protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "REGN2810"
},
{
"name": "Platinum-doublet chemotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tarrytown",
"contacts": null,
"country": "United States",
"facility": "Regeneron Research Facility",
"geoPoint": {
"lat": 41.07621,
"lon": -73.85875
},
"state": "New York",
"status": null,
"zip": "10591"
}
]
},
"descriptionModule": {
"briefSummary": "This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients",
"nctId": "NCT06269133",
"orgStudyIdInfo": {
"id": "R2810-ONC-22115",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Real-world response rate (rwRR)"
},
{
"measure": "Any treatment-emergent immune-mediated adverse event (imAE)"
},
{
"measure": "Any treatment-emergent imAE resulting in hospitalization"
},
{
"measure": "Any treatment-emergent imAE resulting in death"
},
{
"measure": "Specific treatment-emergent imAEs"
}
],
"secondaryOutcomes": [
{
"measure": "Real-world duration of response (rwDOR)"
},
{
"measure": "Real-world progression-free survival (rwPFS)"
},
{
"measure": "Real-world overall survival (rwOS)"
},
{
"measure": "Treatment-emergent immune-mediated adverse events (imAEs)"
},
{
"measure": "Infusion-related reaction (IRR)"
},
{
"measure": "IRR resulting in hospitalization"
},
{
"measure": "IRR resulting in death"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Regeneron Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral Semaglutide"
}
]
},
"conditionsModule": {
"conditions": [
"Type 2 Diabetes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 470,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary",
"nctId": "NCT06269120",
"orgStudyIdInfo": {
"id": "NN9924-7787",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "World Health Organization (WHO)",
"id": "U1111-1290-8109",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5%"
}
],
"secondaryOutcomes": [
{
"measure": "Change in HbA1c"
},
{
"measure": "Change in fasting plasm glucose (FPG)"
},
{
"measure": "Absolute change in body weight (BW)"
},
{
"measure": "Relative change in BW"
},
{
"measure": "HbA1c less than (<) 7.0%"
},
{
"measure": "HbA1c <6.5%"
},
{
"measure": "Body weight reduction ≥5%"
},
{
"measure": "HbA1c reduction ≥1%-point and BW reduction ≥5%"
},
{
"measure": "HbA1c reduction ≥1%-point and BW reduction ≥3%"
},
{
"measure": "Change in waist circumference"
},
{
"measure": "Change in blood pressure (BP) (systolic and diastolic)"
},
{
"measure": "Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG])"
},
{
"measure": "Change in high sensitive C-reactive protein (hsCRP)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novo Nordisk A/S"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IcoSema"
},
{
"name": "Insulin glargine"
}
]
},
"conditionsModule": {
"conditions": [
"Type 2 Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "La Jolla",
"contacts": null,
"country": "United States",
"facility": "Scripps Whittier Diabetes Inst",
"geoPoint": {
"lat": 32.84727,
"lon": -117.2742
},
"state": "California",
"status": "RECRUITING",
"zip": "92037"
},
{
"city": "Lancaster",
"contacts": null,
"country": "United States",
"facility": "First Valley Med Grp Lancaster",
"geoPoint": {
"lat": 34.69804,
"lon": -118.13674
},
"state": "California",
"status": "RECRUITING",
"zip": "93534"
},
{
"city": "Lincoln",
"contacts": null,
"country": "United States",
"facility": "Clinical Trials Research_Sacramento",
"geoPoint": {
"lat": 38.89156,
"lon": -121.29301
},
"state": "California",
"status": "RECRUITING",
"zip": "95648"
},
{
"city": "Palm Springs",
"contacts": null,
"country": "United States",
"facility": "Desert Oasis Hlthcr Med Group",
"geoPoint": {
"lat": 33.8303,
"lon": -116.54529
},
"state": "California",
"status": "RECRUITING",
"zip": "92262"
},
{
"city": "Fleming Island",
"contacts": null,
"country": "United States",
"facility": "Northeast Research Institute",
"geoPoint": {
"lat": 30.0933,
"lon": -81.71898
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32003"
},
{
"city": "Winter Haven",
"contacts": null,
"country": "United States",
"facility": "Clinical Research of Central Florida_Winter Haven",
"geoPoint": {
"lat": 28.02224,
"lon": -81.73286
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33880"
},
{
"city": "Atlanta",
"contacts": null,
"country": "United States",
"facility": "Atlanta Diabetes Associates",
"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia",
"status": "RECRUITING",
"zip": "30318"
},
{
"city": "Roswell",
"contacts": null,
"country": "United States",
"facility": "Endo Res Solutions Inc",
"geoPoint": {
"lat": 34.02316,
"lon": -84.36159
},
"state": "Georgia",
"status": "RECRUITING",
"zip": "30076"
},
{
"city": "Blackfoot",
"contacts": null,
"country": "United States",
"facility": "Elite Clinical Trials",
"geoPoint": {
"lat": 43.19047,
"lon": -112.34498
},
"state": "Idaho",
"status": "RECRUITING",
"zip": "83221"
},
{
"city": "Chicago",
"contacts": null,
"country": "United States",
"facility": "Cedar-Crosse Research Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "60607"
},
{
"city": "Skokie",
"contacts": null,
"country": "United States",
"facility": "NorthShore Univ Hlth Sys",
"geoPoint": {
"lat": 42.03336,
"lon": -87.73339
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "60077"
},
{
"city": "Topeka",
"contacts": null,
"country": "United States",
"facility": "Cotton-O'Neil Diab & Endo Ctr",
"geoPoint": {
"lat": 39.04833,
"lon": -95.67804
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "66606"
},
{
"city": "Omaha",
"contacts": null,
"country": "United States",
"facility": "Methodist Phys. Clinic",
"geoPoint": {
"lat": 41.25626,
"lon": -95.94043
},
"state": "Nebraska",
"status": "RECRUITING",
"zip": "68114"
},
{
"city": "Albuquerque",
"contacts": null,
"country": "United States",
"facility": "Albuquerque Clin Trials, Inc.",
"geoPoint": {
"lat": 35.08449,
"lon": -106.65114
},
"state": "New Mexico",
"status": "RECRUITING",
"zip": "87102"
},
{
"city": "Albany",
"contacts": null,
"country": "United States",
"facility": "Albany Medical College - Endo",
"geoPoint": {
"lat": 42.65258,
"lon": -73.75623
},
"state": "New York",
"status": "RECRUITING",
"zip": "12206"
},
{
"city": "West Seneca",
"contacts": null,
"country": "United States",
"facility": "Southgate Medical Group, LLP",
"geoPoint": {
"lat": 42.85006,
"lon": -78.79975
},
"state": "New York",
"status": "RECRUITING",
"zip": "14224"
},
{
"city": "Greenville",
"contacts": null,
"country": "United States",
"facility": "Physician's East Endocrinology",
"geoPoint": {
"lat": 35.61266,
"lon": -77.36635
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27834"
},
{
"city": "Canton",
"contacts": null,
"country": "United States",
"facility": "Diab & Endo Assoc of Stark Co",
"geoPoint": {
"lat": 40.79895,
"lon": -81.37845
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "44718"
},
{
"city": "Maumee",
"contacts": null,
"country": "United States",
"facility": "Advanced Medical Research",
"geoPoint": {
"lat": 41.56283,
"lon": -83.65382
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43537"
},
{
"city": "Wadsworth",
"contacts": null,
"country": "United States",
"facility": "New Venture Medical Research",
"geoPoint": {
"lat": 41.02561,
"lon": -81.72985
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "44281-9236"
},
{
"city": "Kingsport",
"contacts": null,
"country": "United States",
"facility": "Holston Medical Group",
"geoPoint": {
"lat": 36.54843,
"lon": -82.56182
},
"state": "Tennessee",
"status": "RECRUITING",
"zip": "37660"
},
{
"city": "Amarillo",
"contacts": null,
"country": "United States",
"facility": "Amarillo Med Spec LLP",
"geoPoint": {
"lat": 35.222,
"lon": -101.8313
},
"state": "Texas",
"status": "RECRUITING",
"zip": "79106"
},
{
"city": "Cedar Park",
"contacts": null,
"country": "United States",
"facility": "Velocity Clinical Research- Cedar Park",
"geoPoint": {
"lat": 30.5052,
"lon": -97.82029
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78613"
},
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "Velocity Clinical Res-Dallas",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75230"
},
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "North Texas Endocrine Center",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75231"
},
{
"city": "Fort Worth",
"contacts": null,
"country": "United States",
"facility": "Diabetes and Thyroid Ctr of FW",
"geoPoint": {
"lat": 32.72541,
"lon": -97.32085
},
"state": "Texas",
"status": "RECRUITING",
"zip": "76132"
},
{
"city": "Lampasas",
"contacts": null,
"country": "United States",
"facility": "Fmc Science, Llc",
"geoPoint": {
"lat": 31.06378,
"lon": -98.1817
},
"state": "Texas",
"status": "RECRUITING",
"zip": "76550"
},
{
"city": "Shavano Park",
"contacts": null,
"country": "United States",
"facility": "Consano Clinical Research, LLC",
"geoPoint": {
"lat": 29.58495,
"lon": -98.55252
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78231"
},
{
"city": "Bountiful",
"contacts": null,
"country": "United States",
"facility": "Wade Family Medicine",
"geoPoint": {
"lat": 40.88939,
"lon": -111.88077
},
"state": "Utah",
"status": "RECRUITING",
"zip": "84010"
},
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Peking University People's Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100044"
},
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Beijing Friendship Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100050"
},
{
"city": "Chongqing",
"contacts": null,
"country": "China",
"facility": "Chongqing University Three Gorges Hospital",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": "Chongqing",
"status": "RECRUITING",
"zip": "404000"
},
{
"city": "Huizhou",
"contacts": null,
"country": "China",
"facility": "Huizhou Central People's Hospital",
"geoPoint": {
"lat": 23.11147,
"lon": 114.41523
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "516001"
},
{
"city": "Nanjing",
"contacts": null,
"country": "China",
"facility": "The Second Affiliated Hospital of Nanjing Medical University",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "210011"
},
{
"city": "Nanjing",
"contacts": null,
"country": "China",
"facility": "The Second Affiliated Hospital of Nanjing Medical University",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "NOT_YET_RECRUITING",
"zip": "210011"
},
{
"city": "Zhenjiang",
"contacts": null,
"country": "China",
"facility": "The Affiliated Hospital of Jiangsu University",
"geoPoint": {
"lat": 32.21086,
"lon": 119.45508
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "212001"
},
{
"city": "Jinan",
"contacts": null,
"country": "China",
"facility": "Jinan Central Hospital",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong",
"status": "RECRUITING",
"zip": "250013"
},
{
"city": "Jinan",
"contacts": null,
"country": "China",
"facility": "Jinan Central Hospital",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong",
"status": "NOT_YET_RECRUITING",
"zip": "250013"
},
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Shanghai Pudong New Area People's Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "201200"
},
{
"city": "Hengshui",
"contacts": null,
"country": "China",
"facility": "Harrison International Peace Hospital",
"geoPoint": {
"lat": 37.73222,
"lon": 115.70111
},
"state": null,
"status": "WITHDRAWN",
"zip": "053000"
},
{
"city": "Athens",
"contacts": null,
"country": "Greece",
"facility": "Evangelismos Hospital",
"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
},
"state": null,
"status": "RECRUITING",
"zip": "GR-10676"
},
{
"city": "Athens",
"contacts": null,
"country": "Greece",
"facility": "'G. Gennimatas' General Hospital of Athens",
"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
},
"state": null,
"status": "RECRUITING",
"zip": "GR-115 27"
},
{
"city": "Athens",
"contacts": null,
"country": "Greece",
"facility": "\"Laiko\" General Hospital of Athens",
"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
},
"state": null,
"status": "RECRUITING",
"zip": "GR-11527"
},
{
"city": "Kalamata",
"contacts": null,
"country": "Greece",
"facility": "General Hospital of Kalamata",
"geoPoint": {
"lat": 37.03913,
"lon": 22.11265
},
"state": null,
"status": "RECRUITING",
"zip": "24100"
},
{
"city": "Larissa",
"contacts": null,
"country": "Greece",
"facility": "Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease",
"geoPoint": {
"lat": 39.63689,
"lon": 22.41761
},
"state": null,
"status": "RECRUITING",
"zip": "GR-41110"
},
{
"city": "Thessaloniki",
"contacts": null,
"country": "Greece",
"facility": "\"Thermi\" Private Hosital",
"geoPoint": {
"lat": 40.64361,
"lon": 22.93086
},
"state": null,
"status": "RECRUITING",
"zip": "GR-57001"
},
{
"city": "Bangalore",
"contacts": null,
"country": "India",
"facility": "Ramaiah Memorial Hospital",
"geoPoint": {
"lat": 12.97194,
"lon": 77.59369
},
"state": "Karnataka",
"status": "RECRUITING",
"zip": "560054"
},
{
"city": "Bangalore",
"contacts": null,
"country": "India",
"facility": "Ramaiah Memorial Hospital",
"geoPoint": {
"lat": 12.97194,
"lon": 77.59369
},
"state": "Karnataka",
"status": "NOT_YET_RECRUITING",
"zip": "560054"
},
{
"city": "Mysore",
"contacts": null,
"country": "India",
"facility": "Mysore Medical College and Research Institute",
"geoPoint": {
"lat": 12.29791,
"lon": 76.63925
},
"state": "Karnataka",
"status": "NOT_YET_RECRUITING",
"zip": "570001"
},
{
"city": "Mumbai",
"contacts": null,
"country": "India",
"facility": "BYL Nair Hospital and T N Medical College Department of endo",
"geoPoint": {
"lat": 19.07283,
"lon": 72.88261
},
"state": "Maharashtra",
"status": "RECRUITING",
"zip": "400008"
},
{
"city": "Mumbai",
"contacts": null,
"country": "India",
"facility": "BYL Nair Hospital and T N Medical College Department of endo",
"geoPoint": {
"lat": 19.07283,
"lon": 72.88261
},
"state": "Maharashtra",
"status": "NOT_YET_RECRUITING",
"zip": "400008"
},
{
"city": "Mumbai",
"contacts": null,
"country": "India",
"facility": "Seth GS Medical College & KEM Hospital",
"geoPoint": {
"lat": 19.07283,
"lon": 72.88261
},
"state": "Maharashtra",
"status": "RECRUITING",
"zip": "400012"
},
{
"city": "Mumbai",
"contacts": null,
"country": "India",
"facility": "Seth GS Medical College & KEM Hospital",
"geoPoint": {
"lat": 19.07283,
"lon": 72.88261
},
"state": "Maharashtra",
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{
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{
"measure": "Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL])"
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{
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{
"measure": "Time spent greater than (>) 10.0 mmol/L (180 mg/dL)"
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{
"measure": "Weekly basal insulin dose"
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{
"measure": "Change in fasting plasma glucose (FPG)"
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{
"measure": "Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction"
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{
"measure": "Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3)"
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{
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{
"measure": "Number of severe hypoglycaemic episodes (level 3)"
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"name": "Gina Castiglione, RD",
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"name": "Jennifer Walsh",
"phone": "414-955-7710",
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},
"descriptionModule": {
"briefSummary": "Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 352,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV",
"nctId": "NCT06269081",
"orgStudyIdInfo": {
"id": "R01NR020770",
"link": "https://reporter.nih.gov/quickSearch/R01NR020770",
"type": "NIH"
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01NR020770",
"link": "https://reporter.nih.gov/quickSearch/R01NR020770",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Viral Suppression"
},
{
"measure": "Antiretroviral Treatment Medication Adherence"
},
{
"measure": "Health-Related Quality of Life"
},
{
"measure": "Depressive Symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Social Support"
},
{
"measure": "Loneliness"
},
{
"measure": "Internalized HIV Stigma"
},
{
"measure": "General Self-Efficacy"
},
{
"measure": "HIV Treatment Adherence Self-Efficacy"
},
{
"measure": "Accessing Needed Social and Medical Services"
},
{
"measure": "Structural Barriers"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Nursing Research (NINR)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Medical College of Wisconsin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Central sensitization inventory"
},
{
"name": "Short form-36"
},
{
"name": "Oswestry Low Back Pain Disability Questionnaire"
},
{
"name": "Douleur Neuropathique 4"
},
{
"name": "Visual analogue scale"
}
]
},
"conditionsModule": {
"conditions": [
"Central Sensitisation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Feyza Nur Yücel",
"phone": "5385577059",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Marmara University School of Medicine",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik",
"status": "RECRUITING",
"zip": "34899"
}
