protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexmedetomidine Injection [Precedex],,,"
},
{
"name": "Fentanyl"
}
]
},
"conditionsModule": {
"conditions": [
"Post Spinal Shivering"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section",
"nctId": "NCT06318546",
"orgStudyIdInfo": {
"id": "FMASU MS59/2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Post spinal shivering"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "anti-CD19 CAR NK cells"
}
]
},
"conditionsModule": {
"conditions": [
"Autoimmune Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zhenjiang",
"contacts": [
{
"email": "[email protected]",
"name": "Yu Tang",
"phone": "086-13815153350",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yu Tang, Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Affiliated Hospital of Jiangsu University",
"geoPoint": {
"lat": 32.21086,
"lon": 119.45508
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "212001"
},
{
"city": "Zhenjiang",
"contacts": [
{
"email": "[email protected]",
"name": "Yanru Wang",
"phone": "0511-85026079",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yu Tang, Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Jiangsu University Affiliated Hospital",
"geoPoint": {
"lat": 32.21086,
"lon": 119.45508
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "212001"
}
]
},
"descriptionModule": {
"briefSummary": "A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\\^9 cells, 9×10\\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases."
},
"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": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases",
"nctId": "NCT06318533",
"orgStudyIdInfo": {
"id": "2023-11-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Dose Limiting Toxicity (DLTs)"
},
{
"measure": "Treatment Emergent Adverse Events（TEAEs）"
}
],
"secondaryOutcomes": [
{
"measure": "Disease control rate of subjects"
},
{
"measure": "Remission rate of subjects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Rui Therapeutics Co., Ltd"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "YANRU WANG"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Use of Calcium silicate based resin cement and resin modified glass ionomer cement"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Enamel Hypomineralization"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Afyonkarahisar",
"contacts": [
{
"email": "[email protected]",
"name": "Burcu GUCYETMEZ TOPAL, Asst.Prof",
"phone": "+90 530 281 35 85",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Esma ATIS, Res.Ass.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Afyonkarahisar Health Sciences University",
"geoPoint": {
"lat": 38.75667,
"lon": 30.54333
},
"state": null,
"status": null,
"zip": "03030"
}
]
},
"descriptionModule": {
"briefSummary": "The main question of the study was to evaluate the one-year clinical success of SSc bonded with two different cement types in MIH teeth with excessive material loss. The researchears will compare the survival rate, effect on gingival health and radiographic success of calcium silicate-based resin-containing cement and resin-modified glass ionomer cement."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "9 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Success of Stainless Steel Crowns Applied Using Different Cements",
"nctId": "NCT06318520",
"orgStudyIdInfo": {
"id": "AFSU-DHF-TOPAL-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Anatomical Integrity"
},
{
"measure": "Marginal Compliance"
},
{
"measure": "Proximal Contact"
},
{
"measure": "Crown Marginal Location"
},
{
"measure": "Restoration success"
},
{
"measure": "Green and Vermillion's Oral Hygiene Index"
}
],
"secondaryOutcomes": [
{
"measure": "Marginal Fit of the Crown (RADIOLOGICAL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Afyonkarahisar Health Sciences University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fecal microbial diversity"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baton Rouge",
"contacts": [
{
"email": "[email protected]",
"name": "Justin Brown, Ph.D.",
"phone": "225-763-2715",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Pennington Biomedical Research Center",
"geoPoint": {
"lat": 30.45075,
"lon": -91.15455
},
"state": "Louisiana",
"status": "RECRUITING",
"zip": "70808"
}
]
},
"descriptionModule": {
"briefSummary": "This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMPACT",
"briefTitle": "The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy",
"nctId": "NCT06318507",
"orgStudyIdInfo": {
"id": "PBRC 2023-014",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pathologic Complete Response (pCR)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pennington Biomedical Research Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "jumping performance"
}
]
},
"conditionsModule": {
"conditions": [
"Ankle Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "Istituto Clinico San Siro",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe.The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects.In particular, the primary objective is to verify the difference in the monopodalic CMJ value of the diseased limb of subjects with ankle instability compared to the control group at time 0.The population is made up of patients suffering from ankle instability and a control group of healthy volunteers, divided as follows:25 subjects GROUP A: Study group: patients suffering from ankle instability25 subjects GROUP B: control group: healthy voluntary subjects not affected by ankle pathology"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Ankle-optoga",
"briefTitle": "Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait)",
"nctId": "NCT06318494",
"orgStudyIdInfo": {
"id": "Ankle-optogait",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ticagrelor 90 MG"
},
{
"name": "Clopidogrel"
}
]
},
"conditionsModule": {
"conditions": [
"Stent Thrombosis",
"Myocardial Infarction, Acute"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Karachi",
"contacts": [
{
"email": "[email protected]",
"name": "Abdul Hakeem, MD",
"phone": "6086953048",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jehangir Shah, MBBS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "National Institute of Cardiovascular Diseases",
"geoPoint": {
"lat": 24.8608,
"lon": 67.0104
},
"state": "SIndh",
"status": "RECRUITING",
"zip": "755000"
}
]
},
"descriptionModule": {
"briefSummary": "Compare the safety and efficacy of a twice-daily Clopidogrel regimen vs. Ticagrelor in reducing major adverse events in patients undergoing primary PCI in a double-blind randomized controlled trial."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Care provider and investigator are same so both are blinded in the trial.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 2200,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TADCLOT",
"briefTitle": "TADCLOT- a Double Blind Randomized Controlled Trial",
"nctId": "NCT06318481",
"orgStudyIdInfo": {
"id": "IRB-80/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of efficacy and safety"
}
],
"secondaryOutcomes": [
{
"measure": "Secondary endpoint"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "PharmEvo Pvt Ltd"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "National Institute of Cardiovascular Diseases, Pakistan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nursing health assessment teaching and discussion using humanoid diagrams"
},
{
"name": "Nursing health assessment teaching and discussion using case study"
}
]
},
"conditionsModule": {
"conditions": [
"Competence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": [
{
"email": "[email protected]",
"name": "Mei Fen Tang, master",
"phone": "0970746226",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Taipei Medical University WanFang Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is going to compare different teaching strategies for improving newly recruited nurses' comprehensive nursing assessment skills."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effectiveness of Various Teaching Methods to Enhance the Comprehensive Nursing Assessment Skills of New Nurses",
"nctId": "NCT06318468",
"orgStudyIdInfo": {
"id": "N202306106",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comprehensive health assessment questionnaire"
},
{
"measure": "Comprehensive health assessment questionnaire"
},
{
"measure": "Comprehensive health assessment questionnaire"
},
{
"measure": "Confidence scale (C-scale)"
},
{
"measure": "Confidence scale (C-scale)"
},
{
"measure": "Confidence scale (C-scale)"
}
],
"secondaryOutcomes": [
{
"measure": "Course satisfaction questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Taipei Medical University WanFang Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Breathing exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Women Receiving Chemotherapy",
"18 Years of Age and Above",
"Women With High Stress Levels",
"Women With Poor Sleep Quality"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Gürcan Solmaz, PhD",
"phone": "+90 5556287897",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Gürcan Solmaz",
"phone": "+90 5556287897",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "University of İstanbul-cerrahpaşa (IUC)",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Women receiving chemotherapy have poor sleep quality and high stress levels. With a method such as breathing exercise, which can be applied at any time without side effects, positive improvements in women's sleep and stress levels can be recorded."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 65,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Breathing Exercise on Sleep and Stress Levels in Women With Breast Cancer Receiving Chemotherapy Treatment",
"nctId": "NCT06318455",
"orgStudyIdInfo": {
"id": "İstanbul University-Cerrahpaşa",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "anxiety state scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Yalova"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Semaglutide Oral Product"
},
{
"name": "Metformin Oral Tablet"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Steroid-Induced Diabetes",
"Steroid Induced Hyperglycemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "Imperial College Healthcare NHS Trust",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study)DESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study.AIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin.OUTCOME MEASURES:* Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 minutes, measured in all participants at baseline and on day 7 DEX.* Secondary: Indices of insulin resistance (M-value), beta-cell function (acute insulin response to glucose) and disposition, as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp, performed at baseline and on day 7 DEX.* Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies, taken from a subset of approximately 8 individuals in each group.ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetesSTUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years.ANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"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": "The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes",
"nctId": "NCT06318442",
"orgStudyIdInfo": {
"id": "22HH8018",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Mean glucose and glycaemic variation by continuous glucose monitoring (CGM), using a validated blinded system (Dexcom G7)."
},
{
"measure": "Changes in fasting gut hormones"
},
{
"measure": "Changes in fasting gut hormones"
},
{
"measure": "Changes in fasting gut hormones"
},
{
"measure": "Changes in fasting lipid profile"
},
{
"measure": "Changes in post prandial gut hormones"
},
{
"measure": "Changes in post prandial gut hormones"
},
{
"measure": "Changes in anthropometrics"
},
{
"measure": "Changes in anthropometrics"
},
{
"measure": "Tissue specific changes in AMPK determined from adipose and muscle biopsies"
}
],
"primaryOutcomes": [
{
"measure": "Difference in Glucose tolerance"
}
],
"secondaryOutcomes": [
{
"measure": "Difference in insulin secretion"
},
{
"measure": "Difference in insulin sensitivity"
},
{
"measure": "Difference in insulin sensitivity"
},
{
"measure": "Difference in insulin sensitivity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Imperial College London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "stretching exercise group"
}
]
},
"conditionsModule": {
"conditions": [
"Individuals With Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "GÜRCAN Solmaz, PhD",
"phone": "+90 5556287897",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "University of İstanbul-cerrahpaşa (IUC)",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This research will be carried out as a pretest-posttest randomized controlled study to determine the effect of stretching exercises performed 2 days a week for 12 weeks for one hour each session on physiological parameters and treatment compliance in individuals with diabetes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"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": "Evaluation of the Effect of Stretching Exercises Applied to Diabetes Patients on Physiological Parameters and Compliance to Treatment: A Randomized Controlled Study",
"nctId": "NCT06318429",
"orgStudyIdInfo": {
"id": "diabet",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "blood sugar"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Yalova"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "urine spectrophotometry for rifampin absorbance"
}
]
},
"conditionsModule": {
"conditions": [
"Tuberculosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Individual pharmacokinetic variability is an important driver of tuberculosis (TB) treatment failure particularly among undernourished populations, and that suboptimal serum drug concentrations are associated with delayed response to treatment, death, and acquired bacterial drug resistance. Serum drug exposures can be approximated by urine excretion as measured by spectrophotometry, replacing the need for specialized equipment for serum testing. Anti-TB pharmacokinetic variability has also been associated with enteric pathogen burden. The overall hypothesis is that urine spectrophotometry will identify people with below-target rifampin serum concentrations, which can be corrected to target levels after dose adjustment as confirmed by serum mass spectrometry. Therefore, this protocol includes a clinical trial to assess efficacy and safety of rifampin dose adjustment based on urinary excretion levels among adults and children who are being treated for drug-sensitive pulmonary TB at our longstanding collaborative research site in Haydom Lutheran Hospital, Tanzania."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "P-RIF",
"briefTitle": "Precision Rifampin Trial for Personalized Dosing",
"nctId": "NCT06318416",
"orgStudyIdInfo": {
"id": "HSR230382",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rifampin serum area under the concentration time curve for the 24 hour dosing interval"
},
{
"measure": "Adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "Time to sputum culture conversion to negative"
},
{
"measure": "Weight change"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Haydom Lutheran Hospital"
},
{
"name": "Rutgers University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Virginia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transdermal estrogen"
},
{
"name": "Rotator Cuff Repair Surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Rotator Cuff Tears",
"Rotator Cuff Injuries",
"Rotator Cuff Syndrome",
"Menopause Related Conditions",
"Menopause"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Rotator cuff tears in the shoulder are common, often cause pain and disability, often fail to heal with surgery, and both tears and failure of healing are associated with estradiol deficiency. In this study, women who have gone through menopause will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, and function when given with rotator cuff repair."
},
"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": 58,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ESTRCR",
"briefTitle": "Estradiol Supplementation and Rotator Cuff Repair",
"nctId": "NCT06318403",
"orgStudyIdInfo": {
"id": "177012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Serum Hormone Measurement"
},
{
"measure": "Patch Count"
},
{
"measure": "Averse Event Assessment"
}
],
"primaryOutcomes": [
{
"measure": "American Shoulder and Elbow Surgeons (ASES) Score"
}
],
"secondaryOutcomes": [
{
"measure": "Simple Shoulder Test (SST) Score"
},
{
"measure": "Visual Analogue Score (VAS) for pain"
},
{
"measure": "Magnetic Resonance Imaging (MRI) tendon healing"
},
{
"measure": "Strength Assessment"
},
{
"measure": "Range of motion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Utah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "XO Genius"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Hypertension",
"Cognitive Decline",
"Diet, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Arlington",
"contacts": [
{
"email": "[email protected]",
"name": "Robert M Brothers, PhD",
"phone": "817-272-3288",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Alison Mancera, BS",
"phone": "8172723288",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UT Arlington - Science and Engineering Innovation and Research Building",
"geoPoint": {
"lat": 32.73569,
"lon": -97.10807
},
"state": "Texas",
"status": "RECRUITING",
"zip": "76019"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. And 2) to investigate the effect of daily consumption of the Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health",
"nctId": "NCT06318390",
"orgStudyIdInfo": {
"id": "2023-0271",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Endothelial Function"
},
{
"measure": "Neurocognitive Function"
},
{
"measure": "Peripheral blood pressure (systolic, diastolic, mean)"
},
{
"measure": "Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)"
},
{
"measure": "Arterial stiffness"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Texas at Arlington"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Peanut group"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Hypertension",
"Cognitive Decline",
"Diet, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Arlington",
"contacts": [
{
"email": "[email protected]",
"name": "Robert M Brothers, PhD",
"phone": "817-232-3156",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Alison Mancera",
"phone": "817-232-3156",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UT Arlington - Science and Engineering Innovation and Research Building",
"geoPoint": {
"lat": 32.73569,
"lon": -97.10807
},
"state": "Texas",
"status": "RECRUITING",
"zip": "76019"
}
]
},
"descriptionModule": {
"briefSummary": "The overall research objective of this proposal is to determine the impact of increased daily peanut consumption on indices of neurocognitive and physiological health in BL individuals"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Individual will be randomly assigned either an experimental or a control condittion",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals",
"nctId": "NCT06318377",
"orgStudyIdInfo": {
"id": "2022-0541",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Endothelial Function"
},
{
"measure": "Neurocognitive Function"
},
{
"measure": "Peripheral blood pressure (systolic, diastolic, mean)"
},
{
"measure": "Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)"
},
{
"measure": "Arterial stiffness"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Texas at Arlington"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NO Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Delirium, Postoperative"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Harbin",
"contacts": [
{
"email": "[email protected]",
"name": "Yuting Liu",
"phone": "Hongyan",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yuting Ma",
"phone": "3680",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Hospital of Harbin Medical University",
"geoPoint": {
"lat": 45.75,
"lon": 126.65
},
"state": "Heilongjiang",
"status": "RECRUITING",
"zip": "150000"
},
{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "Xiao Ran, phd",
"phone": "15926207366",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Qin Zhang, phd",
"phone": "15717154768",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Qin Zhang, phd",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": "RECRUITING",
"zip": "430030"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the incidence of postoperative delirium (POD) in the PACU and analyze its influencing factors, in order to provide theoretical basis for early screening and intervention for high-risk POD population. Blood samples of some study subjects will be collected and analyzed using molecular detection methods to provide a basis and insights into the pathophysiological mechanisms of POD."
