protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane"
},
{
"name": "Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane"
}
]
},
"conditionsModule": {
"conditions": [
"Bone Resorption"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Georgios Markantonatos, DDS",
"phone": "+34666022568",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Cristina Vallès, DDS, MS, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Georgios Markantonatos",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": "Sant Cugat Del Vallès",
"status": "RECRUITING",
"zip": "08195"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 26,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes",
"nctId": "NCT06334159",
"orgStudyIdInfo": {
"id": "PER-ECL-2019-08",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Horizontal Bone Gain"
},
{
"measure": "Bone Width Gain"
}
],
"secondaryOutcomes": [
{
"measure": "Horizontal Dimensional Stability"
},
{
"measure": "Post-surgical complications"
},
{
"measure": "Patient's satisfaction"
},
{
"measure": "Histologic examination of the augmented bone at 6 months"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universitat Internacional de Catalunya"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-11-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tap dance program"
}
]
},
"conditionsModule": {
"conditions": [
"Amputation; Traumatic, Leg, Lower"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Las Vegas",
"contacts": [
{
"email": "[email protected]",
"name": "Jenny Kent, PhD",
"phone": "702-895-5949",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Nevada Las Vegas",
"geoPoint": {
"lat": 36.17497,
"lon": -115.13722
},
"state": "Nevada",
"status": "RECRUITING",
"zip": "89154"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance and balance confidence.There is a lack of research investigating therapeutic interventions for people with lower limb amputation (LLA). Tap dance encourages balance and novel movements of the limbs, while providing auditory feedback from the feet that provide information about the foot's contact with the ground, which may help prosthesis users gain a better ability to understand where their prosthetic foot is in space. As with most forms of dance, tap is usually taught and practiced in a group setting, which encourages community involvement. It has been shown to be safer than many forms of dance due to low impact forces. It also, as a genre, can incorporate canes, chairs and partner work, providing the ability to modify steps/moves when required so that they remain practical, achievable and safe for people with mobility limitations, while still enabling participation. It therefore may be an accessible dance medium to help improve balance, balance confidence, and build community for people with LLA.Participants will be asked to:* come to 1 hour dance classes, once per week, for 8 weeks.* do mobility tests before and after the program* complete questionnaires before, during and after the program. The total time for participation is approximately 8-10 weeks."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tap Dance for Adults With Lower Limb Amputation",
"nctId": "NCT06334146",
"orgStudyIdInfo": {
"id": "UNLV-2023-62",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Session Adherence"
},
{
"measure": "Physical Activities Enjoyment Scale (PACES)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Timed Up-and-Go test score"
},
{
"measure": "Change in Four Square Step Test score"
},
{
"measure": "Change in Berg Balance Scale score"
},
{
"measure": "Change in Activities-Specific Balance Confidence Scale score"
},
{
"measure": "Physical Activities Enjoyment Scale (PACES) score - Mid program"
},
{
"measure": "Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) functional activity restriction subscale score"
},
{
"measure": "Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) social activity restriction subscale score"
},
{
"measure": "Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) athletic activity restriction score"
},
{
"measure": "Use of assistive devices per session"
},
{
"measure": "Session completion per session"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Nevada, Las Vegas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cadisegliatin 800 mg QD"
},
{
"name": "Cadisegliatin 800 mg BID"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 1"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CATT1",
"briefTitle": "Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes",
"nctId": "NCT06334133",
"orgStudyIdInfo": {
"id": "TTP399-302",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Change in incidence of Level 2 or Level 3 hypoglycemia"
},
{
"measure": "To assess the change in HbA1c"
},
{
"measure": "To assess the effects of treatment on CGM-based metrics for glycemic control"
},
{
"measure": "To assess the incidence of adverse events"
},
{
"measure": "To assess the effects of treatment on the incidence of diabetic ketoacidosis"
},
{
"measure": "To assess the effects of treatment on insulin dosing"
},
{
"measure": "To assess the effects of treatment on body weight"
},
{
"measure": "High sensitivity C-reactive protein"
},
{
"measure": "N-terminal pro brain [or B-type] natriuretic peptide"
},
{
"measure": "Urinary albumin excretion ratio"
},
{
"measure": "Estimated glomerular filtration rate"
},
{
"measure": "Gold hypoglycemia awareness score"
},
{
"measure": "Item 7 of Clarke hypoglycemia awareness scale"
},
{
"measure": "Snyder's 1-item quality of sleep questionnaire"
},
{
"measure": "World Health Organization-5 Well-Being Index"
},
{
"measure": "8-item Diabetes Distress Scale (participant and partner or family member)"
},
{
"measure": "Hypoglycemia Confidence Scale for participant and partner or family member"
},
{
"measure": "11-item/Short Form Hypoglycemia Fear Scale"
}
],
"primaryOutcomes": [
{
"measure": "Change in incidence of Level 2 or Level 3 hypoglycemia"
}
],
"secondaryOutcomes": [
{
"measure": "To assess the change in HbA1c"
},
{
"measure": "To assess the effects of treatment on CGM-based metrics for glycemic control"
},
{
"measure": "To assess the effects of treatment on the incidence of diabetic ketoacidosis"
},
{
"measure": "To assess the effects of treatment on insulin dosing"
},
{
"measure": "To assess the effects of treatment on body weight"
},
{
"measure": "To assess the incidence of adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "vTv Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Darolutamide (Nubeqa, BAY1841788)"
}
]
},
"conditionsModule": {
"conditions": [
"Non-metastatic Castration-resistant Prostate Cancer",
"Metastatic Hormone-sensitive Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Multiple Locations",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Multiple locations",
"geoPoint": null,
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea",
"nctId": "NCT06334120",
"orgStudyIdInfo": {
"id": "20654",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number, severity of adverse events (including SAEs)"
},
{
"measure": "Number, severity of adverse drug reactions (including SADRs)"
},
{
"measure": "The outcome of (serious) adverse events"
},
{
"measure": "The outcome of (serious) adverse drug reactions"
}
],
"secondaryOutcomes": [
{
"measure": "Metastasis-free survival (MFS)"
},
{
"measure": "Time to symptomatic skeletal event (SSE)"
},
{
"measure": "Time to prostate-specific antigen (PSA) progression"
},
{
"measure": "Number of patients with metastasis of castration-resistant prostate cancer (mCRPC)"
},
{
"measure": "Overall survival"
},
{
"measure": "Duration of Darolutamide treatment"
},
{
"measure": "Reasons for ending Darolutamide"
},
{
"measure": "Dosage and dose modification of Darolutamide"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bayer"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Preterm Birth"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem.One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals.To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability.Questions:1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm?2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term?The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life."
},
"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": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mitochondrial DNA Signatures of Poor Aerobic Exercise Trainability in Young Adults Born Preterm",
"nctId": "NCT06334107",
"orgStudyIdInfo": {
"id": "24AIREA1191995",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mitochondrial DNA heteroplasmy"
},
{
"measure": "Mitochondrial DNA sequence variants"
},
{
"measure": "Change in maximal aerobic capacity"
},
{
"measure": "Change in mitochondrial oxidative capacity in peripheral blood mononuclear cells"
}
],
"secondaryOutcomes": [
{
"measure": "Daily sleep habits"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Texas Tech University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ozanimod"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": [
{
"email": "[email protected]",
"name": "Jessica Ma, BS",
"phone": "972-883-3414",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ashley M Campos, MA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Bart Rypma, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Center for Brain Health",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": null,
"zip": "75228"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to investigate the cognitive benefits of ozanimod in individuals with Multiple Sclerosis (MS). The study aims to understand the neural basis of cognitive improvement in Relapsing-Remitting MS patients under ozanimod treatment using neuroimaging and behavioral techniques to characterize the brain and behavioral changes due to ozanimod treatment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS",
"nctId": "NCT06334094",
"orgStudyIdInfo": {
"id": "IRB-23-486",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Bristol Myers Squibb",
"id": "IM047-1054",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI)"
},
{
"measure": "Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI)"
},
{
"measure": "Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI)"
},
{
"measure": "Change in Whole Brain Volume as Measured By Structural Magnetic Resonance Imaging"
},
{
"measure": "Differences in Diffusion parameters of ozanimod-responders to non-responders as Measured By a Diffusion Kurtosis Resonance Imaging (DKI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Texas Institute for Neurological Disorders"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The University of Texas at Dallas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "undersized drilling technique"
},
{
"name": "single drilling technique"
}
]
},
"conditionsModule": {
"conditions": [
"Missing Teeth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mansoura",
"contacts": null,
"country": "Egypt",
"facility": "Heba Elsheikh",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Different Surgical Drilling Protocols in Posterior Maxilla",
"nctId": "NCT06334081",
"orgStudyIdInfo": {
"id": "A02040230S",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "bone density measurement"
},
{
"measure": "marginal bone loss"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Short-term glycemic control group"
},
{
"name": "Standard-of-care group"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes",
"Uncontrolled Diabtetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mansoura",
"contacts": [
{
"email": "[email protected]",
"name": "Moataz M Emara, MD, EDAIC",
"phone": "01064048848",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Moataz Maher Emara",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": "Aldakahlia",
"status": null,
"zip": "35516"
}
]
},
"descriptionModule": {
"briefSummary": "Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.Consequently, we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The patients in the preoperative anesthesia clinic are divided into one of the following groups:1. Short-term glycemic control group: Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Surg-ShoGR",
"briefTitle": "SHOrt-term Glycemic Control for Reducing Post-SURGical Complications",
"nctId": "NCT06334068",
"orgStudyIdInfo": {
"id": "MS.24.03.2725",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Time to resumption of normal diabetes therapy"
},
{
"measure": "Incidence of diabetic ketoacidosis or hypoglycemia"
},
{
"measure": "Incidence of use of intravenous insulin infusion therapy"
},
{
"measure": "Duration of use of intravenous insulin infusion therapy"
},
{
"measure": "Change in diabetic management at 30 days"
}
],
"primaryOutcomes": [
{
"measure": "Number of days at home after surgery (DAH-30)."
}
],
"secondaryOutcomes": [
{
"measure": "Loss of follow-up after surgery"
},
{
"measure": "Loss of follow up after the clinic preoperative assessment"
},
{
"measure": "30-day mortality"
},
{
"measure": "Length of hospital stay"
},
{
"measure": "incidence of postoperative complications"
},
{
"measure": "Quality of Recovery15 (QoR-15)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": null,
"contactsLocationsModule": null,
"descriptionModule": null,
"designModule": null,
"eligibilityModule": null,
"identificationModule": {
"acronym": null,
"briefTitle": "[Trial of device that is not approved or cleared by the U.S. FDA]",
"nctId": "NCT06334055",
"orgStudyIdInfo": {
"id": "CIP-1091",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": null,
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": null,
"name": "[Redacted]"
}
},
"statusModule": {
"completionDateStruct": null,
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "WITHHELD",
"primaryCompletionDateStruct": null,
"resultsFirstPostDateStruct": null,
"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Serum Chromium Level"
}
]
},
"conditionsModule": {
"conditions": [
"Chromium Deficiency",
"Diabetes Mellitus",
"Hyperlipidemias",
"Hypercholesterolemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Oguzhan Kahveci, MD",
"phone": "+903123051207",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Hacettepe University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": "RECRUITING",
"zip": "06230"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to learn about the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates in critically ill intensive care patients. The investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.Participants will give a single blood sample (into trace element serum tube) on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 350,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit",
"nctId": "NCT06334042",
"orgStudyIdInfo": {
"id": "GO 23/488",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Serum Chromium Level"
}
],
"secondaryOutcomes": [
{
"measure": "HbA1c"
},
{
"measure": "Blood Glucose"
},
{
"measure": "Lipid Profile"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Oguzhan Kahveci"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Functional and structural Connectome"
}
]
},
"conditionsModule": {
"conditions": [
"Epilepsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Conegliano",
"contacts": [
{
"email": "[email protected]",
"name": "Duma Gian Marco, PhD",
"phone": "+39 0438414248",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS E.Medea",
"geoPoint": {
"lat": 45.88805,
"lon": 12.30201
},
"state": "Treviso",
"status": "RECRUITING",
"zip": "31015"
}
]
},
"descriptionModule": {
"briefSummary": "Over the past decade, the concept of the brain as a complex network has extremely influenced the way regarding how the latter is studied (Bartolomei et al., 2017). The structure of both structural and functional networks within the brain has been related to optimal brain functioning (Duma et al., 2022). This evolution of methods and approaches of investigation has directly impacted the study of epilepsy. An early conception of focal epilepsy was that it was related to the activity of the epileptogenic zone, which was identified as the generative element of seizures. However, what was previously considered focal was found to be network alterations at various levels, thus moving from the epileptogenic zone to the concept of the epileptogenic network. Alterations in both the structural and functional network, compared with a healthy control population, have been identified in various forms of epilepsy from focal to idiopathic generalized epilepsy (Lariviere et al., 2022, Zhang et al., 2009). Often the identification and removal of the epileptogenic network, turns out to be the elective therapy in drug-resistant focal epilepsies. The process of diagnosing and defining the epileptogenic network is still debated today. One of the most widely used methods is the implantation of intracranial electrodes for electroencephalographic recording of seizures (Bartolomei et al., 2017). This methodology carries with it several, albeit controlled, risks to the patient. New noninvasive approaches are being developed seeking to integrate information from structural neuroimaging and cortical electrical activity measured by high-density electroencephalography with external electrodes (Duma et al., 2021). These new approaches also include simulative approaches that exploit individualized information such as cortex geometry and patient-specific white matter connections (Courtiol et al. 2020). Thus, starting from a simple structural and diffusion MRI, which is done in routine clinical examinations, multiple localizing hypotheses of the epileptogenic network can be tested using simulative models and then compared with the real EEG signal as validation. Of great relevance is also to understand how the structural-functional connectome relates to cognitive function in patients with epilepsy, who have a high probability of presenting impaired functioning in one or more cognitive domains."