]
},
"descriptionModule": {
"briefSummary": "Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. CS is also one of the main mechanisms proposed in the generation of neuropathic pain, and the relationship between pain sensitization and neuropathic complaints has been shown in different diseases.In this study, it was aimed to investigate the effect of central sensitization on the distribution pattern and neuropathic character of pain in patients with lumbar disc herniation who applied to the physical medicine and rehabilitation outpatient clinic."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation",
"nctId": "NCT06269068",
"orgStudyIdInfo": {
"id": "12.01.2024.10",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Central Sensitization Inventory (CSI)"
},
{
"measure": "DN4"
}
],
"secondaryOutcomes": [
{
"measure": "VAS pain"
},
{
"measure": "SF-36"
},
{
"measure": "ODI"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Marmara University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interview"
}
]
},
"conditionsModule": {
"conditions": [
"Gadolinium Deposition Disease",
"Ca-DTPA"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stanford",
"contacts": [
{
"email": "[email protected]",
"name": "Lorrin Koran, M.D.",
"phone": "650-799-1647",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Stanford University Medical Center",
"geoPoint": {
"lat": 37.42411,
"lon": -122.16608
},
"state": "California",
"status": null,
"zip": "94305"
}
]
},
"descriptionModule": {
"briefSummary": "This study is aimed at describing the degree of benefit, if any, and the adverse effects, if any, from receiving 5 or more treatment sessions of Gadolinium Deposition Disease using two-day chelation treatment with the chelating agents Calcium Diethylenetriamine pentaacetate (Ca-DTPA) and Zinc Diethylenetriamine pentaacetate (Zn-DTPA)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease",
"nctId": "NCT06269055",
"orgStudyIdInfo": {
"id": "73151",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rating of Gadolinium Deposition Disease Symptoms at start of GDD and currently"
}
],
"secondaryOutcomes": [
{
"measure": "PROMIS Item Bank v2.0 - Cognitive Function- Short Form 8a"
},
{
"measure": "Sheehan Disability Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Stanford University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Inspiratory muscle training"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function.In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 18,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability",
"nctId": "NCT06269042",
"orgStudyIdInfo": {
"id": "0010",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Respiratory muscle strength"
},
{
"measure": "Diaphragmatic thickness and thickening fraction"
},
{
"measure": "Diaphragm movement curve"
},
{
"measure": "Heart rate variability"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universidad Europea de Madrid"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Sierra Varona SL"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Chest mobility exercises"
},
{
"name": "proprioceptive neuromuscular facilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Obstructive Pulmonary Disease Moderate"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Zahraa Serry, PHD",
"phone": "012854566880",
"phoneExt": "02",
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Cairo university- faculty of physical therapy",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": "Dokki",
"status": "RECRUITING",
"zip": "12556"
}
]
},
"descriptionModule": {
"briefSummary": "Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "50 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD",
"nctId": "NCT06269029",
"orgStudyIdInfo": {
"id": "P.T.Rec/012/004297",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pulmonary function test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-17"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "expremental pre and post test"
}
]
},
"conditionsModule": {
"conditions": [
"Stress Urinary Incontinence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Mai Mohamed Sherif Mohamed Hassan",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "30 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women",
"nctId": "NCT06269016",
"orgStudyIdInfo": {
"id": "P.T.REC/012/003888",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "hip muscles strengthening exercise."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-08-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Expert"
},
{
"name": "Peer"
},
{
"name": "1 Sided"
},
{
"name": "2 Sided"
}
]
},
"conditionsModule": {
"conditions": [
"Vaping"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Worcester",
"contacts": null,
"country": "United States",
"facility": "UMass Chan Medical School Shaw Building",
"geoPoint": {
"lat": 42.26259,
"lon": -71.80229
},
"state": "Massachusetts",
"status": null,
"zip": "01605"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 112,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Responses to Message Source and Presentation Using Psychophysiology",
"nctId": "NCT06269003",
"orgStudyIdInfo": {
"id": "STUDY00001223",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1K99CA281094-01A1",
"link": "https://reporter.nih.gov/quickSearch/1K99CA281094-01A1",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual attention"
},
{
"measure": "Orienting response"
},
{
"measure": "Arousal"
}
],
"secondaryOutcomes": [
{
"measure": "Attitudes"
},
{
"measure": "Behavioral intentions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Massachusetts, Worcester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-01-17",
"filename": "SAP_000.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 176628,
"typeAbbrev": "SAP",
"uploadDate": "2024-01-31T10:39"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fecal microbiota transplantation"
}
]
},
"conditionsModule": {
"conditions": [
"Morbid Obesity",
"Metabolic Syndrome",
"Diabetes",
"PreDiabetes",
"Insulin Resistance"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Graz",
"contacts": [
{
"email": "[email protected]",
"name": "Julia K Mader, Assoc. Prof.",
"phone": "+43 316 38582383",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Julia K Mader, Assoc. Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Patrizia Kump, PD Dr",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Austria",
"facility": "Department of Internal Medicine, Medical University Graz",
"geoPoint": {
"lat": 47.06667,
"lon": 15.45
},
"state": null,
"status": "RECRUITING",
"zip": "8010"
}
]
},
"descriptionModule": {
"briefSummary": "This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"measure": "Hunger and Satiety Scores"
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"measure": "pain stiffness and physical activity"
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}
} | false | null |
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} | false | null |
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"measure": "Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI)"
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{
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},
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},
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"city": "Hochiminh city",
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},
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},
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}
],
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{
"measure": "To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio)."
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{
"measure": "To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP."
},
{
"measure": "To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease)."
},
{
"measure": "To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate)."
}
]
},
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}
}
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{
"name": "Rocatinlimab prefilled syringe"
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"measure": "Maximum Observed Serum Concentration (Cmax) of Rocatinlimab"
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"measure": "Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab"
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{
"measure": "AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab"
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],
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"measure": "Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)"
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{
"measure": "Number of Participants Experiencing Serious Adverse Events (SAE)"
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"measure": "Number of Participants Positive to Anti-rocatinlimab Antibody"
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}
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{
"name": "ACT02"
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],
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"phases": [
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},
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"id": "DERMATIDYSS",
"link": null,
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],
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{
"measure": "Investigator Global Assessment scale"
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{
"measure": "Corneometer"
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{
"measure": "Tewameter"
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{
"measure": "Quality of Life Index - Perceived Stress"
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{
"measure": "Participant's Satisfaction"
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]
},
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},
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}
}
} | false | null |
{
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"interventions": [
{
"name": "Blood for zonulin level was drawn from the group."
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},
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"conditions": [
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]
},
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"city": "Ankara",
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"date": "2023-10-04"
},
"studyFirstPostDateStruct": {
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}
}
} | false | 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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}
],
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"role": "CONTACT"
}
],
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}
],
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],
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"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Periprosthetic Joint Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wigan",
"contacts": [
{
"email": "[email protected]",
"name": "Zaid Z Hamoodi",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust",
"geoPoint": {
"lat": 53.54295,
"lon": -2.63705
},
"state": "Lancashire",
"status": "RECRUITING",
"zip": "WN6 9EP"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 244,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)",
"nctId": "NCT06268795",
"orgStudyIdInfo": {
"id": "BASE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison of diagnostic accuracy"
}
],
"secondaryOutcomes": [
{
"measure": "Culture analysis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Wrightington, Wigan and Leigh NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rehabilitate your core"
}
]
},
"conditionsModule": {
"conditions": [
"Quality of Life",
"Physical Activity",
"Urinary Incontinence",
"Pelvic Organ Prolapse"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Turku",
"contacts": null,
"country": "Finland",
"facility": "Department of Nursing Science, Faculty of Medicine, University of Turku",
"geoPoint": {
"lat": 60.45148,
"lon": 22.26869
},
"state": null,
"status": null,
"zip": "20014"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this quasi-experimental study was to assess the effectiveness of a 6-week online exercise program on self-assessed quality of life (QoL), physical activity (PA), and dysfunctions of pelvic floor muscles of postpartum women immediately and 6 months after the online intervention. The data were collected with e-questionnaires. The data collection started in September 2021 and ended in September 2023."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 308,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women",
"nctId": "NCT06268782",
"orgStudyIdInfo": {
"id": "1204202118",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Quality of Life"
}
],
"secondaryOutcomes": [
{
"measure": "Physical activity"
},
{
"measure": "Urinary incontinence"
},
{
"measure": "Pelvic organ prolapse"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Finnish Cultural Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Turku"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-01-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-09-21"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tacrolimus Pill"
},
{
"name": "Tacrolimus capsule"
}
]
},
"conditionsModule": {
"conditions": [
"Immunosuppression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Berlin",
"contacts": [
{
"email": null,
"name": "Klemens Budde, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "10117"
},
{
"city": "Dresden",
"contacts": [
{
"email": null,
"name": "Christian Hugo, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Hospital Dresden, Division of Nephrology",
"geoPoint": {
"lat": 51.05089,
"lon": 13.73832
},
"state": null,
"status": "RECRUITING",
"zip": "01307"
},
{
"city": "Hamburg",
"contacts": [
{
"email": null,
"name": "Malte A. Kluger, PD Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology)",
"geoPoint": {
"lat": 53.57532,
"lon": 10.01534
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "20251"
},
{
"city": "Mainz",
"contacts": [
{
"email": null,
"name": "Julia Weinmann-Menke, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology)",
"geoPoint": {
"lat": 49.98419,
"lon": 8.2791
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "55131"
},
{
"city": "Regensburg",
"contacts": [
{
"email": "[email protected]",
"name": "Edward K. Geissler, PhD",
"phone": "+49 941 944",
"phoneExt": "6961",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Bernhard Banas, MD, PhD",
"phone": "+49 941 944",
"phoneExt": "7301",
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Hospital Regensburg, Department of Nephrology",
"geoPoint": {
"lat": 49.01513,
"lon": 12.10161
},
"state": null,
"status": "RECRUITING",
"zip": "93053"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A dynamic allocation technique assigns participants in a 1:1 ratio to one of two treatment arms: Envarsus tablets (test IMP) or Advagraf capsules (comparator IMP). Randomisation is stratified by two factors: a) trial site, in order to minimise systematic treatment bias at the level of the trial centre and reduce the influence of inter-centre variability, and b) participation in the optional pharmacokinetic sub-study, in order to ensure an equal representation of Envarsus- and Advagraf-treated patients in the sub-study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TaC:Drop",
"briefTitle": "Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs",
"nctId": "NCT06268769",
"orgStudyIdInfo": {
"id": "TaC:Drop",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EUCT Number",
"id": "2023-503531-18-00",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose-normalised blood trough level of tacrolimus (concentration/dose ratio)"
}
],
"secondaryOutcomes": [
{
"measure": "Time to reach the first trough level in target range"
},
{
"measure": "Proportion of patients with trough levels lower, within, or higher than the target range"
},
{
"measure": "Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels"
},
{
"measure": "Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose"
},
{
"measure": "Tacrolimus concentration/dose (C/D) ratio"
},
{
"measure": "Intra-patient variability of C/D ratio and daily dose"
},
{
"measure": "Treatment failure rate"
},
{
"measure": "Time to treatment failure after transplantation"
},
{
"measure": "Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection"
},
{
"measure": "Incidence rate of graft failure"
},
{
"measure": "Mortality rate"
},
{
"measure": "Graft function measured by eGFR (estimated glomerular filtration rate)"
},
{
"measure": "Incidence rate of for-cause biopsies"
},
{
"measure": "Incidence rate of acute rejection episodes requiring treatment"
},
{
"measure": "Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection"
},
{
"measure": "Incidence rate of delayed graft function"
},
{
"measure": "Incidence rate of primary non-function of the renal allograft"
},
{
"measure": "Incidence of hepatotoxicity"
},
{
"measure": "Incidence of CMV and BKV infection (including organ manifestation, if relevant)"
