaryOutcomes": [
{
"measure": "TWIST-score"
},
{
"measure": "Knee extension strength"
},
{
"measure": "Balance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Ghent"
},
{
"name": "Research Foundation Flanders"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Vrije Universiteit Brussel"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Low-residue diet"
},
{
"name": "Free diet"
}
]
},
"conditionsModule": {
"conditions": [
"Cesarean Section Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": null,
"country": "Italy",
"facility": "Sapienza University of Rome",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the present study was to evaluate the efficacy of preoperative low-residue diet on postoperative ileus in women undergoing elective cesarean section. It is a surgeon-blind, randomized controlled trial enrolling pregnant women at ≥39 weeks of gestation undergoing elective cesarean section. Patients were preoperatively randomized to receive either low-residue diet (arm A) or free diet (arm B) starting from three days before surgery. The primary outcome was the postoperative ileus at 24 hours after surgery. The secondary outcomes were the postoperative pain (assessed through VAS scale), the quality of the surgical field (scored using a 5-point scale, from poor to excellent), postoperative complications, and the length of hospital stay. Perioperative data were collected and compared between groups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 166,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section",
"nctId": "NCT06320548",
"orgStudyIdInfo": {
"id": "0724/2018",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants who have passage of flatus within the first 24 hours after caesarean section."
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative pain"
},
{
"measure": "Postoperative complications"
},
{
"measure": "Quality of the surgical field"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Roma La Sapienza"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-12-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "R21/Matrix M™ (Group 1)"
},
{
"name": "R21/Matrix M™ (Group 2)"
},
{
"name": "R21/Matrix M™ (Group 3)"
},
{
"name": "Fine needle aspiration (FNA)"
}
]
},
"conditionsModule": {
"conditions": [
"Malaria,Falciparum"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oxford",
"contacts": [
{
"email": "[email protected]",
"name": "Volunteer Recruitment Co-ordinator",
"phone": "01865611386",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford",
"geoPoint": {
"lat": 51.75222,
"lon": -1.25596
},
"state": "Oxfordshire",
"status": "RECRUITING",
"zip": "OX3 7LE"
},
{
"city": "Bristol",
"contacts": [
{
"email": "[email protected]",
"name": "Rajeka Lazarus, DPhil FCRPath",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Rajeka Lazarus, DPhil FRCPath",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "University Hospitals Bristol and Weston NHS Foundation Trust",
"geoPoint": {
"lat": 51.45523,
"lon": -2.59665
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "BS2 8HW"
}
]
},
"descriptionModule": {
"briefSummary": "This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™",
"nctId": "NCT06320535",
"orgStudyIdInfo": {
"id": "VAC096",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "To assess the relationship between vaccination schedule and humoral immune response in participants vaccinated with R21/Matrix-M™ administered in escalating dose, multi-prime vaccination schedules compared with a standard prime-boost regimen"
}
],
"primaryOutcomes": [
{
"measure": "To compare the safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule with a standard prime-boost regimen in healthy UK adults"
},
{
"measure": "To compare the safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule with a standard prime-boost regimen in healthy UK adults"
},
{
"measure": "To compare the humoral immunogenicity of R21/Matrix-M™ administered in an escalating dose, multi-prime vaccination schedule with a standard prime-boost regimen in healthy UK adults"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bill and Melinda Gates Foundation"
},
{
"name": "University Hospitals Bristol and Weston NHS Foundation Trust"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Oxford"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ketone Monoester"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Ketosis",
"Exogenous Ketosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oxford",
"contacts": [
{
"email": "[email protected]",
"name": "Leanne Hodson, PhD",
"phone": "01865 857224",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Leanne Hodson, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Adam Isherwood, MSc",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Oxford Centre for Diabetes, Endocrinology, and Metabolism (OCDEM)",
"geoPoint": {
"lat": 51.75222,
"lon": -1.25596
},
"state": "Oxfordshire",
"status": "RECRUITING",
"zip": "OX3 7LE"
}
]
},
"descriptionModule": {
"briefSummary": "The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state.This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism.As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes.Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exogenous Ketosis in a Fed and a Fasted State",
"nctId": "NCT06320522",
"orgStudyIdInfo": {
"id": "R82053/RE002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Plasma β-hydroxybutyrate (βHB) kinetics"
},
{
"measure": "Plasma glucose kinetics"
},
{
"measure": "Postprandial de novo lipogenesis (DNL)"
}
],
"secondaryOutcomes": [
{
"measure": "Plasma biochemistry"
},
{
"measure": "Very low-density lipoprotein-triglyceride (VLDL-TG) fatty acid composition"
},
{
"measure": "Breath acetone"
},
{
"measure": "Urine volume"
},
{
"measure": "Urine composition"
},
{
"measure": "Indirect calorimetry"
},
{
"measure": "Subjective measures of appetite"
},
{
"measure": "Subjective measures of gastrointestinal distress"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Oxford"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Continuous measurement of uPO2 (both groups)"
}
]
},
"conditionsModule": {
"conditions": [
"Shock Circulatory"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Angers",
"contacts": [
{
"email": null,
"name": "Nicolas Fage, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "University Hospital of Angers",
"geoPoint": {
"lat": 47.46667,
"lon": -0.55
},
"state": null,
"status": null,
"zip": "49933"
}
]
},
"descriptionModule": {
"briefSummary": "Shock state is defined as an acute, life-threatening, circulatory failure with impaired tissue oxygenation (or tissue hypoxia). The cause of the shock state can be septic, anaphylactic, hypovolemic or cardiogenic. Its management is based on etiological treatment and replacement of organ failures. Acute kidney injury (AKI) may be lead by renal hypoxia. Acute kidney injury is frequent in patients admitted to intensive care unit (ICU) and associated with an increased mortality. Serum creatinine is the reference biological marker in the diagnosis of Acute kidney injury. However, its use is limited by a delayed increase in plasma creatinine level in relation to the causal renal agression, at a time when renal tissue damage may already be established. Thus, the identification of a biological marker making it possible to estimate renal hypoxia continuously during a shock could allow us to identify early a situation at risk of evolving into Acute kidney injury.The renal medulla is vulnerable to tissue hypoxia with a risk of acute tubular necrosis. As in situ measurement of mPO2 is not possible in current practice in humans, several studies have shown a positive correlation between variations in mPO2/uPO2 and occurence of Acute kidney injury. In humans, studies have shown a significant association between the reduction in uPO2 in cardiac surgeries and the occurrence of postoperative Acute kidney injury. The aim of the study is to describe the association between uPO2 values and the onset of Acute kidney injury and/or the ocurrence of early recovery of renal function after Acute kidney injury. Any patient in shock (group A) or without shock and requiring urinary catheterization as part of treatment (group B) admitted to the Medical-Intensive Care Unit of Angers University Hospital is eligible for inclusion. After inclusion, a continuous uPO2 measuring probe is introduced with the placement of the urinary probe. uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. uPO2 is also measured by a gasometry on a urine sample on a multi-daily basis. Serum creatinine is collected every 12 hours (twice a day) and diuresis every two hours for 5 days."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 55,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OXYpi",
"briefTitle": "Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study",
"nctId": "NCT06320509",
"orgStudyIdInfo": {
"id": "49RC23_0417",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "A - For patients without acute kidney injury at inclusion, the occurence of acute kidney injury and its severity according to the KDIGO criteria"
},
{
"measure": "B - For patients with acute kidney injury occurring during the first 3 days following inclusion, early recovery is defined by the return to pre-shock renal function 48 hours from the start of acute kidney injury"
}
],
"secondaryOutcomes": [
{
"measure": "In patients in group A, assess the association between uPO2 variation and acute kidney injury, defined by KDIGO criteria, in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock)."
},
{
"measure": "In patients in group A with newly occured acute kidney injury, assess the association between uPO2 variation and recovery of acute kidney injury in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock)."
},
{
"measure": "In patients in group A, assess the evolution of uPO2 during the first 5 days in patients with and without sepsis"
},
{
"measure": "Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received fluid expansion"
},
{
"measure": "Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received blood transfusion"
},
{
"measure": "In patients with need of increasing Mean Arterial Pressure by increase of norepinephrine doses, describe the evolution of uPO2 according to Mean Arterial Pressure evolution."
},
{
"measure": "In patients with need of introduction or increase of dobutamine, describe the evolution of uPO2 according to cardiac output or Mean Arterial Pressure evolution."
},
{
"measure": "Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry."
},
{
"measure": "In patients without shock, describe the evolution of uPO2 during the first 5 days."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "University Hospital, Angers"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Children With Cerebral Palsy",
"Children With Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nancy",
"contacts": [
{
"email": "[email protected]",
"name": "Jonathan Pierret, PhD",
"phone": "+33 3 82 52 6761",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut Régional de Médecine Physique et de Réadaptation",
"geoPoint": {
"lat": 48.68439,
"lon": 6.18496
},
"state": null,
"status": "RECRUITING",
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. While the pathology itself induces limitations and restrictions (prolonged sitting time, assisted movement, etc.), organizational constraints also apply to both children and parents, who have to divide their time between work, school and therapeutic care, which is sometimes numerous and varied over the course of a single week. These limitations generate stress and fatigue, and prolonged sedentary periods lead children with chronic illnesses, rare diseases or disabilities into a process of physical deconditioning. The accumulation of sedentary time is detrimental to cardiovascular and metabolic health.To combat this deconditioning, the 2008 National Physical Activity and Sport Plan (PNAPS) sets out the main guidelines for treatment and implementation. The plan explains that \"for patients with chronic illnesses, rare diseases or disabilities, the aim is to encourage care and guidance towards Adapted Physical Activity (APA). The attending physician will be able to identify local therapeutic education programs, rehabilitation services and \"sport-santé\" offers, to improve access for these patients to supervised local programs\". In addition, the plan suggests \"developing APA programs in healthcare establishments to enable people with chronic illnesses, rare diseases or disabilities to access health education incorporating practical sessions\".In line with this plan, an exercise reconditioning program has been set up at our facility. This three-month stay includes children with a variety of pathologies, but with a common feature of physical deconditioning."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Effect of a Physical Activity Recovery Stay",
"nctId": "NCT06320496",
"orgStudyIdInfo": {
"id": "IRR-FLAVIGNY-2021-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnoform test score"
}
],
"secondaryOutcomes": [
{
"measure": "KidScreen52 quality-of-life scale score."
},
{
"measure": "Impedance measurement"
},
{
"measure": "Exercise test on ergometer"
},
{
"measure": "Anamnesis"
},
{
"measure": "6-minute walk test"
},
{
"measure": "Energy expenditure index"
},
{
"measure": "Gluteal bridge"
},
{
"measure": "Shirado test"
},
{
"measure": "Sorensen test"
},
{
"measure": "Timed Up and Down Stairs (TUDS) test"
},
{
"measure": "Floor survey test"
},
{
"measure": "Mini Bestest : Each of the 14 tests is graded from 0 to 2. \"0\" represents the lowest functional level and \"2\" the highest functional level. Maximal score : 28."
