protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Heart rate variability biofeedback"
}
]
},
"conditionsModule": {
"conditions": [
"Major Depressive Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Umiemah Farrukh",
"phone": "213-740-4503",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Southern California",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": "RECRUITING",
"zip": "90089"
}
]
},
"descriptionModule": {
"briefSummary": "Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 252,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "27 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "RAPID",
"briefTitle": "Regulation of Affect and Physiology in Depression",
"nctId": "NCT06345859",
"orgStudyIdInfo": {
"id": "UP-23-00467",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01MH133842",
"link": "https://reporter.nih.gov/quickSearch/R01MH133842",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Physiological regulation success"
},
{
"measure": "Average level of heart rate variability"
}
],
"secondaryOutcomes": [
{
"measure": "Perceived regulation success"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Mental Health (NIMH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern California"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IFIOL"
},
{
"name": "SFIOL"
}
]
},
"conditionsModule": {
"conditions": [
"Cataract"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Vienna",
"contacts": null,
"country": "Austria",
"facility": "Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna",
"geoPoint": {
"lat": 48.20849,
"lon": 16.37208
},
"state": null,
"status": null,
"zip": "1140"
}
]
},
"descriptionModule": {
"briefSummary": "Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 82,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Stability of Secondary Intraocular Lenses With no Capsular Support",
"nctId": "NCT06345846",
"orgStudyIdInfo": {
"id": "Secondary IOL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Centration of the IOL"
}
],
"secondaryOutcomes": [
{
"measure": "Tilt of the IOL"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Vienna Institute for Research in Ocular Surgery"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "1%Tranexamic acid with standard local"
},
{
"name": "3% TXA"
},
{
"name": "1% TXA with local plus 3% TXA-soaked pledgets"
}
]
},
"conditionsModule": {
"conditions": [
"Hemophilia",
"Hemorrhage",
"Facelift Surgery"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\\[12\\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study",
"nctId": "NCT06345833",
"orgStudyIdInfo": {
"id": "ENT-2024-32847",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Blood loss"
}
],
"secondaryOutcomes": [
{
"measure": "adverse effects of TXA rates"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Minnesota"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Evolux"
},
{
"name": "Tecnis Eyhance"
}
]
},
"conditionsModule": {
"conditions": [
"Cataract"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Vienna",
"contacts": [
{
"email": "[email protected]",
"name": "Andreas Rotter, MD",
"phone": "01 91021",
"phoneExt": "57564",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Manuel Ruiss, MSc",
"phone": "01 91021",
"phoneExt": "57564",
"role": "CONTACT"
}
],
"country": "Austria",
"facility": "Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna",
"geoPoint": {
"lat": 48.20849,
"lon": 16.37208
},
"state": null,
"status": "RECRUITING",
"zip": "1140"
}
]
},
"descriptionModule": {
"briefSummary": "Comparison of the clinical performance of two enhanced monofocal IOLs with similar design."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "105 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses",
"nctId": "NCT06345820",
"orgStudyIdInfo": {
"id": "Evolux",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Monocular intermediate visual acuity"
}
],
"secondaryOutcomes": [
{
"measure": "Monocular distance visual acuity"
},
{
"measure": "Monocular near visual acuity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Vienna Institute for Research in Ocular Surgery"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Individuals activity programs"
},
{
"name": "activity program"
},
{
"name": "no Physical Activity program"
}
]
},
"conditionsModule": {
"conditions": [
"Individualised Physical Activity Program",
"Coronary Patient"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "interventional study, randomized in 3 parallel groups, single center,",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 192,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "APIC",
"briefTitle": "Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation",
"nctId": "NCT06345807",
"orgStudyIdInfo": {
"id": "2023-A02617-38",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6 minutes walk test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Elsan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LY4100511 (DC-853)"
},
{
"name": "Itraconazole"
},
{
"name": "Fluconazole"
},
{
"name": "Carbamazepine"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Antonio",
"contacts": [
{
"email": null,
"name": null,
"phone": "210-283-4500",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Chinonye Ogbonnaya-Odor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "ICON San Antonio Clinical Research Unit",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas",
"status": null,
"zip": "78209"
}
]
},
"descriptionModule": {
"briefSummary": "The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants",
"nctId": "NCT06345794",
"orgStudyIdInfo": {
"id": "27111",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company",
"id": "J5C-MC-FOAG",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)"
},
{
"measure": "PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853)"
},
{
"measure": "PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Eli Lilly and Company"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Abdominal Functional Electrical Stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Cord Injuries",
"Neurogenic Bowel"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Englewood",
"contacts": null,
"country": "United States",
"facility": "Craig Hospital",
"geoPoint": {
"lat": 39.64777,
"lon": -104.98776
},
"state": "Colorado",
"status": null,
"zip": "80113"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury",
"nctId": "NCT06345781",
"orgStudyIdInfo": {
"id": "2174433-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bowel Management Time (BMT)"
}
],
"secondaryOutcomes": [
{
"measure": "Bowel Management Strategy"
},
{
"measure": "Stimulation Dose"
},
{
"measure": "EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire"
},
{
"measure": "International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire"
},
{
"measure": "Visual Analog Scale (VAS)"
},
{
"measure": "Neurogenic Bladder Symptom Score (NBSS)"
},
{
"measure": "Intervention Acceptability"
},
{
"measure": "Intervention Safety"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Neuroscience Research Australia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Craig Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stress Ball"
}
]
},
"conditionsModule": {
"conditions": [
"Cholecystitis",
"Stress",
"Fear",
"Comfort"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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},
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},
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],
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients' Fear, Stress and Comfort.",
"nctId": "NCT06345768",
"orgStudyIdInfo": {
"id": "147258369",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fear of surgery"
},
{
"measure": "Fear of surgery"
},
{
"measure": "Comfort"
},
{
"measure": "Comfort"
},
{
"measure": "Stress"
},
{
"measure": "Stress"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Akdeniz University"
}
},
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"date": "2024-09-01"
},
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},
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"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VX-407"
},
{
"name": "Placebo"
},
{
"name": "Midazolam"
}
]
},
"conditionsModule": {
"conditions": [
"Autosomal Dominant Polycystic Kidney Disease (ADPKD)"
]
},
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"locations": [
{
"city": "Lenexa",
"contacts": null,
"country": "United States",
"facility": "ICON Lenexa",
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"lon": -94.73357
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "66219"
}
]
},
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},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of VX-407 in Healthy Participants",
"nctId": "NCT06345755",
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"id": "VX23-407-001",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)"
},
{
"measure": "Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)"
},
{
"measure": "Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407"
},
{
"measure": "Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407"
}
],
"secondaryOutcomes": [
{
"measure": "Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407"
},
{
"measure": "Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407"
},
{
"measure": "Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407"
},
{
"measure": "Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407"
},
{
"measure": "Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Vertex Pharmaceuticals Incorporated"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No parental participation"
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{
"name": "Mother participation"
},
{
"name": "Father participation"
}
]
},
"conditionsModule": {
"conditions": [
"Preterm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İstanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Tuğba Türker, Nurse",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Acıbadem University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Ataşehir",
"status": "RECRUITING",
"zip": "34750"
}
]
},
"descriptionModule": {
"briefSummary": "It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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},
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},
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},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "28 Days",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Parental Participation on Newborn Comfort During Diaper Care",
"nctId": "NCT06345742",
"orgStudyIdInfo": {
"id": "ATADEK-2023-10/396",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Level of Parental Stress"
},
{
"measure": "Change in Level of Comfort"
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],
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},
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"date": "2025-02-01"
},
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"date": "2025-02-01"
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"startDateStruct": {
"date": "2023-12-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
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{
"name": "MK-1084"
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{
"name": "Placebo"
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{
"name": "Pembrolizumab"
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]
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"conditions": [
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]
},
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},
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"type": "ESTIMATED"
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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},
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"acronym": null,
"briefTitle": "A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004)",
"nctId": "NCT06345729",
"orgStudyIdInfo": {
"id": "1084-004",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Merck",
"id": "MK-1084-004",
"link": null,
"type": "OTHER"
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{
"domain": "UTN",
"id": "U1111-1296-8093",
"link": null,
"type": "OTHER"
},
{
"domain": "EU CT",
"id": "2023-507776-42",
"link": null,
"type": "REGISTRY"
}
]
},
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{
"measure": "Progression-Free Survival (PFS)"
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{
"measure": "Overall Survival (OS)"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response Rate (ORR)"
},
{
"measure": "Duration of Response (DOR)"
},
{
"measure": "Number of Participants Who Experience One or More Adverse Event (AEs)"
},
{
"measure": "Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)"
},
{
"measure": "Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score"
},
{
"measure": "Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score"
},
{
"measure": "Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score"
},
{
"measure": "Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score"
},
{
"measure": "Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score"
},
{
"measure": "Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score"
},
{
"measure": "Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score"
},
{
"measure": "Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score"
},
{
"measure": "Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score"
},
{
"measure": "Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score"
},
{
"measure": "Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score"
},
{
"measure": "Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score"
}
]
},
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"name": "Merck Sharp & Dohme LLC"
}
},
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"date": "2031-02-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2029-02-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
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"interventions": [
{
"name": "paracétamol tramadol"
},
{
"name": "Paracétamol cafeine"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group."
},
"designModule": {
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"maskingDescription": null,
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RC",
"briefTitle": "Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic",
"nctId": "NCT06345716",
"orgStudyIdInfo": {
"id": "renal colic 2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Adverse effects"
}
],
"primaryOutcomes": [
{
"measure": "Pain recurrence"
}
],
"secondaryOutcomes": [
{
"measure": "Painful recurrence"
},
{
"measure": "number of patient who revist the ED for residual pain"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Monastir"
}
},
"statusModule": {
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"date": "2025-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Placebo"
},
{
"name": "NS-136 tablet"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Subjects"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Adelaide",
"contacts": [
{
"email": "[email protected]",
"name": "Study Services Director",
"phone": "+61 08 7088 7900",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "CMAX Clinical Research Pty Ltd",
"geoPoint": {
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"lon": 138.59863
},
"state": "South Australia",
"status": null,
"zip": "5000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?* What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen?"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "The trial consists of three parts: the first part is a single ascending dose (SAD) study, the second part is a multiple ascending dose (MAD) study, and the third part is food effect (FE) study. The first two parts (SAD and MAD) will be randomized, double-blind, single or multiple ascending dose and placebo-controlled study designs. The third part (FE) will be a randomized, open-label, two-period, crossover study design. To evaluate the safety, tolerability, pharmacokinetic profile, and the effect of food on the PK profile of NS-136 in healthy subjects and to determine the maximum tolerated dose (MTD)",
"maskingInfo": {
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},
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},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "First-into-human Study of NS-136 in Healthy Subjects",
"nctId": "NCT06345703",
"orgStudyIdInfo": {
"id": "NeuShen Therapeutics",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants with Treatment-Related Adverse Events"
},
{
"measure": "Main pharmacokinetic parameters"
},
{
"measure": "Main pharmacokinetic parameters"
},
{
"measure": "Main pharmacokinetic parameters"
},
{
"measure": "Main pharmacokinetic parameters"
},
{
"measure": "Main pharmacokinetic parameters"
},
{
"measure": "Main pharmacokinetic parameters"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "NeuShen Therapeutics"
}
},
"statusModule": {
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"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VIA Disc NP"
}
]
},
"conditionsModule": {
"conditions": [
"Discogenic Pain",
"Back Pain",
"Back Pain, Low"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Greenwood Village",
"contacts": [
{
"email": "[email protected]",
"name": "Josephine Steinbrecher",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Scott Bainbridge, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The Denver Spine & Pain Institute",
"geoPoint": {
"lat": 39.61721,
"lon": -104.95081
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80111"
},
{
"city": "Gainesville",
"contacts": [
{
"email": "[email protected]",
"name": "Carole Newell",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ajay Antony, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The Orthopedic Institute",
"geoPoint": {
"lat": 29.65163,
"lon": -82.32483
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32605"
},
{
"city": "Opelousas",
"contacts": [
{
"email": "[email protected]",
"name": "Lisa Briggs",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Albert Gros, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Interventional Pain Specialists - Pain Clinic",
"geoPoint": {
"lat": 30.53353,
"lon": -92.08151
},
"state": "Louisiana",
"status": "RECRUITING",
"zip": "70570"
},
{
"city": "Asheville",
"contacts": [
{
"email": "[email protected]",
"name": "Courtney Musser",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Javid Baksh, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Premier Pain Solutions",
"geoPoint": {
"lat": 35.60095,
"lon": -82.55402
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "28803"
},
{
"city": "New Bern",
"contacts": [
{
"email": "[email protected]",
"name": "Amy Harum",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
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}
],
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"zip": "28560"
}
]
},
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},
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},
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"id": "VIA-2023-003",
"link": null,
"type": null
},
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},
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"measure": "Numeric Pain Rating Scale (NPRS)"
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{
"measure": "Oswestry Disability Index (ODI)"
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{
"measure": "Patient Satisfaction"
},
{
"measure": "Pain Medication"
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"collaborators": [
{
"name": "Moxie Clinical"
}
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"date": "2024-02-27"
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"interventions": [
{
"name": "ViXe Xombination"
},
{
"name": "Placebo + Sham"
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]
},
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"conditions": [
"Overactive Bladder"
]
},
"contactsLocationsModule": {
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"city": "Coimbra",
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},
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"measure": "Daily Urgency Urinary Incontinence"
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"measure": "Total Daily Episodes"
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{
"measure": "Urinary Urgency"
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{
"measure": "Voiding Leaks"
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{
"measure": "Quality of Life Queationnsaire"
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{
"measure": "Nocturia"
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"name": "Blueclinical, Ltd."