},
"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": "65 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Observational Study of the Structural-functional Connectome in Patients With Epilepsy",
"nctId": "NCT06334029",
"orgStudyIdInfo": {
"id": "12.2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Correlation between the Rey Complex figure test and the regional functional alteration"
}
],
"primaryOutcomes": [
{
"measure": "Identification of regional alteration in the value of functional connectivity"
}
],
"secondaryOutcomes": [
{
"measure": "Measuring the spread of the epileptogenic network"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Eugenio Medea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biospecimen Collection"
},
{
"name": "Cannabis sativa Extract"
},
{
"name": "Nicotine"
},
{
"name": "Placebo Administration"
},
{
"name": "Questionnaire Administration"
}
]
},
"conditionsModule": {
"conditions": [
"Cannabis Dependence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Buffalo",
"contacts": [
{
"email": "[email protected]",
"name": "Danielle M. Smith",
"phone": "716-845-8403",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Danielle M. Smith",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Roswell Park Cancer Institute",
"geoPoint": {
"lat": 42.88645,
"lon": -78.87837
},
"state": "New York",
"status": null,
"zip": "14263"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Within-subject crossover study",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Both participants and clinical personnel will be blinded to the nicotine product sequence (active vs. placebo).",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream",
"nctId": "NCT06334016",
"orgStudyIdInfo": {
"id": "I-3597023",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01556",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Roswell Park Cancer Institute",
"id": "I-3597023",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "R01DA057228",
"link": "https://reporter.nih.gov/quickSearch/R01DA057228",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum concentration of THC in plasma (Cmax)"
},
{
"measure": "Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360)"
},
{
"measure": "Time to maximum concentration of THC in plasma (Tmax)"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of adverse events (AEs)"
},
{
"measure": "Puffing behaviors"
},
{
"measure": "Puffing behaviors"
},
{
"measure": "Short-term drug effects"
},
{
"measure": "Marijuana Withdrawal Checklist [MWC)"
},
{
"measure": "Digit Symbol Substitution Task (DSST)"
},
{
"measure": "Paced Auditory Serial Addition Task (PASET)"
},
{
"measure": "Tobacco Craving Questionnaire (Short Form)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Roswell Park Cancer Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-03-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"ART",
"IVF",
"Children, Only",
"Cardiovascular Disease Other"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": null,
"country": "Denmark",
"facility": "Fertility Clinic, Rigshospitalet, Copenhagen University Hospital",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": null,
"zip": "2100"
},
{
"city": "Copenhagen",
"contacts": [
{
"email": null,
"name": "Rikke B. Jensen, MD, Ass. Prof",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Maria L. Vestager, MD, PhD-student",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Dept. of Paediatric and Adolescent Medicine, Herlev Hospital",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers/partners and offspring from pregnancies achieved by frozen embryo transfer (FET), fresh-embryo transfer (fresh ET) and naturally conceived (NC) to investigate maternal cardiometabolic profiles, fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring. Additionally, the aim is to explore genetic and epigenetic patterns in placenta, fetus and parents. As secondary objectives, the investigator group will examine telomere length and minipuberty hormones in children born after FET, fresh-ET and NC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "COMPART",
"briefTitle": "Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology",
"nctId": "NCT06334003",
"orgStudyIdInfo": {
"id": "H-23071266",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Offspring body composition"
},
{
"measure": "Maternal cardiometabolic profile"
}
],
"secondaryOutcomes": [
{
"measure": "Epigenetic in placenta and cord blood"
},
{
"measure": "Early markers of reproductive function in FET, fresh-ET and NC children: LH, FSH, SHBG, AMH, androgens, estrogens (SDS)"
},
{
"measure": "Telomere length in children born after FET, fresh-ET and NC children"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Herlev Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Rigshospitalet, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Quetiapine Fumarate"
},
{
"name": "TAU"
}
]
},
"conditionsModule": {
"conditions": [
"Mild Traumatic Brain Injury"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 146,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI)",
"nctId": "NCT06333990",
"orgStudyIdInfo": {
"id": "20220796HU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neurobehavioral Symptom Inventory"
},
{
"measure": "World Health Organization Disability Assessment Scale"
},
{
"measure": "World Health Organization Quality of Life BREF"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The University of Texas Health Science Center at San Antonio"
},
{
"name": "Biomedical Research Institute of New Mexico"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Foundation for Advancing Veterans' Health Research"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LC542019"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy",
"Diabetes Mellitus, Type 2"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Las Vegas",
"contacts": null,
"country": "United States",
"facility": "PPD Development, LP (PPD Clinical Research Unit, Las Vegas)",
"geoPoint": {
"lat": 36.17497,
"lon": -115.13722
},
"state": "Nevada",
"status": null,
"zip": "89113"
}
]
},
"descriptionModule": {
"briefSummary": "to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of LC542019 in Healthy Subjects and Subjects With T2DM",
"nctId": "NCT06333977",
"orgStudyIdInfo": {
"id": "LG-GQCL001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Cardiodynamic evaluation"
},
{
"measure": "Fasting Plasma Glucose"
},
{
"measure": "HbA1c"
}
],
"primaryOutcomes": [
{
"measure": "Incidence, severity of adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "Maximum Concentration (Cmax) in Plasma"
},
{
"measure": "Renal Clearance (CLR) in urine"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "LG Chem"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AST-001"
},
{
"name": "Placebo of AST-001"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cheonan",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Soon Chun Hyang University Hospital Cheonan",
"geoPoint": {
"lat": 36.8065,
"lon": 127.1522
},
"state": "Chungcheongnam-do",
"status": "RECRUITING",
"zip": null
},
{
"city": "Anyang",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Hallym University Medical Center",
"geoPoint": {
"lat": 37.3925,
"lon": 126.92694
},
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": null
},
{
"city": "Changwon",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Samsung Changwon Medical Center",
"geoPoint": {
"lat": 35.22806,
"lon": 128.68111
},
"state": "Gyeongsangnam-do",
"status": "RECRUITING",
"zip": null
},
{
"city": "Yangsan",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Pusan National University Yangsan Hospital",
"geoPoint": {
"lat": 35.34199,
"lon": 129.03358
},
"state": "Gyeongsangnam-do",
"status": "RECRUITING",
"zip": null
},
{
"city": "Jeonju",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Jeonbuk National University Hospital",
"geoPoint": {
"lat": 35.82194,
"lon": 127.14889
},
"state": "Jeollabuk-do",
"status": "RECRUITING",
"zip": null
},
{
"city": "Daejeon",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Chungnam National University Hospital",
"geoPoint": {
"lat": 36.32139,
"lon": 127.41972
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Asan Medical Center",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Hanyang University Seoul Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Koera University Guro Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Samsung Medical Center",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "The Catholic University of Korea, Seoul St. Mary's Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "1. Study purpose: To demonstrate the superiority of AST-001 compared to placebo in improving core symptoms of autism spectrum disorder (ASD) in children with ASD.2. Background: ASD is a neurodevelopmental disorder characterized by deficits in social communication and social interaction as well as restricted, repetitive patterns of behavior, interests, or activities. There are no approved medicines to treat the core symptom of ASD. Although these drugs and other psychotropic medications are associated with side effects, the use of psychotropic drugs to treat associated psychiatric comorbidities is common. AST-001 is developed to treat the core symptom of ASD.3. Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Main study(0\\~12 weeks) Experimental: AST-001 Comparator: Placebo of AST-001Extension study(12\\~24 weeks) Experimental: AST-001 Comparator: AST-001",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "7 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children",
"nctId": "NCT06333964",
"orgStudyIdInfo": {
"id": "AST-001P_P301_ASD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II)"
}
],
"secondaryOutcomes": [
{
"measure": "CGI (Clinical Global Impression)"
},
{
"measure": "SRS-2 (Social Responsiveness Scale-2)"
},
{
"measure": "K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Astrogen, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AMG 193"
},
{
"name": "Carboplatin"
},
{
"name": "Paclitaxel"
},
{
"name": "Pembrolizumab"
},
{
"name": "Pemetrexed"
},
{
"name": "Sotorasib"
}
]
},
"conditionsModule": {
"conditions": [
"Thoracic Tumors",
"Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Duarte",
"contacts": null,
"country": "United States",
"facility": "City of Hope (COH)",
"geoPoint": {
"lat": 34.13945,
"lon": -117.97729
},
"state": "California",
"status": "RECRUITING",
"zip": "91010"
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)",
"nctId": "NCT06333951",
"orgStudyIdInfo": {
"id": "20230167",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants Experiencing Dose Limiting Toxicities (DLT)"
},
{
"measure": "Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)"
},
{
"measure": "Number of Participants Experiencing Serious Adverse Events (SAE)"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)"
},
{
"measure": "Disease Control (DC) per RECIST v1.1"
},
{
"measure": "Duration of Response (DOR) per RECIST v1.1"
},
{
"measure": "Time to Response (TTR) per RECIST v1.1"
},
{
"measure": "Overall Survival (OS) per RECIST v1.1"
},
{
"measure": "Progression-free Survival (PFS) per RECIST v1.1"
},
{
"measure": "Maximum Plasma Concentration (Cmax) of AMG 193"
},
{
"measure": "Time to Maximum Plasma Concentration (tmax) of AMG 193"
},
{
"measure": "Area Under the Plasma Concentration-time Curve (AUC) of AMG 193"
},
{
"measure": "Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM )"
},
{
"measure": "Intracranial Disease Control (IDC) per RANO-BM"
},
{
"measure": "Intracranial Duration of Response (IDOR) per RANO-BM"
},
{
"measure": "Time to Intracranial Radiation Therapy per RANO-BM"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Amgen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-10-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bridge"
},
{
"name": "BFA"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia",
"Surgery",
"Knee Arthropathy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study aims to assess the effectiveness of NSS2-Bridge in postoperative pain management in comparison to Battlefield Acupuncture (BFA)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VERITAS",
"briefTitle": "Veterans Enhanced Recovery Using Integrative Treatments Around Surgery",
"nctId": "NCT06333938",
"orgStudyIdInfo": {
"id": "01968",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0"
},
{
"measure": "Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate."
},
{
"measure": "Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures."
},
{
"measure": "Fidelity of Treatment among Patients as assessed by a Fidelity Checklist"
},
{
"measure": "Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures."
},
{
"measure": "Fidelity of Treatment among Providers as assessed by a Fidelity Checklist"
}
],
"secondaryOutcomes": [
{
"measure": "Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents."
},
{
"measure": "Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "Durham VA Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS)"
},
{
"name": "Sham Repetitive Transcranial Magnetic Stimulation (sham- rTMS)"
},
{
"name": "Cognitive Restructuring"
}
]
},
"conditionsModule": {
"conditions": [
"Misophonia",
"Emotion Dysregulation",
"Sensory Processing Disorder",
"Auditory Over Responsivity",
"Anxiety Disorder",
"Sound Sensitivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Durham",
"contacts": [
{
"email": "[email protected]",
"name": "Jessica Choi, MA",
"phone": "919-684-4432",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Lisalynn D Kelley, BA, CCRP",
"phone": "919-684-6701",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Andrada D Neacsiu, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Duke University Medical Center",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": null,
"zip": "27710"
}
]
},
"descriptionModule": {
"briefSummary": "Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress.Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In regards to the neurostimulation used in the study, there will be two conditions, receiving either active or sham neurostimulation. Both conditions will receive behavioral training in cognitive restructuring (CR; a type of emotion regulation skill). Randomization procedures will match participants on age, gender at birth, and misophonia impairment severity.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "All participants will engage in a behavioral training session (Cognitive Restructuring).The study team member who will conduct the behavioral session will be kept blind to the type of neurostimulation the participant will receive. Participants will also be kept blinded to what neurostimulation they receive and their perception of what they received will be assessed at follow-up. The intervention provider will also be kept blind to the treatment condition to ensure non-biased administration of the intervention.Participants will only be told about the type of neurostimulation at the end of the study to protect against different expectations",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MISO-STIM",
"briefTitle": "Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study",
"nctId": "NCT06333925",
"orgStudyIdInfo": {
"id": "Pro00114183",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Changes in self-reported cognitive flexibility"
},
{
"measure": "Changes in self-reported cognitive skills"
},
{
"measure": "Baseline emotional dysregulation"
},
{
"measure": "Baseline hyperacusis"
},
{
"measure": "Baseline Affect Intensity"
},
{
"measure": "Change in Emotional distress"
},
{
"measure": "Change in self-reported Emotion regulation"
},
{
"measure": "Change in Sensory sensitivity"
},
{
"measure": "Change in Interoceptive Awareness"
}
],
"primaryOutcomes": [
{
"measure": "Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and exposure to misophonic versus aversive sounds"
},
{
"measure": "Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and downregulation of versus exposure to misophonic sounds"
},
{
"measure": "Differential change in BOLD signal within the Anterior Insular Cortex (AIC) activation when being presented with misophonic versus non-misophonic but aversive sounds"
},
{
"measure": "Differential change in BOLD signal connectivity between the left Anterior Insular Cortex (AIC) and the right dorsolateral prefrontal cortex (dlPFC) when downregulating versus experiencing distress related to misophonic trigger sounds"
},
{
"measure": "Change in misophonia impairment and severity using a composite"
},
{
"measure": "Skin conductance level (scl)"
},
{
"measure": "Change in Subjective Unites of Distress (SUDS)"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in self-reported psychopathology"
},
{
"measure": "Changes in clinician-assessed psychopathology"
},
{
"measure": "Emotional dysregulation as measured by the Difficulties in Emotion Regulation Scale (DERS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Misophonia Research Fund"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Duke University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "dental implant placement with ridge splitting."
}
]
},
"conditionsModule": {
"conditions": [
"Dental Implant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Alexandria",
"contacts": null,
"country": "Egypt",
"facility": "Alexandria University, Faculty of dentistry",
"geoPoint": {
"lat": 31.21564,
"lon": 29.95527
},
"state": null,
"status": null,
"zip": "21619"
}
]
},
"descriptionModule": {
"briefSummary": "Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement",
"nctId": "NCT06333912",
"orgStudyIdInfo": {
"id": "ridgesplittingguided",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessing the accuracy of guided surgery"
}
],
"secondaryOutcomes": [
{
"measure": "the bone-width increase between control and study group."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Alexandria University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lorlatinib"
},
{
"name": "Lorlatinib with chemotherapy1"
},
{
"name": "Lorlatinib with chemotherapy 2"
},
{
"name": "Lorlatinib post Radiation"
}
]
},
"conditionsModule": {
"conditions": [
"High Grade Glioma",
"Diffuse Intrinsic Pontine Glioma",
"Anaplastic Astrocytoma",
"Infant Type Hemispheric Glioma",
"Glioblastoma",
"Glioblastoma Multiforme",
"WHO Grade III Glioma",
"WHO Grade IV Glioma",
"Diffuse Midline Glioma, H3K27-altered"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": [
{
"email": "[email protected]",
"name": "Kathleen Dorris, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Children's Hospital Colorado",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": null,
"zip": "80045"
},
{
"city": "Washington",
"contacts": [
{
"email": "[email protected]",
"name": "Eugene Hwang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Children's National Medical Center",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
},
"state": "District of Columbia",
"status": null,
"zip": "20010"
},
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Ashley Plant, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Ann & Robert H. Lurie Children's Hospital of Chicago",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60611"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Susan Chi",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Dana-Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
},
{
"city": "Durham",
"contacts": [
{
"email": "[email protected]",
"name": "David Ashley, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Duke University Health System",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": null,
"zip": "27708"
},
{
"city": "Cincinnati",
"contacts": [
{
"email": "[email protected]",
"name": "Peter de Blank, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Cincinnati Children's Hospital Medical Center",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio",
"status": null,
"zip": "45229"
},
{
"city": "Columbus",
"contacts": [
{
"email": "[email protected]",
"name": "Maryam Fouladi, MD, MSc",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Nationwide Children's Hospital",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": null,
"zip": "43235"
},
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Michael J Fisher, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Children's Hospital of Philadelphia",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19104"
},
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Patricia Baxter, MD",
"phone": null,
"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": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "Sarah Leary",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Seattle Children's Hospital",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": null,
"zip": "98105"
},
{
"city": "Randwick",
"contacts": [
{
"email": "[email protected]",
"name": "David Ziegler, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Sydney Children's Hospital",
"geoPoint": {
"lat": -33.91439,
"lon": 151.24895
},
"state": "New South Wales",
"status": null,
"zip": "2031"
},
{
"city": "South Brisbane",
"contacts": [
{
"email": "[email protected]",
"name": "Tim Hassall, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Queensland Children's Hospital",
"geoPoint": {
"lat": -27.48034,
"lon": 153.02049
},
"state": "Queensland",
"status": null,
"zip": "4101"
},
{
"city": "Perth",
"contacts": [
{
"email": "[email protected]",
"name": "Nicholas G Gottardo, MBChB",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Perth Children's Hospital",
"geoPoint": {
"lat": -31.95224,
"lon": 115.8614
},
"state": "Western Australia",
"status": null,
"zip": "6000"
},
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Eric Bouffet",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "The Hospital for Sick Children (SickKids)",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5G1X8"
},
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "Genevieve Legault, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Montreal Children's Hospital",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H4A3J1"
},
{
"city": "Heidelberg",
"contacts": [
{
"email": "[email protected]",
"name": "Olaf Witt, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)",
"geoPoint": {
"lat": 49.40768,
"lon": 8.69079
},
"state": "Baden-Württemberg",
"status": null,
"zip": "69120"
},
{
"city": "Utrecht",
"contacts": [
{
"email": "[email protected]",
"name": "Jasper van der Lugt",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Princess Máxima Center",
"geoPoint": {
"lat": 52.09083,
"lon": 5.12222
},
"state": null,
"status": null,
"zip": "3720"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Feasibility",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "21 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion",
"nctId": "NCT06333899",
"orgStudyIdInfo": {
"id": "CONNECT2111",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease Control Rate"
},
{
"measure": "Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response Rate (ORR) in HGG"
},
{
"measure": "Overall Survival (OS) in HGG"
},
{
"measure": "Progression-Free Survival in HGG"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Pfizer"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Nationwide Children's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sacral electromyography"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Cord Injuries",
"Neurogenic Bowel",
"Neurogenic Bladder Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": null,
"country": "Canada",
"facility": "Hôpital du Sacré-Coeur de Montréal",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H4J 1C5"
}
]
},
"descriptionModule": {
"briefSummary": "Assessing the sacral nerves is an integral aspect of the evaluation after a spinal cord injury. Being located at the lower end of the spinal cord, the sacral nerves reflect how signals travel through the injured spinal cord. Sacral assessment is therefore essential to determine the level and severity of the spinal cord injury, which helps selecting the proper treatment and predicting recovery (worse when abnormal sacral function. The current assessment relies solely on a manual evaluation, which depends heavily on the physician's experience and does not provide any quantitative value of the dysfunction. The lack of a quantitative method adapted to the clinical setting is a major barrier limiting our knowledge on the impact of sacral function on recovery. We have recently developed an electrophysiological method providing quantitative sacral assessment at bedside after spinal cord injuries. Using this method, we will quantify sacral function in 250 patients with acute spinal cord injuries, and determine its association with recovery 6 months post-injury. We hypothesize that sacral function assessed early within the first 6 weeks after the injury with our method is associated with a better 6-month recovery of motor, sensory, bowel and bladder function. Our objectives are to assess the changes is sacral function during the first 6 months after the injury, and the relationship between early sacral function and 6-month recovery. Sacral function and recovery will be assessed up to 6 months post-injury by the attending physician, in order to measure the electromyographic magnitude of voluntary anal contraction, electromyographic magnitude of anal contraction elicited through sacral reflex testing, and minimal electrical stimulation for which anal sensation is present. The analysis will determine if and how sacral function evolves in time, and if there are specific quantitative criteria of sacral function that physicians can use to determine if patient will have a favorable recovery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 450,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury",
"nctId": "NCT06333886",
"orgStudyIdInfo": {
"id": "ciusss-nordmtl_ESG",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Precise assessment and evaluation of neuro-sacral dysfunction"
}
],
"secondaryOutcomes": [
{
"measure": "Assessment of clinical phenotypes"
},
{
"measure": "Clinical prognosis assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "patient-reported outcome"
}
]
},
"conditionsModule": {
"conditions": [
"Age-Related Macular Degeneration"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA)"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AMDAY",
"briefTitle": "Impact of Age-related Macular Degeneration on Daily Living Activitie",
"nctId": "NCT06333873",
"orgStudyIdInfo": {
"id": "P22-09",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Validity of criteria"
},
{
"measure": "Validity of content"
},
{
"measure": "Reproducibility of results"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Risankizumab"
},
{
"name": "Deucravacitinib"
}
]
},
"conditionsModule": {
"conditions": [
"Moderate Plaque Psoriasis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly.This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participantsParticipants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 336,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body)",
"nctId": "NCT06333860",
"orgStudyIdInfo": {
"id": "M24-541",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90)"
},
{
"measure": "Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Almost Clear) with at least 2-grade improvement from Baseline"
},
{
"measure": "Period B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) in the Intent to Treat Population for non-responders in Period B (ITT_B_NR)."
}
],
"secondaryOutcomes": [
{
"measure": "Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100)"
},
{
"measure": "Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline"
},
{
"measure": "Period B: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) among participants in the ITT_B_NR Population"
},
{
"measure": "Period B: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baselineamong participants in the ITT_B_NR Population."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AbbVie"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Back Pain",
"Low Back Pain",
"Neck Pain",
"Comorbidities and Coexisting Conditions"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aalborg",
"contacts": null,
"country": "Denmark",
"facility": "Aalborg University Hospital",
"geoPoint": {
"lat": 57.048,
"lon": 9.9187
},
"state": null,
"status": null,
"zip": "9000"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate whether the number of chronic diseases, the treatment burden resulting from multimorbidity, and health-related quality of life contribute to non-response bias in individuals with chronic back pain. Data is collected from patients at Aalborg University Hospital's Rheumatology Department through electronic means and medical records. The statistical analyses consist of two wave analyses, where we examine differences between patients who respond to invitations to participate in the study based on their response patterns; whether they respond after the first, second, or third invitation. Based on baseline data, a one-way ANOVA is conducted to identify any between-group differences in the aforementioned factors, followed by a repeated measures ANOVA to assess if there are differences between the groups over time. Finally, statistical tests are also performed to examine differences in age and gender distribution between those who complete the questionnaires at baseline compared to those who do not respond to the invitation to participate."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Is Multimorbidity a Source of Non-response Bias in Patients With Spinal Pain? - A Pilot Study",
"nctId": "NCT06333847",
"orgStudyIdInfo": {
"id": "K2023-059",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Brief Pain Inventory - Short form"
},
{
"measure": "Insomnia Severity Index"
},
{
"measure": "Patient Health Questionnaire"
},
{
"measure": "Generalized Anxiety Disorder"
},
{
"measure": "Work ability score"
}
],
"primaryOutcomes": [
{
"measure": "Multimorbidity Treatment Burden Questionnaire (MTBQ)."