},
{
"measure": "The Canadian Occupational Performance Measure"
},
{
"measure": "A motivational questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vibroacoustic device BARK VibroLUNG"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Astana",
"contacts": [
{
"email": "[email protected]",
"name": "Makhabbat Sansyzbaeva",
"phone": "+7(7172)703158",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Timur Sayranovich",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Kazakhstan",
"facility": "JSC \"National Research Cardiac Surgery Center\"",
"geoPoint": {
"lat": 51.1801,
"lon": 71.44598
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Atyrau",
"contacts": [
{
"email": "[email protected]",
"name": "Marat Konysov",
"phone": "+7(7122)50-69-26",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zhangeldy Kadirov",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Kazakhstan",
"facility": "State-owned public enterprise with the right of economic management \"Atyrau Regional Cardiology Center\"",
"geoPoint": {
"lat": 47.11667,
"lon": 51.88333
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Oral",
"contacts": [
{
"email": "[email protected]",
"name": "Aktilek Umirbaev",
"phone": "+ 7701 338 35 04",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Daniyar Arenov",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Kazakhstan",
"facility": "State-owned public enterprise with the right of economic management \"Regional Cardiology Center\"",
"geoPoint": {
"lat": 51.23333,
"lon": 51.36667
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Pavlodar",
"contacts": [
{
"email": "[email protected]",
"name": "Gulzhanat Dzhakova",
"phone": "+7(7182)39-08-00",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Inna Glowacka",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Kazakhstan",
"facility": "State-owned public enterprise with the right of economic management \"Pavlodar Regional Cardiology Center\"",
"geoPoint": {
"lat": 52.28333,
"lon": 76.96667
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Ust-Kamenogorsk",
"contacts": [
{
"email": "[email protected]",
"name": "Erlan Burkutov",
"phone": "+7(7232)25-60-34",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Olesya Subbotina",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Kazakhstan",
"facility": "State-owned public enterprise with the right of economic management \"East Kazakhstan Regional Hospital\"",
"geoPoint": {
"lat": 49.97143,
"lon": 82.60586
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with percussion massage in cardiac surgical patients in the early postoperative period."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 310,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period",
"nctId": "NCT06320483",
"orgStudyIdInfo": {
"id": "BT-01-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Partial pressure of oxygen (PaO2)"
},
{
"measure": "Partial pressure of carbon dioxide (PaCO2)"
},
{
"measure": "Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation)"
},
{
"measure": "Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2"
},
{
"measure": "Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2"
},
{
"measure": "ROX Index"
},
{
"measure": "P/F index (ratio of arterial blood PO2 to oxygen fraction)"
}
],
"secondaryOutcomes": [
{
"measure": "pH of blood"
},
{
"measure": "BE (base excess) of blood"
},
{
"measure": "CBC indicators (hemoglobin)"
},
{
"measure": "CBC indicators (hematocrit)"
},
{
"measure": "CBC indicators (platelets)"
},
{
"measure": "Coagulogram indicators (prothrombin time)"
},
{
"measure": "Coagulogram indicators (prothrombin index)"
},
{
"measure": "Coagulogram indicators (international normalized ratio)"
},
{
"measure": "Coagulogram indicators (fibrinogen)"
},
{
"measure": "Coagulogram indicators (activated partial thromboplastin time)"
},
{
"measure": "Number of days spent in the high dependency unit (intensive care ward in the department)"
},
{
"measure": "Number of days in hospital"
},
{
"measure": "Number of days of O2 support"
},
{
"measure": "Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bark Technology LLP"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Educational Session"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ann Arbor",
"contacts": null,
"country": "United States",
"facility": "The University of Michigan",
"geoPoint": {
"lat": 42.27756,
"lon": -83.74088
},
"state": "Michigan",
"status": null,
"zip": "48109"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "MIVetsCan: Can-Coach Trial (Phase 1)",
"nctId": "NCT06320470",
"orgStudyIdInfo": {
"id": "HUM00231159a",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Michigan, State of, Licensing and Regulatory Affairs, Department of 573000",
"id": "VMR2022-03",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient Global Impression of Change (PGIC) score"
}
],
"secondaryOutcomes": [
{
"measure": "Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction."
},
{
"measure": "Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Michigan, State of, Licensing and Regulatory Affairs"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Michigan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Brief case management intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Psychiatric Disorder",
"Involuntary Psychiatric Hospitalization"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lausanne",
"contacts": [
{
"email": "[email protected]",
"name": "Stéphane Morandi",
"phone": "+41 21 3140050",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Stéphane Morandi",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "Lausanne University Hospital",
"geoPoint": {
"lat": 46.516,
"lon": 6.63282
},
"state": "Canton Of Vaud",
"status": null,
"zip": "1003"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. The main questions it aims to answer are:* Is the case management intervention acceptable and feasible?* What are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care?Participants will be asked to take part in:* the five sessions of the case management intervention;* two evaluation sessions (pre and post-intervention);* a final in-depth semi-structured interview (optional)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CARP",
"briefTitle": "A Brief Case Management Intervention for People Involuntarily Admitted to a Psychiatric Hospital",
"nctId": "NCT06320457",
"orgStudyIdInfo": {
"id": "2024-00095",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Eligibility rate"
},
{
"measure": "Participation rate"
},
{
"measure": "Drop-out rate"
},
{
"measure": "Intervention dosage"
},
{
"measure": "Missing data rates"
},
{
"measure": "Number of unexpected adverse events"
},
{
"measure": "Participants' acceptance and degree of satisfaction"
},
{
"measure": "Implementation barriers and facilitating factors"
}
],
"secondaryOutcomes": [
{
"measure": "Recovery Assessment Scale (RAS)"
},
{
"measure": "Empowerment Scale"
},
{
"measure": "Rosenberg Self-Esteem Scale (RSS)"
},
{
"measure": "The Paradox of Self-Stigma scale (PaSS-24)"
},
{
"measure": "Beck Hopelessness Scale (BHS)"
},
{
"measure": "WHOQOL-BREF"
},
{
"measure": "International Trauma Questionnaire (ITQ)"
},
{
"measure": "Coercion Ladder (CL)"
},
{
"measure": "Index of fairness and Index of effectiveness"
},
{
"measure": "Satisfaction with hospital care"
},
{
"measure": "Brief INSPIRE scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Lausanne Hospitals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "232 Electrode Electrophysiology (EEG-ECG-EMG-EXG)"
}
]
},
"conditionsModule": {
"conditions": [
"Motor Neuron Disease, Amyotrophic Lateral Sclerosis",
"Motor Neuron Disease Progressive Spinal Muscle Atrophy",
"Primary Lateral Sclerosis",
"Multiple Sclerosis",
"Postpoliomyelitis Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dublin",
"contacts": [
{
"email": "[email protected]",
"name": "Orla Hardiman,, BSc MB BCh BAO MD FRCPI FAAN",
"phone": "+353 1 896 4497",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Prabhav Mehra, BE MSc",
"phone": "+3530894781347",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Ireland",
"facility": "Academic Unit of Neurology, Trinity College Dublin, The University of Dublin",
"geoPoint": {
"lat": 53.33306,
"lon": -6.24889
},
"state": "Leinster",
"status": "RECRUITING",
"zip": "Dublin 2"
}
]
},
"descriptionModule": {
"briefSummary": "Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due to its unique alignment in spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. The overarching aim of this study is to reveal and quantify the extent of change in the sensorimotor integration and its potential contribution to network disruption in ALS."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease",
"nctId": "NCT06320444",
"orgStudyIdInfo": {
"id": "CRFSJ0297",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Biomarker of sensorimotor integration"
},
{
"measure": "Determination of the feasibility of sensorimotor signatures as reliable biomarkers of ALS"
},
{
"measure": "Non-invasive recording of the SC functional neuro-electric activity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Motor Neurone Disease Association, UK"
},
{
"name": "Irish Research Council, IE"
},
{
"name": "Health Research Board, IE"
},
{
"name": "Research Motor Neurone, IE"
},
{
"name": "Thierry Latran Foundation, FR"
},
{
"name": "ALS Association, USA"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Dublin, Trinity College"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tenecteplase"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Ischemic Stroke AIS",
"Stroke Acute",
"Stroke, Acute, Stroke Ischemic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sydney",
"contacts": [
{
"email": "[email protected]",
"name": "Xiaoying Chen, PHD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Craig Anderson, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Australia",
"facility": "The George Institute for Global Health",
"geoPoint": {
"lat": -33.86785,
"lon": 151.20732
},
"state": "Barangaroo",
"status": null,
"zip": "NSW 2000"
},
{
"city": "Calgary",
"contacts": [
{
"email": "[email protected]",
"name": "Carol C Kenney, RN",
"phone": "4039444286",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Michael D Hill, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael D Hill, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "University of Calgary",
"geoPoint": {
"lat": 51.05011,
"lon": -114.08529
},
"state": "Alberta",
"status": null,
"zip": "T2N 1N4"
}
]
},
"descriptionModule": {
"briefSummary": "This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.This domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 24 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.This domain will currently evaluate four research questions in relation to the use of IVT with tenecteplase:1. In patients with recent (24 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg) or not at all.2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all.3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg).4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age or having a heavy burden of cerebral small vessel disease on brain imaging."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomization will be stratified by: (1) planned emergency endovascular thrombectomy (EVT) and (2) known use or history to suggest use of a standard-dose direct oral anticoagulant (DOAC) within the last 24 hours. Randomization will be centralized, secure and concealed, using a web-based server and permuted blocks of varying sizes will be used.This will result in four pre-defined strata: (i) EVT+ / DOAC+ (ii) EVT+ / DOAC- (iii) EVT- / DOAC+ and (iv) EVT- / DOAC-.Patients in strata 1, 2 and 3 will be randomized to standard-dose IV tenecteplase (0.25 mg/kg body weight) vs. Low-dose tenecteplase (0.18 mg/kg body weight) or no IV thrombolysis (1:1:1 randomization). Patients in strata 4 will be randomized to standard-dose intravenous (IV) tenecteplase (0.25 mg/kg body weight) vs. Low-dose IV tenecteplase (0.18 mg/kg body weight) only (1:1 randomization).Emergency EVT is defined as anticipated arterial puncture time in the enrolling hospital ≤ 60 minutes from randomization.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The trial will have allocation concealment and blinded endpoint assessment, but open-label treatment. Given the time sensitive nature of acute stroke treatment, blinding the enrolling personnel to treatment assignment is not practical. Clinical site staff, including the Principal Investigator (PI), sub-investigators, clinic site staff, and the Sponsor will not be blinded to treatment allocated or received. In the event of an emergency the PI will be already unblinded.The trial will have blinded endpoint assessment on Day 90, with central blinded assessors contacting the participants.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4000,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ACT-WHEN",
"briefTitle": "ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632",
"nctId": "NCT06320431",
"orgStudyIdInfo": {
"id": "ACT-WHEN-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "A reduction of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS),"
}
],
"secondaryOutcomes": [
{
"measure": "90-day mortality"
},
{
"measure": "Proportion of participants with a Modified Rankin Scale (mRS) of 0-1 at Day 90."
},
{
"measure": "Proportion of participants with a Modified Rankin Scale (mRS) of 0-2 at Day 90."
},
{
"measure": "Health-related quality of life, as measured by the EQ-5D-5L at Day 90."
},
{
"measure": "The frequencies of Serious Adverse Events (SAEs) from enrollment up to Day 4"
},
{
"measure": "Symptomatic intracranial hemorrhage"
},
{
"measure": "Large parenchymal hemorrhage (PH-2)"
},
{
"measure": "Ordinal shift of 7 levels of mRS at 90 days"
},
{
"measure": "Proportion of participants achieving first pass (eTICI 2c or higher) reperfusion (when treated with EVT)."
},
{
"measure": "Proportion of participants achieving successful recanalization (revised arterial occlusive lesion [rAOL] score of 2b-3) at first angiographic acquisition (when treated with EVT)."
},
{
"measure": "Ambulatory status at discharge"
},
{
"measure": "Place of residence at 90 days"
},
{
"measure": "Imaging assessment (e.g., infarct size and edema volume)"
},
{
"measure": "Summative total length of hospital stay in the first 90-days after stroke onset"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The George Institute for Global Health, Australia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Calgary"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Ovarian Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": "11566"
}
]
},
"descriptionModule": {
"briefSummary": "Ovarian cancer (OC) has one of the highest mortality rates for female malignant tumors, attributed to advanced cancer stages upon diagnosis as well as a high recurrence rate. Piwi-interacting RNA-823 (piR-823) is a single-stranded non-protein coding RNA (ncRNA) star molecule in epigenetics research. Extensive cellular regulatory functions and aberrant expression of piR-823 have been implicated in carcinogenesis. Therefore, the findings of piwi-ncRNA dysregulated-expression in OC Egyptian female patients' cohort could be employed as a potential novel mechanism for OC precision, a step toward ncRNA-precision"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 56,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Epigenetic Regulatory Role of P-element Induced Wimpy Testis (Piwi) Interacting RNA-823 (piR-823) in Ovarian Cancer Progression",
"nctId": "NCT06320418",
"orgStudyIdInfo": {
"id": "RHDIRB2020110301REC#196",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Association of piR-823 expression with ovarian cancer progression"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-12-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Axatilimab"
},
{
"name": "Biopsy"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Computed Tomography"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Paclitaxel"
},
{
"name": "Positron Emission Tomography"
},
{
"name": "Retifanlimab"
}
]
},
"conditionsModule": {
"conditions": [
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"Metastatic Malignant Solid Neoplasm",
"Recurrent Malignant Solid Neoplasm",
"Refractory Malignant Solid Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Portland",
"contacts": [
{
"email": "[email protected]",
"name": "Shivaani Kummar",
"phone": "503-494-6594",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shivaani Kummar",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "OHSU Knight Cancer Institute",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
},
"state": "Oregon",
"status": null,
"zip": "97239"
}
]
},
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"briefSummary": "This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors."
