documentSection
dict | hasResults
bool 2
classes | protocolSection
dict |
|---|---|---|
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "QHRD106 Injection"
},
{
"name": "placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Ischemic Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": null,
"country": "China",
"facility": "Nanjing Drum Tower Hospital",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": null,
"zip": "210008"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 74,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Assess PK, Safety and Tolerability Early in Healthy Subjects",
"nctId": "NCT06388772",
"orgStudyIdInfo": {
"id": "HJG-CZQH-QHRD106",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety as assessed by incidence, severity, and causality of adverse events"
},
{
"measure": "Plasma measurements of QHRD106"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Changzhou Qianhong Bio-pharma Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-01-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-07-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-07-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "TQ05105 Tablets"
}
]
},
"conditionsModule": {
"conditions": [
"Myelofibrosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hefei",
"contacts": null,
"country": "China",
"facility": "Anhui Provincial Hospital",
"geoPoint": {
"lat": 31.86389,
"lon": 117.28083
},
"state": "Anhui",
"status": null,
"zip": "230001"
},
{
"city": "Wuhu",
"contacts": null,
"country": "China",
"facility": "The First Affiliated Hospital of Wannan Medical College",
"geoPoint": {
"lat": 31.33728,
"lon": 118.37351
},
"state": "Anhui",
"status": null,
"zip": "241001"
},
{
"city": "Wuhan",
"contacts": null,
"country": "China",
"facility": "Union Hospital Tongji College Huazhong University of Science And Technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430071"
},
{
"city": "Xuzhou",
"contacts": null,
"country": "China",
"facility": "The Affiliated Hospital of Xuzhou Medical University",
"geoPoint": {
"lat": 34.18045,
"lon": 117.15707
},
"state": "Jiangsu",
"status": null,
"zip": "221000"
},
{
"city": "Changchun",
"contacts": null,
"country": "China",
"facility": "The First Hospital of Jilin University",
"geoPoint": {
"lat": 43.88,
"lon": 125.32278
},
"state": "Jilin",
"status": null,
"zip": "130021"
},
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Shanghai Sixth People's Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200233"
}
]
},
"descriptionModule": {
"briefSummary": "This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 9,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients",
"nctId": "NCT06388759",
"orgStudyIdInfo": {
"id": "TQ05105-Ib-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Spleen volume reduction (SVR35)≥35% from baseline"
}
],
"secondaryOutcomes": [
{
"measure": "Optimum effective rate"
},
{
"measure": "Onset time of splenic response"
},
{
"measure": "Duration of maintenance of spleen response (DoMSR) ≥35% reduction"
},
{
"measure": "Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline"
},
{
"measure": "The total symptom score of MPN-SAF TSS decreased compared with baseline"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Leukemia free survival (LFS)"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Incidence of adverse events (AEs)"
},
{
"measure": "Severity of AEs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Chia Tai Tianqing Pharmaceutical Group Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "BRIX3000®"
},
{
"name": "Riva Star Aqua, SDI Limited, Australia"
}
]
},
"conditionsModule": {
"conditions": [
"Caries,Dental"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Arresting Carious Lesions With Minimal Intervention Techniques",
"nctId": "NCT06388746",
"orgStudyIdInfo": {
"id": "NKUA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "clinical success"
},
{
"measure": "radiographic success"
}
],
"secondaryOutcomes": [
{
"measure": "Longevity and the quality of the final restoration"
},
{
"measure": "Patient's acceptance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National and Kapodistrian University of Athens"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Niraparib"
},
{
"name": "Temozolomide"
}
]
},
"conditionsModule": {
"conditions": [
"Glioblastoma",
"GBM",
"Brain Neoplasms, Adult, Malignant",
"Brain Tumor"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are:\n\nDoes niraparib improve progression-free survival (PFS) compared to TMZ?\n\nDoes niraparib improve overall survival (OS) compared to TMZ?\n\nParticipants will be randomly assigned to one of two treatment arms: niraparib or TMZ.\n\n* study drug (Niraparib) or\n* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma).\n\nThe study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks.\n\nParticipants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study.\n\nParticipants' tasks will include:\n\n* Complete study visits as scheduled\n* Complete a diary to record study medication"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Blinded Independent Central Review is composed of independent radiologists and will be utilized to assess progression of disease",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 450,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma",
"nctId": "NCT06388733",
"orgStudyIdInfo": {
"id": "IVY P3-24-021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)"
},
{
"measure": "Overall survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall response rate"
},
{
"measure": "Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale)"
},
{
"measure": "Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale)"
},
{
"measure": "Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test"
},
{
"measure": "Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association"
},
{
"measure": "Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B"
},
{
"measure": "Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)"
},
{
"measure": "Number of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements"
},
{
"measure": "Frequency and severity of symptomatic AEs based on PRO-CTCAE"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "GlaxoSmithKline"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ivy Brain Tumor Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml"
}
]
},
"conditionsModule": {
"conditions": [
"Bladder Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Goyang-si",
"contacts": [
{
"email": "seohk@ncc.re.kr",
"name": "Ho Kyung Seo",
"phone": "82-31-920-1678",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ho Kyung Seo, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Eui Hyun Jung, Ph.D",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Korea, Republic of",
"facility": "National Cancer Center",
"geoPoint": {
"lat": 37.65639,
"lon": 126.835
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 82,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMGeS",
"briefTitle": "The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy",
"nctId": "NCT06388720",
"orgStudyIdInfo": {
"id": "NCC2024-0026",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recurrent free survival in sequential treatment group."
}
],
"secondaryOutcomes": [
{
"measure": "Progression free survival in sequential treatment group."
},
{
"measure": "Cystectomy free survival in sequential treatment group."
},
{
"measure": "cancer specific survival in sequential treatment group."
},
{
"measure": "Overall survival in sequential treatment group."
},
{
"measure": "Safety of sequential treatment."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "National Cancer Center, Korea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "NaviFUS System"
}
]
},
"conditionsModule": {
"conditions": [
"Drug Resistant Epilepsy",
"Epilepsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palo Alto",
"contacts": [
{
"email": null,
"name": "Robert Fisher, M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Stanford University School of Medicine",
"geoPoint": {
"lat": 37.44188,
"lon": -122.14302
},
"state": "California",
"status": null,
"zip": "94305"
},
{
"city": "Boston",
"contacts": [
{
"email": null,
"name": "Ellen Bubrick, M.D.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Brigham and Women's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02115"
},
{
"city": "Charlottesville",
"contacts": [
{
"email": null,
"name": "Nathan Fountain, M.D.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Virginia School of Medicine",
"geoPoint": {
"lat": 38.02931,
"lon": -78.47668
},
"state": "Virginia",
"status": null,
"zip": "22903"
}
]
},
"descriptionModule": {
"briefSummary": "This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy",
"nctId": "NCT06388707",
"orgStudyIdInfo": {
"id": "NF-2022-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Change from baseline in subjective seizure strength"
}
],
"primaryOutcomes": [
{
"measure": "Adverse events (AEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline in seizure frequency"
},
{
"measure": "Change from baseline in electroencephalography (EEG) epileptiform discharges"
},
{
"measure": "Days of seizure-free"
},
{
"measure": "Changes from baseline in Beck Anxiety Inventory (BAI)"
},
{
"measure": "Changes from baseline in Beck Depression Inventory (BDI-II)"
},
{
"measure": "Changes from baseline in Personal Impact of Epilepsy Scale (PIES)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "NaviFUS US LLC"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "NaviFUS Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Pharmacist Care"
},
{
"name": "Primary Care Physician Care"
}
]
},
"conditionsModule": {
"conditions": [
"Attention-deficit Hyperactivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oakland",
"contacts": null,
"country": "United States",
"facility": "Kaiser Permanente Northern California",
"geoPoint": {
"lat": 37.80437,
"lon": -122.2708
},
"state": "California",
"status": null,
"zip": "94612"
}
]
},
"descriptionModule": {
"briefSummary": "This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 315,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"maximumAge": "17 Years",
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"sex": "ALL",
"stdAges": [
"CHILD"
]
},
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"acronym": null,
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"id": "RDO KPNC 24-056",
"link": null,
"type": null
},
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},
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"measure": "Percentage of participants appropriately referred for a follow-up weight check"
}
],
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{
"measure": "Timeliness of care"
},
{
"measure": "Parent perception of effectiveness of care"
}
]
},
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"collaborators": null,
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}
},
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"date": "2024-07-31"
},
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"date": "2024-04-29"
},
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"date": "2024-06-28"
},
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"date": "2024-05-02"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
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"interventions": [
{
"name": "The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography"
}
]
},
"conditionsModule": {
"conditions": [
"Pain"
]
},
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"locations": [
{
"city": "Hatay",
"contacts": [
{
"email": null,
"name": "SÜMEYYE AKÇOBAN",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "Hatay Mustafa Kemal University",
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"lon": 27.10486
},
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"zip": null
}
]
},
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"briefSummary": "One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient."
},
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},
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},
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},
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"NA"
],
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},
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
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"id": "HMKU-KMY-SA-02",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "Visual Benchmarking Scale"
},
{
"measure": "Vital Signs Monitoring Form"
}
],
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{
"measure": "Patient Identifying Information Form"
},
{
"measure": "Immobilization Comfort Scale"
}
],
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},
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"collaborators": null,
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"class": "OTHER",
"name": "Mustafa Kemal University"
}
},
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"date": "2024-06-26"
},
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"date": "2024-04-29"
},
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"date": "2024-04-26"
},
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"date": "2024-04-24"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
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"name": "Lipid panel"
}
]
},
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]
},
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"locations": [
{
"city": "Montréal",
"contacts": [
{
"email": "guillaume.marquis.gravel@umontreal.ca",
"name": "Guillaume Marquis-Gravel, MD, MSc",
"phone": "(514) 376-3330",
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},
{
"email": null,
"name": "Guillaume Marquis-Gravel, MD, MSc",
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},
{
"email": null,
"name": "Jean Grégoire, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "François Simard, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
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}
]
},
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},
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},
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]
},
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"id": "ICM 2025-3428",
"link": null,
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},
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},
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{
"measure": "Repeat lipid panel after discharge"
},
{
"measure": "Evaluation of intensification threshold after discharge"
}
],
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{
"measure": "Variation in LDL"
}
],
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{
"measure": "Variation in non-HDL and apoB"
},
{
"measure": "Evaluation of intensification threshold"
}
]
},
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"collaborators": [
{
"name": "Novartis Pharmaceuticals"
}
],
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"class": "OTHER",
"name": "Montreal Heart Institute"
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},
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"date": "2025-09"
},
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"date": "2024-04-29"
},
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"date": "2025-07"
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"date": "2024-06"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "mobile neurofeedback"
},
{
"name": "sham mobile neurofeedback"
}
]
},
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]
},
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{
"city": "Daegu",
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}
]
},
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]
},
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"count": 61,
"type": "ACTUAL"
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],
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},
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"type": null
},
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},
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{
"measure": "Comparisons of the means of children's self-scale variables"
}
],
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{
"measure": "Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II)"
},
{
"measure": "Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI)"
},
{
"measure": "Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV)"
},
{
"measure": "Comparisons of the means of children's Stroop"
},
{
"measure": "Comparisons of the means of children's ATA(Advanced Test of Attention)"
},
{
"measure": "Comparisons of the means of children's CCTT(Children's Color Trails Test)"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "OTHER",
"name": "Daegu Catholic University Medical Center"
}
},
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"date": "2022-06-30"
},
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"date": "2022-06-30"
},
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"date": "2019-06-10"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Afamelanotide 16mg implant"
}
]
},
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"conditions": [
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]
},
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"locations": [
{
"city": "Rotterdam",
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{
"email": null,
"name": "Erasmus Medical Centre",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
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"lon": 4.47917
},
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"zip": null
}
]
},
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"briefSummary": "The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients."
},
"designModule": {
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"interventionModel": "SINGLE_GROUP",
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},
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},
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},
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],
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},
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"maximumAge": "70 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "Pharmacokinetics of Afamelanotide in EPP Patients",
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"id": "CUV052",
"link": null,
"type": null
},
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},
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{
"measure": "Cmax (maximum Plasma Concentration)"
},
{
"measure": "AUC(0-t) (area under the curve from administration to last observed concentration at time t)"
}
],
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{
"measure": "AUC(0-∞) (area under the curve extrapolated to infinite time)"
}
]
},
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"class": "INDUSTRY",
"name": "Clinuvel Europe Limited"
}
},
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"date": "2024-10-01"
},
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"date": "2024-04-29"
},
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"date": "2024-07-01"
},
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"date": "2024-03-07"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Rook Epicardial Access Kit"
}
]
},
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"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Prague",
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{
"email": null,
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"role": "CONTACT"
}
],
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},
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"zip": "15030"
}
]
},
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"briefSummary": "The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.\n\nParticipants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure."
},
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},
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},
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},
"phases": [
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],
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},
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"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EASY-R",
"briefTitle": "Epicardial Access Study With Rook",
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"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": [
{
"measure": "Rate of Adverse Events"
}
],
"primaryOutcomes": [
{
"measure": "Successful Epicardial Access"
}
],
"secondaryOutcomes": [
{
"measure": "Speed of Access"
},
{
"measure": "Rate of Use Errors"
}
]
},
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"name": "Circa Scientific, Inc."