},
{
"measure": "Incidence, type, severity and seriousness of adverse reactions (ARs)"
},
{
"measure": "Blood pressure"
},
{
"measure": "Incidence of de novo tremor"
},
{
"measure": "Incidence of gastrointestinal disorders requiring diagnostic investigation"
},
{
"measure": "Incidence of new onset diabetes mellitus after transplantation (NODAT)"
},
{
"measure": "Recurrence of primary kidney disease"
},
{
"measure": "Incidence of de novo DSA"
},
{
"measure": "Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34)"
},
{
"measure": "Doses and duration of glucocorticosteroid treatment"
},
{
"measure": "Dose of mycophenolate"
},
{
"measure": "Incidence and time to study treatment discontinuation"
},
{
"measure": "Incidence, time to and reason for patient withdrawal from study"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Chiesi Pharmaceuticals GmbH"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Edward Geissler"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Data collection"
}
]
},
"conditionsModule": {
"conditions": [
"Self-esteem"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Reims",
"contacts": [
{
"email": "[email protected]",
"name": "Coralie Barbe",
"phone": "326913665",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Ufr Medecine Urca",
"geoPoint": {
"lat": 49.25,
"lon": 4.03333
},
"state": null,
"status": "RECRUITING",
"zip": "51100"
},
{
"city": "Reims",
"contacts": [
{
"email": "[email protected]",
"name": "CURRS CURRS",
"phone": "0326918822",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Université de Reims Champagne Ardenne",
"geoPoint": {
"lat": 49.25,
"lon": 4.03333
},
"state": null,
"status": "RECRUITING",
"zip": "51100"
}
]
},
"descriptionModule": {
"briefSummary": "Fear of being judged negatively by others can lead to avoidance of social situations or even social isolation. If the intensity of this fear is excessive and results in significant impairment of functioning or significant suffering, the subject may suffer from social anxiety.The considerable growth of social networks in a decade has led to the emergence of new behaviors among young people. Individuals spend on average 2 hours and 27 minutes per day with differences in usage: time spent, social network used, function sought. The use of these networks may be reasonable and moderate but may also be excessive and abusive (Amnon, 2014). Some authors even talk about addiction or dependence on social networks (Perales and Billieux, 2020) even if the existence of this disorder is not consensus.People who fear being judged negatively by others may be more at risk of misuse of social networks. Indeed, the use of social networks would compensate for their existing problems (Kardefelt-Winther, 2014) and would thus be a new emotional management strategy. It would also reduce dreaded social situations such as face-to-face exchanges (Weidman and Rodebaugh, 2012; Yen and Ko, 2012). Self-esteem is defined as a subjective judgment of oneself in relation to one's values and vision of the real and ideal self (Rosenberg. 1979). The greater the gap between the vision of the real self and the ideal self, the lower the self-esteem."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RESANXIEST",
"briefTitle": "Fear of Other's Judgment, Self-esteem and Use of Social Networks Among Students",
"nctId": "NCT06268756",
"orgStudyIdInfo": {
"id": "2023_RIPH_020_RESANXIEST",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rosenberg Self-esteem Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Université de Reims Champagne-Ardenne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High intensity"
},
{
"name": "Moderate intensity"
}
]
},
"conditionsModule": {
"conditions": [
"Type 2 Diabetes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities.Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training.Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel group, single blinded, randomized trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "GUTFIT",
"briefTitle": "Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes",
"nctId": "NCT06268743",
"orgStudyIdInfo": {
"id": "2023-114",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Glycemic control through glycated hemoglobin"
},
{
"measure": "Gut microbiome diversity through 16S ribosomal RNA genes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Laval University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of New Brunswick"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SinuSonic"
}
]
},
"conditionsModule": {
"conditions": [
"Nasal Congestion and Inflammations",
"Sinus Congestion Chronic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Keri J Heilman, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Keri J Heilman, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of North Carolina at Chapel Hill",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27599-7160"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.The study aims are:* Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;* Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;* Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "All participants will follow the same procedures.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of SinuSonic on Psychological and Physical Well-Being",
"nctId": "NCT06268730",
"orgStudyIdInfo": {
"id": "23-2437",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale"
},
{
"measure": "Change in the Depression Subscale of the Hospital Anxiety and Depression Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Change in the Body Perception Questionnaire"
},
{
"measure": "Change in the Total Nasal Symptom Score"
},
{
"measure": "Change in the Patient Global Impression of Change"
},
{
"measure": "Adverse Traumatic Experiences Survey at Baseline"
},
{
"measure": "Short Form Health Survey (SF-20) at Baseline"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Healthy Humming, LLC"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
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"date": "2024-07"
},
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},
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"date": "2024-07"
},
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"startDateStruct": {
"date": "2024-03-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ground pork containing alpha-gal"
},
{
"name": "Pork meat not containing alpha-gal"
}
]
},
"conditionsModule": {
"conditions": [
"Alpha-Gal Syndrome",
"Irritable Bowel Syndrome",
"Diarrhea",
"Abdominal Pain",
"Vomiting"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Sarah McGill, MD",
"phone": "919-966-7047",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sarah McGill, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of North Carolina at Chapel Hill",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27599"
}
]
},
"descriptionModule": {
"briefSummary": "This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Double-blind crossover. Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat containing alpha-gal sugar; one challenge will contain pork meat without alpha-gal sugar.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study. The metabolic kitchen and a delegated research staff member will be unblinded.",
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
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},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "GI Alpha-Gal Study",
"nctId": "NCT06268717",
"orgStudyIdInfo": {
"id": "23-0316",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Allergic reaction (food challenge positive)"
},
{
"measure": "No allergic reaction (food challenge negative)"
},
{
"measure": "Lactulose excretion"
},
{
"measure": "C13 mannitol excretion"
},
{
"measure": "Basophil activation threshold response at timepoint 0"
},
{
"measure": "Basophil activation threshold response at 2 hours"
},
{
"measure": "Basophil activation threshold response at 4 hours"
},
{
"measure": "Basophil activation threshold response at 6 hours"
},
{
"measure": "Serum tryptase at timepoint 0"
},
{
"measure": "Serum tryptase at 2 hours"
},
{
"measure": "Serum tryptase at 4 hours"
},
{
"measure": "Serum tryptase at 6 hours"
},
{
"measure": "Mast cell count on stomach biopsies (per high powered field (hpf))"
},
{
"measure": "Mast cell count on small bowel biopsies (per high powered field (hpf))"
},
{
"measure": "Eosinophil cell count on stomach biopsies (per high powered field (hpf))"
},
{
"measure": "Eosinophil cell count on small bowel biopsies (per high powered field (hpf))"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Revivicor, Inc"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-17"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexamethasone"
},
{
"name": "Methylprednisolone"
},
{
"name": "2% Lidocaine HCl Injection"
}
]
},
"conditionsModule": {
"conditions": [
"Sacroiliac Joint Dysfunction",
"Sacro-Iliac Spondylosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Albuquerque",
"contacts": [
{
"email": "[email protected]",
"name": "Mark W Shilling, BS",
"phone": "505-925-7599",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of New Mexico Hospital",
"geoPoint": {
"lat": 35.08449,
"lon": -106.65114
},
"state": "New Mexico",
"status": "RECRUITING",
"zip": "87131"
}
]
},
"descriptionModule": {
"briefSummary": "This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
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]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection",
"nctId": "NCT06268704",
"orgStudyIdInfo": {
"id": "UNM HRRC #23-503",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain using Numeric Pain Rating Score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of New Mexico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
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"startDateStruct": {
"date": "2024-03-27"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Insecticide Coating INESFLY"
}
]
},
"conditionsModule": {
"conditions": [
"Dengue",
"Vector Borne Diseases",
"Arbovirus Infections",
"Zika",
"Chikungunya Fever"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cúcuta",
"contacts": null,
"country": "Colombia",
"facility": "Instituto Departamental de Salud de Norte de Santander",
"geoPoint": {
"lat": 7.89391,
"lon": -72.50782
},
"state": "Norte De Santander",
"status": null,
"zip": "540001"
},
{
"city": "Freiburg",
"contacts": null,
"country": "Germany",
"facility": "Centre for Medicine and Society",
"geoPoint": {
"lat": 47.9959,
"lon": 7.85222
},
"state": "Baden-Württemberg",
"status": null,
"zip": "79098"
}
]
},
"descriptionModule": {
"briefSummary": "Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.07%) in suspension, without interaction between them, development by INESFLY®, Spain.The main questions it aims to answer are:Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia.Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti.The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA.The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm.In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A cluster randomised trial for the application of a new vector control tool (insecticide coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. Each cluster comprising approximately 2,000 dwellings.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35000,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating",
"nctId": "NCT06268691",
"orgStudyIdInfo": {
"id": "ProjectCOLOMBIA-ZMG.U-Freiburg",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change of dengue incidence for 12 months"
}
],
"secondaryOutcomes": [
{
"measure": "Change of vector densities estimated through larval and pupal indices."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Göteborg University"
},
{
"name": "Instituto Nacional de Salud, Colombia"
},
{
"name": "Instituto Departamental de Salud de Norte de Santander"
},
{
"name": "Universidad Francisco de Paula de Santander"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Rocio Cardenas Sanchez"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-09-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-02-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2019-03-11",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 2263350,
"typeAbbrev": "Prot",
"uploadDate": "2024-02-12T15:19"
},
{
"date": "2019-03-11",
"filename": "SAP_001.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 768947,
"typeAbbrev": "SAP",
"uploadDate": "2024-02-12T15:19"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Phase of the menstrual cycle"
}
]
},
"conditionsModule": {
"conditions": [
"Menstrual Cycle Phase",
"Muscle Protein Synthesis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Exeter",
"contacts": [
{
"email": null,
"name": "Marianna Apicella",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "University of Exeter",
"geoPoint": {
"lat": 50.7236,
"lon": -3.52751
},
"state": "Devon",
"status": "RECRUITING",
"zip": "EX1 2LT"
}
]
},
"descriptionModule": {
"briefSummary": "The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Randomised cross-over design.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis",
"nctId": "NCT06268678",
"orgStudyIdInfo": {
"id": "4539513",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Muscle protein synthesis"
}
],
"secondaryOutcomes": [
{
"measure": "Plasma amino acid kinetics"
},
{
"measure": "Serum insulin concentrations"
},
{
"measure": "Sex hormone concentrations"
},
{
"measure": "Energy expenditure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Pvolve"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Exeter"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tart Cherry Juice"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Breast Cancer Stage I",
"Breast Cancer Stage II",
"Breast Cancer Stage III",
"Breast Cancer Stage IV",
"Invasive Breast Cancer",
"Ovarian Cancer",
"Ovarian Cancer Stage 1",
"Ovarian Cancer Stage II",
"Ovarian Cancer Stage III",
"Ovarian Cancer Stage IV",
"Ovarian Cancer Stage IA",
"Ovarian Cancer Stage IB",
"Ovarian Cancer Stage IC",
"Ovarian Cancer Stage 2",
"Ovarian Cancer Stage 3",
"Ovarian Cancer Stage IIIb",
"Ovarian Cancer Stage IIIC",
"Breast Cancer Stage IIIA",
"Breast Cancer Invasive",
"Breast Cancer, Stage IA",
"Breast Cancer, Stage IB",
"Breast Cancer Stage IIA",
"Breast Cancer Stage IIB",
"Breast Cancer Stage IIIB",
"Breast Cancer Stage IIIc",
"Cancer, Breast",
"Tumors, Breast",
"Mammary Cancer",
"Mammary Carcinoma",
"Breast Carcinoma",
"Breast Neoplasm",
"Malignant Breast Neoplasm",
"Malignant Tumor of Breast",
"Cancer of Ovary",
"Ovary Cancer",
"Ovary Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sacramento",
"contacts": [
{
"email": "[email protected]",
"name": "Eve Rodler, MD",
"phone": "916-734-5409",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Eve Rodler, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of California Davis Comprehensive Cancer Center",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
},
"state": "California",
"status": null,
"zip": "95827"
}
]
},
"descriptionModule": {
"briefSummary": "This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 86,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy",
"nctId": "NCT06268665",
"orgStudyIdInfo": {
"id": "UCDCC307",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy."
}
],
"secondaryOutcomes": [
{
"measure": "Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy."
},
{
"measure": "Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy."
},
{
"measure": "Tolerability of daily intake of high-dose and low-dose tart cherry juice."
},
{
"measure": "Safety profile of daily intake of high-dose and low-dose tart cherry juice."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Eve Rodler"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Organoid-guided personalized treatment"
},
{
"name": "Gemcitabine"
},
{
"name": "Capecitabine"
},
{
"name": "Vinorelbine"
},
{
"name": "Eribulin"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Refractory Breast Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Yanxia Shi",
"phone": "020-87343368",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Yanxia Shi",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "None Selected",
"status": "RECRUITING",
"zip": "510060"
}
]
},
"descriptionModule": {
"briefSummary": "This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 302,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer",
"nctId": "NCT06268652",
"orgStudyIdInfo": {
"id": "B2023-686-01",
"link": null,
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"measure": "Disease Control Rate (DCR)"
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"measure": "Incidence of Treatment-related Adverse Events"
}
]
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]
},
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},
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},
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{
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{
"measure": "Persistence of Mutations and Microbiome Alterations in Participants With Endometrial Hyperplasia."