},
"designModule": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
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"timePerspective": null
},
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"type": "ESTIMATED"
},
"phases": [
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"PHASE2"
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"studyType": "INTERVENTIONAL"
},
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"maximumAge": null,
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"sex": "ALL",
"stdAges": [
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]
},
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"orgStudyIdInfo": {
"id": "STUDY00025940",
"link": null,
"type": null
},
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{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01397",
"link": null,
"type": "REGISTRY"
},
{
"domain": "OHSU Knight Cancer Institute",
"id": "STUDY00025940",
"link": null,
"type": "OTHER"
}
]
},
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"measure": "Incidence of dose limiting toxicities (phase Ib)"
},
{
"measure": "Recommended phase 2 dose of the study drug combination (phase Ib)"
},
{
"measure": "Clinical benefit rate (phase Ib/II)"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs"
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{
"measure": "Changes in immune cell composition and functionality"
},
{
"measure": "Change in immune cell population"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Oregon Health and Science University"
},
{
"name": "Incyte Corporation"
}
],
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"name": "OHSU Knight Cancer Institute"
}
},
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"date": "2029-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
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},
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"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
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"interventions": null
},
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]
},
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{
"city": "Cairo",
"contacts": null,
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"facility": "Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab",
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"lon": 31.24967
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"state": null,
"status": null,
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}
]
},
"descriptionModule": {
"briefSummary": "Being a mechanistic study, this work aims to figure out \"the role of the cytoplasmic mRNA deadenylase CNOT7 expressed protein on NK cell resistance in metastatic BC\". In other words, to explore, whether, \"CNOT7 contributes to metastasis in Egyptian female metastatic BC patient's cohort, through NK cell resistance, or not.\""
},
"designModule": {
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"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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},
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"type": "ACTUAL"
},
"phases": null,
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},
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"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CCR4-NOT",
"briefTitle": "Implication of CCR4-NOT Complex Subunit 7 Expression in Natural Killer Cell Resistance in Metastatic Breast Cancer",
"nctId": "NCT06320392",
"orgStudyIdInfo": {
"id": "RHDIRB2020110301 REC#48",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Cytoplasmic mRNA deadenylase CNOT7 protein expression level in metastatic/advanced localized and non-metastatic BC sera using ELISA."
},
{
"measure": "CNOT7 tissue expression level in BC tissue samples categorized as metastatic vs non-metastatic tumor alongside with adjacent non-tumor tissue margin using immunohistochemistry."
},
{
"measure": "LAIR-1 protein expression level in BC patients peripheral blood samples using ELISA."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"name": "Ain Shams University"
}
},
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},
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"date": "2023-05-01"
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"startDateStruct": {
"date": "2021-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Zypan"
},
{
"name": "Placebo Comparator"
}
]
},
"conditionsModule": {
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]
},
"contactsLocationsModule": {
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{
"city": "Portland",
"contacts": [
{
"email": null,
"name": "Anders Gundersen, MS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "Helfgott Research Institute",
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"status": "RECRUITING",
"zip": "97201"
}
]
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"descriptionModule": {
"briefSummary": "The purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia."
},
"designModule": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomized to take either a placebo or Zypan dietary supplement three times per day for four weeks.",
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},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Zypan Functional Dyspepsia",
"nctId": "NCT06320379",
"orgStudyIdInfo": {
"id": "RB071522",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "Microbiota Relative Abundance and Composition"
},
{
"measure": "Microbiota Relative Abundance and Composition"
},
{
"measure": "Blood glucose"
},
{
"measure": "Blood glucose"
},
{
"measure": "Urea Nitrogen"
},
{
"measure": "Urea Nitrogen"
},
{
"measure": "Creatinine"
},
{
"measure": "Creatinine"
},
{
"measure": "Urea Nitrogen to creatinine ratio"
},
{
"measure": "Urea Nitrogen to creatinine ratio"
},
{
"measure": "Sodium"
},
{
"measure": "Sodium"
},
{
"measure": "Potassium"
},
{
"measure": "Potassium"
},
{
"measure": "Chloride"
},
{
"measure": "Chloride"
},
{
"measure": "Carbon Dioxide"
},
{
"measure": "Carbon Dioxide"
},
{
"measure": "Calcium"
},
{
"measure": "Calcium"
},
{
"measure": "Total Protein"
},
{
"measure": "Total Protein"
},
{
"measure": "Albumin"
},
{
"measure": "Albumin"
},
{
"measure": "Globulin"
},
{
"measure": "Globulin"
},
{
"measure": "Albumin to Globulin ratio"
},
{
"measure": "Albumin to Globulin ratio"
},
{
"measure": "Bilirubin"
},
{
"measure": "Bilirubin"
},
{
"measure": "Alkaline Phosphatase"
},
{
"measure": "Alkaline Phosphatase"
},
{
"measure": "aspartate aminotransferase"
},
{
"measure": "aspartate aminotransferase"
},
{
"measure": "Alanine aminotransferase"
},
{
"measure": "Alanine aminotransferase"
},
{
"measure": "Estimated glomerular filtration rate"
},
{
"measure": "Estimated glomerular filtration rate"
},
{
"measure": "White blood cell count"
},
{
"measure": "White blood cell count"
},
{
"measure": "Red blood cell count"
},
{
"measure": "Red blood cell count"
},
{
"measure": "Hemoglobin"
},
{
"measure": "Hemoglobin"
},
{
"measure": "Hematocrit"
},
{
"measure": "Hematocrit"
},
{
"measure": "Mean corpuscular volume"
},
{
"measure": "Mean corpuscular volume"
},
{
"measure": "Mean corpuscular hemoglobin"
},
{
"measure": "Mean corpuscular hemoglobin"
},
{
"measure": "Mean corpuscular hemoglobin concentration"
},
{
"measure": "Mean corpuscular hemoglobin concentration"
},
{
"measure": "Erythrocyte distribution width"
},
{
"measure": "Erythrocyte distribution width"
},
{
"measure": "Platelet count"
},
{
"measure": "Platelet count"
},
{
"measure": "Neutrophils"
},
{
"measure": "Neutrophils"
},
{
"measure": "Band Neutrophils"
},
{
"measure": "Band Neutrophils"
},
{
"measure": "Absolute band neutrophils"
},
{
"measure": "Absolute band neutrophils"
},
{
"measure": "Metamyelocytes"
},
{
"measure": "Metamyelocytes"
},
{
"measure": "Absolute Metamyelocytes"
},
{
"measure": "Absolute Metamyelocytes"
},
{
"measure": "Myelocytes"
},
{
"measure": "Myelocytes"
},
{
"measure": "Absolute Myelocytes"
},
{
"measure": "Absolute Myelocytes"
},
{
"measure": "Promyelocytes"
},
{
"measure": "Promyelocytes"
},
{
"measure": "Absolute Promyelocytes"
},
{
"measure": "Absolute Promyelocytes"
},
{
"measure": "Absolute Neutrophils"
},
{
"measure": "Absolute Neutrophils"
},
{
"measure": "Lymphocytes"
},
{
"measure": "Lymphocytes"
},
{
"measure": "Reactive Lymphocytes"
},
{
"measure": "Reactive Lymphocytes"
},
{
"measure": "Absolute Lymphocytes"
},
{
"measure": "Absolute Lymphocytes"
},
{
"measure": "Monocytes"
},
{
"measure": "Monocytes"
},
{
"measure": "Absolute monocytes"
},
{
"measure": "Absolute monocytes"
},
{
"measure": "Eosinophils"
},
{
"measure": "Eosinophils"
},
{
"measure": "Absolute Eosinophils"
},
{
"measure": "Absolute Eosinophils"
},
{
"measure": "Basophils"
},
{
"measure": "Basophils"
},
{
"measure": "Absolute Basophils"
},
{
"measure": "Absolute Basophils"
},
{
"measure": "Blasts"
},
{
"measure": "Blasts"
},
{
"measure": "Absolute Blasts"
},
{
"measure": "Absolute Blasts"
},
{
"measure": "Nucleated red blood cells"
},
{
"measure": "Absolute Nucleated red blood cells"
},
{
"measure": "Absolute Nucleated red blood cells"
},
{
"measure": "Platelet mean volume"
},
{
"measure": "Platelet mean volume"
}
],
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{
"measure": "Protein Assimilation"
},
{
"measure": "Protein Assimilation"
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],
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{
"measure": "Mineral concentrations in blood"
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{
"measure": "Mineral concentrations in blood"
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{
"measure": "Fat-soluble vitamin concentration in blood"
},
{
"measure": "Fat-soluble vitamins"
},
{
"measure": "Leeds Dyspepsia Questionnaire"
},
{
"measure": "Leeds Dyspepsia Questionnaire"
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{
"measure": "Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale"
},
{
"measure": "Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale"
}
]
},
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"name": "National University of Natural Medicine"
}
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},
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"date": "2024-03-20"
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"date": "2024-06-01"
},
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"startDateStruct": {
"date": "2023-03-15"
},
"studyFirstPostDateStruct": {
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{
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"interventions": [
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"name": "Sham TMS"
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{
"name": "Active TMS"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
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{
"city": "Aurora",
"contacts": [
{
"email": "[email protected]",
"name": "Joseph T Sakai, MD",
"phone": "303-724-7402",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kristen M Raymond, BA",
"phone": "303-724-3196",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joseph T Sakai, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Colorado Anschutz Medical Campus",
"geoPoint": {
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"lon": -104.83192
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"state": "Colorado",
"status": null,
"zip": "80045"
}
]
},
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"briefTitle": "Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder",
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"link": null,
"type": null
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{
"domain": null,
"id": "K24DA058882",
"link": "https://reporter.nih.gov/quickSearch/K24DA058882",
"type": "NIH"
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]
},
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"measure": "Tolerability"
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{
"measure": "Study emergent adverse events"
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],
"secondaryOutcomes": [
{
"measure": "Weeks of continuous abstinence"
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{
"measure": "Days of methamphetamine use"
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{
"measure": "Methamphetamine craving"
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{
"measure": "Methamphetamine craving on visual analog scale"
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{
"measure": "MRI cue craving"
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{
"measure": "MRI resting state"
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},
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"leadSponsor": {
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},
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"startDateStruct": {
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},
"studyFirstPostDateStruct": {
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}
}
} | false | null |
{
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"interventions": [
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"name": "RPH-075"
},
{
"name": "Keytruda®"
}
]
},
"conditionsModule": {
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]
},
"contactsLocationsModule": {
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"contacts": null,
"country": "Russian Federation",
"facility": "Federal State Budgetary Institution \"National Medical Research Center of Radiology\" of the Ministry of Health of the Russian Federation",
"geoPoint": {
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"lon": 36.61006
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"state": "Kaluga Region",
"status": null,
"zip": "249036"
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{
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"contacts": null,
"country": "Russian Federation",
"facility": "State Budgetary Healthcare Institution \"Clinical Oncological Dispensary No. 1\" of the Ministry of Health of the Krasnodar Territory",
"geoPoint": {
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"lon": 38.97603
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"status": null,
"zip": "350040"
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{
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"contacts": null,
"country": "Russian Federation",
"facility": "Regional Budgetary Healthcare Institution \"Kursk Oncological Research and Clinical Center named after G.E. Ostroverkhov\"",
"geoPoint": null,
"state": "Kursk Region",
"status": null,
"zip": "305524"
},
{
"city": "Istra",
"contacts": null,
"country": "Russian Federation",
"facility": "State Budgetary Healthcare Institution of the city of Moscow \"Moscow City Oncological Hospital No. 62 of the Department of Health of the City of Moscow\"",
"geoPoint": {
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"lon": 36.86867
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"state": "Moscow Region",
"status": null,
"zip": "143515"
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{
"city": "Pyatigorsk",
"contacts": null,
"country": "Russian Federation",
"facility": "The State budgetary healthcare Institution of the Stavropol Territory \"Pyatigorsk Interdistrict Oncological Dispensary\"",
"geoPoint": {
"lat": 44.04861,
"lon": 43.05944
},
"state": "Stavropol Territory",
"status": null,
"zip": "357502"
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{
"city": "Ekaterinburg",
"contacts": null,
"country": "Russian Federation",
"facility": "The State Autonomous Healthcare Institution of the Sverdlovsk region \"Sverdlovsk Regional Oncological Dispensary\"",
"geoPoint": {
"lat": 56.8519,
"lon": 60.6122
},
"state": "Sverdlovsk Region",
"status": null,
"zip": "620036"
},
{
"city": "Ufa",
"contacts": null,
"country": "Russian Federation",
"facility": "State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Bashkortostan",
"geoPoint": {
"lat": 54.74306,
"lon": 55.96779
},
"state": "The Republic Of Bashkortostan",
"status": null,
"zip": "450054"
},
{
"city": "Kazan",
"contacts": null,
"country": "Russian Federation",
"facility": "State Autonomous Healthcare Institution \"Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z.Segal\"",
"geoPoint": {
"lat": 55.78874,
"lon": 49.12214
},
"state": "The Republic Of Tatarstan",
"status": null,
"zip": "420029"
},
{
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"descriptionModule": {
"briefSummary": "The goal of this double-blind, randomized study is to establish the equivalence of the efficacy, safety and immunogenicity of the drugs RPH-075 (international nonproprietary name (INN) is pembrolizumab) and Keytruda® (INN is pembrolizumab) when used in patients with unresectable or metastatic skin melanoma first or second line therapy in a monotherapy regimen.The main task is to evaluate and compare the effectiveness of RPH-075 and Keytruda® drugs when used in patients with unresectable or metastatic skin melanoma as a 1 or 2 line therapy in monotherapy regimen, according to the objective response rate (ORR) parameter for up to 24 weeks of therapy."