}
},
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"date": "2024-05"
},
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"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
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"date": "2024-05"
},
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"startDateStruct": {
"date": "2023-12-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
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"name": "Balcinrenone"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hialeah",
"contacts": null,
"country": "United States",
"facility": "Research Site",
"geoPoint": {
"lat": 25.8576,
"lon": -80.27811
},
"state": "Florida",
"status": null,
"zip": "33014"
},
{
"city": "Orlando",
"contacts": null,
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"lon": -81.37924
},
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"status": null,
"zip": "32809"
},
{
"city": "San Antonio",
"contacts": null,
"country": "United States",
"facility": "Research Site",
"geoPoint": {
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"lon": -98.49363
},
"state": "Texas",
"status": null,
"zip": "78215"
}
]
},
"descriptionModule": {
"briefSummary": "This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Three cohorts (two hepatic impairment cohorts and controls with normal hepatic function) will be enrolled into this study.\n\nAll subjects will receive the study intervention:\n\n* Cohort 1 will enroll 8 participants with mild hepatic impairment\n* Cohort 2 will enroll 8 participants with moderate hepatic impairment\n* Cohort 3 will enroll 8-12 healthy participants matched on a group level regarding age, BMI and sex",
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
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"timePerspective": null
},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "79 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone",
"nctId": "NCT06388616",
"orgStudyIdInfo": {
"id": "D6402C00013",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "Area under plasma concentration-time curve from time zero to the last measurable concentration (AUClast)"
},
{
"measure": "Area under plasma concentration-time curve from zero to infinity (AUCinf)"
},
{
"measure": "Maximum observed plasma concentration (Cmax)"
}
],
"secondaryOutcomes": [
{
"measure": "AEs and SAEs up to the follow-up telephone call (Day 10 [± 3 days])"
},
{
"measure": "Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings"
},
{
"measure": "Number of participants with abnormal laboratory tests results"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AstraZeneca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-11-15"
},
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"startDateStruct": {
"date": "2024-05-02"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
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"name": "Bioactive Glass"
},
{
"name": "Standard of Care"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Monfalcone",
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"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Roberto Da Ros, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"geoPoint": {
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"lon": 13.53292
},
"state": "Gorizia",
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"zip": "34074"
},
{
"city": "Abbiategrasso",
"contacts": [
{
"email": "roberto.degiglio@asst-ovestmi.it",
"name": "Dr. Roberto De Giglio, Med Doctor",
"phone": "+39 331 6989775",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Roberto De Giglio, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Dr. Ilaria Formenti, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Dr. Vincenzo Curci, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "ASST Ovest Milanese - Ospedale di Abbiategrasso",
"geoPoint": {
"lat": 45.39821,
"lon": 8.91678
},
"state": "Milano",
"status": "RECRUITING",
"zip": "20081"
},
{
"city": "Abano Terme",
"contacts": [
{
"email": "cwhisstock@casacura.it",
"name": "Dr. Christine Whisstock, Med Doctor",
"phone": "+39 338 8924624",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Christine Whisstock, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Casa di Cura Abano Terme - POLICLINICO ABANO TERME",
"geoPoint": {
"lat": 45.35753,
"lon": 11.78725
},
"state": "Padova",
"status": "NOT_YET_RECRUITING",
"zip": "35031"
},
{
"city": "Arezzo",
"contacts": [
{
"email": "alessia.scatena@uslsudest.toscana.it",
"name": "Dr. Alessia Scatena, Med Doctor",
"phone": "+39 328 3281501",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Alessia Scatena, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Dr. Matteo Apicella, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "USL Sud Est Toscana - Ospedale San Donato",
"geoPoint": {
"lat": 43.46276,
"lon": 11.88068
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "52100"
},
{
"city": "Forlì",
"contacts": [
{
"email": "silvia.acquati@auslromagna.it",
"name": "Dr. Silvia Acquati, Med Doctor",
"phone": "+39 335 1239344",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Silvia Acquati, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "AUSL Romagna - Ospedale Morgagni Pierantoni",
"geoPoint": {
"lat": 44.22177,
"lon": 12.04144
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "47121"
},
{
"city": "Lucca",
"contacts": [
{
"email": "ilaria.casadidio@uslnordovest.toscana.it",
"name": "Dr. Ilaria Casadidio, Med. Doctor",
"phone": "+39 3284882078",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Ilaria Casadidio, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte",
"geoPoint": {
"lat": 43.84369,
"lon": 10.50447
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "55100"
},
{
"city": "Pisa",
"contacts": [
{
"email": "alberto.piaggesi@med.unipi.it",
"name": "Prof. Alberto Piaggesi, Med Doctor",
"phone": "+39 3473331949",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "chiara.goretti@gmail.com",
"name": "Dr. Chiara Goretti, Med Doctor",
"phone": "+39 3294125791",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Prof. Alberto Piaggesi, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Dr. Chiara Goretti, Med Doctor",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "AOU Pisana - Ospedale di Cisanello",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "5612"
}
]
},
"descriptionModule": {
"briefSummary": "The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.\n\nParticipants will randomized into two groups:\n\n* Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.\n* Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DFORCT",
"briefTitle": "RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)",
"nctId": "NCT06388603",
"orgStudyIdInfo": {
"id": "DFORCT012023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "healing rate"
}
],
"secondaryOutcomes": [
{
"measure": "Duration of antibiotic therapy"
},
{
"measure": "Rate of recurrences"
},
{
"measure": "Number of re-interventions because of the same lesion"
},
{
"measure": "Timing of re-interventions because of the same lesion"
},
{
"measure": "Proportion of patients undergoing amputations"
},
{
"measure": "Patients' Quality of Life"
},
{
"measure": "Patients' Quality of Life"
},
{
"measure": "Time back to walk"
},
{
"measure": "Characteristics of surgery"
},
{
"measure": "Length of surgery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hippocrates Research"
},
{
"name": "Bonalive Biomaterials Ltd"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "ASST Ovest Milanese"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Dragons"
},
{
"name": "Standard of Care"
}
]
},
"conditionsModule": {
"conditions": [
"Pelvic Pain",
"Acupuncture",
"Gynecology"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nellis Air Force Base",
"contacts": [
{
"email": "amanda.j.crawford.ctr@health.mil",
"name": "Amanda J Crawford, MSHS",
"phone": "702-653-3583",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Mike O'Callaghan Military Medical Center",
"geoPoint": {
"lat": 36.24607,
"lon": -115.05721
},
"state": "Nevada",
"status": "RECRUITING",
"zip": "89191"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to determine if alternative pain management strategies, namely acupuncture, may help reduce intensity of female pelvic pain compared to other pain control modalities. This research study will focus specifically on the Dragon's protocol of acupuncture which will seek to alleviate chronic non-endometriosis pelvic pain for women both with and without a history of sexual assault.\n\nThis study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Patient sample will be both control and treatment groups. Individuals will not be divided into distinct groups. Patients will serve as their own controls. Control patients will be participating in standard of care therapies including physical therapy, psychotherapy, behavioral health, typical primary care management, etc. as deemed appropriate by the primary care provider for 4 weeks prior to study intervention. The same patients will then be re-evaluated and will be offered Acupuncture with Dragon technique (see attachment Protocol for Needle Insertion) as a means of pain control once per week for 4 weeks.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "21 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Acupuncture for Chronic Pelvic Pain",
"nctId": "NCT06388590",
"orgStudyIdInfo": {
"id": "MOMMC.2024.0029",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Defense and Veterans Pain Rating Scale (DVPRS)"
},
{
"measure": "Defense and Veterans Pain Rating Scale (DVPRS)"
},
{
"measure": "Defense and Veterans Pain Rating Scale (DVPRS)"
},
{
"measure": "Defense and Veterans Pain Rating Scale (DVPRS)"
},
{
"measure": "Defense and Veterans Pain Rating Scale (DVPRS)"
},
{
"measure": "Defense and Veterans Pain Rating Scale (DVPRS)"
},
{
"measure": "Female Genitourinary Pain Index (GUPI)"
},
{
"measure": "Female Genitourinary Pain Index (GUPI)"
},
{
"measure": "Female Genitourinary Pain Index (GUPI)"
},
{
"measure": "Female Genitourinary Pain Index (GUPI)"
},
{
"measure": "Female Genitourinary Pain Index (GUPI)"
},
{
"measure": "Female Genitourinary Pain Index (GUPI)"
}
],
"secondaryOutcomes": [
{
"measure": "PTSD Checklist for DSM-5 (PCL-5)"
},
{
"measure": "PTSD Checklist for DSM-5 (PCL-5)"
},
{
"measure": "PTSD Checklist for DSM-5 (PCL-5)"
},
{
"measure": "PTSD Checklist for DSM-5 (PCL-5)"
},
{
"measure": "PTSD Checklist for DSM-5 (PCL-5)"
},
{
"measure": "PTSD Checklist for DSM-5 (PCL-5)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "David Moss"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Education"
}
]
},
"conditionsModule": {
"conditions": [
"Parents",
"Epilepsy in Children",
"Disease Management"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mersin",
"contacts": [
{
"email": "2204160171012@mersin.edu.tr",
"name": "Sümerya YASTI, MASTER",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hacer ÇETİN, PROFESSOR",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Turkey, Mersin University",
"geoPoint": {
"lat": 36.79526,
"lon": 34.61792
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This randomised controlled study evaluates the effect of a training programme based on the Health Promotion Model developed for parents of children diagnosed with epilepsy on parents' level of knowledge about epilepsy, parents' general self-efficacy level, parents' health promoting and protective behaviours and the number of hospital admissions of their children. The hypothesis of this study is that education has an effect on these."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective, single-centre, randomised controlled, single-blind interventional study in parallel groups",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participants and the person who will perform the statistical analysis will be blinded. Participants will be assigned to intervention and control groups coded as A and B. Afterwards, it will be determined which of the A and B groups belong to the control and intervention groups by drawing lots.It will not be explained to the parents which group they are in, and it will be stated that education about epilepsy will be given. While entering the data, the researcher will enter the data encrypted as A and B in order to prevent measurement bias, the statistical analysis of the data will be carried out according to this encryption and the report of the study will be written in encrypted form. After the statistical analyses of the research are carried out and the research report is written as a result of the data found, it will be explained which of the groups the individuals are included in.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 76,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of the Training Programme Based on the Health Promotion Model Given to Parents",
"nctId": "NCT06388577",
"orgStudyIdInfo": {
"id": "MEU-HEM-SY-189",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy"
},
{
"measure": "Self-efficacy evaluated using the General Self-Efficacy Scale"
},
{
"measure": "Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mersin University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-13"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Axatilimab"
},
{
"name": "Ruxolitinib"
},
{
"name": "Corticosteroids"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Graft-versus-host-disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease",
"nctId": "NCT06388564",
"orgStudyIdInfo": {
"id": "INCA34176-254",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU CT Number",
"id": "2022-502168-19-00",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective Response Rate"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with Treatment-emergent Adverse Events (TEAEs)"
},
{
"measure": "Duration of Response"
},
{
"measure": "Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score"
},
{
"measure": "Best overall response in the first 6 months"
},
{
"measure": "OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD."
},
{
"measure": "Proportion of participants who remain corticosteroid-free"
},
{
"measure": "Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD."
},
{
"measure": "Failure-free Survival (FFS)"
},
{
"measure": "Axatilimab pharmacokinetic (PK) in Plasma"
},
{
"measure": "Ruxolitinib PK in Plasma"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Incyte Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-09-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "LY03017"
},
{
"name": "LY03017-Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis",
"Hallucinations and Delusions Associated With Parkinson Disease Psychosis",
"Negative Symptoms of Schizophrenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": null,
"name": "Huafang Li",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shanghai Mental Health Center",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects."
},
"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": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017",
"nctId": "NCT06388551",
"orgStudyIdInfo": {
"id": "LY03017/CT-CHN-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Maximum observed concentration (Cmax) of LPM526000133 in plasma"
},
{
"measure": "Time to maximum observed concentration (Tmax) of LPM526000133 in plasma"
},
{
"measure": "The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma"
},
{
"measure": "Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma"
},
{
"measure": "Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Luye Pharma Group Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Conservative treatment (non-operative treatment)"
},
{
"name": "Surgical treatment (operative treatment)"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Diverticulitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bari",
"contacts": [
{
"email": null,
"name": "Francesco Paolo Prete",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari",
"geoPoint": {
"lat": 41.11148,
"lon": 16.8554
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Florence",
"contacts": [
{
"email": "drcarlobergamini@gmail.com",
"name": "Carlo Bergamini, MD",
"phone": "+39(0)557949173",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Carlo Bergamini",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Alessio Giordano",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": null,
"zip": "50134"
},
{
"city": "Trieste",
"contacts": [
{
"email": null,
"name": "Manuela Mastronardi",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Department of Medicine, Surgery and Health Sciences, University of Trieste",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Vittorio Veneto",
"contacts": [
{
"email": null,
"name": "Giulia Montori",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana",
"geoPoint": {
"lat": 45.98026,
"lon": 12.30065
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Since it is still debated whether 2b acute diverticulitis (AD), according to the World Society of Emergency Surgery (WSES) classification, should be initially treated surgically or conservatively, we launched the COLD2B study to compare the clinical results of both therapeutic regimens in a multi-institutional cohort of prospectively enrolled patients.\n\nThe primary aim of the COLD2B (Conservative vs surgical (either Open or Laparoscopic) approach in the emergency management of acute Diverticulitis WSES 2B) study is to develop a model able to predict the length of hospitalization, comparing the management of WSES 2b AD in the emergency setting (conservative versus surgical approach) (primary endpoint of the first arm of the study).\n\nMoreover, the two groups will be compared regarding mortality and morbidity (secondary end-point).\n\nThe second arm of the study will consider the population undergoing surgery, develop a model able to predict the length of hospitalization, and compare the open vs laparoscopic approach (primary end-point), and mortality, morbidity, and surgical outcome indices (secondary end-point)."
},
"designModule": {
"designInfo": {
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"maskingInfo": null,
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},
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"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "COLD2B",
"briefTitle": "The COLD2B Multicenter, Two-arm Prospective Cohort Study",
"nctId": "NCT06388538",
"orgStudyIdInfo": {
"id": "Carlo Bergamini",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Length of hospital stay in the overall population"
}
],
"secondaryOutcomes": [
{
"measure": "Morbidity rate for both arms"
},
{
"measure": "Mortality rate for both arms"
},
{
"measure": "Surgical complications rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Azienda Sanitaria di Firenze"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Endoscopic Retrograde Cholangiopancreatography"
}
]
},
"conditionsModule": {
"conditions": [
"Endoscopic Retrograde Cholangiopancreatography",
"ERCP-Laparoscopic Cholecystectomy Interval",
"Number of Preoperative ERCPs",
"Stone Extraction Status in ERCP Procedures",
"Biliary Stents",
"Mechanical Lithotripsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Bakirkoy Dr. Sadi Konuk Training and Research Hospital",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In this retrospective study, we aimed to detect of effects of ERCP on outcomes of Laparoscopic Cholecystectomy. Patients underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis were identified and divided into two main groups regarding to have a ERCP procedure prior to surgery or not. To eliminate possible differences in baseline characteristics, patients in ERCP and non-ERCP groups were propensity score-matched 1:1 using nearest-neighbor matching without replacement based on age, sex and ASA score. Following propensity score matching (PSM), the ERCP and non-ERCP groups were first compared to detect effects of the ERCP procedure itself. After comparison of two main groups, subgroup analyzes performed for the ERCP group to detect effect of ERCP-related variables (indication for ERCP procedure, time between last ERCP procedure and surgery, number of preoperative ERCPs, stone extractions, and biliary stent use)"
},
"designModule": {
"designInfo": {
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},
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"count": 426,
"type": "ACTUAL"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes?",
"nctId": "NCT06388525",
"orgStudyIdInfo": {
"id": "PostERCPLC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Conversion to open"
},
{
"measure": "Subtotal Cholecystectomy"
},
{
"measure": "Postoperative Complications"
},
{
"measure": "Adhesion levels"
},
{
"measure": "Operative time"
},
{
"measure": "Length of hospital stay"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Kanuni Sultan Suleyman Training and Research Hospital"
}
},
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"completionDateStruct": {
"date": "2020-01-01"
},
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"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
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"date": "2020-01-01"
},
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"startDateStruct": {
"date": "2016-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "prototype prone positioning device"
}
]
},
"conditionsModule": {
"conditions": [
"Epilepsy",
"Pulmonary Embolism"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kansas City",
"contacts": [
{
"email": "aguillotte@kumc.edu",
"name": "Andrew Guillotte, MD",
"phone": "309-648-7036",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anand Dharia, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jennifer Cheng, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Michael Kinsman, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Christopher Miller, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Kansas Medical Center",
"geoPoint": {
"lat": 39.11417,
"lon": -94.62746
},
"state": "Kansas",
"status": null,
"zip": "66160"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are:\n\n* Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI?\n* Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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"whoMasked": null
},
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},
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"count": 5,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "iMRI Prone Positioning Frame Design Feasibility Study",
"nctId": "NCT06388512",
"orgStudyIdInfo": {
"id": "STUDY00160044",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of devices that meet functional requirements"
},
{
"measure": "Number of devices that are damaged during use"
}
],
"secondaryOutcomes": [
{
"measure": "Number of patients with skin complications"
},
{
"measure": "Number of patients with thromboembolic complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Continuum Educational Technologies"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Kansas Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
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"date": "2024-04-29"
},
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"date": "2024-12"
},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "TECC (Telerehabilitation and Exercise for Chronic Conditions)"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Conditions, Multiple"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tipperary",
"contacts": [
{
"email": null,
"name": "Niamh Julian, BSc",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Ireland",
"facility": "South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir",
"geoPoint": {
"lat": 52.47333,
"lon": -8.15583
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This protocol outlines a planned mixed methods feasibility trial which will be conducted to examine the feasibility and acceptability of a physiotherapy-led exercise-based telerehabilitation programme for groups of people with mixed chronic health conditions."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions",
"nctId": "NCT06388499",
"orgStudyIdInfo": {
"id": "GOIPG/2022/1854",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recruitment rate assessed by number of participants recruited during recruitment period."
},
{
"measure": "Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments."
},
{
"measure": "Adherence rate assessed by the attendance at synchronous group exercise sessions"
},
{
"measure": "Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8)"
},
{
"measure": "Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS)"
},
{
"measure": "Adverse events assessed via self-report questionnaire"
},
{
"measure": "Intervention acceptability as assessed by qualitative feedback from participants via focus groups"
}
],
"secondaryOutcomes": [
{
"measure": "Physical function assessed by the 30-second chair stand test (30CST)."
},
{
"measure": "Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Limerick"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-22"
},
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"startDateStruct": {
"date": "2024-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Psychotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Depression"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:\n\n* Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?\n* Are subjects with these psychological traits affected differently by psychotherapeutic intervention?\n\nStudy subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 63,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CitDip",
"briefTitle": "Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy",
"nctId": "NCT06388486",
"orgStudyIdInfo": {
"id": "UMCGoettingen9/9/16",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in depression"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Medical Center Goettingen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-03-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Tailored implementation intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Men's Health Screening",
"Implementation",
"Web-based Application"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kuala Lumpur",
"contacts": null,
"country": "Malaysia",
"facility": "Klinik Kesihatan Cheras Baru",
"geoPoint": {
"lat": 3.1412,
"lon": 101.68653
},
"state": null,
"status": null,
"zip": "56100"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months."