},
"designModule": {
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}
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},
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"name": "Jiemin Deng",
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},
{
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}
],
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{
"email": "[email protected]",
"name": "Qin Zhang, phd",
"phone": "15717154768",
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},
{
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],
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]
},
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}
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},
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"id": "854756",
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}
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{
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{
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{
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],
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},
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}
}
} | false | null |
{
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]
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},
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"link": null,
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},
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"measure": "Memory"
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{
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{
"measure": "Anticipation"
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{
"measure": "Reaction time"
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],
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},
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}
}
} | false | null |
{
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{
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},
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"name": "Simon Kjær Simonsen, MD",
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"phoneExt": null,
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},
{
"email": "[email protected]",
"name": "Mads Vandsted Svart, PhD",
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}
],
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"briefSummary": "It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies.Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier.To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study.Aims:* The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint* The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling* If concentration measurements by point-of-care testing are non-inferior to mass spectrometry* If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels"
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},
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"link": null,
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],
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},
{
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},
{
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},
{
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},
{
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},
{
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},
{
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},
{
"measure": "Blood 3-OHB concentrations"
},
{
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},
{
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},
{
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}
]
},
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},
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}
}
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{
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{
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{
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{
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"name": "Kozo Kuribayashi, MD, PhD",
"phone": "+81-798-45-6596",
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},
{
"email": "[email protected]",
"name": "Tetsuya Takagawa, MD, PhD",
"phone": "+81- 798-45-6265",
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"role": "CONTACT"
},
{
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"name": "Nobukazu Fujimoto, MD, PhD",
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},
{
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"name": "Keisuke Aoe, MD, PhD",
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}
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},
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"maskingInfo": {
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},
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]
},
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"link": null,
"type": null
},
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},
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}
],
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{
"measure": "Progression-Free survival (PFS) (Physician Judgment by Medical Institution, Modified RECIST criteria)"
},
{
"measure": "Overall survival time (OS)"
},
{
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},
{
"measure": "Duration of response (Physician Judgment by Medical Institution, Modified RECIST criteria)"
},
{
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},
{
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}
]
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},
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},
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},
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}
}
} | false | null |
{
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"name": "ABBV-969"
}
]
},
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"conditions": [
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]
},
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"locations": [
{
"city": "Duarte",
"contacts": null,
"country": "United States",
"facility": "City of Hope /ID# 262059",
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"lon": -117.97729
},
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"zip": "91010"
},
{
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"facility": "Carolina BioOncology Institute /ID# 261602",
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},
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},
{
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"contacts": null,
"country": "United States",
"facility": "NEXT Oncology /ID# 261601",
"geoPoint": {
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"lon": -98.49363
},
"state": "Texas",
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"zip": "78229"
}
]
},
"descriptionModule": {
"briefSummary": "Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy.ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 120 adult participants will be enrolled in the study across sites worldwide.In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer",
"nctId": "NCT06318273",
"orgStudyIdInfo": {
"id": "M24-742",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of Participants With Adverse Events (AEs)"
},
{
"measure": "Percentage of Participants Achieving Prostate Specific Antigen (PSA) response"
}
],
"secondaryOutcomes": [
{
"measure": "Maximum Observed Plasma Concentration (Cmax) of ABBV-969"
},
{
"measure": "Time to Maximum Observed Concentration (Tmax) of ABBV-969"
},
{
"measure": "Terminal Phase Elimination Half-Life (t1/2) of ABBV-969"
},
{
"measure": "Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969"
},
{
"measure": "Antidrug Antibody (ADA)"
},
{
"measure": "Neutralizing Antibodies (nAbs)"
},
{
"measure": "Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AbbVie"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dobutrex"
}
]
},
"conditionsModule": {
"conditions": [
"ATTR Amyloidosis Wild Type"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aarhus",
"contacts": [
{
"email": "[email protected]",
"name": "Ali Hussein Jaber Mejren, MD",
"phone": "0045 91 65 18 48",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Department of Cardiology, Aarhus University Hospital",
"geoPoint": {
"lat": 56.15674,
"lon": 10.21076
},
"state": null,
"status": "RECRUITING",
"zip": "8200"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test the effects of the inotropic drug named dobutamine, in patients with wild-type Transthyretin Amyoid Cardiomyopathy (ATTRwt). The main questions it aims to answer are:* What are the effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt.* Safety of dobutamine infusion in this patient population.Participants will be given increasing dosages of dobutamine infusion, and its effect on cardiac output and filling pressures will be assessed non-invasively by echocardiography, and invasively by right heart catheterization, simultaneously."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective, single-centre, one arm clinical explorative study, with consecutive enrolment.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DobATTR",
"briefTitle": "Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)",
"nctId": "NCT06318260",
"orgStudyIdInfo": {
"id": "2023-508298-10-00",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cardiac output"
}
],
"secondaryOutcomes": [
{
"measure": "Increase in invasively measured SVI by ≥ 20%."
},
{
"measure": "Reduction in mean PAWP and/or mPAP by 10 %."
},
{
"measure": "Increase in LVEF and LV-global longitudinal strain (LV-GLS) of absolute 10 %."
},
{
"measure": "Correlation between echo- and invasive measured SVI, and CO."
},
{
"measure": "Rate of complications (i.e. Systolic blood pressure drop < 90 mmHg, arrhythmias)/symptomatic side effects."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Steen Hvitfeldt Poulsen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "site preservation"
}
]
},
"conditionsModule": {
"conditions": [
"Periodontal Pocket",
"Periodontal Bone Loss",
"Impacted Third Molar Tooth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Jue Shi, Doctor",
"phone": "+86 13757171359",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Stomatology Hospital, Zhejiang University School of Medicine",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": "RECRUITING",
"zip": "310000"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars."
},
"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": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "26 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets",
"nctId": "NCT06318247",
"orgStudyIdInfo": {
"id": "2022-134(R)",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Probing pocket depths (PPD)"
},
{
"measure": "Distal bone wall defect (DBWD)"
},
{
"measure": "Clinical attachment lose (CAL)"
},
{
"measure": "Bleeding on probing (BOP)"
}
],
"secondaryOutcomes": [
{
"measure": "Pain score"
},
{
"measure": "Patient satisfaction"
},
{
"measure": "Gingival index (GI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Dental Hospital of Zhejiang University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "18F-FAPI，18F-FDG"
}
]
},
"conditionsModule": {
"conditions": [
"Rectal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": [
{
"email": "[email protected]",
"name": "Xiao Chen, Ph.D",
"phone": "+8615922970174",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Department of Nuclear Medicine, Daping Hospital of Army Medical University",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PET/MR Evaluation of Regression Grading After Neoadjuvant Therapy for Rectal Cancer",
"nctId": "NCT06318234",
"orgStudyIdInfo": {
"id": "202435",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation efficacy of tumor regression level"
}
],
"secondaryOutcomes": [
{
"measure": "expression of FAP"
},
{
"measure": "expression of GLUT1"
},
{
"measure": "SUV"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xiao Chen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental (Immunonutrition) Group"
},
{
"name": "Active Comparator Group ( Standard enteral nutrition)"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Cancer",
"Nutrition, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Talas",
"contacts": null,
"country": "Turkey",
"facility": "Erciyes University",
"geoPoint": {
"lat": 38.6908,
"lon": 35.5538
},
"state": "Kayseri",
"status": null,
"zip": "38280"
}
]
},
"descriptionModule": {
"briefSummary": "A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients were classified according to tumor location (oral cavity, oropharynx, larynx or hypopharynx) and body weight loss, approximately equally in both groups. Accordingly, patients were randomly assigned (by computer) into either the immunonutrition (intervention group) or standard EN (control group) groups.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer",
"nctId": "NCT06318221",
"orgStudyIdInfo": {
"id": "06156930",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Body weight"
},
{
"measure": "Body weight loss"
},
{
"measure": "Body mass index"
},
{
"measure": "Resting metabolic rate"
},
{
"measure": "Nutrition Risk Screening 2002"
},
{
"measure": "The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30)"
},
{
"measure": "The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35)"
},
{
"measure": "Albumin"
},
{
"measure": "C-reactive protein"
},
{
"measure": "Prealbumin"
}
],
"secondaryOutcomes": [
{
"measure": "Length of hospital stay"
},
{
"measure": "Complication development status"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "TC Erciyes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "lung function testing"
}
]
},
"conditionsModule": {
"conditions": [
"SARS-CoV-2 Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rostock",
"contacts": null,
"country": "Germany",
"facility": "Kinder- und Jugendklinik Universitätsmedizin Rostock",
"geoPoint": {
"lat": 54.0887,
"lon": 12.14049
},
"state": null,
"status": null,
"zip": "18057"
}
]
},
"descriptionModule": {
"briefSummary": "The study investigates whether patients with mild SARS-CoV-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function.Therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive PCR and invited for a lung function testing. Every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values.Patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand.Additionally to lung function testing we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the pulmonary function testing."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 110,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19",
"nctId": "NCT06318208",
"orgStudyIdInfo": {
"id": "C-LCI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pulmonary function"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in pulmonary function"
},
{
"measure": "Sociodemographic factors"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Rostock"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-01-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-01-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Condensed Internet delivered prolonged exposure (CIPE)"
}
]
},
"conditionsModule": {
"conditions": [
"Post Traumatic Stress Disorder",
"Acute Stress Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stockholm",
"contacts": [
{
"email": "[email protected]",
"name": "Charlotte Gentili, PhD",
"phone": "+46760482895",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mike Kemani, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin",
"geoPoint": {
"lat": 59.33258,
"lon": 18.0649
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prolonged exposure will be offered in a brief digital format with therapist support for three weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure and relapse prevention.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CiPE",
"briefTitle": "Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.",
"nctId": "NCT06318195",
"orgStudyIdInfo": {
"id": "2023-06821-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Participants satisfaction with treatment."
},
{
"measure": "Adverse events related to treatment."
},
{
"measure": "Number of completed treatment modules"
},
{
"measure": "Number of messages sent and received in the digital platform"
},
{
"measure": "Number of completed home work assignments by the participant during the treatment period"
},
{
"measure": "The proportion of participants that conducts the weekly measures and further assessment points"
},
{
"measure": "The proportion of participants that go through the entire treatment period"
},
{
"measure": "Number of drop-outs from treatment"
},
{
"measure": "Rates of inclusion to the study"
}
],
"primaryOutcomes": [
{
"measure": "Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)"
},
{
"measure": "Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Karolinska Universitetssjukhuset"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Karolinska Institutet"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Education"
}
]
},
"conditionsModule": {
"conditions": [
"Testicular Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Corum",
"contacts": null,
"country": "Turkey",
"facility": "Hitit University",
"geoPoint": {
"lat": 40.54889,
"lon": 34.95333
},
"state": null,
"status": null,
"zip": "19000"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to determine the effect of education based on the health belief model on testicular self-examination awareness and health beliefs in young men.H0 Hypothesis: Education based on the health belief model has no effect on the awareness of testicular self-examination and health beliefs about testicular self-examination of young men in the experimental and control groups.H1a Hypothesis: The training based on the health belief model will increase the awareness of young men in the experimental group about testicular self-examination compared to those in the control group.H1b Hypothesis: The training based on the health belief model will increase the mean scores of the sensitivity subscale of young men in the experimental group compared to those in the control group.H1c Hypothesis: The training based on the health belief model will increase the mean scores of the benefit subscale of young men in the experimental group compared to those in the control group.H1d Hypothesis: The training based on the health belief model will increase the mean scores of the seriousness subscale of young men in the experimental group compared to those in the control group.H1e Hypothesis: The training based on the health belief model will decrease the mean scores of the barriers subscale of young men in the experimental group compared to those in the control group.H1f Hypothesis: The training based on the health belief model will increase the mean scores of the health motivation subscale of young men in the experimental group compared to those in the control group.H1g Hypothesis: The training based on the health belief model will increase the mean scores of the self-efficacy subscale of young men in the experimental group compared to those in the control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "15 Years",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Testicular Self-Examination Awareness in Young Men",
"nctId": "NCT06318182",
"orgStudyIdInfo": {
"id": "NCT-SBF-EK-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Testicular Cancer Knowledge Test"
},
{
"measure": "Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination"
}
],
"primaryOutcomes": [
{
"measure": "Demographic information and testicular cancer questionnaire"
},
{
"measure": "Testicular Cancer Knowledge Test"
},
{
"measure": "Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination"
}
],
"secondaryOutcomes": [
{
"measure": "For the control group, Testicular Cancer Knowledge Test"
},
{
"measure": "For the control group, Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ondokuz Mayıs University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Hitit University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-11-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pegozafermin"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Little Rock",
"contacts": [
{
"email": null,
"name": "89bio Clinical Study Site",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "89bio Clinical Study Site",
"geoPoint": {
"lat": 34.74648,
"lon": -92.28959
},
"state": "Arkansas",
"status": "RECRUITING",
"zip": "72211-3859"
},
{
"city": "Ocala",
"contacts": [
{
"email": null,
"name": "89bio Clinical Study Site",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "89bio Clinical Study Site",
"geoPoint": {
"lat": 29.1872,
"lon": -82.14009
},
"state": "Florida",
"status": "RECRUITING",
"zip": "34471"
},
{
"city": "Hermitage",
"contacts": [
{
"email": null,
"name": "89bio Clinical Study Site",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "89bio Clinical Study Site",
"geoPoint": {
"lat": 36.19617,
"lon": -86.6225
},
"state": "Tennessee",
"status": "RECRUITING",
"zip": "37076"
},
{
"city": "Wichita Falls",
"contacts": [
{
"email": null,
"name": "89bio Clinical Study Site",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "89bio Clinical Study Site",
"geoPoint": {
"lat": 33.91371,
"lon": -98.49339
},
"state": "Texas",
"status": "RECRUITING",
"zip": "76301"
},
{
"city": "Richmond",
"contacts": [
{
"email": null,
"name": "89bio Clinical Study Site",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "89bio Clinical Study Site",
"geoPoint": {
"lat": 37.55376,
"lon": -77.46026
},
"state": "Virginia",
"status": "RECRUITING",
"zip": "23226-1925"
}
]
},
"descriptionModule": {
"briefSummary": "The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \\[NASH\\])."
},
"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": 1050,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)",
"nctId": "NCT06318169",
"orgStudyIdInfo": {
"id": "BIO89-100-131",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52"
},
{
"measure": "Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52"
}
],
"secondaryOutcomes": [
{
"measure": "Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52"
},
{
"measure": "Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36"
},
{
"measure": "Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "89bio, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Infrared thermal imaging"
}
]
},
"conditionsModule": {
"conditions": [
"Lumbar Disc Herniation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Xingchen Zhou, Dr",
"phone": "+86-18370133761",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Third Affiliated Hospital of Zhejiang Chinese Medical University",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": "RECRUITING",
"zip": "310053"
}
]
},
"descriptionModule": {
"briefSummary": "Utilizing the \"responsive acupoint palpation\" technique and infrared thermography, we investigated the distribution patterns of pressure-sensitive acupoints across different lumbar spinal segments in patients with lumbar disc herniation (LDH). Methodology: The Finger TPS tactile pressure measurement system was employed to conduct sensitivity examinations on the acupoints of the L1\\~L5 lumbar spine in 80 LDH patients (Group 1) and 80 healthy individuals (Group 2), applying a standardized force of 60N. When a sensation of comfort was elicited, the points were marked on a human cutaneous nerve segment map. We then utilized infrared thermography to collect and compare the temperature differences of the top 10 most frequently responsive acupoint areas in the experimental group against those in the control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exploring the Distribution Patterns and Infrared Characteristics of Force-sensitive Acupoints in Different Lumbar Nerve Segments in Patients With LDH Based on \"Press Quickly\" Theory",
"nctId": "NCT06318156",
"orgStudyIdInfo": {
"id": "ZSLL-KY-2024-056-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "skin temperature"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zhou Xingchen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TASSH"
}
]
},
"conditionsModule": {
"conditions": [
"Sickle Cell Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse outcomes and mortality. The use of HU in SSA is \\<1% among SCD patients. The investigators' preliminary findings indicate that provider-level barriers are significant and must be addressed to improve HU adoption. To address HU adoption, the investigators will use the NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH) Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as our intervention. The Nigerian government released guidelines supporting the SIM intervention for HU adoption for improved SCD management, and HU is on the list of essential medicines for Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the investigators will conduct this study using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 900,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "9 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ACCELERATE",
"briefTitle": "mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria",
"nctId": "NCT06318143",
"orgStudyIdInfo": {
"id": "U01HL168084",
"link": "https://reporter.nih.gov/quickSearch/U01HL168084",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient numbers - screening"
},
{
"measure": "Patient numbers - proportion on HU"
},
{
"measure": "Patient numbers - dosage"
}
],
"secondaryOutcomes": [
{
"measure": "Mediators"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "New York University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fixed helix, lumenless pacing lead."
},
{
"name": "Extendable helix, stylet-driven pacing lead."
}
]
},
"conditionsModule": {
"conditions": [
"Pacemaker DDD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Singapore",
"contacts": [
{
"email": "[email protected]",
"name": "Eugene Tan, MBBS",
"phone": "+6567795555",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Singapore",
"facility": "National University Heart Centre Singapore",
"geoPoint": {
"lat": 1.28967,
"lon": 103.85007
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (EHL) compared to the fixed helix, lumenless pacing lead (FHL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A target of 210 participants will be enrolled in this study consisting of two groups and randomised in a 1:1 fashion to either of two groups.Group 1: Fixed helix, lumenless pacing lead (FHL) Group 2: Extendable helix, stylet driven pacing lead (EHL)",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Subjects will be blinded to the type of pacing lead received. Operators will not be blinded as they will be performing the procedure. Post-procedure, investigators and outcomes assessors will be blinded to the treatment arm during adjudication of outcomes.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 210,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LEAD-LBP",
"briefTitle": "Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes",
"nctId": "NCT06318130",
"orgStudyIdInfo": {
"id": "LEAD-LBP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of loss of left bundle branch capture"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of acute lead failure"
},
{
"measure": "Serial changes in pacing thresholds (V)"
},
{
"measure": "Serial changes in R-wave amplitude (mV)"
},
{
"measure": "Serial changes in lead impedance (ohm)"
},
{
"measure": "Serial changes in QRS duration (ms)"
},
{
"measure": "Incidence of peri-procedural complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National University Hospital, Singapore"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rice infant formula"
}
]
},
"conditionsModule": {
"conditions": [
"Infant Formula"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bécon-les-Granits",
"contacts": [
{
"email": null,
"name": "Christine Regimbart, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Dr Christine REGIMBART - Private Practice",
"geoPoint": {
"lat": 47.50134,
"lon": -0.8
},
"state": "Becon-les-Granits",
"status": null,
"zip": "49026"
},
{
"city": "Auxerre",
"contacts": [
{
"email": null,
"name": "Bertrand Soto, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department",
"geoPoint": {
"lat": 47.8,
"lon": 3.56667
},
"state": null,
"status": null,
"zip": "89011"
},
{
"city": "Nantes",
"contacts": [
{
"email": null,
"name": "Hugues Piloquet, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Hospitalier Universitaire de Nantes - Pediatric emergency department",
"geoPoint": {
"lat": 47.21725,
"lon": -1.55336
},
"state": null,
"status": null,
"zip": "44093"
},
{
"city": "Pontoise",
"contacts": [
{
"email": null,
"name": "Mariana Englender, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital NOVO - Pediatric department",
"geoPoint": {
"lat": 49.05,
"lon": 2.1
},
"state": null,
"status": null,
"zip": "95300"
}
]
},
"descriptionModule": {
"briefSummary": "The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Months",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Reason for Prescribing Rice Infant Formula",
"nctId": "NCT06318117",
"orgStudyIdInfo": {
"id": "3398-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Questionnaire - reason for prescribing a RIF during the 1st year of life."