},
"designModule": {
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},
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"timePerspective": null
},
"enrollmentInfo": {
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"type": "ACTUAL"
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"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma",
"nctId": "NCT06320353",
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"id": "CL01860211",
"link": null,
"type": null
},
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},
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"measure": "The objective response rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "The disease control rate (DCR)"
},
{
"measure": "The time to response (TTR)"
},
{
"measure": "The Duration of response (DOR)"
},
{
"measure": "The Progression-free survival (PFS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Data Management 365"
},
{
"name": "Exacte Labs LLC"
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{
"name": "Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "R-Pharm"
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},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
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"date": "2024-03-20"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
},
{
"name": "Electrotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Neck Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İstanbul",
"contacts": null,
"country": "Turkey",
"facility": "İstanbul Aydın University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of NMES on Neck Pain",
"nctId": "NCT06320340",
"orgStudyIdInfo": {
"id": "07032024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neck disability"
},
{
"measure": "Neck disability"
}
],
"secondaryOutcomes": [
{
"measure": "Pain intensity"
},
{
"measure": "Pain intensity"
},
{
"measure": "Range of Motion"
},
{
"measure": "Range of Motion"
},
{
"measure": "Static endurance of cervical deep flexor muscles"
},
{
"measure": "Static endurance of cervical deep flexor muscles"
},
{
"measure": "Fear of the movement"
},
{
"measure": "Fear of the movement"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "OTHER",
"name": "Istanbul University - Cerrahpasa (IUC)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-09-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cannabidiol cream"
},
{
"name": "Placebo cream"
}
]
},
"conditionsModule": {
"conditions": [
"Muscle Soreness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lexington",
"contacts": null,
"country": "United States",
"facility": "Seaton Center Building",
"geoPoint": {
"lat": 37.98869,
"lon": -84.47772
},
"state": "Kentucky",
"status": null,
"zip": "40502"
},
{
"city": "Lexington",
"contacts": null,
"country": "United States",
"facility": "Multidisciplinary Science Building",
"geoPoint": {
"lat": 37.98869,
"lon": -84.47772
},
"state": "Kentucky",
"status": null,
"zip": "40536"
}
]
},
"descriptionModule": {
"briefSummary": "Exercise-induced muscle damage (EIMD) results from unaccustomed exercise and can lead to delayed onset muscle soreness (DOMS). Impairments associated with EIMD and DOMS can result in moderate-to-severe discomfort and hindered performance. Recently, a compound derived from the cannabis plant, cannabidiol (CBD), has been used as a recovery tool for EIMD and DOMS. Despite the rising popularity of CBD products, their effectiveness in mitigating EIMD and DOMS is unknown. Specifically, to the investigators' knowledge, no clinical trials have been completed to assess the effects of topical CBD cream application on soreness, recovery and performance.Therefore, the purpose of the present study was to investigate the effects of CBD cream on DOMS and performance after an intensive lower-body exercise protocol. Specifically, the study's aims were:Aim 1: To assess the effect of topical CBD cream administration on muscle soreness following fatiguing exercise.Hypothesis 1: CBD cream would decrease perceived muscle soreness when compared to a placebo or control (no cream) group.Aim 2: To assess the effect of topical CBD cream administration on muscular performance following fatiguing exercise.Hypothesis 2: Recovery of muscular power would be quicker when CBD cream is applied, compared to a placebo or control (no cream) group.Aim 3: To assess if topical CBD cream has a localized (if any) or systemic effect on muscle soreness.Hypothesis 3: Improvements in muscle soreness would only be observed in localized muscles around where the CBD cream was applied."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The research participant's and research personnel conducting the testing will be blinded to who is in the CBD and placebo groups throughout the study. Those in Group 3 (the control group) will be aware that they are in the control group, as they will be skipping the steps involving cream application. The protocols for Group 1 and Group 2 will be identical and the respective cream will be made available to the testers and participants in identical containers.",
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Topical CBD's Effects on Soreness and Performance",
"nctId": "NCT06320327",
"orgStudyIdInfo": {
"id": "80177",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Vertical Jump Test"
}
],
"secondaryOutcomes": [
{
"measure": "Peak Isokinetic Torque Test"
},
{
"measure": "Pressure-Pain Threshold Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Joseph Pastina"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2022-08-04",
"filename": "ICF_000.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 187622,
"typeAbbrev": "ICF",
"uploadDate": "2024-03-13T17:59"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "tested product (2039125 03)"
}
]
},
"conditionsModule": {
"conditions": [
"Hyperpigmentation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lisboa",
"contacts": [
{
"email": "[email protected]",
"name": "Pedro Pinto",
"phone": "+351 216034267",
"phoneExt": "501",
"role": "CONTACT"
}
],
"country": "Portugal",
"facility": "PhDTrials Center",
"geoPoint": {
"lat": 38.71667,
"lon": -9.13333
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins",
"nctId": "NCT06320314",
"orgStudyIdInfo": {
"id": "LRP23021-E serum",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)"
},
{
"measure": "modified Melasma Area and Severity Index (mMASI) for patients with melasma"
},
{
"measure": "Post-Acne Hyperpigmentation Index (PAHPI)"
}
],
"secondaryOutcomes": [
{
"measure": "colorimetry measurements"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Cosmetique Active International"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adebrelimab + GEMOX + TKI"
}
]
},
"conditionsModule": {
"conditions": [
"Biliary Tract Cancer",
"Gemox Chemotherapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guanzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Junkai Ren",
"phone": "86-18664506517",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Wenbin Li",
"phone": "86-13602773101",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Sun Yat-sen Memorial Hospital, Sun Yat-sen University",
"geoPoint": null,
"state": "Guangdong",
"status": "RECRUITING",
"zip": "512000"
}
]
},
"descriptionModule": {
"briefSummary": "Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 43,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)",
"nctId": "NCT06320301",
"orgStudyIdInfo": {
"id": "SYSKY-2024-027-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "To explore the correlation between biomarkers and the efficacy of the combination regimen."
},
{
"measure": "The PFS based on an immunomodified RECIST (imRECIST）"
},
{
"measure": "The TTP based on an immunomodified RECIST (imRECIST）"
},
{
"measure": "The ORR based on an immunomodified RECIST (imRECIST）"
},
{
"measure": "The DCR based on an immunomodified RECIST (imRECIST）"
},
{
"measure": "The DoR based on an immunomodified RECIST (imRECIST）"
}
],
"primaryOutcomes": [
{
"measure": "the effectiveness of first-line treatment with Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX) in patients with advanced BTC"
}
],
"secondaryOutcomes": [
{
"measure": "To assess the progression-free survival (PFS)"
},
{
"measure": "To evaluate the time to progression (TTP)"
},
{
"measure": "To evaluate the disease control rate (DCR),"
},
{
"measure": "To evaluate the objective response rate (ORR)"
},
{
"measure": "To evaluate the duration of response (DoR)"
},
{
"measure": "To evaluate the overall survival (OS)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Suzhou Suncadia Biopharmaceuticals Co., Ltd."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Children With Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nancy",
"contacts": [
{
"email": "[email protected]",
"name": "Jonathan Pierret, PhD",
"phone": "+33 3 82 52 6761",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut Régional de Médecine Physique et de Réadaptation",
"geoPoint": {
"lat": 48.68439,
"lon": 6.18496
},
"state": null,
"status": "RECRUITING",
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
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},
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"count": 270,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "18 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "VERTEBRAL",
"briefTitle": "Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy (VERTEBRAL)",
"nctId": "NCT06320288",
"orgStudyIdInfo": {
"id": "IRR-FLAVIGNY-2023-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Trunk and center-of-mass accelerations and acceleration variability"
}
],
"secondaryOutcomes": [
{
"measure": "Gait Variability Index"
},
{
"measure": "Trunk Control Measurement Scale score (TCMS)"
},
{
"measure": "Early Clinical Assessment of Balance score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Storytelling Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"FATHER",
"BREASTFEEDING"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Adana",
"contacts": null,
"country": "Turkey",
"facility": "Cukurova University",
"geoPoint": {
"lat": 37.00167,
"lon": 35.32889
},
"state": "Balcalı",
"status": null,
"zip": "01 330"
},
{
"city": "Adana",
"contacts": null,
"country": "Turkey",
"facility": "Çukurova",
"geoPoint": {
"lat": 37.00167,
"lon": 35.32889
},
"state": "Balcalı",
"status": null,
"zip": "01330"
},
{
"city": "Adana",
"contacts": null,
"country": "Turkey",
"facility": "Çukurova University",
"geoPoint": {
"lat": 37.00167,
"lon": 35.32889
},
"state": null,
"status": null,
"zip": "01330"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study was planned to examine the effect of the education given through digital storytelling method on fathers' breastfeeding self-efficacy perception. The research is in a quasi-experimental design with no pretest-posttest control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fathers' Breastfeeding Self-efficiency",
"nctId": "NCT06320275",
"orgStudyIdInfo": {
"id": "self-efficiency",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Breastfeeding Self-Efficacy Scale for Fathers Short Form"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cukurova University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Wet cupping therapy (WCT)"
}
]
},
"conditionsModule": {
"conditions": [
"Treatment"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Fibromyalgia has become one of the most prevalent chronic pain conditions that impair quality of life. Wet cupping has gained increasing popularity in treating painful conditions.This study aims to investigate the effectiveness of wet cupping therapy combined with home-based exercise compared to home-based exercise alone in improving patients diagnosed with primary fibromyalgia syndrome."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled drugs",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia",
"nctId": "NCT06320262",
"orgStudyIdInfo": {
"id": "NRC/TDF/01/F",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline brain MRS"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline Visual Analog Scale (VAS)"
},
{
"measure": "Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR)"
},
{
"measure": "Change from the baseline sleep disturbance using the Jenkins sleep score (JSS)"
},
{
"measure": "Change from baseline Fatigue- VAS."