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{
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{
"email": null,
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{
"email": null,
"name": "Tobias Renner, Prof. Dr.",
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"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
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},
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"measure": "Sleep Self Report (SSR)"
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"measure": "Somatics"
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{
"measure": "Parent's Stress Inventory (EBI)"
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{
"measure": "App-questions"
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{
"measure": "Postexperimental questionnaire"
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"measure": "Demographic data"
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{
"measure": "Sleep cartoon for children"
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{
"measure": "Kiddie-Sads-Present and Lifetime Version (K-SADS PL)"
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{
"measure": "Self efficacy dealing with social situations (WIRKSOZ)"
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{
"measure": "Group interviews"
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},
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"conditions": [
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},
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"name": "Anne Lieb, Dr.",
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},
{
"email": null,
"name": "Andreas J. Fallgatter, Prof.",
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{
"email": null,
"name": "Ulf Ziemann, Prof.",
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},
{
"email": null,
"name": "Julia Becker-Sadzio, Dr.",
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{
"email": null,
"name": "Anne Lieb, Dr.",
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],
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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]
},
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"briefTitle": "Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder",
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"id": "2023-03, Version 7",
"link": null,
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{
"measure": "HDRS-17 (Hamilton Depression Rating Scale-17)"
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{
"measure": "BDI-2 (Beck Depression Inventory-2)"
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{
"measure": "IDS-30 (Inventory of depressive symptoms-30)"
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{
"measure": "Response Rate"
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{
"measure": "Remission Rate"
}
]
},
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"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
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},
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]
},
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{
"city": "Philadelphia",
"contacts": null,
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"lon": -75.16379
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{
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{
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},
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"minimumAge": "18 Years",
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},
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"link": null,
"type": null
},
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},
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"measure": "C-reactive protein level"
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},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
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}
}
} | false | null |
{
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"interventions": [
{
"name": "Cognition"
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{
"name": "Sensory function"
},
{
"name": "Frailty"
},
{
"name": "Biomechanical movement analysis"
},
{
"name": "Screening"
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{
"name": "Follow up"
}
]
},
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"conditions": [
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"Postural Balance",
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{
"city": "Antwerp",
"contacts": [
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"email": "[email protected]",
"name": "Ann Hallemans, PhD",
"phone": "+32 3 265 29 12",
"phoneExt": null,
"role": "CONTACT"
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{
"email": null,
"name": "PhD",
"phone": null,
"phoneExt": null,
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},
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"briefSummary": "The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing."
},
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"phases": null,
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},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
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},
"identificationModule": {
"acronym": "BALANCAR",
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"orgStudyIdInfo": {
"id": "6012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": [
{
"measure": "Age"
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{
"measure": "Gender"
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{
"measure": "Medical history"
},
{
"measure": "Fall history"
}
],
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"measure": "Spatio-temporal parameters of gait"
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{
"measure": "Foot placement estimator"
},
{
"measure": "Onset latency"
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{
"measure": "Peak amplitude"
},
{
"measure": "Fixation duration"
},
{
"measure": "Gain"
},
{
"measure": "Latency"
},
{
"measure": "Fall characteristics"
}
],
"secondaryOutcomes": [
{
"measure": "Multisensory integration"
},
{
"measure": "Digit symbol substitution test"
},
{
"measure": "Trail making test"
},
{
"measure": "Go/No Go test"
},
{
"measure": "Head Repositioning Accuracy"
},
{
"measure": "Fly test"
},
{
"measure": "Fly test"
},
{
"measure": "vHIT"
},
{
"measure": "fHIT"
},
{
"measure": "Frailty"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Universiteit Antwerpen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01"
},
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"date": "2024-04-16"
},
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"date": "2027-01"
},
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"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "hypoxia"
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{
"name": "normoxia"
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{
"name": "creatine supplementation"
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{
"name": "no creatine supplementation"
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},
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},
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"email": "[email protected]",
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"role": "CONTACT"
}
],
"country": "Poland",
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}
]
},
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},
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"ADULT"
]
},
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},
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"measure": "Metabolic control of diabetes"
},
{
"measure": "Time in range"
},
{
"measure": "Time below range"
},
{
"measure": "Maximum oxygen consumption (VO2max)"
}
],
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"class": "OTHER",
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}
},
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"date": "2025-07"
},
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"date": "2025-06"
},
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"date": "2023-11-15"
},
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}
}
} | false | null |
{
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"name": "Radiotherapy"
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{
"name": "Chemotherapy:Albumin-bound paclitaxel、Gemcitabine"
}
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"ADULT",
"OLDER_ADULT"
]
},
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"id": "LK2023100",
"link": null,
"type": null
},
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},
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"measure": "Adverse events"
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{
"measure": "Serious adverse events"
},
{
"measure": "1-year overall survival"
}
],
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{
"measure": "Objective response rate"
},
{
"measure": "Disease control rate"
},
{
"measure": "Overall survival"
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{
"measure": "R0 resection rate"
},
{
"measure": "Progression free survival"
}
]
},
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"class": "OTHER",
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}
},
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"date": "2027-01-10"
},
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"date": "2024-04-03"
},
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"date": "2027-01-10"
},
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"date": "2024-05-01"
},
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}
}
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{
"date": "2023-09-22",
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{
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]
}
} |
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{
"name": "Drospirenone"
}
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},
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]
},
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{
"city": "Bangkok",
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},
"state": null,
"status": null,
"zip": "10330"
}
]
},
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"briefSummary": "The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery"
},
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"allocation": "NA",
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},
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"NA"
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"maximumAge": "45 Years",
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"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study",
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"orgStudyIdInfo": {
"id": "078066",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cervical mucus by modified Insler score"
}
],
"secondaryOutcomes": [
{
"measure": "Estrogen and progesterone levels versus time"
},
{
"measure": "Number of Participants With Treatment-Related Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chulalongkorn University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
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"date": "2025-04"
},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mental stress"
}
]
},
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"conditions": [
"Mental Stress",
"Myocardial Ischemia",
"Sex Role",
"Gender"
]
},
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{
"city": "Zürich",
"contacts": null,
"country": "Switzerland",
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"zip": "8091"
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]
},
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"briefSummary": "The main study objective is to prospectively determine the influence of sex-related risk factors and psychosocial variables on neuronal stress responses and myocardial perfusion in a population of 64 female and male individuals 50-75 years of age and free of cardiovascular disease."
},
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"designInfo": {
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},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "ALL",
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Heart-brain-axis and Psychosocial Stress",
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"id": "BASEC 2020-02922",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "Rate-Pressure-Product (RPP, in beats per minute x mmHg)"
},
{
"measure": "vmPFC-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV)"
},
{
"measure": "Nail cortisol value (pg/mg)"
},
{
"measure": "General Anxiety Disorder (GAD-7) Questionnaire"
},
{
"measure": "Patient Health Questionnaire (PHQ-8)"
},
{
"measure": "Shortened Maastricht Exhaustion Questionnaire"
},
{
"measure": "Type D Personality (DS14) questionnaire"
},
{
"measure": "Wagnild & Young Score resilience questionnaire"
},
{
"measure": "Perceived Stress Scale (PSS-4) questionnaire"
},
{
"measure": "Jenkins Sleep Scale (JSS-4)"
},
{
"measure": "Trier Inventory for Chronic Stress (TICS)"
},
{
"measure": "Perceived stress"
},
{
"measure": "Left ventricular stroke volume (LVSV, mL)"
},
{
"measure": "Left ventricular end-systolic volume (LVESV, mL)"
},
{
"measure": "Left ventricular end-diastolic volume (LVEDV, mL)"
},
{
"measure": "Estradiol levels (pmol/L)"
},
{
"measure": "Progesterone levels (nmol/L)"
},
{
"measure": "Sex Hormone Binding Globulin (SHBG) levels (nmol/L)"
},
{
"measure": "Total testosterone levels (nmol/L)"
},
{
"measure": "Free testosterone levels (pmol/L)"
}
],
"primaryOutcomes": [
{
"measure": "Amygdala-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV)"
},
{
"measure": "Difference between the rest and stress amygdala-to-cerebellum perfusion ratios (kBq/kBq)"
},
{
"measure": "Myocardial flow reserve (MFR, no unit)"
}
],
"secondaryOutcomes": [
{
"measure": "Amygdala-to-vmPFC ratio of glycolytic metabolic activities (SUV/SUV)"
},
{
"measure": "Difference between the rest and stress amygdala-to-vmPFC perfusion ratios (kBq/kBq)"
},
{
"measure": "Myocardial blood flow (MBF) at rest (mL/g/min)"
},
{
"measure": "Myocardial blood flow (MBF) at stress (mL/g/min)"
},
{
"measure": "Heart-rate response (HRR, no unit)"
},
{
"measure": "Salivary cortisol (mol/L)"
},
{
"measure": "Noradrenaline (mL/min)"
},
{
"measure": "Adrenaline (mL/min)"
},
{
"measure": "Dopamine (mL/min)"
},
{
"measure": "Spleen metabolic activity (SUV)"
},
{
"measure": "Bone marrow metabolic activity (SUV)"
},
{
"measure": "Aorta metabolic activity (SUV)"
},
{
"measure": "Left ventricular ejection fraction (LVEF, %)"
},
{
"measure": "C-reactive protein (CRP, mg/L)"
},
{
"measure": "Interleukin-2 (IL-2, pg/mL)"
},
{
"measure": "Interleukin-4 (IL-4, pg/mL)"
},
{
"measure": "Interleukin-6 (IL-6, pg/mL)"
},
{
"measure": "Interleukin-8 (IL-8, pg/mL)"
},
{
"measure": "Interleukin-10 (IL-10, pg/mL)"
},
{
"measure": "Tumor necrosis factor (TNF, pg/mL)"
},
{
"measure": "Matrix metalloproteinase-9 (MMP9, pg/mL)"
},
{
"measure": "Monocyte Chemoattractant Protein-1 (MCP1, pg/mL)"
},
{
"measure": "Vascular Cell Adhesion Molecule (VCAM)"
},
{
"measure": "Gender score questionnaire"
}
]
},
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"collaborators": null,
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"name": "University of Zurich"
}
},
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},
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},
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"date": "2023-11-20"
},
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"startDateStruct": {
"date": "2021-10-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Drospirenone"
}
]
},
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"conditions": [
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},
"contactsLocationsModule": {
"locations": [
{
"city": "Bangkok",
"contacts": [
{
"email": null,
"name": "Punyawee Utaipatanacheep",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Thailand",
"facility": "Chulalongkorn University",
"geoPoint": {
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"lon": 100.50144
},
"state": null,
"status": null,
"zip": "10330"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Pre-bariatric surgery pharmacokinetics study of Drospirenone compare with post-bariatric surgery",
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"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
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"nctId": "NCT06345560",
"orgStudyIdInfo": {
"id": "077766",
"link": null,
"type": null
},
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},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Plasma concentration versus Time of Drospirenone"
}
],
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{
"measure": "Number of Participants With Treatment-Related Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
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"class": "OTHER",
"name": "Chulalongkorn University"
}
},
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},
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"date": "2024-04-03"
},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ultrasound"
}
]
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"conditions": [
"Sarcopenia",
"Cirrhosis",
"Malnutrition"
]
},
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"locations": [
{
"city": "Edegem",
"contacts": [
{
"email": "[email protected]",
"name": "Karolien Dams, MD",
"phone": "+3238213635",
"phoneExt": "5175",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jolien Derdeyn, MD",
"phone": "+328213807",
"phoneExt": "3807",
"role": "CONTACT"
},
{
"email": null,
"name": "Jolien Derdeyn, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Thomas Vanwolleghem, MD, Phd",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Philippe Jorens, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Stany Perkisas, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Karolien Dams, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "University Hospital Antwerp",
"geoPoint": {
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"state": "Antwerpen",
"status": null,
"zip": "2650"
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]
},
"descriptionModule": {
"briefSummary": "The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\\[s\\] it aims to answer are:* what is the prevalence and development of sarcopenia in cirrhosis?* what is the role of malnutrition? Participants will * undergo a muscle ultrasound of the lower and upper limb muscles * handgrip strength will be measured * malnutrition screening and assessment * complete a questionnaire to assess quality of life"
},