},
"designModule": {
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"allocation": "NA",
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 101,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "iScreenMen",
"briefTitle": "Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting",
"nctId": "NCT06388473",
"orgStudyIdInfo": {
"id": "NMRR-20-2188-56086 IIR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Reach"
},
{
"measure": "Reach"
},
{
"measure": "Adoption of ScreenMen using qualitative methods"
},
{
"measure": "Implementation of ScreenMen using qualitative methods"
},
{
"measure": "Maintenance of ScreenMen using qualitative methods"
}
],
"secondaryOutcomes": [
{
"measure": "Impact of COVID-19 on the clinic using qualitative methods"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Malaya"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-06-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
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"date": "2021-06-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Asthma Link"
},
{
"name": "Enhanced Usual Care"
}
]
},
"conditionsModule": {
"conditions": [
"Childhood Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Worcester",
"contacts": [
{
"email": "michelle.spano@umassmed.edu",
"name": "Michelle Spano",
"phone": "508-856-2990",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "MIchelle Trivedi, MD MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Massachusetts Chan Medical School",
"geoPoint": {
"lat": 42.26259,
"lon": -71.80229
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "01655"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this cluster RCT is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 350,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial",
"nctId": "NCT06388460",
"orgStudyIdInfo": {
"id": "STUDY00001015",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01HL169229",
"link": "https://reporter.nih.gov/quickSearch/R01HL169229",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Improving Asthma Symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Improving Medication Adherence"
},
{
"measure": "Improving Healthcare Utilization"
},
{
"measure": "Reducing Parental Lost Workdays"
},
{
"measure": "Reducing School Absences"
},
{
"measure": "Improving Quality of Life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institutes of Health (NIH)"
},
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Massachusetts, Worcester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Umbilical cord-mesenchymal stem cells"
}
]
},
"conditionsModule": {
"conditions": [
"Gingival Recession, Localized"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kuala Lumpur",
"contacts": null,
"country": "Malaysia",
"facility": "Orthodontic Postgraduate Clinic",
"geoPoint": {
"lat": 3.1412,
"lon": 101.68653
},
"state": "Wilayah Persekutuan Kuala Lumpur",
"status": null,
"zip": "50603"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to assess the reconstruction of interdental papilla following the injection of UC-MSCs or physiological saline in patients with interdental papilla deficiency. Participants will be randomised into 2 groups (intervention vs placebo) to receive the treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline: a RCT",
"nctId": "NCT06388447",
"orgStudyIdInfo": {
"id": "UCMSC1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Reconstruction of the deficient interdental papilla with soft tissue"
},
{
"measure": "Reconstruction of the deficient interdental papilla with bone"
},
{
"measure": "Reconstruction of the deficient interdental papilla with bone"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Malaya"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
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"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Protective Arm Balance Response Training"
}
]
},
"conditionsModule": {
"conditions": [
"Old Age; Debility",
"Peripheral Neuropathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baltimore",
"contacts": [
{
"email": "kwestlake@som.umaryland.edu",
"name": "Kelly P Westlake, PhD",
"phone": "410-706-5919",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Allied Health Research Building",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "21201"
}
]
},
"descriptionModule": {
"briefSummary": "The overall objective of this study is to investigate the effect of attention control training on reach-grasp stabilizing responses during fall-induced perturbations. The central hypothesis is that training attention control during reach to grasp balance perturbations will lead to increased grasp accuracies and reduced in-task falls. This research will mark the first explore the effects of training attention control on protective arm responses and fall rate during a balance perturbation paradigm and the first feasibility testing of a fully integrated cognitive and physical rehabilitation paradigm, moving beyond correlative designs and parallel treatments. The overall public health significance of the proposed research is that with improved protective arm responses and grasp accuracies, a larger randomized control study may be designed to mitigate falls among community dwelling older adults.\n\nParticipants will be involved in 6 sessions. Session 1 will include the assessment, questionnaires, and training. Session 2 will include just the training. Session 3 will include the assessment and training. Sessions 4-5 will include just the training. Session 6 will include the assessment, questionnaires, and training."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "The study will include two groups (older adults and people with peripheral neuropathy) which will be assessed pre- and post-intervention",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "88 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PAT",
"briefTitle": "Protective Arm Balance Responses",
"nctId": "NCT06388434",
"orgStudyIdInfo": {
"id": "HP-00100309",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Grasp Accuracy"
},
{
"measure": "In-task falls incidence"
}
],
"secondaryOutcomes": [
{
"measure": "Electromyography (EMG) of the shoulder muscles"
},
{
"measure": "Physiological responses (heart rate variability)"
},
{
"measure": "Physiological responses (electrodermal activity)"
},
{
"measure": "Activity specific balance confidence scale"
},
{
"measure": "Stait Trait Anxiety Inventory"
},
{
"measure": "Subjective Units of Distress Scale"
},
{
"measure": "Mini Mental State Examination (MMSE)"
},
{
"measure": "Beck Anxiety Inventory"
},
{
"measure": "Somatosensation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Maryland, Baltimore"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
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"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Prospective study assessments"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Hypertension Due to Lung Diseases and Hypoxia",
"Pulmonary Hypertension",
"Interstitial Lung Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a prospective, non-interventional, multicenter, registry of patients with pulmonary associated with interstitial lung disease (PH-ILD)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)",
"nctId": "NCT06388421",
"orgStudyIdInfo": {
"id": "GMS-PH-401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in clinical features relating to patients' interstitial lung disease and pulmonary hypertension"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "United Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-08-01"
},
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"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Anesthesia Brain Monitor",
"Sufentanil",
"Target Controlled Infusion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Treviso",
"contacts": null,
"country": "Italy",
"facility": "Treviso Regional Hospital",
"geoPoint": {
"lat": 45.66673,
"lon": 12.2416
},
"state": "TV",
"status": null,
"zip": "31100"
}
]
},
"descriptionModule": {
"briefSummary": "Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.\n\nAuthors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) nad pupillometry values during maintenance durin TIVA-TCI with Propofol and Sufentanil."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
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"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol",
"nctId": "NCT06388408",
"orgStudyIdInfo": {
"id": "SufMAST",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia"
},
{
"measure": "Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia"
},
{
"measure": "Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia"
}
],
"secondaryOutcomes": [
{
"measure": "Analgesia Nociception Index (ANI) values and postoperative pain"
},
{
"measure": "Patient State Index (PSi) values and postoperative delirium"
},
{
"measure": "Analgesia Nociception Index (ANi) values and postoperative delirium"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Padova"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Accuracy of full-arch surgical guides"
},
{
"name": "Survival and complications of the prostheses"
},
{
"name": "Survival and complications of the implants"
},
{
"name": "Conventional (metal-resin) implant-supported prosthesis"
},
{
"name": "PEEK implant-supported prosthesis"
}
]
},
"conditionsModule": {
"conditions": [
"Failure, Prosthesis",
"Dental Prosthesis, Implant-Supported",
"Survival, Prosthesis",
"Complete Edentulism",
"Complication;Prostheses"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sharjah",
"contacts": null,
"country": "United Arab Emirates",
"facility": "University of Sharjah",
"geoPoint": {
"lat": 25.33737,
"lon": 55.41206
},
"state": null,
"status": null,
"zip": "7724"
}
]
},
"descriptionModule": {
"briefSummary": "The all-on-4 treatment approach for completely edentulous mandible is a proven concept. However, there are still issues regarding the use of metal substructure to support the prostheses such as allergy, metallic taste, and aesthetic. Therefore, other materials such as polyetheretherketone (PEEK) are being tested for its suitability and is showing good potential. However, available evidence is limited regarding its clinical performance. Thus, the aim of this study is to compare clinical performance of all-on-4 treatment concept utilizing PEEK versus conventional metal framework as substructure in fully edentulous mandible. Thirty suitable patients will receive either PEEK or conventional all-on-4 prostheses for fully edentulous mandible. The prostheses will be retained by four implants utilizing the all-on-4 principle. Clinical performance will be assessed during the follow up period of up 3 years concerning screw loosening, material chipping or fracture, wear or staining, prosthesis survival and success, implant survival and success."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two groups will be provided with two types of implant-supported prostheses",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Block randomization will be used to randomly assign participants. The sequences will be concealed in opaque, consecutively numbered envelopes for each block. One envelope will be obtained for each participant, corresponding to the assignment of the protocol (conventional versus PEEK). The outcome assessor will be independent and not involved in any treatment procedure",
"whoMasked": [
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Performance of All-on-4 PEEK and Conventional Prostheses",
"nctId": "NCT06388395",
"orgStudyIdInfo": {
"id": "REC-23-05-12-02-F",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Accuracy of full-arch surgical guides"
},
{
"measure": "Survival rate of implants"
},
{
"measure": "Success rates of the Prostheses"
},
{
"measure": "Pain level"
}
],
"secondaryOutcomes": [
{
"measure": "Marginal bone loss"
},
{
"measure": "Plaque index"
},
{
"measure": "Pocket depth"
},
{
"measure": "Bleeding index"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Sharjah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Alert tone demonstration"
}
]
},
"conditionsModule": {
"conditions": [
"Implantable Defibrillator User"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cologne",
"contacts": null,
"country": "Germany",
"facility": "University Hospital Cologne",
"geoPoint": {
"lat": 50.93333,
"lon": 6.95
},
"state": null,
"status": null,
"zip": "50937"
}
]
},
"descriptionModule": {
"briefSummary": "Ability of ICD patients to hear the audible ICD alert is being assessed."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
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"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of the Audible ICD Alert Tone",
"nctId": "NCT06388382",
"orgStudyIdInfo": {
"id": "UKKx2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Alert tone audible"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universitätsklinikum Köln"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "[177Lu]Lu-PSMA-617"
},
{
"name": "Ipilimumab"
}
]
},
"conditionsModule": {
"conditions": [
"Very High Risk Prostate Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Essen",
"contacts": [
{
"email": "ulrich.krafft@uk-essen.de",
"name": "PD Dr. med. Ulrich Krafft",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Hospital Essen, Clinic of Urology",
"geoPoint": {
"lat": 51.45657,
"lon": 7.01228
},
"state": null,
"status": null,
"zip": "45147"
}
]
},
"descriptionModule": {
"briefSummary": "A randomized, open-label Phase I/II study of neoadjuvant treatment with \\[177Lu\\]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The first patients are enrolled - without randomization - into the Safety Cohort to assess whether the treatment regime under investigation, i.e. Ipilimumab (3mg/kg) + \\[177Lu\\]Lu-PSMA-617 RLT (7,4 GBq), is appropriately tolerated as per dose escalation algorithm.\n\nIf it is established that Ipilimumab (3mg/kg) + \\[177Lu\\]Lu-PSMA-617 RLT (7,4 GBq) is appropriately tolerated, patients will be randomized into the two arms of the Analysis Cohort:\n\n* Arm A: Ipilimumab + \\[177Lu\\]Lu-PSMA-617 RLT\n* Arm B: \\[177Lu\\]Lu-PSMA-617 RLT",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 58,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NEPI",
"briefTitle": "Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer",
"nctId": "NCT06388369",
"orgStudyIdInfo": {
"id": "CA184-608",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility to perform prostatectomy on time"
},
{
"measure": "Clinical activity: Proportion of participants in the full analysis set who achieve a pCR"
}
],
"secondaryOutcomes": [
{
"measure": "Safety Profile of neoadjuvant treatment before radical prostatectomy"
},
{
"measure": "Safety Profile of neoadjuvant treatment before radical prostatectomy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Advanced Accelerator Applications"
},
{
"name": "Bristol-Myers Squibb"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Essen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Educational intervention - Yksityisyyttä ensihoitoon / Informational privacy for preospital emergency care"
}
]
},
"conditionsModule": {
"conditions": [
"Knowledge",
"Attitude of Health Personnel"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Turku",
"contacts": null,
"country": "Finland",
"facility": "University of Turku",
"geoPoint": {
"lat": 60.45148,
"lon": 22.26869
},
"state": null,
"status": null,
"zip": "20520"
}
]
},
"descriptionModule": {
"briefSummary": "The main goal of this educational intervention study about patient's informational privacy (IP) is to evaluate the effect of the educational intervention into the paramedics' knowledge and attitude regarding patient's IP. The study also investigates the usability and the feasibility of the educational intervention.\n\nThe main questions it aims to answer are:\n\n1. What is the effect of the educational intervention on the\n\n 1. theoretical knowledge of paramedics' regarding IP?\n 2. the paramedics' attitude towards patient's IP?\n2. What is the usability and feasibility of the intervention being evaluated according to the respondents?"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two groups, intervention and control group. Only intervention group is receiveing the intervention.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Patient's Informational Privacy in Prehospital Emergency Care - Educational Intervention Study for the Paramedics",
"nctId": "NCT06388356",
"orgStudyIdInfo": {
"id": "042024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Paramedics' knowledge about patient's informational privacy"
}
],
"secondaryOutcomes": [
{
"measure": "paramedics' attitude towards patient's informational privacy."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Eini Koskimies"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-05-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Evaluation of Children's Listening and Processing Skills"
},
{
"name": "Multidisciplinary behavioral assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Listening Difficulties"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Many children experience listening and processing difficulties (LiD), especially in background noise, despite normal hearing sensitivity. The prevalence of these problems is estimated at 0.5-1% in the general population. Listening difficulties are associated with developmental disorders (DD) such as specific language disorders, autism spectrum disorder (ASD), ADHD and learning disabilities. Many children with developmental problems are easily distracted by sounds, have difficulty concentrating for long periods, processing language, remembering and summarizing oral information, and can experience academic difficulties (reading, writing). Early identification, differential diagnosis and intervention are important to help children overcome these difficulties and reach their full potential. Some concerns about these listening and processing problems, such as the lack of a gold standard to diagnose LiD and age-appropriate reference data, led to the initiation of this study.\n\nCLINIC aims to develop a new approach to diagnose the causes of listening difficulties in children. This is accomplished through (1) a validated parent questionnaire and (2) a multidisciplinary behavioral assessment tool. Data from these combined measures will lead to evidence-based profiles of children with LiD, which in turn will help streamline their referral pathways and care pathways."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 280,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "CLINIC",
"briefTitle": "Causes of Listening Difficulties in Children",
"nctId": "NCT06388343",
"orgStudyIdInfo": {
"id": "S68485",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ECLiPS questionnaire"
},
{
"measure": "Behavioral measures"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universitair Ziekenhuis Brussel"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "low FODMAP diet"
}
]
},
"conditionsModule": {
"conditions": [
"Functional Dyspepsia",
"FODMAP Diet"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leuven",
"contacts": null,
"country": "Belgium",
"facility": "KU Leuven",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": "Vlaams-Brabant",
"status": null,
"zip": "3000"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "open label strict diet phase blinded participant during reintroduction",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FFD",
"briefTitle": "The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms",
"nctId": "NCT06388330",
"orgStudyIdInfo": {
"id": "s61692",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Improvement on gastrointestinal symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Reintroduction period"
},
{
"measure": "Evaluation of the low FODMAP diet on IBS related symptoms"
},
{
"measure": "Evaluation of the low FODMAP diet on symptom response and quality of life"
},
{
"measure": "Evaluation of the low FODMAP diet on depression, somatization"
},
{
"measure": "Evaluation of the low FODMAP diet on duodenal barrier function"
},
{
"measure": "Evaluation of the low FODMAP diet on gastric emptying"
},
{
"measure": "Evaluation of the low FODMAP diet on gastric accommodation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universitaire Ziekenhuizen KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-03-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-03-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-04-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Adaptive Step Goal (Intervention)"
},
{
"name": "Static Step Goal (Control)"
}
]
},
"conditionsModule": {
"conditions": [
"Health Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": null,
"country": "Canada",
"facility": "Western University",
"geoPoint": {
"lat": 42.98339,
"lon": -81.23304
},
"state": "Ontario",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This 12-week study compares the effectiveness of personalized daily step goals generated by a machine learning algorithm in the Sprout app versus fixed daily step goals of 10,000 steps among adults. Participants will be recruited through the Sprout app, and after a 1-week run-in period, they will be assigned to either the intervention or control group. The intervention group will receive adaptive goals based on their historical step data, while the control group will have a fixed goal. Both groups will receive financial incentives. This study aims to inform future interventions measuring changes in daily steps and app engagement levels (i.e., time spent on app, number of app opens) by studying how using financial incentives and an adaptive goal-setting design can improve physical activity levels of app users, informed by a machine learning algorithm."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Retrospective, quasi-experimental study.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Participants are unaware of the other intervention arm (i.e., adaptive step goals versus static step goals).",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Machine-based Algorithm for Increased Physical Activity and Sustained User Engagement",
"nctId": "NCT06388317",
"orgStudyIdInfo": {
"id": "123632",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Step count"
}
],
"secondaryOutcomes": [
{
"measure": "Number of app opens, total time spent on app, number of pages opened"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Western University, Canada"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "THRIVE Online PAT Program"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"DCIS"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boulder",
"contacts": [
{
"email": "archlab@colorado.edu",
"name": "Sienna Russel",
"phone": "720-897-1850",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "archlab@colorado.edu",
"name": "Madeline Nealis, MPH",
"phone": "720-897-1850",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joanna Arch, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Colorado Boulder",
"geoPoint": {
"lat": 40.01499,
"lon": -105.27055
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80309"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed ET to prevent recurrence of breast cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "THRIVE",
"briefTitle": "THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence",
"nctId": "NCT06388304",
"orgStudyIdInfo": {
"id": "23-0556",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acceptability of THRIVE intervention (AIM)"
},
{
"measure": "Feasibility of THRIVE intervention"
},
{
"measure": "Client Satisfaction Survey"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Joanna Arch"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Deep Brain Stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Tourette Syndrome",
"Deep Brain Stimulation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": null,
"name": "Patricia Limousin",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "National Hospital of Neurology & Neurosurgery",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS).\n\nIt is a randomised, double-blind, crossover clinical investigation for 20 patients. Op-TICS will be performed at the National Hospital for Neurology \\& Neurosurgery.\n\nFollowing DBS surgery, participants will first enter an open adjustment phase, of 6 months, where the electrical stimulation settings of the device are optimised. Participants will then enter the double-blind phase that will include successively up to 2 weeks with stimulation on and up to 2 weeks with the stimulation off in a randomised order.\n\nThe primary outcome measure is the tic severity score measured by the Yale Global Tic Severity Scale -Total Tic Score after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "All participants will have electrodes implanted in the globus pallidus interna and connected to a subcutaneous pulse generator.\n\nThis will be followed by a 6 months open-phase period of stimulation for electrical parameter adjustment.\n\nFollowing these 6 months, participants will be randomised into two groups by the order of treatment condition (ON/OFF-stimulation vs OFF/ON-stimulation): one group will be kept with the stimulation on (\"ON-stimulation\") and the other switched off (\"OFF-stimulation\") for up to two weeks. Tic severity will be assessed and all participants will enter a 2-day interval, in the ON state, before switching to the other treatment condition for another two weeks.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Double Blind",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"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": "Op-TICS",
"briefTitle": "Deep Brain Stimulation in Tourette Syndrome",
"nctId": "NCT06388291",
"orgStudyIdInfo": {
"id": "CTU/2018/321",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "A mechanistic part of the study will look at possible explanations of differing responses in both the open and randomised phase."
}
],
"primaryOutcomes": [
{
"measure": "Tic severity score measured by the YGTSS-TTS (total tic) after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase"
}
],
"secondaryOutcomes": [
{
"measure": "MRVRS at the end of the OFF-stimulation state versus the end of the ON-stimulation state in the blinded, randomised crossover phase."