}
],
"secondaryOutcomes": [
{
"measure": "Health-related quality of life (EQ-5D-5L)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Aalborg Municipality"
},
{
"name": "Aalborg University"
},
{
"name": "Aalborg University Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Jacob Christiansen Gandløse"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-04-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Traditional scorpion antivenom regimen"
},
{
"name": "Serial dose of scorpion antivenom regimen"
}
]
},
"conditionsModule": {
"conditions": [
"Centruroides Envenomation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tlaquepaque",
"contacts": [
{
"email": "[email protected]",
"name": "Héctor A González-Ruiz, PhD Student",
"phone": "+52 33 1787 9139",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Selene G Huerta-Olvera, PhD",
"phone": "+52 392 111 0753",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Mexico",
"facility": "Servicios Médicos Municipales de San Pedro Tlaquepaque.",
"geoPoint": {
"lat": 20.64091,
"lon": -103.29327
},
"state": "Jalisco",
"status": null,
"zip": "45560"
}
]
},
"descriptionModule": {
"briefSummary": "The clinical study aims to compare the effectiveness of applying two different regimens of scorpion antivenom therapy. In the first regimen (control), the medication is administered to all patients, and depending on the severity of the condition, the dosage varies. In the experimental regimen, an identical dose of scorpion antivenom is administered to patients exhibiting signs and symptoms of scorpion sting intoxication, in addition to pain and other symptoms at the sting site. The primary response variable is the time taken for signs and symptoms to resolve, but differences in complications, adverse effects, venom and antivenom concentration in the blood, and the need for other therapeutic measures are also evaluated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Experimental Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy in a reduced regimen. The dosing regimen based on response will be one initial intravenous vial in patients with grade III scorpion envenomation, and two initial intravenous vials as the starting dose in patients with grade IV scorpion envenomation, according to the FDA classification of scorpion envenomation. In both scenarios, an additional vial can be administered every 30 minutes if symptoms persist, with no limit on vials. Control Group: Patients with scorpion envenomation of any grade will receive scorpion antivenom therapy according to the traditional regimen proposed in the Mexican Clinical Practice Guideline, where, according to the severity classification of scorpion envenomation, between one and six vials of anti-scorpion venom will be administered, and equal doses can be repeated every 30 minutes if necessary.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "A pharmacist will be responsible for randomizing the patients and preparing the study medication in a blinded manner, so that the treatment is administered by the physician without the care provider or the participant being able to identify it. The pharmacist will keep the randomization results in a sealed envelope that will be opened at the end of the study.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 121,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism",
"nctId": "NCT06333834",
"orgStudyIdInfo": {
"id": "Dosis Seriada de Alacramyn",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time to resolution of signs and symptoms"
},
{
"measure": "Serum venom concentration"
}
],
"secondaryOutcomes": [
{
"measure": "Mortality"
},
{
"measure": "Length of intrahospital stay"
},
{
"measure": "Serum antivenom concentration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Selene Guadalupe Huerta Olvera"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nimotuzumab"
},
{
"name": "Cisplatin"
},
{
"name": "External Beam Radiotherapy (EBRT)"
},
{
"name": "Brachytherapy"
},
{
"name": "placebo for Nimotuzumab"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III trial",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "This study is double-blind and will blind both the investigator and the subjects. All participants in the study (including data managers and biostatisticians) will be unaware of treatment assignment (except blind statisticians).",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 460,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma",
"nctId": "NCT06333821",
"orgStudyIdInfo": {
"id": "BPL-Nim-CC-3003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR)"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator"
},
{
"measure": "3-,5-Year Overall Survival (OS)"
},
{
"measure": "3-,5-Year Disease Free Survival(DFS)"
},
{
"measure": "3-,5-Year Locoregional Recurrence-Free Survival(LRRFS)"
},
{
"measure": "3-,5-Year Distant Metastasis-free Survival (DMFS)"
},
{
"measure": "Tumor Regression Rate(TRR)"
},
{
"measure": "Complete Response Rate"
},
{
"measure": "Complete Response Rate"
},
{
"measure": "Objective Response Rate"
},
{
"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 Score"
},
{
"measure": "Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score"
},
{
"measure": "Incidence of Treatment-Emergent Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Biotech Pharmaceutical Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bictegravir"
},
{
"name": "Lenacapavir"
},
{
"name": "B/F/TAF"
},
{
"name": "Placebo to match B/F/TAF"
},
{
"name": "Placebo to match BIC/LEN"
}
]
},
"conditionsModule": {
"conditions": [
"HIV-1-infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": null,
"country": "United States",
"facility": "Ruane Medical and Clinical Research Institute",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": "RECRUITING",
"zip": "90036"
},
{
"city": "Fort Lauderdale",
"contacts": null,
"country": "United States",
"facility": "Therafirst Medical Center",
"geoPoint": {
"lat": 26.12231,
"lon": -80.14338
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33308"
},
{
"city": "Fort Pierce",
"contacts": null,
"country": "United States",
"facility": "Midway Immunology and Research Center",
"geoPoint": {
"lat": 27.44671,
"lon": -80.32561
},
"state": "Florida",
"status": "RECRUITING",
"zip": "34982"
},
{
"city": "Decatur",
"contacts": null,
"country": "United States",
"facility": "Infectious Disease Specialists of Atlanta",
"geoPoint": {
"lat": 33.77483,
"lon": -84.29631
},
"state": "Georgia",
"status": "RECRUITING",
"zip": "30033"
},
{
"city": "Saint Louis",
"contacts": null,
"country": "United States",
"facility": "Southhampton Community Healthcare, Inc.",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri",
"status": "RECRUITING",
"zip": "63139"
},
{
"city": "Somers Point",
"contacts": null,
"country": "United States",
"facility": "South Jersey Infectious Disease",
"geoPoint": {
"lat": 39.31762,
"lon": -74.5946
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "08244"
},
{
"city": "Houston",
"contacts": null,
"country": "United States",
"facility": "The Crofoot research Center, INC.",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77098"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomized in parallel in one of two treatment groups during the Blinded Phase. Participants in both treatment groups will be given the option to continue BIC/LEN FDC treatment during the Open-Label Phase.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 546,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ARTISTRY-2",
"briefTitle": "Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy",
"nctId": "NCT06333808",
"orgStudyIdInfo": {
"id": "GS-US-621-6290",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "European Medicines Agency",
"id": "2023-510022-33",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm"
},
{
"measure": "Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48"
},
{
"measure": "Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm"
},
{
"measure": "Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm"
},
{
"measure": "Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96"
},
{
"measure": "Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48"
},
{
"measure": "Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Gilead Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Faecal Microbiota Transplantation (FMT)"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Diarrhea",
"Systemic Sclerosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aarhus",
"contacts": null,
"country": "Denmark",
"facility": "Aarhus University Hospital",
"geoPoint": {
"lat": 56.15674,
"lon": 10.21076
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will undergo 2 interventions. For the first intervention participants are randomised 1:1 for either Active FMT or placebo For the second intervention, all participants receive active treatment.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "The study is blinded throughout the active study period, both the patient and investigator are blinded.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FaeMiCue",
"briefTitle": "Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis",
"nctId": "NCT06333795",
"orgStudyIdInfo": {
"id": "1-10-72-131-23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo)."
}
],
"secondaryOutcomes": [
{
"measure": "Patient-reported treatment outcome on symptoms"
},
{
"measure": "Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention."
},
{
"measure": "Patient-reported outcomes from questionnaires."
},
{
"measure": "Patient-reported outcomes from questionnaires."
},
{
"measure": "Patient-reported outcomes from questionnaires."
},
{
"measure": "Patient-reported overall symptom burden"
},
{
"measure": "Objective measures from the wireless motility capsule."
},
{
"measure": "Objective measures from the wireless motility capsule."
},
{
"measure": "Objective measures from the wireless motility capsule."
},
{
"measure": "Objective measures from the wireless motility capsule."
},
{
"measure": "Objective measures from the low-dose CT scan."
},
{
"measure": "Breath Test"
},
{
"measure": "Faecal microbiota composition"
},
{
"measure": "Faecal-calprotectin"
},
{
"measure": "Blood plasma proteomics"
},
{
"measure": "Blood plasma Fibrosis markers"
},
{
"measure": "Blood parameters"
},
{
"measure": "Health-related Quality of life"
},
{
"measure": "Patient perception of FMT treatment satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Aarhus"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental- Genefill Contour®"
},
{
"name": "Marketed comparator - Desirial®Plus"
}
]
},
"conditionsModule": {
"conditions": [
"Vulvar Atrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Levallois-Perret",
"contacts": [
{
"email": null,
"name": "Massimo Gianfermi, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Cabinet renaissance",
"geoPoint": {
"lat": 48.89389,
"lon": 2.28864
},
"state": "Paris",
"status": null,
"zip": "92300"
},
{
"city": "Lyon",
"contacts": [
{
"email": null,
"name": "Johanna Gratadour, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Palais Flore",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
"status": null,
"zip": "69006"
},
{
"city": "Gdańsk",
"contacts": [
{
"email": null,
"name": "Katarzyna Kopacz-Petranyuk, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "Medical Center \"Tu sie leczy\"",
"geoPoint": {
"lat": 54.35205,
"lon": 18.64637
},
"state": "Gdansk",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy.The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \\& pain during injection).Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants would be randomized on two groups: Genefill Contour or comparator (Desirial Plus) at a ratio 1:1",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Single blind",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation",
"nctId": "NCT06333782",
"orgStudyIdInfo": {
"id": "2023-EU-GEN-01",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ANSM",
"id": "2023-A02012-43",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean of number of occurred ADEs (Adverse device effects)"
}
],
"secondaryOutcomes": [
{
"measure": "Global Aesthetic Improvement Scale (GAIS) assessment by investigator"
},
{
"measure": "Global Aesthetic Improvement Scale (GAIS) assessment by participant"
},
{
"measure": "Patient (Atrophy/Hypotrophy) symptoms"
},
{
"measure": "Sexual function Assessment, The Female Sexual Function Index (FSFI)"
},
{
"measure": "Patient´s satisfaction"
},
{
"measure": "Pain during injection-Visual Analogical Scale (VAS)"
},
{
"measure": "Adverse Events collection (Global safety during the study period)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Eurofins"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bioscience Cosmetics SL"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Short-course Radiotherapy"
},
{
"name": "Tislelizumab"
},
{
"name": "capecitabine"
},
{
"name": "Oxaliplatin"
}
]
},
"conditionsModule": {
"conditions": [
"Mid-low Rectal Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To explore the complete response (CR) rate of improved short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal 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": 31,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase II Multicenter Clinical Study of Improved Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer",
"nctId": "NCT06333769",
"orgStudyIdInfo": {
"id": "CATIMOR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "complete response (CR) rate"
}
],
"secondaryOutcomes": [
{
"measure": "3y-DFS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Fujian Cancer Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cross education"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Adults"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": null,
"country": "Taiwan",
"facility": "National Yang-Ming University",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null,
"status": null,
"zip": "112"
}
]
},
"descriptionModule": {
"briefSummary": "We will explored the effect of cross education training on different cortex functional connectivity, cortex and muscle functional connectivity, and maximal voluntary contraction.Healthy participants receive cross education training of the elbow flexor (12 rep./set, 3sets, 60%MVC, 180°/s, eccentric).Maximal voluntary contraction, electroencephalogram and electromyogram will record during cross education tasks to determine the effects of cross education training on cortical network and muscle functional connectivity"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Parallel Assignment",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "YM110099E",
"briefTitle": "Effects of Muscle Strengthening and Fatigue on Activities in Cortex and Muscle",
"nctId": "NCT06333756",
"orgStudyIdInfo": {
"id": "YM110099E",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Corticocortical coherence"
},
{
"measure": "Corticomuscular coherence"
},
{
"measure": "Maximal voluntary contraction"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Yang Ming University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "laser ablation"
},
{
"name": "LEEP or Conization"
}
]
},
"conditionsModule": {
"conditions": [
"High-Grade Squamous Intraepithelial Lesions"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 308,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Laser Ablation in the Treatment of High-grade Cervical Lesions",
"nctId": "NCT06333743",
"orgStudyIdInfo": {
"id": "ZhuLan",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the rate of HSIL recurrence"
}
],
"secondaryOutcomes": [
{
"measure": "the satisfaction with the treatment"
},
{
"measure": "the length of the cervix"
},
{
"measure": "Psychological state change related to the treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Obstetrics & Gynecology Hospital of Fudan University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "inferior alveolar nerve block"
},
{
"name": "mental nerve block"
}
]
},
"conditionsModule": {
"conditions": [
"Symptomatic Irreversible Pulpitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Peshawar",
"contacts": [
{
"email": "[email protected]",
"name": "Prof. Dr. Iftikhar Akbar, FCPS, CHIPE",
"phone": "00923479368676",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Marghalara Noor, BDS",
"phone": "00923359631393",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Saifa Rashad, BDS",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Peshawar Dental College",
"geoPoint": {
"lat": 34.008,
"lon": 71.57849
},
"state": "Khyber Pakhtunkhwa",
"status": "RECRUITING",
"zip": "25000"
}
]
},
"descriptionModule": {
"briefSummary": "Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth.Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB.Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included.Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded.Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis",
"nctId": "NCT06333730",
"orgStudyIdInfo": {
"id": "PMC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prime Foundation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Whole grain bread"
},
{
"name": "Control bread"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Diet"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Örebro",
"contacts": null,
"country": "Sweden",
"facility": "Örebro University",
"geoPoint": {
"lat": 59.27412,
"lon": 15.2066
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects, and how this, in turn, impacts on the release of gut peptides, intestinal permeability, stress and cognitive performance."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "double blinding",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 33,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "44 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "FBS",
"briefTitle": "Impact of Whole Grain Rye Bread on Health",
"nctId": "NCT06333717",
"orgStudyIdInfo": {
"id": "Dnr 2020-03709",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale in Irritable Bowel Syndrome (GSRS-IBS)"
},
{
"measure": "Food habits measured by an electronic food frequency questionnaire Mealq"
},
{
"measure": "Food habits measured by a Food diary"
},
{
"measure": "Physical activity measured by the International Physical Activity Questionnaire (IPAQ)"
},
{
"measure": "Quality of life measured by the Euro Quality of Life questionnaire"
},
{
"measure": "Perceived stress measured by a Visual analog scale questionnaire"
},
{
"measure": "Cognitive control using Eriksen flanker task (Flanker task)"
},
{
"measure": "Working memory performance using a modified N-back task combined with recent-probes item-recognition task (Sternberg task)"
},
{
"measure": "Electrocardiogram (ECG) using the Biopac system"
},
{
"measure": "Electrodermal activity (EDA) using the Biopac system"
}
],
"primaryOutcomes": [
{
"measure": "Microbiota composition baseline vs after intervention using 16S RNA gene sequencing"
}
],
"secondaryOutcomes": [
{
"measure": "Microbiota composition whole grain rye bread vs control bread using 16S RNA gene sequencing"
},
{
"measure": "Concentrations of circulatory short-chain fatty acids SCFA"
},
{
"measure": "Concentrations of faecal SCFA"
},
{
"measure": "Concentrations of blood glucagon like peptide-1 (GLP-1)"
},
{
"measure": "Concentrations of blood glucagon like peptide-2 (GLP-2)"
},
{
"measure": "Concentrations of blood peptide YY (PYY)"
},
{
"measure": "Concentrations of blood gastric inhibitory polypeptide (GIP)"
},
{
"measure": "Concentrations of blood neuroactive peptide Y (NPY)"
},
{
"measure": "Concentrations of blood brain-derived neurotrophic factor (BDNF)"
},
{
"measure": "Concentrations of blood cytokines"
},
{
"measure": "Concentrations of blood alkylresorcinols"
},
{
"measure": "Concentrations of blood lipopolysaccharide-binding protein (LBP)"
},
{
"measure": "Concentrations of blood soluble CD-14 (sCD-14)"
},
{
"measure": "Concentrations of sugars in urine"
},
{
"measure": "Concentrations of saliva cortisol during stress test"
},
{
"measure": "Concentrations of saliva alpha-amylase during stress test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Örebro University, Sweden"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-11-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-03-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-03-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SPIKEVAX Bivalent"
},
{
"name": "SPIKEVAX X"
}
]
},
"conditionsModule": {
"conditions": [
"SARS-CoV-2"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wonju",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Yonseimin Clinic",
"geoPoint": {
"lat": 37.35139,
"lon": 127.94528
},
"state": "Gangwon-do",
"status": "RECRUITING",
"zip": "26428"
},
{
"city": "Bucheon",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Hyundai Clinic",
"geoPoint": {
"lat": 37.49889,
"lon": 126.78306
},
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "14483"
},
{
"city": "Bucheon",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Ma Hak ki Family Medicine Clinic",
"geoPoint": {
"lat": 37.49889,
"lon": 126.78306
},
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "14614"
},
{
"city": "Gimpo",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Nalee Hospital",
"geoPoint": null,
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "10108"
},
{
"city": "Goyang",
"contacts": null,
"country": "Korea, Republic of",
"facility": "COA ENT Clinic",
"geoPoint": {
"lat": 37.65639,
"lon": 126.835
},
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "10234"
},
{
"city": "Gwangmyeong",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Joon Pediatric Clinic",
"geoPoint": null,
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "14250"
},
{
"city": "Siheung",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Janghyeon Medicine Clinic",
"geoPoint": null,
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "14998"
},
{
"city": "Yangju",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Hanyang Union Rehabilitation Medicine Clinic",
"geoPoint": {
"lat": 37.83311,
"lon": 127.06169
},
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "11404"
},
{
"city": "Yangju",
"contacts": null,
"country": "Korea, Republic of",
"facility": "KimHyungjoo Clinic",
"geoPoint": {
"lat": 37.83311,
"lon": 127.06169
},
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "11456"
},
{
"city": "Gunsan",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Kium Children Hospital",
"geoPoint": {
"lat": 35.97861,
"lon": 126.71139
},
"state": "Jeollabuk-do",
"status": "RECRUITING",
"zip": "54072"
},
{
"city": "Busan",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Sinsegie ENT Clinic",
"geoPoint": {
"lat": 35.10278,
"lon": 129.04028
},
"state": null,
"status": "TERMINATED",
"zip": "48111"
},
{
"city": "Gwangju",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Jeil Family Medicine Clinic",
"geoPoint": {
"lat": 35.15472,
"lon": 126.91556
},
"state": null,
"status": "WITHDRAWN",
"zip": "61108"
},
{
"city": "Incheon",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Bupyeong Yonsei Medical Clinic",
"geoPoint": {
"lat": 37.45646,
"lon": 126.70515
},
"state": null,
"status": "RECRUITING",
"zip": "21405"
},
{
"city": "Incheon",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Inha University Hospital",
"geoPoint": {
"lat": 37.45646,
"lon": 126.70515
},
"state": null,
"status": "RECRUITING",
"zip": "22332"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Woori Medical Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "01684"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Yonsei Kids Pediatrics Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "01851"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Star Pediatrics Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "03912"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Seoul Bon Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "04032"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Dr Cho's Family Medical Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "05351"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Songpa Korea Neurosurgical Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "05769"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "GF Pediatrics Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "06568"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Kim Il Joong Internal Medicine Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "06727"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "New Yonsei ENT Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "07327"
},
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Soo Orthopedics Clinic",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "TERMINATED",
"zip": "08701"
}
]
},
"descriptionModule": {
"briefSummary": "The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 3300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.",
"nctId": "NCT06333704",
"orgStudyIdInfo": {
"id": "mRNA-1273-P924",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants With AEs"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "ModernaTX, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Calcium Gluconate"
}
]
},
"conditionsModule": {
"conditions": [
"Ovarian Hyperstimulation Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Minya",
"contacts": null,
"country": "Egypt",
"facility": "Minia University, Faculty of Pharmacy",
"geoPoint": {
"lat": 28.10988,
"lon": 30.7503
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition. This syndrome is characterized by a sudden increase of the vascular permeability which results in the development of a massive extravascular exudate in the peritoneal cavity, pleural, pericardium causing ascites, pleural and pericardial effusion.Severe forms are also accompanied by electrolyte disturbances and cardiopulmonary, hepatic, renal, and hemoconcentration associated with increased thromboembolic risk.This syndrome is avoidable by the judicious use of gonadotropins and careful monitoring of stimulation regimens."