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MMUSCLE",
"briefTitle": "Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)",
"nctId": "NCT06345547",
"orgStudyIdInfo": {
"id": "EDGE 003539",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prevalence of sarcopenia: muscle mass"
},
{
"measure": "Prevalence of sarcopenia: muscle strength"
},
{
"measure": "Development of sarcopenia: changes in muscle mass"
},
{
"measure": "Development of sarcopenia: changes in muscle strength"
},
{
"measure": "Development of sarcopenia: changes in muscle quality"
}
],
"secondaryOutcomes": [
{
"measure": "Decompensation events: MELD score • MELD evolution"
},
{
"measure": "Decompensation events: mortality • MELD evolution"
},
{
"measure": "Decompensation events: transplantation • MELD evolution"
},
{
"measure": "Malnutrition"
},
{
"measure": "Quality of life in cirrhosis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Antwerp"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer, Breast"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ghent",
"contacts": [
{
"email": "[email protected]",
"name": "Liv Veldeman, MD, PhD",
"phone": "09 332 30 15",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Emma Van Damme, MD",
"phone": "09 332 19 53",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Universitary Hospital",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
"state": null,
"status": null,
"zip": "9000"
}
]
},
"descriptionModule": {
"briefSummary": "Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients participating in the study will be randomized 1:1 between the FAST-FORWARD schedule and the HAI5 schedule. The first group is treated according to the FAST-FORWARD schedule, consisting of 5 radiation sessions on 5 consecutive working days (e.g. Monday to Friday). 2 rest days are allowed in the schedule, so that the treatment lasts a maximum of 7 days. The second group is treated according to the HAI5 schedule, developed by the radiotherapy department of Ghent University Hospital. In this schedule, at least 1 day of rest is scheduled between each treatment session, so the treatment is administered over 10-14 days.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Both healthcare provider and patient know the treatment",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 740,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "FAST-FORWARD vs HAI5",
"nctId": "NCT06345534",
"orgStudyIdInfo": {
"id": "ONZ-2023-0255",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Early side effects"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Ghent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2033-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2033-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure",
"Congenital",
"End-stage Heart Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Shoujun Li, MD",
"phone": "+86 13501071589",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fuwai hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
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},
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},
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"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Follow-up System of Pediatric Heart Failure and the Establishment of End-stage Heart Failure Registry",
"nctId": "NCT06345521",
"orgStudyIdInfo": {
"id": "2022-1-4032-3",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the recurrence rate of heart failure"
}
],
"secondaryOutcomes": [
{
"measure": "NT-proBNP level"
},
{
"measure": "Incidence rate of drug adverse reactions"
},
{
"measure": "Readmission rate for heart failure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Peking University First Hospital"
},
{
"name": "Beijing Children's Hospital"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "China National Center for Cardiovascular Diseases"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
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"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
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"date": "2024-06-22"
},
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"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Quantitative Ultrasound"
},
{
"name": "B-mode Ultrasound"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Liver Biopsy"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma",
"Liver Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "An Tang, MD, MSc",
"phone": "514-890-8000",
"phoneExt": "36400",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Casey Bourdeau Caporuscio, MSc",
"phone": "514-890-8000",
"phoneExt": "14756",
"role": "CONTACT"
},
{
"email": null,
"name": "An Tang, MD, MSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Centre Hospitalier de l'Université de Montréal (CHUM)",
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"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H2X 0A9"
}
]
},
"descriptionModule": {
"briefSummary": "Worldwide, liver cancers are the third most common cause of cancer mortality. Even when liver cancer is suspected by blood tests, imaging is required to determine the location, size, and extent of disease. Medical societies therefore recommend surveillance with ultrasound every 6 months in at-risk patients. However, a key challenge to improving the survival is that ultrasound may miss half of early-stage liver cancers, thus diagnosis must rely on additional tests such as computed tomography (CT), magnetic resonance imaging (MRI), or biopsy. Hence, there is a clear need to improve the ability to detect liver cancers, especially with ultrasound. The investigator's team proposes novel ultrasound approaches to detect cancer nodules invisible on conventional ultrasound based on differences in mechanical and structural properties between liver and tumor. Improving detection is critical because liver cancer can be cured only if detected at an early stage, as shown by improvements in survival rates in patients enrolled in surveillance programs. The investigator's multi-disciplinary, national, and international team includes experts in clinical fields (hepatology, oncology, radiology, pathology), basic sciences (engineering, medical physics, machine learning, biostatistics), and patient partnership. The investirgator will apply the methodology of patient partner recruitment and collaborate with the Centre of Excellence on Partnership with Patients and the Public to select potential new collaborators. This will permit this project to be informed at every stage by patient and family perspectives, ensuring that the results of this project will be more robust, impactful, and aligned with the priorities, needs and experiences of those who live with liver cancer. The investigator submits a research proposal focused on advanced imaging techniques because imaging constitutes a foundation for surveillance, diagnosis, staging, treatment selection and assessment of treatment response in patients with liver cancer."
},
"designModule": {
"designInfo": {
"allocation": null,
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"primaryPurpose": null,
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},
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"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "QUS in HCC",
"briefTitle": "Early Detection of Liver Cancer by QUS",
"nctId": "NCT06345508",
"orgStudyIdInfo": {
"id": "2024-12161",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Compare the sensitivity of QUS + B-mode US vs B-mode US alone for lesion detection, using MRI as the reference standard for detection"
}
],
"secondaryOutcomes": [
{
"measure": "Compare the specificity of QUS + B-mode US vs B-mode US alone for diagnosis of HCC, using MRI or biopsy as the composite reference standard for classification"
},
{
"measure": "Determine the lesion-to-liver contrast of investigational QUS techniques for detection of HCC"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Centre de Recherche du Centre Hospitalier de l'Université de Montréal"
},
{
"name": "Canadian Institutes of Health Research (CIHR)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centre hospitalier de l'Université de Montréal (CHUM)"
}
},
"statusModule": {
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"date": "2029-12"
},
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"date": "2024-04-12"
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},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ruxolitinib"
},
{
"name": "Allogeneic Stem Cell Transplantation"
},
{
"name": "Levetiracetam"
},
{
"name": "Eltrombopag"
},
{
"name": "Busulfan"
},
{
"name": "Romiplostim"
},
{
"name": "Fludarabine phosphate"
},
{
"name": "Cyclophosphamide"
},
{
"name": "Mesna"
},
{
"name": "Tacrolimus"
}
]
},
"conditionsModule": {
"conditions": [
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"Myelofibrosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": null,
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed."
},
"designModule": {
"designInfo": {
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"interventionModel": "SINGLE_GROUP",
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},
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},
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},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly",
"nctId": "NCT06345495",
"orgStudyIdInfo": {
"id": "2023-0899",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-02814",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Incyte Corporation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MHB039A"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Shun Lu, MD",
"phone": "13601813062",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shanghai Chest Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200030"
}
]
},
"descriptionModule": {
"briefSummary": "Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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},
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},
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"type": "ESTIMATED"
},
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"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of MHB039A for Advanced Solid Tumor",
"nctId": "NCT06345482",
"orgStudyIdInfo": {
"id": "MHB039A-A-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of participants with adverse events (AE)"
},
{
"measure": "Number of participants with dose-limiting toxicity (DLT)"
}
],
"secondaryOutcomes": [
{
"measure": "Maximum Plasma Concentration (Cmax) of MHB039A"
},
{
"measure": "The area under the plasma concentration-time curve (AUC) of MHB039A"
},
{
"measure": "To detectable anti-drug antibodies with treated subjects"
},
{
"measure": "Objective response rate (ORR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Minghui Pharmaceutical (Hangzhou) Ltd"
}
},
"statusModule": {
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"date": "2029-06-01"
},
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},
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"date": "2028-04-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patient blood management (PBM)"
},
{
"name": "Allogeneic transfusion"
}
]
},
"conditionsModule": {
"conditions": [
"Severe Anemia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses.The main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia?"
},
"designModule": {
"designInfo": {
"allocation": null,
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},
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"minimumAge": "18 Years",
"sex": "ALL",
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cost Analysis of Therapies for Severe Anemia",
"nctId": "NCT06345469",
"orgStudyIdInfo": {
"id": "O-PBM2",
"link": null,
"type": null
},
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},
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"measure": "cost-effectiveness"
}
],
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},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Marisa Eichner"
}
],
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"class": "OTHER",
"name": "Helios Klinik Gotha/Ohrdruf"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-01"
},
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},
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"date": "2026-04-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "End-tidal capnography"
}
]
},
"conditionsModule": {
"conditions": [
"Gastro Intestinal Bleeding"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İzmir",
"contacts": null,
"country": "Turkey",
"facility": "Katip Çelebi Üniversitesi",
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"lon": 27.13838
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"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level.In our study, the investigators aimed to determine the severity of gastrointestinal bleeding by using the Glaskow Blachford Score and AIMS65 score in cases presenting with gastrointestinal bleeding, to determine the end tidal carbon dioxide value by capnography in these cases and to determine its effectiveness in evaluating mortality and morbidity in gastrointestinal bleeding."
},
"designModule": {
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},
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},
"enrollmentInfo": {
"count": 103,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Value of End-tidal Capnography in Gastrointestinal Bleeding",
"nctId": "NCT06345456",
"orgStudyIdInfo": {
"id": "izmirkatip",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Izmir Katip Celebi University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-01-01"
},
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"date": "2024-04-08"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | {
"largeDocumentModule": {
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"date": "2020-06-01",
"filename": "SAP_000.pdf",
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"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 281538,
"typeAbbrev": "SAP",
"uploadDate": "2024-04-01T04:48"
},
{
"date": "2020-06-01",
"filename": "ICF_001.pdf",
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"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 418132,
"typeAbbrev": "ICF",
"uploadDate": "2024-04-01T04:35"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nicotinamide Riboside Malate"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Vascular Stiffness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Snigdha Panda, BS",
"phone": "507-538-5827",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jennifer Soderlind",
"phone": "507-284-4799",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
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}
]
},
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},
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},
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},
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},
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},
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},
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"measure": "Reduction of Endothelial stiffness"
}
],
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},
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},
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}
}
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"name": "Exopulse Molli-Suit (Wearable Technological Device)"
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]
},
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"conditions": [
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"Chronic Pain",
"Musculoskeletal Pain"
]
},
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"facility": "Yasemin Özel Aslıyüce",
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}
]
},
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},
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},
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"link": null,
"type": null
},
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},
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"measure": "Pain Severity"
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],
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"measure": "Disability Level"
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{
"measure": "Repetitive Reach Test"
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{
"measure": "Body Composition Analysis"
},
{
"measure": "Lifting object overhead test"
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{
"measure": "Sustained Overhead Work Test"
},
{
"measure": "back performance test"
}
]
},
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}
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},
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}
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{
"name": "Allogeneic transfusion"
}
]
},
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]
},
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"city": "Erfurt",
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"email": "[email protected]",
"name": "Achim Spenner",
"phone": "+49-361-7810",
"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "Helios Klinikum",
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},
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"status": null,
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},
{
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"email": "[email protected]",
"name": "Petra See",
"phone": "+49-3621-220 0",
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"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kai D",
"phone": "+49-3621-220",
"phoneExt": "5058",
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Helios Klinikum",
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]
},
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},
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]
},
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"type": null
},
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}
],
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"measure": "Number of participants with surgical wound complications"
},
{
"measure": "Number of participants with a documented acute myocardial infarction"
},
{
"measure": "Number of participants suffering renal injury"
},
{
"measure": "Number of days spent in hospital (Length of stay in hospital)"
},
{
"measure": "Number of participants readmitted to the studied hospital"
},
{
"measure": "Number of participants with a documented transfusion reaction"
},
{
"measure": "Number of participants receiving an allogeneic transfusion"
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{
"measure": "Number of participants treated in an intensive care ward"
},
{