},
{
"measure": "Change from baseline of Hospital Anxiety and Depression Scale (HADS)"
},
{
"measure": "Change from baseline of the Montreal Cognitive Assessment (MoCA)"
},
{
"measure": "Change from baseline of the Widespread pain index (WPI)"
},
{
"measure": "Change from baseline hemoglobin"
},
{
"measure": "patient compliance on exercise as instructed"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rasmia Elgohary"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High-frequency rotation-traction manipulation"
},
{
"name": "Low-frequency rotation-traction manipulation"
},
{
"name": "Cervical traction"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Radiculopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Xu Wei, Ph.D",
"phone": "13488716557",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Tianxiao Feng, Ph.D",
"phone": "15733196045",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Xu Wei, Ph.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Aifeng Liu, Ph.D",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Yanguo Wang, Ph.D",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Zhenhua Li, Ph.D",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "China",
"facility": "Wangjing Hospital, China Academy of Chinese Medical Sciences",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100102"
}
]
},
"descriptionModule": {
"briefSummary": "The evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient. This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a multicenter randomized controlled trial."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "This study did not implement blinding for the manipulative therapists and participants. However, blinding procedures were employed for the outcome assessors and data analysts, meaning that they remained unaware of the group.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 216,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy",
"nctId": "NCT06320249",
"orgStudyIdInfo": {
"id": "WJYY-XZKT-2023-05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Visual Analog Scale for Pain"
}
],
"secondaryOutcomes": [
{
"measure": "The Visual Analog Scale for Pain"
},
{
"measure": "The Visual Analog Scale for Pain"
},
{
"measure": "The Visual Analog Scale for Pain"
},
{
"measure": "The Visual Analog Scale for Pain"
},
{
"measure": "The Visual Analog Scale for Pain"
},
{
"measure": "The Visual Analog Scale for Numbness"
},
{
"measure": "The Visual Analog Scale for Numbness"
},
{
"measure": "The Visual Analog Scale for Numbness"
},
{
"measure": "The Visual Analog Scale for Numbness"
},
{
"measure": "The Visual Analog Scale for Numbness"
},
{
"measure": "The Visual Analog Scale for Numbness"
},
{
"measure": "The Neck Disability Index"
},
{
"measure": "The Neck Disability Index"
},
{
"measure": "The Neck Disability Index"
},
{
"measure": "The Neck Disability Index"
},
{
"measure": "The Neck Disability Index"
},
{
"measure": "The Neck Disability Index"
},
{
"measure": "The Short Form 12"
},
{
"measure": "The Short Form 12"
},
{
"measure": "The Short Form 12"
},
{
"measure": "The Short Form 12"
},
{
"measure": "The Short Form 12"
},
{
"measure": "The Short Form 12"
},
{
"measure": "The total cost"
},
{
"measure": "The recurrence rate"
},
{
"measure": "Expectation of Treatment and Credibility Scale"
},
{
"measure": "Expectation of Treatment and Credibility Scale"
},
{
"measure": "Adverse reactions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "First Teaching Hospital of Tianjin University of Traditional Chinese Medicine"
},
{
"name": "Affiliated Hospital of Changchun University of Chinese Medicine"
},
{
"name": "Dongzhimen Hospital, Beijing University of Chinese Medicine"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Wangjing Hospital, China Academy of Chinese Medical Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adjust-Unlikely"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Embolism",
"D-dimer",
"Diagnosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kingston",
"contacts": [
{
"email": "[email protected]",
"name": "Natasha Clayton, CRA, RA",
"phone": "4165663590",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kerstin de Wit, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Kingston Health Sciences Centre",
"geoPoint": {
"lat": 44.22976,
"lon": -76.48101
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "K7L 2V7"
}
]
},
"descriptionModule": {
"briefSummary": "It is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. More than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although positive results are low. Imaging for PE testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. Existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. Too many patients undergo unnecessary pulmonary embolism imaging.We have created a new tool (called Adjust-Unlikely) which could safely reduce pulmonary embolism imaging in Canada. Our research group composed of researchers, emergency physicians, and patients developed the Adjust-Unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. Adjust-Unlikely is highly sensitive at the bedside, meaning there are very few false negative results.Our study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 4000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EMPET",
"briefTitle": "Emergency Medicine Pulmonary Embolism Testing Multicentre Study",
"nctId": "NCT06320236",
"orgStudyIdInfo": {
"id": "4603",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Venous thrombosis"
}
],
"secondaryOutcomes": [
{
"measure": "Venous thrombosis"
},
{
"measure": "Index presentation Adjust-Unlikely testing results"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Canadian Institutes of Health Research (CIHR)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Dr. Kerstin de Wit"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Prostate Cancer",
"PET/CT",
"Survivorship",
"PSMA"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Essen",
"contacts": [
{
"email": "[email protected]",
"name": "Wolfgang P Fendler, M.D.",
"phone": "+492017232032",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Hospital Essen",
"geoPoint": {
"lat": 51.45657,
"lon": 7.01228
},
"state": null,
"status": "RECRUITING",
"zip": "45147"
}
]
},
"descriptionModule": {
"briefSummary": "Background:PROMISE criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET whole-body stage of prostate cancer. PSMA PET disease extent by PROMISE has been associated with oncologic outcome.Need:Improved prognostication across various stages of prostate cancer is needed for management guidance and study design.Aim:1. To assess the prognostic value of PSMA PET2. To compare the prognostic value of PSMA PET with clinical prognostic scores in patients with prostate cancer at various disease stagesInclusion:* Adult patients with* biopsy/histo proven prostate cancer who* underwent PSMA PET (any type)* for staging or re-staging at any stage and who* have at least 3-year overall survival follow-up data available will be included consecutively.Exclusion:* Patients with neuroendocrine prostate cancer* Patients with metastasized or disseminated malignancy other than prostate cancer"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
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"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROMISE-PET",
"briefTitle": "PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer",
"nctId": "NCT06320223",
"orgStudyIdInfo": {
"id": "PROMISE PET Registry",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall survival"
}
],
"secondaryOutcomes": [
{
"measure": "Metastasis-free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Essen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2035-03-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-03-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Multicomponent program"
}
]
},
"conditionsModule": {
"conditions": [
"Asthma in Children"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": null,
"country": "United States",
"facility": "University of Chicago Charter Schools",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "60640"
}
]
},
"descriptionModule": {
"briefSummary": "Research has shown that adherence to evidence-based asthma guidelines leads to improved outcomes, yet critical gaps remain in the implementation of these guidelines, particularly among minority and low-income youth. Schools represent a crucial point of intervention, as demonstrated by school-based asthma programs that have addressed individual components of the guidelines with promising results. This project aims to develop, implement, and evaluate a pragmatic, multi-component asthma program that builds upon existing targeted interventions to fully implement the asthma guidelines and integrate them in school practices to foster sustainability. The investigator seeks to understand whether this type of program will improve asthma outcomes at the child and school level."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CASCADE",
"briefTitle": "Chicago Asthma School-Directed Child-Centered Assessment and Dissemination of Evidence",
"nctId": "NCT06320210",
"orgStudyIdInfo": {
"id": "IRB19-1308",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Asthma control"
}
],
"secondaryOutcomes": [
{
"measure": "Missed work days in parents"
},
{
"measure": "Asthma knowledge - parents"
},
{
"measure": "Asthma knowledge - child"
},
{
"measure": "Asthma quality of life - child"
},
{
"measure": "Caregiver quality of life"
},
{
"measure": "Asthma impact - parent"
},
{
"measure": "Missed school days"
},
{
"measure": "Healthcare utilization"
},
{
"measure": "Asthma impact - child"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Chicago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "In situ simulation assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Drowning",
"Drowning, Near",
"Drowning and Nonfatal Submersion",
"Drowning/Submersion",
"Drowning and Submersion While in Natural Water"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Næstved",
"contacts": [
{
"email": "[email protected]",
"name": "Niklas Breindahl, MD",
"phone": "004528566410",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Helle Collatz Christensen, MD, PhD",
"phone": "004521673452",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Prehospital Center",
"geoPoint": {
"lat": 55.22992,
"lon": 11.76092
},
"state": "Region Zealand",
"status": "RECRUITING",
"zip": "4700"
}
]
},
"descriptionModule": {
"briefSummary": "This retrospective study will analyse a dataset consisting of 919 in situ simulation assessments collected between 2018 and 2023 in a Danish nationwide surf lifeguard organisation. The primary objective is to estimate the pass/fail ratio of in situ simulation assessments. The secondary objective is to analyse risk factors associated with a failed assessment. These results may guide future efforts to improve the Danish surf lifeguard training program."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DROWN_INSITU",
"briefTitle": "In Situ Simulation Training in Lifeguard Organisations",
"nctId": "NCT06320197",
"orgStudyIdInfo": {
"id": "DROWN_INSITU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pass/fail ratio of in situ simulation assessments"
}
],
"secondaryOutcomes": [
{
"measure": "Risk factors associated with a failed assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prehospital Center, Region Zealand"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Artificial Intelligence risk model"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer",
"Blood Biomarkers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "Fondazione IRCCS Istituto Nazionale dei Tumori",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": "20133"
}
]
},
"descriptionModule": {
"briefSummary": "Low-dose computed tomography (LDCT) lung cancer (LC) screening can reduce mortality among heavy smokers, but there is a critical need to better identify people at higher risk and to reduce harms related to management of benign nodules. The most promising strategy is to combine novel tools to optimize clinical decisions and increase the benefit of screening.In this respect, the investigators already demonstrated that the combination of baseline LDCT features with a minimal invasive microRNA blood test was able to more precisely estimate the individual risk of developing LC. The investigators posit that additional immune-related and radiologic features can be integrated with the help of artificial intelligence (AI) to further implement LDCT screening strategies. The project will answer whether the combination of (bio)markers of different origin can predict LC development at baseline and over time, indicate which screen-detected lung nodules are likely to be malignant and ultimately reduce LC and all cause mortality."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 650,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "AI for Lung Cancer Risk Definition in Computed Tomography Screening Programs",
"nctId": "NCT06320184",
"orgStudyIdInfo": {
"id": "INT 0083/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Aim 1"
}
],
"secondaryOutcomes": [
{
"measure": "Aim 2"
},
{
"measure": "Aim 3"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Milano Bicocca"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Istituto Nazionale dei Tumori, Milano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Invasive neuromodulation"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The study, conducted by the Universidad Europea de Madrid, examines the immediate effects of a single session using NESA microcurrents on various circulatory system variables in healthy subjects. It divides participants into three groups based on session duration (15, 30, 45 minutes), measuring pre and post-intervention changes. The focus is on autonomic nervous system responses, aiming to understand the minimum treatment characteristics needed for significant autonomic changes. Variables studied include systolic and diastolic blood pressure, heart rate, and several ultrasound measurements of the common carotid artery (CSA), including thickness and peak systolic flow velocity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
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},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System",
"nctId": "NCT06320171",
"orgStudyIdInfo": {
"id": "240118,2024-481",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Systolic and diastolic Blood Pressure:"
},
{
"measure": "Heart rate"
}
],
"secondaryOutcomes": [
{
"measure": "Ultrasonographic variables: Cross-sectional area of the jugular vein"
},
{
"measure": "Ultrasonographic variables:Cross-sectional area of the common carotid"
},
{
"measure": "Ultrasonographic variables:Thickness of the common carotid"
},
{
"measure": "Ultrasonographic variables:Peak systolic velocity."