},
{
"measure": "Change in the MRVRS between baseline 0 and the end of the open-phase (Baseline 1)"
},
{
"measure": "Change in the YGTSS (global) between baseline 0 and the end of the open-phase (Baseline 1)"
},
{
"measure": "Change in the GTS-QOL questionnaire measures at baseline 0 and the end of the open-phase (Baseline 1)"
},
{
"measure": "Change in the YBOCS between baseline 0 and the end of the open-phase (Baseline 1)"
},
{
"measure": "Change in the BDI scale between baseline 0 and the end of the open-phase (Baseline 1)"
},
{
"measure": "Change in the BAI scale between baseline 0 and the end of the open-phase (Baseline 1)"
},
{
"measure": "Change in the BAARS-IV between baseline 0 and the end of the open-phase (Baseline 1)"
},
{
"measure": "Safety of DBS as indicated by the number of participants with any adverse events and number with any serious adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute for Health Research, United Kingdom"
},
{
"name": "University College London Hospitals"
},
{
"name": "Northern Care Alliance NHS Foundation Trust"
},
{
"name": "St George's University Hospitals NHS Foundation Trust"
},
{
"name": "Royal Devon and Exeter NHS Foundation Trust"
},
{
"name": "University of Bristol"
},
{
"name": "University of Dundee"
},
{
"name": "London School of Hygiene and Tropical Medicine"
},
{
"name": "King's College London"
},
{
"name": "University Hospital, Rouen"
},
{
"name": "Imperial College London"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University College, London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Antimicrobial Stewardship",
"Cost-effectiveness Analysis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "giulia.renisi@policlinico.mi.it",
"name": "GIULIA dr RENISI, Doctor",
"phone": "3887429609",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "alessandra.bandera@unimi.it",
"name": "Alessandra dr Bandera, Doctor",
"phone": "0255034770",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Fondazione Policlinico of Milan",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20135"
}
]
},
"descriptionModule": {
"briefSummary": "Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: \"RF-net2018\" is a prospective, experimental, multicenter, pre-post study, whose objectives are the evaluation of the efficiency of economic resources allocated to the antimicrobial stewardship program (AMS) in patients with infection and in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria, identified in a network of 18 hospital facilities participating in our study. Moreover, this study aims to compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. The study will include two main phases of analysis: the pre-intervention-phase and the intervention phase, both of 6 months duration. The pre-intervention phase will serve as a control for the intervention phase. The intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include a group of activities listed above (Hospital commitment, Tracking and reporting, Action and Education). Data source and analysis for the cost-effectiveness analysis, using month-department as statistical unit, are regional data: Discharge record ICD-9 codes (identification of target population 1, 2, 3, average days of hospitalization and mortality), R file (for antibiotic drug consumption month-ward) and Microbio (identification of target population 2, CR-GN and MRSA bacteremia and Cases of C. difficile infection). For what concerns healthcare costs data, each Management control office of the 18 facilities has to provide: AVERAGE HOSPITALISATION DAYS, NUMBER OF HOSPITALIZED AND TRANSFERRED PATIENTS and HEALTHCARE COSTS (healthcare personnel, diagnostic services, surgical interventions and consumption of operating rooms)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
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},
"identificationModule": {
"acronym": "RF-net2018",
"briefTitle": "Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia (RF-net2018)",
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"id": "NET-2018-12366982-4/ASP_LOMB",
"link": null,
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},
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{
"measure": "evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection"
},
{
"measure": "evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria."
},
{
"measure": "compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project"
}
],
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},
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"collaborators": [
{
"name": "Regione Lombardia"
},
{
"name": "Ministero della Salute, Italy"
}
],
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"class": "OTHER",
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}
},
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"date": "2025-04-15"
},
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"date": "2024-11-01"
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"date": "2023-03-01"
},
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"date": "2024-04-29"
}
}
} |
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"name": "Trifold information"
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"conditions": [
"Anxiety and Fear"
]
},
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{
"city": "L'Hospitalet De Llobregat",
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}
]
},
"descriptionModule": {
"briefSummary": "Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona."
},
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"allocation": "RANDOMIZED",
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},
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"sex": "ALL",
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"OLDER_ADULT"
]
},
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"id": "18/2018, Acta 26-6-2018",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Changes in STAI-S"
},
{
"measure": "Changes in MDAS"
}
],
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{
"measure": "Changes in blood pressure"
},
{
"measure": "Changes in Heart rate"
},
{
"measure": "Changes in Oxygen saturation"
},
{
"measure": "Patient Satisfaction of procedure"
}
]
},
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"class": "OTHER",
"name": "University of Barcelona"
}
},
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},
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"date": "2022-01-09"
},
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"date": "2024-04-29"
}
}
} |
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]
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"name": "Electrochemotherapy with Intratumoral Cysplatin"
},
{
"name": "Electrochemotherapy with Intravenous Bleomycin"
}
]
},
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"conditions": [
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]
},
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{
"city": "Ljubljana",
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"facility": "Institute of Oncology Ljubljana",
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"lat": 46.05108,
"lon": 14.50513
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}
]
},
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"briefSummary": "In the last 10 years, the treatment of metastatic cutaneous melanoma has changed dramatically. The new systemic treatment with immunotherapy has led to a dramatic improvement in quality of life and overall survival. Systemic treatment means that the patient receives the drug as an infusion into a vein. Unfortunately, we know that immunotherapy is not equally successful in all patients. Recent studies have shown that the success of the treatment is not only influenced by the cellular composition of the metastasis, but also by its surroundings. This is called tumor microenvironment. Depending on the differences in the composition of this microenvironment, some metastases can be described as immunologically hot and others as immunologically cold. Immunologically hot metastases respond better to immunotherapy than immunologically cold metastases.\n\nStudies have shown that with some interventions we can change the tumor microenvironment from being immune-cold to being immune-hot. Electrochemotherapy is one of the interventions that might improve the efficacy of immunotherapy in cutaneous melanoma. Electrochemotherapy is an established method for the local treatment of tumors, in which only a certain tumor is treated with special electrodes, to which a weak electric current is applied. We hypothesize that electrochemotherapy stimulates the body's own immune response and enables more effective treatment. Since immunotherapy also stimulates the body's own immune response to cutaneous melanoma cells, the interaction of the two drugs could be even more successful. Recent research results support this assumption.\n\nThe primary objective is to evaluate the changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases induced by electrochemotherapy, based on the histologic analysis of treated and untreated metastases before and after treatment. The secondary aim is to determine whether the changes in the tumor microenvironment differ depending on the chemotherapeutic agent used.\n\nThe results will help us to better understand the synergistic effects of electrochemotherapy and immunotherapy on cutaneous melanoma metastases. The combination of systemic immunotherapy and electrochemotherapy could become an important treatment method for patients with metastatic melanoma."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
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"maskingInfo": {
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},
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"id": "ERID-KSOPR-0049/2023",
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"type": null
},
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{
"domain": "National Medical Ethics Committee of the Republic of Slovenia",
"id": "0120-297/2023/3",
"link": null,
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"measure": "Changes in the tumor microenvironment of cutaneoys and subcutaneousm melanoma metastases induced by electrochemotherapy"
}
],
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{
"measure": "Diferrent changes in the tumor microenvironment induced by electrochemotherapy with bleomycin or cysplatin"
}
]
},
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{
"name": "Slovenian Research and Innovation Agency"
}
],
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}
},
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"date": "2025-11-30"
},
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},
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},
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"date": "2023-11-10"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
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"name": "Apixaban 5MG"
},
{
"name": "ELIQUIS"
}
]
},
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"Healthy Volunteer"
]
},
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"locations": null
},
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"briefSummary": "The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects. Twenty-eight (28) subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets (1 x 5 mg; Test) or ELIQUISTM (1 x 5 mg; Reference) in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2."
},
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},
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"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
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]
},
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"acronym": null,
"briefTitle": "Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers",
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"id": "BE24-006",
"link": null,
"type": null
},
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},
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"measure": "Plasma Area Under the Curve (AUC(0 to 36hr)) for Apixaban"
},
{
"measure": "Peak Plasma Concentration (Cmax) of Apixaban"
}
],
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},
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"class": "NETWORK",
"name": "International Bio service"
}
},
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"date": "2024-09-23"
},
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"date": "2024-04-29"
},
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"date": "2024-09-14"
},
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"date": "2024-08-26"
},
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"date": "2024-04-29"
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}
} |
null | false | {
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"name": "Leg heat therapy"
},
{
"name": "Leg sham therapy"
}
]
},
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"conditions": [
"Heart Failure With Preserved Ejection Fraction"
]
},
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"locations": null
},
"descriptionModule": {
"briefSummary": "The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF."
},
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"allocation": "RANDOMIZED",
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"OLDER_ADULT"
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},
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"acronym": null,
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"id": "IRB # 16143",
"link": null,
"type": null
},
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},
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{
"measure": "Change in time to exhaustion during treadmill exercise"
}
],
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{
"measure": "Change in maximal pulmonary oxygen uptake during treadmill exercise"
},
{
"measure": "Change in triceps surae microvascular oxygenation during treadmill exercise"
},
{
"measure": "Change in systolic blood pressure"
},
{
"measure": "Change in diastolic blood pressure"
},
{
"measure": "Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score"
},
{
"measure": "Change in triceps surae microvascular oxygenation during reactive hyperemia"
},
{
"measure": "Change in triceps surae volume"
},
{
"measure": "Change in triceps surae intramuscular fat content"
},
{
"measure": "Change in the time constant for phosphocreatine recovery after dynamic exercise"
},
{
"measure": "Change in maximal plantar flexor strength"
}
]
},
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"collaborators": [
{
"name": "Purdue University"
}
],
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"class": "OTHER",
"name": "Indiana University"
}
},
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"date": "2026-07-31"
},
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"date": "2024-04-29"
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"date": "2026-07-31"
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"date": "2024-05-06"
},
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"date": "2024-04-29"
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}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Gastric Ultrasonography"
}
]
},
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"conditions": [
"Diabetes Mellitus, Type 2",
"Anesthesia",
"Pulmonary Aspiration of Gastric Contents"
]
},
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"locations": null
},
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"briefSummary": "Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells. Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia. It also inhibits gastric emptying and food intake. GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin. GLP-1 receptors are also present in multiple region of the central nervous system such as the hypothalamus and hindbrain where it results in reducing food intake. For anesthesiologist it is important to understand how GLP-1 RA influence gastric emptying. Indeed, respecting a fasting period (6 hours for solid and 2 hours for liquid) before each surgery is one of the cornerstones of anesthesiology to significantly reduce the risk of pulmonary aspiration. One of the side effects of GLP-1 RA is slowing gastric emptying and increasing the risk of regurgitation in patient that observed a recommended fasting period. During 2023 a lot of cases reports have emerged of pulmonary aspiration or the presence of a full stomach in patient treated by GLP-1 RA for a type 2 diabetes. Despite recommendations made by the American Society of Anesthesiology, it is still unkown what is the best fasting period and how long patients should pause a long acting GLP-1 RA before surgery. In this observational study, we would like to determine the effect of GLP-1 RA on gastric emptying in patient scheduled for general anesthesia. We will measure and compare residual gastric content with gastric ultrasonography in patients treated by GLP-1 RA and in those who are not. We will also do these comparisons in a group of patients with type 2 diabetes treated by weekly GLP-1 RA at different days after the injection of the medication. Our hypothesis is that we will observe a reduction in gastric residue in patients who stopped weekly GLP-1 RA 7 days prior the examination compared to those who have stopped less days considering the same fasting period. This would lead us to propose an optimal duration of stopping time for GLP-1 inhibitors in the preoperative period."
},
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},
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"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period.",
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"id": "GLP-1 RA patients GE by GUS",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Reduction of 5.5 cm2 of the CSA in patients pausing 7 days their GLP-1 RA treatment."
}
],
"secondaryOutcomes": [
{
"measure": "Correlation between a full stomach evaluated on gastric ultrasonography and gastric symptoms such as nausea and bloating."
}
]
},
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"class": "OTHER",
"name": "University Hospital, Geneva"
}
},
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"date": "2026-05"
},
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"date": "2024-04-29"
},
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"date": "2025-06"
},
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"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Sub-Retinal Administration of OCU400-301"
}
]
},
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"conditions": [
"Retinitis Pigmentosa"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Phoenix",
"contacts": [
{
"email": "Mallory.mintert@doctrials.com",
"name": "Mallory Mintert, MS",
"phone": "480-999-5458",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "Jillian.bollinger@doctrials.com",
"name": "Jillian Bollinger, BS",
"phone": "480-999-5458",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Benjamin Bakall",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Associated Retina Consultants",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona",
"status": "RECRUITING",
"zip": "85020"
},
{
"city": "Bellaire",
"contacts": [
{
"email": "rebbecca.taing@retinaconsultantstexas.com",
"name": "Rebbeca C Taing",
"phone": "713-524-3434",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kenneth C Fan, M.D, MBA",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Retina Consultants of Texas",
"geoPoint": {
"lat": 29.70579,
"lon": -95.45883
},
"state": "Texas",
"status": "NOT_YET_RECRUITING",
"zip": "77401"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.\n\nThis is a multicenter, assessor blinded and randomized study which will enroll 150 subjects."
},
"designModule": {
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},
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},
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"count": 150,
"type": "ESTIMATED"
},
"phases": [
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],
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},
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"minimumAge": "8 Years",
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "liMeliGhT",
"briefTitle": "A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa",
"nctId": "NCT06388200",
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"id": "OCU400-301",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "Patients Global Impression of Change (PGIC) score"
}
],
"primaryOutcomes": [
{
"measure": "Number of participants with change in functional vision in the study eye of RP subjects as assessed by LDNA"
},
{
"measure": "Number of participants with change in functional vision in the study eye in Gene Agnostic group as assessed by LDNA"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with change in functional vision in the all treated eyes of RP subjects as assessed by LDNA"
},
{
"measure": "Number of participants with change in functional vision in the all treated eyes of subjects in Gene Agnostic Arm as assessed by LDNA"
},
{
"measure": "Number of participants with change in visual function in subjects with RHO mutation as assessed by LLVA letter score"
},
{
"measure": "Number of participants with change in visual function in Gene Agnostic Arm as assessed by LLVA letter scores"
},
{
"measure": "Ocular and non-ocular Events"
}
]
},
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"name": "Ocugen"
}
},
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"date": "2026-10-30"
},
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"date": "2024-04-29"
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"id": "2023-509273-24",
"link": null,
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}
]
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"measure": "Relative change in body weight"
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"measure": "Achievement of ≥5% weight reduction"
}
],
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"measure": "Achievement of ≥10% weight reduction"
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"measure": "Achievement of ≥20% weight reduction"
},
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"measure": "Change in waist circumference"
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{
"measure": "Change in systolic blood pressure"
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{
"measure": "Ratio to baseline in lipids: Total cholesterol"
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{
"measure": "Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol"
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{
"measure": "Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol"
},
{
"measure": "Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol"
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"measure": "Ratio to baseline in lipids: Triglycerides"
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{
"measure": "Ratio to baseline in lipids: Free fatty acids"
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}
} |
null | false | {
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]
},
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{
"city": "Hangzhou",
"contacts": [
{
"email": "shen_neurology@zju.edu.cn",
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"role": "CONTACT"
}
],
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"briefSummary": "The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.\n\nAccording to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis."
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},
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"link": null,
"type": null
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{
"measure": "The proportion of seizure freedom"
}
],
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"measure": "The proportion of psychiatric comorbidity"
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{
"measure": "The proportion of psychosocial outcome"
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{
"measure": "The proportion of seizure relapse after antiseizure medication withdrawn"
}
]
},
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"date": "2033-12-31"
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"date": "2026-12-31"
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"date": "2023-01-01"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
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]
},
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"email": "shen_neurology@zju.edu.cn",
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],
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},
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]
},
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"link": null,
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"measure": "Detectable serum neural autoantibodies"
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{
"measure": "Neuronal surface antibodies-mediated autoimmune- encephalitis"
}
],
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"measure": "The proportion of seizure freedom"
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{
"measure": "The proportion of drug-resistent epilepsy"
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{
"measure": "Clinical severity and recovery"
}
]
},
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"name": "Sir Run Run Shaw Hospital"
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{
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{
"name": "Shaoxing People's Hospital"
}
],
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},
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},
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},
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"date": "2023-08-01"
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}
}
} |
null | false | {
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"interventions": [
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"name": "Medical management"
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{
"name": "Endovascular thrombectomy"
}
]
},
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"conditions": [
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]
},
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"locations": [
{
"city": "Xiangtan",
"contacts": null,
"country": "China",
"facility": "Xiangtan Central Hospital",
"geoPoint": {
"lat": 27.85,
"lon": 112.9
},
"state": "Hunan",
"status": null,
"zip": "421001"
},
{
"city": "Ganzhou",
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"country": "China",
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"state": "Jiangxi",
"status": null,
"zip": null
}
]
},
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"briefSummary": "The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion."
},
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},
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},
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"count": 286,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
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},
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"acronym": "XL STROKE-2",
"briefTitle": "Endovascular Treatment for eXtra-Large Ischemic Stroke",
"nctId": "NCT06388148",
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"id": "XL STROKE-2",
"link": null,
"type": null
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},
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"measure": "Modified Rankin Scale score"
}
],
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{
"measure": "Rate of successful reperfusion"
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{
"measure": "Rate of excellent outcome"
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{
"measure": "Rate of functional independence"
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{
"measure": "Rate of independent ambulation"
}
]
},
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"name": "The First Affiliated Hospital, University of South China"
},
{
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{
"name": "Zhejiang University"
},
{
"name": "Longyan First Affiliated Hospital of Fujian Medical University"
}
],
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"name": "Zhongming Qiu"
}
},
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"date": "2027-01-31"
},
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},
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"date": "2026-10-31"
},
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"date": "2024-07-01"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
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{
"name": "nab-paclitaxel，Cisplatin"
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},
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"conditions": [
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]
},
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"briefSummary": "Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).\n\nThe efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).\n\nEthics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1)."