}
],
"secondaryOutcomes": [
{
"measure": "Questionnaire - Reason for prescribing a RIF in first 6 months of life"
},
{
"measure": "Questionnaire - Diet characteristics"
},
{
"measure": "Growth z-scores body mass index (BMI)-for-age"
},
{
"measure": "Growth z-score"
},
{
"measure": "Growth z-score"
},
{
"measure": "Growth z-score"
},
{
"measure": "Growth z-score"
},
{
"measure": "Questionnaire - Evolution of digestive and allergic symptoms"
},
{
"measure": "Socio-demographic characteristics"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "BioFortis"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Mead Johnson Nutrition"
}
},
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"completionDateStruct": {
"date": "2025-12-31"
},
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"date": "2024-03-25"
},
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"date": "2025-09-30"
},
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"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tegoprazan"
},
{
"name": "Esomeprazole 40mg"
}
]
},
"conditionsModule": {
"conditions": [
"Helicobacter Pylori Infection"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole",
"nctId": "NCT06318104",
"orgStudyIdInfo": {
"id": "DI/24/310/03/4",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Response to treatment by determining the eradication rate"
},
{
"measure": "Compared Treatment-related adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "Brief Medication Questionnaire"
},
{
"measure": "Percentage of patients with adherence to treatment"
},
{
"measure": "Report all Treatment-related adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Hospital General de México Dr. Eduardo Liceaga"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "platelet poor plasma gel"
},
{
"name": "nanofat"
}
]
},
"conditionsModule": {
"conditions": [
"Tear Trough Eyelid Deformity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mansoura",
"contacts": null,
"country": "Egypt",
"facility": "Manousra University, Faculty of Medicine",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": "Dakahlia",
"status": null,
"zip": "35511"
}
]
},
"descriptionModule": {
"briefSummary": "this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation",
"nctId": "NCT06318091",
"orgStudyIdInfo": {
"id": "MS.21.09.1640",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the degree of changes in the skin texture and homogeneity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "eCHIS"
}
]
},
"conditionsModule": {
"conditions": [
"Malaria",
"Diarrhea",
"Pneumonia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Buikwe",
"contacts": [
{
"email": null,
"name": "John Baptist Bwanika, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "John Baptist Bwanika, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Uganda",
"facility": "Buikwe",
"geoPoint": {
"lat": 0.3375,
"lon": 33.01056
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Cluster Randomised Control Trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1140,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "59 Months",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Buikwe Electronic Community Health Information System Impact Study",
"nctId": "NCT06318078",
"orgStudyIdInfo": {
"id": "UG2024001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Out Patient Department attendance (due to malaria, pneumonia and diarrhoea)"
},
{
"measure": "Hospitalisation (due to malaria, pneumonia and diarrhoea)"
},
{
"measure": "malaria related mortality in the community and health facilities"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Malaria Consortium"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Brain Metastases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tainan",
"contacts": [
{
"email": "[email protected]",
"name": "Jung-Shun Lee, M.D.",
"phone": "886-6-2353535",
"phoneExt": "5181",
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Jung-Shun Lee",
"geoPoint": {
"lat": 22.99083,
"lon": 120.21333
},
"state": "None Selected",
"status": "RECRUITING",
"zip": "70403"
}
]
},
"descriptionModule": {
"briefSummary": "While many studies have investigated the prognostic factors for patients undergoing surgical resection for primary brain tumors, decision-making for patients with brain metastasis (BM) is more complex because of their higher burden of comorbidities compared to those with primary brain tumors. In addition, although various prognostic indicators have been identified to predict prognosis in several types of cancer, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), prognostic nutritional index (PNI), and systemic immune-inflammation index (SII), limited studies have yet determined which group of patients would yield beater survival outcome after surgical resection for BM. This study aimed to investigate the impact of patient and perioperative characteristics and prognostic indicators on survival outcome of patients undergoing surgical resection of BM."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"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": "Surgical Resection Outcomes in Patients With Brain Metastasis",
"nctId": "NCT06318065",
"orgStudyIdInfo": {
"id": "B-ER111-370",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "survival outcome of patients undergoing surgery for brain metastasis"
},
{
"measure": "Functional outcome of patients undergoing surgery for brain metastasis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Cheng-Kung University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2010-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The FemTouch delivery system"
},
{
"name": "Gynomunal gel treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Vaginal Atrophy Patients With GSM"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hamburg",
"contacts": [
{
"email": "[email protected]",
"name": "Matthias Theden-Scow, Dr",
"phone": "4210613",
"phoneExt": "040",
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Frauenarztpraxis Heussweg",
"geoPoint": {
"lat": 53.57532,
"lon": 10.01534
},
"state": null,
"status": "RECRUITING",
"zip": "20255"
}
]
},
"descriptionModule": {
"briefSummary": "Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause symptoms and conventional hormonal treatments are contraindicated for these patients. The use of CO2 laser treatment has been shown to provide relief of Genitourinary Syndrome Of Menopause (GSM) symptoms in women and might provide a significant improvement in the quality of life for cancer survivors. The current study is designed to demonstrate the safety and efficacy of CO2 laser for treatment of GSM symptoms in cancer survivors suffering from GSM symptoms, with limited access to hormonal treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "21 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)",
"nctId": "NCT06318052",
"orgStudyIdInfo": {
"id": "LUM-ABU-CO2-FemTouch-19-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment"
}
],
"secondaryOutcomes": [
{
"measure": "To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment"
},
{
"measure": "To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Lumenis Be Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Novel program"
},
{
"name": "Traditional program"
}
]
},
"conditionsModule": {
"conditions": [
"Anterior Cruciate Ligament Reconstruction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kalmar",
"contacts": null,
"country": "Sweden",
"facility": "Linnaeus University",
"geoPoint": {
"lat": 56.66157,
"lon": 16.36163
},
"state": "Sverige",
"status": null,
"zip": "39363"
}
]
},
"descriptionModule": {
"briefSummary": "Scientific Research QuestionOverall Purpose:Regarding rehabilitation after anterior cruciate ligament reconstruction (ACLR), there is a knowledge gap - a lack of evidence. Important questions such as how rehabilitation should be structured, what it should include, and how it should be evaluated are currently not clear. Therefore, the investigators plan to conduct a two-year follow-up randomized controlled trial (RCT) on post-ACLR rehabilitation.Moreover, detailed information on how/under what circumstances the ACL injury occurred is not satisfactorily described in the literature. Therefore, the investigators are planning a new survey that can identify, explain, and prevent the risk factors causing a person to suffer from an anterior cruciate ligament injury.Specific Objectives:How should guidelines for rehabilitation after ACLR be structured, what should they include, and how should they be evaluated to best restore knee function in the patient? Can a detailed and comprehensive survey identify, explain, and prevent the risk factors causing a person to suffer from an ACL injury?"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized controlled trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction",
"nctId": "NCT06318039",
"orgStudyIdInfo": {
"id": "IRB2022-06554-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Isokinetic muscle strength"
},
{
"measure": "Single-leg hop performance"
}
],
"secondaryOutcomes": [
{
"measure": "Knee Injury and Osteoarthritis Outcome Score (KOOS)"
},
{
"measure": "ACL Return to Sport after Injury scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Linnaeus University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Centralized Intervention"
},
{
"name": "Primary Care Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Alcohol Use Disorder",
"Unhealthy Alcohol Use"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "Megan Addis",
"phone": "206-287-2052",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Kaiser Permanente Washington",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": null,
"zip": "98112"
}
]
},
"descriptionModule": {
"briefSummary": "The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 30 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "EHR and survey (latter masked)",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment",
"nctId": "NCT06318026",
"orgStudyIdInfo": {
"id": "R01AA031231",
"link": "https://reporter.nih.gov/quickSearch/R01AA031231",
"type": "NIH"
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01AA031231",
"link": "https://reporter.nih.gov/quickSearch/R01AA031231",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims)."
},
{
"measure": "Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Alcohol Abuse and Alcoholism (NIAAA)"
},
{
"name": "Kaiser Permanente Washington"
},
{
"name": "University of Washington"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kaiser Permanente"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "vitality test"
}
]
},
"conditionsModule": {
"conditions": [
"Impacted Third Molar Tooth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Karaman",
"contacts": [
{
"email": "[email protected]",
"name": "Faruk Ayhan Başçiftçi, Dr",
"phone": "338-226-2082",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Sümeyye Çelik Özsoy, Dr",
"phone": "338-226-2082",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Doğan Ilgaz Kaya, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry",
"geoPoint": {
"lat": 37.18111,
"lon": 33.215
},
"state": null,
"status": "RECRUITING",
"zip": "70100"
}
]
},
"descriptionModule": {
"briefSummary": "Participants will be asked to use some medications after the tooth extraction procedure. These drugs can be used in different ways. Investigators plan to monitor the pain, swelling and duration of anesthesia in the body as a result of participants use."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Perineural and Systemic Dexamethasone Use in Dental Surgeries in Terms of Anesthesia Duration and Postop Complaints",
"nctId": "NCT06318013",
"orgStudyIdInfo": {
"id": "2022-KAEK-15427-04-204-2022101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Swelling"
},
{
"measure": "Duration of anesthesia"
}
],
"secondaryOutcomes": [
{
"measure": "Pain Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Karamanoğlu Mehmetbey University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Balance test, bilateral coordination test, fundamental motor skills test"
}
]
},
"conditionsModule": {
"conditions": [
"Blindness",
"Visual Impairment"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Warsaw",
"contacts": null,
"country": "Poland",
"facility": "University of Physical Education",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": null,
"status": null,
"zip": "00-968"
}
]
},
"descriptionModule": {
"briefSummary": "Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
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"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 76,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Physical Activity and Sports for People With Visual Impairments",
"nctId": "NCT06318000",
"orgStudyIdInfo": {
"id": "SN4/20/22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Center of pressure (CoP) path length was measured"
},
{
"measure": "Surface area of stabilogram was measured"
},
{
"measure": "Raw and scale score for each item"
},
{
"measure": "Qualitative performance criteria (points)"
}
],
"secondaryOutcomes": [
{
"measure": "Body mass in kg"
},
{
"measure": "Body height in cm"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Józef Piłsudski University of Physical Education"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Care Navigation"
}
]
},
"conditionsModule": {
"conditions": [
"Drug Use Disorders",
"Illicit Drug Use",
"Alcohol-Related Disorders"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The Addressing Barriers to Care for Substance Use Disorder Pilot (ABC-SUD Pilot) is a randomized pilot study that will precede a larger trial. The ABC-SUD Pilot is a parallel group, cluster-randomized pilot feasibility trial, with clinicians (care coordinators) as the unit of randomization.This study will be conducted in a mental health treatment access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a \"care coordinator\" to obtain contact information for potential venues to obtain treatment for substance use disorder.The experimental intervention, Care Navigation, will be evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contact the mental health treatment access center. The investigators note that Care Navigation will be delivered by study \"care navigators\", who are distinct from the health system's care coordinators."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Care coordinators will be randomized to two parallel groups: usual care (UC; i.e., the comparator group) and usual care plus care navigation (UC + CN; i.e., the experimental group). All care coordinators will continue offering substance use resources and treatment options to patients as usual. Clinicians randomized to UC + CN will be able to offer and refer patients to a care navigator.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "All study outcomes are extracted from secondary data including electronic health record and healthcare claims databases",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ABCSUD Pilot",
"briefTitle": "Addressing Barriers to Care for Substance Use Disorder Pilot Study",
"nctId": "NCT06317987",
"orgStudyIdInfo": {
"id": "2068557",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "P50DA054072",
"link": "https://reporter.nih.gov/quickSearch/P50DA054072",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "SUD treatment - 30 days"
},
{
"measure": "SUD treatment - 60 days"
},
{
"measure": "SUD treatment - 90 days"
},
{
"measure": "SUD treatment visits - 30 days"
},
{
"measure": "SUD treatment visits - 60 days"
},
{
"measure": "SUD treatment visits - 90 days"
},
{
"measure": "Days until SUD treatment utilization from clinical assessment appointment"
}
],
"primaryOutcomes": [
{
"measure": "Rate of patient interest in care navigation"
}
],
"secondaryOutcomes": [
{
"measure": "Feasibility of patient consent procedures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
},
{
"name": "Stanford University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kaiser Permanente"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Breastfeeding education based on the Health Belief model"
}
]
},
"conditionsModule": {
"conditions": [
"Breastfeeding Education"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul University - Cerrahpasa",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled, experimental research design in pre-test, post-test design Made with",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 220,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Breastfeeding Education on Breast Milk Perception and Self-Efficacy in the Pregnancy Health Belief Model",
"nctId": "NCT06317974",
"orgStudyIdInfo": {
"id": "2022/210",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Paternal breastfeeding self-efficacy assessed using the Paternal Breastfeeding Self-Efficacy Scale."
}
],
"primaryOutcomes": [
{
"measure": "Mothers' and fathers' perception of breast milk, assessed using the Adults' Breast Milk Perception Scale."
}
],
"secondaryOutcomes": [
{
"measure": "Breastfeeding self-efficacy of mothers evaluated using the Breastfeeding Self-Efficacy Scale-Short Form during Pregnancy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul University - Cerrahpasa (IUC)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": [
{
"email": "[email protected]",
"name": "Rosalba Miceli, PhD",
"phone": "+39 0223903198",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Sara Iadecola",
"phone": "+39 0223903198",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS Istituto Nazionale dei Tumori",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20133"
}
]
},
"descriptionModule": {
"briefSummary": "Precision oncology is the future of fighting cancer. Cancer Core Europe (CCE) developed a precision medicine trial, i.e. the Basket of Basket (BoB) study, to provide personalised treatment to a large number of patients by incorporating a molecular profiling platform. The EU-funded CCE_DART project, developed within the CCE Consortium, is aimed at improving efficiency and transform platform trials into data-rich translational research programmes. Within the CCE_DART project working area D \"Patient involvement through information and partnership\" three interconnected web e-tools were developed aimed at promoting patient information, recruitment, and involvement as well as facilitating adherence to the CCE BoB trial: 1) iENTER: informative web site addressed to potential BoB trial participants, their caregivers, patients' advocates, and the public; 2) iCONSENT: web app for remote management of the informed consent process in the CCE BoB trial.3) iPARTICIPATE: web app allowing remote access to BoB trial patients trial visits calendar, medications list and posology, to upload documents and download reports, messaging between patients and clinical staff. The main objective of this study is to carry out field testing and assess usability of the e-tools iENTER, iCONSENT and iPARTICIPATE. The study is also addressed at collecting patients' suggestions for improvements of the e-tools."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools",
"nctId": "NCT06317961",
"orgStudyIdInfo": {
"id": "INT200-22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "SUS questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Vall d'Hebron Institute of Oncology"
},
{
"name": "The Netherlands Cancer Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Istituto Nazionale dei Tumori, Milano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "treatment plan comparison"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milano",
"contacts": null,
"country": "Italy",
"facility": "IRCCS Ospedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": "20133"
}
]
},
"descriptionModule": {
"briefSummary": "Investigators central hypothesis is that it is possible to create libraries of \"consistent\" Knowledge-Based plan-models derived from large Institutional experiences. These libraries can be used to guide automated RT planning and serve as tools to assist centers for plan quality assurance (QA) and plan prediction.Quantifying Inter-institute variability of RT planning and building libraries of interchangeable and validated multi-Institutional KB plan prediction models is expected to impact on the quality of planning at the national level. The project has the potential of facilitating the introduction of AI approaches in plan optimization, thus reducing intra and inter-Institute planning variability. Improving plan quality is expected to translate into better outcome after RT in terms of local control and, even more, of side effects and Quality of life. Positive impact is also expected in patient selection for advanced techniques, in plan audit and plan optimization in clinical trials, in technology comparison and cost-benefit analyses as well as in the RT educational field."
},
"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": "MIKAPOCo",
"briefTitle": "Improving the Quality of Radiotherapy by Multi-Institution Knowledge-Based Planning Optimization Models (Acronym: MIKAPOCo, Multi-Institutional Knowledge-based Approach in Plan Optimization for the Community)",
"nctId": "NCT06317948",
"orgStudyIdInfo": {
"id": "IG23150",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "model interchangeability"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Ospedale San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2022-10-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ArmeoSenso"
},
{
"name": "Traditional Rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Hemiplegic Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Multiple Locations",
"contacts": [
{
"email": "[email protected]",
"name": "Başak Karadağ, MSc",
"phone": "+905059462128",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Berke Aras, Ass. Prof.",
"phone": "+90365851518",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ankara Bilkent City Hospital",
"geoPoint": null,
"state": "Ankara",
"status": null,
"zip": "06000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy.The research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.The upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.After the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.Measurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.Intervention group (A) will receive virtual reality application for 30 minutes, 5 days a week for 3 weeks, in addition to traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and will receive only traditional treatments between 3-6 weeks.The control group (B) will receive only traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and between 3-6 weeks, they will receive virtual reality application in addition to traditional approaches for 30 minutes, 5 days a week for 3 weeks.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 52,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP",
"nctId": "NCT06317935",
"orgStudyIdInfo": {
"id": "HU-ERG-BK-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP."