},
"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": 180,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "39 Years",
"minimumAge": "23 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin",
"nctId": "NCT06333691",
"orgStudyIdInfo": {
"id": "Aya Mohammed",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the incidence rate of moderate to severe OHSS."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Minia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Durvalumab"
},
{
"name": "Sotorasib"
}
]
},
"conditionsModule": {
"conditions": [
"Non-Small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Basking Ridge",
"contacts": [
{
"email": null,
"name": "Narek Shaverdian, MD",
"phone": "631-212-6323",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Basking Ridge (All Protocol Activities)",
"geoPoint": {
"lat": 40.70621,
"lon": -74.54932
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07920"
},
{
"city": "Middletown",
"contacts": [
{
"email": null,
"name": "Narek Shaverdian, MD",
"phone": "631-212-6323",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Monmouth (All Protocol Activities)",
"geoPoint": {
"lat": 40.39652,
"lon": -74.09211
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07748"
},
{
"city": "Montvale",
"contacts": [
{
"email": null,
"name": "Narek Shaverdian, MD",
"phone": "631-212-6323",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Bergen (All Protocol Activities)",
"geoPoint": {
"lat": 41.04676,
"lon": -74.02292
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07645"
},
{
"city": "Commack",
"contacts": [
{
"email": null,
"name": "Narek Shaverdian, MD",
"phone": "631-212-6323",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)",
"geoPoint": {
"lat": 40.84288,
"lon": -73.29289
},
"state": "New York",
"status": "RECRUITING",
"zip": "11725"
},
{
"city": "Harrison",
"contacts": [
{
"email": null,
"name": "Narek Shaverdian, MD",
"phone": "631-212-6323",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Westchester (All Protocol Activities)",
"geoPoint": {
"lat": 40.96899,
"lon": -73.71263
},
"state": "New York",
"status": "RECRUITING",
"zip": "10604"
},
{
"city": "New York",
"contacts": [
{
"email": null,
"name": "Narek Shaverdian, MD",
"phone": "631-212-6323",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Cancer Center (All Protocol Activities)",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10065"
},
{
"city": "Uniondale",
"contacts": [
{
"email": null,
"name": "Narek Shaverdian, MD",
"phone": "631-212-6323",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Nassau (All Protocol Activities)",
"geoPoint": {
"lat": 40.70038,
"lon": -73.59291
},
"state": "New York",
"status": "RECRUITING",
"zip": "11553"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase II randomized trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)",
"nctId": "NCT06333678",
"orgStudyIdInfo": {
"id": "22-321",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-free survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of dose-limiting toxicity (DLT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Amgen"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Memorial Sloan Kettering Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Whether there is type 2 diabetes mellitus before surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Esophageal Squamous Cell Carcinoma",
"Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": null,
"country": "China",
"facility": "Army Medical Center of the People's Liberation Army",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": "Chongqing",
"status": null,
"zip": "400042"
}
]
},
"descriptionModule": {
"briefSummary": "To date, there is controversy as to whether type II diabetes mellitus is associated with adverse short- and long-term outcomes in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy. At the same time, to the best of our knowledge, the impact of metformin use and glycemic control on short- and long-term outcomes in this patient population is also controversial. Therefore, this study aims to test the hypothesis that diabetes mellitus is associated with reduced survival in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy and that treatment with metformin and/or good glycemic control (HbA1c\\<7.0%) is associated with improved survival."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 605,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PPIO-007 Correlation Analysis of Type II Diabetes Mellitus on Short-term and Long-term Outcomes of Patients With Esophageal Squamous Cell Cancer Undergoing Minimally Invasive Esophagectomy",
"nctId": "NCT06333665",
"orgStudyIdInfo": {
"id": "Wei G",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Disease-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "postoperative adverse events"
},
{
"measure": "perioperative 90-day mortality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Daping Hospital and the Research Institute of Surgery of the Third Military Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ravulizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Preeclampsia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Maria L. Gonzalez Suarez, MD,PhD",
"phone": "507-284-4083",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Mayo Clinic Minnesota",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 14,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders",
"nctId": "NCT06333652",
"orgStudyIdInfo": {
"id": "22-009239",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Alternative Complement Pathway Biomarkers at time of delivery"
}
],
"secondaryOutcomes": [
{
"measure": "Pregnancy duration"
},
{
"measure": "Clinical biomarkers of severe features of preeclampsia and HELLP syndrome"
},
{
"measure": "Hospitalization length in the postpartum period"
},
{
"measure": "Meningococcal infection after use of ravulizumab"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "orthopaedic surgery"
},
{
"name": "orthopaedic surgery and fitted with a virtual reality headset"
}
]
},
"conditionsModule": {
"conditions": [
"General Surgery",
"Orthopedic Procedures"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nice",
"contacts": [
{
"email": "[email protected]",
"name": "GAUCI Marc-Olivier",
"phone": "04 92 03 69 04",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU NiICE",
"geoPoint": {
"lat": 43.70313,
"lon": 7.26608
},
"state": "Alpes Maritimes",
"status": null,
"zip": "0600"
}
]
},
"descriptionModule": {
"briefSummary": "\"Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour.\""
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IRVABO",
"briefTitle": "Implementing Virtual Reality in the Operating Room",
"nctId": "NCT06333639",
"orgStudyIdInfo": {
"id": "24Chirortho01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset."
}
],
"secondaryOutcomes": [
{
"measure": "1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset."
},
{
"measure": "Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Nice"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "multi-vitamin carbohydrate"
}
]
},
"conditionsModule": {
"conditions": [
"Nausea and Vomiting, Aspiration, Intraoperative"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting",
"nctId": "NCT06333626",
"orgStudyIdInfo": {
"id": "2020281",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gastric antrum area"
}
],
"secondaryOutcomes": [
{
"measure": "vomiting"
},
{
"measure": "The pH of vomiting fluid"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital of Soochow University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D)"
}
]
},
"conditionsModule": {
"conditions": [
"Visual Acuity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Diego",
"contacts": null,
"country": "United States",
"facility": "Scripps Poway Eyecare & Optometry",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California",
"status": "RECRUITING",
"zip": "92131"
},
{
"city": "Longwood",
"contacts": null,
"country": "United States",
"facility": "Omega Vision Center",
"geoPoint": {
"lat": 28.70305,
"lon": -81.3384
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32779"
},
{
"city": "Maitland",
"contacts": null,
"country": "United States",
"facility": "Maitland Vision Center - North Orlando Ave",
"geoPoint": {
"lat": 28.62778,
"lon": -81.36312
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32751"
},
{
"city": "Pittsburg",
"contacts": null,
"country": "United States",
"facility": "Kannarr Eye Care",
"geoPoint": {
"lat": 37.41088,
"lon": -94.70496
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "66762"
},
{
"city": "Granville",
"contacts": null,
"country": "United States",
"facility": "Procare Vision Centers",
"geoPoint": {
"lat": 40.06812,
"lon": -82.5196
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43023"
}
]
},
"descriptionModule": {
"briefSummary": "This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study to evaluate visual acuity in neophytes."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "39 Years",
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers",
"nctId": "NCT06333613",
"orgStudyIdInfo": {
"id": "CR-6565",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of eyes with slit-lamp findings (Grade 3 or 4) related to study lens wear"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Johnson & Johnson Vision Care, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Topical minoxidil"
},
{
"name": "Topical Vitamin D"
},
{
"name": "Saline spray"
}
]
},
"conditionsModule": {
"conditions": [
"Dermatology",
"Female Pattern Baldness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sohag",
"contacts": [
{
"email": "[email protected]",
"name": "Doaa G Abdelbaset, MSc",
"phone": "01022330810",
"phoneExt": "002",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Doaa G Abdelbaset, Msc",
"phone": "01014733007",
"phoneExt": "002",
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Facult of Medicine, Sohag Uniiversity",
"geoPoint": {
"lat": 26.55695,
"lon": 31.69478
},
"state": null,
"status": "RECRUITING",
"zip": "82515"
}
]
},
"descriptionModule": {
"briefSummary": "The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "15 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss",
"nctId": "NCT06333600",
"orgStudyIdInfo": {
"id": "Soh-Med-23-07-05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change of Sinclaire grading of Female pattern hair loss"
},
{
"measure": "Change of Trichoscopic parameters (Hair dermoscopy)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sohag University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "image-guided thermal ablation"
}
]
},
"conditionsModule": {
"conditions": [
"Papillary Thyroid Microcarcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": null,
"name": "Giovanni Mauri",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "European Institute of Oncology",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 270,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MIPA-MITT",
"briefTitle": "Minimally Invasive Treatments of the Thyroid",
"nctId": "NCT06333587",
"orgStudyIdInfo": {
"id": "IEO 1810",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The proportion of patients with major complications occurring within one month after the date of intervention"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of patients with local recurrence at 10 years"
},
{
"measure": "Percentage of patients with distant metastasis at 10 years"
},
{
"measure": "Percentage of patients died at 10 years"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "European Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2035-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Family weight self-measurement and remote follow-up management based on wechat."
},
{
"name": "Routine care"
}
]
},
"conditionsModule": {
"conditions": [
"Hemodialysis",
"Life Quality",
"Interdialytic Weight Gain",
"Cardiovascular Events",
"Hypertension",
"Dry Weight"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to Improve the quality of life in Hemodialysis patient. The main questions it aims to answer are:* \\[Improve the self-compliance of dialysis patients with weight management\\]* \\[alleviate the volume load of dialysis patients and reduce cardiovascular complications\\] Participants will be divided into two groups based on a weight management regimen： Control group: received routine outpatient management. Specific methods: The dialysis doctor registered the information of the patient\\'s weight and blood pressure at the end of dialysis, and informed the patient of the purpose, role and importance of weight management.Intervention group: On the basis of routine outpatient management, patients or their family members were subjected to remote follow-up management based on wechat, and the follow-up time was 6 months. Specific methods: Same as the control group, the information of weight and blood pressure of the patients was registered at the end of dialysis, and the purpose, role and importance of weight management were informed to the patients. On this basis, a special wechat signal is set up to add patients or patients\\' family members as wechat friends and establish a wechat interaction platform with patients. In the interdialysis period, remind patients to weigh themselves through wechat (the time of each weighing is fixed, preferably consistent with the time of weighing in the hemodialysis center), control the weight gain during the interdialysis period not to exceed 4.5% of dry weight, and inform patients again about the purpose, role and importance of weight management."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Weight Management of Dialysis Patients",
"nctId": "NCT06333574",
"orgStudyIdInfo": {
"id": "CDUTCM20240313",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adverse event rate"
},
{
"measure": "Rate of completion"
}
],
"secondaryOutcomes": [
{
"measure": "dialysis related symptoms"
},
{
"measure": "Laboratory index"
},
{
"measure": "level of Ga"
},
{
"measure": "level of P"
},
{
"measure": "level of PTH"
},
{
"measure": "level of K"
},
{
"measure": "level of Na"
},
{
"measure": "level of Cl"
},
{
"measure": "concentration of albumin and prealbumin"
},
{
"measure": "Laboratory index of total protein"
},
{
"measure": "Dialysis efficiency \\ dialysis adequacy (KTV)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "qinxiu zhang"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hepatic arterial infusion chemotherapy"
},
{
"name": "Lenvatinib"
},
{
"name": "Tislelizumab"
},
{
"name": "Toripalimab"
},
{
"name": "Sintilimab"
},
{
"name": "Camrelizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma",
"Lenvatinib",
"PD-1 Inhibitor",
"Hepatic Arterial Infusion Chemotherapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Qunfang Zhou, Md",
"phone": "8619868000115",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Feng Duan, MD",
"phone": "8613910984586",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Chinese PLA General hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100853"
}
]
},
"descriptionModule": {
"briefSummary": "Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma",
"nctId": "NCT06333561",
"orgStudyIdInfo": {
"id": "Liver Project 7",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Objective response rate"
}
],
"primaryOutcomes": [
{
"measure": "Overall survival"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-Free-Survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM"
}
]
},
"conditionsModule": {
"conditions": [
"Birth Weight"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Konya",
"contacts": null,
"country": "Turkey",
"facility": "MELEK",
"geoPoint": {
"lat": 37.87135,
"lon": 32.48464
},
"state": "Sıhhiye",
"status": null,
"zip": "06100"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 87,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Minutes",
"minimumAge": "1 Minute",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cord Blood Alarin Levels in Term Babies",
"nctId": "NCT06333548",
"orgStudyIdInfo": {
"id": "KSH_MB_2024_1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Konya City Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "foot massage"
},
{
"name": "abdominal massage"
},
{
"name": "foot and abdominal massage"
}
]
},
"conditionsModule": {
"conditions": [
"Abdominal Pain",
"Distention",
"Satisfaction, Patient"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kayseri",
"contacts": null,
"country": "Turkey",
"facility": "Erciyes University",
"geoPoint": {
"lat": 38.73222,
"lon": 35.48528
},
"state": null,
"status": null,
"zip": "38000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only \"routine care\" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Foot and Abdominal Massage Applied to After Colonoscopy",
"nctId": "NCT06333535",
"orgStudyIdInfo": {
"id": "2022/568",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "abdominal pain"
},
{
"measure": "Abdominal distension"
},
{
"measure": "Patient Satisfaction"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "TC Erciyes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Losartan"
}
]
},
"conditionsModule": {
"conditions": [
"Arthrofibrosis of Knee"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": null,
"country": "United States",
"facility": "NYU Langone Health",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10016"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty",
"nctId": "NCT06333522",
"orgStudyIdInfo": {
"id": "23-00979",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in range of motion"
},
{
"measure": "Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "NYU Langone Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CT071"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Myeloma",
"Primary Plasma Cell Leukemia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Phase 1; Dose escalation followed by dose expansion Phase 2; Single group of each indication will be dosed at the recommended dose level from Phase 1.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "N/Ap",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 166,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL",
"nctId": "NCT06333509",
"orgStudyIdInfo": {
"id": "CT071-HM-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD)."
},
{
"measure": "Phase 2: Objective response rate"
}
],
"secondaryOutcomes": [
{
"measure": "Phase 1 and 2: Evaluate additional clinical efficacy outcomes"
},
{
"measure": "Phase 1 and 2: Evaluate additional clinical efficacy outcomes"
},
{
"measure": "Phase 1 and 2: Evaluate additional clinical efficacy outcomes"
},
{
"measure": "Phase 1 and 2: Evaluate additional clinical efficacy outcomes"
},
{
"measure": "Phase 2: Evaluate additional Safety of CT071."
},
{
"measure": "Phase 1 and 2: Assess immunogenicity of CT071"
},
{
"measure": "Phase 1 and 2: Evaluate PK profile of CT071"
},
{
"measure": "Phase 1 and 2: Evaluate PK profile of CT071"
},
{
"measure": "Phase 1 and 2: Evaluate PK profile of CT071"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "CARsgen Therapeutics Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GLP1 Booster (GB)"
}
]
},
"conditionsModule": {
"conditions": [
"Blood Sugar; High",
"Overweight and Obesity",
"Fat Burn",
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salt Lake City",
"contacts": null,
"country": "United States",
"facility": "Alpine Bio",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": null,
"zip": "84109"
}
]
},
"descriptionModule": {
"briefSummary": "BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints."
},
"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": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans",
"nctId": "NCT06333496",
"orgStudyIdInfo": {
"id": "AB20240102H",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "blood glucose level"
},
{
"measure": "blood HbA1c level"
},
{
"measure": "blood insulin level"
},
{
"measure": "blood GLP1 level"
},
{
"measure": "blood cholesterol level"
},
{
"measure": "body weight"
},
{
"measure": "body fat mass"
},
{
"measure": "body lean mass"
},
{
"measure": "body mass index"
},
{
"measure": "body fat index"
},
{
"measure": "waist hip ratio"
}
],
"secondaryOutcomes": [
{
"measure": "Satiety score"
},
{
"measure": "Resting metabolic rate"
},
{
"measure": "Blood pressure"
},
{
"measure": "Heart rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Alpine Biotech LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Obecabtagene autoleucel (obe-cel)"
}
]
},
"conditionsModule": {
"conditions": [
"Systemic Lupus Erythematosus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Maria Leandro",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "University College London Hospitals NHS Foundation Trust",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE."