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},
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"type": "ESTIMATED"
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},
"eligibilityModule": {
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},
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"id": "SNC-01",
"link": null,
"type": null
},
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},
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"measure": "pCR"
}
],
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"measure": "MPR"
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{
"measure": "DFS"
},
{
"measure": "ORR"
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{
"measure": "AEs"
}
]
},
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}
},
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"date": "2027-05"
},
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},
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},
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"date": "2024-05-01"
},
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}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Biospecimen Collection"
}
]
},
"conditionsModule": {
"conditions": [
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"Hormone-receptor-positive Breast Cancer",
"Metastatic Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jacksonville",
"contacts": [
{
"email": "mayocliniccancerstudies@mayo.edu",
"name": "Clinical Trials",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Pooja Advani, MBBS, MD",
"phone": null,
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
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"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida",
"status": null,
"zip": "32224-9980"
}
]
},
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"briefSummary": "The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor."
},
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},
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},
"phases": null,
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},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
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"nctId": "NCT06388122",
"orgStudyIdInfo": {
"id": "23-009689",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trials Reporting Program)",
"id": "NCI-2024-03405",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic",
"id": "MC240301",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "DiviTum®TKa assay as an early predictor of primary treatment resistance"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
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"date": "2026-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-06-15"
},
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"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Positive Peers mobile app"
}
]
},
"conditionsModule": {
"conditions": [
"HIV Infections"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Van Nuys",
"contacts": [
{
"email": "edgarbanuelos@nevhc.org",
"name": "Edgar Banuelos",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Herberth Osorio, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Northeast Valley Health Corporation",
"geoPoint": {
"lat": 34.18667,
"lon": -118.44897
},
"state": "California",
"status": null,
"zip": "91405"
},
{
"city": "Newark",
"contacts": [
{
"email": "khanjj@njms.rutgers.edu",
"name": "Jared Khan",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shoba Swaminathan, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Infectious Disease Practice- Rutgers University",
"geoPoint": {
"lat": 40.73566,
"lon": -74.17237
},
"state": "New Jersey",
"status": null,
"zip": "07103"
},
{
"city": "Cincinnati",
"contacts": [
{
"email": "TaniaSlack@equitashealth.com",
"name": "Tania Slack-Peterson",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kelly Wesp, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Equitas Health",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio",
"status": null,
"zip": "45206"
},
{
"city": "Columbus",
"contacts": [
{
"email": "TaniaSlack@equitashealth.com",
"name": "Tania Slack-Peterson",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kelly Wesp, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Equitas Health",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": null,
"zip": "43203"
},
{
"city": "Houston",
"contacts": [
{
"email": "Ernesto.LinaresPineda@bcm.edu",
"name": "Ernesto Linares Pineda",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shital Patel, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Thomas Street Clinic",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77004-8004"
},
{
"city": "Seattle",
"contacts": [
{
"email": "talam2@uw.edu",
"name": "Tala Mahmoud",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "H Nina Kim, MD, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Raaka Kumbhakar, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UW Madison Clinic at Harborview",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": null,
"zip": "98104"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y/o) persons with HIV.\n\nDoes use of the Positive Peers app improve viral suppression among young minority persons with HIV? What user characteristics are associated with a) viral suppression, b) retention in care, and c) perceived HIV-related stigma?\n\nParticipants will:\n\n* download the mobile app onto their personal smartphone\n* Use the mobile app as they find useful\n* complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized control trial with observational cohort for eligible patients who decline participation",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "34 Years",
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "PoPIT",
"briefTitle": "Positive Peers Intervention Clinical Trial",
"nctId": "NCT06388109",
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"id": "IRB15-00741",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Viral suppression"
}
],
"secondaryOutcomes": [
{
"measure": "Correlates of app use and viral suppression"
},
{
"measure": "Correlates of app use and retention in care"
},
{
"measure": "Correlates of app use and HIV related perceived stigma"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kent State University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "MetroHealth Medical Center"
}
},
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"completionDateStruct": {
"date": "2027-11"
},
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"date": "2024-04-29"
},
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"date": "2027-05"
},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "No Intervention Provided"
}
]
},
"conditionsModule": {
"conditions": [
"Glaucoma, Suspect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Miami",
"contacts": [
{
"email": "vporciatti@med.miami.edu",
"name": "Vittorio Porciatti, MD/PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street",
"geoPoint": {
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"lon": -80.19366
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33136"
}
]
},
"descriptionModule": {
"briefSummary": "Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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},
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"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "CLAD Deconvolved PERG Responses in Glaucoma Patients",
"nctId": "NCT06388096",
"orgStudyIdInfo": {
"id": "PERGCLAD001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PERG Amplitude"
},
{
"measure": "PERG Latency"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Miami"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Jorvec Corp."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Tinlarebant"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"STGD1",
"Stargardt Disease 1"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "Belite Study Site",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": null,
"zip": "75231"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease"
},
"designModule": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "20 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "DRAGON II",
"briefTitle": "A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease",
"nctId": "NCT06388083",
"orgStudyIdInfo": {
"id": "LBS-008-CT07",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy"
}
],
"secondaryOutcomes": [
{
"measure": "To measure the annualized rate of change in total area of atrophy"
},
{
"measure": "Change in BCVA measured by the ETDRS method"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Belite Bio, Inc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "HUC3-053"
},
{
"name": "Hyalein Mini Drops"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye Syndromes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a multi-center, randomized, double-blinded, non-inferiority study to evluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.\n\nAfter a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 280,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome",
"nctId": "NCT06388070",
"orgStudyIdInfo": {
"id": "HUC3-053",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from Baseline in Corneal staining score"
}
],
"secondaryOutcomes": [
{
"measure": "Change from Baseline in Corneal staining score"
},
{
"measure": "Change from Baseline in Conjunctival staining score"
},
{
"measure": "Change from Baseline in Schirmer test"
},
{
"measure": "Change from Baseline in Tear film break-up time"
},
{
"measure": "Change from Baseline in Ocular surface disease index"
},
{
"measure": "Change from Baseline in Soreness after eye drop assessed by NRS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Huons Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Intraoperative Small Bowel Ultrasonography"
}
]
},
"conditionsModule": {
"conditions": [
"Crohn Disease"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "To study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from Crohn's Disease."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Patients with Crohn's disease with an indication for surgery",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intraoperative Ultrasound in Crohn's Disease",
"nctId": "NCT06388057",
"orgStudyIdInfo": {
"id": "5836",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Acceptance and Commitment Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility",
"Psychological Distress",
"Acceptance and Commitment Therapy",
"Psychological Flexibility"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Durham",
"contacts": [
{
"email": "fs158@duke.edu",
"name": "Francesca Scheiber, PhD",
"phone": "919-668-8696",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Julia Woodward, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ashley Moskovich, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Duke North Pavilion",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": null,
"zip": "27705"
}
]
},
"descriptionModule": {
"briefSummary": "In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ACT for Infertility: Case Series",
"nctId": "NCT06388044",
"orgStudyIdInfo": {
"id": "PRO00115010",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acceptability of the Intervention"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Fertility Problem Inventory (FPI)"
},
{
"measure": "Change in Patient Health Questionnaire 9 (PHQ-9)"
},
{
"measure": "Change in Patient Health Questionnaire 2 (PHQ-2)"
},
{
"measure": "Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7)"
},
{
"measure": "Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2)"
},
{
"measure": "Change in Modified Differential Emotions Scale (mDES)"
},
{
"measure": "Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15)"
},
{
"measure": "Change in Intolerance of Uncertainty (IUS)"
},
{
"measure": "Change in Valuing Questionnaire (VQ)"
},
{
"measure": "Change in Values-Based Behavior"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Duke University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Immune checkpoint inhibitor"
}
]
},
"conditionsModule": {
"conditions": [
"Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": null,
"zip": "100730"
}
]
},
"descriptionModule": {
"briefSummary": "An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy).\n\nThis study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI",
"nctId": "NCT06388031",
"orgStudyIdInfo": {
"id": "CAPTRAL2024v1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Safety profile"
}
],
"primaryOutcomes": [
{
"measure": "Progression Free Survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Objective Response Rate (ORR)"
},
{
"measure": "Progression Free Survival 2 (PFS 2)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Clinical Observation"
},
{
"name": "External Beam Radiation Therapy"
},
{
"name": "High-Dose-Rate Vaginal Brachytherapy"
},
{
"name": "Computed Tomography"
},
{
"name": "Positron Emission Tomography"
},
{
"name": "X-Ray Imaging"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Questionnaire Administration"
}
]
},
"conditionsModule": {
"conditions": [
"Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC V8",
"Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC V8",
"Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC V8"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint Louis",
"contacts": null,
"country": "United States",
"facility": "Washington University School of Medicine",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri",
"status": null,
"zip": "63110"
}
]
},
"descriptionModule": {
"briefSummary": "This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 325,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer",
"nctId": "NCT06388018",
"orgStudyIdInfo": {
"id": "NRG-GY032",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP",
"id": "NCI-2023-09355",
"link": null,
"type": "REGISTRY"
},
{
"domain": "CCTG",
"id": "CCTG EN.10",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "U10CA180868",
"link": "https://reporter.nih.gov/quickSearch/U10CA180868",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time to pelvic recurrence"
}
],
"secondaryOutcomes": [
{
"measure": "Time to isolated vaginal recurrence"
},
{
"measure": "Recurrence-free survival"
},
{
"measure": "Endometrial cancer-specific survival"
},
{
"measure": "Fear of recurrence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
},
{
"name": "Canadian Cancer Trials Group"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "NRG Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "SUSPENDED",
"primaryCompletionDateStruct": {
"date": "2025-01-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "emotional freedom technique (EFT)"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety",
"Day Surgery",
"Preoperative Nursing Care",
"Emotional Freedom Technique"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Yantai",
"contacts": null,
"country": "China",
"facility": "Yantai Yuhuangding Hospital",
"geoPoint": {
"lat": 37.47649,
"lon": 121.44081
},
"state": "Shandong",
"status": null,
"zip": "264000"
}
]
},
"descriptionModule": {
"briefSummary": "Research methods\n\n1 Data collection and evaluation tools\n\n1. The general data record sheet was self-designed by the research team, and the collected content included age, gender, BMI, occupation, general family status, economic situation, history of hypertension and cardiovascular diseases, history of anxiety and depression, self-rating anxiety scale (SAS) score, blood pressure and heart rate before and after intervention, disease diagnosis and severity, etc.\n2. The anxiety was self-scored using the VAS-A (0-10 points), with 0 point as no anxiety and 10 as severe anxiety.\n3. Negative emotional intensity was scored using the subjective unit of disturbance scale (SUDS, 0-10 points), with 0 point as no and 10 points as severe.\n4. Nursing satisfaction was scored by the self-designed questionnaire (1-5 points): 5 points, very satisfied; 4 points, relatively satisfied; 3 points, satisfied; 2 points, medium; 1 point, dissatisfied.\n\n2 Intervention method of the control group The control group was given routine nursing. After entering the pre-anesthesia room, the patients were scored using the VAS-A, and those with VAS-A score ≥ 5 were considered to meet the inclusion criteria. After identity authentication, the preoperative precautions and reasons for waiting in the pre-anesthesia room were explained to the patients, and answers were provided to the questions raised by the patients. After routine nursing, VAS-A score was recorded, blood pressure and heart rate were monitored, and nursing satisfaction was inquired. The survey of patient satisfaction with nursing was completed before entering the operating room.\n\n3 Intervention method of the experimental group 3.1 Researcher training Before intervention, 4 nurses were trained for 5 d by a nurse with EFT qualification certificate, 1 h per day. The training content included: theoretical knowledge of EFT, tapping techniques, etc. After training, two assessments were conducted. Only those who scored above 90 points in both assessments could participate in the study.\n\n3.2 Operating instructions The acupoint diagram was distributed to the experimental group by nurses, and the essentials and precautions of acupoint tapping were explained. The nurses demonstrated and tapped the acupoints on the patients while explaining, and then instructed them to tap on their own until they were able to complete the task independently and proficiently. For patients with upper limb vein puncture, proper fixation and close observation were needed, and the flexible nature of the puncture needle that would not affect operations was explained to the patients to eliminate their concerns.\n\n3.3 Intervention content After routine nursing, the patients received EFT intervention. In addition, subjective anxiety was scored, blood pressure and heart rate were monitored, and nursing satisfaction was surveyed after admission and intervention. The specific methods are as follows.\n\n1. Preparation stage The patients with VAS-A score ≥ 5 meeting the inclusion criteria were in a comfortable position with eyes closed, and adopted breathing exercise to relax their whole body. The patients were guided to summarize the main current distresses, such as fear, tension, pain, surgical prognosis, economic burden, etc., name the caused negative emotions, and use the SUDS to evaluate the intensity of negative emotions. The patients were asked to recite silently the prompt \"Although I am very \\*\\* (a negative emotional word) now, I still deeply and completely love and accept myself\" while tapping.\n2. Tapping stage The patients were guided to gently massage the sore points on both sides of the body (2-3 fingers below the midpoint of the clavicle) with their five fingers together in a clockwise direction, while silently reciting the prompt 3 times. Then, the patients were guided to close their index and middle fingers together and gently tap the Zanzhu, Tongziliao, Chengqi, Renzhong, Chengjiang, Shufu, Dabao and Baihui acupoints successively with their fingertips at 2-3 times/s and the force they can bear. The prompt was recited silently when tapping each acupoint. After 3-5 rounds of tapping, 3 deep breaths were taken to re-evaluate the intensity of negative emotions.\n3. Feedback stage After tapping, the patients communicated with the nurses at least once about their evaluated negative emotional intensity score and whether the score was accepted. If the tapping effect was not obvious, the evaluation was conducted by nurses, and the patients were guided to massage the sore points while silently reciting the prompt 3 times. To relieve reverse psychological drive, tapping was continued until the intensity of negative emotions reduced."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 237,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Application of Emotion Release Technology in Anxiety Patients Before Daytime Thyroid Surgery",
"nctId": "NCT06388005",
"orgStudyIdInfo": {
"id": "2021-060",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "VAS-A score"
},
{
"measure": "hemodynamic and endocrine indicators"
},
{
"measure": "nursing satisfaction"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Yantai Yuhuangding Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Three-dimensional dental acquisition"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Care for Institutionalized Elderly Persons"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Reims",
"contacts": [
{
"email": "cetiennot@chu-reims.fr",
"name": "Carole ETIENNOT",
"phone": "03 10 73 66 79",
"phoneExt": "0033",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Damien JOLLY",
"geoPoint": {
"lat": 49.25,
"lon": 4.03333
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental consultation and eligible will be included once written informed consent is signed. Their dental consultation will start with a consultation with a nurse to record 3D intraoral images, then a consultation with a dental surgeon for standard dental care, blinded from the nurse consultation will be performed. Thereafter, 3D images will be analyzed by another dental surgeon blinded from the results of both consultations. Agreement on different outcomes between the analysis of the images acquired by the nurse and the standard dental evaluation by a dental surgeon will be assessed.\n\nAgreement on the results between the interpretation of the 3D images acquired by a nurse and the standard consultation by a dental surgeon could lead, in the long term, to a significant step forward in dental care of institutionalized patients.\n\nIndeed, training nursing home nurses to acquire 3D dental images would enable the identification of patients in need of immediate dental care and thus extend the possibilities of access to consultations with a dentist for these patients. This would increase the efficiency of care."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GEROdonto3D",