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},
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"measure": "Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1"
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{
"measure": "Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6"
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"measure": "Disease-free Survival"
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} | false | null |
{
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} | false | null |
{
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},
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],
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"measure": "Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group"
},
{
"measure": "Measure the impact of the protocol on the occurrence of nausea and vomiting on day one"
},
{
"measure": "Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction"
}
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},
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"studyFirstPostDateStruct": {
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} | false | null |
{
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"state": "Mazowieckie Województwo",
"status": "RECRUITING",
"zip": "02-172"
},
{
"city": "Toruń",
"contacts": [
{
"email": "[email protected]",
"name": "Dominik Chraniuk",
"phone": "+48 56 300 43",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dominik Chraniuk, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Poland",
"facility": "MICS Centrum Medyczne Toruń",
"geoPoint": {
"lat": 53.01375,
"lon": 18.59814
},
"state": null,
"status": "RECRUITING",
"zip": "87-100"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Single Group Assignment",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 94,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RIVER-52",
"briefTitle": "Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML",
"nctId": "NCT06268574",
"orgStudyIdInfo": {
"id": "RIVER-52",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Complete Remission (CR), with and without measurable residual disease (MRD)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall response rate"
},
{
"measure": "Duration of response"
},
{
"measure": "Progression-free survival"
},
{
"measure": "Overall survival"
},
{
"measure": "Incidence of Adverse Events (Safety and Tolerability)"
},
{
"measure": "Percentage of participants bridged to hematopoietic stem cell transplantation"
},
{
"measure": "Maximum Plasma Concentration (Cmax)"
},
{
"measure": "Maximum Plasma Concentration (Tmax)"
},
{
"measure": "Area Under the Concentration Time-Curve (AUC)"
},
{
"measure": "Impact of treatment on hematological malignancy patient-reported outcomes (HM-PRO)"
},
{
"measure": "Impact of treatment on health-related quality of life (QOL-E)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Ryvu Therapeutics SA"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Visual acuity analysis"
},
{
"name": "Intraocular pressure analysis"
},
{
"name": "Analysis of optical coherence tomography (OCT) images"
},
{
"name": "Analysis of retinograms"
}
]
},
"conditionsModule": {
"conditions": [
"Endophthalmitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint-Étienne",
"contacts": [
{
"email": "[email protected]",
"name": "Thibaud GARCIN, MD PhD",
"phone": "(0)477829662",
"phoneExt": "+33",
"role": "CONTACT"
},
{
"email": null,
"name": "Thibaud GARCIN, MD PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Henri PITEAU, resident",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU Saint Etienne",
"geoPoint": {
"lat": 45.43389,
"lon": 4.39
},
"state": null,
"status": "RECRUITING",
"zip": "42000"
}
]
},
"descriptionModule": {
"briefSummary": "OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 8,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months",
"nctId": "NCT06268561",
"orgStudyIdInfo": {
"id": "IRBN852023/CHUSTE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual acuity"
}
],
"secondaryOutcomes": [
{
"measure": "IOP measured in mmHg by tonometer and confirmed with Goldman Applanation"
},
{
"measure": "Tomography"
},
{
"measure": "Resumption of intravitreal therapy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Saint Etienne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Manual diaphragmatic activation"
}
]
},
"conditionsModule": {
"conditions": [
"Diaphragm Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": [
{
"email": "[email protected]",
"name": "Nesreen Ghareb Mohamed, Professor",
"phone": "01002227242",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of physical therapy",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": "RECRUITING",
"zip": "12613"
}
]
},
"descriptionModule": {
"briefSummary": "This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease"
},
"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": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease",
"nctId": "NCT06268548",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004790",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diaphragm Excursion"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cancer therapy with FDA and/or EMA approval on the 31st March 2022"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure",
"Cancer, Therapy-Related"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Caen",
"contacts": null,
"country": "France",
"facility": "Caen University Hospital",
"geoPoint": {
"lat": 49.18585,
"lon": -0.35912
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 3406383,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis",
"nctId": "NCT06268535",
"orgStudyIdInfo": {
"id": "CaenUH_DL_1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies"
}
],
"secondaryOutcomes": [
{
"measure": "Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies"
},
{
"measure": "Description of the pathologies (cancer) for which the incriminated drugs have been prescribed"
},
{
"measure": "Description of the drug-drug interactions associated with adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Caen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mindfulness-Oriented Recovery Enhancement: (MORE) group"
},
{
"name": "Psychoeducation"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chestnut Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Marie Curiel",
"phone": "617-732-9578",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Asimina Lazaridou, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Robert Edwards, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Brigham and Women's Hospital",
"geoPoint": {
"lat": 42.33065,
"lon": -71.16616
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02467"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Behavioral",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)",
"nctId": "NCT06268522",
"orgStudyIdInfo": {
"id": "2023P001582",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Interference"
},
{
"measure": "Opioid Dose"
}
],
"secondaryOutcomes": [
{
"measure": "Pain Intensity"
},
{
"measure": "Opioid Misuse"
},
{
"measure": "Opioid Withdrawal"
},
{
"measure": "Opioid Craving"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Brigham and Women's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nutritional panel laboratory examination"
},
{
"name": "Pregnancy supplements (other than provided by Ministry of Health)"
},
{
"name": "Fetomaternal ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Pregnancy Complications",
"Maternal Death",
"Preeclampsia",
"Intrauterine Infection",
"Pregnancy Hemorrhage",
"Preterm Birth",
"Neonatal Death",
"Low; Birthweight, Extremely (999 Grams or Less)",
"Asphyxia Neonatorum",
"IUGR"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta",
"contacts": [
{
"email": "[email protected]",
"name": "Risal, M.D., M.Sc.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office",
"geoPoint": {
"lat": -6.21462,
"lon": 106.84513
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?Participants in the intervention group will receive:* Fetomaternal ultrasound examination each trimester* Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination* Supplements: multivitamin, minerals, vitamin D, fatty acid* Intervention regarding any abnormal results of nutritional panel* All standard maternal health services according to Indonesian Ministry of Health protocolParticipants in the control group will receive:- All standard maternal health services according to Indonesian Ministry of Health protocol"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 245,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MONAS",
"briefTitle": "Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta",
"nctId": "NCT06268509",
"orgStudyIdInfo": {
"id": "MONAS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Composite of poor maternal outcomes"
},
{
"measure": "Composite of poor neonatal outcomes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Dinas Kesehatan DKI Jakarta"
},
{
"name": "Fakultas Kedokteran Universitas Indonesia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Dr Cipto Mangunkusumo General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "serum formula 2039125 03"
}
]
},
"conditionsModule": {
"conditions": [
"Hyperpigmentation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Osasco",
"contacts": null,
"country": "Brazil",
"facility": "Medcin Instituto da Pele Ltda",
"geoPoint": {
"lat": -23.5325,
"lon": -46.79167
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins",
"nctId": "NCT06268496",
"orgStudyIdInfo": {
"id": "LRP23021-A serum",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)"
},
{
"measure": "modified Melasma Area and Severity Index (mMASI) for patients with melasma"
},
{
"measure": "Post-Acne Hyperpigmentation Index (PAHPI)"
},
{
"measure": "solar lentigo pigmentation scale"
}
],
"secondaryOutcomes": [
{
"measure": "colorimetry measurements"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Cosmetique Active International"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg + cranberry, D-mannose, propolis extract, tumeric and Boswellia"
},
{
"name": "cranberry, D-mannose, propolis extract, tumeric and Boswellia"
}
]
},
"conditionsModule": {
"conditions": [
"Urinary Tract Infections, Recurrent"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": "MI",
"status": null,
"zip": "20122"
}
]
},
"descriptionModule": {
"briefSummary": "Uncomplicated urinary tract infections (UTI) are one of the most common bacterial infections globally, causing a significant proportion of medical consultations in primary and outpatient settings. Recurrent UTI (rUTI) have a detrimental impact on the patient's quality of life, causing a negative effect on women's social relationships, self-esteem, as well as irritability and tiredness. Moreover, several real-life studies have shown that reproductive-aged women with rUTI more frequently experience sexual dysfunction as compared to controls without infections. The glycosaminoglycan layer of the bladder urothelium, mainly composed by chondroitin sulfate (CS) and hyaluronic acid (HA), provides a protective barrier against the penetration of bacteria. A deficiency of this layer facilitates bacterial adherence, leading to recurrent infection. Treatment to restore this layer with intravesical instillation of HA has been proven to reduce the incidence of rUTI episodes. Furthermore, intravesical instillation with HA has been associates with sexual function improvement in women with rUTI and painful bladder . Therefore, in conditions where the glycosaminoglycan layer of the bladder is impaired, such as rUTIs, treatment with HA to restore it appears to have a beneficial effect on urinary and sexual symptoms.Recently, a randomized control trial has demonstrated that an oral formulation of HA, CS, quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer. However, there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI. Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on women's quality of life, sexual and urinary symptoms, the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance.Therefore we will conduct this randomized, cross-over trial to evaluate the efficacy of an oral preparation of HA, CS, N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI.Methods:Pre-menopausal, sexually active women referred to our center for symptomatic rUTIs. At the time of enrollment, participants were randomized with a 1:1 allocation ratio by means of a computer-generated random list in two groups: intervention (I) and control (C) (Figure 1).Inclusion and exclusion criteria We included sexually active, reproductive-aged women with symptomatic rUTIs. Exclusion criteria: younger than 18, if they had used combined hormonal contraception during the previous 6 months; pregnant, breastfeeding or trying to conceive, if they had symptoms of upper UTI, a history of urinary tract anomalies/vesicoureteral reflux, stress urinary incontinence, interstitial cystitis, diabetes, urinary tract stones, neurologic conditions, clinical depression or depressive symptoms.All women will be assessed with a thorough medical and sexual history. To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index (FSFI) questionnaire at baseline and at each follow up assessment.Treatment Protocol Group I: an oral preparation (capsule) of HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.Group C: an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.After three months of treatment (follow up 1) all women were evaluated with medical and sexual history. Participants also completed the FSFI and IPSS questionnaires. At this point the treatment was reversed (crossover scheme) for additional three months.At 6 months follow up (follow up 2) participants were again investigated with medical and sexual history and the IPSS and FSFI were completed. Figure 2 report the complete study design. Monthly phone calls were performed to check for adherence to treatment.Statistics: The sample size consisted of 25 participants in each group, calculated by using the two-sample t-test analysis. Baseline clinical and psychometric scores will be compared between I and C groups. Second, potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups. Potential predictors of FSFI improvement will be evaluated."
},
"designModule": {
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"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
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},
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"type": "ACTUAL"
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"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "JalUrol",
"briefTitle": "Effect of Hyaluronic Acid Oral Supplementation on Sexual and Urinary Symptoms of Women With Recurrent Urinary Tract Infections",
"nctId": "NCT06268483",
"orgStudyIdInfo": {
"id": "JalUrol",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico",
"id": "Policlinico",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Improvement in sexual symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Improvement in urinary symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-03-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-03-28"
},
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"startDateStruct": {
"date": "2022-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Desloratadine plus cilostazol and dipyridamole"
},
{
"name": "Desloratadine"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Urticaria"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bangkok",
"contacts": null,
"country": "Thailand",
"facility": "Faculty of Medicine, Chulalongkorn University",
"geoPoint": {
"lat": 13.75398,
"lon": 100.50144
},
"state": null,
"status": null,
"zip": "10330"
}
]
},
"descriptionModule": {
"briefSummary": "This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone.",
"maskingInfo": {
"masking": "TRIPLE",
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},
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"type": "ESTIMATED"
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"PHASE2"
],
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},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Antiplatelet Therapy in Chronic Urticaria",
"nctId": "NCT06268470",
"orgStudyIdInfo": {
"id": "Chula-ARC 001/18",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Weekly urticaria activity score"
}
],
"secondaryOutcomes": [
{
"measure": "D-dimer levels"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Chulalongkorn University"
}
},
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"completionDateStruct": {
"date": "2024-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2024-03-01"
},
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"startDateStruct": {
"date": "2018-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Chemoembolization with Doxorubicin"
}
]
},
"conditionsModule": {
"conditions": [
"Desmoid"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Giancarlo Facchini, MD",
"phone": "+39 333 650 0944",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Ortopedico Rizzoli",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": "Emilia Romagna",
"status": "RECRUITING",
"zip": "40136"
}
]
},
"descriptionModule": {
"briefSummary": "Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Embodesmo",
"briefTitle": "Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis",
"nctId": "NCT06268457",
"orgStudyIdInfo": {
"id": "CE-AVEC 789/2023/Oss/IOR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Volume reduction in cm"
},
{
"measure": "Reduction of pain (VAS score)"
},
{
"measure": "Reduction of antalgic therapy (mg)"
}
],
"secondaryOutcomes": [
{
"measure": "Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)"
},
{
"measure": "Improvement in quality of life (EORTC QLQ - BM22)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Ortopedico Rizzoli"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-01"
},
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"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "7-day actimetry sleep recording"
},
{
"name": "Determination of environmental pollutants in breast milk"
},
{
"name": "Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child"
},
{
"name": "Continuous recording of the child's temperature for 7 days"
},
{
"name": "Use of a sleep diary for 7 days"
},
{
"name": "Parental questionnaire of environmental exposure"
}
]
},
"conditionsModule": {
"conditions": [
"Newborn",
"Chemical Pollutants Exposure",
"Sleep"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amiens",
"contacts": [
{
"email": "[email protected]",
"name": "Karen CHARDON, Pr",
"phone": "03.22.82.78. 65",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Elodie HARAUX, HARAUX",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Pierre TOURNEUX, Pr",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHRU Amiens",
"geoPoint": {
"lat": 49.9,
"lon": 2.3
},
"state": null,
"status": "RECRUITING",
"zip": "80054"
}
]
},
"descriptionModule": {
"briefSummary": "During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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},
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},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "6 Months",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "SOLANGE",
"briefTitle": "Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants",
"nctId": "NCT06268444",
"orgStudyIdInfo": {
"id": "PI2023_843_0077",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "total sleep time per day in infants using actimetry"
}
],
"secondaryOutcomes": [
{
"measure": "Concentration of various substances in breast milk"
},
{
"measure": "concentration of chemical polluants on newborn bracelets"
},
{
"measure": "Child Temperature level (°C)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire, Amiens"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02"
},
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"date": "2024-02-20"
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"date": "2026-02"
},
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"startDateStruct": {
"date": "2024-02-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oxytocin rest"
}
]
},
"conditionsModule": {
"conditions": [
"Prolonged Labor",
"Failed Induction",
"Labor Dystocia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Newark",
"contacts": [
{
"email": "[email protected]",
"name": "Teresa C Logue",
"phone": "302-733-6563",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "ChristianaCare Health System",
"geoPoint": {
"lat": 39.68372,
"lon": -75.74966
},
"state": "Delaware",
"status": "RECRUITING",
"zip": "19718"
}
]
},
"descriptionModule": {
"briefSummary": "Prolonged labor is usually managed with continuous oxytocin infusion. \"Oxytocin rest\" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. \"Oxytocin rest\" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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},
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"primaryPurpose": "TREATMENT",
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},
"enrollmentInfo": {
"count": 350,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "ORCA",
"briefTitle": "Oxytocin Rest to Reduce Cesarean Delivery",
"nctId": "NCT06268431",
"orgStudyIdInfo": {
"id": "43084",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cesarean rate"
}
],
"secondaryOutcomes": [
{
"measure": "Time to delivery (hours)"
},
{
"measure": "Time to vaginal delivery (hours)"
},
{
"measure": "Time to active labor (hours)"
},
{
"measure": "Duration of active labor (hours)"
},
{
"measure": "Composite maternal adverse outcome"
},
{
"measure": "Composite neonatal adverse outcome"
},
{
"measure": "Labor Agentry Scale score"
},
{
"measure": "Rate of intraamniotic infection (IAI)"
},
{
"measure": "Rate of postpartum endometritis"
},
{
"measure": "Rate of postpartum hemorrhage"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Christiana Care Health Services"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-01-21",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 239099,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-02-11T17:37"
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]
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} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Artificial intelligence"
}
]
},
"conditionsModule": {
"conditions": [
"Radionucleide Therapy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Targeted Radionuclide Therapy (TRT) is a contemporary approach to radiation oncology, aiming to deliver the maximal destructive radiation dose via cancer-targeting radiopharmaceutical. Radioactive ligands for the prostate-specific membrane antigen (PSMA) have emerged for the treatment of metastatic castration-resistant prostate cancer (mCRPC).Normal organ and tumor dose can be assessed by a series of cross-sectional whole-body SPECT scans, however, these require a large amount imaging time and are often not feasible in routine clinical practice.An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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},
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"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PADL",
"briefTitle": "Pre-therapeutic 68Ga-PSMA PET AI Based Dose Prediction for 177Lu-PSMA Targeted Radionuclide Therapy",
"nctId": "NCT06268418",
"orgStudyIdInfo": {
"id": "2024PI020",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluate the prediction of the absorbed dose by Deep Learning approaches for RLT with 177Lu-PSMA, from pre-treatment 68Ga-PSMA.PET/CT images"
}
],
"secondaryOutcomes": [
{