},
{
"measure": "The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP."
}
],
"secondaryOutcomes": [
{
"measure": "Dosimetry of virtual reality applications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ankara Bilkent City Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Thealoz Duo;"
},
{
"name": "sham (Hydrabak)"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye Syndromes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Giulia Basile, MPharm",
"phone": "+39 0226433545",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Ospedale San Raffaele _O.U. Ophthalmology",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20123"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections.The main questions it aims to answer are:* can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs?* can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision?Each participant will be randomized into each of two arms:1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement.In any case, the instillation of saline solution should not alter the ocular surface."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The participants will be randomized in two arms (treatment arm and control arm) in a ratio of 1:1.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "There are two teams:1. MASKED TEAM: Sub-investigators and study coordinators delegated to perform the following tasks: * dispensation to the patient the Investigational medical device (Thealoz Duo) or saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate); * accountability of Investigational medical device and saline solution; * verify the compliance and therapeutic adherence of the patient; * discussion with the patient regarding the respect of the masked condition of the study;2. UNMASKED TEAMS: * informed consent process; * to perform the follow-up visit and assessments provided to test the ocular surface.",
"whoMasked": [
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"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": "DRYEYE-IVT",
"briefTitle": "Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections",
"nctId": "NCT06317922",
"orgStudyIdInfo": {
"id": "DRYEYE-IVT Project",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Administration of Ocular Surface Disease Index (OSDI) to the patient"
}
],
"secondaryOutcomes": [
{
"measure": "administration of Visual Analog Scale for Pain to the patient"
},
{
"measure": "evaluation of matrix metalloproteinase 9 gene expression"
},
{
"measure": "TearLab Osmolarity"
},
{
"measure": "Schirmer's test"
},
{
"measure": "tear film Break Up Time (tBUT)"
},
{
"measure": "conjunctival hyperemia according to Efron grading scale"
},
{
"measure": "fluorescein staining"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Francesco Bandello"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "allergen challenge"
}
]
},
"conditionsModule": {
"conditions": [
"Mild Allergic Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hannover",
"contacts": [
{
"email": "[email protected]",
"name": "Jens M Hohlfeld",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Fraunhofer Institute for Toxicology and Experimental Medicine",
"geoPoint": {
"lat": 52.37052,
"lon": 9.73322
},
"state": "Lower Saxony",
"status": "RECRUITING",
"zip": "30625"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma.The investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods. The hypothesis of the project is that local inflammatory changes in the lung induced by allergen can be captured by gas-enhanced magnetic resonance imaging (MRI) and analysis of exhaled breath.The validation of cellular outcome measures and non-invasive inflammometry can be used in future clinical trials for proof of concept of novel anti-inflammatory medications.Participants will undergo* methacholine challenge* 2 inhaled allergen challenges* 2 MRI with hyperpolarized xenon and gadolinium based contrast agent* 2 bronchoscopies with bronchoalveolar lavage (BAL)* segmental allergen challenge during the first bronchoscopy* spirometry* skin prick test and skin prick dilution tests* measurement of particles in exhaled air* nasal filter* nasal lavage* sputum induction* peak flow meter tests* exhaled NO (nictric oxide)* blood sampling (in total approx. 190 ml)"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma",
"nctId": "NCT06317909",
"orgStudyIdInfo": {
"id": "23-03 DONNER-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin] in Bronchoalveolar lavage (BAL) after segmental allergen challenge"
},
{
"measure": "Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin] in Sputum after inhalative allergen challenge"
},
{
"measure": "Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after inhalative allergen challenge"
},
{
"measure": "Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after segmental allergen challenge"
},
{
"measure": "Exploratory (1. priority) Changes in cell analyzation in BAL [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after segmental allergen challenge"
},
{
"measure": "Exploratory (1. priority) Changes in cell analyzation in Sputum [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after inhalative allergen challenge"
}
],
"secondaryOutcomes": [
{
"measure": "Exploratory (2. priority) Detection of Ribonucleic acid (RNA) in exhaled particles"
},
{
"measure": "Exploratory (2. priority) Changes in Fractional exhaled nitric oxide (FeNO) after inhalative allergen challenge"
},
{
"measure": "Exploratory (2. priority) Changes in FeNO after segmental allergen challenge"
},
{
"measure": "Exploratory (2. priority) Quantification of regional ventilation, perfusion, and diffusion by magnetic resonance imaging (MRI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fraunhofer-Institute of Toxicology and Experimental Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "circulating tumor cells"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma",
"Circulating Tumor Cell",
"Recurrence",
"Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Foshan",
"contacts": [
{
"email": null,
"name": "Weichao Liang, Prof.",
"phone": "13590542927",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Weichao Liang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The Sixth Affiliated Hospital of South China University of Technology",
"geoPoint": {
"lat": 23.02677,
"lon": 113.13148
},
"state": "Guangdong",
"status": null,
"zip": null
},
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Mingxin Pan, Prof.",
"phone": "+8618928918216",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Zhoubin Feng",
"phone": "19830551997",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mingxin Pan, Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Zhujiang Hospital of Southern Medical University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510220"
},
{
"city": "Guangzhou",
"contacts": [
{
"email": null,
"name": "Yinbing Wu, Prof.",
"phone": "18620007296",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yinbing Wu",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Affiliated Cancer Hospital and Institute of Guangzhou Medical University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized\"Early diagnosis and treatment\"."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 82,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS",
"nctId": "NCT06317896",
"orgStudyIdInfo": {
"id": "2024-KY-048-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "2-year recurrence-free survival rate"
}
],
"secondaryOutcomes": [
{
"measure": "Correlation between CTCs status dynamic changes and relapse"
},
{
"measure": "Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zhujiang Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Child Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santiago De Compostela",
"contacts": null,
"country": "Spain",
"facility": "University of Santiago de Compostela",
"geoPoint": {
"lat": 42.88052,
"lon": -8.54569
},
"state": "La Coruña",
"status": null,
"zip": "15782"
},
{
"city": "Pamplona",
"contacts": null,
"country": "Spain",
"facility": "University of Navarra",
"geoPoint": {
"lat": 42.81687,
"lon": -1.64323
},
"state": "Navarra",
"status": null,
"zip": "31009"
},
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Institut Hospital del Mar d'Investigacions Mèdiques",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": "08003"
},
{
"city": "Córdoba",
"contacts": null,
"country": "Spain",
"facility": "University of Cordoba",
"geoPoint": {
"lat": 37.89155,
"lon": -4.77275
},
"state": null,
"status": null,
"zip": "14071"
},
{
"city": "Tarragona",
"contacts": null,
"country": "Spain",
"facility": "Rovira i Virgili University",
"geoPoint": {
"lat": 41.11667,
"lon": 1.25
},
"state": null,
"status": null,
"zip": "43002"
},
{
"city": "Valencia",
"contacts": null,
"country": "Spain",
"facility": "University of Valencia",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": null,
"zip": "46010"
},
{
"city": "Zaragoza",
"contacts": null,
"country": "Spain",
"facility": "University of Zaragoza",
"geoPoint": {
"lat": 41.65606,
"lon": -0.87734
},
"state": null,
"status": null,
"zip": "50018"
}
]
},
"descriptionModule": {
"briefSummary": "Childhood obesity is a major public health problem worldwide. Europe has a high prevalence of obesity, which is accentuated in Mediterranean countries. Spain has a high prevalence of both overweight (percentage: 21.5 in boys and 22.2 in girls) and obesity (percentage: 10.6 in boys and 11.8 in girls) in children aged 6-9 years.From childhood, obesity is associated with an increased risk of diseases such as insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, musculoskeletal problems, sleep disorders and mental health problems. Obesity is a complex, multi-causal problem involving individual risk factors such as behavior and genetics. Behavioral factors include diet, physical activity, sedentary lifestyle, sleep, and others. It is therefore important to study each of the individual risk factors for obesity. There are few large sample studies in European/Spanish children and no longitudinal studies estimating the incidence of obesity in preschool children based on exposure to different risk factors, considering not only the effect of food consumption but also dietary habits and patterns.The aim of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1508,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "6 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "CORALS",
"briefTitle": "Childhood Obesity Risk Assessment Longitudinal Study",
"nctId": "NCT06317883",
"orgStudyIdInfo": {
"id": "CORALS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of dietary intake and habits"
},
{
"measure": "Assessment of physical activity, sedentary behavior and sleep pattern"
},
{
"measure": "Early risk factors"
},
{
"measure": "Body composition: Height"
},
{
"measure": "Body composition: Weight"
},
{
"measure": "Body composition: Body mass index"
},
{
"measure": "Body composition: Waist circumference"
},
{
"measure": "Psychosocial and neuropsychological behavioral assessment"
},
{
"measure": "Verbal fluency"
},
{
"measure": "Muscular strength"
},
{
"measure": "Cardiorespiratory endurance"
}
],
"secondaryOutcomes": [
{
"measure": "Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity."
},
{
"measure": "Body composition: Waist height"
},
{
"measure": "Body composition: Fat mass"
},
{
"measure": "Body composition: Fat mass index"
},
{
"measure": "Body composition: Fat-free mass"
},
{
"measure": "Body composition: Total body water"
},
{
"measure": "Systolic blood pressure measurement"
},
{
"measure": "Diastolic blood pressure measurement"
},
{
"measure": "Heart rate measurement"
},
{
"measure": "Hematological analysis: Hemoglobine"
},
{
"measure": "Hematological analysis: Hematocrite"
},
{
"measure": "Hematological analysis: Erythrocytes"
},
{
"measure": "Hematological analysis: Mean corpuscular volume"
},
{
"measure": "Hematological analysis: Mean corpuscular hemoglobin"
},
{
"measure": "Hematological analysis: Mean corpuscular hemoglobin concentration"
},
{
"measure": "Hematological analysis: Red cell blood distribution width"
},
{
"measure": "Hematological analysis: White blood cells"
},
{
"measure": "Hematological analysis: Neutrophils"
},
{
"measure": "Hematological analysis: Lymphocytes"
},
{
"measure": "Hematological analysis: Monocytes"
},
{
"measure": "Hematological analysis: Eosinophils"
},
{
"measure": "Hematological analysis: Basophiles"
},
{
"measure": "Hematological analysis: Platelets"
},
{
"measure": "Hematological analysis: Mean platelet volume"
},
{
"measure": "Biochemical analysis: Glucose"
},
{
"measure": "Biochemical analysis: Bilirubin"
},
{
"measure": "Biochemical analysis: Creatinine"
},
{
"measure": "Biochemical analysis: Urate"
},
{
"measure": "Biochemical analysis: Urea"
},
{
"measure": "Biochemical analysis: Total protein"
},
{
"measure": "Biochemical analysis: Aspartate aminotransferase"
},
{
"measure": "Biochemical analysis: Alanine aminotransferase"
},
{
"measure": "Biochemical analysis: Gamma-glutamyl transferase"
},
{
"measure": "Biochemical analysis: Alkaline phosphatase"
},
{
"measure": "Biochemical analysis: Total cholesterol"
},
{
"measure": "Biochemical analysis: High density lipoproteins"
},
{
"measure": "Biochemical analysis: Non-HDL cholesterol"
},
{
"measure": "Biochemical analysis: Low density lipoproteins"
},
{
"measure": "Biochemical analysis: Apolipoprotein A1"
},
{
"measure": "Biochemical analysis: Apolipoprotein B"
},
{
"measure": "Biochemical analysis: Calcium"
},
{
"measure": "Biochemical analysis: Potassium"
},
{
"measure": "Biochemical analysis: Sodium"
},
{
"measure": "Biochemical analysis: Phosphorus"
},
{
"measure": "Biochemical analysis: Iron"
},
{
"measure": "Biochemical analysis: Magnesium"
},
{
"measure": "Biochemical analysis: Zinc"
},
{
"measure": "Biochemical analysis: Insulin"
},
{
"measure": "Biochemical analysis: Insulin resistance"
},
{
"measure": "Biochemical analysis: C-reactive protein"
},
{
"measure": "Biochemical analysis: Tumor necrosis factor alpha"
},
{
"measure": "Biochemical analysis: Adiponectin"
},
{
"measure": "Biochemical analysis: Energy"
},
{
"measure": "Biochemical analysis: Carbohydrates"
},
{
"measure": "Biochemical analysis: Sugars"
},
{
"measure": "Biochemical analysis: Fiber"
},
{
"measure": "Biochemical analysis: Polysaccharides"
},
{
"measure": "Biochemical analysis: Total fat"
},
{
"measure": "Biochemical analysis: Saturated fatty acids"
},
{
"measure": "Biochemical analysis: Monounsaturated fatty acids"
},
{
"measure": "Biochemical analysis: Polyunsaturated fatty acids"
},
{
"measure": "Biochemical analysis: Vitamin B1"
},
{
"measure": "Biochemical analysis: Vitamin B2"
},
{
"measure": "Biochemical analysis: Vitamin B3"
},
{
"measure": "Biochemical analysis: Vitamin B6"
},
{
"measure": "Biochemical analysis: Vitamin B9"
},
{
"measure": "Biochemical analysis: Vitamin B12"
},
{
"measure": "Biochemical analysis: Vitamin C"
},
{
"measure": "Biochemical analysis: Vitamin A"
},
{
"measure": "Biochemical analysis: Vitamin D"
},
{
"measure": "Biochemical analysis: Vitamin E"
},
{
"measure": "Biochemical analysis: Carotenes"
},
{
"measure": "Biochemical analysis: Retinol"
},
{
"measure": "Biochemical analysis: Water"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto de Salud Carlos III"
},
{
"name": "Maimónides Biomedical Research Institute of Córdoba"
},
{
"name": "Universidad de Córdoba"
},
{
"name": "Institut Investigacio Sanitaria Pere Virgili"
},
{
"name": "University Rovira i Virgili"
},
{
"name": "Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN)"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Consorcio Centro de Investigación Biomédica en Red (CIBER)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-07-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2032-07-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-05-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intrathecal morphine"
},
{
"name": "Pericapsular nerve group block (PENG)"
}
]
},
"conditionsModule": {
"conditions": [
"Analgesia",
"Hip Arthropathy",
"Post Operative Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lausanne",
"contacts": [
{
"email": "[email protected]",
"name": "Marta Szyszko du Bois d'Aische",
"phone": "+41795564002",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Corey Kull",
"phone": "+41795561781",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "University Hospital of Lausanne",
"geoPoint": {
"lat": 46.516,
"lon": 6.63282
},
"state": "Vaud",
"status": null,
"zip": "1011"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain.Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "single centered, prospective, double blinded non inferiority trial",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "quadruple",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PENGIT",
"briefTitle": "Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty",
"nctId": "NCT06317870",
"orgStudyIdInfo": {
"id": "CHUV_PENGIT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cumulative postoperative morphine consumption at day 1"
}
],
"secondaryOutcomes": [
{
"measure": "Morphine consumption in the recovery room"
},
{
"measure": "PCA administered morphine consumption at day 2"
},
{
"measure": "rest and dynamic pain scores"
},
{
"measure": "Incidence of postoperative nausea and vomiting"
},
{
"measure": "Incidence of pruritus"
},
{
"measure": "Incidence of urinary retention requiring bladder catheterisation"
},
{
"measure": "Duration of analgesia"
},
{
"measure": "operated limb quadriceps strength"
},
{
"measure": "Walking test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire Vaudois"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Centio Forte"
}
]
},
"conditionsModule": {
"conditions": [
"Caries, Dental"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Although resin composite materials' mechanical and aesthetic properties have greatly improved over the past 20 years, research is currently on to find ways to prevent secondary caries from forming beneath and at the margins of restorations. In order to circumvent these problems, there is a growing tendency towards the use of resin-based bioactive and remineralizing restorative materials to strengthen and lengthen the lifespan of bonded dental restorations."
},
"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": 68,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Performance of an Alkasite-based Restorative Material",
"nctId": "NCT06317857",
"orgStudyIdInfo": {
"id": "14422021443228",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Retention success rate % with modified USPH criteria"
}
],
"secondaryOutcomes": [
{
"measure": "Marginal adaptation with modified USPH criteria marginal discolouration, recurrent caries, anatomic form and postoperative sensitivity."