"measure": "Number of participants with documented respiratory complications"
}
]
},
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],
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},
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}
}
} | false | null |
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"name": "Soquelitinib"
},
{
"name": "Placebo"
}
]
},
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},
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"email": "[email protected]",
"name": "Liza Tom",
"phone": "650-900-4514",
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{
"email": "[email protected]",
"name": "Gabriel Luciano",
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],
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"measure": "To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI)"
},
{
"measure": "To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1"
}
]
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},
"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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"name": "Kelly Ickmans, PhD",
"phone": "+32498483347",
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},
{
"email": null,
"name": "Sophie Pleysier, MSc",
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}
],
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"status": null,
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}
]
},
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},
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},
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"link": null,
"type": null
},
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},
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],
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},
{
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{
"measure": "Ownership of the intervention development"
}
]
},
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"name": "Universitair Ziekenhuis Brussel"
},
{
"name": "University Ghent"
},
{
"name": "University Hospital, Ghent"
},
{
"name": "University of Calgary"
}
],
"leadSponsor": {
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"name": "Vrije Universiteit Brussel"
}
},
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}
}
} | false | null |
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},
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},
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},
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"measure": "Algorithm creation"
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},
"studyFirstPostDateStruct": {
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}
}
} | false | null |
{
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"name": "mitoxantrone liposome, Ara-Cytarabine and azacitidine"
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{
"name": "Daunorubicin,Ara-Cytarabine, azacitidine"
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},
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]
},
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"country": "China",
"facility": "The First Affiliated Hospital of Zhengzhou University",
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{
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{
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{
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"facility": "Shiyan Taihe Hospital",
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"lon": 110.77806
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{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "Zhou Fuling, director",
"phone": "+86-02767813137",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
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{
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},
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},
{
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"facility": "The Central Hospital of Xiaogan",
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"state": "Hubei",
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"zip": "432100"
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{
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"facility": "Yichang Central Hospital",
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"zip": "443003"
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{
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"lon": 120.28857
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{
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"facility": "Shanxi Cancer Hospital",
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},
"descriptionModule": {
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},
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},
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},
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},
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],
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},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)",
"nctId": "NCT06345365",
"orgStudyIdInfo": {
"id": "09",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Complete remission rate"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of adverse events"
},
{
"measure": "Compound CR rate"
},
{
"measure": "Objective remission rate"
},
{
"measure": "No remission rate"
},
{
"measure": "Event-free survival"
},
{
"measure": "Disease-free survival"
},
{
"measure": "Overall survival"
},
{
"measure": "Mortality rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ruijin Hospital"
},
{
"name": "Shanxi Province Cancer Hospital"
},
{
"name": "The First Affiliated Hospital of Zhengzhou University"
},
{
"name": "Jingzhou Central Hospital"
},
{
"name": "Yichang Central People's Hospital"
},
{
"name": "Taihe Hospital"
},
{
"name": "The Central Hospital of Xiaogan"
},
{
"name": "Xianning Central Hospital"
},
{
"name": "The First People's Hospital of Jingzhou"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Zhongnan Hospital"
}
},
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"completionDateStruct": {
"date": "2028-12-31"
},
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"date": "2024-04-10"
},
"overallStatus": "RECRUITING",
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"date": "2026-12-31"
},
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"date": "2024-01-18"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
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]
},
"contactsLocationsModule": {
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{
"city": "Milano",
"contacts": null,
"country": "Italy",
"facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano",
"geoPoint": {
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"lon": 9.18951
},
"state": "MI",
"status": null,
"zip": "20122"
}
]
},
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},
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},
"phases": null,
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},
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"OLDER_ADULT"
]
},
"identificationModule": {
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"nctId": "NCT06345352",
"orgStudyIdInfo": {
"id": "IRFMN_7520_PoliMI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Algorithm creation"
},
{
"measure": "Algorithm validation"
},
{
"measure": "Algorithm application"
},
{
"measure": "Appropriateness estimation"
}
],
"secondaryOutcomes": null
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"sponsorCollaboratorsModule": {
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"class": "OTHER",
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}
},
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},
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"date": "2024-12"
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"date": "2020-09-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Armour Thyroid"
},
{
"name": "Levothyroxine"
}
]
},
"conditionsModule": {
"conditions": [
"Hypothyroidism"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Encinitas",
"contacts": null,
"country": "United States",
"facility": "Diagnamics Inc. /ID# 262680",
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"lon": -117.29198
},
"state": "California",
"status": "RECRUITING",
"zip": "92024"
},
{
"city": "Greenbrae",
"contacts": null,
"country": "United States",
"facility": "NorCal Medical Research /ID# 256512",
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"lon": -122.5247
},
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"status": "RECRUITING",
"zip": "94904"
},
{
"city": "Ocoee",
"contacts": null,
"country": "United States",
"facility": "West Orange Endocrinology /ID# 256139",
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"lon": -81.54396
},
"state": "Florida",
"status": "RECRUITING",
"zip": "34761-4547"
},
{
"city": "Roswell",
"contacts": [
{
"email": null,
"name": "Site Coordinator",
"phone": "678-878-4750",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Endocrine Research Solutions /ID# 256784",
"geoPoint": {
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"lon": -84.36159
},
"state": "Georgia",
"status": "RECRUITING",
"zip": "30076"
},
{
"city": "Council Bluffs",
"contacts": null,
"country": "United States",
"facility": "West Broadway Clinic /ID# 256756",
"geoPoint": {
"lat": 41.26194,
"lon": -95.86083
},
"state": "Iowa",
"status": "RECRUITING",
"zip": "51501-3822"
},
{
"city": "Louisville",
"contacts": null,
"country": "United States",
"facility": "L-MARC Research Center /ID# 255733",
"geoPoint": {
"lat": 38.25424,
"lon": -85.75941
},
"state": "Kentucky",
"status": "RECRUITING",
"zip": "40213-1014"
},
{
"city": "Greenville",
"contacts": null,
"country": "United States",
"facility": "Physician's East Endocrinology /ID# 256491",
"geoPoint": {
"lat": 35.61266,
"lon": -77.36635
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27834"
},
{
"city": "Canton",
"contacts": null,
"country": "United States",
"facility": "Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751",
"geoPoint": {
"lat": 40.79895,
"lon": -81.37845
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "44718"
},
{
"city": "Norman",
"contacts": null,
"country": "United States",
"facility": "Lynn Institute of Norman /ID# 256785",
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"lat": 35.22257,
"lon": -97.43948
},
"state": "Oklahoma",
"status": "RECRUITING",
"zip": "73072"
},
{
"city": "Oklahoma City",
"contacts": null,
"country": "United States",
"facility": "Lynn Institute of Oklahoma City /ID# 263141",
"geoPoint": {
"lat": 35.46756,
"lon": -97.51643
},
"state": "Oklahoma",
"status": "RECRUITING",
"zip": "73112"
},
{
"city": "Austin",
"contacts": [
{
"email": null,
"name": "Site Coordinator",
"phone": "512-334-3505",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Texas Diabetes and Endocrinology - Central Austin /ID# 255728",
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"lat": 30.26715,
"lon": -97.74306
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78731"
},
{
"city": "Austin",
"contacts": null,
"country": "United States",
"facility": "Texas Diabetes and Endocrinology - South Austin /ID# 255723",
"geoPoint": {
"lat": 30.26715,
"lon": -97.74306
},
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"status": "RECRUITING",
"zip": "78749"
},
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "North TX Endocrine Center /ID# 255737",
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"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75231"
},
{
"city": "Fort Worth",
"contacts": null,
"country": "United States",
"facility": "Diabetes and Thyroid Center of Ft. Worth /ID# 256781",
"geoPoint": {
"lat": 32.72541,
"lon": -97.32085
},
"state": "Texas",
"status": "RECRUITING",
"zip": "76132"
},
{
"city": "Houston",
"contacts": null,
"country": "United States",
"facility": "Juno Research /ID# 259238",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77040-5059"
},
{
"city": "Shavano Park",
"contacts": [
{
"email": null,
"name": "Site Coordinator",
"phone": "210.291.3797",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Consano Clinical Research, LLC /ID# 256138",
"geoPoint": {
"lat": 29.58495,
"lon": -98.55252
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78231"
},
{
"city": "Weslaco",
"contacts": null,
"country": "United States",
"facility": "Texas Valley Clinical Research /ID# 261476",
"geoPoint": {
"lat": 26.15952,
"lon": -97.99084
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78596"
}
]
},
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},
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"INVESTIGATOR"
]
},
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants",
"nctId": "NCT06345339",
"orgStudyIdInfo": {
"id": "M21-341",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response"
},
{
"measure": "Number of Participants with Adverse Events (AEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of Participants who Achieve TSH Response"
},
{
"measure": "Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid"
},
{
"measure": "Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AbbVie"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Greater occipital nerve block"
}
]
},
"conditionsModule": {
"conditions": [
"Migraine"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Sukriye Dadali, MD",
"phone": "+905333316636",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ankara City Hospital Bilkent",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": "RECRUITING",
"zip": "06680"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF)"
},
"designModule": {
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"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective observational",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GON-B/PRF",
"briefTitle": "Greater Occipital Nerve Block Versus Pulse Radiofrequency in Migraine",
"nctId": "NCT06345326",
"orgStudyIdInfo": {
"id": "E1-22-3155",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "NRS"
}
],
"secondaryOutcomes": [
{
"measure": "Complications"
},
{
"measure": "the frequency of headhache"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ankara City Hospital Bilkent"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Adiyaman University Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Day Group"
},
{
"name": "Night Group"
}
]
},
"conditionsModule": {
"conditions": [
"Inflammatory Response"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Burcu Dikmen Demiryorgan",
"phone": "+905067611029",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Fatma Kavak Akelma",
"phone": "+905327079113",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ankara Bilkent City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Cankaya",
"status": null,
"zip": "06800"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"whoMasked": [
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]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "EFFECT OF CIRCADIAN RHYTHM ON INFLAMMATORY PARAMETERS IN UNILATERAL INGUINAL HERNIORRAHIES",
"nctId": "NCT06345313",
"orgStudyIdInfo": {
"id": "CIRCADIAN RHYTHM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Postoperative pain scores according to the difference in circadian rhythm"
}
],
"primaryOutcomes": [
{
"measure": "Change of IL6 (interleukin) (ng/ml)"
}
],
"secondaryOutcomes": [
{
"measure": "Quality of recovery from anesthesia according to difference in circadian rhythm"
},
{
"measure": "Change of NLR ( Neutrophil/ Lymphocyte Ratio )"
},
{
"measure": "Change of PLR ( Platelet / Lymphocyte Ratio )"
},
{
"measure": "Change of SII (Systemic immune-inflammation index )"
},
{
"measure": "Change of CRP (C Reactive Protein) (mg/dl)"
},
{
"measure": "Change of Fibrinogen (mg)"
},
{
"measure": "Change of Sedimentation (mm/hour)"
},
{
"measure": "Change of Procalcitonin (µg/l)"
},
{
"measure": "Change of Ferritin (ml/ng)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab"
},
{
"name": "Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate"
}
]
},
"conditionsModule": {
"conditions": [
"Borderline Resectable Pancreatic Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijin",
"contacts": [
{
"email": "[email protected]",
"name": "Yongkun Sun",
"phone": "13141276041",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Cancer Institute and Hospital, Chinese Academy of Medical Sciences",
"geoPoint": null,
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study",
"nctId": "NCT06345300",
"orgStudyIdInfo": {
"id": "NCC4309",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "R0 resection rate"
}
],
"secondaryOutcomes": [
{
"measure": "Event free survival (EFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Objective Response Rate(ORR)"
},
{
"measure": "Disease Control Rate（DCR）"
},
{
"measure": "Safety and tolerability by incidence, severity and outcome of adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Jiangsu HengRui Medicine Co., Ltd."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Cancer Institute and Hospital, Chinese Academy of Medical Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-24"
},
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"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "radical radiotherapy (60Gy)"
},
{
"name": "radical radiotherapy (66Gy)"
},
{
"name": "radical radiotherapy (70Gy)"
},
{
"name": "anti-PD-1 or PD-L1 antibody"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Jingbo Wang, Doctor",
"phone": "15811166516",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 133,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC",
"nctId": "NCT06345287",
"orgStudyIdInfo": {
"id": "24/018-4298",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Deep partial response"
},
{
"measure": "Local-Regional failure survival"
},
{
"measure": "Toxicity Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cancer Institute and Hospital, Chinese Academy of Medical Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Measurement Based Care Training and Monthly Consultation"
}
]
},
"conditionsModule": {
"conditions": [
"Opioid Use Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": null,
"country": "United States",
"facility": "Family Guidance Centers, Inc.",
"geoPoint": {
"lat": 41.76058,
"lon": -88.32007
},
"state": "Illinois",
"status": null,
"zip": "60505"
},
{
"city": "Chicago",
"contacts": [
{
"email": null,
"name": "Kelli Scott, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Northwestern University Feinberg School of Medicine",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60611"
},
{
"city": "Chicago",
"contacts": [
{
"email": null,
"name": "Kelli Scott, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Family Guidance Centers, Inc.",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60654"
},
{
"city": "Des Plaines",
"contacts": null,
"country": "United States",