},
{
"measure": "Cortisol measurement"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidad Europea de Madrid"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "clinical evaluation of sarcopenic obesity"
}
]
},
"conditionsModule": {
"conditions": [
"Sarcopenic Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Patrizia Rovere Querini, MD, PhD",
"phone": "+390226433065",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Rebecca De Lorenzo, MD",
"phone": "+390226433065",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20132"
}
]
},
"descriptionModule": {
"briefSummary": "Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). SO is characterised by the coexistence of obesity and sarcopenia (i.e. reduced muscle mass and function) and is a growing public health problem in the elderly. The health risks of obesity and sarcopenia act synergistically, maximising the risk of disability of OS. The molecular mechanisms underlying OS are largely unknown. Increased fat mass induces chronic systemic inflammation and alters the profiles of adipokines and hormones, promoting the development of sarcopenia. On the other hand, the reduction in muscle tissue (SM) typical of sarcopenia is characterised by an alteration in the metabolic properties of skeletal muscle with an increase in insulin resistance and a reduction in energy expenditure that favours the accumulation and dysfunction of adipose tissue (AT). The cellular alterations that would seem to underlie OS are: altered autophagy, cellular senescence, epigenetic and mitochondrial alterations and maladaptive activation of intra- and intercellular inflammatory circuits (e.g. cytokines, extracellular vesicles, dysfunctional circulating leukocytes). However, the interconnections between these mechanisms are still unclear. The impact of OS can be dramatic on the health and quality of life of those affected. Therefore, the identification of early biomarkers that can recognise overweight and obese individuals at risk of developing SO is of paramount importance. This would shed light on the heterogeneity of an otherwise homogeneous clinical condition, opening new horizons towards the conscious design of more personalised therapeutic strategies, allowing a more rational use of the limited resources available for the growing elderly population.The study design designed to achieve this aim is a cross-sectional observational study with an additional multicentre procedure lasting two years."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1108,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly",
"nctId": "NCT06320158",
"orgStudyIdInfo": {
"id": "PNRR-MAD-2022-12376672",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identifying new molecular markers in elderly patients with sarcopenic obesity"
}
],
"secondaryOutcomes": [
{
"measure": "Assessing the ability of new markers (identified in the pre-clinical phase of this project) to predict individual disease trajectories"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cryotherapy"
},
{
"name": "core stability exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Dysmenorrhea Primary"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Physical Therapy,Cairo University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women.Cryotherapy, therapeutic cooling, is one of the modalities widely used in sports medicine for a variety of treatment purposes. Physiological and neurological responses of musculoskeletal tissues to cooling have been extensively examined in the literature."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Cryotherapy on Primary Dysmenorrhoea",
"nctId": "NCT06320145",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004045",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain assessed by VAS"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Treatment of spontaneous intracranial hemorrhage"
}
]
},
"conditionsModule": {
"conditions": [
"Intracranial Hemorrhages"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Francesca Guzzo, MD",
"phone": "+393470830669",
"phoneExt": "+390226433333",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Margherita Tozzi, MD",
"phone": "+393343138755",
"phoneExt": "+390226433333",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Ospedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": "MI",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis.Participants will be treated as per standard clinical practice."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 2000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BLANDISH",
"briefTitle": "BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage)",
"nctId": "NCT06320132",
"orgStudyIdInfo": {
"id": "BLANDISH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mortality"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Ospedale San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PDO Group"
}
]
},
"conditionsModule": {
"conditions": [
"Bronchial Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bergamo",
"contacts": [
{
"email": null,
"name": "Fabiano Di Marco, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "ASST Papa Giovanni XXIII",
"geoPoint": {
"lat": 45.69601,
"lon": 9.66721
},
"state": null,
"status": "RECRUITING",
"zip": "24127"
},
{
"city": "Brescia",
"contacts": [
{
"email": null,
"name": "Laura Pini, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Azienda ospedaliera Spedali Civili di Brescia",
"geoPoint": {
"lat": 45.53558,
"lon": 10.21472
},
"state": null,
"status": "RECRUITING",
"zip": "25123"
},
{
"city": "Genova",
"contacts": [
{
"email": null,
"name": "Fulvio Braido, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale San Martino di Genova",
"geoPoint": {
"lat": 44.40478,
"lon": 8.94438
},
"state": null,
"status": "RECRUITING",
"zip": "16132"
},
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Francesco Blasi, Prof.",
"phone": "+390250320627",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20122"
},
{
"city": "Milan",
"contacts": [
{
"email": null,
"name": "Pierachille Santus",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "ASST Fate Bene e Fratelli Sacco",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20100"
},
{
"city": "Milan",
"contacts": [
{
"email": null,
"name": "Paolo Tarsia, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "ASST Grande Ospedale Metropolitano Niguarda",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "20100"
},
{
"city": "Milan",
"contacts": [
{
"email": null,
"name": "Stefano Centanni, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "ASST Santi Paolo e Carlo",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20100"
},
{
"city": "Pavia",
"contacts": [
{
"email": null,
"name": "Angelo Corsico, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Policlinico San Matteo",
"geoPoint": {
"lat": 45.19205,
"lon": 9.15917
},
"state": null,
"status": "RECRUITING",
"zip": "27100"
},
{
"city": "Rovigo",
"contacts": [
{
"email": null,
"name": "Gianluca Casoni, Dott.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale di Rovigo",
"geoPoint": {
"lat": 45.06982,
"lon": 11.79022
},
"state": null,
"status": "RECRUITING",
"zip": "45100"
},
{
"city": "Rozzano",
"contacts": [
{
"email": null,
"name": "Enrico Heffler",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Humanitas Hospital - UO Allergologia",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": null,
"status": "RECRUITING",
"zip": "20089"
},
{
"city": "Rozzano",
"contacts": [
{
"email": null,
"name": "Stefano Aliberti, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Humanitas Hospital - UO Pneumologia",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "20089"
},
{
"city": "Tradate",
"contacts": [
{
"email": null,
"name": "Antonio Spanevello, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituti Clinici Scientifici Maugeri, IRCCS Tradate",
"geoPoint": {
"lat": 45.70843,
"lon": 8.90763
},
"state": null,
"status": "RECRUITING",
"zip": "21049"
}
]
},
"descriptionModule": {
"briefSummary": "To optimize the effectiveness of asthma therapy there is a need to identify and address individual patient goals. Considering the self-management discussion as central for the achievement of health outcomes, Healthcare Providers may help patients make specific actions to obtain their desired goals.The current evidence suggest that Healthcare Professionals need to develop a more patient-centered and partnership-based approach based on the development and review of action plans, including the experiential asthma knowledge of patients and caregivers. From a practical perspective, the specialist (i.e. pulmunologists, allergologists, etc) has clear therapeutic targets to be reached in asthmatic patients: for example, improving the disease control, the spirometric values and asthma control test (ACT) score vs. pre-treatment evaluations represent the standard outcomes to reach (GINA 2019). However, as previously described, patients are more likely to achieve an improved clinical outcome when the treatment is driven by a personalized goal. This builds on the same principle as shared decision making between the physician and patient, recognizing both the personal motivation and the accountability on behalf of the patient (Hoskins et al. 2016).This study aims to evaluate if the identification of a personalized outcome allows patients to achieve a better control of asthma in terms of asthma control test (ACT) and asthma quality of life questionnaire (AQLQ). In addition, a set of clinical outcomes (i.e. forced expiratory volume in one second - FEV1, use of rescue therapy, night awakeness) will also be assessed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 190,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PERSONAS",
"briefTitle": "Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study",
"nctId": "NCT06320119",
"orgStudyIdInfo": {
"id": "2943",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary Outcome. The primary outcome of the study is to evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group)."
}
],
"secondaryOutcomes": [
{
"measure": "Secondary Outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of ACT from month 3 to month 6."
},
{
"measure": "Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from baseline to month 3."
},
{
"measure": "Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from month 3 to month 6."
},
{
"measure": "Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline to month 3."
},
{
"measure": "Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline from month 3 to month 6."
},
{
"measure": "Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 3, assessed by VAS (1-10) to V1."
},
{
"measure": "Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 6, assessed by a VAS (1-10) as minimal clinically important difference (MCID) of 1.5 points to V1."
},
{
"measure": "Secondary outcome. To measure the proportion of patients in the PDO group who maintain/improve their own personal outcome at month 6, assessed by a VAS (1-10) to V2."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual Reality baseline assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy",
"Healthy Volunteers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bosisio Parini",
"contacts": [
{
"email": "[email protected]",
"name": "Emilia Biffi, PhD",
"phone": "+39 31877862",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Emilia Biffi, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Scientific Institute, IRCCS E. Medea",
"geoPoint": {
"lat": 45.80075,
"lon": 9.29
},
"state": "Lecco",
"status": "RECRUITING",
"zip": "23842"
}
]
},
"descriptionModule": {
"briefSummary": "Spatial navigation skills are very important in everyday activities and quality of life but spatial navigation abilities are not part of the standard process of assessment and rehabilitation of patients. Furthermore, it is known that children with cerebral palsy have impaired visuo-spatial competences. The main objective of this study is to evaluate and compare the spatial navigation abilities of typically developing children and of children with cerebral palsy using the \"StarMaze\" application delivered by means of a Head Mounted Display (HMD). The second aim is to investigate the user experience during the session. A similar application was already developed and tested in a virtual reality large scale platform whose size and cost limit the accessibility. Therefore, the assessment (and future training) of navigation abilities with affordable and easy-to-use technology such as HMD open new perspectives."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 26,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers",
"nctId": "NCT06320106",
"orgStudyIdInfo": {
"id": "GIP 1021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Navigation strategy"
}
],
"secondaryOutcomes": [
{
"measure": "Learning rate"
},
{
"measure": "Simulator Sickness Questionnaire"
},
{
"measure": "System Usability Scale"
},
{
"measure": "Independent Television Commission-Sense of Presence Inventory"
},
{
"measure": "Suitability Evaluation Questionnaire - simplified version"
},
{
"measure": "Short-form of PANAS-Positive Affect and Negative Affect Scales"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Eugenio Medea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SOUND Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Dementia",
"Older People"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ancona",
"contacts": null,
"country": "Italy",
"facility": "INRCA Hospital",
"geoPoint": {
"lat": 43.5942,
"lon": 13.50337
},
"state": null,
"status": null,
"zip": "60127"
},
{
"city": "Trofa",
"contacts": null,
"country": "Portugal",
"facility": "Sons do Estamine Associacao",
"geoPoint": null,
"state": null,
"status": null,
"zip": null
},
{
"city": "Bucarest",
"contacts": null,
"country": "Romania",
"facility": "Associatia Habilitas",
"geoPoint": {
"lat": 44.43225,
"lon": 26.10626
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SOUND",
"briefTitle": "Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia",
"nctId": "NCT06320093",
"orgStudyIdInfo": {
"id": "INRCA_002_2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in mental wellbeing of patients with dementia"
},
{
"measure": "Change in cognitive status of patients with dementia"
},
{
"measure": "Change in stress of health care providers"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "European Union"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Nazionale di Ricovero e Cura per Anziani"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TQB2223 injection"
},
{
"name": "Penpulimab Injection"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Hepatocellular Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Harbin",
"contacts": [
{
"email": "[email protected]",
"name": "Zhiwei Li, Doctor",
"phone": "15004683651",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Affiliated Cancer Hospital of Harbin Medical University",
"geoPoint": {
"lat": 45.75,
"lon": 126.65
},
"state": "Heilongjiang",
"status": null,
"zip": "150000"
},
{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "Feng Zhang, Doctor",
"phone": "13871410719",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Hubei Provincial Tumor Hospital",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430079"
},
{
"city": "Changsha",
"contacts": [
{
"email": "[email protected]",
"name": "Shanzhi Gu, Master",
"phone": "13574865998",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Hunan Provincial Tumor Hospital",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan",
"status": null,
"zip": "410031"
}
]
},
"descriptionModule": {
"briefSummary": "TQB2223 is a recombinant, fully human antibody that binds to lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase Ib study aimed at evaluating the safety, tolerability, and immunogenicity characteristics of TQB2223 injection combined with AK105 injection in the treatment of advanced hepatocellular carcinoma."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma.",
"nctId": "NCT06320080",
"orgStudyIdInfo": {
"id": "TQB2223-AK105-Ib-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective Response Rate (ORR)"
},
{
"measure": "Progression-free survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "Disease control rate (DCR)"
},
{
"measure": "Duration of Response (DOR)"
},
{
"measure": "Number of patients with adverse events (AEs) and/or serious adverse events (SAEs)"
},
{
"measure": "Immunogenicity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Chia Tai Tianqing Pharmaceutical Group Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stereotactic Ablative Body Radiotherapy (SABR)"
},
{
"name": "177Lu-PSMA-617"
},
{
"name": "Niraparib and Abiraterone Acetate Dual Action Tablet DAT"
},
{
"name": "Abiraterone Acetate"
},
{
"name": "Apalutamide"
},
{
"name": "Androgen Deprivation Therapy (ADT)"
},
{
"name": "Androgen Receptor Signalling Inhibitor (ARSI)"
},
{
"name": "Local Radiotherapy"
},
{
"name": "Prednisolone"
},
{
"name": "Docetaxel"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer Metastatic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "STAMPEDE2 is a clinical trial comparing three new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy. People from all backgrounds and ethnicities are encouraged to take part and multiple hospitals across the UK are involved. University College London is running the trial.Each comparison within the trial has its own control arm where people get the best standard of care (Arm A) versus a research arm where a new treatment is added to standard of care.Participants are allocated to an arm by a computerised system with a 50% chance of getting the research treatment.Comparison S: Arm A versus Arm S (Stereotactic Ablative Body Radiotherapy (SABR)) - Tests whether giving targeted doses of radiotherapy (SABR) to parts of the body where the cancer has spread slows the spread of the cancer and improves survival. 2476 people will be in this comparison.Comparison P: Arm A versus Arm P (PSMA-Lutetium (177Lu-PSMA-617)) - Tests whether giving a radioactive material (177Lu-PSMA-617) that targets prostate cancer cells slows the spread of the cancer and improves survival. 1756 people will be in this comparison.Comparison N: Arm A(N) versus Arm N (Niraparib-Abiraterone Acetate+Prednisolone (Nira-AA+P)) - Tests whether giving a new drug (Nira-AA+P) slows the spread of the cancer and improves survival. Only people with certain genetic changes in their tumour sample can take part in Comparison N. 682 people will be in this comparison.Participants may be able to take part in more than one comparison.All participants will be followed up with scans and tests to monitor their cancer. Doctors will check for any side effects from the treatments. Treatments will be stopped if side effects are serious, or people no longer wish to take the treatments."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Platform trial testing three research comparisons where patients are randomised either to experimental treatments in Arms S, P and N or their corresponding SoC control Arms A and A(N).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8000,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STAMPEDE2",
"briefTitle": "A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer",
"nctId": "NCT06320067",
"orgStudyIdInfo": {
"id": "PR12",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IRAS",
"id": "1006437",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Radiographic Progression-Free-Survival (rPFS)"
},
{
"measure": "Overall Survival (OS)"
}
],
"secondaryOutcomes": [
{
"measure": "Failure-Free Survival (FFS)"
},
{
"measure": "Prostate cancer specific survival (PCSS)"
},
{
"measure": "Safety through reporting of SAEs"
},
{
"measure": "Toxicity using CTCAE classification and reporting of all Adverse Events that are ≥ grade 3 or grade 1 and 2 leading to a change in trial treatment"
},
{
"measure": "Compliance with randomised allocation. Formal definitions for compliance with treatment will be pre-specified in the statistical analysis plan. This is still in development."