},
{
"measure": "Postoperative sensitivity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Behavioral Writing Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Pain",
"Positive Thinking",
"Emotions"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. Furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Examination of Psychological and Physiological Pathways Linking Gratitude and Pain",
"nctId": "NCT06317844",
"orgStudyIdInfo": {
"id": "BlackHillsHealthPsych",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "P20GM103443",
"link": "https://reporter.nih.gov/quickSearch/P20GM103443",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Subjective Pain Ratings from Baseline to 10-minutes Post Cold Pressor Test"
},
{
"measure": "Differences in Pain Tolerance to Cold Pressor Test"
},
{
"measure": "Differences in Pain Onset to Cold Pressor Test"
}
],
"secondaryOutcomes": [
{
"measure": "Differences in Pain-Related Cognition"
},
{
"measure": "Differences in Autonomic Nervous System Responsivity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of General Medical Sciences (NIGMS)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Black Hills State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Interstitial Lung Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aveiro",
"contacts": null,
"country": "Portugal",
"facility": "University of Aveiro",
"geoPoint": {
"lat": 40.64427,
"lon": -8.64554
},
"state": null,
"status": null,
"zip": "3810-193"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to i) To characterize the functional status and explore the determinants of functional status decline of people with IlD ii)To determine the measurement properties of functional status instruments in people with Interstitial lung diseases (ILD) iii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iv) Explore the progression of functional status progression in people with ILD and v) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.Patients with ILD will be recruited via the pulmonology services at hospitals, namely from Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up spirometric measurements and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.The assessments will be conducted at 6 time points: baseline and 1 week after for instrument validation, followed by assessments every 6 months for 2 years.It is expected that: i) Functional status limitations can be comprehensively identified and measured in individuals with ILD. ii) Some measures are valid and reliable indicators of functional status in individuals with ILD. iii) Different profiles of functional status progression will be identified in individuals with ILD, including stable, slow, and fast decline. iv) A multidimensional index incorporating functional status will improve the accuracy of predicting mortality and outperform the predictive ability of the current GAP Index."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SUNSET",
"briefTitle": "LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease",
"nctId": "NCT06317831",
"orgStudyIdInfo": {
"id": "2023.03936.BDANA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Weight"
},
{
"measure": "Height"
},
{
"measure": "Body mass index"
},
{
"measure": "Heart rate"
},
{
"measure": "Respiratory rate"
},
{
"measure": "Blood pressure"
},
{
"measure": "Peripheral Oxygen Saturation"
}
],
"primaryOutcomes": [
{
"measure": "Short physical performance battery (SPPB)"
}
],
"secondaryOutcomes": [
{
"measure": "Six Minute Walk Test (6MWT)"
},
{
"measure": "The 1-minute sit-to-stand"
},
{
"measure": "The grocery shelving task"
},
{
"measure": "The Physical Performance Test (PPT)"
},
{
"measure": "Handgrip strenght"
},
{
"measure": "Peripheral muscle strength"
},
{
"measure": "The Tilburg Frailty Indicator (TFI)"
},
{
"measure": "The Canadian Occupational Performance Measure (COPM)"
},
{
"measure": "Symptoms of fatigue"
},
{
"measure": "Symptoms of fatigue"
},
{
"measure": "Symptoms of dyspnoea"
},
{
"measure": "The Pulmonary Functional Status and Dyspnea Questionnaire Modified version (PFSDQ-M)"
},
{
"measure": "Health-related quality of life (HRQOL)"
},
{
"measure": "Health-related quality of life (HRQOL)"
},
{
"measure": "London Chest Activities of Daily Living (LCADL)"
},
{
"measure": "Daily physical activity"
},
{
"measure": "Qualitative data: Interviews"
},
{
"measure": "Number of hospitalizations"
},
{
"measure": "Acute exacerbations"
},
{
"measure": "Non-invasive ventilation"
},
{
"measure": "Oxygen therapy"
},
{
"measure": "Medication"
},
{
"measure": "Mortality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fundação para a Ciência e a Tecnologia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Aveiro University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mesenchymal Stem Cells"
},
{
"name": "Comparative placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Safety Issues",
"Efficacy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Liège",
"contacts": [
{
"email": "[email protected]",
"name": "Sophie Vieujean, MD",
"phone": "+ 32 4 323 72 56",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Layla Boutaffala",
"phone": "+32 4 323 38 10",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "CHU de Liège",
"geoPoint": {
"lat": 50.63373,
"lon": 5.56749
},
"state": null,
"status": "RECRUITING",
"zip": "4000"
}
]
},
"descriptionModule": {
"briefSummary": "This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. The impact of combined treatment by endoscopic dilation and local injection of MSCs will be compared with that of a control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, double-blind, controlled study",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Is Local Injection of Mesenchymal Stem Cells After Endoscopic Dilation Safe and Does it Improve the Outcome of Intestinal Stricture in Patients With Crohn's Disease?",
"nctId": "NCT06317818",
"orgStudyIdInfo": {
"id": "TJT2301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of safety of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease."
},
{
"measure": "Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating symptomatic clinical response"
},
{
"measure": "Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating endoscopic response"
},
{
"measure": "Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating radiological response"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of studying, in addition to biomarkers (CRP and fecal calprotectin),"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Liege"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Generic treprostinil sodium + Standard of Care (Double Oral)"
},
{
"name": "Standard of Care - Double Oral"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Arterial Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Linz",
"contacts": [
{
"email": "[email protected]",
"name": "Regina Steringer-Mascherbauer",
"phone": "+437327676",
"phoneExt": "4916",
"role": "CONTACT"
},
{
"email": null,
"name": "Regina Steringer-Mascherbauer",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Austria",
"facility": "Ordensklinikum Linz",
"geoPoint": {
"lat": 48.30639,
"lon": 14.28611
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Vienna",
"contacts": [
{
"email": "[email protected]",
"name": "Irene Lang",
"phone": "+43140400",
"phoneExt": "4623",
"role": "CONTACT"
},
{
"email": null,
"name": "Irene Lang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Austria",
"facility": "Medical University Vienna",
"geoPoint": {
"lat": 48.20849,
"lon": 16.37208
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Olomouc",
"contacts": [
{
"email": "[email protected]",
"name": "Jan Přeček",
"phone": "+420588445102",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jan Přeček",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Czechia",
"facility": "Fakultní Nemocnice Olomouc",
"geoPoint": {
"lat": 49.59552,
"lon": 17.25175
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Praha",
"contacts": [
{
"email": "[email protected]",
"name": "Pavel Jansa",
"phone": "+420224962629",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Pavel Jansa",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Czechia",
"facility": "Všeobecná fakultní nemocnice v Praze",
"geoPoint": {
"lat": 50.08804,
"lon": 14.42076
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Olivier Sitbon",
"phone": "+33145217883",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Olivier Sitbon",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Strasbourg",
"contacts": [
{
"email": "[email protected]",
"name": "Marianne Riou",
"phone": "+330369550686",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marianne Riou",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Hôpitaux Universitaires de Strasbourg",
"geoPoint": {
"lat": 48.58392,
"lon": 7.74553
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Berlin",
"contacts": [
{
"email": "[email protected]",
"name": "Christian Opitz",
"phone": "+493030354815",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christian Opitz",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "DRK Kliniken Berlin Westend",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Dresden",
"contacts": [
{
"email": "[email protected]",
"name": "Michael Halank",
"phone": "+4935145813981",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael Halank",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "University Hospital Carl Gustav Carus of Technical University Dresden",
"geoPoint": {
"lat": 51.05089,
"lon": 13.73832
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Greifswald",
"contacts": [
{
"email": "[email protected]",
"name": "Ralf Ewert",
"phone": "+4938348680500",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ralf Ewert",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Universitätsmedizin Greifswald",
"geoPoint": {
"lat": 54.09311,
"lon": 13.38786
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Budapest",
"contacts": [
{
"email": "[email protected]",
"name": "Olga Hajnalka Balint",
"phone": "+3612152139",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Olga Hajnalka Balint",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Hungary",
"facility": "Gottsegen National Cardiovascular lnstitute",
"geoPoint": {
"lat": 47.49801,
"lon": 19.03991
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Szeged",
"contacts": [
{
"email": "[email protected]",
"name": "Gergely Ágoston",
"phone": "+3662545553",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gergely Ágoston",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Hungary",
"facility": "Medical University of Szeged",
"geoPoint": {
"lat": 46.253,
"lon": 20.14824
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Rome",
"contacts": [
{
"email": "[email protected]",
"name": "Roberto Badagliacca",
"phone": "+39064402727",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Roberto Badagliacca",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Sapienza University of Rome",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Kraków",
"contacts": [
{
"email": null,
"name": "Grzegorz Kopeć",
"phone": "+48126143399",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Grzegorz Kopeć",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Poland",
"facility": "John Paul II Hospital Krakow",
"geoPoint": {
"lat": 50.06143,
"lon": 19.93658
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Otwock",
"contacts": [
{
"email": "[email protected]",
"name": "Marcin Kurzyna",
"phone": "+48227103052",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marcin Kurzyna",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Poland",
"facility": "Fryderyk Chopin Hospital in European Health Centre Otwock",
"geoPoint": {
"lat": 52.10577,
"lon": 21.26129
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Lisboa",
"contacts": [
{
"email": "[email protected]",
"name": "Rui Miguel Freire Plácido",
"phone": "+351217805306",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Rui Miguel Freire Plácido",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Portugal",
"facility": "Centro Hospitalar Lisboa Norte - Santa Maria University Hospital",
"geoPoint": {
"lat": 38.71667,
"lon": -9.13333
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Bucharest",
"contacts": [
{
"email": null,
"name": "Ioan Mircea Coman",
"phone": "+40213175222",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ioan Mircea Coman",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Romania",
"facility": "Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu",
"geoPoint": {
"lat": 44.43225,
"lon": 26.10626
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Târgu-Mureş",
"contacts": [
{
"email": "[email protected]",
"name": "Ioan Tilea",
"phone": "+40265215551",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ioan Tilea",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Romania",
"facility": "Emergency Clinical County Hospital of Targu Mures",
"geoPoint": {
"lat": 46.54245,
"lon": 24.55747
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Isabel Blanco Vich",
"phone": "+34932275779",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Isabel Blanco Vich",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Clinic of Barcelona",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "Jose Andres Tenes Mayen",
"phone": "+34913368263",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jose Andres Tenes Mayen",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Ramon y Cajal",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH.The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective, randomized, two-arm, open-label, low-interventional, phase IV, multi-centre clinical trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy (background therapy with endothelin receptor antagonist - ERA and phosphodiesterase type-5 inhibitor - PDE-5i) by proportion of patients achieving low risk status according to the simplified four-strata risk-assessment tool from week 24 up to 48 weeks in 110 (55/group) treatment-naïve adult intermediate-high risk or intermediate-low risk patients with severe hemodynamic impairment with pulmonary arterial hypertension (PAH) (group I).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TripleTRE",
"briefTitle": "Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients",
"nctId": "NCT06317805",
"orgStudyIdInfo": {
"id": "TREV1-10P.401",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2023-504351-26-01",
"link": null,
"type": "CTIS"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Safety outcomes:"
}
],
"primaryOutcomes": [
{
"measure": "Patients achieving (non-)response status to the assigned treatment in terms of achievement of low-risk status"
}
],
"secondaryOutcomes": [
{
"measure": "Change in hemodynamic parameters by means of right heart catheterization (RHC) - PVR"
},
{
"measure": "Change in hemodynamic parameters by means of right heart catheterization (RHC) - mPAP"
},
{
"measure": "Change in hemodynamic parameters by means of right heart catheterization (RHC) - mRAP"
},
{
"measure": "Change in hemodynamic parameters by means of right heart catheterization (RHC) - CI"
},
{
"measure": "Change in hemodynamic parameters by means of right heart catheterization (RHC) - CO"
},
{
"measure": "Change in hemodynamic parameters by means of right heart catheterization (RHC) - RAP"
},
{
"measure": "Change in right heart structure and function assessed by echocardiography - TAPSE/sPAP"
},
{
"measure": "Change in right heart structure and function assessed by echocardiography - RVEDA"
},
{
"measure": "Change in right heart structure and function assessed by echocardiography - RVESA"
},
{
"measure": "Change in right heart structure and function assessed by echocardiography - RVFAC"
},
{
"measure": "Change in right heart structure and function assessed by echocardiography - RA"
},
{
"measure": "Change in right heart structure and function assessed by echocardiography - Pericardial effusion"
},
{
"measure": "Time to achievement of low-risk status"
},
{
"measure": "Rate of change of risk status"
},
{
"measure": "Change in the number of low-risk criteria based on the French PH Network Registry (FPHR) risk assessment tool"
},
{
"measure": "Change in REVEAL 2.0 risk score"
},
{
"measure": "Rate of change in WHO-FC"
},
{
"measure": "Rate of change in 6MWD"
},
{
"measure": "Rate of change in NT-proBNP/BNP levels"
},
{
"measure": "Total number of clinical worsening(s)"
},
{
"measure": "Overall and transplant free survival"
},
{
"measure": "Rate of change in quality of life - emPHasis-10"
},
{
"measure": "Rate of change in quality of life - EQ-5D-5L"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "ANOVA CRO s.r.o."
},
{
"name": "PharmaLex Belgium"
},
{
"name": "Aixial s.r.o."
},
{
"name": "GCP-Service International Ltd. & Co. KG"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "AOP Orphan Pharmaceuticals AG"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "online exergaming-based physiotherapy programs"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinsonism in Diseases Classified Elsewhere"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kaohsiung",
"contacts": null,
"country": "Taiwan",
"facility": "Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine",
"geoPoint": {
"lat": 22.61626,
"lon": 120.31333
},
"state": null,
"status": null,
"zip": "83304"
}
]
},
"descriptionModule": {
"briefSummary": "To validate the efficiency of online exergaming-based physiotherapy. We will enroll patients with Parkinson's disease in postural instability and gait disturbance motor phenotype in the study and divide them into two groups in a randomized controlled study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be divided into two groups in a randomized controlled study",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease",
"nctId": "NCT06317792",
"orgStudyIdInfo": {
"id": "202201719B0",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Unified Parkinson's Disease Rating Scale score assessment"
},
{
"measure": "Tinetti balance and gait score assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Fall Risk assessment using Berg Balance Scale"
},
{
"measure": "Depression severity assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Science and Technology Council"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Chang Gung Memorial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Abdominal Disorder"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "10 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair",
"nctId": "NCT06317779",
"orgStudyIdInfo": {
"id": "abdominal laparotomy",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair"
}
],
"secondaryOutcomes": [
{
"measure": "Secondary outcomes measures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation"
},
{
"name": "2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation"
}
]
},
"conditionsModule": {
"conditions": [
"Skin Laxity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "UT Soutwestern Medical Center",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": null,
"zip": "75390"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device\\'s capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment.Part 1 Pre-Clinical Study Procedure:* 1 healthy adult (male or female)* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.* On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.Part 2 Clinical Study Procedure:* 1 healthy adult (male or female)* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.* The study team will utilize the specific setting based off the results of Part 1.* Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.* At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.* On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis."