"facility": "Family Guidance Centers, Inc.",
"geoPoint": {
"lat": 42.03336,
"lon": -87.8834
},
"state": "Illinois",
"status": null,
"zip": "60016"
},
{
"city": "Joliet",
"contacts": null,
"country": "United States",
"facility": "Family Guidance Centers, Inc.",
"geoPoint": {
"lat": 41.52519,
"lon": -88.0834
},
"state": "Illinois",
"status": null,
"zip": "60435"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MBC2OTP",
"briefTitle": "MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs)",
"nctId": "NCT06345274",
"orgStudyIdInfo": {
"id": "SP0077172",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "K23DA050729",
"link": "https://reporter.nih.gov/quickSearch/K23DA050729",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient treatment attendance (effectiveness outcome)"
},
{
"measure": "Patient treatment attendance (effectiveness outcome)"
},
{
"measure": "Treatment provider measurement based care exposure (implementation outcome)"
}
],
"secondaryOutcomes": [
{
"measure": "Patient opioid abstinence (effectiveness outcome)"
},
{
"measure": "Treatment provider measurement based care fidelity (implementation outcome)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Northwestern University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DiphenhydrAMINE 50 Mg/mL Injectable Solution"
},
{
"name": "Saline"
}
]
},
"conditionsModule": {
"conditions": [
"Catheter Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Cairo university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": "11562"
}
]
},
"descriptionModule": {
"briefSummary": "Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action ."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 104,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Diphenhydramine in Catheter Related Bladder Discomfort",
"nctId": "NCT06345261",
"orgStudyIdInfo": {
"id": "2024-872",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "incidence of catheter related bladder discomfort postoperative"
}
],
"secondaryOutcomes": [
{
"measure": "visual analog scale (VAS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "US-TAP"
},
{
"name": "LAPTAP"
}
]
},
"conditionsModule": {
"conditions": [
"Transversus Abdominis Plane"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Cairo university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": "11562"
}
]
},
"descriptionModule": {
"briefSummary": "The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 74,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy",
"nctId": "NCT06345248",
"orgStudyIdInfo": {
"id": "2024-854",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "morphine needed"
}
],
"secondaryOutcomes": [
{
"measure": "first analgesic request time"
},
{
"measure": "patients' satisfaction"
},
{
"measure": "opioid-associated side effects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "blood test"
}
]
},
"conditionsModule": {
"conditions": [
"Transthyretin Amyloidosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kraków",
"contacts": [
{
"email": "[email protected]",
"name": "Katarzyna Holcman, MD",
"phone": "608214249",
"phoneExt": "48",
"role": "CONTACT"
},
{
"email": null,
"name": "Katarzyna Holcman, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Poland",
"facility": "John Paul II Hospital",
"geoPoint": {
"lat": 50.06143,
"lon": 19.93658
},
"state": null,
"status": "RECRUITING",
"zip": "31-202"
}
]
},
"descriptionModule": {
"briefSummary": "The development of cardiac amyloidosis is caused by the deposition of misfolded, insoluble proteins in the extracellular matrix of tissues. An important element of the clinical picture of the disease is the increased risk of thromboembolic complications, independent of the occurrence of atrial fibrillation, and the presence of intracardiac thrombi. The pathomechanism may be related to an increase in filling pressure or amyloid infiltration leading to myocardial damage and endothelial dysfunction, which may activate the prothrombotic inflammatory cascade, resulting in increased thrombogenic potential. Currently, there is limited published data on the potential role of new heart failure biomarkers in the assessment of ATTR cardiomyopathy, particularly in the assessment of asymptomatic carriers of pathogenic TTR variants. Moreover, there are few literature reports on the direct assessment of the coagulation system in this group of patients, and the pathomechanism of the increased thromboembolic risk is unexplored.Purpose of the study: To assess the diagnostic value of biomarkers related to heart failure (growth differentiation factor-15 (GDF15), soluble suppression of tumorigenicity-2 (ST2), galectin-3), amyloidosis ( TTR, tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9, matrix metalloproteinase-9), neurofilament light chain (NfL)) and the generation potential thrombin as a marker of the prothrombotic state in the course of ATTR.Methods: This prospective, single-center study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3 , n=20). Material for research was collected and secured from all study participants. After giving informed consent, all patients will be tested using the ELISA method from peripheral blood (enzyme-linked immunosorbent assay) GDF15, ST2, TTR, TIMP-1, MMP-9, galectin-3, NfL. The values of these biomarkers will be compared in subgroups and correlated with clinical data, laboratory test results, echocardiography including analysis of left ventricular global strain (GLS), and scintigraphy. Additionally, the prothrombotic potential of plasma will be tested in both groups of patients using the calibrated automatic thrombogram (CAT) method, in accordance with the protocol previously used in the laboratory Expected results: The project will provide information on the value of biomarkers in the assessment of ATTR cardiomyopathy, especially in the assessment of asymptomatic carriers of pathogenic TTR variants, which may translate into the creation of a diagnostic algorithm for early identification of the development of the disease. Moreover, it will allow us to determine whether patients with cardiac ATTR are characterized by a prothrombotic state, which has not yet been described in the literature and may have potential clinical implications."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "FAMILY_BASED",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "New Biomarkers and Plasma Prothrombotic Potential in Cardiac Transthyretin Amyloidosis",
"nctId": "NCT06345235",
"orgStudyIdInfo": {
"id": "ID DEC-2023/07/X/NZ5/00141",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Biomarkers"
},
{
"measure": "Thrombin as a marker"
},
{
"measure": "Biomarkers"
},
{
"measure": "Biomarkers"
},
{
"measure": "Biomarkers"
},
{
"measure": "Biomarkers"
},
{
"measure": "Biomarkers"
},
{
"measure": "Biomarkers"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "John Paul II Hospital, Krakow"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Prolotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bursa",
"contacts": null,
"country": "Turkey",
"facility": "Bursa Yuksek Ihtisas Training and Research Hospital",
"geoPoint": {
"lat": 40.19559,
"lon": 29.06013
},
"state": "Türkiye",
"status": null,
"zip": "16310"
}
]
},
"descriptionModule": {
"briefSummary": "92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Case control study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 65,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain",
"nctId": "NCT06345222",
"orgStudyIdInfo": {
"id": "GETAT 23/05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "change in knee pain with prolotherapy application"
},
{
"measure": "change in quality of life"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Bursa Yüksek İhtisas Education and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sirolimus-coated Coronary Balloon Dilatation Catheter"
},
{
"name": "Drug-coated Coronary Balloon Dilatation Catheter"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Disease"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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},
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"minimumAge": "18 Years",
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels",
"nctId": "NCT06345209",
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"id": "BM-D19",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Late luminal loss (LLL)"
}
],
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{
"measure": "Device success rate"
}
]
},
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"collaborators": [
{
"name": "Chinese Academy of Medical Sciences, Fuwai Hospital"
}
],
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},
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"date": "2024-12"
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"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "motivational interview"
}
]
},
"conditionsModule": {
"conditions": [
"Motivational Interviewing",
"Stress",
"Well-Being, Psychological",
"Diabetes Mellitus",
"Type2diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Yozgat",
"contacts": [
{
"email": "[email protected]",
"name": "Betül Bal",
"phone": "0 (354) 314 14 15",
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"role": "CONTACT"
}
],
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"lon": 34.80444
},
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"zip": null
},
{
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{
"email": "[email protected]",
"name": "Betül Bal",
"phone": "0 (354) 314 14 15",
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"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Bozok University",
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"zip": null
}
]
},
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"briefSummary": "This study will be conducted using a randomized controlled trial design to evaluate the effect of online individual motivational interviewing on well-being, stress and difficulties in individuals with diabetes. The study will be conducted between March 2024 and March 2025 with individuals with Type 2 Diabetes who are followed up in Yozgat Bozok University Health Practice and Research Center Internal Medicine Polyclinic. The motivational interview group will receive a motivational interview once a week, lasting a maximum of 40 minutes, consisting of a total of four sessions. Chi-square (X2), t-test, repeated measures analysis of variance, Pearson correlation coefficient, partial eta-square and linear regression analysis will be used to evaluate the data."
},
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"NA"
],
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},
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"maximumAge": "85 Years",
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"sex": "ALL",
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"ADULT",
"OLDER_ADULT"
]
},
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"briefTitle": "Motivational Interviewing Applied to Individuals With Diabetes",
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"id": "BozokUni",
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"type": null
},
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"otherOutcomes": [
{
"measure": "Changing Strength and Difficulties in Diabetes"
}
],
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{
"measure": "Change in coping with stress"
}
],
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{
"measure": "State of Well-Being Change"
}
]
},
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},
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"date": "2024-10-15"
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"date": "2024-05-15"
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"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
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"name": "Nivolumab + Ipilimumab combination therapy"
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{
"name": "Pembrolizumab + Lenvatinib combination therapy"
}
]
},
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"conditions": [
"Advanced Renal Cell Carcinoma (aRCC)"
]
},
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"locations": [
{
"city": "Dublin",
"contacts": null,
"country": "United States",
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"lon": -83.11408
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43017"
}
]
},
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"briefSummary": "This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy"
},
"designModule": {
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]
},
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"briefTitle": "Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients",
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"id": "CA209-1275",
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{
"measure": "Participant year of birth"
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{
"measure": "Participant sex at birth"
},
{
"measure": "Participant primary payer"
},
{
"measure": "Participant race"
},
{
"measure": "Participant ethnicity"
},
{
"measure": "Participant U.S. state of residence"
},
{
"measure": "Participant initial Renal Cell Carcinoma (RCC) diagnoses"
},
{
"measure": "American Joint Committee on Cancer (AJCC) TNM stage"
},
{
"measure": "Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis"
},
{
"measure": "Participant renal cell carcinoma (RCC) histology results"
},
{
"measure": "Participant tumor grade"
},
{
"measure": "Participant biomarker or genetic testing method"
},
{
"measure": "Participant molecular and/or genetic mutations reported"
},
{
"measure": "Participant site of metastatic disease"
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{
"measure": "Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)"
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{
"measure": "Participant Karnofsky score (KPS)"
},
{
"measure": "Participant comorbidities and/or chronic conditions"
},
{
"measure": "Participant blood test results"
},
{
"measure": "Participant Memorial Sloan Kettering Cancer Center (MSKCC) score"
},
{
"measure": "Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score"
},
{
"measure": "Participant smoking status"
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{
"measure": "Participant COVID-19 status"
},
{
"measure": "Participant surgical history"
},
{
"measure": "Participant radiation treatment history"
},
{
"measure": "Participant treatment regimen received"
},
{
"measure": "Participant treatment initiation and discontinuation dates"
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{
"measure": "Participant rationale for discontinuation of treatment"
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{
"measure": "Participant radiation therapy prescribed"
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{
"measure": "Participant total number of radiotherapy cycles"
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{
"measure": "Participant initial dose and frequency/schedule of index therapy"
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{
"measure": "Participant index treatment dose modifications"
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{
"measure": "Participant rationale for dose modifications of index therapy"
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{
"measure": "Participant date of dose modifications of index therapy"
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{
"measure": "Participant last dose and frequency/schedule of index therapy"
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"date": "2024-02-19"
},
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}
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{
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"measure": "The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI)"
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"measure": "Age and Stages Questionnarie (ASQ)"
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{
"measure": "Age and Stages Questionnaires: Social-Emotional (ASQ-SE)"
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"measure": "Brief Infant and Toddler Social Emotional Assessment (BITSEA)"
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"measure": "Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)"
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"measure": "Fatigue Severity Scale [FSS]"
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"measure": "Quality of life parameters assessed by EQ-5D-3L"
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{
"measure": "Treatment satisfaction assessed by TSQM-9"
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{
"measure": "Expanded Disability Status Scale (EDSS)"
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{
"measure": "Variation of NfL in plasma"
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{
"measure": "Adverse Events (AEs)"
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{
"measure": "Discontinuation rates due to AE and/or other reasons"
}
]
},
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"briefSummary": "Clinical practices are crucial experiences for nursing students as they prepare themselves for future nursing work. Despite some research having been studied among Taiwanese nursing students in the past, there has been limited research into the experiences within pediatric oncology wards, where diseases are complex and frequently involve life-and-death issues. Therefore, the purpose of this study is to explore the experiences of undergraduate nursing students in pediatric oncology wards."
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"interventions": [
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"name": "Non invasive blood pressure monitoring"
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"conditions": [
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"briefSummary": "By observing the anatomical relationship and influencing factors of the radial artery through ultrasound, the optimal puncture location is selected, and puncture catheterization is guided to reduce the number of punctures, reduce complications, and improve safety and accuracy."
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},
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"date": "2023-07-01"
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{
"armsInterventionsModule": {
"interventions": [
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"name": "Otago exercise program"
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},
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"measure": "The intervention is safe - Suicide behaviour while in treatment."
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{
"measure": "The potential benefits of the intervention - Relapse to alcohol abuse at 3- and 12-months follow up."