},
{
"measure": "EQ-5D-5L questionnaire for QoL and cost effectiveness assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Cancer Research UK"
},
{
"name": "Novartis"
},
{
"name": "Janssen Pharmaceutica NV"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University College, London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2031-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Maternal Health Management Program"
}
]
},
"conditionsModule": {
"conditions": [
"Gestational Diabetes",
"Gestational Hypertension",
"High Risk Pregnancy",
"Preeclampsia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:* Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?* Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.Participants in the standard of care will be asked to:* Complete surveys* Biometric screeningsParticipants in the intervention group will be asked to:* Complete surveys* Biometric screenings* Participate in weekly personal health coaching* Receive and consume provided weekly meals.Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PLATE",
"briefTitle": "Preventing Obstetric Complications With Dietary Intervention",
"nctId": "NCT06320054",
"orgStudyIdInfo": {
"id": "PRO00049771",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical Outcomes"
},
{
"measure": "Clinical Outcomes"
},
{
"measure": "Clinical Outcomes"
},
{
"measure": "Clinical Outcomes"
},
{
"measure": "Clinical Outcomes"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Reported Outcomes"
},
{
"measure": "Patient Reported Outcomes"
},
{
"measure": "Patient Reported Outcomes"
},
{
"measure": "Patient Reported Outcomes"
},
{
"measure": "Patient Reported Outcomes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Advancing a Healthier Wisconsin Endowment"
},
{
"name": "Food for Health, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Medical College of Wisconsin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Low dose oxelidine group"
},
{
"name": "High dose oxelidine group"
},
{
"name": "Hydromorphone group"
}
]
},
"conditionsModule": {
"conditions": [
"Postoperative Pain"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial\\] is to further explore the effectiveness and safety of oxelidine in the treatment of moderate to severe acute pain after orthopedic surgery. The main question it aims to answer is: Pain management after orthopaedic surgery provides more effective and safe drug options, provides new options for clinical treatment, and provides a scientific basis for clinical practice.Participants will be asked to pain score in the different time, treatments they'll be given and use optimal drug. Researchers will compare analgesic effect of oxelidine of different dose."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 162,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery",
"nctId": "NCT06320041",
"orgStudyIdInfo": {
"id": "KY-2024-028",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain score at rest 0-72 hours after surgery"
}
],
"secondaryOutcomes": [
{
"measure": "The total amount of opioid after operation."
},
{
"measure": "PCIA as a remedial analgesic press time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Fourth Affiliated Hospital of Zhejiang University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Invasive Transcranial Focused Ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Depressive Disorder, Major",
"Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tucson",
"contacts": null,
"country": "United States",
"facility": "University of Arizona",
"geoPoint": {
"lat": 32.22174,
"lon": -110.92648
},
"state": "Arizona",
"status": null,
"zip": "85721"
}
]
},
"descriptionModule": {
"briefSummary": "Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Research also suggests that the Default Mode Network (DMN), responsible for self-referential processing, plays an important role in depression wherein it has been linked to RNT. In depressed individuals, this network appears to be hyper-connected, or \"too connected\", within itself which, in turn, is thought to promote RNT.Half of depressed individuals are treatment-resistant, creating a critical need to identify more effective interventions derived from a better mechanistic understanding of the development and maintenance of depression. Non-invasive Transcranial-Focused Ultrasound Stimulation (tFUS) is promising for the treatment of depression. tFUS directs a low-intensity (nonthermal) focused ultrasound beam that passes safely through the skull. Compared to other noninvasive neuromodulation approaches, tFUS can target deeper brain regions with high spatial precision.The present study is an exploratory non-blinded single treatment study to investigate whether tFUS targeting a major hub of the DMN, the anterior-medial prefrontal cortex, can improve depression symptoms and reduce RNT. Twenty depressed individuals with high RNT (75th percentile) will complete up to eleven ultrasound sessions targeting the anterior medial prefrontal cortex, a hub of the brain's default mode network that has been found to be hyper-connected in depression. MRI scans will be obtained before the first and after the last ultrasound sessions. Based on previous literature, it is predicted that depression interview ratings and self-report symptoms will decrease after the intervention, and also that DMN connectivity will decrease following intervention."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "All participants will receive the same treatment protocol.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "There is no masking.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "DMNtFUS",
"briefTitle": "Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms",
"nctId": "NCT06320028",
"orgStudyIdInfo": {
"id": "019782-00001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Beck Depression Inventory - II (BDI-II)"
},
{
"measure": "Perseverative Thinking Questionnaire (PTQ)"
},
{
"measure": "Hamilton Depression Rating Scale (HDRS)"
},
{
"measure": "Default Mode Network (DMN) Connectivity"
}
],
"secondaryOutcomes": [
{
"measure": "The Montgomery-Åsberg Depression Rating Scale (MADRS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Openwater"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Arizona"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-01-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-01-13",
"filename": "SAP_000.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 123058,
"typeAbbrev": "SAP",
"uploadDate": "2024-03-13T20:19"
},
{
"date": "2022-12-22",
"filename": "ICF_001.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 159488,
"typeAbbrev": "ICF",
"uploadDate": "2024-01-17T15:37"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Substance Misuse Assistance Response Team (SMART)"
}
]
},
"conditionsModule": {
"conditions": [
"Substance Use Disorders",
"Overdose",
"Opioid Use Disorder",
"Alcohol Use Disorder"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is an observational, prospective case-control study evaluating the effects of an emergency department community health worker-peer recovery specialist program (PCHW), the Substance Misuse Assistance Response Team (SMART). Aims of this study are to 1) understand participant experiences working with a SMART PCHW and identify possible mechanisms for successful recovery linkage; 2) Evaluate SMART effectiveness on patient-centered outcomes, building recovery capital, and recovery linkage; 3) Evaluate SMART implementation and effectiveness on patient outcomes over time.Using a combination of surveys and data linkages to state administrative databases, study investigators will prospectively compare changes in addiction treatment engagement, recovery capital, health related social needs, acute care utilization, and death between people receiving a ED PCHW and those who do not. After consenting to study participation, participants will complete surveys at time of study enrollment and 3 and 6 months after their initial ED visit. Primary outcomes include engagement in addiction treatment, social services engagement, acute care utilization, and mortality will be assessed through linkages to state administrative databases."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EMPOWER",
"briefTitle": "Emergency Medicine Peer Outreach Worker Engagement for Recovery",
"nctId": "NCT06320015",
"orgStudyIdInfo": {
"id": "R01CE003632-01-00",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01CE003632",
"link": "https://reporter.nih.gov/quickSearch/R01CE003632",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment engagement"
},
{
"measure": "Recovery Capital"
}
],
"secondaryOutcomes": [
{
"measure": "Emergency Department Utilization"
},
{
"measure": "Repeat Hospitalization"
},
{
"measure": "Repeat Overdose"
},
{
"measure": "Mortality"
},
{
"measure": "Social Services Engagement"
},
{
"measure": "Housing Services Engagement"
},
{
"measure": "Employment"
},
{
"measure": "Incarceration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Rhode Island Hospital"
},
{
"name": "The Miriam Hospital"
},
{
"name": "Brown University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Los Angeles"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Communication Intervention for fecal ostomy surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Surgery",
"Colostomy Stoma",
"Ileostomy - Stoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Christy E Cauley, MD",
"phone": "617-726-8129",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Massachusetts General Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02114"
}
]
},
"descriptionModule": {
"briefSummary": "In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CI-oSurg",
"briefTitle": "Communication Intervention for Fecal Ostomy Surgery",
"nctId": "NCT06320002",
"orgStudyIdInfo": {
"id": "2023P003564",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Emotional Distress"
},
{
"measure": "World Health Organization Brief quality of life evaluation"
},
{
"measure": "Hospital Anxiety and Depression Scale"
},
{
"measure": "Therapy Evaluation Form"
},
{
"measure": "Client Satisfaction Questionnaire"
}
],
"primaryOutcomes": [
{
"measure": "Intervention Acceptability"
}
],
"secondaryOutcomes": [
{
"measure": "Intervention Usability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Massachusetts General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biplane Ultrasound"
},
{
"name": "Single plane ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Educational Problems"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a prospective, randomized, parallel study to assess the efficacy of biplane ultrasound-guided caudal epidural anesthesia in pediatric patients.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "The intervention group will receive caudal epidural block under the guidance of biplane ultrasound. The procedures for patients in the control group will be guided by conventional single-plane ultrasound.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 281,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "4 Months",
"sex": "MALE",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.",
"nctId": "NCT06319989",
"orgStudyIdInfo": {
"id": "IRB202301905",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "First puncture success"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Needle redirections"
},
{
"measure": "Duration of epidural"
},
{
"measure": "Postoperative analgesic use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Florida"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "open chain exercises for rotator cuff muscles"
},
{
"name": "Advices for postural correction"
}
]
},
"conditionsModule": {
"conditions": [
"Hand Grasp"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Purpose of the study:* To investigate the effect of rotator cuff training on hand grip strength in adults with different body mass index.* To investigate the effect of rotator cuff training on hand grip static endurance in adults with different body mass index.* To investigate the effect of rotator cuff training on hand grip dynamic endurance in adults with different body mass index.* To investigate the effect of rotator cuff training on upper limb function in adults with different body mass index."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
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},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Rotator Cuff Training on Hand Grip in Adults",
"nctId": "NCT06319976",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004883",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hand grip strength"
}
],
"secondaryOutcomes": [
{
"measure": "Hand grip static endurance"
},
{
"measure": "Hand grip dynamic endurance"
},
{
"measure": "Upper limb function"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-30"
},
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"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Two IM injections Lenti-HPV-07"
},
{
"name": "One IM injection Lenti-HPV-07"
}
]
},
"conditionsModule": {
"conditions": [
"HPV-Related Cervical Carcinoma",
"HPV Positive Oropharyngeal Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Orlando",
"contacts": [
{
"email": null,
"name": "Cesar Augusto Perez Batista, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Florida Cancer Specialists (from Sarah Canon research Institute)",
"geoPoint": {
"lat": 28.53834,
"lon": -81.37924
},
"state": "Florida",
"status": null,
"zip": "32827"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).The main questions aim to answer are:* Is Lenti-HPV-07 safe?* Does Lenti-HPV-07 induce an immune response?Participants will be assigned to a group based on their cancer type* either study drug group A: recurrent and/or metastatic cancer* or study drug group B: newly diagnosed with locally advanced cancerAfter they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Phase 1/2a, open label, multicenter, dose-escalation and dose expansion trial to assess the safety, tolerability, and preliminary efficacy of Lenti-HPV-07 to participants with HPV associated oropharyngeal squamous cell cancer or cervical cancer. Three dose strengths will be investigated: a low, midlevel, and high dose. Lenti HPV-07 will be administered as either 2 × intramuscular (IM) injections to participants in arm A (recurrent or metastatic stage, refractory to previous treatments) or as a single IM injection to participants in Arm B (newly diagnosed with locally advanced HPV+ cancer never treated). Eligible participants in Arm B will receive only 1 injection of Lenti-HPV-07 prior to the initiation of their standard of care (SoC) therapy. After 18 participants in either arm have been treated in the escalation phase and have completed the 14 day DLT period, the Safety Review Committee and Sponsor will determine the OBD for use in the dose expansion phase.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer",