},
"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": 2,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Histological Study of the Effects of a 2910 nm Fiber Laser Technology",
"nctId": "NCT06317766",
"orgStudyIdInfo": {
"id": "UC 20-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "TUNEL Staining"
},
{
"measure": "Mason's Trichrome"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Texas Southwestern Medical Center"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "FA Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Aerobic Exercise"
},
{
"name": "Agility-Cognitive Exercise"
},
{
"name": "Stretching/relaxation"
}
]
},
"conditionsModule": {
"conditions": [
"Physical Exercise"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. This proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. Uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth BD and AUD."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The protocol includes a randomized controlled trial with a follow-up at three months involving three groups of adolescents (18-24 Y) -experimental group 1, will be enrolled in the Aerobic program, experimental group 2 will be involved in the agility program, and an active control group that will be participating in a stretching program. Participants will be randomly assigned to each group.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "REWIRED",
"briefTitle": "Can Exercise Rewire the Brain Addiction Circuitry?",
"nctId": "NCT06317753",
"orgStudyIdInfo": {
"id": "UMinho1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Behavioral: alcohol consumption"
},
{
"measure": "Behavioral: binge episodes"
},
{
"measure": "Behavioral : drunkenness"
},
{
"measure": "Psychological (craving levels)"
},
{
"measure": "Brain structure"
},
{
"measure": "Brain structural connectivity- FA"
},
{
"measure": "Brain structural connectivity - MD"
},
{
"measure": "Brain structural connectivity - AD"
},
{
"measure": "Brain structural connectivity - RD"
},
{
"measure": "Brain function"
},
{
"measure": "Brain function-resting state"
}
],
"secondaryOutcomes": [
{
"measure": "Monetary Incentive Delay Task (included in the fMRI paradigm) - hits"
},
{
"measure": "Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time"
},
{
"measure": "Maximal oxygen consumption (VO2max)"
},
{
"measure": "Brain-derived neurotrophic factor (BDNF)"
},
{
"measure": "Dopamine"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Minho"
}
},
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"date": "2027-12"
},
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"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2027-12"
},
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"startDateStruct": {
"date": "2025-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "green management intervention program"
}
]
},
"conditionsModule": {
"conditions": [
"Intervention",
"Knowledge, Attitudes, Practice"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Marsa Matruh",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Nursing, Matrouh University",
"geoPoint": {
"lat": 31.3529,
"lon": 27.23725
},
"state": null,
"status": null,
"zip": "002"
}
]
},
"descriptionModule": {
"briefSummary": "Green management is the organization-wide strategy that aims to integrate environmental sustainability development into organizational management procedures for maintaining safety and striving high quality of care. The study aimed to examine the effect of a randomized trial of a green management intervention program on nurse manager outcomes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A randomized controlled trial using two-group pretest-posttest designs",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The study was carried out as a randomized controlled trial using two-group pretest-posttest designs in which the intervention group received an intervention program, in contrast to the comparison group. The study design of the present work followed the CONSORT 2010statement",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Green Management Intervention Program For Nurse Managers",
"nctId": "NCT06317740",
"orgStudyIdInfo": {
"id": "0306369",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Questionnaire to measure nurse managers' knowledge"
},
{
"measure": "Questionnaires to measure nurse manager outcomes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Matrouh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
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"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Irreversible Electroporation using EndoVE(Endoscopic Vacuum Electrode) and electrical pulses generated using ePORE(electroporation device)"
}
]
},
"conditionsModule": {
"conditions": [
"Colon Polyp"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to learn about the role of electroporation (the use of small electric pulses applied to tissue) in the treatment (ablation) of colorectal polyps. The main questions to answer in this pilot phase of the study are:1. The safety of pulsed field ablation (PFA) for the removal of colorectal polyps2. The efficacy and feasibility of PFA in the treatment of colorectal polyps using metrics such as treatment coverage, treatment time, post treatment fibrosis, post treatment recurrence and patient satisfaction"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
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"observationalModel": "COHORT",
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"timePerspective": "PROSPECTIVE"
},
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"count": 20,
"type": "ESTIMATED"
},
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"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PULSAR",
"briefTitle": "PULSed Field ablAtion of coloRectal Polyps",
"nctId": "NCT06317727",
"orgStudyIdInfo": {
"id": "IRAS 337105",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Treatment-Emergent Adverse Events"
}
],
"secondaryOutcomes": [
{
"measure": "Efficacy of pulsed field ablation in the treatment of colorectal polyps"
},
{
"measure": "Efficacy of pulsed field ablation in the treatment of colorectal polyps"
},
{
"measure": "Efficacy of pulsed field ablation in the treatment of colorectal polyps"
},
{
"measure": "Efficacy of pulsed field ablation in the treatment of colorectal polyps"
},
{
"measure": "Efficacy of pulsed field ablation in the treatment of colorectal polyps"
},
{
"measure": "Efficacy of pulsed field ablation in the treatment of colorectal polyps"
},
{
"measure": "Evaluation of Quality of Life following pulsed field ablation treatment of colorectal polyps"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Mirai Medical"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "King's College Hospital NHS Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "questionnaires"
}
]
},
"conditionsModule": {
"conditions": [
"Oncology",
"Quality of Life",
"Symptoms and Signs"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Levallois Perret",
"contacts": [
{
"email": null,
"name": "Alain Toledano",
"phone": "33 (0)1 47 58 05 96",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institute Rafaël",
"geoPoint": {
"lat": 48.89389,
"lon": 2.28864
},
"state": "Institut Rafael",
"status": "RECRUITING",
"zip": "92300"
}
]
},
"descriptionModule": {
"briefSummary": "Currently, aspects related to the effects of anticancer treatments and the quality of life of patients and their needs are still poorly documented at the Rafael Institute. Thus this study will meet a dual objective: (1) the establishment of a registry to collect data on the safety and effectiveness of innovative and expensive anticancer drugs when administered in real life and (2) a measurement quantitative quality of life of patients treated with these drugs."
},
"designModule": {
"designInfo": {
"allocation": null,
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"maskingInfo": null,
"observationalModel": "COHORT",
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"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "THERAPINNOV",
"briefTitle": "Long-term Follow-up and Quality of Life of Patients Treated With Anticancer Drugs",
"nctId": "NCT06317714",
"orgStudyIdInfo": {
"id": "IR-2023/0002",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM",
"id": "2023-A02233-42",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "overall survival"
},
{
"measure": "progression free survival"
},
{
"measure": "incidence of adverse events"
},
{
"measure": "incidence of serious adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score"
},
{
"measure": "change from baseline in quality of life measured with the EQ5D5L questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institut Rafael"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hypoglossal Nerve Stimulation (HGNS)"
}
]
},
"conditionsModule": {
"conditions": [
"Obstructive Sleep Apnea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Phillip LoSavio, MD, MS",
"phone": "773-702-5189",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Leila Yazdanbakhsh",
"phone": "773-834-5087",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Phillip LoSavio, MD, MS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The University of Chicago",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "60637"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine if the treatment of Obstructive sleep apnea (OSA) by hypoglossal nerve stimulation (HGNS) will alter glucose metabolism. The study team will also determine if the treatment of Obstructive sleep apnea (OSA) by (hypoglossal nerve stimulation) HGNS will alter predictors of cardiovascular outcomes."
},
"designModule": {
"designInfo": {
"allocation": null,
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},
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},
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},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation",
"nctId": "NCT06317701",
"orgStudyIdInfo": {
"id": "IRB23-1801",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Glycemic variability"
},
{
"measure": "Mean systolic BP (daytime and nocturnal)"
},
{
"measure": "Glycemic variability"
}
],
"secondaryOutcomes": [
{
"measure": "mean blood glucose levels"
},
{
"measure": "mean ambulatory glucose excursions"
},
{
"measure": "time blocks"
},
{
"measure": "Morning fasting insulin, including calculated insulin resistance (HOMA-IR)"
},
{
"measure": "Mean norepinephrine levels"
},
{
"measure": "Morning fasting blood glucose"
},
{
"measure": "Hemoglobin A1c"
},
{
"measure": "Insulin levels"
},
{
"measure": "c-peptide levels"
},
{
"measure": "fasting lipid profile (triglycerides)"
},
{
"measure": "heart rate indices by activity monitor"
},
{
"measure": "sympathetic activity by plasma norepinephrine"
},
{
"measure": "Morning fasting insulin of c-peptide level"
},
{
"measure": "fasting lipid profile (HDL- cholesterol)"
},
{
"measure": "fasting lipid profile ( LDL-cholesterol)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Chicago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
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"date": "2028-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Extra-Virgin Coconut Oil"
}
]
},
"conditionsModule": {
"conditions": [
"Lactation Mastitis",
"Breast Feeding",
"Staphylococcus Aureus Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": null,
"country": "United States",
"facility": "Harris Health System",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "Problem of the Study This study was designed to test the effectiveness of the application of extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in ameliorating nipple pain, cracking and eventually the prevention of subacute lactation mastitis in breastfeeding women. It is theorized that the nipple crack, nipple pain are early warning signs of subacute clinical lactation mastitis. Goal is after application of extra-virgin coconut oil comparative analysis will be done at one week, three weeks, and six weeks. These complications associated with development of subacute mastitis can be addressed early during the first six weeks of lactation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis",
"nctId": "NCT06317688",
"orgStudyIdInfo": {
"id": "TWU IRB-FY2023-157",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Measurement of change in pain level (Numeric Pain Rating Scale McCaffery, 1989)"
},
{
"measure": "Measurement of Development of Nipple Crack (Nipple Tenderness Scale Storr 1988)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Harris Health System (Houston, Texas)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Texas Woman's University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-08-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Osteopathic manipulative treatment (OMT)"
}
]
},
"conditionsModule": {
"conditions": [
"Gastro-oesophageal Reflux Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saronno",
"contacts": [
{
"email": null,
"name": "+39 02 96701013",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "CTFO",
"geoPoint": {
"lat": 45.62513,
"lon": 9.03517
},
"state": "Varese",
"status": "RECRUITING",
"zip": "21047"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"masking": "DOUBLE",
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"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease",
"nctId": "NCT06317675",
"orgStudyIdInfo": {
"id": "ct9873",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean change in GERD-HRQL"
},
{
"measure": "Adverse effects"
}
],
"secondaryOutcomes": [
{
"measure": "Exercise adherence"
},
{
"measure": "Change in drugs use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Studio Osteopatico Busto Arsizio"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Asparaginase Erwinia chrysanthemi"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Blinatumomab"
},
{
"name": "Bone Marrow Aspiration"
},
{
"name": "Calaspargase Pegol"
},
{
"name": "Computed Tomography"
},
{
"name": "Cyclophosphamide"
},
{
"name": "Cytarabine"
},
{
"name": "Daunorubicin"
},
{
"name": "Dexamethasone"
},
{
"name": "Doxorubicin"
},
{
"name": "Echocardiography"
},
{
"name": "FDG-Positron Emission Tomography"
},
{
"name": "Leucovorin"
},
{
"name": "Lumbar Puncture"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Mercaptopurine"
},
{
"name": "Methotrexate"
},
{
"name": "Multigated Acquisition Scan"
},
{
"name": "Pegaspargase"
},
{
"name": "Prednisolone"
},
{
"name": "Prednisone"
},
{
"name": "Therapeutic Hydrocortisone"
},
{
"name": "Thioguanine"
},
{
"name": "Venetoclax"
},
{
"name": "Vincristine"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Leukemia of Ambiguous Lineage",
"B Acute Lymphoblastic Leukemia"
]
},
"contactsLocationsModule": {
"locations": null
},
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"briefSummary": "This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \\[R\\]) or without a KMT2A gene rearrangement (KMT2A-germline \\[G\\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL."
},
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},
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},
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"type": "ESTIMATED"
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],
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"minimumAge": null,
"sex": "ALL",
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]
},
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"briefTitle": "Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia",
"nctId": "NCT06317662",
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"id": "NCI-2024-01994",
"link": null,
"type": null
},
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"id": "NCI-2024-01994",
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"domain": "Children's Oncology Group",
"id": "AALL2321",
"link": null,
"type": "OTHER"
},
{
"domain": "CTEP",
"id": "AALL2321",
"link": null,
"type": "OTHER"
},
{
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"id": "U10CA180886",
"link": "https://reporter.nih.gov/quickSearch/U10CA180886",
"type": "NIH"
}
]
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"measure": "3-year EFS of infants with KMT2A-R ALL treated on Arm B"
},
{
"measure": "3-year EFS of infants with KMT2A-G ALL treated on Arm C"
},
{
"measure": "Use of high-throughput sequencing (HTS) for MRD detection in infant ALL compared to centralized flow cytometry"
},
{
"measure": "PK of calaspargase pegol in infants with ALL"
},
{
"measure": "Incidence of CD19-negative relapse and myeloid switch relapse with protocol therapy"
},
{
"measure": "Impact of venetoclax in combination with chemotherapy on T-cell subsets and function"
},
{
"measure": "Feasibility of T-cell collection and success of T-cell manufacturing for infants with KMT2A-R ALL who receive chimeric antigen receptor T-cell therapy"
},
{
"measure": "Predictors of response and resistance to venetoclax and overall protocol therapy"
},
{
"measure": "Impact of subsequent anti-cancer therapy on overall survival"
}
],
"primaryOutcomes": [
{
"measure": "Incidence of dose-limiting toxicities (DLTs) (safety phase)"
},
{
"measure": "Incidence of DLTs (expansion phase)"
},
{
"measure": "Minimal residual disease (MRD)-negative remission rate"
}
],
"secondaryOutcomes": [
{
"measure": "Event free survival (EFS) rates of infants with KMT2A-R acute lymphoblastic leukemia (ALL)"
},
{
"measure": "3-year EFS of infants with KMT2A-R ALL"
},
{
"measure": "Proportion of KMT2A-G patients in Arm C who are able to receive all treatment cycles before maintenance"
},
{
"measure": "Pharmacokinetics (PK) of venetoclax in infants"
}
]
},
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"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
},
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"date": "2027-12-21"
},
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},
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"date": "2024-07-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
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{
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"interventions": [
{
"name": "Azacitidine"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Bone Marrow Aspiration"
},
{
"name": "Bone Marrow Biopsy"
},
{
"name": "Gilteritinib"
},
{
"name": "Venetoclax"
}
]
},
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"conditions": [
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]
},
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},
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"briefSummary": "This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach."
},
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},
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},
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},
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],
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"OLDER_ADULT"
]
},
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},
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},
{
"domain": "ECOG-ACRIN Cancer Research Group",
"id": "MM1OA-EA02",
"link": null,
"type": "OTHER"
},
{
"domain": "CTEP",
"id": "MM1OA-EA02",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "U10CA180820",
"link": "https://reporter.nih.gov/quickSearch/U10CA180820",
"type": "NIH"
}
]
},
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"primaryOutcomes": [
{
"measure": "Rate of measured residual disease (MRD) negative complete remission (CR)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Event-free survival"
},
{
"measure": "Incidence of adverse events"
}
]
},
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"leadSponsor": {
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
},
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"date": "2025-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-10-31"
},
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"startDateStruct": {
"date": "2024-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ketamine"
},
{
"name": "Normal saline"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Pain",
"Depression"
]
},
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"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during sedation in adults with chronic pain and depression. This study aims to:* Evaluate whether ketamine is more effective than a placebo in treating chronic pain and depression* Confirm that propofol sedation is a safe way to keep participants blinded to treatment* Assess patients' comfort with the sedation process to improve future studies* Explore whether patient expectations affects their pain and depressionParticipants will:* Need to qualify for the study based on stringent medical criteria* Undergo sedation with propofol* Randomly receive either a ketamine or a placebo (saline) infusion during sedation* Complete several study assessments over 5-7 weeks"
},
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"sex": "ALL",
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]
},
"identificationModule": {
"acronym": "PEAK",
"briefTitle": "Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression",
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"id": "73487",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "Number and severity of adverse events related to sedation"
},
{
"measure": "Proportion of participants who accurately recall intra-sedation events"
},
{
"measure": "Treatment guess"
},
{
"measure": "Treatment expectancies"
},
{
"measure": "Pain interference"
},
{
"measure": "Physical function"
},
{
"measure": "Number of painful body regions"
},
{
"measure": "Change in pain medication utilization"
},
{
"measure": "Pressure pain threshold"
},
{
"measure": "Enrollment rate"
},
{
"measure": "Consent fraction"
},
{
"measure": "Participant Experience Survey"
}
],
"primaryOutcomes": [
{
"measure": "Pain Intensity (past 24 hours)"
}
],
"secondaryOutcomes": [
{
"measure": "Depression severity"
},
{
"measure": "Pain Intensity (current)"
}
]
},
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"name": "Stanford University"
}
},
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"date": "2025-05"
},
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},
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},
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"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Prenatal and postnatal ultrasound examination"
}
]
},
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"conditions": [
"Urinary Tract Dilatation"
]
},
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"locations": [
{
"city": "Záborské",
"contacts": [
{
"email": "[email protected]",
"name": "Svetlana Jánošová",
"phone": "+421908369470",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Róbert Dankovčík",
"phone": "+4219051291297",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Slovakia",
"facility": "Svetlana Jánošová",
"geoPoint": {
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"lon": 21.28977
},
"state": null,
"status": "RECRUITING",
"zip": "08253"
}
]
},
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"briefSummary": "The goals of this study are to use a questionnaire survey to determine the state of awareness of the diagnosis and management of patients with urinary tract dilation across several medical professionals, to predict the severity of the postnatal course and surgical intervention in fetuses with urinary tract dilation detected during pregnancy, and to create a model of prenatal and postnatal care for patients with dilation of the urinary tract for multidisciplinary use."
},
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},
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},
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},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Urinary Tract Dilations in Prenatal and Postnatal Life",
"nctId": "NCT06317623",
"orgStudyIdInfo": {
"id": "0292/21/2023-00590",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "The goal is the prediction of severe postnatal course and surgical intervention in fetuses with dilatation of the urinary tract according to the UTD classification created in 2014."
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
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"name": "SonoClinic"
}
},
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"date": "2026-06"
},
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},
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},
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"startDateStruct": {
"date": "2023-01-01"
},
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"date": "2024-03-19"
}
}
} | false | {
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"label": "Study Protocol",
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{
"date": "2023-12-19",
"filename": "ICF_001.pdf",
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"label": "Informed Consent Form",
"size": 373557,
"typeAbbrev": "ICF",
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]
}
} |
{
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"interventions": [
{
"name": "growth prediction of ovarian cancer organoids in the frame of bright field image by leveraging AI"
}
]
},
"conditionsModule": {
"conditions": [
"Ovarian Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": [
{
"email": "[email protected]",
"name": "Dongling Zou, M.D.",
"phone": "13657690699",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dongling Zou, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Chongqing Cancer Hospital",
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"lon": 106.55278
},
"state": "Chongqing",
"status": "RECRUITING",
"zip": "400030"
}
]
},
"descriptionModule": {
"briefSummary": "The present study aims to collect early bright field image of patient-derived organoids with ovarian cancer. By leveraging artificial intelligence, this study will seek to construct and refine algorithms that able to predict growth of ovarian cancer organoids."
},
"designModule": {
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},
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},
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"sex": "FEMALE",
"stdAges": [
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Artificial Intelligence Model for Growth Prediction of Ovarian Cancer Organoids",
"nctId": "NCT06317610",
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"id": "CQGOG0206",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "AUC of growth prediction performance using deep learning model"
},
{
"measure": "Accuracy of growth prediction using deep learning model"
}
],
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},
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"name": "Chongqing University Cancer Hospital"
}
},
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"date": "2024-05-30"
},
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"date": "2024-03-19"
},
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"date": "2024-04-30"
},
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"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution"
},
{
"name": "Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
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{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Changhai Hospital",
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"lon": 121.45806
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"state": null,
"status": null,
"zip": null
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},
"descriptionModule": {
"briefSummary": "To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality."