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"size": 621574,
"typeAbbrev": "ICF",
"uploadDate": "2024-03-25T10:01"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual-reality intervention"
},
{
"name": "TAU - specialized treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Eating Disorders",
"Anorexia Nervosa",
"Bulimia Nervosa"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hellerup",
"contacts": [
{
"email": "[email protected]",
"name": "Nina K Hansen, MSc (Psych.)",
"phone": "21699487",
"phoneExt": "+45",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Louise B Glenthøj, DMSc, PhD",
"phone": "21452889",
"phoneExt": "+45",
"role": "CONTACT"
},
{
"email": null,
"name": "Louise B Glenthøj, DMSc, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Denmark",
"facility": "Copenhagen Research Center for Mental Health - CORE",
"geoPoint": {
"lat": 55.73204,
"lon": 12.57093
},
"state": "Copenhagen",
"status": "RECRUITING",
"zip": "2900"
}
]
},
"descriptionModule": {
"briefSummary": "The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders",
"nctId": "NCT06345040",
"orgStudyIdInfo": {
"id": "H-22067692",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Total score of eating disorder voice characteristics post treatment"
},
{
"measure": "Level of quality of life post treatment"
},
{
"measure": "Perceived difference in power between eating disorder voice and eating disorder patient post treatment"
},
{
"measure": "Level of acceptance of and action in relation to the eating disorder voice post treatment"
},
{
"measure": "Level of self-compassion post treatment"
},
{
"measure": "Level of body dissatisfaction post treatment"
},
{
"measure": "Level of perceived self-efficacy post treatment"
},
{
"measure": "Ability to regulate emotion post treatment"
},
{
"measure": "Level of executive functioning post treatment"
},
{
"measure": "Participant satisfaction"
},
{
"measure": "Presence of childhood traumas"
},
{
"measure": "Level of simulator sickness"
},
{
"measure": "Level of dysfunctional cognitive beliefs post treatment"
},
{
"measure": "Positive and negative aspects of eating disorders as perceived by the participant post treatment"
},
{
"measure": "Personal recovery post treatment"
},
{
"measure": "Presence of comorbidity"
},
{
"measure": "Cost effectiveness of the intervention"
},
{
"measure": "Level of cognitive (in)flexibility post treatment"
},
{
"measure": "Monitoring and reporting of adverse and unwanted events"
},
{
"measure": "Level of immersion in virtual reality"
}
],
"primaryOutcomes": [
{
"measure": "Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "Level of depressive symptoms post treatment"
},
{
"measure": "Motivation for change post treatment"
},
{
"measure": "Level of identification with the eating disorder and level of embodiment post treatment"
},
{
"measure": "Experience of the eating disorder voice post treatment"
},
{
"measure": "Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mental Health Services in the Capital Region, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Treatment Arm A"
}
]
},
"conditionsModule": {
"conditions": [
"Leukemia, Myeloid, Acute",
"Leukemia, B-cell",
"Leukemia, T-Cell",
"Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Bilal Omer, MD",
"phone": "832-826-0860",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Texas Children's Hospital",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
},
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Bilal Omer, MD",
"phone": "832-826-0860",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The Methodist Hospital",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "This study is for patients that have lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease and the patients condition has come back or has not gone away after treatment, including the best treatment we know for these diseases.Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV). This virus causes mononucleosis or glandular fever (\"mono\") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma. This suggests that the EBV plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction.T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in blood and affect the tumor. We have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses (meaning the cancer could no longer be detected).We think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study we will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. We know that T cells need substances called cytokines (substances such as proteins released by specific cells of the immune system) to survive and that the cells may not get enough cytokines after the cells are infused into the body. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on the cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CASEY",
"briefTitle": "CHIMERIC ANTIGEN RECEPTOR TREATMENT TARGETING CD70 (SEVENTY)",
"nctId": "NCT06345027",
"orgStudyIdInfo": {
"id": "H-53163 CASEY",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose limiting toxicity (DLT) rate"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Response Rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Baylor College of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2042-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "OM-89 [Uro-Vaxom® Capsule]"
},
{
"name": "OM-89 Placebo [Uro-Vaxom® Capsule Placebo]"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Prostatitis With Chronic Pelvic Pain Syndrome",
"Chronic Prostatitis",
"Chronic Pelvic Pain Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": [
{
"email": "[email protected]",
"name": "JUNGMIN LEE",
"phone": "+82-02-2630-0700",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Korea, Republic of",
"facility": "AJU Pharm Co., Ltd.",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 \\[Uro-Vaxom® Capsule\\]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks.In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26. The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Background treatment - Xatral® XL Tab. 10 mg (alfuzosin hydrochloride): With the treatment of the investigational product, it will be administered for the first 13 weeks (Administration of the placebo will be continued to maintain the treatment compliance and blinding for the rest 13 weeks).After week 13, Background treatment will be blinded for subject only until end of treatment period(Week 26).",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 332,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "19 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome",
"nctId": "NCT06345014",
"orgStudyIdInfo": {
"id": "23CP40803",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "NIH-CPSI total score"
}
],
"secondaryOutcomes": [
{
"measure": "NIH-CPSI domain score"
},
{
"measure": "Subject and Investigator's Global Assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "OM Pharma SA"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "AJU Pharm Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BAY3630942"
},
{
"name": "BAY3547922"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma (HCC)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Scottsdale",
"contacts": null,
"country": "United States",
"facility": "HonorHealth",
"geoPoint": {
"lat": 33.50921,
"lon": -111.89903
},
"state": "Arizona",
"status": null,
"zip": "85258"
},
{
"city": "Los Angeles",
"contacts": null,
"country": "United States",
"facility": "University of Southern California Keck School of Medicine",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": null,
"zip": "90089"
},
{
"city": "Miami",
"contacts": null,
"country": "United States",
"facility": "Biogenix Molecular, LLC",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida",
"status": null,
"zip": "33165"
}
]
},
"descriptionModule": {
"briefSummary": "Researchers are studying a new potential treatment for liver cancer.To do this, researchers have developed a protein, called a monoclonal antibody, which can find and attach itself to another protein present on the surface of liver cancer cells. This can help the new treatment to specifically target cancer cells in the liver.In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer.Researchers will use the following two forms of monoclonal antibody as study interventions during this study:* BAY3630942: This is the monoclonal antibody attached to a tracer. A tracer emits radiation that can help researchers track the monoclonal antibody in the body using imaging tests like PET/CT (positron emission tomography / computed tomography). All participants will receive a fixed dose of BAY3630942 during the study.* BAY3547922: This is the monoclonal antibody without the tracer. Participants may receive different amounts of BAY3547922 during the study.In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help researchers develop a new treatment for people with liver cancer and find a dose to be tested in future studies.The main purpose of this first-in-human study is to check how BAY3630942 distributes among different organs in the body and how much of the radiation it emits is absorbed by the organs based on the total dose of BAY3630942 and BAY3547922 given. For this, the researchers will:* measure the amount of BAY3630942 radiation found in different organs over time.* measure the amount of BAY3630942 radiation absorbed by different organs.* use the above information to estimate the amount of radiation that would be absorbed by the same organs from the new potential treatment.Researchers will also monitor the number and severity of medical problems participants have after receiving BAY3630942 and BAY3547922. These medical problems are also known as \"adverse events\". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study interventions.The study participants will first receive BAY3547922 as an infusion into a vein followed by BAY3630942 as an injection into the same vein. Both interventions will be administered only once, on the same day.Each participant will be in the study for around 44 days with up to 7 visits to the study clinic which includes:* a visit up to 14 days before the start of the study to confirm if the participant can take part in the study.* up to 5 visits during the imaging intervention period. During this period, participants: * will receive the study interventions and have blood tests on the first visit, * will have imaging and blood tests on the next 3 visits. The tests scheduled for the second visit may be performed during the first visit. * may have blood tests on the last visit.* a follow-up visit to check their health after 30 days of receiving the study interventions.During the study, the doctors and their study team will:* check participants' health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)* track and study BAY3630942 using PET/CT imaging testsAs the study interventions are not yet treatments for liver cancer, access to BAY3630942 and BAY3547922 after the end of the study will not be required."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 17,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer",
"nctId": "NCT06345001",
"orgStudyIdInfo": {
"id": "22261",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Radioactivity concentration (SUVmean, %ID/g) of BAY3630942 in normal organs (including but not limited to kidney, spleen, liver, and bone marrow) as a function of time using 3 post-administration PET/CT scans"
},
{
"measure": "Zirconium-89 absorbed doses (mGy/MBq) in normal organs"
},
{
"measure": "Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922"
},
{
"measure": "Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)"
},
{
"measure": "AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood)"
},
{
"measure": "Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)"
},
{
"measure": "AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bayer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The exercise program"
},
{
"name": "Online education presentation"
},
{
"name": "Smart band"
}
]
},
"conditionsModule": {
"conditions": [
"Musculoskeletal Diseases or Conditions",
"Musculoskeletal Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bursa",
"contacts": [
{
"email": null,
"name": "Umut Çanakçı, Musician",
"phone": "+90 (224) 225 59 70",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sule Kecelioglu, MSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Selnur Narin Aral, Assoc. Prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Bursa Regional State Symphony Orchestra",
"geoPoint": {
"lat": 40.19559,
"lon": 29.06013
},
"state": null,
"status": "RECRUITING",
"zip": "16000"
},
{
"city": "Bursa",
"contacts": [
{
"email": null,
"name": "Gülnihal Gül, Assoc. Prof.",
"phone": "+90 (224) 294 09 42",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sule Kecelioglu, MSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Selnur Narin Aral, Assoc. Prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Bursa Uludağ University Faculty of Education Fine Arts Education Department, Department of Music Education",
"geoPoint": {
"lat": 40.19559,
"lon": 29.06013
},
"state": null,
"status": "RECRUITING",
"zip": "16285"
},
{
"city": "Bursa",
"contacts": [
{
"email": null,
"name": "Görkem Çalgan, Prof. Dr.",
"phone": "+90 (224) 294 27 00",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sule Kecelioglu, MSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Selnur Narin Aral, Assoc. Prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Bursa Uludağ University State Conservatory",
"geoPoint": {
"lat": 40.19559,
"lon": 29.06013
},
"state": null,
"status": "RECRUITING",
"zip": "16285"
},
{
"city": "İzmir",
"contacts": [
{
"email": null,
"name": "Nurdan Gürtunca, Assoc. Prof.",
"phone": "+90 (232) 311 29 44",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sule Kecelioglu, MSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Selnur Narin Aral, Assoc. Prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Ege University State Conservatory of Turkish Music",
"geoPoint": {
"lat": 38.41273,
"lon": 27.13838
},
"state": null,
"status": "RECRUITING",
"zip": "35100"
}
]
},
"descriptionModule": {
"briefSummary": "Musculoskeletal problems related to instrument playing or performance are frequently seen in musicians. Different interventions such as strength training, endurance training and yoga have been used in the management of these problems. The first specific exercise program for professional orchestra musicians was developed by Chan et al. However, it has been stated that it is difficult to encourage musicians' participation in exercise due to their constantly changing work schedules, and at this point, the use of digital media such as DVDs, USBs, and educational exercise videos may have a potential role.On the other hand, it has been stated that smart wearable devices with mobile applications (such as smart watches, smart band) as digital health interventions are an interesting, interactive and efficient psychological strategy to promote physical activity and can be used as an intervention to promote a healthy lifestyle. Based on the literature, in our study, the exercise program developed by Chan et al., will be done online via \"Google Meet\" and symptoms can be evaluated with objective evaluation methods. Unlike other studies using digital media, exercises will be performed synchronously and feedback will be given to the musicians simultaneously, as in face-to-face exercises. In addition, all participants will be given a smart band, they will be encouraged to use it until the end of the study, and the change in their physical activity levels will be evaluated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 38,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Physical and Functional Effects of Online Exercise Program on Musicians Playing Stringed Instruments",
"nctId": "NCT06344988",
"orgStudyIdInfo": {
"id": "2023/41-10",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Musculoskeletal problems"
},
{
"measure": "Muscle oxygenation"
},
{
"measure": "Pressure pain threshold"
},
{
"measure": "Reaction time"
},
{
"measure": "Grip strength"
}
],
"secondaryOutcomes": [
{
"measure": "Upper extremity function"
},
{
"measure": "Physical activity level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Bandırma Onyedi Eylül University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "STR-V003/Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Respiratory Syncytial Virus Infections"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STR-V003",
"briefTitle": "A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy Adults",
"nctId": "NCT06344975",
"orgStudyIdInfo": {
"id": "Starna Therapeutics",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Immediate unsolicited AEs for 30 minutes post-vaccination"
},
{
"measure": "Solicited injection site (local) and systemic reactions for 7 days postvaccination."
},
{
"measure": "Unsolicited AEs for 28 days postvaccination"
},
{
"measure": "Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Starna Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Absorbable Suture"
},
{
"name": "Non-absorbable Suture"
}
]
},
"conditionsModule": {
"conditions": [
"Suture, Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Qingdao",
"contacts": [
{
"email": "[email protected]",
"name": "Zhe Wu, PhD",
"phone": "+86 17863934867",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "the Affiliated Hospital of Qingdao University",
"geoPoint": {
"lat": 36.06488,
"lon": 120.38042
},
"state": "Shandong",
"status": "RECRUITING",
"zip": "266000"
}
]
},
"descriptionModule": {
"briefSummary": "Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection",
"nctId": "NCT06344962",
"orgStudyIdInfo": {
"id": "QYFYKYLL930611921",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence rate of anastomotic complications"
}
],
"secondaryOutcomes": [
{
"measure": "Time of bronchial anastomosis"
},
{
"measure": "Number of stitches"
},
{
"measure": "5-year survival rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Affiliated Hospital of Qingdao University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ciprofol"
},
{
"name": "Propofol"
}
]
},
"conditionsModule": {
"conditions": [
"Emergency Tracheal Intubation in Critically Ill Patients"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ciprofol Versus Propofol for Tracheal Intubation in ICU",
"nctId": "NCT06344949",
"orgStudyIdInfo": {
"id": "B2024-074",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "cardiovascular collapse within 30minutes from the start of the intubation procedure"
}
],
"secondaryOutcomes": [
{
"measure": "Success rate of sedation"
},
{
"measure": "Successful intubation on the first attempt"
},
{
"measure": "Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes)"
},
{
"measure": "The incidence of cardiac arrest within 30 minutes after tracheal intubation"
},
{
"measure": "The incidence of bradycardia within 30 minutes after tracheal intubation"
},
{
"measure": "The incidence of hypoxemia within 30 minutes after tracheal intubation"
},
{
"measure": "new requirement or increase of vasopressors"
},
{
"measure": "new requirement or increase of antiarrhythmic drugs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Zhongshan Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Kidney Disease(CKD)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Xin Wang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Beijing Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100730"
}
]
},
"descriptionModule": {
"briefSummary": "The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Drug-drug Interaction Study of HRS-1780 Tablets in Healthy Subjects",
"nctId": "NCT06344936",
"orgStudyIdInfo": {
"id": "HRS-1780-103",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess the Cmax of HRS-1780 in plasma."
},
{
"measure": "Assess the Tmax of HRS-1780 in plasma."
},
{
"measure": "Assess the t1/2 of HRS-1780 in plasma."
},
{
"measure": "Assess the AUC0-t of HRS-1780 in plasma."
},
{
"measure": "Assess the AUC0-inf of HRS-1780 in plasma."