"measure": "Automatically contour the total tumor metabolic volume on 68Ga-PSMA pretreatment PET images using Deep Learning approaches"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Central Hospital, Nancy, France"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
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"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Liquid Biopsy"
},
{
"name": "Positron Emission Mammography (PEM)"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Samira Taeb, MSc",
"phone": "416-946-4501",
"phoneExt": "5853",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Vivianne Freitas",
"phone": "416-946-2000",
"phoneExt": "5608",
"role": "CONTACT"
},
{
"email": null,
"name": "Vivianne Freitas, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "University Health Network",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "M5G 2M9"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this pilot research study is to compare two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to evaluate if findings from Liquid Biopsy can be matched to images obtained by PEM.Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses an injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.If correlations between paired samples are observed between imaging using PEM and the Liquid Biopsy data, further studies will be conducted to evaluate if these techniques can help refine screening investigations and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings",
"nctId": "NCT06268405",
"orgStudyIdInfo": {
"id": "22-5806",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Correlation of paired samples between Liquid Biopsy data and Positron Emission Mammography (PEM) images"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Health Network, Toronto"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-21"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Fetal Growth Retardation",
"Fetal Macrosomia",
"Fetal Growth"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound",
"nctId": "NCT06268392",
"orgStudyIdInfo": {
"id": "CT-2023-11-20-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fetal weight"
},
{
"measure": "Ultrasound fetal weight estimation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Slagelse Hospital"
},
{
"name": "Technical University of Denmark"
},
{
"name": "Rigshospitalet, Denmark"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Copenhagen Academy for Medical Education and Simulation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Colon Cancer",
"Model Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Melbourne",
"contacts": null,
"country": "Australia",
"facility": "Cabrini Health",
"geoPoint": {
"lat": -37.814,
"lon": 144.96332
},
"state": "Victoria",
"status": null,
"zip": "3144"
}
]
},
"descriptionModule": {
"briefSummary": "This project will examine the outstanding statistical techniques for predicting the survival of patients with colorectal cancer (CRC) (colorectal neoplasia database). The motivating clinical question that led to proposing this project is based on the general assumption that: \"Right-sided colorectal cancer (CRC) has worse survival than left-sided CRC.\" The question is, which aspects of the patient's characteristics are responsible for this difference? This led us to BMA model selection and provide a clinician-friendly online nomogram."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 2475,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "101 Years",
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC",
"nctId": "NCT06268379",
"orgStudyIdInfo": {
"id": "#08-01-03-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "OS"
},
{
"measure": "RFS"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cabrini Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2010-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Movement Disorders"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Musculoskeletal screening for physical risk factors requires equipment and a trained healthcare or fitness professional to perform and interpret the scoring so that appropriate exercise interventions can be prescribed. However, barriers such as healthcare costs and accessibility, low perceived need to seek medical care, and previous unfavorable evaluation of seeking medical care are associated with healthcare avoidant behaviors. This research aims to explore the effectiveness of the Symmio Self-Screen application to generate specific exercise interventions to address an individual's associated physical risk factors. The ability of the Symmio application to prescribe a targeted exercise program which can reduce asymmetries, improve movement quality, and enhance overall function is unknown. Therefore, the purpose of this study is to determine the effectiveness of the Symmio application in designing individualized exercise interventions which target the unique movement limitations and asymmetries in adults."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The primary investigators and statisticians will be blinded to the group allocation",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Exercise-Based Interventions on Symmio Self-Movement Screen",
"nctId": "NCT06268366",
"orgStudyIdInfo": {
"id": "UEvansville",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Symmio Self-Movement Screen"
}
],
"secondaryOutcomes": [
{
"measure": "Global Rating of Change"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Evansville"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "blood sampling"
}
]
},
"conditionsModule": {
"conditions": [
"Pregnancy Related"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Background and Purpose During pregnancy, the hormone GDF15 rises between 100-200 times higher than before pregnancy. The significance of this dramatic increase is not clarified, but it has been shown that pregnant women with insufficient increase in GDF15 have a higher risk of spontaneous abortion. CAPGDF15 is a small peptide consisting of 12 amino acids recently found in plasma in both mice and humans, and this peptide is part of the prohormone from which GDF15 is synthesized. Therefore, the assumption is that CAPGDF15 is secreted simultaneously with GDF15. The significance of CAPGDF15 in the organism is completely unknown, except that injection into mice reduces food intake. Therefore, the investigators are interested in investigating whether there is a similar dramatic upregulation of CAPGDF15 as with GDF15 itself. The investigators will not set up a large-scale study without having some prior knowledge of whether this is indeed the case. Therefore, the investigators will conduct a pilot study on 3 pregnant women and 3 control women to examine whether there is any reason to proceed with an actual scientific experiment. Since the increase in GDF15 itself is very large at least100 fold, a pilot study involving only 3 pregnant women and 3 non-pregnant women will be sufficient to gain an impression of whether there is also a significant increase in CAPGDF15. The data will be used to assess whether an actual research project is worth establishing.Purpose:The purpose of conducting this pilot study is to investigate whether there is an upregulation of CAPGDF15 similar to that of the hormone GDF15 during pregnancy. By conducting a pilot study on 3 pregnant women and 3 control women, the investigators will see if this is actually the case before setting up an actual scientific experiment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Non-pregnant controls and pregnant women",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "CAP",
"briefTitle": "Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study",
"nctId": "NCT06268353",
"orgStudyIdInfo": {
"id": "109324-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "CAPGDF15 levels in plasma"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Stanford University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Copenhagen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ECochG monitored CI surgery incl. corrective action guide"
},
{
"name": "Routine CI surgery without ECochG monitoring"
}
]
},
"conditionsModule": {
"conditions": [
"Hearing Loss, Sensorineural",
"Severe-to-profound Hearing Loss"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gent",
"contacts": [
{
"email": "[email protected]",
"name": "Lara Derycke, Ms",
"phone": "+3293321246",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ingeborg Dhooge, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Freya Swinnen, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Universitair Ziekenhuis Gent",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
"state": null,
"status": null,
"zip": "9000"
},
{
"city": "Tours",
"contacts": [
{
"email": "[email protected]",
"name": "Mme Nollet",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "David Bakhos, Prof",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mathieu Robier, Mr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Le Centre Hospitalier Régional Universitaire de Tours",
"geoPoint": {
"lat": 47.38333,
"lon": 0.68333
},
"state": null,
"status": null,
"zip": "37000"
},
{
"city": "Freiburg",
"contacts": [
{
"email": "[email protected]",
"name": "Claudia Greulich, Ms",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Antje Aschendorff, Prof",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Thomas Wesarg, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Universitätsklinikum Freiburg Klinik",
"geoPoint": {
"lat": 47.9959,
"lon": 7.85222
},
"state": null,
"status": null,
"zip": "79106"
},
{
"city": "Torino",
"contacts": [
{
"email": null,
"name": "Diego Di Lisi, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Patrizia Consolino, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale Martini",
"geoPoint": {
"lat": 45.07049,
"lon": 7.68682
},
"state": "TO",
"status": null,
"zip": "10141"
},
{
"city": "Warsaw",
"contacts": [
{
"email": "[email protected]",
"name": "Iwona Tomaszewska-Hert, Ms",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Piotr Skarżyński, Prof",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Adam Walkowiak, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Poland",
"facility": "World Hearing Center",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": "Nadarzyn",
"status": null,
"zip": "05-830"
},
{
"city": "Cambridge",
"contacts": [
{
"email": "[email protected]",
"name": "Sophie McKenny, Ms",
"phone": "+441223586625",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Matthew E Smith, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Patrick Axon, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Cambridge University Hospitals NHS Foundation Trust",
"geoPoint": {
"lat": 52.2,
"lon": 0.11667
},
"state": "England",
"status": null,
"zip": "CB2 0QQ"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 102,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PRESERVE",
"briefTitle": "Hearing and Structure Preservation Via ECochG",
"nctId": "NCT06268340",
"orgStudyIdInfo": {
"id": "ABIntl-23-25",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Surgeons' feedback"
}
],
"primaryOutcomes": [
{
"measure": "Hearing Preservation"
}
],
"secondaryOutcomes": [
{
"measure": "Structure Preservation"
},
{
"measure": "Speech perception"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Advanced Bionics AG"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cisplatin injection and gemcitabine"
},
{
"name": "Capecitabine tablets"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy",
"nctId": "NCT06268327",
"orgStudyIdInfo": {
"id": "Adjuvant treatment in BC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy"
}
],
"secondaryOutcomes": [
{
"measure": "Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Chronic Kidney Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
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},
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.",
"nctId": "NCT06268314",
"orgStudyIdInfo": {
"id": "hypoalbuminemia in pediatrics.",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Budesonide"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lincoln",
"contacts": null,
"country": "United States",
"facility": "Celerion",
"geoPoint": {
"lat": 40.8,
"lon": -96.66696
},
"state": "Nebraska",
"status": null,
"zip": "68502"
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
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"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults",
"nctId": "NCT06268301",
"orgStudyIdInfo": {
"id": "TAK-721-1003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum Observed Concentration (Cmax)"
},
{
"measure": "Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)"
},
{
"measure": "Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) by Severity, Serious Adverse Events (SAE) and Death"
},
{
"measure": "Number of Participants With Clinically Significant Abnormal Vital Sign Values"
},
{
"measure": "Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values"
},
{
"measure": "Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12)"
},
{
"measure": "Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%)"
},
{
"measure": "Time to First Occurrence of Cmax (tmax)"
},
{
"measure": "Lag Time to First Quantifiable Concentration (tlag)"
},
{
"measure": "Terminal Disposition Phase Half-life (t1/2z)"
},
{
"measure": "Terminal Disposition Phase Rate Constant (λz)."
},
{
"measure": "Apparent Clearance (CL/F) Calculated Using the Observed Value of the Last Quantifiable Concentration"
},
{
"measure": "Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) Calculated Using the Observed Value of the Last Quantifiable Concentration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Takeda"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-02-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-02-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GammaCore intervention"
},
{
"name": "STEPS management protocol"
}
]
},
"conditionsModule": {
"conditions": [
"Postural Tachycardia Syndrome",
"Autonomic Dysfunction",
"Postural Orthostatic Tachycardia Syndrome",
"POTS - Postural Orthostatic Tachycardia Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": null,
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": null,
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Half of the patient population will be randomized to standard management only. The other half of the population will be randomized to standard management plus use of the vagal nerve stimulator",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "19 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)",
"nctId": "NCT06268288",
"orgStudyIdInfo": {
"id": "22-011492",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The change in COMPASS-31 scores between individuals in both arms of the study"
},
{
"measure": "The change in Child Functional Disability Inventory scores between individuals in both arms of the study"
},
{
"measure": "The change in heart rate increase in head up tilt table tests in individuals in both arms of the study"
}
],
"secondaryOutcomes": [
{
"measure": "Does nVNS influence headache frequency in adolescent patients with POTS"
},
{
"measure": "Does nVNS influence ability to increase exercise duration in adolescent patients with POTS"
},
{
"measure": "Does use of nVNS influence degree of depression in adolescent patients with POTS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Scalp block"
},
{
"name": "Esmolol"
}
]
},
"conditionsModule": {
"conditions": [
"Hemodynamic Instability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Khon Kaen",
"contacts": null,
"country": "Thailand",
"facility": "Khon Kaen University",
"geoPoint": {
"lat": 16.44671,
"lon": 102.833
},
"state": "Naimuang, Muang",
"status": null,
"zip": "40002"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare hemodynamic response (MAP, SBP, DBP and HR) between scalp block and intravenous esmolol while skull pins application in patients undergoing elective supratentorial craniotomy under general anesthesia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "RCT",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy",
"nctId": "NCT06268275",
"orgStudyIdInfo": {
"id": "HE651314",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MAP"
},
{
"measure": "SBP"
},
{
"measure": "DBP"
},
{
"measure": "HR"
}
],
"secondaryOutcomes": [
{
"measure": "BIS"
},
{
"measure": "Cumulative postoperative opioids consumption"
},
{
"measure": "Postoperative adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Khon Kaen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Overweight and Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xuzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Kai Liu, M.D/Ph.D",
"phone": "+86-15920157720",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Affiliated Hospital of Xuzhou Medical University",
"geoPoint": {
"lat": 34.18045,
"lon": 117.15707
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "221000"
}
]
},
"descriptionModule": {
"briefSummary": "The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
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"observationalModel": "CASE_CONTROL",
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},
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Surgical-imaging Research on Obesity (SIRO)",
"nctId": "NCT06268262",
"orgStudyIdInfo": {
"id": "XYFY2023-KL045-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Imaging parameters of obesity"
},
{
"measure": "Imaging parameters of obesity"
},
{
"measure": "Imaging parameters of obesity"
}
],
"secondaryOutcomes": [
{
"measure": "Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample"
},
{
"measure": "Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample"
},
{
"measure": "Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample"
},
{
"measure": "Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Affiliated Hospital of Xuzhou Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ulinastatin"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": null,
"country": "China",
"facility": "Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430030"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a retrospective, observational study that aims to include patients undergoing cardiac surgery. 1. Evaluate the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over the past eight years. 2. Utilize the pre-existing preoperative and postoperative 24-hour plasma samples from previous studies to measure the levels of glycocalyx and its related regulatory factors. 3. Assess the clinical correlation between the measured parameters and patient outcomes."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 7065,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction",
"nctId": "NCT06268249",
"orgStudyIdInfo": {
"id": "TJ-IRB20231224",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "POCD - Postoperative Cognitive Dysfunction"
}
],
"secondaryOutcomes": [
{
"measure": "Survival time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Qin Zhang"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2015-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Electroacupuncture"
},
{
"name": "Sham electroacupuncture"
}
]
},
"conditionsModule": {
"conditions": [
"Disorder of Consciousness",
"Electroacupuncture"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Fang Yuan, PhD",
"phone": "+86-20-81887233",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Guangzhou University of Chinese Medicine",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "510120"
}
]
},
"descriptionModule": {
"briefSummary": "With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Electro-acupuncture to Treat Disorder of Consciousness",
"nctId": "NCT06268236",
"orgStudyIdInfo": {
"id": "BF2023-252",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Coma Recovery Scale - Revised score"
}
],
"secondaryOutcomes": [
{
"measure": "phase locking value"
},
{
"measure": "amplitude of low-frequency fluctuation"
},
{
"measure": "Amide proton transfer-weighted signal"
},
{
"measure": "f value"
},
{
"measure": "neurite density index"
},
{
"measure": "latency value of N20"
},
{
"measure": "latency between III and V potentials"
},
{
"measure": "Glasgow Outcome Scale-Extended score"
},
{
"measure": "Glasgow Outcome Scale-Extended score"
},
{
"measure": "brain-computer interface accuracy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Chewing Exercise Training"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy",
"Chewing Disease",
"Action Obervation Training"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Samsun",
"contacts": [
{
"email": "[email protected]",
"name": "Seda Nur Kemer, 1",
"phone": "+9005467861866",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer",
"geoPoint": {
"lat": 41.27976,
"lon": 36.3361
},
"state": "Atakum",
"status": "RECRUITING",
"zip": "55200"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to investigate the effects of home-based Action Observation Training (AOT) applied together with Functional Chewing Training (FuCT) on chewing and swallowing functions and feeding behavior in children with Cerebral Palsy (CP) who have chewing disorders. The main questions it aims to answer are:* Is the application of Home-Based AOT together with FuCT effective on chewing function in children with CP?* Is the application of Home-Based AOT together with FuCT effective on swallowing function in children with CP?* Is the application of Home-Based AOT together with FuCT effective on feeding behavior in children with CP? Within the scope of the study, children with CP will be divided into two groups as the study group and the control group. All groups will implement FuCT routines, comprising 5 sets per day, 5 days a week, for 12 weeks. Additionally, the study group will be included in an AOT program, conducted via telerehabilitation, for 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. All children with CP will be evaluated at the beginning, after 6 weeks, and at the end of the study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
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},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Home-Based Action Observation Training for Chewing and Swallowing Function",
"nctId": "NCT06268223",
"orgStudyIdInfo": {
"id": "2023/315",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Karaduman Chewing Performance Scale"
},
{
"measure": "Turkish version of the Mastication Observation and Evaluation Instrument"
},
{
"measure": "Test of Masticating and Swallowing Solids in Children"
},
{
"measure": "Nutrient consistency according toInternational Dysphagia Diet Standardisation Initiative"
},
{
"measure": "The Pediatric version of the Eating Assessment Tool"
},
{
"measure": "Dysphagia Disorder Survey"
},
{
"measure": "Behavioral Pediatrics Feeding Assessment Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hacettepe University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ondokuz Mayıs University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-01"
},
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"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
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"date": "2024-05-01"
},
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"startDateStruct": {
"date": "2023-10-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lazertinib+Pemetrexed+Carboplatin"
},
{
"name": "Lazertinib"
}
]
},
"conditionsModule": {
"conditions": [
"Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": [
{
"email": "[email protected]",
"name": "Hye Ryun Kim",
"phone": "82-2-2228-8125",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Korea, Republic of",
"facility": "Severance hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations."