"nctId": "NCT06319963",
"orgStudyIdInfo": {
"id": "Lenti-HPV-07-CT01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and Tolerability"
},
{
"measure": "OBD"
}
],
"secondaryOutcomes": [
{
"measure": "Immunogenicity"
},
{
"measure": "PD-L1 expression"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Theravectys S.A."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Furmonertinib"
},
{
"name": "Osimertinib"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer, Nonsmall Cell"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 255,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases",
"nctId": "NCT06319950",
"orgStudyIdInfo": {
"id": "20240229",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Dynamic changes of ct-DNA"
}
],
"primaryOutcomes": [
{
"measure": "progression free survival(PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "objective response rate(ORR)"
},
{
"measure": "Intracranial objective Response Rate(iORR)"
},
{
"measure": "Intracranial progression free survival(iPFS)"
},
{
"measure": "overal survival time(OS)"
},
{
"measure": "Disease control rate(DCR)"
},
{
"measure": "Intracranial disease control rate(iDCR)"
},
{
"measure": "Depth of response (DepOR)"
},
{
"measure": "Depth of intracranial response(iDepOR)"
},
{
"measure": "Time to intracranial remission(iTTR)"
},
{
"measure": "Duration of response(DoR)"
},
{
"measure": "Duration of intracranial response(iDoR)"
},
{
"measure": "Rate of improvement in neural function"
},
{
"measure": "Health-related quality of life"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Taizhou Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis",
"Foot Deformities",
"Muscle Weakness",
"Kinesiophobia"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "45 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Muscle Architecture in Knee Osteoarthritis",
"nctId": "NCT06319937",
"orgStudyIdInfo": {
"id": "OA2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Muscle thickness"
},
{
"measure": "Pennation angle"
},
{
"measure": "Fat thickness"
}
],
"secondaryOutcomes": [
{
"measure": "Stair climbing test"
},
{
"measure": "Sit-stand test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Simethicone combined with Macrogol 4000 (PEG)"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer",
"Colonoscopy",
"Bowel Preparation Solution"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cornebarrieu",
"contacts": null,
"country": "France",
"facility": "Clinique des Cèdres, Ramsay Santé,",
"geoPoint": {
"lat": 43.64895,
"lon": 1.32407
},
"state": null,
"status": null,
"zip": "31700"
},
{
"city": "Essey-les-Nancy",
"contacts": null,
"country": "France",
"facility": "Polyclinique Louis Pasteur,",
"geoPoint": {
"lat": 48.70179,
"lon": 6.22425
},
"state": null,
"status": null,
"zip": "54280"
},
{
"city": "Marseille",
"contacts": null,
"country": "France",
"facility": "Saint Joseph Hospital",
"geoPoint": {
"lat": 43.29551,
"lon": 5.38958
},
"state": null,
"status": null,
"zip": "13008"
},
{
"city": "Toulouse",
"contacts": null,
"country": "France",
"facility": "5. Clinique Ambroise Paré",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
},
"state": null,
"status": null,
"zip": "31082"
},
{
"city": "Vesoul",
"contacts": null,
"country": "France",
"facility": "Pole Santé des Haberges",
"geoPoint": {
"lat": 47.63333,
"lon": 6.16667
},
"state": null,
"status": null,
"zip": "70000"
}
]
},
"descriptionModule": {
"briefSummary": "Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 601,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "XIMEPEG-RL",
"briefTitle": "Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy",
"nctId": "NCT06319924",
"orgStudyIdInfo": {
"id": "XIMEPEG-RL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess the quality of the bowel preparation assessed by Bubble scale"
},
{
"measure": "Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)"
}
],
"secondaryOutcomes": [
{
"measure": "Colonoscope removal time"
},
{
"measure": "The frequency of adverse events (AEs)"
},
{
"measure": "volume of bowel preparation ingested"
},
{
"measure": "Caecal intubation rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospital St. Joseph, Marseille, France"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-09-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AETOS"
}
]
},
"conditionsModule": {
"conditions": [
"Shoulder Osteoarthritis",
"Shoulder Arthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Francisco",
"contacts": [
{
"email": "[email protected]",
"name": "Katie Sheehi",
"phone": "415-668-8010",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "James Kelly, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "California Pacific Orthopedics",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California",
"status": "RECRUITING",
"zip": "94118"
},
{
"city": "Denver",
"contacts": [
{
"email": "[email protected]",
"name": "Libby Mauter",
"phone": "303-321-1333",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Armand Hatzidakis",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Western Orthopaedics",
"geoPoint": {
"lat": 39.73915,
"lon": -104.9847
},
"state": "Colorado",
"status": "NOT_YET_RECRUITING",
"zip": "80210"
},
{
"city": "Columbus",
"contacts": [
{
"email": "[email protected]",
"name": "Cholly Minton",
"phone": "706-494-3330",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Brent Ponce",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Hughston Foundation",
"geoPoint": {
"lat": 32.46098,
"lon": -84.98771
},
"state": "Georgia",
"status": "NOT_YET_RECRUITING",
"zip": "31909"
},
{
"city": "Bend",
"contacts": [
{
"email": "[email protected]",
"name": "Cody Manriquez",
"phone": "541-420-0774",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Scott Jacobson, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Center for Orthopedics and Neurosurgical Care",
"geoPoint": {
"lat": 44.05817,
"lon": -121.31531
},
"state": "Oregon",
"status": "RECRUITING",
"zip": "97701"
},
{
"city": "Philadelphia",
"contacts": [
{
"email": null,
"name": "Brooke Olin",
"phone": "267-516-9393",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Matthew Ramsey, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Rothman Institute",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "19107"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 220,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "AETOS Shoulder System",
"nctId": "NCT06319911",
"orgStudyIdInfo": {
"id": "AETOS 2022.04",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Implant Survivorship"
}
],
"secondaryOutcomes": [
{
"measure": "Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years"
},
{
"measure": "Radiographic Assessment - Glenoid Migration/Subsidence"
},
{
"measure": "Radiographic Assessment - Glenoid Radiolucency"
},
{
"measure": "Radiographic Assessment - Humeral Radiolucency"
},
{
"measure": "Radiographic Assessment - Humeral Migration/Subsidence"
},
{
"measure": "Radiographic Assessment - Humeral Head Centeredness"
},
{
"measure": "Radiographic Assessment - Bone Remodeling"
},
{
"measure": "Radiographic Assessment - Glenohumeral Subluxation"
},
{
"measure": "Radiographic Assessment - Device Condition: Anatomic"
},
{
"measure": "Radiographic Assessment - Device Condition: Reverse"
},
{
"measure": "American Shoulder and Elbow Score (ASES)"
},
{
"measure": "Constant Murley Score"
},
{
"measure": "Simple Shoulder Test (SST)"
},
{
"measure": "Single Assessment Numeric Evaluation (SANE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Smith & Nephew, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-08-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lavender aromatherapy sticker"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety",
"Pain",
"Burnout, Professional"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Winston-Salem",
"contacts": [
{
"email": "[email protected]",
"name": "Megan Tarr, MD",
"phone": "704-304-1160",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Wake Forest University Health Sciences",
"geoPoint": {
"lat": 36.09986,
"lon": -80.24422
},
"state": "North Carolina",
"status": null,
"zip": "27157"
}
]
},
"descriptionModule": {
"briefSummary": "Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population.The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \\& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RELAX",
"briefTitle": "Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder",
"nctId": "NCT06319898",
"orgStudyIdInfo": {
"id": "IRB00110787",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean change in Visual Analog Scale (VAS) Anxiety Scores"
}
],
"secondaryOutcomes": [
{
"measure": "Visual Analog Scale (VAS) Pain during the chemodenervation procedure"
},
{
"measure": "Procedure Staff Burnout Scores - Burnout Battery visual analog scale for healthcare worker burnout"
},
{
"measure": "Patient satisfaction with their procedure experience Scores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Wake Forest University Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Text messaging"
}
]
},
"conditionsModule": {
"conditions": [
"Hazardous Alcohol Use"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants are assigned to either one out of six intervention conditions with different types of text messaging (including one assessment-only control condition).",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Participants are informed in the study material that they are allocated to groups that receive different text messages. They receive no further information on the intervention groups.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Text Messaging to Reduce High-risk Alcohol Use Among Older Adults",
"nctId": "NCT06319885",
"orgStudyIdInfo": {
"id": "SDU project nr. 3110386",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Trygfonden",
"id": "ID: 158341",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "High-risk alcohol use (yes/no)"
}
],
"secondaryOutcomes": [
{
"measure": "WHOQOL-Bref (The World Health Organization Quality of Life Brief Version )"
},
{
"measure": "OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)"
},
{
"measure": "Drinker Inventory of Consequences (DrInC-2R)"
},
{
"measure": "Frequency of alcohol use"
},
{
"measure": "Amount of alcohol use"
},
{
"measure": "Heavy drinking days"
},
{
"measure": "User evaluation (tailor-made)"
},
{
"measure": "PHQ-9 (Patient Health Questionnaire-9 )"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Anette Søgaard Nielsen, PhD"
},
{
"name": "Kjeld Andersen, PhD"
},
{
"name": "Angelina Mellentin, PhD"
},
{
"name": "Alexis Kuerbis"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral disulfiram"
}
]
},
"conditionsModule": {
"conditions": [
"Alcohol Use Disorder",
"Retinal Dystrophies",
"Age-Related Macular Degeneration",
"Retinitis Pigmentosa",
"Stargardt Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Gary Gagarinas",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alex Levin, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Flaum Eye Institute, University of Rochester Medical Center",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York",
"status": null,
"zip": "14642"
}
]
},
"descriptionModule": {
"briefSummary": "Oral disulfiram (Antabuse®) has been shown to improve image-forming vision in animal models with retinal degeneration due to its ability to decrease Retinoic Acid synthesis and consequently reduce hyperactivity in the inner retina. The investigator will aim to evaluate the impact of oral disulfiram on the vision of patients with retinal degeneration who are being treated with the drug in the management of their concurrent alcohol use disorder."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration",
"nctId": "NCT06319872",
"orgStudyIdInfo": {
"id": "STUDY00009118",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS"
}
],
"secondaryOutcomes": [
{
"measure": "mean change in total contrast sensitivity score using Pelli-Robson charts"
},
{
"measure": "mean change in light-adapted microperimetry sensitivity assessed using standard MAIA microperimetry equipment"
},
{
"measure": "mean change in outer retinal thickness assessed using Spectral Domain Optical Coherence Tomography (SD-OCT)"
},
{
"measure": "mean change in fundus autofluorescence (FAF)"
},
{
"measure": "number of participants with retinal anatomy changes assessed using fundus photos"
},
{
"measure": "mean change in visual field perimetry using full-field stimulus test"
},
{
"measure": "mean change in isopter constriction using Goldmann visual field"
},
{
"measure": "mean change in size of scotomas using Goldmann visual field"
},
{
"measure": "mean change in cone and rod latency assessed using Full field electroretinogram (ffERG)"
},
{
"measure": "mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG)"
},
{
"measure": "mean change in cone and rod latency assessed using multifocal electroretinogram (mfERG)"
},
{
"measure": "mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG)"
},
{
"measure": "mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Rochester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Morphine"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Pain, Postoperative"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Kasr Alaini hospital",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries",
"nctId": "NCT06319859",
"orgStudyIdInfo": {
"id": "N-72-2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time to first analgesic requirement"
}
],
"secondaryOutcomes": [
{
"measure": "Nalbuphine consumption"
},
{
"measure": "Postoperative pain"
},
{
"measure": "The incidence of other adverse effects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-20"
}
}
} | false | null |
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