}
],
"secondaryOutcomes": [
{
"measure": "Assess the incidence and severity of adverse events in healthy subjects after administration of HRS-1780 tablets."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Shandong Suncadia Medicine Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing"
},
{
"name": "Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing"
}
]
},
"conditionsModule": {
"conditions": [
"Ileostomy - Stoma",
"Rectal Neoplasms"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy",
"nctId": "NCT06344923",
"orgStudyIdInfo": {
"id": "KYLL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "postoperative complications related to ileostomy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Qilu Hospital of Shandong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure With Reduced Ejection Fraction"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a prospective cohort study, where we aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 900,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROMPT-HF-AUMC",
"briefTitle": "PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC",
"nctId": "NCT06344910",
"orgStudyIdInfo": {
"id": "20230416-C1_v2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Use of guideline-directed medical therapy (GDMT)"
}
],
"secondaryOutcomes": [
{
"measure": "All-cause mortality"
},
{
"measure": "Hospitalisation for Heart Failure"
},
{
"measure": "other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)"
},
{
"measure": "renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "AstraZeneca"
},
{
"name": "Yale University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Kinesio taping"
}
]
},
"conditionsModule": {
"conditions": [
"Appendicitis",
"Surgery",
"Pain, Acute"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Konya",
"contacts": null,
"country": "Turkey",
"facility": "University of Health Sciences Konya Health Application and Research Center",
"geoPoint": {
"lat": 37.87135,
"lon": 32.48464
},
"state": "Karatay",
"status": null,
"zip": "42020"
}
]
},
"descriptionModule": {
"briefSummary": "This study was planned to determine the effect of kinesio taping (KT) applied to the abdominal area after surgery on pain and gas output in children aged 6-12 years who had open appendicitis surgery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The effect of kinesio taping on pain in children aged 6-12 years who had open appendicitis surgery.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The research is in a parallel group, single-blind randomized controlled experimental design.Simple randomization will be applied to children who have had open appendicitis surgery and meet the inclusion criteria, without any stratification in the study.In order to determine which group the 68 children who meet the sample selection criteria in the study group will be included in, numbers from 1 to 68 will be randomly distributed to 2 groups through a computer program (https://www.randomizer.org/) without number repetition. 34 patients will be assigned to the experimental group and 34 patients to the control group. Since the person who will actively apply the taping in the study is the researcher, only the children will be blinded, therefore a single blind design will be applied.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Kinesio Taping in Pediatric Surgery",
"nctId": "NCT06344897",
"orgStudyIdInfo": {
"id": "mac1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Kinesio tape applying affects pain in children aged 6-12 years who have appendicitis surgery."
},
{
"measure": "Kinesio tape applying affects fear in children aged 6-12 years who have appendicitis surgery."
}
],
"secondaryOutcomes": [
{
"measure": "Kinesio taping affects gas output time in children aged 6-12 years who have appendicitis surgery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Nigde Omer Halisdemir University"
},
{
"name": "University of Health Sciences Konya Health Application and Research Center"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "KTO Karatay University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Early catheter removal"
}
]
},
"conditionsModule": {
"conditions": [
"Urinary Retention Postoperative",
"Postoperative Urinary Tract Infection",
"Catheter Site Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Raleigh",
"contacts": [
{
"email": "[email protected]",
"name": "Lauren Tholemeier, MD",
"phone": "984-974-0496",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UNC Health Rex",
"geoPoint": {
"lat": 35.7721,
"lon": -78.63861
},
"state": "North Carolina",
"status": null,
"zip": "27607"
}
]
},
"descriptionModule": {
"briefSummary": "Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 128,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CARES2",
"briefTitle": "Early Patient Removal of Urinary Catheters After Urogynecologic Surgery",
"nctId": "NCT06344884",
"orgStudyIdInfo": {
"id": "23-2619",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of patients with ongoing urinary retention (noninferiority)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of patient contacts for voiding dysfunction by Type"
},
{
"measure": "Total patient contacts for voiding dysfunction Combined"
},
{
"measure": "Number of patients treated for postoperative UTI."
},
{
"measure": "Number of patients with ongoing urinary retention"
},
{
"measure": "Patient Satisfaction Survey Score-Pain"
},
{
"measure": "Patient Satisfaction Survey Score-Ease of Use"
},
{
"measure": "Patient Satisfaction Survey Score-Satisfaction"
},
{
"measure": "Patient Satisfaction Survey Score-Likelihood to Use Again"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NeuroLF"
},
{
"name": "Conventional PET scan"
}
]
},
"conditionsModule": {
"conditions": [
"Brain Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leipzig",
"contacts": [
{
"email": "[email protected]",
"name": "Henryk Barthel, Prof.Dr.",
"phone": "+49 341 97 18082",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Henryk Barthel, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "University Hospital Leipzig",
"geoPoint": {
"lat": 51.33962,
"lon": 12.37129
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Zürich",
"contacts": [
{
"email": "[email protected]",
"name": "Martin Hüllner, Prof. Dr.",
"phone": "+41 44 255 25 80",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Martin Hüllner, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "University Hospital Zurich",
"geoPoint": {
"lat": 47.36667,
"lon": 8.54999
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The \"NeuroLF prototype\" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF",
"nctId": "NCT06344871",
"orgStudyIdInfo": {
"id": "002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PET Image of the Brain"
}
],
"secondaryOutcomes": [
{
"measure": "Ease of Placement (Usability)"
},
{
"measure": "Usage of accessories for patient placement (Usability)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Zurich"
},
{
"name": "University of Leipzig"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Positrigo AG"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ketamine"
}
]
},
"conditionsModule": {
"conditions": [
"Analgesia",
"Ketamine",
"Pharmacokinetic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santiago",
"contacts": null,
"country": "Chile",
"facility": "Pontificia Universidad Catolica de Chile",
"geoPoint": {
"lat": -33.45694,
"lon": -70.64827
},
"state": "Metropolitana",
"status": null,
"zip": "450881"
}
]
},
"descriptionModule": {
"briefSummary": "Ketamine, an intravenous anesthetic, and analgesic agent has experienced a resurgence in its clinical application, particularly in subanesthetic doses. The aim of this observational study is to characterize the changes in the Nociception Analgesia Index (ANI) associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic (PKPD) modeling approach. The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose. An Emax model and a link model assuming a first order rate constant (ke0) will be used to fit the data. Modeling analysis will use the program NONMEM. It is expected to recruit a total of 20 patients between 40 and 80 years, ASA I, II or III, programmed for elective surgery with general anesthesia. ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Keta-ANI",
"briefTitle": "Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI",
"nctId": "NCT06344858",
"orgStudyIdInfo": {
"id": "124/2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To measure ANI values after ketamine bolus dose administration."
},
{
"measure": "To determine the time maximum predicted concentrations in each patient"
},
{
"measure": "To determine the time to maximum effect of a bolus dose of ketamine"
},
{
"measure": "To predict ketamine plasma concentrations values after ketamine bolus"
},
{
"measure": "To calculate the difference between the time of maximum ANI effect"
}
],
"secondaryOutcomes": [
{
"measure": "Patient weight"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pontificia Universidad Catolica de Chile"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "18F-PBB3 PET/CT scan"
}
]
},
"conditionsModule": {
"conditions": [
"Neurodegenerative Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Chenhao Jia, M.D.",
"phone": "18548703382",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ruixue Cui, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100730"
}
]
},
"descriptionModule": {
"briefSummary": "In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through \\[18F\\]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of \\[11C\\]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "49 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases",
"nctId": "NCT06344845",
"orgStudyIdInfo": {
"id": "PUMCH-NM-PBB3",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic Performance"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical Stage"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Gastro-entero-pancreatic Neuroendocrine Tumor"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The research aims to prospectively include patients with GEP-NENs, undergo preoperative imaging assessment (including PET/CT and contrast-enhanced CT), and accurately delineate lymph node regions. Through postoperative pathological reports, the diagnostic performance of lymph node metastasis (LNM) in GEP-NENs is evaluated. Factors influencing the diagnostic accuracy of SSTR-PET/CT and contrast-enhanced CT are also investigated."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs",
"nctId": "NCT06344832",
"orgStudyIdInfo": {
"id": "K5098",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "lymph node metastasis status"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acupuncture"
},
{
"name": "Sham Acupuncture"
}
]
},
"conditionsModule": {
"conditions": [
"Sepsis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": null,
"name": "Gary Deng, MD, PhD",
"phone": "646-608-8556",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Cancer Center",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10065"
}
]
},
"descriptionModule": {
"briefSummary": "Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Acupuncture Study for People At High Risk for Sepsis",
"nctId": "NCT06344819",
"orgStudyIdInfo": {
"id": "24-062",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants recruited compared to the number of participants who complete study treatment."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Memorial Sloan Kettering Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gamified Breastfeeding Education"
}
]
},
"conditionsModule": {
"conditions": [
"Breastfeeding"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Lokman Hekim University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Objective: This study was conducted to determine the effect of breastfeeding education given through gamification on breastfeeding self-efficacy and infant feeding attitudes of pregnant women.Method: This study is a randomized controlled pretest-posttest parallel group experimental study, and 28 women included in the experimental group and 28 women in the control group. In the study, \"Sociodemographic Information Form\", \"Breastfeeding Self-Efficacy Scale Short Form-Antenatal Form (BSES-SF), \", \"Infant Nutrition Attitude Scale (IOWA)\" Form was used. The data analyzed in SPSS program.Breastfeeding education content integrated into the game program designed with the gamification technique. A training program was applied to the women in the experimental group in the last trimester. Women in the control group received the standard breastfeeding training in the hospital. Measurement tools was applied to all participants before and after the training.Conclusion and Suggestions: In this planned study, it was aimed to teach women about breastfeeding in a digital environment in a fun way. In this study, it is found that breastfeeding education given through gamification have a positive effect on breastfeeding self-efficacy and infant feeding attitudes of pregnant women."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "49 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "gamification",
"briefTitle": "The Effect of Gamification on Breastfeeding Self-Efficacy and Infant Nutrition Attitudes of Pregnant Women",
"nctId": "NCT06344806",
"orgStudyIdInfo": {
"id": "oyunlastirmabeslenme",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "breastfeeding self-efficacy"
},
{
"measure": "infant feeding attitudes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Lokman Hekim Üniversitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Biyun Wang",
"phone": "18017312387",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer",
"nctId": "NCT06344793",
"orgStudyIdInfo": {
"id": "YOUNGBC-30",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PFS"
}
],
"secondaryOutcomes": [
{
"measure": "OS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Biyun Wang",
"phone": "18017312387",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer."