"briefTitle": "Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects",
"nctId": "NCT06387992",
"orgStudyIdInfo": {
"id": "PP24023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "DMFT index"
}
],
"secondaryOutcomes": [
{
"measure": "Plaque control record"
},
{
"measure": "General Oral Health Assessment Index (GOHAI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "CHU de Reims"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Interventional Study"
}
]
},
"conditionsModule": {
"conditions": [
"Glioma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jacksonville",
"contacts": [
{
"email": "mayocliniccancerstudies@mayo.edu",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alfredo Quinones-Hinojosa, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Florida",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32224-9980"
}
]
},
"descriptionModule": {
"briefSummary": "This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 185,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies",
"nctId": "NCT06387979",
"orgStudyIdInfo": {
"id": "19-010725",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01000",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic in Florida",
"id": "19-010725",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "P30CA015083",
"link": "https://reporter.nih.gov/quickSearch/P30CA015083",
"type": "NIH"
},
{
"domain": null,
"id": "R33CA240181",
"link": "https://reporter.nih.gov/quickSearch/R33CA240181",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pathological state of the tissue"
},
{
"measure": "Percentage of tumor infiltration"
},
{
"measure": "Presence of IDH mutations"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-10-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "flunotinib"
},
{
"name": "flunotinib placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Person"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chengdu",
"contacts": [
{
"email": "yongxlan@126.com",
"name": "Xiaolan Yong, bachelor",
"phone": "13568843829",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Chengdu Xinhua Hospital",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": "RECRUITING",
"zip": "610000"
}
]
},
"descriptionModule": {
"briefSummary": "Evaluate the safety and tolerability of a single increasing dose of Flibanserin Maleate tablets administered orally to healthy adult Chinese subjects; preliminarily assess the pharmacokinetic characteristics of a single dose of oral Flibanserin Maleate tablets"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Randomized, Double-blind,Dose-escalating, Single-dose, Oral Phase I Clinical Study of Flunotinib Healthy People",
"nctId": "NCT06387966",
"orgStudyIdInfo": {
"id": "H-FNTN-PI-Ia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：Cmax"
},
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：Tmax"
},
{
"measure": "The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144h) and excretion rate (Ae%);"
},
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：AUC0-∞"
},
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：MRT"
},
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：Vd"
},
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：t1/2"
},
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：CLz/F"
},
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：Vz/F"
},
{
"measure": "Prilinostat Mesylate Pharmacokinetics (PK)：Ke"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Chengdu Zenitar Biomedical Technology Co., Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Bridge Therapy"
},
{
"name": "Sham Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Emergence Delirium",
"Agitation, Emergence"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a randomized, prospective, double-blinded (patient and outcome-assessor) trial. Our goal is to assess efficacy of Bridge Therapy (versus sham bridge therapy) to prevent emergence agitation following general anesthesia.\n\nPrimary Objective: Activation of Bridge Therapy from the time of the pre incision \"time out\" until 24 hours after admission to the PACU (Post Anesthesia Care Unit) is associated with reduced frequency and intensity of emergence agitation.\n\nSecondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation.\n\nTertiary Objective: Activation of Bridge Therapy during a stable anesthetic state is associated with a reduced Patient State Index as measured on Sedline"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy",
"nctId": "NCT06387953",
"orgStudyIdInfo": {
"id": "STUDY00019480",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Patient State Index"
}
],
"primaryOutcomes": [
{
"measure": "Emergence agitation"
},
{
"measure": "Emergence agitation"
}
],
"secondaryOutcomes": [
{
"measure": "Rescue pharmacologic treatment of agitation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Washington"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "nEB Diet, followed for 36 hours"
},
{
"name": "LC25 Diet, followed for 36 hours"
},
{
"name": "LCEB Diet, followed for 36 hours"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guildford",
"contacts": null,
"country": "United Kingdom",
"facility": "University of Surrey",
"geoPoint": {
"lat": 51.23536,
"lon": -0.57427
},
"state": null,
"status": null,
"zip": "GU2 7XH"
}
]
},
"descriptionModule": {
"briefSummary": "This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels",
"nctId": "NCT06387940",
"orgStudyIdInfo": {
"id": "UEC 2019 008 FHMS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Biomarkers in blood Measured"
},
{
"measure": "Resting metabolic rate"
}
],
"secondaryOutcomes": [
{
"measure": "Perceived Appetite Scores"
},
{
"measure": "Food intake"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Surrey"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-11-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-11-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "home exercise program"
},
{
"name": "the core stability exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension",
"Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of physical therapy",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": null,
"zip": "3387722"
}
]
},
"descriptionModule": {
"briefSummary": "Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain",
"nctId": "NCT06387927",
"orgStudyIdInfo": {
"id": "PT-NEUR-10/2023-520",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of pain"
},
{
"measure": "Assessment of lumbar flexion range of motion"
},
{
"measure": "Assessment of functional disability"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ahram Canadian University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Stimulation ON"
},
{
"name": "Stimulation Pseudo-ON"
}
]
},
"conditionsModule": {
"conditions": [
"Central Post Stroke Pain"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat severe pain following a stroke in adults. It will also learn about the safety of deep brain stimulation. The main questions it aims to answer are:\n\n* Does DBS lower the pain score in these participants.\n* What medical problems do participants have when having DBS? Researchers will compare different settings, to see if DBS works to treat severe post stroke pain.\n\nParticipants will:\n\n* Undergo baseline screening procedures and have an MRI scan.\n* Have neurosurgery to put the DBS system in\n* Have follow up for 10 months\n* Visit the clinic at least 5 times in the study for check-ups and tests\n* Fill in questionnaires about pain and mood and have check ups remotely"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Double-blind trial, within subject randomisation and cross-over.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Blinding maintained using the hand held controller (shows ON at all times) and programs which ensure equivalent battery drain at all stimulation settings.\n\nPseudo-ON =high frequency, low amplitude stimulation. Frequency up to 250 Hertz(Hz), Amplitude less than 0.5 milliamps(mA), Pulse Width 500 microseconds(uS).",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EPIONE",
"briefTitle": "Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation",
"nctId": "NCT06387914",
"orgStudyIdInfo": {
"id": "PID 16707",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Ethics Committee (South Birmingham REC) UK",
"id": "23/WM/0219",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Heart rate variability (HRV)"
},
{
"measure": "Client Service Receipt Inventory (CSRI)"
},
{
"measure": "MRI"
}
],
"primaryOutcomes": [
{
"measure": "McGill Pain Questionnaire V2.0 -Short Form - Present Pain Intensity (MQ-SF-PPI) score"
}
],
"secondaryOutcomes": [
{
"measure": "Numerical Rating Scale (NRS)"
},
{
"measure": "McGill Pain Questionnaire V2.0 short form (MPQ-SF) McGill Pain Questionnaire V2.0 short form) MPQ-SF (McGill Pain Questionnaire V2.0 short form)"
},
{
"measure": "Brief Pain Inventory (BPI) - Short Form"
},
{
"measure": "Beck Depression Inventory (BDI II)"
},
{
"measure": "Patients' Global Impression of Change (PGIC)"
},
{
"measure": "EuroQol Quality of life (EQ5D-5L)"
},
{
"measure": "Healthy Days Measures (HDM)"
},
{
"measure": "Adverse Events (AEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Jon MoultonTrust"
},
{
"name": "Placito Bequest"
},
{
"name": "Bioinduction"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Oxford"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Paclitaxel Chemotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Paclitaxel Adverse Reaction",
"Chemotherapeutic Toxicity",
"Chemotherapeutic Agent Toxicity",
"Body Weight",
"Physical Inactivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brussel",
"contacts": [
{
"email": "Nele.Adriaenssens@vub.be",
"name": "Nele Adriaenssens",
"phone": "+32 2 476 36 23",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "Len.de.nys@vub.be",
"name": "Len De Nys",
"phone": "+32 472 99 49 48",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Vrije Universiteit Brussel",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": "Jette",
"status": null,
"zip": "1090"
}
]
},
"descriptionModule": {
"briefSummary": "This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects.\n\nThe researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices.\n\nThe goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer.\n\nIn simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PABTOX",
"briefTitle": "Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition.",
"nctId": "NCT06387901",
"orgStudyIdInfo": {
"id": "PABTOX - part 1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Treatment-Related Adverse Events"
},
{
"measure": "Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (muscle mass)"
},
{
"measure": "Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (fat %)"
},
{
"measure": "Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (muscle mass)"
},
{
"measure": "Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (fat mass)"
},
{
"measure": "Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (extracellular fluid)"
},
{
"measure": "The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)"
},
{
"measure": "EORTC QLQ-BR45 Breast (BR) Cancer Module"
},
{
"measure": "EORTC QLQ- Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20"
},
{
"measure": "European Health Interview Survey Physical Activity Questionnaire (EHIS PAQ)"
}
],
"primaryOutcomes": [
{
"measure": "Identification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs)"
},
{
"measure": "Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs)"
},
{
"measure": "Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs)"
}
],
"secondaryOutcomes": [
{
"measure": "Paclitaxel Exposure Analysis (Cmax)"
},
{
"measure": "Paclitaxel Exposure Analysis (AUC)"
},
{
"measure": "Number and Type of Dose-Limiting Toxicities"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Vrije Universiteit Brussel"
},
{
"name": "University Ghent"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universitair Ziekenhuis Brussel"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Listening to mother's voice"
}
]
},
"conditionsModule": {
"conditions": [
"Newborns"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul Medipol University Hospital",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Beykoz",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "41 Weeks",
"minimumAge": "3 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "Newborn",
"briefTitle": "The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns",
"nctId": "NCT06387888",
"orgStudyIdInfo": {
"id": "E-31034136-302.08.01-4221",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neonatal Comfort Behavior Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Neonatal Comfort Behavior Scale (COMFORTneo):"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Medipol University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Stroke",
"Non-Communicable Chronic Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "pujun310@hotmail.com",
"name": "Jun Pu, MD,PHD",
"phone": "86-21-68383477",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span."
},
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},
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"count": 30000,
"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cohort in Qianwan New District, Ningbo",
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"orgStudyIdInfo": {
"id": "Hangzhou Bay Cohort",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "death"
},
{
"measure": "incidence of cardio-cerebrovascular diseases"
},
{
"measure": "incidence of other non-communicable chronic diseases"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ningbo Hangzhou Bay Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "RenJi Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
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"date": "2027-06-30"
},
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"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled"
},
{
"name": "Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous"
}
]
},
"conditionsModule": {
"conditions": [
"Left Ventricular Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brussel",
"contacts": [
{
"email": "matthias.raes@uzbrussel.be",
"name": "Matthias Raes, MD",
"phone": "024749872",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "marieclaire.vanmalderen@uzbrussel.be",
"name": "Marie-Claire Van Malderen, SC",
"phone": "024763110",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "UZ Brussel",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null,
"status": null,
"zip": "1090"
}
]
},
"descriptionModule": {
"briefSummary": "Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan."
},
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"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
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"timePerspective": null
},
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"count": 6,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Symbiov",
"briefTitle": "Pharmacokinetics of Inhaled Levosimendan",
"nctId": "NCT06387862",
"orgStudyIdInfo": {
"id": "2022SIMBIOV",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bioavailability of inhaled levosimendan"
},
{
"measure": "Time-to-peak of inhaled levosimendan"
},
{
"measure": "Elimination half-life of inhaled levosimenan"
}
],
"secondaryOutcomes": [
{
"measure": "Effect of inhaled levosimendan on MAP"
},
{
"measure": "Effect of inhaled levosimendan on TVR"
},
{
"measure": "Effect of inhaled levosimendan on CO"
},
{
"measure": "Effect of inhaled levosimendan on LVOT VTI"
},
{
"measure": "Effect of inhaled levosimendan on FAC of the right vetricle"
},
{
"measure": "Effect of inhaled levosimendan on S'"
},
{
"measure": "Effect of inhaled levosimendan on SPAP"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universitair Ziekenhuis Brussel"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Aromatherapy"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Post-operative Pain",
"Post-operative Anxiety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ben Arous",
"contacts": null,
"country": "Tunisia",
"facility": "Ben Arous Regional Hospital",
"geoPoint": {
"lat": 36.75306,
"lon": 10.21889
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.\n\nThe aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"timePerspective": null
},
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"count": 100,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Aromatherapy Effect on Pain and Anxiety After C-section",
"nctId": "NCT06387849",
"orgStudyIdInfo": {
"id": "03/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Post-operative pain level"
},
{
"measure": "Post-operative anxiety level"
}
],
"secondaryOutcomes": [
{
"measure": "Heart Rate (HR)"
},
{
"measure": "Systolic Blood Pressure (SBP)"
},
{
"measure": "Diastolic Blood Pressure (DBP)"
},
{
"measure": "Respiratory Rate (RR)"
},
{
"measure": "Pulsatile Oxygen Saturation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Tunis El Manar"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Postoperative Cognitive Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "jindanfeng0506@163.com",
"name": "Danfeng Jin, M.D.",
"phone": "+8613795306154",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "ge.shengjin@zs-hospital.sh.cn",
"name": "Shengjin Ge, Ph.D.",
"phone": "+8613601926171",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shengjin Ge, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Zhongshan Hospital Fudan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "Postoperative cognitive dysfunction (POCD) is a common complication after surgery that is associated with more adverse events and death. The goal of this observational study is to learn about the diagnosis performance of long intergenic non-coding RNA(LINC01844) level in blood of older people for POCD. The main question it aims to answer is:\n\nDoes the relative level of LINC01844 in blood help diagnose POCD of older people after surgery? Participants undergoing elective lumbar decompression and fusion will finish neuropsychological evaluations one day before and 1st, 3rd and 5th day after surgery. At the same timepoint, the relative level of LINC01844 in blood will also be tested."
},
"designModule": {
"designInfo": {
"allocation": null,
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
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},
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"count": 63,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "LINC01844 as a Diagnostic Biomarker for POCD in Elderly Patients",
"nctId": "NCT06387836",
"orgStudyIdInfo": {
"id": "B2024-063",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
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{
"measure": "relative level of LINC01844"
}
],
"secondaryOutcomes": [
{
"measure": "serum reactive protein-C"
},
{
"measure": "serum interleukin-6"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Zhongshan Hospital"
}
},
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"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
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"date": "2025-02-21"
},
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"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Sivelestat sodium"
},
{
"name": "Dexamethasone"
},
{
"name": "Sivelestat sodium placebo"
},
{
"name": "Dexamethasone placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Respiratory Distress Syndrome"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:\n\n* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?\n* Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STAR",
"briefTitle": "Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS",
"nctId": "NCT06387823",
"orgStudyIdInfo": {
"id": "K5321",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "28-day ventilator-free days"
},
{
"measure": "Informed consent rate"
},
{
"measure": "Recruitment rate"
},
{
"measure": "Recruitment compliance rate"
},
{
"measure": "Protocol adherence rate"
},
{
"measure": "Completion of follow-up visits"
}
],
"secondaryOutcomes": [
{
"measure": "28-day mortality"
},
{
"measure": "90-day mortality"
},
{
"measure": "28-day length of stay"
},
{
"measure": "28-day organ support free day"
},
{
"measure": "Sequential organ failure assessment (SOFA)"
},
{
"measure": "Murray's acute lung injury score"
},
{
"measure": "C-reactive protein (CRP)"
},
{
"measure": "Interleukin-6 (IL-6)"
},
{
"measure": "Interleukin-8 (IL-8)"
},
{
"measure": "Procalcitonin (PCT)"
},
{
"measure": "Neutrophil-to-lymphocyte Ratio (NLR)"
},
{
"measure": "Neutrophil elastase"
},
{
"measure": "New-onset infection rate"
},
{
"measure": "Re-intubation rate"
},
{
"measure": "Adverse event"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Peking University"
},
{
"name": "Shanghai Huilun Pharmaceutical Co., Ltd."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-27"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "irinotecan liposome II combined with 5-FU/LV and oxaliplatin"
}
]
},
"conditionsModule": {
"conditions": [
"Borderline Resectable Pancreatic Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients."