},
"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": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CARLYSE",
"briefTitle": "A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE)",
"nctId": "NCT06333483",
"orgStudyIdInfo": {
"id": "AUTO1-SL1",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2023-508236-60-00",
"link": null,
"type": "CTIS"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose limiting toxicities"
},
{
"measure": "Adverse events"
}
],
"secondaryOutcomes": [
{
"measure": "Remission rate according to Definition of Remission in SLE (DORIS)"
},
{
"measure": "Response over time according to Definition of Remission in SLE (DORIS)"
},
{
"measure": "Time to response according to Definition of Remission in SLE (DORIS)"
},
{
"measure": "Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)"
},
{
"measure": "Change over time in Physician's global assessment (PGA)"
},
{
"measure": "Pharmacokinetics (maximum serum concentration [Cmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood"
},
{
"measure": "Pharmacokinetics (time to reaching maximum serum concentration [Tmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood"
},
{
"measure": "Pharmacokinetics (area under the curve [AUC]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood"
},
{
"measure": "Pharmacokinetics (last observed quantifiable concentration [Clast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood"
},
{
"measure": "Pharmacokinetics (time to reach last observed quantifiable concentration [Tlast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood"
},
{
"measure": "Pharmacodynamics: B cell aplasia"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Autolus Limited"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Primary angle closure diseases"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Angle-Closure Glaucoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Primary angle-closure glaucoma (PACG) is one of the major causes of blindness affecting more than 20 million patients worldwide. The goals of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged 50 years and to develop prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to PACG."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "70 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Liwan Eye Study: the Fourth Follow-up",
"nctId": "NCT06333470",
"orgStudyIdInfo": {
"id": "2024KYPJ025",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The 20-year incidence of primary angle-closure glaucoma (PACG) in Chinese population aged over 50 years"
}
],
"secondaryOutcomes": [
{
"measure": "The development of prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to primary angle-closure glaucoma (PACG)"
},
{
"measure": "The 20-year incidence of visual impairment in Chinese population aged over 50 years"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zhongshan Ophthalmic Center, Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VR Cue-Exposure Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Alcohol Dependence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Berlin",
"contacts": null,
"country": "Germany",
"facility": "Psychiatric University Hospital Charité at St. Hedwig Hospital",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": null,
"zip": "10115"
}
]
},
"descriptionModule": {
"briefSummary": "Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PRE-VR",
"briefTitle": "Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality",
"nctId": "NCT06333457",
"orgStudyIdInfo": {
"id": "EA4/024/24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Craving"
},
{
"measure": "Craving"
},
{
"measure": "Craving"
}
],
"secondaryOutcomes": [
{
"measure": "Relapse rates"
},
{
"measure": "Quality of Life"
},
{
"measure": "Motion Sickness"
},
{
"measure": "Presence in VR"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Charite University, Berlin, Germany"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "four weekly psychological counselling intervention"
}
]
},
"conditionsModule": {
"conditions": [
"University Students",
"Psychological Intervention",
"Psychological Distress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Caserta",
"contacts": [
{
"email": "[email protected]",
"name": "ALDA TRONCONE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "University of Campania",
"geoPoint": {
"lat": 41.07262,
"lon": 14.33231
},
"state": null,
"status": "RECRUITING",
"zip": "81100"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate mental health and academic motivation in university students asking help to university counselling service (UCS) in Southern Italy before anf after four weekly psychological sessions.The main question it aims to answer are:* is the psychological counselling intervention useful in improving psychological distress and academic motivation* which psychological variables predict the intervention outcome"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Four weekly psychological counselling intervention",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "TRESPASS",
"briefTitle": "Counselling Intervention for College Students Experienced Psychological Distress",
"nctId": "NCT06333444",
"orgStudyIdInfo": {
"id": "n. 08, 09/03/2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "psychological distress"
},
{
"measure": "Academic motivation"
}
],
"secondaryOutcomes": [
{
"measure": "Emotion regulation ability"
},
{
"measure": "perceived loneliness"
},
{
"measure": "drop-out intention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Campania \"Luigi Vanvitelli\""
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Glass Waterfall group"
},
{
"name": "white noise group"
}
]
},
"conditionsModule": {
"conditions": [
"Misadventure During Endoscopic Examination"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Assignment experimental model using randomized pretest and posttest with control group",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 156,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "WF/WN_GCPY",
"briefTitle": "Effects of WN and WF During Gastroscopy",
"nctId": "NCT06333431",
"orgStudyIdInfo": {
"id": "WN/WF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient Information Form"
},
{
"measure": "Visual Analogue Scale (VAS)"
},
{
"measure": "State and Trait Anxiety Scale (STAI)"
},
{
"measure": "The Patient Observation Form"
},
{
"measure": "Pulse rate before and after gatroscopy procedure"
},
{
"measure": "Respiratory rate before and after gatroscopy procedure"
},
{
"measure": "Systolic and diastolic blood pressure before and after gatroscopy procedure"
},
{
"measure": "Oxygen saturation values before and after gatroscopy procedure"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Suleyman Demirel University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual Reality Glasses Group"
},
{
"name": "Glass waterfall"
}
]
},
"conditionsModule": {
"conditions": [
"Misadventure During Endoscopic Examination"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as fear, and anxiety in the patient.Purpose: To examine the effect of virtual rain forest and glass waterfall on satisfaction, comfort, anxiety, and vital signs before colonoscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for colonoscopy. The sample will be represented by 135 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 0.40, 95% power and 0.01% margin of error for this study, that a total of 135 individuals for the three groups and at 60 individuals for each group. G\\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 45 rain forest video VR group, 45 glass waterfall group and 45 control group. All participants in the study will first fill out a patient identification form containing patient demographic information."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Assignment experimental model using randomized pretest and posttest with control group",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Double (Participant, Investigator)",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 135,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VR/WN_colon",
"briefTitle": "Effects of VR and Glass WF Colonoscopy",
"nctId": "NCT06333418",
"orgStudyIdInfo": {
"id": "VR/WF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient Information Form"
},
{
"measure": "Visual Analogue Scale (VAS)"
},
{
"measure": "State and Trait Anxiety Scale (STAI)"
},
{
"measure": "The Patient Observation Form"
},
{
"measure": "Pulse rate before colonoscopy procedure"
},
{
"measure": "Respiratory rate before colonoscopy procedure"
},
{
"measure": "Systolic and diastolic blood pressure before colonoscopy procedure"
},
{
"measure": "Oxygen saturation values before colonoscopy procedure"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Suleyman Demirel University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fecal Microbiota Transplantation"
}
]
},
"conditionsModule": {
"conditions": [
"Necrotizing Enterocolitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Warsaw",
"contacts": [
{
"email": "[email protected]",
"name": "Marek Wolski, MD, PhD",
"phone": "665578922",
"phoneExt": "+48",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ewa A. Biegańska, MD",
"phone": "692542543",
"phoneExt": "+48",
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "Medical University of Warsaw, Pediatric Surgery Clinic",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
},
"state": "Mazovian Voivodeship",
"status": null,
"zip": "02-097"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to assess the safety of fecal microbiota transplantation (FMT) as a preventive method for the development of Necrotizing enterocolitis (NEC) in a group of premature infants.This is the first stage of a clinical trial testing the effectiveness of FMT in NEC, the aim of which is to examine the safety profile and analyze all side effects."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "single group, open label, observational study with intervention (FMT)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "36 Weeks",
"minimumAge": "24 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study",
"nctId": "NCT06333405",
"orgStudyIdInfo": {
"id": "FMTNEC/01/2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adverse reactions monitoring"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Warsaw"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Total underwater colonoscopy"
},
{
"name": "Conventional colonoscopy"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Neoplasia",
"Screening Colonoscopy",
"Colorectal Cancer",
"Colorectal Cancer Screening",
"Vasovagal Reaction"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC:1. SSLs will be more visible as they \"float\" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult.2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier.3. uEMR is eased.4. Improved bowel cleansingThe goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test.The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination.The project has five main hypotheses:1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs.2. TUC increases the rate of complete resection of lesions \\>= 10mm.3. TUC reduces the rate of painful colonoscopies and vasovagal reactions.4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon.5. TUC reduces the carbon footprint by reduced use of single use accessories.If TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres.The trial can be linked to three of the Global Goals:* Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor).* Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women's barriers to attend screening.* Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1070,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial",
"nctId": "NCT06333392",
"orgStudyIdInfo": {
"id": "TotalUnderwater_REK577567",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proximal sessile serrated lesion detection rate"
}
],
"secondaryOutcomes": [
{
"measure": "Complete resection rate for lesions > 10mm"
},
{
"measure": "Rate of painful procedures and vasovagal reactions"
},
{
"measure": "Leakage after colonoscopy"
},
{
"measure": "Detection rate for other neoplasia than SSL"
},
{
"measure": "Withdrawal time"
},
{
"measure": "Total procedure time"
},
{
"measure": "Bowel cleansing quality"
},
{
"measure": "Complications"
},
{
"measure": "Number of colonoscopies to achieve polyp free colon"
},
{
"measure": "Single use accessories for the procedure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ullevaal University Hospital"
},
{
"name": "Sahlgrenska University Hospital, Sweden"
},
{
"name": "Ostfold Hospital Trust"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Vestre Viken Hospital Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF"
}
]
},
"conditionsModule": {
"conditions": [
"Bronchoalveolar Lavage Fluid",
"Sensitivity and Specificity",
"Critical Illness",
"Respiration Failure",
"Respiratory Fungal Infection",
"Exhaled Breath Condensate",
"Aspergillosis, Invasive Pulmonary"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chengdu",
"contacts": null,
"country": "China",
"facility": "Sichuan Provincial People's Hospital",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": null,
"zip": "86610072"
}
]
},
"descriptionModule": {
"briefSummary": "Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. This study proposes a non-invasive, innovative approach utilizing galactomannan (GM) analysis in Exhaled Breath Condensate (EBC) for early IPA detection.Objective: To evaluate the diagnostic accuracy of measuring GM levels in EBC for detecting IPA in mechanically ventilated patients, comparing it against the conventional Bronchoalveolar Lavage Fluid (BALF)-GM measurements.Methods: A clinical trial will be conducted with 75 mechanically ventilated patients suspected of having IPA. The study will compare the effectiveness of EBC-GM levels against BALF-GM levels in diagnosing IPA, focusing on sensitivity, specificity, and diagnostic accuracy. The novel, self-designed EBC collection device will facilitate the safe and efficient collection of EBC from patients.Expected Outcomes:Validation of EBC-GM Diagnostic Accuracy: Anticipate demonstrating that EBC-GM levels provide a comparable diagnostic accuracy to BALF-GM, establishing a non-invasive, safer alternative for IPA detection.Implementation of a Non-Invasive Diagnostic Tool: The study aims to introduce a non-invasive diagnostic approach that can potentially replace more risky, invasive methods, improving patient care in ICUs.Contribution to Clinical Practice: By providing a new method for early and safer detection of IPA, the study is expected to influence clinical guidelines and practices in the management of critically ill, ventilated patients.Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 75,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Aspergillosis Detection Via EBC-GM in Ventilated Patients",
"nctId": "NCT06333379",
"orgStudyIdInfo": {
"id": "SichuanPPHLC04",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Sichuan Provincial People's Hospital",
"id": "2020LY01",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic accuracy of EBC-GM vs. BALF-GM"
},
{
"measure": "EBC-GM levels:"
}
],
"secondaryOutcomes": [
{
"measure": "Correlation between EBC-GM and BALF-GM levels"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Lin Chen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-04-12",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 81579,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-03-22T15:01"
},
{
"date": "2023-04-12",
"filename": "ICF_001.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 133154,
"typeAbbrev": "ICF",
"uploadDate": "2024-03-22T15:02"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intra-gastrointestinal monitoring device (PDT)"
}
]
},
"conditionsModule": {
"conditions": [
"Intra-Abdominal Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chiayi City",
"contacts": [
{
"email": "[email protected]",
"name": "Dong-Ru Ho, MD, PhD",
"phone": "886-975353211",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": null,
"phone": null,
"phoneExt": "Ho",
"role": "CONTACT"
},
{
"email": null,
"name": "Dong-Ru Ho, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Taiwan",
"facility": "Dong-Ru Ho",
"geoPoint": {
"lat": 23.47917,
"lon": 120.44889
},
"state": null,
"status": "RECRUITING",
"zip": "60061"
}
]
},
"descriptionModule": {
"briefSummary": "PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "First-In-Human Study of PDT to Detect IAH",
"nctId": "NCT06333366",
"orgStudyIdInfo": {
"id": "202301590A0C501",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Chang Gung Memorial Hospital",
"id": "Application No.2402020052",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm"
},
{
"measure": "Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris )"
}
],
"primaryOutcomes": [
{
"measure": "Incidence of device-related or sensor insertion/removal procedure-related adverse events"
},
{
"measure": "Rate of foreign body reaction due intra-gastrointestinal insertion"
},
{
"measure": "Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus"
},
{
"measure": "Incidence of sensor failure"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire"
},
{
"measure": "Duration of PDT insertion and explantation procedure"
},
{
"measure": "Incidence of side effects in Post explantation follow-up"
},
{
"measure": "Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "DOTSPACE"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Chang Gung Memorial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Real RepetitiveTranscranial Magnetic Stimulation 5 sessions"
},
{
"name": "Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions"
},
{
"name": "Real RepetitiveTranscranial Magnetic Stimulation 10 sessions"
},
{
"name": "Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions"
}
]
},
"conditionsModule": {
"conditions": [
"Endometriosis",
"Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ottawa",
"contacts": [
{
"email": "[email protected]",
"name": "Anne-Marie MacDonald, MSc",
"phone": "613-562-5800",
"phoneExt": "4102",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Linda McLean, PhD",
"phone": "613-562-5800",
"phoneExt": "4102",
"role": "CONTACT"
},
{
"email": null,
"name": "Linda McLean, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "McLean Function Measurement Lab",
"geoPoint": {
"lat": 45.41117,
"lon": -75.69812
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "K1S1S2"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP.The objectives of this trial are:1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP,2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS.5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Assignment",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "All participants, care providers, investigators and outcome assessors will remain blinded to real/sham intervention. The outcomes assessor and the investigator will remain blinded to intervention duration.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 152,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain",
"nctId": "NCT06333353",
"orgStudyIdInfo": {
"id": "H-06-23-9278",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numeric rating scale (NRS) used to record daily pain over 30 days"
},
{
"measure": "Numeric rating scale(NRS) used to record daily pain over 30 days"
},
{
"measure": "Patient Global Impression of Change (PGIC) in pain"
},
{
"measure": "Patient Global Impression of Change (PGIC) in pain"
},
{
"measure": "Patient Global Impression of Change (PGIC) in pain"
}
],
"secondaryOutcomes": [
{
"measure": "The Beck Depression Inventory (BDI-II)"
},
{
"measure": "The Beck Depression Inventory (BDI-II)"
},
{
"measure": "The Beck Depression Inventory (BDI-II)"
},
{
"measure": "The State-Trait Anxiety Inventory (STAI)"
},
{
"measure": "The Pain Catastrophizing Scale"
},
{
"measure": "The Central sensitization index"
},
{
"measure": "Female Sexual Distress Scale (FSDS)"
},
{
"measure": "Adherence to the intervention protocol"
},
{
"measure": "Pressure pain threshold (PPThresh)"
},
{
"measure": "Pressure pain threshold (PPThresh)"
},
{
"measure": "Pressure Pain Tolerance (PPTol)"
},
{
"measure": "Pressure Pain Tolerance (PPTol)"
},
{
"measure": "Perceived pain intensity (PPI)"
},
{
"measure": "Perceived pain intensity (PPI)"
},
{
"measure": "Temporal summation (TS) of pain"
},
{
"measure": "Temporal summation (TS) of pain"
},
{
"measure": "Pain rating during the tampon test"
},
{
"measure": "Pain rating during the tampon test"
},
{
"measure": "Conditioned pain modulation (CPM)"
},
{
"measure": "Conditioned pain modulation (CPM)"
},
{
"measure": "The Brief Pain Inventory"
},
{
"measure": "The Brief Pain Inventory"
},
{
"measure": "The Brief Pain Inventory"
},
{
"measure": "The Endometriosis Health Profile Questionnaire (EPH-30)"
},
{
"measure": "The Endometriosis Health Profile Questionnaire (EPH-30)"
},
{
"measure": "The Endometriosis Health Profile Questionnaire (EPH-30)"
},
{
"measure": "Patient satisfaction with treatment (PST)"
},
{
"measure": "Patient satisfaction with treatment (PST)"
},
{
"measure": "Patient satisfaction with treatment (PST)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Ottawa"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oxytocin"
},
{
"name": "Carbetocin"
}
]
},
"conditionsModule": {
"conditions": [
"Post Partum Hemorrhage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Mrinalini Balki, MD",
"phone": "416-586-4800",
"phoneExt": "5270",
"role": "CONTACT"
},
{
"email": null,
"name": "Narinder Singh, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ronald George, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Kristi Downey, MSc",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Mount Sinai Hospital",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5G1X5"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery",
"nctId": "NCT06333340",
"orgStudyIdInfo": {