},
"designModule": {
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},
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},
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},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NeoLazer",
"briefTitle": "Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer",
"nctId": "NCT06268210",
"orgStudyIdInfo": {
"id": "4-2023-1546",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary pathological response"
}
],
"secondaryOutcomes": [
{
"measure": "Surgical Resection Methods (Segmentectomy or Lobectomy)"
},
{
"measure": "Pathologic Complete Response"
},
{
"measure": "Objective Response Rate"
},
{
"measure": "Event-Free Survival"
},
{
"measure": "Disease-Free Survival"
},
{
"measure": "Overall Survival"
},
{
"measure": "Number of patients with Adverse events according to CTCAE v5.0"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Yonsei University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Yoga Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Urbana",
"contacts": [
{
"email": "[email protected]",
"name": "Project Coordinator",
"phone": "217-265-0741",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Neha P Gothe, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Steven Petruzzello, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Illinois Urbana-Champaign",
"geoPoint": {
"lat": 40.11059,
"lon": -88.20727
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "61801"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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},
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},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Interoception-Based Yoga for Chronic Pain",
"nctId": "NCT06268197",
"orgStudyIdInfo": {
"id": "IRB23-0329",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Interoceptive Accuracy"
},
{
"measure": "Mindfulness"
},
{
"measure": "PROMIS Pain Intensity"
},
{
"measure": "Quality of Life"
},
{
"measure": "Spiritual Wellbeing"
},
{
"measure": "Pain Impact"
}
],
"primaryOutcomes": [
{
"measure": "Feasibility"
},
{
"measure": "Acceptability"
}
],
"secondaryOutcomes": [
{
"measure": "Interoceptive Sensibility"
},
{
"measure": "PROMIS Pain Interference"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Illinois at Urbana-Champaign"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "D3 LAB SYRUP"
},
{
"name": "placebo capsule"
}
]
},
"conditionsModule": {
"conditions": [
"Oxidative Stress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tanta",
"contacts": [
{
"email": "[email protected]",
"name": "Noha sayed ahmed, M.Sc",
"phone": "01016919217",
"phoneExt": "01097722167",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "rasha gamal elshafaay, MD",
"phone": "01227405988",
"phoneExt": "01114277784",
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of Medicine",
"geoPoint": {
"lat": 30.78847,
"lon": 31.00192
},
"state": "Gharbia",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo",
"maskingInfo": {
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"maximumAge": "18 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis",
"nctId": "NCT06268184",
"orgStudyIdInfo": {
"id": "omega3 in oxidative stress",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "decrease oxidative stress"
},
{
"measure": "increase antioxidant activity"
},
{
"measure": "improvement of nutritional status assessed by anthropometric measurements."
},
{
"measure": "mid upper arm circumference in centimeters"
},
{
"measure": "triceps skin fold thickness in millimeter's"
},
{
"measure": "improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)"
},
{
"measure": "improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)"
},
{
"measure": "improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)"
},
{
"measure": "improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)"
},
{
"measure": "improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA)"
},
{
"measure": "improvement of nutritional status assessed by laboratory investigations."
},
{
"measure": "s. ionized calcium level"
},
{
"measure": "s.phosphorus level"
},
{
"measure": "alkaline phosphatase level"
},
{
"measure": "parathormone hormone level"
},
{
"measure": "25(oh)vitamin D level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tanta University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
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"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-10-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ultrasound measurement of the cross-sectional area of the rectus femoris"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Transplant",
"Physiotherapy",
"Sarcopenia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality.After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU.Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity.In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies."
},
"designModule": {
"designInfo": {
"allocation": null,
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"observationalModel": "COHORT",
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"timePerspective": "PROSPECTIVE"
},
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EchoSS-TP",
"briefTitle": "Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation",
"nctId": "NCT06268171",
"orgStudyIdInfo": {
"id": "2023_0214",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM",
"id": "2023-A02390-45",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation"
}
],
"secondaryOutcomes": [
{
"measure": "Measure change in CSA-RF at D7 according to LT pattern"
},
{
"measure": "Evaluate the relationship between length of stay in intensive care unit and variation in CSA-RF at D7"
},
{
"measure": "Determine the relationship between CSA-RF at D-1 and Body Mass Index"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hopital Foch"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Eye patch"
}
]
},
"conditionsModule": {
"conditions": [
"Abdominal Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kayseri",
"contacts": [
{
"email": "[email protected]",
"name": "Yeliz Sürme, PhD",
"phone": "+0905532051130",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Tuğçe TOPAL",
"phone": "+9005075698312",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Tuğçe TOPAL, Msn",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Yeliz SÜRME, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Erciyes University",
"geoPoint": {
"lat": 38.73222,
"lon": 35.48528
},
"state": "Talas",
"status": "RECRUITING",
"zip": "38080"
}
]
},
"descriptionModule": {
"briefSummary": "After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study will be conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, will be used."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit",
"nctId": "NCT06268158",
"orgStudyIdInfo": {
"id": "2023/45",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Richard-Campbell Sleep Scale"
},
{
"measure": "Nursing Delirium Screening Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Richmond Agitation-Sedation Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "TC Erciyes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ECC5004"
}
]
},
"conditionsModule": {
"conditions": [
"Type 2 Diabetes Mellitus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Anaheim",
"contacts": [
{
"email": null,
"name": "Eccogene",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Eccogene Investigational Site",
"geoPoint": {
"lat": 33.83529,
"lon": -117.9145
},
"state": "California",
"status": "RECRUITING",
"zip": "92801"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 14,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ECC5004 RBA FE Study in Healthy Participants",
"nctId": "NCT06268145",
"orgStudyIdInfo": {
"id": "EC0006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ECC5004 PK parameters: AUC0-tlast"
},
{
"measure": "ECC5004 PK parameters: AUC0-inf"
},
{
"measure": "ECC5004 PK parameters: Cmax"
},
{
"measure": "ECC5004 PK parameters: tmax"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations"
},
{
"measure": "ECC5004 PK parameters: AUC0-tau"
},
{
"measure": "ECC5004 PK parameters: AUC 0-24"
},
{
"measure": "ECC5004 PK parameters: tlag"
},
{
"measure": "ECC5004 PK parameters: t1/2"
},
{
"measure": "ECC5004 PK parameters: CL/F"
},
{
"measure": "ECC5004 PK parameters: AUC(extr)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Eccogene"
}
},
"statusModule": {
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"date": "2024-03-30"
},
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"date": "2024-02-20"
},
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"date": "2024-03-30"
},
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"startDateStruct": {
"date": "2024-02-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"LONGEVITY 1",
"Frailty",
"Aging",
"Age-related Cognitive Decline",
"Aging Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Moscow",
"contacts": [
{
"email": "[email protected]",
"name": "Irina D. Strazhesko, M.D., Ph.D",
"phone": "+7 (499) 187-64-67",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation",
"geoPoint": {
"lat": 55.75222,
"lon": 37.61556
},
"state": null,
"status": "RECRUITING",
"zip": "129226"
}
]
},
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"briefSummary": "This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity.The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration."
},
"designModule": {
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},
"enrollmentInfo": {
"count": 4000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "90 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Longevity in Russia",
"nctId": "NCT06268132",
"orgStudyIdInfo": {
"id": "MLS90",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mortality among long-living adults"
},
{
"measure": "Morbidity among long-living adults"
}
],
"secondaryOutcomes": [
{
"measure": "Aging phenotypes"
},
{
"measure": "Social, economic, and medical- history-related determinants"
},
{
"measure": "Genetic determinants"
},
{
"measure": "Epigenetic determinants"
},
{
"measure": "Metagenomic determinants"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Pirogov Russian National Research Medical University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Center for Strategic Planning, of the Federal Medical and Biological Agency"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-12-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium."
}
]
},
"conditionsModule": {
"conditions": [
"Delirium, Postoperative"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Antalya",
"contacts": null,
"country": "Turkey",
"facility": "Antalya Training and Research Hospital",
"geoPoint": {
"lat": 36.90812,
"lon": 30.69556
},
"state": "Center",
"status": null,
"zip": "07000"
}
]
},
"descriptionModule": {
"briefSummary": "This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Delirium Care Protocol After Cardiac Surgery",
"nctId": "NCT06268119",
"orgStudyIdInfo": {
"id": "MustafaKU-SBF-GKS-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU)"
}
],
"secondaryOutcomes": [
{
"measure": "Glasgow Coma Scale (GCS)"
},
{
"measure": "Richmond Agitation-Sedation Scale (RASS)"
},
{
"measure": "Information Assessment Form for Postoperative Delirium (Pretest-Posttest)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Gonul Kara Soylemez"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-05-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Graphic novel visualization"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety",
"Pancreatic Cancer",
"Pancreatic Cystic Lesions",
"Stress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palermo",
"contacts": [
{
"email": "[email protected]",
"name": "Giacomo Emanuele Maria Rizzo, MD",
"phone": null,
"phoneExt": "+393406602502",
"role": "CONTACT"
},
{
"email": null,
"name": "Ilaria Tarantino, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Giacomo Emanuele Maria Rizzo, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mario Traina, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Irccs - Ismett",
"geoPoint": {
"lat": 38.13205,
"lon": 13.33561
},
"state": "PA",
"status": null,
"zip": "90127"
}
]
},
"descriptionModule": {
"briefSummary": "Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety.This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels.Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels.This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Graphic novel will be visualized by interventional group before EUS-FNB",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Graphic Novel for Patients Undergoing EUS-FNB",
"nctId": "NCT06268106",
"orgStudyIdInfo": {
"id": "IRB N/A",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Anxiety and stress level according to BAI"
},
{
"measure": "Anxiety and stress level according to mASS-14"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Mediterranean Institute for Transplantation and Advanced Specialized Therapies"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Thalidomide"
}
]
},
"conditionsModule": {
"conditions": [
"Syringomyelia",
"Thalidomide"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "fengzeng jian, md",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fengzeng Jian",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing City",
"status": "RECRUITING",
"zip": "100032"
}
]
},
"descriptionModule": {
"briefSummary": "Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia.Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Therapeutic Effect of Thalidomide in Syringomyelia",
"nctId": "NCT06268093",
"orgStudyIdInfo": {
"id": "XWTETS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ASIA Score"
}
],
"secondaryOutcomes": [
{
"measure": "syringomyelia remission"
},
{
"measure": "The evoked electromyographic signal (eEMG) potential"
},
{
"measure": "Visual Analog Scale (VAS)"
},
{
"measure": "Klekamp and Sammi syringomyelia scale"
},
{
"measure": "modified Japanese Orthopaedic Association Scores (mJOA)"
},
{
"measure": "xuanwu syringomyelia scale"
},
{
"measure": "Incidence of complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xuanwu Hospital, Beijing"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Depth of anesthesia titration using pEEG"
}
]
},
"conditionsModule": {
"conditions": [
"Delirium, Postoperative",
"Anesthesia",
"Surgery-Complications",
"Cognition Disorder",
"Delirium",
"Cognitive Decline"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery.Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time.Older adults (aged ≥65 years, or Indigenous, Pasific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured.If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Multicentre, prospective, randomized, active control, parallel group, intention to treat, safety and efficacy study.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Blinding of procedural anesthesiologist is not possible. Patients, surgeons, and all outcome assessors will be blinded. One unblinded research coordinator at each site will collect pEEG related data points. Other research coordinators will be blinded as to treatment allocation and will collect data relating to primary and secondary outcomes. Clinicians carrying out participant usual care will be able to unblind study allocation if necessary by viewing the patients anesthesia record via password protected, accessing clinician identity logged, Electronic Health Record (EHR). This record will be unavailable for access by other means.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 2766,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Balanced-2",
"briefTitle": "Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery",
"nctId": "NCT06268080",
"orgStudyIdInfo": {
"id": "A+9317",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Incidence of awareness"
},
{
"measure": "Adverse and serious adverse events"
}
],
"primaryOutcomes": [
{
"measure": "Incidence of postoperative delirium (POD)"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of severe delirium"
},
{
"measure": "Incidence of new mild and major postoperative neurocognitive disorders"
},
{
"measure": "Postoperative cognitive decline"
},
{
"measure": "Functional decline"
},
{
"measure": "All-cause mortality"
},
{
"measure": "Duration of delirium"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Auckland City Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PET/CT"
}
]
},
"conditionsModule": {
"conditions": [
"Renal Uptake at F-18-FDG PET/CT"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 97,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status",
"nctId": "NCT06268067",
"orgStudyIdInfo": {
"id": "Renal uptake at F18 FDG PET/CT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "significance of renal uptake at F18-FDG PET CT studies"
}
],
"secondaryOutcomes": [
{
"measure": "Early detection of patients with CKD"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DEH113"
},
{
"name": "Placebo Comparator"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Dysmenorrhea"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "16 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "LIBERTÀ",
"briefTitle": "Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea",
"nctId": "NCT06268054",
"orgStudyIdInfo": {
"id": "DEH113-III-0123",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose"
}
],
"secondaryOutcomes": [
{
"measure": "Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose"
},
{
"measure": "Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose."