},
"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": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "110 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "undetermined",
"briefTitle": "Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer",
"nctId": "NCT06387810",
"orgStudyIdInfo": {
"id": "MA-PC-II-010",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "event free survival"
}
],
"secondaryOutcomes": [
{
"measure": "overall survival"
},
{
"measure": "R0 resection rate"
},
{
"measure": "R1 excision rate"
},
{
"measure": "adverse event"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Cooking Matters for Adults (CMA+)"
},
{
"name": "Cooking Matters for Adults (CMA)"
}
]
},
"conditionsModule": {
"conditions": [
"At Risk for Type 2 Diabetes Mellitus",
"Pre Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Las Vegas",
"contacts": [
{
"email": "Sara.Rosenkranz@unlv.edu",
"name": "Sara K Rosenkranz, PhD",
"phone": "702-895-0938",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "Richard.Rosenkranz@unlv.edu",
"name": "Richard Rosenkranz, PhD",
"phone": "702-895-5198",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Keren Morales, B.S., RD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Donya Shahamati, B.S.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Laura Kruskall, PhD, RD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Elika Nematian, M.S.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Nevada, Las Vegas",
"geoPoint": {
"lat": 36.17497,
"lon": -115.13722
},
"state": "Nevada",
"status": null,
"zip": "89154"
}
]
},
"descriptionModule": {
"briefSummary": "This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomized to one of two parallel study arms.\n\n1. Cooking Matters for Adults (CMA) Curriculum Delivery over 6 weeks\n2. CMA + Enhanced cooking classes with added components comprising cooking practices specific to diabetes prevention, online information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. The CMA+ arm will also have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment visit. This will be an optional component and participants will not be excluded if they do not wish to use the CGM. (6 weeks)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Because of the parallel arm differences, it would not be possible to mask the arm assignment for the participant or investigator. However, we will mask the arm assignment for the outcomes assessor, in particular for the HbA1c% assessment.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Primary and Secondary Prevention of Type 2 Diabetes Mellitus in Clark County",
"nctId": "NCT06387797",
"orgStudyIdInfo": {
"id": "UNLV-2023-321",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "blood pressure in mmHg"
},
{
"measure": "fasting blood glucose in mg/dL"
},
{
"measure": "fasting total cholesterol in mg/dL"
},
{
"measure": "fasting LDL cholesterol in mg/dL"
},
{
"measure": "fasting HDL cholesterol in mg/dL"
},
{
"measure": "fasting triglyceride level in mg/dL"
},
{
"measure": "Usual dietary quality"
},
{
"measure": "Week 6 dietary quality"
},
{
"measure": "physical activity energy expenditure average kcals per day"
},
{
"measure": "Time spent in sedentary behavior in minutes per day"
},
{
"measure": "physical activity intensity distribution as minutes per day and average percentage of day"
},
{
"measure": "sleep quantity in hours per day"
},
{
"measure": "sleep quality"
},
{
"measure": "stress levels"
},
{
"measure": "Nutrition Security"
}
],
"primaryOutcomes": [
{
"measure": "Feasibility of conducting the intervention"
},
{
"measure": "Acceptability of the intervention"
},
{
"measure": "Acceptability of each cooking class"
}
],
"secondaryOutcomes": [
{
"measure": "Knowledge about the importance of produce consumption"
},
{
"measure": "Attitudes toward produce consumption"
},
{
"measure": "Intentions to consume recommended amounts of produce during and after intervention"
},
{
"measure": "Changes in fruit and vegetable consumption in servings per day"
},
{
"measure": "HbA1c%"
},
{
"measure": "Body weight in kg"
},
{
"measure": "Gut Microbiota composition"
},
{
"measure": "waist circumference in cm"
},
{
"measure": "body fat percentage (%)"
},
{
"measure": "non fat mass in kg"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Nevada, Reno"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Nevada, Las Vegas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Beetroot juice"
},
{
"name": "Placebo juice"
}
]
},
"conditionsModule": {
"conditions": [
"Pre-Eclampsia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy, characterized by high blood pressure and damage to organs such as the kidneys and liver. Currently, treatment options are limited, which has prompted researchers to explore alternative approaches. One such promising alternative is dietary nitrate found in vegetables like beetroot, as nitrate can be converted into nitric oxide in the body, which helps lower blood pressure. This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure, several blood and salivary markers in pregnant women with pre-eclampsia. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. The investigators want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, the investigators seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, placebo-controlled, single-blind, parallel-group study assessing acute rich-nitrate juice on pregnant women diagnosed with early and late-onset pre-eclampsia. Participants will be divided into four distinct groups: two groups for each onset category. Within each group, participants will be further divided into a control group and a treated group. The assignment of participants to these groups will be randomized using an online program.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "BEET_PE",
"briefTitle": "Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies",
"nctId": "NCT06387784",
"orgStudyIdInfo": {
"id": "2024/823",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acute Effect of Beetroot Juice Supplementation on Blood Pressure"
}
],
"secondaryOutcomes": [
{
"measure": "Plasma Concentrations of Nitric Oxide Metabolites"
},
{
"measure": "Concentration of Salivary Nitrate Reductase Enzyme"
},
{
"measure": "Plasma Lipid Peroxidation Levels"
},
{
"measure": "Concentration of Total Antioxidant Capacity in Plasma"
},
{
"measure": "Maternal Blood Flow Velocity"
},
{
"measure": "Fetal Heart Rate"
},
{
"measure": "Umbilical Arterial Pulsatility Index"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hospital das Clínicas de Ribeirão Preto"
},
{
"name": "Universidade Estadual Paulista Júlio de Mesquita Filho"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Sao Paulo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Tolcapone"
}
]
},
"conditionsModule": {
"conditions": [
"Schizophrenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pamplona",
"contacts": [
{
"email": "ucicec@unav.es",
"name": "Jose Maria Galindo",
"phone": "34 948 255400",
"phoneExt": "2725",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Clinica Universidad de Navarra",
"geoPoint": {
"lat": 42.81687,
"lon": -1.64323
},
"state": "Navarra",
"status": "RECRUITING",
"zip": "31008"
}
]
},
"descriptionModule": {
"briefSummary": "Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680.\n\nMethodology: 20 patients with chronic and stabilized schizophrenia (10 patients with genotype Val/Val and 10 patients with genotype Met/Met according to polymorphism rs4680) will receive treatment with tolcapone during 7 days. The cognitive function and clinical status will be evaluated with a neuropsychological battery and appropriate clinical scales before and after treatment. The efficiency of the activation of the prefrontal cortex will be measured using functional magnetic resonance imaging (fMRI) before and after treatment.\n\nHypothesis: Only patients with genotype Val/Val treated with tolcapone would show a cognitive improvement, a higher efficiency of the activation of the prefrontal cortex and an amelioration of some negative symptoms."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia",
"nctId": "NCT06387771",
"orgStudyIdInfo": {
"id": "rs4680-tolcapona",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Patient Reported Outcome: change from baseline in the Profile of Mood States (POMS) scores at day 8"
},
{
"measure": "Patient Reported Outcome: change from baseline in the mood state Visual Analogue Scale (VAS) scores at day 8"
}
],
"primaryOutcomes": [
{
"measure": "Efficacy: Change from baseline in cognitive test scores at day 8"
},
{
"measure": "Efficacy: Change from baseline in the brain blood-oxygen-level-dependent (BOLD) response at day 8"
}
],
"secondaryOutcomes": [
{
"measure": "Efficacy: change from baseline in psychotic symptoms intensity measured by the PANSS scores at day 8"
},
{
"measure": "Efficacy: negative symptoms intensity: change from baseline in the 16-item Negative Symptom Assessment (NSA-16) scale scores at day 8"
},
{
"measure": "Efficacy: change from baseline in the intensity of psychotic symptoms measured by the Brief Psychiatric Rating Scale (BPRS) scores at day 8"
},
{
"measure": "Efficacy: change from baseline in the clinical global impression measured by the Clinical Global Impression (CGI) scale scores at day 8"
},
{
"measure": "Efficacy: change from baseline in the global assessment of functioning measured by the Global Assessment of Functioning (GAF) scale scores at day 8"
},
{
"measure": "Efficacy: change from baseline in the anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A) scale scores at day 8"
},
{
"measure": "Efficacy: change from baseline in the depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D) scale scores at day 8"
},
{
"measure": "Efficacy: change from baseline in the Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scale scores at day 8"
},
{
"measure": "Change from baseline in plasmatic homocysteine (umol/L)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Clinica Universidad de Navarra, Universidad de Navarra"
}
},
"statusModule": {
"completionDateStruct": null,
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2014-09-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Low systemic strength training"
},
{
"name": "Moderate systemic exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Sickle Cell Anemia in Children"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jackson",
"contacts": [
{
"email": "ckarlson@umc.edu",
"name": "Cynthia Karlson, PhD",
"phone": "601-984-2723",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Mississippi Medical Center",
"geoPoint": {
"lat": 32.29876,
"lon": -90.18481
},
"state": "Mississippi",
"status": "RECRUITING",
"zip": "39216"
}
]
},
"descriptionModule": {
"briefSummary": "This research study wants to learn about what kind of exercise is best for kids with sickle cell disease. Participating children will have a small amount of blood drawn one time at the beginning of the study. Children will then complete some questionnaires that measure pain, physical function, and emotions (depression, anxiety) and complete some tests that measure physical fitness at the beginning and end of the study. Children will be randomized to either a home-based telehealth (1) walking or (2) strengthening exercise program that lasts for 8-weeks, 3-x week, for 45 minutes each session. Children's participation will last up to 10 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Low Systemic/High Local Exercise Load in Peds SCD",
"nctId": "NCT06387758",
"orgStudyIdInfo": {
"id": "UMMC-IRB-2022-473",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Demographics and medical history (parents)"
},
{
"measure": "Pediatric Pain Questionnaire"
},
{
"measure": "Functional Disability Inventory"
},
{
"measure": "NIH PROMIS 2582"
},
{
"measure": "Heart Rate Variability"
},
{
"measure": "Heart Rate"
},
{
"measure": "Blood Pressure"
},
{
"measure": "Bruininks-Oseretsky Test of Motor Proficiency"
},
{
"measure": "American Thoracic Society 6-minute walk test"
},
{
"measure": "Actigraphy"
},
{
"measure": "Daily diaries"
},
{
"measure": "Biomarkers"
},
{
"measure": "Medical Chart Review"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Alabama at Birmingham"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Mississippi Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Hepatoscope"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Liver Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "US-REFERRAL",
"briefTitle": "Referral of Patients to Hepatology With Hepatoscope",
"nctId": "NCT06387745",
"orgStudyIdInfo": {
"id": "US-REFERRAL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Positive Predictive Value for significant fibrosis"
}
],
"secondaryOutcomes": [
{
"measure": "Correlation of stiffness measurements"
},
{
"measure": "Concordance of stiffness measurements"
},
{
"measure": "Diagnostic performance of liver stiffness measurements"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "E-Scopics"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Antwerp"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Aerobic exercise"
},
{
"name": "Stretching and relaxation"
}
]
},
"conditionsModule": {
"conditions": [
"Depression"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "It is well established that any level of physical activity can help prevent and treat depression, with more strenuous activity having a greater effect. Understanding the mechanisms driving this antidepressant effect is important because it could allow exercise programmes to be made more effective, accessible, and targeted. Such knowledge could contribute to social prescribing, increasingly a priority for mental healthcare. Importantly, physical activity is highly scalable, low cost, well suited to early intervention, and has beneficial impacts on physical health co-morbidities. This trial may provide initial indications of whether there are sub-groups of depressed individuals who are particularly likely to benefit from physical activity, lead to strategies to personalise physical activity prescription based on motivational factors, and pave the way for augmentative approaches, for example combining physical activity with psychological interventions.\n\nTo date the mechanisms driving the antidepressant effects of physical activity in humans are poorly understood. Building on links between depressive symptoms, reward processing and dopamine, plus evidence from animal studies that physical activity is anti-inflammatory and boosts both dopamine and reward processing, the overarching aim of this trial is to understand the mechanisms underlying the effects of physical activity in depression, focusing on the concept of motivation.\n\nThe key objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining a range of mechanistic factors. The proposed trial will examine the impact of physical activity at multiple, linked potential levels of explanation: (1) immune-metabolic markers; (2) dopamine synthesis capacity; (3) activation in the brain's reward and effort processing circuitry;(4) effort-based decision making incorporating computational analysis; and (5) symptom networks based on fine-grained, daily measurements."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The trial will use a single-site parallel group design with depressed participants randomised to eight weeks of either 45 minutes of aerobic exercise of moderate-to-vigorous activity (experimental group: three times per week, N=125) or 45 minutes of non-aerobic stretching/guided relaxation (control group: three times per week, N=125).",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The control arm is stretching and relaxation. Prior research indicates that participants have similar efficacy expectations regarding mild stretching and aerobic exercise, which will help to improve masking. Due to the nature of the interventions, it is not possible for the participants to be masked as to the intervention they are undergoing, but all study information will be agnostic about which intervention we expect to be more effective, and all analysis will be performed by blinded staff. The trial will assess expectations and preferences about the intervention conditions, allowing for sensitivity analyses.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "LIFE",
"briefTitle": "Mechanisms Underlying Antidepressant Effects of Physical Activity",
"nctId": "NCT06387732",
"orgStudyIdInfo": {
"id": "161223",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient Health Questionnaire-9 score"
}
],
"secondaryOutcomes": [
{
"measure": "Physical activity"
},
{
"measure": "Aerobic capacity: CPET"
},
{
"measure": "Ecological Momentary Assessment"
},
{
"measure": "Inflammatory response (cytokines)"
},
{
"measure": "Inflammatory response (genetic markers)"
},
{
"measure": "Inflammatory response (flow cytometry immunophenotype)"
},
{
"measure": "Neuroendocrine system"
},
{
"measure": "Metabolic function"
},
{
"measure": "Dopamine synthesis capacity"
},
{
"measure": "Functional magnetic resonance imaging (fMRI) during cognitive tasks"
},
{
"measure": "Online cognitive tasks"
},
{
"measure": "Depression symptoms"
},
{
"measure": "Anxiety (GAD7 score)"
},
{
"measure": "Anxiety (STAI score)"
},
{
"measure": "Anhedonia (SHAPS score)"
},
{
"measure": "Anhedonia (DARS score)"
},
{
"measure": "Apathy"
},
{
"measure": "Fatigue"
},
{
"measure": "Cognitive impairment"
},
{
"measure": "Self-efficacy"
},
{
"measure": "Self-esteem"
},
{
"measure": "Sleep quality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "King's College London"
},
{
"name": "Queen Mary University of London"
},
{
"name": "University of Dublin, Trinity College"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University College, London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Magnetic resonance imaging"
}
]
},
"conditionsModule": {
"conditions": [
"Binge-Eating Disorder",
"Obesity",
"Eating Disorders",
"BED",
"Other Specified Feeding or Eating Disorder",
"Eating Disorder Nos",
"Emotion Regulation",
"Food Addiction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Esplugues De Llobregat",
"contacts": [
{
"email": "esther.via@sjd.es",
"name": "ESTHER VIA VIRGILI",
"phone": "34 + 673342094",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "ESTHER VIA VIRGILI",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "EDUARDO SERRANO",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "RAQUEL CECILIA",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "SILVIA MARÍN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "MARINA LLOBET",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "LAURA MARITZA ASTIASUAINZARRA VILLA",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "LILIANA SZEGHALMI",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "ANTONIO PÉREZ",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "MATTHIEU GILSON",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "MANEL VILA-VIDAL",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "GUIDO FRANK",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "CHRISTIAN STEPHAN OTTO",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Sant Joan de Déu",
"geoPoint": {
"lat": 41.37732,
"lon": 2.08809
},
"state": "Barcelona",
"status": "RECRUITING",
"zip": "08950"
}
]
},
"descriptionModule": {
"briefSummary": "BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 102,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PREC-BED",
"briefTitle": "Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity",
"nctId": "NCT06387719",
"orgStudyIdInfo": {
"id": "PREC-BED Study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neuroimaging assessment"
},
{
"measure": "Neuroimaging assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Height"
},
{
"measure": "Weight"
},
{
"measure": "Waist perimeter"
},
{
"measure": "BMI"
},
{
"measure": "Blood pressure"
},
{
"measure": "Fasting glucose"
},
{
"measure": "Triglycerides"
},
{
"measure": "HDL cholesterol"
},
{
"measure": "Developmental Tanner stage"
},
{
"measure": "Adherence to Mediterranean diet"
},
{
"measure": "Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis."
},
{
"measure": "Functioning"
},
{
"measure": "Depression"
},
{
"measure": "Anxiety"
},
{
"measure": "Emotion Regulation"
},
{
"measure": "Eating symptomatology"
},
{
"measure": "Eating symptomatology"
},
{
"measure": "Temperamental tendencies for sensitivity to punishment and sensitivity to reward."
},
{
"measure": "Food Addiction"
},
{
"measure": "Food intake"
},
{
"measure": "General Intelligence"
},
{
"measure": "Attention ability"
},
{
"measure": "Visuo-constructional ability and visual memory"
},
{
"measure": "Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed."
},
{
"measure": "Executive function: working memory ability"
},
{
"measure": "Executive function: decision-making abilities reward based"
},
{
"measure": "Executive function: ability to inhibit cognitive interference"
},
{
"measure": "Executive function: planning and strategic organisation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto de Salud Carlos III"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundació Sant Joan de Déu"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Gamified web-based pain management Program"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Pain Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "mmytse@hkmu.edu.hk",
"name": "Mimi Mun Yee Tse, PhD.",
"phone": "(852)39708764",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mimi Mun Yee Mimi Mun Yee, PhD.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Tyrone Tai On Kwok, PhD.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Timothy Chung Ming Wu, Master",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Hong Kong",
"facility": "Hong Kong Metropolitan University",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Pain Management in Older Adults: Pain significantly impacts the well-being of older adults, often leading to diminished physical abilities and a reduced quality of life. Despite this, pain management remains suboptimal, with concerns about medication side effects and a tendency to view pain as a natural aspect of aging. Consequently, many seniors are hesitant to use painkillers. As an alternative, non-pharmacological strategies such as educational programs, physical activity, massage, relaxation techniques, and music therapy are gaining traction.\n\nInnovative Non-Drug Solutions: To improve participation in non-medication pain relief methods, we suggest incorporating gaming elements into these programs (GAP). Originating in digital media in 2008, gamification has since spread across various industries. It involves adding game-like elements to activities to boost engagement, experience, and motivation.\n\nProject Goals: The aims of this initiative include creating a web-based Gamified Pain Management Program (GAP), engaging older adults with chronic pain in the development of GAP, and gathering their feedback on the program's effectiveness."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain",
"nctId": "NCT06387706",
"orgStudyIdInfo": {
"id": "GAP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Relief"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Hong Kong Polytechnic University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Holter monitoring, intracoronary ECG"
}
]
},
"conditionsModule": {
"conditions": [
"Angina, Stable"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Angina pectoris is diagnosed in \\>180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.\n\nThe origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.\n\nDuring CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "(AI)NOCA",
"briefTitle": "Artificial Intelligence in ANOCA",
"nctId": "NCT06387693",
"orgStudyIdInfo": {
"id": "24U-1359",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prevalence of myocardial ischemia in patients with equivocal coronary function test results"
},
{
"measure": "Diagnostic accuracy of perprocedural Holter ECG monitoring to diagnose coronary vasomotor disorders"
},
{
"measure": "Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "UMC Utrecht"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial"
}
]
},
"conditionsModule": {
"conditions": [
"Birth Outcome, Adverse",
"Birth, First",
"Labor Long",
"Apgar; 4-7 at 1 Minute"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Konya",
"contacts": null,
"country": "Turkey",
"facility": "Selcuk University",
"geoPoint": {
"lat": 37.87135,
"lon": 32.48464
},
"state": null,
"status": null,
"zip": "42250"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Peanut Ball Use on Labor",
"nctId": "NCT06387680",
"orgStudyIdInfo": {
"id": "2022/187",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison of sociodemographic of pregnant women."
},
{
"measure": "Comparison of obstetric characteristics of pregnant women"
},
{
"measure": "Comparison of postpartum characteristics of pregnant women"
},
{
"measure": "Comparison of duration of 1st and 2nd stage of labor by group"
},
{
"measure": "Comparison of 1st and 5th minute APGAR scores of newborns by group"
},
{
"measure": "Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups"
},
{
"measure": "Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Selcuk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Complete blood count"
},
{
"name": "C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT)"
},
{
"name": "CT chest"
},
{
"name": "Microscopic examination"
},
{
"name": "culture and sensitivity"
}
]
},
"conditionsModule": {
"conditions": [
"Immunocompromised ICU Patients With Respiratory Tract Infections"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Immunocompromised individuals face a heightened risk of life-threatening fungal infections, which arise from a multitude of environmental and commensal fungi. Surveillance data from ICUs worldwide identifies Candida spp. as the dominant foe, responsible for 80% of such infections, earning it the dubious distinction of being the third most prevalent pathogen. While C. albicans holds the dubious crown as the most common Candida offender, recent years have witnessed a concerning trend toward non-Albicans candida, raising concerns about potential antifungal resistance."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Immunocompromised ICU Patients with Respiratory tract infections",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections",
"nctId": "NCT06387667",
"orgStudyIdInfo": {
"id": "FIRTI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of fungal species causing pneumonia in immunocompromised ICU patients"
}
],
"secondaryOutcomes": [
{
"measure": "Determine the antifungal susceptibility profiles of the identified fungal isolates."