"id": "24-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of parturients requiring additional uterotonic agents intraoperatively"
}
],
"secondaryOutcomes": [
{
"measure": "Uterine Tone 3 minutes"
},
{
"measure": "Uterine Tone 5 minutes"
},
{
"measure": "Uterine Tone 10 minutes"
},
{
"measure": "Calculated blood loss (CBL)"
},
{
"measure": "Semi-quantitative blood loss (SQBL)"
},
{
"measure": "Presence of blood transfusion"
},
{
"measure": "Number of patients with ICU admission"
},
{
"measure": "Number of patients with conservative surgical methods to manage post partum hemorrhage"
},
{
"measure": "Number of patients with radiological methods used to manage post partum hemorrhage"
},
{
"measure": "Number of patients with surgical post partum hemorrhage management measures"
},
{
"measure": "Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline"
},
{
"measure": "Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline"
},
{
"measure": "Number of patients with tachycardia defined as heart rate greater than 130% of baseline"
},
{
"measure": "Number of patients with bradycardia defined as heart rate less than 70% of baseline"
},
{
"measure": "Presence of ventricular tachycardia: ECG"
},
{
"measure": "Presence of atrial fibrillation: ECG"
},
{
"measure": "Presence of atrial flutter: ECG"
},
{
"measure": "Presence of nausea: questionnaire"
},
{
"measure": "Presence of vomiting: questionnaire"
},
{
"measure": "Number of patients with chest pain: questionnaire"
},
{
"measure": "Number of patients with shortness of breath: questionnaire"
},
{
"measure": "Number of patients with headache: questionnaire"
},
{
"measure": "Number of patients with flushing: questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Samuel Lunenfeld Research Institute, Mount Sinai Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brussels",
"contacts": [
{
"email": "[email protected]",
"name": "Carlo de Asmundis, MD, PhD",
"phone": "+32024763704",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "UZ Brussel Heart Rhythm Management Center",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null,
"status": "RECRUITING",
"zip": "1090"
}
]
},
"descriptionModule": {
"briefSummary": "All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) \"Heliostar\" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 2000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "COLLABORATE",
"briefTitle": "Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter",
"nctId": "NCT06333327",
"orgStudyIdInfo": {
"id": "1432022000278",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Atrial arrhythmia recurrence after ablation"
},
{
"measure": "Procedural safety"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universitair Ziekenhuis Brussel"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dostarlimab"
},
{
"name": "Chemotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Adenocarcinoma",
"Ampulla of Vater Carcinoma",
"Adrenocortical Carcinoma",
"Neuroendocrine Carcinoma",
"Soft Tissue Sarcoma",
"Small Bowel Adenocarcinoma",
"Duodenum Adenocarcinoma",
"Gastric Adenocarcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Angers",
"contacts": [
{
"email": null,
"name": "Victor SIMMET, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut de Cancérologie de l'Ouest",
"geoPoint": {
"lat": 47.46667,
"lon": -0.55
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Avignon",
"contacts": [
{
"email": null,
"name": "Clémence TOULLEC, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut du Cancer Avignon-Provence",
"geoPoint": {
"lat": 43.94834,
"lon": 4.80892
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Besançon",
"contacts": [
{
"email": null,
"name": "Angélique VIENOT, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Jean Minjoz",
"geoPoint": {
"lat": 47.24878,
"lon": 6.01815
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Brest",
"contacts": [
{
"email": null,
"name": "Pierre-Guillaume POUREAU, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Morvan",
"geoPoint": {
"lat": 48.3903,
"lon": -4.48628
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Caen",
"contacts": [
{
"email": null,
"name": "Elodie COQUAN, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre François Baclesse",
"geoPoint": {
"lat": 49.18585,
"lon": -0.35912
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Clermont-Ferrand",
"contacts": [
{
"email": null,
"name": "Florence OSAER-POLYCARPE, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Jean Perrin",
"geoPoint": {
"lat": 45.77966,
"lon": 3.08628
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Créteil",
"contacts": [
{
"email": null,
"name": "Christophe TOURNIGAND, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU - Henri Mondor",
"geoPoint": {
"lat": 48.78333,
"lon": 2.46667
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Dijon",
"contacts": [
{
"email": null,
"name": "François GHIRINGHELLI, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Georges François Leclerc",
"geoPoint": {
"lat": 47.31667,
"lon": 5.01667
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Lyon",
"contacts": [
{
"email": null,
"name": "Clélia COUTZAC, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Léon Bérard",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Marseille",
"contacts": [
{
"email": null,
"name": "Laëtitia DAHAN, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital la Timone",
"geoPoint": {
"lat": 43.29551,
"lon": 5.38958
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Marseille",
"contacts": [
{
"email": null,
"name": "Christelle DE LA FOUCHARDIERE, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut Paoli Calmettes",
"geoPoint": {
"lat": 43.29551,
"lon": 5.38958
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Nancy",
"contacts": [
{
"email": null,
"name": "Aurélien LAMBERT, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut de Cancérologie de Lorraine",
"geoPoint": {
"lat": 48.68439,
"lon": 6.18496
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Raphaël COLLE, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut Mutualiste Montsouris",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Pessac",
"contacts": [
{
"email": null,
"name": "Denis SMITH, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU de Bordeaux - Hôpital Haut -Lèvêque",
"geoPoint": {
"lat": 44.81011,
"lon": -0.64129
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Poitiers",
"contacts": [
{
"email": null,
"name": "David TOUGERON, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU de Poitiers",
"geoPoint": {
"lat": 46.58333,
"lon": 0.33333
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Reims",
"contacts": [
{
"email": null,
"name": "Damien BOTSEN, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut Jean Godinot",
"geoPoint": {
"lat": 49.25,
"lon": 4.03333
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Rennes",
"contacts": [
{
"email": null,
"name": "Héloïse BOURIEN, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre Eugène Marquis",
"geoPoint": {
"lat": 48.11198,
"lon": -1.67429
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Rouen",
"contacts": [
{
"email": null,
"name": "Frédéric DI FIORE, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU de Rouen",
"geoPoint": {
"lat": 49.44313,
"lon": 1.09932
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Saint-Herblain",
"contacts": [
{
"email": null,
"name": "Sandrine HIRET, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Institut de Cancérologie de l'Ouest",
"geoPoint": {
"lat": 47.21765,
"lon": -1.64841
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Toulouse",
"contacts": [
{
"email": null,
"name": "Rosine GUIMBAUD, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU de Toulouse Hôpital Rangueil",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Villejuif",
"contacts": [
{
"email": null,
"name": "Cristina SMOLENSCHI, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Gustave Roussy Grand Paris",
"geoPoint": {
"lat": 48.7939,
"lon": 2.35992
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Thierry ANDRE, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Saint-Antoine",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Île-de-France",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)/microsatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.Adult patients (aged ≥18 years) with histologically confirmed dMMR/MSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\\<5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).Patients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, multicenter, comparative phase II trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Pan-MSI-ACSE",
"briefTitle": "Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI",
"nctId": "NCT06333314",
"orgStudyIdInfo": {
"id": "UC-IMM-2302",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response Rate"
},
{
"measure": "Duration of response"
},
{
"measure": "Overall Survival"
},
{
"measure": "Progression-Free Survival 2"
},
{
"measure": "Objective response rate 2"
},
{
"measure": "Progression-Free Survival -crossover"
},
{
"measure": "Circulating tumor DNA level"
},
{
"measure": "Incidence of treatment-emergent adverse events"
},
{
"measure": "Quality of life questionnaire - Core 30 (QLQ-C30)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute, France"
},
{
"name": "GlaxoSmithKline"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "UNICANCER"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Surveys"
}
]
},
"conditionsModule": {
"conditions": [
"Biological Aging"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working \"out-of-phase\" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TIME-ZZZ",
"briefTitle": "Translational Initiative to Map Epigenetics in Sleep",
"nctId": "NCT06333301",
"orgStudyIdInfo": {
"id": "TIME-ZZZ",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effect of being \"out of phase\" with chronotype on biological age"
}
],
"secondaryOutcomes": [
{
"measure": "Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging"
},
{
"measure": "Identification of DNA methylation markers associated with chronotype"
},
{
"measure": "Identification of DNA methylation markers associated with depression"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Oxford"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Elysium Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PST-APPLE Watch group"
},
{
"name": "Education-only control group"
}
]
},
"conditionsModule": {
"conditions": [
"Alcohol Use Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": null,
"name": "Hagar Hallihan",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Illinois at Chicago",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60608"
}
]
},
"descriptionModule": {
"briefSummary": "The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "PRO-APPLE Study is a 2-arm pilot Randomized Control Trial (RCT).",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students",
"nctId": "NCT06333288",
"orgStudyIdInfo": {
"id": "2024-0268",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Intervention Acceptability"
},
{
"measure": "Intervention Fidelity"
},
{
"measure": "Participant Retention"
},
{
"measure": "Protocol Acceptability"
}
],
"primaryOutcomes": [
{
"measure": "Alcohol abstinence"
}
],
"secondaryOutcomes": [
{
"measure": "Change in AUD severity at 3 months."
},
{
"measure": "Change in AUD frequency status."
},
{
"measure": "Change in Alcohol-related negative consequences at 3 months."
},
{
"measure": "Change in Alcohol use at 3 months."
},
{
"measure": "Change in Reasons for drinking at 3 months."
},
{
"measure": "Change in negative affect at 3 months."
},
{
"measure": "Change in positive affect at 3 months."
},
{
"measure": "Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months."
},
{
"measure": "Change in the quality of life at 3 months."
},
{
"measure": "Percent heavy drinking days at 3 months."
},
{
"measure": "Percent binge drinking days at 3 months."
},
{
"measure": "Percent days abstinence at 3 months."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Illinois at Chicago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vaccines against: Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b, varicella and measles"
}
]
},
"conditionsModule": {
"conditions": [
"Vaccine Immunity in CAR-T Cell Therapy Recipients"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bern",
"contacts": [
{
"email": "[email protected]",
"name": "Lukas N Baumann, MD",
"phone": "+41 31 66 4 30 69",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Cédric Hirzel, PD, MD",
"phone": "+41 31 66 4 01 17",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christine Thurnheer Zürcher, PD, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Cédric Hirzel, PD, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Lukas N Baumann, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Urban Novak, Professor",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "University Hospital Bern",
"geoPoint": {
"lat": 46.94809,
"lon": 7.44744
},
"state": null,
"status": "RECRUITING",
"zip": "3010"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are:* Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens* Are current re-vaccination recommendations sufficient in restoring vaccine-protection* Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual* Do clinical or immunological factors predict vaccine response after CAR-T cell therapy"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMCAR",
"briefTitle": "Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy",
"nctId": "NCT06333275",
"orgStudyIdInfo": {
"id": "DLF-Nr: 5564",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "BASEC (Business Administration System for Ethics Committees) - Switzerland",
"id": "BASEC-Nr: 2023-01141",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "CAR-T cell therapy associated change in antibody levels against 5 vaccine preventable pathogens"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of seroprotection against tetanus 6 months after CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against haemophilus influenza type B 6 months after CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against hepatitis B virus 6 months after CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against poliovirus 6 months after CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against measles virus 12 months after CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against tetanus after re-vaccination following CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against haemophilus influenza type B after re-vaccination following CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against hepatitis B virus after re-vaccination following CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against poliovirus after re-vaccination following CAR-T cell therapy"
},
{
"measure": "Rate of seroprotection against measles after re-vaccination following CAR-T cell therapy"
},
{
"measure": "Clinical predictors of vaccine elicited immune response"
},
{
"measure": "Immunological predictors of vaccine elicited immune response"
},
{
"measure": "Persistence of vaccine elicited seroprotection"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Insel Gruppe AG, University Hospital Bern"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pirtobrutinib"
},
{
"name": "Obinutuzumab"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Lymphocytic Leukemia",
"Small Lymphocytic Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": null,
"name": "Jon Arnason, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jon Arnason, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Beth Israel Deaconess Medical Center",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02215"
},
{
"city": "Boston",
"contacts": [
{
"email": null,
"name": "Inhye Ahn",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Inhye Ahn, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Brigham & Women's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02215"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Megan Forsyth",
"phone": "857-215-1405",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Inhye Ahn, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Dana-Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02215"
}
]
},
"descriptionModule": {
"briefSummary": "This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia",
"nctId": "NCT06333262",
"orgStudyIdInfo": {
"id": "24-017",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of complete response after initial therapy"
}
],
"secondaryOutcomes": [
{
"measure": "Overall response rate"
},
{
"measure": "Rate of partial response"
},
{
"measure": "Time to next line of therapy"
},
{
"measure": "Event-free survival"
},
{
"measure": "Progression-free survival"
},
{
"measure": "Overall survival"
},
{
"measure": "Rate of re-treatment with pirtobrutinib"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Loxo Oncology, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Inhye Ahn"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "rAAV2tYF-GRK1-RPGR"
}
]
},
"conditionsModule": {
"conditions": [
"X-Linked Retinitis Pigmentosa"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jacksonville",
"contacts": null,
"country": "United States",
"facility": "University of Florida",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida",
"status": null,
"zip": "32209"
},
{
"city": "Boston",
"contacts": null,
"country": "United States",
"facility": "Boston Children's Hosptial",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02115"
},
{
"city": "Cincinnati",
"contacts": null,
"country": "United States",
"facility": "Cincinnati Eye Institute",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio",
"status": null,
"zip": "45242"
},
{
"city": "Cleveland",
"contacts": null,
"country": "United States",
"facility": "Cleveland Clinic",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio",
"status": null,
"zip": "44195"
},
{
"city": "Portland",
"contacts": null,
"country": "United States",
"facility": "Casey Eye Institute",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
},
"state": "Oregon",
"status": null,
"zip": "97239"
},
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "Retina Foundation of the Southwest",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": null,
"zip": "75231"
}
]
},
"descriptionModule": {
"briefSummary": "This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The purpose of the Phase 2 study is to evaluate the efficacy, safety, and tolerability of two doses of AGTC-501 in male subjects between 8 - 50 years of age (inclusive) with XLRP genetically confirmed by at least one pathogenic variant in the RPGR gene.Approximately 12 subjects who meet the inclusion criteria, will be randomized in a 1:1 ratio to 1 of 2 treatment groups. Each subject will receive the assigned dose of AGTC-501 in the study eye; no treatment will be administered in the fellow eye. As treatment outcomes in pediatric vs. adult subjects may differ, randomization to dose groups will be stratified by age.Each subject will receive a central subretinal injection of AGTC-501 at the assigned dose in the central macula of the study eye.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "The Phase 2 study is a masked study; therefore, neither the investigator nor the subject will know the dose assignment. Both the subject and the investigator will know which eye received treatment.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 14,
"type": "ACTUAL"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "8 Years",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE)",
"nctId": "NCT06333249",
"orgStudyIdInfo": {
"id": "AGTC-RPGR-001 SKYLINE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The difference in the proportion of responding eyes between treated and control eyes in the low dose group and high dose group at 12 months, as measured by MAIA microperimetry, where response is defined as a 7dB or more improvement in at least 5 loci."
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of responding eyes in treated eyes versus control eyes in the low dose group and the high dose group at Month 12 where responder is defined as an ORA-VNC mobility test score improvement of 2 or more luminance levels."
},
{
"measure": "Proportion of responding eyes in treated versus control eyes in the low dose group and the high dose group at Month 12, as measured by MAIA microperimetry, where responder is defined as a 7 dB or more improvement in at least 5 loci within bleb."
},
{
"measure": "Proportion of responding eyes in treated vs control eyes in the low dose group and the high dose group at Month 12, measured by MAIA microperimetry where responder is defined as 7 dB or more improvement in at least 5 loci within the central 16 loci"
},
{
"measure": "Difference in mean change from baseline in the central 36 loci (C36) mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12."
},
{
"measure": "Difference in mean change from baseline in \"within bleb\" mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12."
},
{
"measure": "Difference in mean change from baseline in central 10 degrees of vision on light adapted static perimetry, as measured by Octopus 900, in treated eyes versus control eyes in the low dose group and high dose group at Month 12."
},
{
"measure": "Difference in mean change from baseline in BCVA, as measured by ETDRS or tumbling \"E\" chart, in treated eyes versus control eyes in the low dose group and high dose group at Month 12."
},
{
"measure": "Proportion of responding eyes in treated versus control eyes in the low dose group and high dose group at Month 12 where responder is defined as a 10-letter vision gain as measured by ETDRS or tumbling \"E\" chart."
},
{
"measure": "Difference in mean change from baseline in the EZ area, as measured by SD-OCT, in treated eyes versus control eyes in the low dose group and high dose group at Month 12 Visit."