},
{
"measure": "Use of rescue medication"
},
{
"measure": "Number of additional drug intake"
},
{
"measure": "Patients' Global Impression of Change (PGIC)"
},
{
"measure": "Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "EMS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Moderate-Intensity Aerobic Training"
},
{
"name": "High-Intensity Interval Training"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Newark",
"contacts": [
{
"email": "[email protected]",
"name": "Jane Diehl",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Darcy Reisman, PT, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Delaware",
"geoPoint": {
"lat": 39.68372,
"lon": -75.74966
},
"state": "Delaware",
"status": "RECRUITING",
"zip": "19713"
},
{
"city": "Kansas City",
"contacts": [
{
"email": "[email protected]",
"name": "Sasha Moores",
"phone": "913-588-2697",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sandra Billinger, PT, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Kansas Medical Center",
"geoPoint": {
"lat": 39.11417,
"lon": -94.62746
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "66160"
}
]
},
"descriptionModule": {
"briefSummary": "People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 156,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HST2",
"briefTitle": "HIT-Stroke Trial 2",
"nctId": "NCT06268041",
"orgStudyIdInfo": {
"id": "427659",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01HD093694",
"link": "https://reporter.nih.gov/quickSearch/R01HD093694",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6-Minute Walk Test Distance"
}
],
"secondaryOutcomes": [
{
"measure": "6-Minute Walk Test Distance"
},
{
"measure": "Self-Selected Gait Speed"
},
{
"measure": "Fastest Gait Speed"
},
{
"measure": "PROMIS-Fatigue Scale version 8a"
},
{
"measure": "Aerobic Capacity"
},
{
"measure": "EuroQol-5D-5L"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)"
},
{
"name": "University of Kansas Medical Center"
},
{
"name": "University of Delaware"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Cincinnati"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Training"
}
]
},
"conditionsModule": {
"conditions": [
"Education"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aydın",
"contacts": null,
"country": "Turkey",
"facility": "Aydın Maternity and Child Health Hospital",
"geoPoint": {
"lat": 37.84501,
"lon": 27.83963
},
"state": null,
"status": null,
"zip": "09010"
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.The research is a pre-test-post-test, randomized controlled experimental study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery",
"nctId": "NCT06268028",
"orgStudyIdInfo": {
"id": "BELMA TA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "A pre-test will be applied to 70 women who constitute the sample of the research."
}
],
"secondaryOutcomes": [
{
"measure": "Apost-test will be applied to 70 women who constitute the sample of the research."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Aydin Adnan Menderes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-06-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Botensilimab"
},
{
"name": "Balstilimab"
},
{
"name": "Oxaliplatin"
},
{
"name": "Leucovorin"
},
{
"name": "Fluorouracil"
},
{
"name": "Bevacizumab"
},
{
"name": "Panitumumab"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Durham",
"contacts": [
{
"email": null,
"name": "Nicholas C. DeVito, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Duke University",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": null,
"zip": "27710"
}
]
},
"descriptionModule": {
"briefSummary": "This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years."
},
"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": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BBOpCo",
"briefTitle": "Botensilimab and Balstilimab Optimization in Colorectal Cancer",
"nctId": "NCT06268015",
"orgStudyIdInfo": {
"id": "Pro00115311",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease control rate based on iRECIST at second restaging scan"
},
{
"measure": "Proportion of subjects with a best overall response of complete response or partial response according to iRECIST"
}
],
"secondaryOutcomes": [
{
"measure": "Disease control rate based on RECIST v1.1 at second restaging scan"
},
{
"measure": "Proportion of subjects with a best overall response of complete response or partial response according to RECIST v1.1"
},
{
"measure": "Months of overall survival"
},
{
"measure": "Months of progression-free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Gateway for Cancer Research"
},
{
"name": "Agenus Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Nicholas DeVito, MD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vernonia cinerea"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Smoking Cessation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bangkok",
"contacts": null,
"country": "Thailand",
"facility": "Krittin Bunditanukul",
"geoPoint": {
"lat": 13.75398,
"lon": 100.50144
},
"state": null,
"status": null,
"zip": "10600"
}
]
},
"descriptionModule": {
"briefSummary": "Vernonia cinerea is an herbal which has been recorded in many Thai herbal formulation and Thai traditional medicine has used this herbal for treating various diseases included hypertension, asthma, fever, hepatitis, kidney stone and smoking cessation. Now aday there are more interest for using Vernonia cinerea as a medication to aid smoker to quit smoking because it is cheaper than other current therapeutic medications. The objective of this study is to evaluate efficacy and safety of Vernonia cinerea lozenge for smoking cessation when compared to placebo."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study was a multicenter randomized, paralleled, double-blind, controlled trial at 5 hospitals and 2 community pharmacies in Thailand",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 93,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases",
"nctId": "NCT06268002",
"orgStudyIdInfo": {
"id": "5876557033",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "continuous abstinence rate"
}
],
"secondaryOutcomes": [
{
"measure": "continuous abstinence rate (CAR) and point prevalence rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chulalongkorn University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Extraction of the primary canine teeth"
},
{
"name": "Expansion"
}
]
},
"conditionsModule": {
"conditions": [
"Ectopic Tooth Eruption",
"Palatal Expansion Technique",
"Randomized Clinical Trial"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gothenburg",
"contacts": [
{
"email": null,
"name": "Farhan Bazargani, DDS, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Björn Ludwig, DDS, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Martyn Coborune, DDS, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Gothenbrug University",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Approximately 2-3% of children will have problems with one or both of their permanent or 'adult' canine teeth in the upper jaw. These canine teeth sometimes fail to erupt properly, because they are displaced into the roof of the mouth or palate. These are known as palatally displaced canines, PDC, (Brin et al., 1986, Ericson and Kurol, 1987). In addition to failing to erupt, displaced teeth can cause problems, such as damage to the roots or displacement of the neighbouring teeth (Ericson and Kurol, 1988a, Ericson and Kurol, 2000, Falahat et al., 2008).It has been suggested that if the primary ('baby' or 'milk') canine is extracted at an appropriate time in a child with a suspected palatally displaced canine, then the displaced tooth might spontaneously correct its position (Ericson and Kurol, 1988b) and the extraction of the baby canine when a clinician suspects that the adult canine is displaced has become accepted clinical practice (Short, 2009). This appears to be on the basis of one report of a series of 35 children who received the intervention and no control group (Ericson and Kurol, 1988b). Two recent systematic reviews have examined the evidence for the effectiveness of removal of the primary canine with the aim of correcting the eruption path of a palatally displaced canine. A recent systematic review published in The Cochrane Library in 2021 (Benson et al., 2021) noted that the evidence for any intervention to correct the eruption path of a displaced permanent canine is weak and further research is required. Numerous problems with the reported studies were identified by both reviews.Other authors have suggested that using a RME (Rapid Maxillary expansion) or headgrear (EOT) to create sufficient space within the dental arch for the permanent canine tooth will encourage the tooth to erupt (Baccetti et al., 2011). This approach might be less traumatic to a child who may have had no experience of dental treatment, other than routine check-ups. If either or both approaches are shown to be effective then their widespread use would be advantageous to both the child and the healthcare provider, because the need for an operation, under general anaesthetic, to uncover the tooth and extensive brace treatment to straighten the tooth will be avoided."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 318,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "10 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PDC",
"briefTitle": "The Effectiveness of Early Intervention to Correct the Position of PDC:s",
"nctId": "NCT06267989",
"orgStudyIdInfo": {
"id": "Gothenburg University",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Succeful eruption of the palatally displaced canines into the dental arch"
}
],
"secondaryOutcomes": [
{
"measure": "Cost effectiveness of the interventions"
},
{
"measure": "Prevalence and severity of damage to surrounding teeth either due to the unerupted tooth or orthodontic intervention."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Region Örebro County"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ProSomnus RPMO2"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Calgary",
"contacts": [
{
"email": "[email protected]",
"name": "Brad Hansen",
"phone": "403-210-8925",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "University of Calgary",
"geoPoint": {
"lat": 51.05011,
"lon": -114.08529
},
"state": "Alberta",
"status": null,
"zip": "T2N4N1"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to:1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Validation of the ProSomnus® RPMO2 Device",
"nctId": "NCT06267976",
"orgStudyIdInfo": {
"id": "REB23-1003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "SpO2 accuracy"
},
{
"measure": "Pulse rate accuracy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "ProSomnus Sleep Technologies"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral [14C]PF-07220060"
},
{
"name": "Oral PF-07220060"
},
{
"name": "IV [14C] PF-07220060"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Participants"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Groningen",
"contacts": null,
"country": "Netherlands",
"facility": "PRA Health Sciences",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null,
"status": null,
"zip": "9728 NZ"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.The study is seeking for participants who:* are males aged 18 to 65 years and are healthy.* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2* have a total body weight of at least 50 kilograms.The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults",
"nctId": "NCT06267963",
"orgStudyIdInfo": {
"id": "C4391010",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTIS (EU)",
"id": "2023-507074-40-00",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered."
},
{
"measure": "Amount of metabolites of [14C]PF-07220060 in plasma, urine, and feces."
}
],
"secondaryOutcomes": [
{
"measure": "Dose normalized AUCinf of intravenous radiolabeled PF-07220060 in plasma (if data permit)"
},
{
"measure": "The absolute oral bioavailability (F) of PF-07220060"
},
{
"measure": "The fraction of PF-07220060 dose absorbed (Fa)"
},
{
"measure": "Number of participants with treatment emergent clinically significant laboratory abnormalities"
},
{
"measure": "Number of participants with treatment emergent clinically significant abnormal ECG measurements"
},
{
"measure": "Number of participants with treatment emergent clinically significant abnormal vital measurements"
},
{
"measure": "Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)"
},
{
"measure": "Number of participants with treatment emergent clinically significant abnormal physical examination"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Pfizer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "systematic therapy"
},
{
"name": "intermittent oro-esophageal tube feeding"
},
{
"name": "gastric tube feeding"
}
]
},
"conditionsModule": {
"conditions": [
"Pierre Robin Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xinzhu",
"contacts": [
{
"email": null,
"name": "Haim Liu, Master",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Hsinchu Rehabilitation Hospital",
"geoPoint": {
"lat": 22.46205,
"lon": 120.47335
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared."