},
"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": "75 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Abemaciclib, Palbociclib or Dalpiciclib Combined With Endocrine Therapy as First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer",
"nctId": "NCT06344780",
"orgStudyIdInfo": {
"id": "YOUNGBC-28",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PFS"
}
],
"secondaryOutcomes": [
{
"measure": "OS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "China,Shanghai",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "To investigate the treatment pattern and efficacy of patients with negative primary ER lesion but positive ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 19,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Positive ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-negative Primary Tumor",
"nctId": "NCT06344767",
"orgStudyIdInfo": {
"id": "YOUNGBC-27",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression free survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gamified education"
}
]
},
"conditionsModule": {
"conditions": [
"Gamification",
"Reproductive Health",
"Family Planning",
"Students"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Lokman Hekim University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06300"
}
]
},
"descriptionModule": {
"briefSummary": "More than 3 billion of the worlds population are young people under the age of 25. According to WHO data, one million girls under the age of 15 give birth each year, mostly in low- and middle-income countries, and 3 million adolescent girls between the ages of 15 and 19 are exposed to unsafe abortions. Failure to meet the family planning needs of young people in a timely, adequate and appropriate manner can have significant public health impacts. According to World Health Statistics, the global birth rate for girls between 15 and 19 years of age is 49 out of 1000, and early pregnancy and childbirth can lead to serious health and social problems. In addition, this age group does not have sufficient information about pregnancy and its complications, and their access to and utilization of health services is low. Inadequacies in the education of adolescents on sexual issues and sociocultural differences further increase the sexual and reproductive health risks of young people in the university period. Information and services that will enable individuals to understand their sexuality and help them protect themselves from sexual risks should be provided specifically for that age. Therefore, it is important for young people to know family planning methods. In this study, it was aimed to examine the effect of family planning education to be given with gamification method, which is different from the classical method in the literature, on the knowledge and attitudes of university students."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "pre-test and post-test interventional study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "the person doing the statistical analysis will be blinded",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Gamification in Family Planning Education: Impact on University Students",
"nctId": "NCT06344754",
"orgStudyIdInfo": {
"id": "gamifiedfamilyplanning",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Knowledge and attitude towards family planning"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Lokman Hekim Üniversitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Accepted in latent phase"
},
{
"name": "Accepted in active phase"
}
]
},
"conditionsModule": {
"conditions": [
"Fear of Childbirth",
"Neonatal",
"Pain",
"Maternal Distress (During Labor)",
"Satisfaction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kocaeli",
"contacts": [
{
"email": "[email protected]",
"name": "Sena Dilek Aksoy, Ph.D.",
"phone": "+902623034739",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Cemile Gokce",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Kocaeli University",
"geoPoint": {
"lat": 39.62497,
"lon": 27.51145
},
"state": null,
"status": "RECRUITING",
"zip": "41380"
}
]
},
"descriptionModule": {
"briefSummary": "This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G\\*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Consequences of Admission to the Delivery Room in the Early and Late Phases",
"nctId": "NCT06344741",
"orgStudyIdInfo": {
"id": "sdilek6",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neonatal pain and stress"
},
{
"measure": "Birth satisfaction"
}
],
"secondaryOutcomes": [
{
"measure": "Maternal Anxiety"
},
{
"measure": "Fear of Birth"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kocaeli University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-13"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Brensocatib Oral Solution"
},
{
"name": "Brensocatib Oral Tablet"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Participants"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "USA001",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75230"
}
]
},
"descriptionModule": {
"briefSummary": "The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets 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": 24,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "INS1007",
"briefTitle": "A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants",
"nctId": "NCT06344728",
"orgStudyIdInfo": {
"id": "INS1007-110",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants who Experienced at Least one Adverse Event (AE)"
},
{
"measure": "Concentration of Brensocatib in Plasma"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Insmed Incorporated"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SL-T10"
},
{
"name": "GX-I7"
},
{
"name": "Pembrolizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Castration-resistant Prostate Cancer (mCRPC)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Seoul National University Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.",
"nctId": "NCT06344715",
"orgStudyIdInfo": {
"id": "SL-T10-001_P1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with treatment-emergent adverse events (TEAEs)"
},
{
"measure": "Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0"
}
],
"secondaryOutcomes": [
{
"measure": "PSA response rate"
},
{
"measure": "PSA progression free survival"
},
{
"measure": "Radiographic progression free survival"
},
{
"measure": "Change of induced T-cell responses for SL-T10 vaccine"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "SL VAXiGEN"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CPAP"
}
]
},
"conditionsModule": {
"conditions": [
"Maternal Hypertension"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about the impact of CPAP on the maternal and infant outcomes of women with obstructive sleep apnea syndrome. The main questions aim to answer are:\\[question 1\\]Explore the impact of different CPAP treatment times on the maternal and infant outcomes of pregnant women with combined OSAS; \\[question 2\\]Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women.The CPAP treatment group received standardized CPAP treatment and routine prenatal care, while the non CPAP treatment group and non OSAS group only received routine prenatal care."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 108,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of CPAP on Maternal and Infant Outcomes in Pregnant Women With OSAS",
"nctId": "NCT06344702",
"orgStudyIdInfo": {
"id": "2024PHB065-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking University People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Surgical treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Patients With Cicatricial Ectropion",
"Over 18-year-old",
"With Complete Clinical Record"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Shanghai ninth people's hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": null,
"zip": "200011"
}
]
},
"descriptionModule": {
"briefSummary": "The main purpose of this study is to verify and compare the treatment effects of scarred ectropion surgery, perform statistical descriptions, compare patients undergoing tarsal strip and skin flap procedures with those undergoing simple skin flap treatment, and compare their pre- and post-operative Ectropion Grading Scale (EGS) and subjective and objective symptom changes.Secondary Objective: To observe the incidence and resolution of complications after lower eyelid ectropion surgery. Compare postoperative effects among patients of different ages undergoing the same surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 26,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Surgical Correction of Cicatricial Ectropion",
"nctId": "NCT06344689",
"orgStudyIdInfo": {
"id": "SH9H-2023-T477",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ectropion Grading Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cognitive"
},
{
"name": "Mobility"
},
{
"name": "Social"
},
{
"name": "Relational"
},
{
"name": "Usual Care"
}
]
},
"conditionsModule": {
"conditions": [
"Elderly People",
"Nursing Home Residents",
"Loneliness",
"Quality of Life",
"Wellbeing",
"Social Interaction"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. The main questions it aims to answer are:* Can social robots reduce unwanted loneliness?* Can social robots improve quality of live and well-being? The selected centers are organized in several classes of living units. Living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). Living units of the same class gather persons with similar characteristics.To compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group.The persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. Namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. Furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities.The intervention will last 8 weeks. To assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 162,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "WITHPEPPER",
"briefTitle": "Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes",
"nctId": "NCT06344676",
"orgStudyIdInfo": {
"id": "FSIE2024Robot",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CERec UAB",
"id": "6773",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Loneliness"
}
],
"secondaryOutcomes": [
{
"measure": "Well-being"
},
{
"measure": "Quality of life, irrespective of the disease"
},
{
"measure": "Satisfaction with life"
},
{
"measure": "Depressive symptoms"
},
{
"measure": "Social Support"
},
{
"measure": "Communication"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sara Domenech"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "motivational interview"
}
]
},
"conditionsModule": {
"conditions": [
"Motivation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kahramanmaraş",
"contacts": [
{
"email": "[email protected]",
"name": "eda sever",
"phone": "+90 531 232 10 96",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Eda Sever",
"geoPoint": {
"lat": 37.5847,
"lon": 36.92641
},
"state": "Onikişubat",
"status": "RECRUITING",
"zip": "46370"
}
]
},
"descriptionModule": {
"briefSummary": "Motivational interviewing is a technique used in many fields. No study has been found in national and international databases investigating the effect of motivational interviewing on the perception of insufficient milk, breastfeeding motivation and cortisol level. The study aimed to evaluate the effect of motivational interviews on the perception of insufficient milk, breastfeeding motivation and cortisol level."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 130,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Motivational Interviewing Inadequate Milk and Cortisol",
"nctId": "NCT06344663",
"orgStudyIdInfo": {
"id": "KSIU-SBF-ES-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Visual Analog Scale (VAS)"
}
],
"primaryOutcomes": [
{
"measure": "Insufficient Milk Perception Scale (ANN)"
}
],
"secondaryOutcomes": [
{
"measure": "Breastfeeding Motivation Scale (EMS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kahramanmaras Sutcu Imam University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood sample"
}
]
},
"conditionsModule": {
"conditions": [
"Acromegaly",
"Bone Fracture"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Gabriela Felipe",
"phone": "0226435062",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Andrea Giustina",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20132"
}
]
},
"descriptionModule": {
"briefSummary": "Prospective observational clinical, molecular, translational and basic study aimed at identifying the main determinants and predictive factors of risk of bone damage in acromegaly patients"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CROSSOVER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study",
"nctId": "NCT06344650",
"orgStudyIdInfo": {
"id": "RF-2021-12373584",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identify the rate of morphometric vertebral fractures in acromegalic patients"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fondazione Policlinico Universitario Campus Bio-Medico"
},
{
"name": "Istituto Auxologico Italiano"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "10 % lidocaine spray without adrenaline"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Pain, Procedural",
"Lidocaine",
"Obstetric Surgical Procedures"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Udon Thani",
"contacts": null,
"country": "Thailand",
"facility": "UdonThani Hospital",
"geoPoint": {
"lat": 17.41567,
"lon": 102.78589
},
"state": "UdonThani",
"status": null,
"zip": "41000"
}
]
},
"descriptionModule": {
"briefSummary": "This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 216,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration",
"nctId": "NCT06344637",
"orgStudyIdInfo": {
"id": "2566/081 I",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "pain score during manual vauum aspiration"
},
{
"measure": "pain score after manual vauum aspiration"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "UdonThani Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-10-30",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 178265,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-03-20T05:36"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CBT group"
},
{
"name": "Laughter group"
}
]
},
"conditionsModule": {
"conditions": [
"Mental Health Issue"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mersin",
"contacts": [
{
"email": "[email protected]",
"name": "EMİNE ÖNCÜ, Assoc.Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zeliha Yaman, Doctorate",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Filiz Değirmenci, Doctorate",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Turkey, Mersin University",
"geoPoint": {
"lat": 36.79526,
"lon": 34.61792
},
"state": null,
"status": null,
"zip": "33180"
}
]
},
"descriptionModule": {
"briefSummary": "The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A randomized controlled trial with a pretest-posttest design",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Using the block randomization technique, the sampled students will be split into two groups: the CBT group and the laughter group. Six will be the block size. Excel will be used to create blocks (allocation concealment) and random numbers will be generated by an assistant researcher who does not attend therapy sessions. The purpose of the program is to support mental health and evaluate its effectiveness; students will not be informed about which group they are in (participant blinding).Research data will be coded as A and B and entered into the computer database by someone other than the researchers conducting the therapy sessions, and statistical analysis will be performed using this coding (statistician blinding).",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 114,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students",
"nctId": "NCT06344624",
"orgStudyIdInfo": {
"id": "Mersin_U",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The change in mental symptoms will be assessed using the Brief Symptom Inventory."
}
],
"secondaryOutcomes": [
{
"measure": "Psychological resilience will be assessed using the Psychological Resilience Scale."
},
{
"measure": "Negative self-evaluations and thought patterns will be assessed using the Automatic Thoughts Scale."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mersin University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Other"
}
]
},
"conditionsModule": {
"conditions": [
"Decompensated Cirrhosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New Delhi",
"contacts": [
{
"email": "[email protected]",
"name": "Dr Anmol Anmol, MD",
"phone": "01146300000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "India",
"facility": "Institute of Liver and Biliary Sciences",
"geoPoint": {
"lat": 28.63576,
"lon": 77.22445
},
"state": "Delhi",
"status": null,
"zip": "110070"
}
]
},
"descriptionModule": {
"briefSummary": "Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or chronic liver injury due to toxic, infectious, metabolic and genetic pathogenic factors. Traditionally, the natural history of cirrhosis has often been considered a one-way street, with a definite and irreversible progression from a compensated to a decompensated disease stage. But recent data has shown that if the underlying etiology can be successfully treated, cirrhosis can regress and recompensation of liver disease can occur. Hence, in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria. We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase (DCLD) subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria",
"nctId": "NCT06344611",
"orgStudyIdInfo": {
"id": "ILBS-DCLD-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria"
}
],
"secondaryOutcomes": [
{
"measure": "To evaluate the predictive factors of recompensation in pediatric DCLD subjects"
},
{
"measure": "To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in in pediatric subjects with decompensated cirrhosis."
},
{
"measure": "To assess incidence of re-decompensation in patients with recompensation."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institute of Liver and Biliary Sciences, India"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Improving the Early Diagnosis of Osteoporosis in Adults and Children Living in the Abay Region of Kazakhstan"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Semey",
"contacts": [
{
"email": "[email protected]",
"name": "Madina MD Madiyeva, PhD",
"phone": "+77085244745",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Gulzhan MD Bersimbekova",
"phone": "+77023728412",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Kazakhstan",
"facility": "Semey Medical University",
"geoPoint": {
"lat": 50.42675,
"lon": 80.26669
},
"state": null,
"status": "RECRUITING",
"zip": "071400"
}
]
},
"descriptionModule": {
"briefSummary": "A survey of people to identify risk factors for osteoporosis, which include age, gender, lifestyle, diet, physical activity, the presence or absence of somatic pathology. Diagnosis of osteoporosis by dual-energy X-ray absorptiometry. Conducting a correlation analysis of the relationship of the data obtained."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "ECOLOGIC_OR_COMMUNITY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Identification and Assessment of Risk Factors for the Development of Osteoporosis in Adults and Children Living in the Abay Region of the Republic of Kazakhstan Using the Method of Dual-energy X-ray Absorptiometry and Clinical and Epidemiological Research",
"nctId": "NCT06344598",
"orgStudyIdInfo": {
"id": "0123РК00314",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan",
"id": "AP19680262",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Risk factors for the development of osteoporosis will be identified and quantified in the formed study groups of adults"
},
{
"measure": "to determine the diagnostic value of the risk factors for the development of osteoporosis obtained during the examination"
},
{
"measure": "to assess the state of BMD in adults using X-ray absorptiometry (DXA)"
},
{
"measure": "To carry out a correlation analysis of the relationship between the obtained data in adults of the Abay region of of the Republic of Kazakhstan"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ministry of Science and Higher Education of the Republic of Kazakhstan"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Semey State Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Drop out patients who had their first access in 2021 were additionally asked to answer to a phone -call questionnaire to assess their motivation of discontinuation"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rozzano",
"contacts": null,
"country": "Italy",
"facility": "Istituto Clinico Humanitas",
"geoPoint": {
"lat": 45.38193,
"lon": 9.1559
},
"state": "Milano",
"status": null,
"zip": "20089"
}
]
},
"descriptionModule": {
"briefSummary": "Conducted at a single-center, this prospective-retrospective study focused on all couples who initiated their journey at the Fertility Center of Humanitas Research Hospital, Rozzano (Milan), Italy.The prospective study focused on the couples whose first consultation occurred in 2021. A tailored questionnaire was administered via telephone by staff members to gather insights into the personal reasons for treatment discontinuation among non-returning patients.Conversely, the retrospective study included all infertile couples initiating treatment between January 2012 and December 2021 at the Fertility Center. Data encompassing personal history and demographic details were extracted from the internal database of Humanitas Fertility Center to assess the factors involved in a treatment discontinuation."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 24773,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "46 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "dropout",
"briefTitle": "Drop-out of Infertile Couples: a Large Single Center Experience Over 10 Years",
"nctId": "NCT06344585",
"orgStudyIdInfo": {
"id": "DROPOUT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dropout rate"
}
],
"secondaryOutcomes": [
{
"measure": "Reasons for dropout collected by a phone call questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Clinico Humanitas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2012-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SAT-001"
},
{
"name": "Single vision spectacles"
}
]
},
"conditionsModule": {
"conditions": [
"Myopia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Incheon",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Gachon University Gil Hospital",
"geoPoint": {
"lat": 37.45646,
"lon": 126.70515
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia",
"nctId": "NCT06344572",
"orgStudyIdInfo": {
"id": "SAT001-KP-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Cycloplegic Spherical Equivalent Refractive Error"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Cycloplegic Spherical Equivalent Refractive Error"
},
{
"measure": "Change in Axial Length"
},
{
"measure": "Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia)"
},
{
"measure": "Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "S-Alpha Therapeutics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-27"
},
"studyFirstPostDateStruct": {
"date": "2024-04-03"
}
}
} | false | null |
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