},
{
"measure": "Mean change from baseline in Impact of Vision Impairment (IVI) (Weih et al, 2002; Lamoureaux et al, 2007) or Impact of Vision Impairment for Children (IVI-C) (Cochrane et al, 2008) in the low dose group and high dose group at Month 12 Visit"
},
{
"measure": "Mean change from baseline in Patient Global Impressions of Change (PGI-C) and Patient Global Impressions of Severity (PGIS) in the low dose group and high dose group at Month 12 Visit."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Beacon Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-04-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-04-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Food for Special Medical Purposes: Kron®"
}
]
},
"conditionsModule": {
"conditions": [
"Glaucoma"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma",
"nctId": "NCT06333236",
"orgStudyIdInfo": {
"id": "OCU_KRON",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Electrofunctional evaluation"
}
],
"secondaryOutcomes": [
{
"measure": "VF and SD-OCT"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "ASST Santi Paolo e Carlo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mixture of (Poly)phenols and a probiotic supplement"
},
{
"name": "Placebo comparator"
}
]
},
"conditionsModule": {
"conditions": [
"Menopause"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": null,
"name": "Adele Costabile",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Health Sciences Research Centre, Life Sciences Department, University of Roehampton",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": "UK",
"status": "RECRUITING",
"zip": "SW15 4JD"
},
{
"city": "London",
"contacts": [
{
"email": null,
"name": "Adele Costabile, Prof",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zicheng Zhang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Adele Costabile",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": "SW145JD"
}
]
},
"descriptionModule": {
"briefSummary": "Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics.To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo)",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "48 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "SYMPTOGUT",
"briefTitle": "Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis",
"nctId": "NCT06333223",
"orgStudyIdInfo": {
"id": "LSC 23/ 396",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in blood chemistry levels"
}
],
"secondaryOutcomes": [
{
"measure": "Change in BMI (body mass index) Scores"
},
{
"measure": "Change in the gut microbiota diversity"
},
{
"measure": "Change in dietary habits"
},
{
"measure": "Change in Quality IPAQ"
},
{
"measure": "Change in inflammatory biomarkes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "King's College"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Roehampton"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "anti-TRBV9 monoclonal antibody infusions"
},
{
"name": "Placebo infusions"
},
{
"name": "Adalimumab subcutaneous injection"
},
{
"name": "Placebo subcutaneous injection"
}
]
},
"conditionsModule": {
"conditions": [
"Axial Spondyloarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chelyabinsk",
"contacts": [
{
"email": "[email protected]",
"name": "Olga Nesmeianova, PhD",
"phone": "+73517493727",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Chelyabinsk Regional Clinical hospital",
"geoPoint": {
"lat": 55.15402,
"lon": 61.42915
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Moscow",
"contacts": [
{
"email": "[email protected]",
"name": "Sergey Moiseev, PhD, Doc Med Sci",
"phone": "+7 499 248 25 44",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University",
"geoPoint": {
"lat": 55.75222,
"lon": 37.61556
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Saint Petersburg",
"contacts": [
{
"email": "[email protected]",
"name": "Inna Gaidukova",
"phone": "+7 (812) 670 30 90",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Clinical Rheumatology Hospital №25",
"geoPoint": {
"lat": 59.93863,
"lon": 30.31413
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Saint-Petersburg",
"contacts": [
{
"email": null,
"name": "Vadim Mazurov, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "North-Western State Medical University n.a. I.I.Mechnikov",
"geoPoint": {
"lat": 59.93863,
"lon": 30.31413
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 421,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)",
"nctId": "NCT06333210",
"orgStudyIdInfo": {
"id": "BCD-180-3",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects"
},
{
"measure": "Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of subjects who achieved ASAS40 among subjects with r-axSpA"
},
{
"measure": "Proportion of subjects who achieved ASAS40 among subjects with nr-axSpA"
},
{
"measure": "Proportion of subjects with the ASDAS-CRP <1.3"
},
{
"measure": "Proportion of subjects with the ASDAS-CRP ≥1.3 - <2.1"
},
{
"measure": "Proportion of subjects with the ASDAS-CRP ≥2.1 - ≤3.5"
},
{
"measure": "Proportion of subjects with the ASDAS-CRP >3.5"
},
{
"measure": "Proportion of subjects who achieved ASDAS-CII (clinically important improvement)"
},
{
"measure": "Proportion of subjects who achieved ASDAS-MI (Major improvement)"
},
{
"measure": "ASDAS-CRP change from baseline"
},
{
"measure": "Proportion of patients who achieved clinical response defined as an improvement of BASDAI by at least 50% compared to baseline"
},
{
"measure": "Change from baseline in BASDAI"
},
{
"measure": "Proportion of subjects who achieved ASAS40"
},
{
"measure": "Proportion of subjects who achieved ASAS20"
},
{
"measure": "Proportion of subjects who achieved ASAS5/6"
},
{
"measure": "Proportion of subjects who achieved ASAS partial remission"
},
{
"measure": "Change from baseline in BASMI"
},
{
"measure": "Change from baseline in BASFI"
},
{
"measure": "Change from baseline in the swollen joint count (44 joints)"
},
{
"measure": "Change from baseline in MASES"
},
{
"measure": "Change from baseline in overall back pain severity (BASDAI No. 2)"
},
{
"measure": "Change from baseline in nocturnal back pain severity"
},
{
"measure": "Change in the patient global assessment of disease activity from baseline"
},
{
"measure": "Change in the quality of life score assessed with EQ-5D-3L questionnaire from baseline"
},
{
"measure": "Change from baseline in SF-36 Physical Functioning compared to baseline"
},
{
"measure": "Change from baseline in SF-36 Mental Health compared to baseline"
},
{
"measure": "Change in the WPAI score from baseline"
},
{
"measure": "Change in the ASAS HI score from baseline"
},
{
"measure": "Change in the concentration of hsCRP from baseline"
},
{
"measure": "Change in ESR from baseline"
},
{
"measure": "Changes in the SPARCC score (spine, SIJ) from baseline"
},
{
"measure": "Changes in mSASSS scores from baseline"
},
{
"measure": "Proportion of subjects with adverse events"
},
{
"measure": "Proportion of subjects with serious adverse events"
},
{
"measure": "Proportion of subjects with grade 3 or higher adverse events according to CTCAE 5.0"
},
{
"measure": "Proportion of subjects prematurely withdrawn from the study due to adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Biocad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ORIF through transparotid approach"
},
{
"name": "ORIF through retroparotid approach"
}
]
},
"conditionsModule": {
"conditions": [
"Mandibular Fractures"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The condylar region is the most frequent anatomical site for mandibular fractures .Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "ALL Patients diagnosed with Extra Capsular Fracture of Mandibular Condyle amenable for surgery.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture",
"nctId": "NCT06333197",
"orgStudyIdInfo": {
"id": "Mandibular condylar fracture",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Facial nerve injury"
},
{
"measure": "Operative time"
}
],
"secondaryOutcomes": [
{
"measure": "Fracture stability"
},
{
"measure": "Mouth opening"
},
{
"measure": "Other Complication related to the Approach"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Food"
}
]
},
"conditionsModule": {
"conditions": [
"Metabolic Disturbance"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bath",
"contacts": [
{
"email": "[email protected]",
"name": "Javier T Gonzalez, PhD",
"phone": "+44 (0) 1225 38",
"phoneExt": "5125",
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Department for Health, University of Bath",
"geoPoint": {
"lat": 51.3751,
"lon": -2.36172
},
"state": null,
"status": "RECRUITING",
"zip": "BA2 7AY"
}
]
},
"descriptionModule": {
"briefSummary": "Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Smoothies and Blood Sugars",
"nctId": "NCT06333184",
"orgStudyIdInfo": {
"id": "3085-4215",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Condition-by-sampling interaction"
},
{
"measure": "GI of products in capillary samples"
},
{
"measure": "GI of products in continuous glucose monitors"
},
{
"measure": "Peak glucose capillary vs CGM"
},
{
"measure": "Time to peak glucose capillary vs CGM"
}
],
"primaryOutcomes": [
{
"measure": "Glycaemic index of product with capillary vs CGM"
}
],
"secondaryOutcomes": [
{
"measure": "Glycaemic index of all conditions with capillary vs CGM"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Bath"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "4-Aminopyridine"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Wounds",
"Wound of Skin",
"Wound Heal",
"Wounds and Injuries"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tucson",
"contacts": [
{
"email": "[email protected]",
"name": "Andrea Horne",
"phone": "520-626-6456",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Arizona",
"geoPoint": {
"lat": 32.22174,
"lon": -110.92648
},
"state": "Arizona",
"status": null,
"zip": "85724"
}
]
},
"descriptionModule": {
"briefSummary": "Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults.The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing.The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a double-blind, randomized, placebo-controlled trial design.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Subjects in both aims will be assigned to Group A or Group B using a randomization scheme. Each study participant for each aim is randomly assigned to either treatment of placebo using permuted block randomization",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "4-aminopyridine for Skin Wound Healing",
"nctId": "NCT06333171",
"orgStudyIdInfo": {
"id": "00003872",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Return of skin integrity and wound closure after skin punch biopsy"
}
],
"secondaryOutcomes": [
{
"measure": "The effect of 4-AP on the hair number and growth at the skin punch biopsy site."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "John Elfar"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cholesfytol NG"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wilrijk",
"contacts": [
{
"email": "[email protected]",
"name": "Nina Hermans, Prof.",
"phone": "003232652732",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "UAntwerp, NatuRAPT",
"geoPoint": {
"lat": 51.16734,
"lon": 4.39513
},
"state": "Antwerp",
"status": "RECRUITING",
"zip": "2610"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,2. Leads to a clinically relevant reduction of blood pressure on the short term,3. Leads to a change in oxidative stress biomarkers.Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:* Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day* Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "76 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AmWaRO",
"briefTitle": "Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention",
"nctId": "NCT06333158",
"orgStudyIdInfo": {
"id": "AmWaRO Study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Change from baseline glucose level at 8 weeks"
},
{
"measure": "Change from baseline HbA1c level at 8 weeks"
},
{
"measure": "Change from baseline insuline level at 8 weeks"
},
{
"measure": "Change from baseline Body Mass Index (BMI) at 8 weeks"
},
{
"measure": "Change from baseline waist circumference at 8 weeks"
},
{
"measure": "Change from baseline hemoglobine level at 8 weeks"
},
{
"measure": "Change from baseline creatinine level at 8 weeks"
},
{
"measure": "Change from baseline hs-CRP level at 8 weeks"
},
{
"measure": "Change from baseline homocysteine level at 8 weeks"
},
{
"measure": "Change from baseline creatine kinase (CK) level at 8 weeks"
},
{
"measure": "Change from baseline C-peptide level at 8 weeks"
}
],
"primaryOutcomes": [
{
"measure": "Change from baseline LDL cholesterol at 8 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Frequency of side effects (+ their burden) as reported in the final questionnaire"
},
{
"measure": "Change from baseline Blood Pressure, Systolic at 8 weeks"
},
{
"measure": "Change from baseline Blood Pressure, diastolic at 8 weeks"
},
{
"measure": "Change from baseline total cholesterol level at 8 weeks"
},
{
"measure": "Change from baseline HDL cholesterol level at 8 weeks"
},
{
"measure": "Change from baseline non-HDL cholesterol level at 8 weeks"
},
{
"measure": "Change from baseline Remnant Cholesterol at 8 weeks"
},
{
"measure": "Change from baseline triglycerides level at 8 weeks"
},
{
"measure": "Change from baseline Apo A1 level at 8 weeks"
},
{
"measure": "Change from baseline Apo B level at 8 weeks"
},
{
"measure": "Change from baseline lipoprotein A (LP(a)) level at 8 weeks"
},
{
"measure": "Change from baseline OxLDL level at 8 weeks"
},
{
"measure": "Change from baseline malondialdehyde (MDA) level at 8 weeks"
},
{
"measure": "Change from baseline glutathion (GSH) level at 8 weeks"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Hospital, Antwerp"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Nina Hermans"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remimazolam"
}
]
},
"conditionsModule": {
"conditions": [
"Effect of Drug"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "aijun xu, Dr.",
"phone": "027-83663173",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "yuan Bi, Dr.",
"phone": "027-18972718216",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Tongji Hospital",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": "RECRUITING",
"zip": "430000"
}
]
},
"descriptionModule": {
"briefSummary": "Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults",
"nctId": "NCT06333145",
"orgStudyIdInfo": {
"id": "EDRA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ramsey Sedation Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Time records"
},
{
"measure": "Use of drugs"
},
{
"measure": "Respiratory suppression incidence"
},
{
"measure": "Incidence of Treatment-Emergent Adverse Events"
},
{
"measure": "Incidence of PACU Adverse Reactions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tongji Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Weight loss-induced Diabetes Remission"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity",
"Diabetes Mellitus Type 2 in Obese"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pisa",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliero-Universitaria Pisana",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": "PI",
"status": null,
"zip": "56127"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DiabEATit",
"briefTitle": "Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)",
"nctId": "NCT06333132",
"orgStudyIdInfo": {
"id": "DiabEAT.it",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Azienda Ospedaliero, Universitaria Pisana"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "modified rankin scale"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Urinary Incontinence",
"Motor Skills Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Isparta",
"contacts": null,
"country": "Turkey",
"facility": "Suleyman Demirel University",
"geoPoint": {
"lat": 37.76444,
"lon": 30.55222
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 46,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Relationship Between Urinary Incontinence and Motor Symptoms",
"nctId": "NCT06333119",
"orgStudyIdInfo": {
"id": "72867572-050.01.04-320",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "relationship with between urinary incontinence and motor symptoms"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pinar Yasar"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "POCUS diagnostic value"
}
]
},
"conditionsModule": {
"conditions": [
"Fecal Impaction of Colon"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Many medical and paramedical specialties regularly use point-of-care ultrasound (PoCUS) in clinical practice. The diagnosis of fecal impaction is quite common in the elderly living in nursing homes with a prevalence of 47.3%. Fecal impaction remains a major source of morbidity, while its etiology is often multifactorial and its diagnosis challenging. Current recommendations for the diagnosis of fecal impaction support the use of plain abdominal x-rays. PoCUS is a non-irradiating procedure and a clinical diagnostic tool that can be used in a variety of ways during abdominal examinations. Most scientific societies encourage the use of PoCUS to respond to a specific clinical question rather than to provide a diagnosis, which is usually confirmed by conventional ultrasound. However, the combination of physical examination and PoCUS may improve the diagnostic approach. This multicentric prospective study protocol aims to evaluate the diagnostic accuracy of PoCUS in patients aged 75 years or older with suspected fecal impaction in the emergency department compared with plain abdominal x-ray (or abdominal CT scan if required as part of the emergency department investigations)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 247,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "130 Years",
"minimumAge": "75 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PoCUS Diagnostic Accuracy for Fecal Impaction in the Emergency Department: A Prospective Study",
"nctId": "NCT06333106",
"orgStudyIdInfo": {
"id": "FICUS - 2024/16FEV/077",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room"
}
],
"secondaryOutcomes": [
{
"measure": "Influence of BMI on the diagnosis of fecal impaction at PoCUS"
},
{
"measure": "Influence of bladder repletion on the diagnosis of fecal impaction using PoCUS"
},
{
"measure": "Influence of patient echogenicity on the diagnosis of fecal impaction using PoCUS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Université de Liège"
},
{
"name": "Grand Hôpital de Charleroi"
},
{
"name": "Clinique Saint-Jean, Bruxelles"
},
{
"name": "Clinique Saint Pierre Ottignies"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Cliniques universitaires Saint-Luc- Université Catholique de Louvain"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cold snare"
}
]
},
"conditionsModule": {
"conditions": [
"Duodenum Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amsterdam",
"contacts": [
{
"email": "[email protected]",
"name": "Celine BE Busch, MD",
"phone": "+31621357593",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jacques JG Bergman, MD PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Celine BE Busch, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Netherlands",
"facility": "Amsterdam UMC",
"geoPoint": {
"lat": 52.37403,
"lon": 4.88969
},
"state": "North-Holland",
"status": "RECRUITING",
"zip": "1105 AZ"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the quality of cold snare resection specimens of duodenal mucosa tissue in patients undergoing an upper gastrointestinal interventional endoscopy in order to improve the processing of histological samples and its assessment in general and for future duodenal ablation studies."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DIRECT",
"briefTitle": "Duodenal tIssue ResEction aCquisiTion (DIRECT) Study",
"nctId": "NCT06333093",
"orgStudyIdInfo": {
"id": "NL82178.018.22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acquiring larger pieces of tissue from the duodenum"
},
{
"measure": "Histopatholocial assessment of larger pieces of tissue from the duodenum"
},
{
"measure": "Checking if the tissue is of good quality enough for single cell RNA sequencing"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aalborg",
"contacts": [
{
"email": "[email protected]",
"name": "Mette Pilegaard Rasmussen, BSc",
"phone": "00 45 30 36 46 84",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Peter Vestergaard, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Nynne S Holdt-Caspersen, MSc",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Denmark",
"facility": "Steno Diabetes Center North Denmark",
"geoPoint": {
"lat": 57.048,
"lon": 9.9187
},
"state": null,
"status": "RECRUITING",
"zip": "9000"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of the trial is to investigate the effect of adherence to oral semaglutide dosing instructions on glycaemic control in people with type 2 diabetes, which are dysregulated on metformin and naïve to second line antidiabetic treatment."
},
"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": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DIACRON",
"briefTitle": "The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin",
"nctId": "NCT06333080",
"orgStudyIdInfo": {
"id": "N-20220017",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time-in-Range (TIR)"
}
],
"secondaryOutcomes": [
{
"measure": "Pre-dose Fasting"
},
{
"measure": "Post-dose Fasting"
},
{
"measure": "Occurrence of nausea or vomiting"
},
{
"measure": "Water Intake at Dosing Time"
},
{
"measure": "Treatment-Related Impact Measure for Diabetes (TRIM-D)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Aalborg University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sofwave"
}
]
},
"conditionsModule": {
"conditions": [
"Lax Skin"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "La Mesa",
"contacts": [
{
"email": "[email protected]",
"name": "Christopher V.Crosby, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christopher V.Crosby, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Costal Skin & Eye Institute",
"geoPoint": {
"lat": 32.76783,
"lon": -117.02308
},
"state": "California",
"status": "RECRUITING",
"zip": "91942"
},
{
"city": "Durham",
"contacts": [
{
"email": "[email protected]",
"name": "Talasia Smith",
"phone": "919-294-9440",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Brooke Jackson, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Skin Wellness Dermatology Associates",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27713"
}
]
},
"descriptionModule": {
"briefSummary": "Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "35 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators",
"nctId": "NCT06333067",
"orgStudyIdInfo": {
"id": "Sofwave21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary Outcome Measure"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sofwave Medical LTD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pyrethrum Extract"
},
{
"name": "Silcap Shampoo"
}
]
},
"conditionsModule": {
"conditions": [
"Head Lice"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erfurt",
"contacts": null,
"country": "Germany",
"facility": "CardioSec Clinical Research GmbH",
"geoPoint": {
"lat": 50.9787,
"lon": 11.03283
},
"state": null,
"status": null,
"zip": "99084"
}
]
},
"descriptionModule": {
"briefSummary": "This study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 109,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety and Efficacy of a Head Lice Shampoo",
"nctId": "NCT06333054",
"orgStudyIdInfo": {
"id": "NCLIN0091/ 14ct/mp37li",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Severity of the lice infestation"
}
],
"primaryOutcomes": [
{
"measure": "Cure Rate superior to 70% for the test product"
}
],
"secondaryOutcomes": [
{
"measure": "Cure Rate superior to 70% for the reference product"
},
{
"measure": "Superior cure rate to the reference"
},
{
"measure": "Non-inferiority rate to the reference"
},
{
"measure": "Local tolerability"
},
{
"measure": "Global tolerability"
},
{
"measure": "Skin irritation assessment"
},
{
"measure": "Eye irritation assessment"
},
{
"measure": "Esthetical effect of the anti-lice products"
},
{
"measure": "Adverse Events (AEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Oystershell NV"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2015-06-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2015-06-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2014-10-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Epidiolex"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Sanfilippo Syndrome",
"Mucopolysaccharidosis III"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Torrance",
"contacts": [
{
"email": "[email protected]",
"name": "Cristi Williams",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lynda Polgreen, MD, MS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center",
"geoPoint": {
"lat": 33.83585,
"lon": -118.34063
},
"state": "California",
"status": null,
"zip": "90502"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test cannabidiol in Sanfilippo syndrome. The main questions it aims to answer are: 1) determine the safety of cannabidiol in Sanfilippo syndrome, and 2) explore the efficacy of cannabidiol in treating the neurobehavioral symptoms and functional outcomes of Sanfilippo syndrome.Each participant's caregiver will be asked to complete surveys related to the participant's behavior, mood, sleep, stooling, pain, and caregiver stress intermittently throughout the study. All participants will be enrolled into one of two cohorts based on enrollment order:1. Sentinel Safety Cohort (first 5 participants) - all participants treated with Epidiolex (cannabidiol)2. Controlled Cohort (next 30 participants) - participants randomized 1:1 (equal chance) to start treatment with Epidiolex (cannabidiol) or placebo for 16 weeks, followed by an 8-week washout period (no treatment). Participants then switch to the opposite treatment group for 16 weeks followed by all participants treated for 52 weeks with Epidiolex (cannabidiol)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Double-blind, placebo-controlled, cross-over study",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of Cannabidiol in Sanfilippo Syndrome",
"nctId": "NCT06333041",
"orgStudyIdInfo": {
"id": "32977-01-00",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sanfilippo Behavior Rating Scale (SBRS)- mood/anger/aggression score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "enVista Aspire EA IOLs"
}
]
},
"conditionsModule": {
"conditions": [
"Cataract"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dover",
"contacts": null,
"country": "United States",
"facility": "SITE 104",
"geoPoint": {
"lat": 40.88399,
"lon": -74.5621
},
"state": "New Jersey",
"status": null,
"zip": "07801"
},
{
"city": "Woodland Park",
"contacts": null,
"country": "United States",
"facility": "Site 105",
"geoPoint": {
"lat": 40.88982,
"lon": -74.19487
},
"state": "New Jersey",
"status": null,
"zip": "07424"
},
{
"city": "Garden City",
"contacts": null,
"country": "United States",
"facility": "Site 103",
"geoPoint": {
"lat": 40.72677,
"lon": -73.6343
},
"state": "New York",
"status": null,
"zip": "11530"
},
{
"city": "Charleston",
"contacts": null,
"country": "United States",
"facility": "Site 106",
"geoPoint": {
"lat": 32.77657,
"lon": -79.93092
},
"state": "South Carolina",
"status": null,
"zip": "29407"
},
{
"city": "Sugar Land",
"contacts": null,
"country": "United States",
"facility": "Site 101",
"geoPoint": {
"lat": 29.61968,
"lon": -95.63495
},
"state": "Texas",
"status": null,
"zip": "77478"
},
{
"city": "Mount Pleasant",
"contacts": null,
"country": "United States",
"facility": "Site 102",
"geoPoint": {
"lat": 42.69743,
"lon": -87.85577
},
"state": "Wisconsin",
"status": null,
"zip": "53405"
}
]
},
"descriptionModule": {
"briefSummary": "A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction",
"nctId": "NCT06333028",
"orgStudyIdInfo": {
"id": "938",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean binocular BCDVA (logMAR) at Visit 1"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bausch & Lomb Incorporated"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "enVista EY Beyond IOL"
},
{
"name": "TECNIS 1-Piece monofocal IOL"
}
]
},
"conditionsModule": {
"conditions": [
"Cataract"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Northridge",
"contacts": null,
"country": "United States",
"facility": "Site 108",
"geoPoint": {
"lat": 34.22834,
"lon": -118.53675
},
"state": "California",
"status": null,
"zip": "91325"
},
{
"city": "Bloomington",
"contacts": null,
"country": "United States",
"facility": "Site 107",
"geoPoint": {
"lat": 44.8408,
"lon": -93.29828
},
"state": "Minnesota",
"status": null,
"zip": "55420"
},
{
"city": "Omaha",
"contacts": null,
"country": "United States",
"facility": "Site 101",
"geoPoint": {
"lat": 41.25626,
"lon": -95.94043
},
"state": "Nebraska",
"status": null,
"zip": "68137"
},
{
"city": "Las Vegas",
"contacts": null,
"country": "United States",
"facility": "Site 109",
"geoPoint": {
"lat": 36.17497,
"lon": -115.13722
},
"state": "Nevada",
"status": null,
"zip": "89145"
},
{
"city": "Brecksville",
"contacts": null,
"country": "United States",
"facility": "Site 102",
"geoPoint": {
"lat": 41.31978,
"lon": -81.62679
},
"state": "Ohio",
"status": null,
"zip": "44141"
},
{
"city": "North Charleston",
"contacts": null,
"country": "United States",
"facility": "Site 105",
"geoPoint": {
"lat": 32.85462,
"lon": -79.97481
},
"state": "South Carolina",
"status": null,
"zip": "29406"
},
{
"city": "Sioux Falls",
"contacts": null,
"country": "United States",
"facility": "Site 106",
"geoPoint": {
"lat": 43.54997,
"lon": -96.70033
},
"state": "South Dakota",
"status": null,
"zip": "57108"
},
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "Site 103",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": null,
"zip": "75243"
},
{
"city": "Mount Pleasant",
"contacts": null,
"country": "United States",
"facility": "Site 111",
"geoPoint": {
"lat": 42.69743,
"lon": -87.85577
},
"state": "Wisconsin",
"status": null,
"zip": "53405"
},
{
"city": "Calgary",
"contacts": null,
"country": "Canada",
"facility": "Site 110",
"geoPoint": {
"lat": 51.05011,
"lon": -114.08529
},
"state": "Alberta",
"status": null,
"zip": "T2N 1N4"
},
{
"city": "Montréal",
"contacts": null,
"country": "Canada",
"facility": "Site 104",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H1V 1G5"
}
]
},
"descriptionModule": {
"briefSummary": "This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Approximately 224 subjects (448 eyes) will be enrolled in this study with plans to bilaterally implant approximately 112 subjects with each of the test and control IOLs.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Subjects and designated postoperative evaluator(s) will be masked to the IOLs assigned. The Investigator implanting the IOL and designated site personnel will be unmasked to the treatment assignment for a subject.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 224,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction",
"nctId": "NCT06333015",
"orgStudyIdInfo": {
"id": "924",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4."