},
"designModule": {
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},
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},
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},
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],
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"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy",
"nctId": "NCT06317597",
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"id": "OSS2024-0311",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "Incidence of laxative-related adverse events assessed by clinical examinations"
},
{
"measure": "Colonoscopy completion rate"
}
],
"primaryOutcomes": [
{
"measure": "Bowel preparation adequate rate"
}
],
"secondaryOutcomes": [
{
"measure": "Acceptability of bowel preparation by questionnaire survey"
}
]
},
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"collaborators": [
{
"name": "Peking University People's Hospital"
},
{
"name": "Internet Hospital of Tianjin Medical University General Hospital"
},
{
"name": "The Affiliated Suzhou Hospital of Nanjing Medical University"
},
{
"name": "Tianjin First Central Hospital"
},
{
"name": "Tianjin Beichen Hospital"
},
{
"name": "ShangDong Provincial Hospital"
},
{
"name": "The Affiliated Hospital of Qingdao University"
},
{
"name": "First People's Hospital of Hangzhou"
},
{
"name": "The Third People's Hospital of Chengdu"
},
{
"name": "Ningbo Yinzhou District Second Hospital"
},
{
"name": "Changshu Affiliated Hospital of Soochow University"
},
{
"name": "Linyi People's Hospital"
},
{
"name": "Shanghai East Hospital"
},
{
"name": "Heilongjiang Province Hospital Nangang Branch"
},
{
"name": "The Affiliated Jiangyin Hospital of Nantong University"
},
{
"name": "West China Hospital"
}
],
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"name": "Changhai Hospital"
}
},
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},
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},
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},
"studyFirstPostDateStruct": {
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}
}
} | false | null |
{
"armsInterventionsModule": {
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{
"name": "Experimental: Empowerment Application for CAM Health Education"
},
{
"name": "Written Paper for CAM Health Education"
}
]
},
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"conditions": [
"Diabetes"
]
},
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"locations": [
{
"city": "Taoyuan City",
"contacts": null,
"country": "Taiwan",
"facility": "CHENG GUNG MEMORIAL HOSPITAL, Linkou",
"geoPoint": {
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"lon": 121.20193
},
"state": "Guishan District",
"status": null,
"zip": "333"
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]
},
"descriptionModule": {
"briefSummary": "This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes."
},
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"interventionModelDescription": "Randomized trail method",
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"masking": "QUADRUPLE",
"maskingDescription": "The process of keeping the study group assignment hidden after the allocation to participant, care provider, investigator, outcomes assessor",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 86,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CAM",
"briefTitle": "Empowerment-based Complementary and Alternative Medicine (ECAM)",
"nctId": "NCT06317584",
"orgStudyIdInfo": {
"id": "NMRPF3M0042",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Understanding the benefits-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire"
},
{
"measure": "Quality of life questionnaire"
},
{
"measure": "Diabetes Empowerment scale"
}
],
"secondaryOutcomes": [
{
"measure": "Blood Glucose (GLU)"
},
{
"measure": "Glycated Hemoglobin(HbA1c)"
},
{
"measure": "ALanine aminoTransferase，Glutamic Pyruvic Transaminase(ALT/GPT)"
},
{
"measure": "ASpartate aminoTransferase，Glutamic Oxaloacetic Transaminase (AST/GOT)"
},
{
"measure": "Blood Urea Nitrogen(BUN)"
},
{
"measure": "Creatinine(CREA)"
},
{
"measure": "High Density Lipoprotein(HDL)"
},
{
"measure": "Total Bilirubin(T.BIL)"
},
{
"measure": "Serum total cholesterol(TC)"
},
{
"measure": "Triglyceride (TG)"
},
{
"measure": "Glomerular filtration rate(GFR)"
},
{
"measure": "Albumin to Creatinine Ratio (ACR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Science and Technology Council"
},
{
"name": "Chang Gung Memorial Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Chang Gung University of Science and Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "fertility support education"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Manisa",
"contacts": null,
"country": "Turkey",
"facility": "Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi",
"geoPoint": {
"lat": 38.61202,
"lon": 27.42647
},
"state": null,
"status": null,
"zip": "45060"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two groups with intervention group and control group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of The Effect of Fertility Support Education Given to Infertile Couples",
"nctId": "NCT06317571",
"orgStudyIdInfo": {
"id": "CelalBayarU-SBF-OT-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Infertility Stress Scale"
},
{
"measure": "Infertility Self-Efficacy Scale-Short Form"
},
{
"measure": "Fertility Readiness Scale"
},
{
"measure": "Fertiqol Quality of Life Scale"
},
{
"measure": "Blood cortisol level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Celal Bayar University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-08-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-12-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neoadjuvant immunotherapy"
},
{
"name": "Other drugs for neoadjuvant treatment"
}
]
},
"conditionsModule": {
"conditions": [
"NSCLC"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Shugeng Gao, Vice president",
"phone": "010-87788177",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shugeng Gao",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100020"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in NSCLC patients using the real-world data. The main questions it aims to answer are:* What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?* How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 4000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NeoIM-Lung",
"briefTitle": "Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy",
"nctId": "NCT06317558",
"orgStudyIdInfo": {
"id": "22/492-3694",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pathological Complete Response (pCR)"
},
{
"measure": "Disease-free survival(DFS)"
}
],
"secondaryOutcomes": [
{
"measure": "OS (overall survival)"
},
{
"measure": "EFS (event-free survival)"
},
{
"measure": "Major Pathological Response (MPR)"
},
{
"measure": "Relapse Patterns"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cancer Institute and Hospital, Chinese Academy of Medical Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mulligan Taping"
}
]
},
"conditionsModule": {
"conditions": [
"Lateral Epicondylitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Multan",
"contacts": null,
"country": "Pakistan",
"facility": "BARKI Advanced Physiotherapy Center",
"geoPoint": {
"lat": 30.19679,
"lon": 71.47824
},
"state": "Punjab",
"status": null,
"zip": "60000"
},
{
"city": "Multan",
"contacts": null,
"country": "Pakistan",
"facility": "KAIMS Physiotherapy and Rehabilitation Center",
"geoPoint": {
"lat": 30.19679,
"lon": 71.47824
},
"state": "Punjab",
"status": null,
"zip": "60000"
}
]
},
"descriptionModule": {
"briefSummary": "Painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. The above symptom is associated with a clinical diagnosis of lateral elbow tendinopathy (LET), also known as tennis elbow or lateral epicondylalgia the two effective treatment approaches for lateral epicondylitis are Nirschl exercises and Mulligan taping. This study aims to evaluate the effectiveness of Nirschl exercises with or without Mulligan taping in treating lateral epicondylitis. The study design for this project employs a randomized controlled trial and a sample of individuals with lateral epicondylitis randomly assigned in one of the two groups i.e., Nirschl exercises only and Nirschl exercises with Mulligan taping. Nirschl exercises involve the eccentric strengthening of the wrist extensor muscles and forearm. The participants in both groups will receive Nirschl exercises while the second group will also receive Mulligan taping, which involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. Different outcome measures including pain intensity, functional disability, grip strength, range of motion will be evaluated using, PRTEE Scale, Visual Analogue Scale (VAS) and Calibrated Jammer hand held dynamometer. Statistical analysis, including independent t-tests or chi-square tests, will be conducted to compare the outcomes between the two groups. The significance level will be set at p \\< 0.05. This study will contribute to the evidence base regarding the efficacy of Nirschl exercises and Mulligan taping in managing lateral epicondylitis and will help the clinicians and patients in deciding the best treatment approach for lateral epicondylitis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 56,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Nerchal Exercises on Lateral Epicondylitis.",
"nctId": "NCT06317545",
"orgStudyIdInfo": {
"id": "REC/RCR&AH/23/0167/shan ali",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain intensity"
},
{
"measure": "Grip strength"
}
],
"secondaryOutcomes": [
{
"measure": "Disability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lifestyle modification advice"
},
{
"name": "Functional exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Dysmenorrhea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": [
{
"email": "[email protected]",
"name": "Manar E. Al-Emary, M.Sc. Stud",
"phone": "+20 128 660 0931",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mai Mohamed Ali, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Soheir Mahmoud Elkosery, Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Amr Hazem Abbassy, Assis. Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Cairo University",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea."
},
"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": 58,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea",
"nctId": "NCT06317532",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004766",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual analogue scale (VAS)"
},
{
"measure": "The Menstrual Distress Questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "Quality of life enjoyment and satisfaction questionnaire"
},
{
"measure": "Pressure pain threshold assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physical Rehabilitation"
},
{
"name": "Gait Real-time Analysis Interactive Lab"
}
]
},
"conditionsModule": {
"conditions": [
"Acquired Brain Injury",
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bosisio Parini",
"contacts": [
{
"email": "[email protected]",
"name": "Elena Beretta, MD",
"phone": "031877851",
"phoneExt": "+39",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Scientific Institute IRCCS Eugenio Medea",
"geoPoint": {
"lat": 45.80075,
"lon": 9.29
},
"state": "Lecco",
"status": "RECRUITING",
"zip": "23842"
}
]
},
"descriptionModule": {
"briefSummary": "Gait pattern difficulties, balance and coordination deficits often characterize patients with congenital and acquired neuromotor disorders and have a significant impact on the quality of life of these subjects. There are various treatments used and in recent years, the advent of advanced technologies in rehabilitation and, in particular, devices based on virtual reality, has opened up new possibilities in rehabilitation. Virtual reality is a promising strategy that incorporates many principles crucial to motor learning, such as high-intensity, repetitive, goal-oriented tasks, enhanced synchronized sensory signals, and active participation. The virtual environment is also suitable for personalized treatment based on the needs of the individual patient.The GRAIL (Gait Real-time Analysis Interactive Lab) is a device that integrates immersive virtual reality with an instrumented treadmill and a motion capture system, which can be used with both rehabilitation and evaluation goals. To date, there are still few studies of this device in the pediatric field.The objective of the study is to verify the performance in clinical practice of the immersive virtual reality platform GRAIL and determine any secondary effects by evaluating whether they entail acceptable risks compared to the expected performances following the protocol defined at the IRCCS Medea by Bosisio Parini, in children and adolescents with congenital and acquired neuromotor pathology.Patients suffering from acquired and congenital brain injuries undergo a combined rehabilitation treatment consisting of 20 sessions with GRAIL and 20 physiotherapy sessions in four weeks. The same subjects undergo evaluations before and at the end of the treatmentThe study is prospective and involves the verification of performance through clinical and instrumental evaluations in the population of subjects treated with the GRAIL device at the IRCCS Medea-Bosisio Parini."
},
"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": "20 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab)",
"nctId": "NCT06317519",
"orgStudyIdInfo": {
"id": "09.2020-Oss",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6 minute walking test"
},
{
"measure": "Gross Motor Function Measure -total score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Eugenio Medea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-04-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Intellectual Disability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trieste",
"contacts": null,
"country": "Italy",
"facility": "Institute for Maternal and Child Health - IRCCS \"Burlo Garofolo\"",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": null,
"zip": "34137"
}
]
},
"descriptionModule": {
"briefSummary": "Previous literature data indicate that children with intellectual disability (ID) experience more severe pain and more frequently than their cognitively healthy peers, during their daily life. Repeated and chronic pain exposure triggers a vicious circle of hyperalgesia and reduction of the impaired cognitive and adaptive function. Furthermore, these children are unable to rationalize any intervention targeted to contain potentially painful actions.Epigenetics studies mechanisms responsible for a set of modifications that regulate gene expression without altering the DNA sequence itself. DNA methylation and posttranslational modification of histones are the main epigenetic mechanisms. It is widely accepted that these mechanisms can be engaged by environmental experience, such as early life trauma, pain or addiction leading to the idea of epigenetics as 'a bridge' between genes and environment.Several epigenetic studies evaluated genes coding proteins involved in recycling of neurotransmitters (SCL6A4), in transmission of painful stimuli (TRPA1) and in response to analgesics (OPRM1). In particular, some studies assessed TRPA1 gene, coding for a cationic channel responsible for the transmission of thermal-painful sensations, and SCL6A4, a serotonin-recycling transmembrane protein presents at inter-synaptic level, have highlighted the importance of methylation in a pathological experience of chronic pain and anxiety disorder in the adult population. Opioid receptor OPRM1 is involved in the endogenous and exogenous opioid-mediated analgesia and a recent work in a group of adolescents treated for idiopathic scoliosis highlights a link between greater pain post-surgery and methylation of this gene. In this context, children with ID are at greater risk of undertreatment both for the difficulty in pain recognition and for the fear of medication-adverse reactions.The epigenetic study of the aforementioned genes in children with ID associated with an evaluation of painful experiences and clinical history, could help understanding a scenario that it is still complex nowadays before the eyes of parents and caregivers and healthcare workers.The finding of a different methylation pattern in children with ID could in part explain the different pain experience."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 36,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Methylation Pattern and Pain Sensation in Children With Intellectual Disability",
"nctId": "NCT06317506",
"orgStudyIdInfo": {
"id": "RC 43/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Between groups differences in methylation levels"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Burlo Garofolo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-10-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-10-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stimuli"
}
]
},
"conditionsModule": {
"conditions": [
"Hearing Impaired Children"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trieste",
"contacts": [
{
"email": "[email protected]",
"name": "Eva Orzan, MD",
"phone": "+39.040.3785.537",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Institute for Maternal and Child Health - IRCCS \"Burlo Garofolo\"",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "RECRUITING",
"zip": "34137"
}
]
},
"descriptionModule": {
"briefSummary": "The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "36 Months",
"minimumAge": "4 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment",
"nctId": "NCT06317493",
"orgStudyIdInfo": {
"id": "RC 15/2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sensitivity index of pupillometry test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Burlo Garofolo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "bone resection"
},
{
"name": "subperiosteal excision"
}
]
},
"conditionsModule": {
"conditions": [
"Soft Tissue Sarcoma",
"Cortical Contact"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "the purpose of this study is to assess whether bone resection for thigh soft tissue sarcoma with cortical involvement of the adjacent bone result in better local control and survival compared to sub-periosteal dissection. Investigators also aim to find out the prognostic factors for clinical outcomes in this group of patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 142,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Outcomes Comparison Between Bone Resection and Subperiosteal Dissection for Specific Type of Soft Tissue Sarcoma",
"nctId": "NCT06317480",
"orgStudyIdInfo": {
"id": "QH_2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "survival"
},
{
"measure": "recurrence"
},
{
"measure": "metastasis"
}
],
"secondaryOutcomes": [
{
"measure": "functional outcomes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Second Affiliated Hospital, School of Medicine, Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2000-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood sampling"
},
{
"name": "Blood sampling"
}
]
},
"conditionsModule": {
"conditions": [
"Pre-Eclampsia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trieste",
"contacts": [
{
"email": "[email protected]",
"name": "Chiara Agostinis, BSc",
"phone": "040/5588652",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Institute for Maternal and Child Health - IRCCS \"Burlo Garofolo\"",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "RECRUITING",
"zip": "34137"
}
]
},
"descriptionModule": {
"briefSummary": "Preeclampsia (PE) is a very frequent obstetric complication. C1q, the first recognition molecule of the classical pathway of complement system (C), represents a double-edged molecule in determining pregnancy outcomes. In animal models, C1q deficiency caused the development of a dysfunctional placenta and PE-like symptoms. Conversely, lower levels of C components were detected in the sera of patients with PE due to C consumption and increased deposition of activated C components in the placenta, as well as to the binding to placental apoptotic bodies, syncytiotrophoblast microvesicles (STBM) and debris which are increased in the circulation of patients with PE.C1q is a hexameric glycoprotein of 460kDa composed by six copies of three polypeptide chains A, B and C, each made by a C-terminal globular head (gC1q) and a N-terminal collagen-like region (CLR). This molecule can be the target of an antibody response. Autoantibodies targeting C1q were first recognized in the serum of Systemic Lupus Erythematosus (SLE) patients. The presence of anti-C1q autoantibodies was also detected in patient affected by autoimmune disease (ie, kidney disorders, vasculitis, thyroiditis). Almost all of these autoimmune disorders are associated with an increased risk of developing PE during pregnancy.Anti-C1q detection mainly concerns the prediction of the onset of lupus nephritis (LN) in SLE patients. Although anti-C1q autoantibodies do not deplete circulating C1q, their presence in maternal circulation and in placenta may trigger improper C activation and impair C1q activity. In pregnancies complicated by autoimmune affection such as SLE, autoimmune thyroid disorders and Antiphospholipid syndrome (APS) the prevalence of anti-C1q appeared to be higher than in control pregnancies and associated with miscarriage. High levels of anti-C1q have been found in a group of Japanese patients suffering recurrent pregnancy loss (RPL). In a group of anti-C1q positive healthy pregnancies and LN patients was assessed whether C1q autoantigenic behaviour could vary among individuals with or without correlated manifestation. Sera from healthy pregnancies and LN patients were screened for the presence of autoantibodies against the CLR fragment and/or the gC1q: antibodies against gC1q were found in both groups, whereas anti-CLR were only detected in the LN one, suggesting that only the latter may have a pathogenic role. Despite this, the biological functions of anti-C1q remain far from clear"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Role of Anti-C1q Autoantibodies in Pregnancy",
"nctId": "NCT06317467",
"orgStudyIdInfo": {
"id": "RC 01/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies"
},
{
"measure": "Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies"
},
{
"measure": "Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies"
},
{
"measure": "Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies"
},
{
"measure": "Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies"
},
{
"measure": "Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies"
},
{
"measure": "Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies"
},
{
"measure": "Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Burlo Garofolo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood and saliva analysis"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 1"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trieste",
"contacts": [
{
"email": "[email protected]",
"name": "Antonietta Robino",
"phone": "+39.040.3785.470",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Silvia Tommasi",
"phone": "+39.040.3785.863",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Institute for Maternal and Child Health - IRCCS \"Burlo Garofolo\"",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "RECRUITING",
"zip": "34137"
}
]
},
"descriptionModule": {
"briefSummary": "A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic.While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "21 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus",
"nctId": "NCT06317454",
"orgStudyIdInfo": {
"id": "GR-2019-12369573",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identification of environmental factors affecting T1DM metabolic control"
},
{
"measure": "Identification of genetic factors affecting T1DM metabolic control"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Burlo Garofolo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-11-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Probiotic"
}
]
},
"conditionsModule": {
"conditions": [
"Small Intestinal Bacterial Overgrowth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Calgary",
"contacts": [
{
"email": "[email protected]",
"name": "Gwen Duytschaever",
"phone": "4037032436",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christopher N Andrews, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Nimble Science",
"geoPoint": {
"lat": 51.05011,
"lon": -114.08529
},
"state": "Alberta",
"status": null,
"zip": "T2L 1Y8"
},
{
"city": "Calgary",
"contacts": [
{
"email": "[email protected]",
"name": "Marsha Burnes",
"phone": "4037032436",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christopher N Andrews, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Nimble Science",
"geoPoint": {
"lat": 51.05011,
"lon": -114.08529
},
"state": "Alberta",
"status": null,
"zip": "T2L 1Y8"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, the goal is to evaluate whether a probiotic formula may reduce symptoms of bloating and abdominal distension in a population suffering from Small Intestinal Bacterial Overgrowth (SIBO) in comparison to a placebo. In addition to the incidence of SIBO, changes to other gastrointestinal symptoms will be assessed. Lastly, the associations between the SIBO status and microbiome from the small and large intestines will be explored using the SIMBA capsule."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 105,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms",
"nctId": "NCT06317441",
"orgStudyIdInfo": {
"id": "NIMCSF137",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Exploratory metabolomic analysis"
},
{
"measure": "Exploratory: Quantifying B. subtilis cell proportions"
},
{
"measure": "Safety outcomes"
}
],
"primaryOutcomes": [
{
"measure": "Change in bloating/distension severity"
}
],
"secondaryOutcomes": [
{
"measure": "Median bloating-free days"
},
{
"measure": "Change in median bloating/distension severity"
},
{
"measure": "Change in abdominal discomfort/pain"
},
{
"measure": "Changes in gastrointestinal symptoms"
},
{
"measure": "Changes in stool frequency and consistency"
},
{
"measure": "Changes in the quality of life"
},
{
"measure": "Changes in reflux incidence and severity"
},
{
"measure": "Changes in the severity of IBS symptoms"
},
{
"measure": "Recovery rate of the probiotic strain"
},
{
"measure": "Microbiome changes within small intestine, fecal and saliva samples"
},
{
"measure": "Investigation how the microbiome and SIBO associate with each other though bacterial population analyses."