},
"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": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Months",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Oral Feeding in Infants With Pierre Robin Syndrome",
"nctId": "NCT06267950",
"orgStudyIdInfo": {
"id": "PILUO-INFANT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of patients diagnosed as the pulmonary infection \"Positive\""
}
],
"secondaryOutcomes": [
{
"measure": "Nutritional status-total protein"
},
{
"measure": "Nutritional status-hemoglobin"
},
{
"measure": "Nutritional status-albumin"
},
{
"measure": "Body weight"
},
{
"measure": "The Functional Oral Intake Scale for Infants"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zeng Changhao"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Access to surgery"
},
{
"name": "type of intitution"
}
]
},
"conditionsModule": {
"conditions": [
"Hip Fractures"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santiago",
"contacts": null,
"country": "Chile",
"facility": "hospital Clinico Universidad de Chile",
"geoPoint": {
"lat": -33.45694,
"lon": -70.64827
},
"state": "Region Metropolitana",
"status": null,
"zip": "8380456"
}
]
},
"descriptionModule": {
"briefSummary": "Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. A comprehensive analysis of 35,520 patients revealed that factors such as age, type of health insurance, access to surgery, and treatment in public hospitals significantly influence mortality rates after hip fractures. The study found that patients with hip fractures experience lower 5-year survival rates compared to the general population, particularly when affiliated with public insurance and treated in public institutions. Modifiable factors like delayed surgery and prolonged hospital stays contribute to increased mortality rates. The findings underscore the urgent need for optimized public health policies and healthcare delivery systems to enhance outcomes for hip fracture patients in Chile.Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 46380,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hip Fractures in Chile: Implications for Public Health Policy and Healthcare Delivery",
"nctId": "NCT06267937",
"orgStudyIdInfo": {
"id": "101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "survival after hip fracture"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto Sistemas Complejos de Ingeniería, Universidad de Chile, Santiago, Chile"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Chile"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-03-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Otoband Experimental"
},
{
"name": "Otoband Sham"
}
]
},
"conditionsModule": {
"conditions": [
"Vestibular Migraine",
"Migraine Associated Vertigo"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Washington",
"contacts": null,
"country": "United States",
"facility": "Otolith Labs",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
},
"state": "District of Columbia",
"status": null,
"zip": "20001"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.Participants will be:* Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)* Randomized and stratified into groups based on the referring clinic to be assigned one study device* Asked to use the study device as instructed by the study coordinator* Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators* Asked to provide their vertigo diagnosis from their physician* Compensated for their participationResearchers will compare the randomized groups to determine which group responds better to which device."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The proposed clinical trial for the study device will be a randomized, sham-controlled, double-blind study with two-parallel arms (active/sham device).",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines",
"nctId": "NCT06267924",
"orgStudyIdInfo": {
"id": "Olith10703",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "DHI Change in Scores"
}
],
"secondaryOutcomes": [
{
"measure": "Number of related adverse events"
},
{
"measure": "Change in number of vestibular migraine episodes weekly"
},
{
"measure": "Global Impression of Change (severity of episodes)"
},
{
"measure": "DHI change from transition to end of study"
},
{
"measure": "Device responder rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "MCRA"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Otolith Labs"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cognitive stimulation and psychological support (RGS-ICU)"
}
]
},
"conditionsModule": {
"conditions": [
"Critical Illness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palma De Mallorca",
"contacts": [
{
"email": "[email protected]",
"name": "Guillem Navarra-Ventura, PhD",
"phone": "+34971259888",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "University of the Balearic Islands",
"geoPoint": {
"lat": 39.56939,
"lon": 2.65024
},
"state": "Balearic Islands",
"status": null,
"zip": "07122"
},
{
"city": "Palma De Mallorca",
"contacts": [
{
"email": "[email protected]",
"name": "Gemma Rialp, MD, PhD",
"phone": "+34871202000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital Universitari Son Llàtzer",
"geoPoint": {
"lat": 39.56939,
"lon": 2.65024
},
"state": "Balearic Islands",
"status": null,
"zip": "07198"
},
{
"city": "Sabadell",
"contacts": [
{
"email": "[email protected]",
"name": "Sol Fernández-Gonzalo, PhD",
"phone": "+34937236673",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Corporacion Parc Tauli",
"geoPoint": {
"lat": 41.54329,
"lon": 2.10942
},
"state": "Catalonia",
"status": null,
"zip": "08208"
}
]
},
"descriptionModule": {
"briefSummary": "Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.The investigadors hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"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": "RGS-ICU",
"briefTitle": "Rehabilitation Gaming System for Intensive Care Units",
"nctId": "NCT06267911",
"orgStudyIdInfo": {
"id": "202223-10",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Fundació La Marató de TV3",
"id": "160/U/2022",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Subjective cognition"
},
{
"measure": "Functionality"
},
{
"measure": "Health-related quality of life"
}
],
"primaryOutcomes": [
{
"measure": "Attention performance"
},
{
"measure": "Working memory performance"
},
{
"measure": "Learning/memory performance"
},
{
"measure": "Executive function performance"
},
{
"measure": "Processing speed performance"
},
{
"measure": "Incidence of Treatment-Emergent Adverse Events [Safety]"
}
],
"secondaryOutcomes": [
{
"measure": "Dyspnea intensity"
},
{
"measure": "Pain intensity"
},
{
"measure": "Worry intensity"
},
{
"measure": "Sadness intensity"
},
{
"measure": "Comfort experienced"
},
{
"measure": "Anxiety symptoms"
},
{
"measure": "Symptoms of depression"
},
{
"measure": "Symptoms of post-traumatic stress disorder"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Corporacion Parc Tauli"
},
{
"name": "Hospital Son Llatzer"
},
{
"name": "Fundació La Marató de TV3"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of the Balearic Islands"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"MDS",
"CMML"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Antwerp",
"contacts": null,
"country": "Belgium",
"facility": "Antwerp University Hospital (UZA)",
"geoPoint": {
"lat": 51.21989,
"lon": 4.40346
},
"state": null,
"status": null,
"zip": "2650"
},
{
"city": "Leuven",
"contacts": null,
"country": "Belgium",
"facility": "University Hospital Gasthuisberg",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": null,
"status": null,
"zip": "3000"
},
{
"city": "Liege",
"contacts": null,
"country": "Belgium",
"facility": "University of Liege",
"geoPoint": {
"lat": 50.63373,
"lon": 5.56749
},
"state": null,
"status": null,
"zip": "4000"
},
{
"city": "Pilsen",
"contacts": null,
"country": "Czechia",
"facility": "Charles University Hospital",
"geoPoint": {
"lat": 49.74747,
"lon": 13.37759
},
"state": null,
"status": null,
"zip": "304 60"
},
{
"city": "Essen",
"contacts": null,
"country": "Germany",
"facility": "University Hospital",
"geoPoint": {
"lat": 51.45657,
"lon": 7.01228
},
"state": null,
"status": null,
"zip": "45122"
},
{
"city": "Leipzig",
"contacts": null,
"country": "Germany",
"facility": "University Hospital Leipzig",
"geoPoint": {
"lat": 51.33962,
"lon": 12.37129
},
"state": null,
"status": null,
"zip": "04103"
}
]
},
"descriptionModule": {
"briefSummary": "Stem cell transplantation and blood product transfusions are standard of care for Myelodysplastic Syndromes (MDS). Several studies have shown changes in serum ferritin and non-transferrin-bound iron (NTBI) in patients undergoing stem cell transplantation. A large proportion of MDS patients are at risk for organ damage from tissue siderosis, due to the development of iron overload.Toxic effects of iron may play an important role in the complications associated with HSCT. Iron chelation therapy may reduce the acute and chronic treatment-related toxicity by removing excess of iron, iron radicals and reactive oxygen species (ROS).There is little information about the efficacy and safety of iron chelation in MDS patients. This audit wants to evaluate the effect of iron toxicity on treatment-related mortality in untreated, adult MDS or CMML patients during and after treatment with myeloablative conditioning (MAC) and reduced intensity conditioning (RIC) allo-HSCT, by prospectively collecting data from 200 MDS or CMML patients from 2009 onwards."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 222,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non Interventional Study on Iron Toxicity After First Allo-transplant in MDS/CMML",
"nctId": "NCT06267898",
"orgStudyIdInfo": {
"id": "EBMT- 842205547",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "non-relapse mortality (treatment related mortality)."
}
],
"secondaryOutcomes": [
{
"measure": "treatment-related toxic effects"
},
{
"measure": "relapse rate"
},
{
"measure": "event-free survival"
},
{
"measure": "overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Novartis"
}
],
"leadSponsor": {
"class": "NETWORK",
"name": "European Society for Blood and Marrow Transplantation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2015-05-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-20"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2015-01-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2009-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cannulated screws vs wagner's technique"
}
]
},
"conditionsModule": {
"conditions": [
"Fracture Neck of Femur"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Assiut",
"contacts": [
{
"email": null,
"name": "Mina Maged",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Assiut university",
"geoPoint": {
"lat": 27.18096,
"lon": 31.18368
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
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},
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],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "14 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
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]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fixation of Fracture Neck of Femur in Children",
"nctId": "NCT06267885",
"orgStudyIdInfo": {
"id": "Children NOF fracture fixation",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The better method for fixation of fracture neck of femur"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
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}
},
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"date": "2026-03"
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},
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"primaryCompletionDateStruct": {
"date": "2026-02"
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"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
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{
"name": "CD4BS CH505M5 Pr-NP1"
},
{
"name": "CH505TF chTrimer"
},
{
"name": "3M-052-AF (labeled as AP 60-702)"
},
{
"name": "Aluminum Hydroxide Suspension (Alum)"
},
{
"name": "ACU-026-001-1 (labeled as empty LNP)"
}
]
},
"conditionsModule": {
"conditions": [
"HIV"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Birmingham",
"contacts": [
{
"email": "[email protected]",
"name": "Heather Logan, A.N.P.",
"phone": "205-873-8686",
"phoneExt": null,
"role": "CONTACT"
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],
"country": "United States",
"facility": "Alabama CRS (Site ID: 31788)",
"geoPoint": {
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},
"state": "Alabama",
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{
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{
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"name": "Ericka Patrick, M.S.N",
"phone": "404-616-6313",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The Ponce de Leon Center CRS (Site ID: 5802)",
"geoPoint": {
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"lon": -84.38798
},
"state": "Georgia",
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},
{
"city": "Nashville",
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{
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"name": "Shonda E. Sumner, B.S.N.",
"phone": "615-343-6906",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
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"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee",
"status": null,
"zip": "37232"
},
{
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"contacts": [
{
"email": "[email protected]",
"name": "Magdeline K. Molapo",
"phone": "27-12-7992422",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "South Africa",
"facility": "Setshaba Research Centre CRS (Site ID: 31829)",
"geoPoint": null,
"state": "Gauteng",
"status": null,
"zip": "0152"
},
{
"city": "Isipingo",
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{
"email": "[email protected]",
"name": "Girisha Kistnasami, B.Sc., D.P.M.",
"phone": "27-31-2423600",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "South Africa",
"facility": "Isipingo CRS (Site ID: 31635)",
"geoPoint": {
"lat": -29.98639,
"lon": 30.91853
},
"state": "Kwa Zulu Natal",
"status": null,
"zip": "4110"
},
{
"city": "Klerksdorp",
"contacts": [
{
"email": "[email protected]",
"name": "Olebogeng Jonkane",
"phone": "None Listed",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "South Africa",
"facility": "Klerksdorp CRS (Site ID: 30325)",
"geoPoint": {
"lat": -26.85213,
"lon": 26.66672
},
"state": "North West Province",
"status": null,
"zip": "2571"
}
]
},
"descriptionModule": {
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},
"designModule": {
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"maskingInfo": {
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},
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},
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"type": "ESTIMATED"
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"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
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"nctId": "NCT06267872",
"orgStudyIdInfo": {
"id": "HVTN 309",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine"
},
{
"measure": "Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine"
},
{
"measure": "Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation"
},
{
"measure": "Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation"
},
{
"measure": "Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation"
},
{
"measure": "Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation"
},
{
"measure": "Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry"
},
{
"measure": "Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay"
},
{
"measure": "Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay"
}
],
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{
"measure": "Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)"
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{
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{
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{
"measure": "Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay"
},
{
"measure": "Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay"
},
{
"measure": "Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay"
},
{
"measure": "Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay"
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},
{
"measure": "Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry"
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{
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{
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{
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},
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"startDateStruct": {
"date": "2024-05-31"
},
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"date": "2024-02-20"
}
}
} | false | null |
{
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"interventions": [
{
"name": "The use of a combination of microelements and vitamins against the background of physiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
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"Congenital Heart Defects"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tashkent",
"contacts": [
{
"email": "[email protected]",
"name": "Shokhida T Turdieva, M.D., D.Sc.",
"phone": "+998935872570",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kholida B Abdurashidova",
"phone": "+998935092934",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gulmira R Nasirova, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Uzbekistan",
"facility": "Turdieva Shokhida Tolkunovna",
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"lon": 69.21627
},
"state": "Yunus-obad District",
"status": "RECRUITING",
"zip": "100140"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.The main questions it aims to answer:* Analysis of common congenital diseases among children;* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;* Based on the results of the primary research, common diseases among children will be identified;* Analysis of existing treatment methods and their effectiveness;* Development of modern methods of treatment and rehabilitation of children."
},
"designModule": {
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "identification of children from the group of \"frequently ill children\"",
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"maskingDescription": "working with children from the \"frequently ill children\" group",
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]
},
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},
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"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "3 Days",
"sex": "ALL",
"stdAges": [
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]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children",
"nctId": "NCT06267859",
"orgStudyIdInfo": {
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"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Working with archival documentation."
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{
"measure": "Formation of a group of patients to study immunity and the antioxidant system in venous blood."
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{
"measure": "Clinical scientific research."
},
{
"measure": "Clinical trial evaluation."
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
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}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-01-30"
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"date": "2024-02-28"
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"date": "2033-12-30"
},
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"startDateStruct": {
"date": "2023-11-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NBI-1070770"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Little Rock",
"contacts": null,
"country": "United States",
"facility": "Neurocrine Clinical Site",
"geoPoint": {
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"lon": -92.28959
},
"state": "Arkansas",
"status": "RECRUITING",
"zip": "72211"
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{
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"contacts": null,
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"facility": "Neurocrine Clinical Site",
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"lon": -94.11854
},
"state": "Arkansas",
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"zip": "72758"
},
{
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"contacts": null,
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"facility": "Neurocrine Clinical Site",
"geoPoint": {
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},
"state": "California",
"status": "RECRUITING",
"zip": "91945"
},
{
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"contacts": null,
"country": "United States",
"facility": "Neurocrine Clinical Site",
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"lon": -118.18923
},
"state": "California",
"status": "RECRUITING",
"zip": "90806"
},
{
"city": "Hollywood",
"contacts": null,
"country": "United States",
"facility": "Neurocrine Clinical Site",
"geoPoint": {
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"lon": -80.14949
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33024"
},
{
"city": "Decatur",
"contacts": null,
"country": "United States",
"facility": "Neurocrine Clinical Site",
"geoPoint": {
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"lon": -84.29631
},
"state": "Georgia",
"status": "RECRUITING",
"zip": "30030"
},
{
"city": "Savannah",
"contacts": null,
"country": "United States",
"facility": "Neurocrine Clinical Site",
"geoPoint": {
"lat": 32.08354,
"lon": -81.09983
},
"state": "Georgia",
"status": "RECRUITING",
"zip": "31405"
},
{
"city": "Gaithersburg",
"contacts": null,
"country": "United States",
"facility": "Neurocrine Clinical Site",
"geoPoint": {
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"lon": -77.20137
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "20877"
},
{
"city": "North Canton",
"contacts": null,
"country": "United States",
"facility": "Neurocrine Clinical Site",
"geoPoint": {
"lat": 40.87589,
"lon": -81.40234
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "44730"
},
{
"city": "Houston",
"contacts": null,
"country": "United States",
"facility": "Neurocrine Clinical Site",
"geoPoint": {
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"lon": -95.36327
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77008"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD)."
},
"designModule": {
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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"INVESTIGATOR"
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},
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},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder",
"nctId": "NCT06267846",
"orgStudyIdInfo": {
"id": "NBI-1070770-MDD2029",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Total MADRS Score from Baseline at Postbaseline Timepoints"
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]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Neurocrine Biosciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
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"primaryCompletionDateStruct": {
"date": "2025-09"
},
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"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-20"
}
}
} | false | null |
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