},
{
"measure": "Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4."
},
{
"measure": "Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4."
},
{
"measure": "Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4."
},
{
"measure": "Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4."
}
],
"secondaryOutcomes": [
{
"measure": "Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bausch & Lomb Incorporated"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "machine learning analysis"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Hypoxemic Respiratory Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ciudad Real",
"contacts": null,
"country": "Spain",
"facility": "Hospital General Universitario de Ciudad Real",
"geoPoint": {
"lat": 38.98626,
"lon": -3.92907
},
"state": null,
"status": null,
"zip": "13005"
},
{
"city": "Cuenca",
"contacts": null,
"country": "Spain",
"facility": "Hospital Virgen de La Luz",
"geoPoint": {
"lat": 40.06667,
"lon": -2.13333
},
"state": null,
"status": null,
"zip": "16002"
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario La Paz",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": "28046"
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Puerta de Hierro",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": "28222"
},
{
"city": "Murcia",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Virgen de Arrixaca",
"geoPoint": {
"lat": 37.98704,
"lon": -1.13004
},
"state": null,
"status": null,
"zip": "3012"
},
{
"city": "Santa Cruz De Tenerife",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario NS de Candelaria",
"geoPoint": {
"lat": 28.46824,
"lon": -16.25462
},
"state": null,
"status": null,
"zip": "38010"
},
{
"city": "Valencia",
"contacts": null,
"country": "Spain",
"facility": "Hospital Cinico de Valencia",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": null,
"zip": "46010"
},
{
"city": "Valladolid",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Rio Hortega",
"geoPoint": {
"lat": 41.65518,
"lon": -4.72372
},
"state": null,
"status": null,
"zip": "47012"
}
]
},
"descriptionModule": {
"briefSummary": "Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death and prolonged duration (\\>7 days) of mechanical ventilation (MV) in 1,241 patients enrolled in the PANDORA (Prevalence AND Outcome of acute Respiratory fAilure) Study in Spain. The study was registered with ClinicalTrials.gov (NCT03145974). Our aim is to evaluate the minimum number of variables models using logistic regression and four supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1241,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MEMORIAL",
"briefTitle": "Machine Learning Model to Predict Outcome and Duration of Mechanical Ventilation in Acute Hypoxemic Respiratory Failure",
"nctId": "NCT06333002",
"orgStudyIdInfo": {
"id": "PI24/00325",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ICU mortality"
}
],
"secondaryOutcomes": [
{
"measure": "MV duration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Dr. Negrin University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "stroke-APP"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke, Acute",
"Pre-hospital Triage",
"Stroke Treatment",
"Stroke Code"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leiden",
"contacts": [
{
"email": "[email protected]",
"name": "Nyika D Kruyt, MD. PhD",
"phone": "0031-715262139",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Leiden University medical center",
"geoPoint": {
"lat": 52.15833,
"lon": 4.49306
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 3000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STROKE-APP",
"briefTitle": "Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting",
"nctId": "NCT06332989",
"orgStudyIdInfo": {
"id": "N22.129",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "final diagnosis"
},
{
"measure": "treated with reperfusion therapy"
},
{
"measure": "additional investigations"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Alrijne Ziekenhuis Leiderdorp"
},
{
"name": "Groene Hart Ziekenhuis"
},
{
"name": "Medical Center Haaglanden"
},
{
"name": "HagaZiekenhuis"
},
{
"name": "Reinier de Graaf Groep"
},
{
"name": "Regionale Ambulance Voorziening Hollands Midden"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Leiden University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Completion of questionnaires"
}
]
},
"conditionsModule": {
"conditions": [
"Female Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Emilia Montagna, MD",
"phone": "+390257489970",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "European Institute of Oncology",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20141"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:1. before to start the chemotherapy2. during chemotherapy3. after the end of chemotherapy"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 450,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PRACTICE",
"briefTitle": "PrefeRences And ChemoTherapy In Breast Cancer patiEnts",
"nctId": "NCT06332976",
"orgStudyIdInfo": {
"id": "IEO 1521",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile"
},
{
"measure": "Prolonged survival time gain needed to consider CT worthwhile"
}
],
"secondaryOutcomes": [
{
"measure": "Behavior assessment"
},
{
"measure": "Reaction to uncertain situations assessment"
},
{
"measure": "Regret and disappointment assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "European Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-06-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Floatation-REST"
},
{
"name": "IFT"
},
{
"name": "EFT"
}
]
},
"conditionsModule": {
"conditions": [
"Anorexia Nervosa",
"Body Image Disturbance",
"Interoception"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Equal groups parallel randomized clinical trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 102,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "15 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa",
"nctId": "NCT06332963",
"orgStudyIdInfo": {
"id": "2023-007",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS)"
},
{
"measure": "Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS)"
}
],
"secondaryOutcomes": [
{
"measure": "Cognitive/affective body image on the Body Image State Scale (BISS)"
},
{
"measure": "Body image dissatisfaction on the Somatomap3D"
},
{
"measure": "Appearance evaluation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Evaluation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance)"
},
{
"measure": "Appearance orientation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Orientation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance)"
},
{
"measure": "Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction"
},
{
"measure": "Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale"
},
{
"measure": "Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)"
},
{
"measure": "Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)"
},
{
"measure": "Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)"
},
{
"measure": "Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)"
},
{
"measure": "Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)"
},
{
"measure": "Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)"
},
{
"measure": "Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)"
},
{
"measure": "Interoceptive attention on the Interoceptive Attention Scale (IATS)"
},
{
"measure": "Cardiac interoceptive accuracy on the Heartbeat Tapping Task"
},
{
"measure": "Cardiac interoceptive intensity on the Heartbeat Tapping Task"
},
{
"measure": "Interoceptive intensity during experimental conditions"
},
{
"measure": "Perceived respiratory interoceptive intensity on the Breath Hold Task"
},
{
"measure": "Body image distortion on the Aperture Task"
},
{
"measure": "Body image distortion on the String task"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Laureate Institute for Brain Research, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adebrelimab, Irinotecan Liposome (II)"
},
{
"name": "Adebrelimab, Irinotecan Liposome (II), Famitinib"
}
]
},
"conditionsModule": {
"conditions": [
"Extensive-stage Small-cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Baohui Han, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shanghai Chest Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy",
"nctId": "NCT06332950",
"orgStudyIdInfo": {
"id": "MA-SCLC-II-015",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6-month progression-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Safety"
},
{
"measure": "Objective response rate"
},
{
"measure": "Progression-free survival"
},
{
"measure": "Overall survival"
},
{
"measure": "Disease control rate"
},
{
"measure": "Duration of response"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Baohui Han"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "postmastectomy breast reconstruction"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Implant; Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Seoul National University Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": null,
"zip": "03080"
}
]
},
"descriptionModule": {
"briefSummary": "Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 5000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Breast Reconstruction",
"nctId": "NCT06332937",
"orgStudyIdInfo": {
"id": "H-2102-079-1197",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Infection"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Seoul National University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-02-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "motivational discussion group"
}
]
},
"conditionsModule": {
"conditions": [
"Pregnancy Related"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In the project, it was calculated that the experimental and control groups should have at least 30 observations each, and the sample of the study was calculated as 60 pregnant women. It was aimed to interview a total of 60 pregnant women, 30 in the control group and 30 in the experimental group.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Primipara Pregnant Women and Motivational Interview",
"nctId": "NCT06332924",
"orgStudyIdInfo": {
"id": "2023/19",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primipara Pregnant Women and Traumatic Birth"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Saglik Bilimleri Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+"
}
]
},
"conditionsModule": {
"conditions": [
"Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture",
"Abdominal Aortic Aneurysm Without Rupture",
"Thoracic Aortic Aneurysm Without Rupture"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TEVAR",
"briefTitle": "Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair",
"nctId": "NCT06332911",
"orgStudyIdInfo": {
"id": "RO-231129",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy: Technical success - defined as intention-to-treat basis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shockwave Medical, Inc."
}
],
"leadSponsor": {
"class": "NETWORK",
"name": "Rede Optimus Hospitalar SA"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AG1 - Nutritional Supplement"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Nutrition, Healthy",
"Gastrointestinal Microbiome",
"Healthy Aging"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, Double-Blind, Placebo Controlled Design",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life",
"nctId": "NCT06332898",
"orgStudyIdInfo": {
"id": "AG-01-0324",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Homocysteine"
},
{
"measure": "Vitamin B12"
},
{
"measure": "Folate"
},
{
"measure": "Red Blood Cell Folate"
},
{
"measure": "Zinc"
},
{
"measure": "Vitamin C"
},
{
"measure": "Gut Microbiome"
}
],
"secondaryOutcomes": [
{
"measure": "Dietary habits"
},
{
"measure": "Gastrointestinal Health"
},
{
"measure": "Fatigue & energy"
},
{
"measure": "Well-being"
},
{
"measure": "Complete Metabolic Blood Panel"
},
{
"measure": "Complete Blood Count"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Citruslabs"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Athletic Greens International"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Zephyr Endobronchial Valve"
}
]
},
"conditionsModule": {
"conditions": [
"Emphysema",
"COPD",
"Severe Emphysema"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gifu",
"contacts": [
{
"email": "[email protected]",
"name": "Takahiro Masami",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Fumihiro Asano, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Gifu Prefectural Medical Center",
"geoPoint": {
"lat": 35.42291,
"lon": 136.76039
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Kanagawa",
"contacts": [
{
"email": "[email protected]",
"name": "Takashi Niwa, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Takashi Niwa, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Kanagawa Cardio Chest Center",
"geoPoint": {
"lat": 37.58333,
"lon": 139.91667
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Kanazawa",
"contacts": [
{
"email": "[email protected]",
"name": "Satoshi Watanabe, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Satoshi Watanabe, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Kanazawa University Hospital",
"geoPoint": {
"lat": 36.6,
"lon": 136.61667
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Kawasaki",
"contacts": [
{
"email": "[email protected]",
"name": "Masamichi Mineshita, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Masamichi Mineshita, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "St Marianna University Hospital",
"geoPoint": {
"lat": 35.52056,
"lon": 139.71722
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Nagasaki",
"contacts": [
{
"email": "[email protected]",
"name": "Keitaro Matsumoto, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Keitaro Matsumoto, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Nagasaki University Hospital",
"geoPoint": {
"lat": 32.75,
"lon": 129.88333
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Nagoya",
"contacts": [
{
"email": "[email protected]",
"name": "Masahide Oki, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Masahide Oki, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Nagoya Medical Center",
"geoPoint": {
"lat": 35.18147,
"lon": 136.90641
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Okayama",
"contacts": [
{
"email": "[email protected]",
"name": "Yanagihara",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ken Sato, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Okayama Medical Center",
"geoPoint": {
"lat": 34.65,
"lon": 133.93333
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Osaka",
"contacts": [
{
"email": "[email protected]",
"name": "Akihiro Tamiya, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Akihiro Tamiya, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Kinki Chuo Chest Medical Center",
"geoPoint": {
"lat": 34.69374,
"lon": 135.50218
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Sapporo",
"contacts": [
{
"email": "[email protected]",
"name": "Naofumi Shinagawa, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Naofumi Shinagawa, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Hokkaido University Hospital",
"geoPoint": {
"lat": 43.06667,
"lon": 141.35
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Sendai",
"contacts": [
{
"email": "[email protected]",
"name": "Hirotsugu Notsuda, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hirotsugu Notsuda, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Tohoku University Hospital",
"geoPoint": {
"lat": 38.26667,
"lon": 140.86667
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Shiga",
"contacts": [
{
"email": "[email protected]",
"name": "Yasuki Uchida, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yasuki Uchida, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Shiga University Hospital",
"geoPoint": null,
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Tokyo",
"contacts": [
{
"email": null,
"name": "Hiroyuki Tashimo, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hiroyuki Tashimo, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Tokyo National Hospital",
"geoPoint": {
"lat": 35.6895,
"lon": 139.69171
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Toyoake",
"contacts": [
{
"email": "[email protected]",
"name": "Risako Koshiyama",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kazuyoshi Imaizumi, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Fujita Health University Hospital",
"geoPoint": {
"lat": 35.038,
"lon": 136.99931
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Utsunomiya",
"contacts": [
{
"email": "[email protected]",
"name": "Yasuo Shimizu, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yasuo Shimizu, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Dokkyo University Hospital (Pulmonary Medicine and Clinical Immunology)",
"geoPoint": {
"lat": 36.56667,
"lon": 139.88333
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Utsunomiya",
"contacts": [
{
"email": "[email protected]",
"name": "Masayuki Chida, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Masayuki Chida, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Japan",
"facility": "Dokkyo University Hospital",
"geoPoint": {
"lat": 36.56667,
"lon": 139.88333
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 140,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Zephyr Valve Japan Post-Marketing Surveillance",
"nctId": "NCT06332885",
"orgStudyIdInfo": {
"id": "630-2001-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Forced Expiratory Volume in 1 second (FEV1)"
},
{
"measure": "Residual Volume (RV)"
},
{
"measure": "Treated lobe volume reduction (TLVR)"
},
{
"measure": "Six-Minute Walk Distance (6MWD)"
},
{
"measure": "Modified Medical Research Council Dyspnea (mMRC) Scale score"
},
{
"measure": "St. George's Respiratory Questionnaire (SGRQ) Total Score"
}
],
"primaryOutcomes": [
{
"measure": "Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Pulmonx Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral Ivermectin"
},
{
"name": "4% dimenticone liquid gel"
}
]
},
"conditionsModule": {
"conditions": [
"Pediculus Capitis Infestation",
"Permethrin Adverse Reaction",
"Dimethicone Adverse Reaction",
"Permethrin Allergy",
"Dimethicone Allergy",
"Ivermectin",
"School-age Children"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bangkok",
"contacts": null,
"country": "Thailand",
"facility": "Phramongkutklao college of medicine",
"geoPoint": {
"lat": 13.75398,
"lon": 100.50144
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis, to assess the prevalence of lice and associated risk factors between severity groups by using questionnaire-based surveys and diagnostic tests among school children in Baan Nayao, Chachoengsao Province, Thailand.The main questions it aims to answer are* What is more effective between Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel in the treatment of Pediculosis capitis in school children in Baan Nayao, Chachoengsao Province, Thailand?* What is Prevalence and risk factors of being infected with in head lice in school and community?* What is Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel?Participants will receive three different drugs are* oral ivermectin* 4% Dimeticone liquid gel* 1% Permethrin shampooParticipants voluntarily received oral ivermectin as per medical prescription, with treatment outcomes, side effects, and satisfaction levels monitored following two treatment cycles. Those exhibiting persistent lice infestations were subsequently treated with 1% permethrin shampoo, the standard treatment, while alternatives were provided for individuals allergic to permethrin. These findings will contribute to formulating tailored, effective, and safe treatment regimens for future 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": 117,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "13 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison Effectiveness of Oral Ivermectin , 1% Permethrin Shampoo and 4% Dimeticone Liquid Gel in the Treatment of Pediculosis Capitis Among School Children in Chachoengsao Province, Thailand",
"nctId": "NCT06332872",
"orgStudyIdInfo": {
"id": "M046q/66",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis"
}
],
"secondaryOutcomes": [
{
"measure": "Prevalence of head louse infestation among school children in Chachoengsao Province, Thailand"
},
{
"measure": "Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel"
},
{
"measure": "The association factor of head lice infestation among school children in Chachoengsao Province, Thailand"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Phramongkutklao College of Medicine and Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-27"
}
}
} | false | null |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.