},
{
"measure": "Change in SIBO positivity rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Lallemand Health Solutions"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Nimble Science Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"COPD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ancona",
"contacts": [
{
"email": "[email protected]",
"name": "Francesco Spannella",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Riccardo Sarzani, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "INRCA Hospital",
"geoPoint": {
"lat": 43.5942,
"lon": 13.50337
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Osimo",
"contacts": [
{
"email": "[email protected]",
"name": "Erilda Kamberi, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yuri Rosati",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRCCS INRCA Hospital",
"geoPoint": {
"lat": 43.48539,
"lon": 13.48222
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 29,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NTproBNP",
"briefTitle": "NT-proBNP Levels During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD.",
"nctId": "NCT06317428",
"orgStudyIdInfo": {
"id": "INRCA_001_2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in serum NT-pro-BNP levels"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Nazionale di Ricovero e Cura per Anziani"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "WeChat-based health education on antibiotic use"
},
{
"name": "Regular public health education"
}
]
},
"conditionsModule": {
"conditions": [
"Non-Prescription Drug Misuse",
"Antibiotic Use"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shenzhen",
"contacts": null,
"country": "China",
"facility": "Fuyong People's Hospital",
"geoPoint": {
"lat": 22.54554,
"lon": 114.0683
},
"state": "Guangdong",
"status": null,
"zip": "518103"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to test the effectiveness of health education int led by community health workers for non-prescription antibiotic use among the public. In this two arm cluster randomised trial, In this two-arm cluster randomized controlled trial, 22 communities were randomly allocated in a 1:1 ratio to intervention and control groups. In the intervention group, family doctors will conduct WeChat-based health education on responsible use of antibiotic for the participants. In the control group, only routine public health education will be provided without any involvement in antibiotic use. The primary outcome is the incidence of antibiotic use without prescription in the past month."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1550,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intervention on Non-prescription Antibiotic Use Among the Public",
"nctId": "NCT06317415",
"orgStudyIdInfo": {
"id": "HuazhongU20240312",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of non-prescription antibiotic use among the public"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fuyong People's Hospital, Bao 'an District, Shenzhen City, Guangdong"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Huazhong University of Science and Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "malnutrition questionary"
}
]
},
"conditionsModule": {
"conditions": [
"Malnutrition"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Pauline Faucher, Dr",
"phone": "01 42 17 57 71",
"phoneExt": "33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Service de nutrition, Hôpital Pitié-Salpêtrière",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": "RECRUITING",
"zip": "75013"
}
]
},
"descriptionModule": {
"briefSummary": "According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age \\<70 years) and 2021 (if age ≥ 70 years)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 385,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EPIDENUT_PSL",
"briefTitle": "Epidemiology and Management of Malnutrition of Patients Hospitalized at the Pitié-Salpêtrière Hospital: a One-day Survey Combined With Focus Groups (Mixed Methods)",
"nctId": "NCT06317402",
"orgStudyIdInfo": {
"id": "APHP240133",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prevalence of undernutrition diagnosed according to HAS 2019 and 2021 criteria on a given day in hospitalized PSL patients."
}
],
"secondaryOutcomes": [
{
"measure": "Compare the prevalence and the severity of undernutrition in hospitalized PSL patients according to the HAS criteria of 2019 (if age <70 years) and 2021 (if age ≥ 70 years) versus those of 2003 (if age <70 years) and 2007 (if age ≥ 70 years)."
},
{
"measure": "Evaluate the quality of nutritional management for malnourished patients hospitalized at PSL. Using PMSI coding, assess the value of activities associated with undernutrition in undernourished patients hospitalized at PSL."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questionnaires"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer",
"Oncology",
"Oncoral Program"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pierre-Bénite",
"contacts": [
{
"email": null,
"name": "Catherine RIOUFOL, Pr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Florence RANCHON, MCU-PH",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Anne-Gaëlle CAFFIN, Dr",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Marie-Anne CERFON, PH",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "Groupement Hospitalier Sud - Unité de Pharmacie Clinique Oncologique",
"geoPoint": {
"lat": 45.7009,
"lon": 4.82511
},
"state": null,
"status": null,
"zip": "69495"
}
]
},
"descriptionModule": {
"briefSummary": "With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks. These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction, in life actual, dose-intensity and expected response. Furthermore, insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination, DRPs lead to an increase in the consumption of care.Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs. Set up in 2014 by the Hospices Civils de Lyon, this educational monitoring is based on a tripartite hospital intervention (oncologist, pharmacist, nurse) and a structured city-hospital link with private health professionals (attending doctor, community pharmacist and freelance nurse). Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities.The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population, on the real-life use of ATCO and on new methods of organizing ambulatory cancer care.The PACOME database collects sociodemographic, clinical and therapeutic data, and experiences in this population. Patients quality of life and other PROs (symptoms and adverse effects experienced by patients), social determinants, health care consumption, the caregiver-patient relationship, the use of digital technology in health, the organization of care, the city-hospital link (interventions of actors and their temporality).This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials, which are expected by health professionals and decision-makers. With patient data from the secure Oncoral pathway, PACOME brings together the three major and inseparable assets of real-life databases: quality, completeness and meaning of the data. It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies, which will contribute to the animation of the new ecosystem of real-life health data in oncology."
},
"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": 3000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PACOME",
"briefTitle": "PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments",
"nctId": "NCT06317389",
"orgStudyIdInfo": {
"id": "69HCL23_1237",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Relative-Dose-Intensity (RDI) in real life with a prospective follow-up of 6 months within the limit of the duration of treatment with oral anticancer drugs by setting up a data platform for adult patients taking oral anticancer drugs"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospices Civils de Lyon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2037-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MICT with Aerobic exercise on treadmill"
},
{
"name": "standard hospital protocol"
}
]
},
"conditionsModule": {
"conditions": [
"Post-cardiac Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Peshawar",
"contacts": null,
"country": "Pakistan",
"facility": "RMI",
"geoPoint": {
"lat": 34.008,
"lon": 71.57849
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "1. To determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients.2. To determine the effect of MICT on aerobic Capacity of CABG patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Group-based Cardiac Rehabilitation on Patients With Coronary Artery Bypass Graft Surgery",
"nctId": "NCT06317376",
"orgStudyIdInfo": {
"id": "REC/014131 Maria Haseen",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Borg rating of perceived exertion scale"
},
{
"measure": "6min walk test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Base Line + ACEPELLA"
},
{
"name": "Base Line + Manual Chest Physiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"CABG"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": null,
"country": "Pakistan",
"facility": "Jinnah Hospital",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": "54600"
}
]
},
"descriptionModule": {
"briefSummary": "Coronary artery bypass grafting (CABG) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. CABG is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. Chest physiotherapy is commonly use to prevent and treat these complications, but its effectiveness in post-operative CABG patients is not well established.The purpose of this study is to evaluate the effects of Acapella device vs chest physiotherapy on pulmonary function, airway clearance and dyspnea in post-operative CABG patients. The group A will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella), while the group B will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute The primary outcome measures of the study will be pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC, and Modified Borg dyspnea scale . The secondary outcome measures will be the amount of sputum cleared. The study will be conducted over a period of 6 months after approval of synopsis.The study will be conducted in a tertiary care hospital in Lahore, Pakistan. Patients who have undergone CABG surgery will be screen for eligibility and those who meet the inclusion criteria will be enroll in the study. Patients who have a history of chronic lung disease, smoking, intubated patient or other respiratory conditions will be exclude from the study"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients",
"nctId": "NCT06317363",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0353",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Modified Borg Dyspnea Scale"
},
{
"measure": "FEV1"
},
{
"measure": "FVC"
},
{
"measure": "FEV1/FVC"
},
{
"measure": "sputum volume"
}
],
"secondaryOutcomes": [
{
"measure": "body temperature(degree centigrade)"
},
{
"measure": "pulse rate (beats/minute)"
},
{
"measure": "respiratory rate( breaths/minute)"
},
{
"measure": "blood pressure (mmHg)"
},
{
"measure": "SpO2 (%)"
},
{
"measure": "SaO2 (%)"
},
{
"measure": "PaO2 (%)"
},
{
"measure": "PaCO2 (%)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GNS-212-E1"
},
{
"name": "GNS-212-E2"
},
{
"name": "GNS-212-ER"
}
]
},
"conditionsModule": {
"conditions": [
"Colonoscopy",
"Bowel Preparation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": [
{
"email": null,
"name": "Byeong Gwan Kim",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Korea, Republic of",
"facility": "Seoul National University Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial."
},
"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": 318,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "79 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GNS-212-E",
"briefTitle": "Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy",
"nctId": "NCT06317350",
"orgStudyIdInfo": {
"id": "GNS-212-E",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "MFDS",
"id": "101772",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall rate of bowel preparation"
},
{
"measure": "Overall patient satisfaction and compliance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Gunkang Pharmaceuticals, Inc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "focused ultrasound cavitation augmented with aerobic exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Central Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Peshawar",
"contacts": null,
"country": "Pakistan",
"facility": "Bioflex Aesthetic Clinic",
"geoPoint": {
"lat": 34.008,
"lon": 71.57849
},
"state": "KPK",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life."
},
"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": 54,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "25 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Focused Ultrasound Cavitation Augmented With Aerobic Exercise",
"nctId": "NCT06317337",
"orgStudyIdInfo": {
"id": "Sana Bshir",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Borg rating of perceived exertion scale"
},
{
"measure": "girth"
},
{
"measure": "6min walk test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Different treatments"
}
]
},
"conditionsModule": {
"conditions": [
"NSCLC",
"Radiotherapy",
"Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tianjin",
"contacts": [
{
"email": "[email protected]",
"name": "Zhao Yan",
"phone": "+86-22-23340123",
"phoneExt": "5509",
"role": "CONTACT"
},
{
"email": null,
"name": "Xishan Hao, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy",
"geoPoint": {
"lat": 39.14222,
"lon": 117.17667
},
"state": "Tianjin",
"status": "RECRUITING",
"zip": "300060"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are:1. Explore the survival differences.2. Explore of the lung function changes before and after different treatments."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Peking University First Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GSK3915393"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Idiopathic Pulmonary Fibrosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "This will be a double-blind study with respect to allocation of GSK3915393 or placebo to participants.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)",
"nctId": "NCT06317285",
"orgStudyIdInfo": {
"id": "220929",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU CTR",
"id": "2023-509371-16-00",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Absolute Change from Baseline in Forced Vital Capacity (FVC) in milliliters (mL) at Week 26"
}
],
"secondaryOutcomes": [
{
"measure": "Absolute Change from Baseline in Forced Vital Capacity (mL) at Weeks 4, 8, 12 and 18"
},
{
"measure": "Absolute Change from Baseline in Percent Predicted Forced Vital Capacity (%) at Weeks 4, 8, 12, 18 and 26"
},
{
"measure": "Participants Achieving Relative Decline from Baseline in FVC (mL) Less than or Equal to (≤) 5 Percent (%) at Week 26"
},
{
"measure": "Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)"
},
{
"measure": "Number of Participants with Clinically Important Findings in Vital Signs"
},
{
"measure": "Number of Participants with Clinically Important Findings in Electrocardiogram (ECG)"
},
{
"measure": "Number of Participants with Clinically Important Findings in Haematology"
},
{
"measure": "Number of Participants with Clinically Important Findings in Hepatobiliary Parameters"
},
{
"measure": "Number of Participants with Clinically Important Findings in Clinical Chemistry"
},
{
"measure": "Maximum observed concentration (Cmax) of GSK3915393 in IPF Participants"
},
{
"measure": "Area under the time-concentration curve (AUC) from Zero (pre-dose) to 4 hours (h) post-dose sample [0-4 h]) of GSK3915393"
},
{
"measure": "Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC- inf) of GSK3915393"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "GlaxoSmithKline"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DIBH using ABC technique"
},
{
"name": "DIBH using VC technique"
}
]
},
"conditionsModule": {
"conditions": [
"Esophageal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Groningen",
"contacts": null,
"country": "Netherlands",
"facility": "UMC Groningen",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "The participating patients will undergo weekly (during radiotherapy treatment) 2 CTs in DIBH; one using ABC and one using voluntary coaching (VC).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BROTHER",
"briefTitle": "BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma",
"nctId": "NCT06317272",
"orgStudyIdInfo": {
"id": "RT2016-04-BROTHER Part 1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility DIBH"
},
{
"measure": "Reproducibility DIBH"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Medical Center Groningen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "TERMINATED",
"primaryCompletionDateStruct": {
"date": "2023-09-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-02-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hypoxic breathwork plus music and messaging"
},
{
"name": "Hypoxic breathwork only"
},
{
"name": "Music and messaging meditation"
}
]
},
"conditionsModule": {
"conditions": [
"Hypoxic Breathwork With Music and Affirmative Messaging",
"Hypoxic Breathwork Only",
"Music and Affirmative Messaging"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This project will study changes that occur during a short period of intensive daily slow-paced breathing and breath hold practice (i.e., \"breathwork\"). On the first and last days of the week-long practice, investigators will conduct high-density EEG recordings during breathwork to evaluate spectral power, coherence, and causality dynamics of the brain when it is naïve to breathwork and after adaptation to a breathwork practice. Breath, blood, urine, saliva, stool samples, biometric data, and sleep EEG will be collected before the start of daily breathwork practice and again after 1 week of breathwork practice to examine the effect of breathwork on full body biochemistry, molecular biology, and sleep. Investigators will also use questionnaires to assess the impact of breathwork on stress and sleep quality."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "We have 3 groups running in parallel (one of each group running in the same week). Group 1 will do breathwork that includes music and positive messaging, group 2 will do breathwork alone with only guided breathing instructions, and group 3 will listen to the music and positive messaging but no breathwork which we call the \"meditation\" group.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Subjects will be unaware of the other conditions and will thus not know if they are in a 'control' group or not. All experimenters will know subject group assignments. Subjects will be told of all groups at the end.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Hypoxic Breathwork",
"nctId": "NCT06317259",
"orgStudyIdInfo": {
"id": "809163",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "EEG power and/or connectivity differences between groups"
},
{
"measure": "Group differences in sleep EEG power and/or stage changes from baseline to the intervention period"
}
],
"secondaryOutcomes": [
{
"measure": "Group differences between physiological changes in proteomics, microbiome, and other factors from baseline following intervention"
},
{
"measure": "Group differences in mood and stress from before to after the intervention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Diego"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-19"
}
}
} | false | null |
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