},
{
"measure": "Number of associated specific patient factors with the type or antifungal resistance of fungal infections"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "New Valley University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood sampling"
},
{
"name": "Remainders of samples taken as part of the treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Autoimmune Bullous Dermatosis",
"Systemic Autoimmune Diseases With Dermatological Presentation",
"Dysimmune Dermatological Diseases",
"Auto-inflammatory Dermatological Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toulouse",
"contacts": [
{
"email": "bost.c@chu-toulouse.fr",
"name": "Chloé BOST, MD, PhD",
"phone": "5 61 77 61 44",
"phoneExt": "0033",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Purpan University Hospital",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
},
"state": null,
"status": null,
"zip": "31059"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TekAPo",
"briefTitle": "Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases",
"nctId": "NCT06387654",
"orgStudyIdInfo": {
"id": "RC31/23/0361",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease"
}
],
"secondaryOutcomes": [
{
"measure": "Identification of new autoantibodies"
},
{
"measure": "Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions"
},
{
"measure": "Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies"
},
{
"measure": "Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Toulouse"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Life review"
},
{
"name": "Routine community health services"
}
]
},
"conditionsModule": {
"conditions": [
"Disabilities, Psychological"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hanzhou",
"contacts": null,
"country": "China",
"facility": "Xixi Street Community Health Service Center",
"geoPoint": {
"lat": 26.4965,
"lon": 99.437
},
"state": "Zhejiang",
"status": null,
"zip": "310012"
},
{
"city": "Hanzhou",
"contacts": null,
"country": "China",
"facility": "Gongchenqiao Street Community Health Service Centre",
"geoPoint": {
"lat": 26.4965,
"lon": 99.437
},
"state": "Zhejiang",
"status": null,
"zip": "310015"
},
{
"city": "Hanzhou",
"contacts": null,
"country": "China",
"facility": "Baiyang Street Wenchao Community Health Centre",
"geoPoint": {
"lat": 26.4965,
"lon": 99.437
},
"state": "Zhejiang",
"status": null,
"zip": "310018"
},
{
"city": "Hanzhou",
"contacts": null,
"country": "China",
"facility": "School of Nursing, Hangzhou Normal University",
"geoPoint": {
"lat": 26.4965,
"lon": 99.437
},
"state": "Zhejiang",
"status": null,
"zip": "311121"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are:\n\nDoes life review enhance the sense of meaning in life of participants? Dose life reviews enhance the life satisfaction of participants. Dose life reviews enhance the quality of life of participants?\n\nResearchers will compare the life review program to routine community health services to see if the life review intervention program is effective in enhancing the sense of meaning in life of older adults with disabilities who live at home.\n\nParticipants will:\n\nTake face-to-face life review interview or routine community health service every week for 6 weeks.\n\nTake the the questionnaire survey before and after the six-week life review intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 68,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities",
"nctId": "NCT06387641",
"orgStudyIdInfo": {
"id": "2024004",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from Baseline in Meaning in life on the Meaning in Life Questionnaire (MLQ) at Week6"
}
],
"secondaryOutcomes": [
{
"measure": "Change from Baseline in Life satisfaction on the Life Satisfaction In-dex A (LSIA) at Week6"
},
{
"measure": "Change from Baseline in Quality of life on the 12-Item Short Form Survey (SF-12) at Week6"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Bao Huimin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
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"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "LM-108"
},
{
"name": "Toripalimab"
},
{
"name": "Eribulin"
},
{
"name": "Nab paclitaxel"
}
]
},
"conditionsModule": {
"conditions": [
"TNBC - Triple-Negative Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "pro_wangbiyun@163.com",
"name": "Biyun Wang",
"phone": "18017312387",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
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"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or eribulin as first-line or post-line treatment in patients with metastatic triple-negative breast cancer."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 74,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer",
"nctId": "NCT06387628",
"orgStudyIdInfo": {
"id": "LM108-IIT-202",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "ORR"
}
],
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{
"measure": "DoR"
},
{
"measure": "DCR"
},
{
"measure": "PFS"
},
{
"measure": "OS"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
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"date": "2026-04-01"
},
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"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Active cTBS"
},
{
"name": "Sham"
}
]
},
"conditionsModule": {
"conditions": [
"Dyslexia",
"Dyslexia, Developmental",
"Learning; Developmental Disorder, Reading"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Atlanta",
"contacts": [
{
"email": null,
"name": "C.Nikki Arrington, PhD",
"phone": "404-385-8621",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI)",
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"lon": -84.38798
},
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"zip": "30318"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability."
},
"designModule": {
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"maskingInfo": {
"masking": "SINGLE",
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"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words",
"nctId": "NCT06387615",
"orgStudyIdInfo": {
"id": "H22086",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1R21HD108576-01A1",
"link": "https://reporter.nih.gov/quickSearch/1R21HD108576-01A1",
"type": "NIH"
}
]
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Novel Word Learning Task"
},
{
"measure": "Pseudoword Discrimination Task"
}
],
"secondaryOutcomes": [
{
"measure": "MRI Scan"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Georgia State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
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"date": "2024-10-31"
},
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"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Cryotherapy"
},
{
"name": "Strengthening of adductors"
},
{
"name": "Active release technique"
},
{
"name": "Post-Isometric Relaxation"
}
]
},
"conditionsModule": {
"conditions": [
"Adductor Strain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "furqan.yaqoob@fui.edu.pk",
"name": "Furqan Yaqoob, MS-OMPT,PHD*",
"phone": "03465333101",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Foundation University College of Physical Therapy",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "46000"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison Between Effects of Active Release Technique and Post Isometric Relaxation on Adductor Strain in Mixed Martial Arts Fighters",
"nctId": "NCT06387602",
"orgStudyIdInfo": {
"id": "FUI/CTR/2024/6",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Pain Intensity"
},
{
"measure": "Range of motion"
},
{
"measure": "Functionality"
},
{
"measure": "Flexibility"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Foundation University Islamabad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
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"date": "2023-11-20"
},
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"startDateStruct": {
"date": "2023-07-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Core stability exercises"
},
{
"name": "Static Stretching of Iliopsoas"
},
{
"name": "Post Facilitation Stretch of Iliopsoas"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "sana.khalid@fui.edu.pk",
"name": "Sana Khalid, MSNMPT,PHD",
"phone": "03315050460",
"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "Foundation University College of Physical Therapy",
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"lon": 73.0679
},
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"status": "RECRUITING",
"zip": "46000"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a randomized controlled trial and the purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas combined with core stability exercises in Non-Specific Low Back Pain\""
},
"designModule": {
"designInfo": {
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"whoMasked": null
},
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"timePerspective": null
},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
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"orgStudyIdInfo": {
"id": "FUI/CTR/2024/5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"measure": "Pain intensity"
},
{
"measure": "Level of disability"
},
{
"measure": "Lumbar Range of motion"
},
{
"measure": "Hip Range of motion"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Foundation University Islamabad"
}
},
"statusModule": {
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"date": "2024-06-20"
},
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"date": "2024-04-29"
},
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"date": "2023-11-20"
},
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"startDateStruct": {
"date": "2023-07-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Behaviorally informed pre-discharge iPad video scheduling"
}
]
},
"conditionsModule": {
"conditions": [
"Appointments and Schedules"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Santa Monica",
"contacts": [
{
"email": "rleuchter@mednet.ucla.edu",
"name": "Rich Leuchter, MD",
"phone": "310-825-9111",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UCLA Santa Monica Medical Center",
"geoPoint": {
"lat": 34.01945,
"lon": -118.49119
},
"state": "California",
"status": "RECRUITING",
"zip": "90404"
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective clinical trial evaluating whether a behaviorally informed intervention (pre-discharge iPad video scheduling) increases post-discharge primary care physician (PCP) appointment completion compared to the status-quo scheduling process (post-discharge via phone), with the ultimate goal of improving patient health outcomes."
},
"designModule": {
"designInfo": {
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"interventionModel": "PARALLEL",
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"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
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"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
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},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post-Discharge Follow-up Appointment Scheduling",
"nctId": "NCT06387576",
"orgStudyIdInfo": {
"id": "Post-discharge Appointments",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Post-discharge follow-up PCP appointment completion rate within 7 days"
}
],
"secondaryOutcomes": [
{
"measure": "Post-discharge follow-up PCP appointment completion rate within 14 days"
},
{
"measure": "Post-discharge follow-up PCP appointment scheduling rate within 7 days"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Los Angeles"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Abdominal activation using pressure biofeedback"
},
{
"name": "Abdominal activation using SEMG biofeedback"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "anam.rehman@fui.edu.pk",
"name": "Anam Rehman, MS-OMPT",
"phone": "03355082299",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Foundation University College of Physical Therapy",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "46000"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a randomized control trial and the purpose of this study to determine the effects of abdominal muscle activation training on non-specific low back pain; using pressure biofeedback in comparison with surface electromyography biofeedback: a randomized control trial."
},
"designModule": {
"designInfo": {
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"maskingDescription": null,
"whoMasked": null
},
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"timePerspective": null
},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "44 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography",
"nctId": "NCT06387563",
"orgStudyIdInfo": {
"id": "FUI/CTR/2024/4",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Intensity"
},
{
"measure": "Level of Disability"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Foundation University Islamabad"
}
},
"statusModule": {
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"date": "2024-05-30"
},
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"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
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"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Eccentric Training"
}
]
},
"conditionsModule": {
"conditions": [
"Type II Diabetes Mellitus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "zara.khalid@fui.edu.pk",
"name": "Zara Khalid, PhD*",
"phone": "+923335415822",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Foundation University College of Physical Therapy",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "46000"
}
]
},
"descriptionModule": {
"briefSummary": "Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Life dependency is increased due to long term effects of diabetes in specifically older individuals. Physical activity and exercise improves glucose tolerance and also reduces other life threatening diabetic complications, improving the quality of life in diabetic population."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is a pre-post quasi experimental study having one group analysis.Participants will be selected through inclusion and exclusion criteria then pre assessment would be done that include HBA1C and EQ5DL QOL tool, followed by intervention and post assessment.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus",
"nctId": "NCT06387550",
"orgStudyIdInfo": {
"id": "FUI/CTR/2024/3",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Glycemic control"
},
{
"measure": "Patient's quality of life"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Foundation University Islamabad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Conventional physical therapy"
},
{
"name": "Scapular mobilization."
}
]
},
"conditionsModule": {
"conditions": [
"Adhesive Capsulitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "zara.khalid@fui.edu.pk",
"name": "Zara Khalid, DPT, MS-CPPT,PHD*",
"phone": "+923335415822",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Foundation University College of Physical Therapy",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "460000"
}
]
},
"descriptionModule": {
"briefSummary": "Adhesive capsulitis is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis. Physiotherapists have a wide range of options in managing Adhesive capsulitis including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.Few studies on proprioception in rotator cuff tear, sub acromial impingment syndrome, but no obseved effects of scapular mobilization on shoulder proprioception in patients with adhesive capsulitis.Physical therapist focus on lowering pain and ROM limitations in the shoulder,but often neglect to evaluate proprioception/joint position sense as well as the roleof scapula in adhesive capsulitis during treatment.If found effective,this study can help in probviding treatment protocols for improving proprioception in patients with adhesive capsulits."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the second will receive conventional physical therapy along with scapular mobilization. Both groups will be recruited concurrently.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Scapular Mobilization on Shoulder Proprioception and Pain in Patients With Adhesive Capsulitis",
"nctId": "NCT06387537",
"orgStudyIdInfo": {
"id": "FUI/CTR/2024/2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Shoulder Proprioception"
},
{
"measure": "Pain Intensity"
}
],
"secondaryOutcomes": [
{
"measure": "Shoulder Range of motion"
},
{
"measure": "Shoulder Disability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Foundation University Islamabad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "McConnell Taping"
},
{
"name": "ECCENTRIC EXERCISES:"
}
]
},
"conditionsModule": {
"conditions": [
"Patellofemoral Pain Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "quratulain.saeed@fui.edu.pk",
"name": "Qurat ul Ain Saeed, MS-OMPT,PHD*",
"phone": "03315562889",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Foundation University College of Physical Therapy",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "46000"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a quasi experimental and the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi - experimental study"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Quasi experimental study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Eccentric Exercises on Gait Parameters in Patellofemoral Pain Syndrome: A Quasi-Experimental Study",
"nctId": "NCT06387524",
"orgStudyIdInfo": {
"id": "FUI/CTR/2024/1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dynamic knee valgus angle"
},
{
"measure": "Hip Range of Motion"
},
{
"measure": "Knee Range of Motion"
},
{
"measure": "Pain intensity"
},
{
"measure": "Gait Speed"
},
{
"measure": "Cadence"
},
{
"measure": "Stride length"
},
{
"measure": "Step length"
},
{
"measure": "Cycle length"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Foundation University Islamabad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax"
}
]
},
"conditionsModule": {
"conditions": [
"Immunization Coverage Improvment"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services.\n\nWe will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the endline cross-sectional household survey, 2) in children aged 6-12 months at inclusion in a longitudinal 12 months follow-up survey.\n\nSecondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of the\n\nThis study will implrmented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria.\n\nThis is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and endline cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized sub-sample of health facilities.\n\nClusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm:\n\n* The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts, named the standard EPI arm;\n* The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A two arms opened pragmatic parallel cluster-randomized controlled trial with baseline measure",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "No possible to mask intervention due to the specifity of the intervention tested",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 3720,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "23 Months",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months",
"nctId": "NCT06387511",
"orgStudyIdInfo": {
"id": "NutriVax-Measles",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Measles vaccine coverage in children aged 12-23 months"
},
{
"measure": "Measles vaccine coverage in children 6-12 months at inclusion"
}
],
"secondaryOutcomes": [
{
"measure": "Measles vaccine coverage: at least one dose"
},
{
"measure": "Measles vaccine coverage : two doses"
},
{
"measure": "Timeliness of measles 1 vaccination"
},
{
"measure": "Other infant vaccines coverage"
},
{
"measure": "Zero-dose"
},
{
"measure": "Fully immunization"
},
{
"measure": "Acceptability"
},
{
"measure": "Cost-efficiency"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Institut National de la Santé Et de la Recherche Médicale, France"
},
{
"name": "Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire"
},
{
"name": "Yobe State Ministry of Health, Nigeria"
},
{
"name": "Eleanor Crook Foundation"
},
{
"name": "Gavi, The Vaccine Alliance"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Alliance for International Medical Action"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Testicular tissue biopsy and cryopreservation"
}
]
},
"conditionsModule": {
"conditions": [
"Fertility Issues"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": [
{
"email": "jocelyn.phipers@cuanschutz.edu",
"name": "Jocelyn Phipers, RN",
"phone": "303-724-7807",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "LESLIE.APPIAH@CUANSCHUTZ.EDU",
"name": "Leslie Appiah, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Leslie Appiah, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Colorado",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80045"
}
]
},
"descriptionModule": {
"briefSummary": "The \"Testicular Tissue Cryopreservation\" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TTC",
"briefTitle": "Testicular Tissue Cryopreservation (TTC)",
"nctId": "NCT06387498",
"orgStudyIdInfo": {
"id": "20-2286",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure"
},
{
"measure": "Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve"
},
{
"measure": "Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event"
},
{
"measure": "Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event"
},
{
"measure": "Safety, as Assessed via the Number of Participants with At Least One Pre-specified"
},
{
"measure": "Safety, as Assessed via the Number of Participants with At Least One Pre-specified"
}
],
"secondaryOutcomes": [
{
"measure": "Acceptability, as Assessed via Annual Survey Regret Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Colorado, Denver"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-09-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "3D Printed Anatomic Model"
},
{
"name": "CT/MRI"
}
]
},
"conditionsModule": {
"conditions": [
"Sarcoma, Ewing",
"Chondrosarcoma",
"Osteosarcoma",
"Fibrous Histiocytoma",
"Fibrosarcoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Royal Oak",
"contacts": [
{
"email": "Pamela.Sloan@corewellheath.org",
"name": "Pamela Sloan, RN, CCRP",
"phone": "248-551-6059",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "William Beaumont University Hospital",
"geoPoint": {
"lat": 42.48948,
"lon": -83.14465
},
"state": "Michigan",
"status": "RECRUITING",
"zip": "48073"
},
{
"city": "Columbus",
"contacts": [
{
"email": "rachel.herster@osumc.edu",
"name": "Rachel Herster, BS",
"phone": "248-514-4490",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The Ohio State University Wexner Medical Center",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43212"
}
]
},
"descriptionModule": {
"briefSummary": "This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.\n\nPrimary endpoint: Operative time of surgical procedure.\n\nSecondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.\n\nExploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning",
"nctId": "NCT06387485",
"orgStudyIdInfo": {
"id": "SR-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Operative time"
}
],
"secondaryOutcomes": [
{
"measure": "Blood loss"
},
{
"measure": "Adverse Events"
},
{
"measure": "Tumor margin status"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Ricoh USA, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |