protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Defactinib"
},
{
"name": "Cetuximab"
},
{
"name": "Avutometinib"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Colorectal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": null,
"name": "Christine Parseghian, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christine Parseghian, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77807"
}
]
},
"descriptionModule": {
"briefSummary": "To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer."
},
"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": 33,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer",
"nctId": "NCT06369259",
"orgStudyIdInfo": {
"id": "2023-0997",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-03302",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stereotactic Body Radiation Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Comron Hassanzadeh, MD",
"phone": "713-657-9802",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Comron Hassanzadeh, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer",
"nctId": "NCT06369246",
"orgStudyIdInfo": {
"id": "2023-0893",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-03308",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MegaShield®-SP"
},
{
"name": "Guardix-SP Plus"
}
]
},
"conditionsModule": {
"conditions": [
"Herniation, Disc"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": [
{
"email": "[email protected]",
"name": "HyungYul Park",
"phone": "02-2030-4536",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "HyungYul Kim, Professor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Korea, Republic of",
"facility": "Eunpyeong ST. Mary's Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "03312"
},
{
"city": "Seoul",
"contacts": [
{
"email": "[email protected]",
"name": "Siyoung Park",
"phone": "2228-2194",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Siyoung Park, Professor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Korea, Republic of",
"facility": "Severance Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "03722"
},
{
"city": "Seoul",
"contacts": [
{
"email": "[email protected]",
"name": "Jiwon Kwon",
"phone": "2019-3411",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jiwon Kwon, Professor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Korea, Republic of",
"facility": "Gangnam Severance Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "06273"
},
{
"city": "Seoul",
"contacts": [
{
"email": "[email protected]",
"name": "Hojung Kim",
"phone": "031-787-7202",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hojung Kim, Professor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Korea, Republic of",
"facility": "Bundang Seoul National University Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": "13620"
}
]
},
"descriptionModule": {
"briefSummary": "This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery",
"nctId": "NCT06369233",
"orgStudyIdInfo": {
"id": "LNC-MS-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MRI scar score"
}
],
"secondaryOutcomes": [
{
"measure": "Oswestry Disability Index(ODI) score"
},
{
"measure": "Visual Analog Scale(VAS) Back & Leg Pain Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "PROMeDis"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "L&C Bio"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "cobas® liat CT/NG/MG nucleic acid test"
},
{
"name": "Standard of Care (SOC): Clinician's Standard Practice"
}
]
},
"conditionsModule": {
"conditions": [
"Chlamydia Trachomatis Infection",
"Neisseria Gonorrhoeae Infection",
"Mycoplasma Genitalium Infection"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 348,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections",
"nctId": "NCT06369220",
"orgStudyIdInfo": {
"id": "LIA-STI-542",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of Participants Given Inappropriate Treatment for CT Infection"
},
{
"measure": "Percentage of Participants Given Inappropriate Treatment for NG Infection"
},
{
"measure": "Percentage of Participants Given Inappropriate Treatment for MG Infection"
},
{
"measure": "Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire"
},
{
"measure": "Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Roche Molecular Systems, Inc"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hoffmann-La Roche"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Venous Insufficiency"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gorgan",
"contacts": null,
"country": "Iran, Islamic Republic of",
"facility": "Pezhman Kharazm, MD",
"geoPoint": {
"lat": 36.8427,
"lon": 54.44391
},
"state": "Golestan",
"status": null,
"zip": "4917956808"
}
]
},
"descriptionModule": {
"briefSummary": "Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. ."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux",
"nctId": "NCT06369207",
"orgStudyIdInfo": {
"id": "113454",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Determination of reflux transmission pathways in CVI patients with SFJ incompetency"
}
],
"secondaryOutcomes": [
{
"measure": "Anatomic variations of GSV in CVI patients with SFJ incompetency"
},
{
"measure": "Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency"
},
{
"measure": "Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Golestan University of Medical sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Colorectal Surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Surgery",
"Critical Pathways",
"Enhanced Recovery After Surgery",
"Retrospective Studies",
"Chemotherapy, Adjuvant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Alcoy",
"contacts": null,
"country": "Spain",
"facility": "Hospital Virgen de los Lirios de Alcoy",
"geoPoint": {
"lat": 38.70545,
"lon": -0.47432
},
"state": "Alicante",
"status": null,
"zip": null
},
{
"city": "Elche",
"contacts": null,
"country": "Spain",
"facility": "Hospital General Universitario de Elche",
"geoPoint": {
"lat": 38.26218,
"lon": -0.70107
},
"state": "Alicante",
"status": null,
"zip": null
},
{
"city": "Oviedo",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Central de Asturias",
"geoPoint": {
"lat": 43.36029,
"lon": -5.84476
},
"state": "Asturias",
"status": null,
"zip": null
},
{
"city": "Igualada",
"contacts": null,
"country": "Spain",
"facility": "Hospital de Igualada",
"geoPoint": {
"lat": 41.58098,
"lon": 1.6172
},
"state": "Barcelona",
"status": null,
"zip": null
},
{
"city": "Sant Joan d'Espi",
"contacts": null,
"country": "Spain",
"facility": "Hospital de Sant Joan Despí Moisès Broggi",
"geoPoint": {
"lat": 41.36718,
"lon": 2.0574
},
"state": "Barcelona",
"status": null,
"zip": null
},
{
"city": "Santa Coloma De Gramenet",
"contacts": null,
"country": "Spain",
"facility": "Fundación Hospital del Espíritu Santo",
"geoPoint": {
"lat": 41.45152,
"lon": 2.2081
},
"state": "Barcelona",
"status": null,
"zip": null
},
{
"city": "Terrassa",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitari Mútua Terrassa",
"geoPoint": {
"lat": 41.56667,
"lon": 2.01667
},
"state": "Barcelona",
"status": null,
"zip": null
},
{
"city": "Vic",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario de Vic",
"geoPoint": {
"lat": 41.93012,
"lon": 2.25486
},
"state": "Barcelona",
"status": null,
"zip": null
},
{
"city": "Castellon de la Plana",
"contacts": null,
"country": "Spain",
"facility": "Hospital General Universitario de Castellón",
"geoPoint": {
"lat": 39.98567,
"lon": -0.04935
},
"state": "Castellón",
"status": null,
"zip": null
},
{
"city": "Majadahonda",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Puerta de Hierro",
"geoPoint": {
"lat": 40.47353,
"lon": -3.87182
},
"state": "Madrid",
"status": null,
"zip": null
},
{
"city": "Mostoles",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario de Móstoles",
"geoPoint": {
"lat": 40.32234,
"lon": -3.86496
},
"state": "Madrid",
"status": null,
"zip": null
},
{
"city": "Lorca",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Rafael Méndez",
"geoPoint": {
"lat": 37.67119,
"lon": -1.7017
},
"state": "Murcia",
"status": null,
"zip": null
},
{
"city": "Marbella",
"contacts": null,
"country": "Spain",
"facility": "Hospital Costa del Sol",
"geoPoint": {
"lat": 36.51543,
"lon": -4.88583
},
"state": "Málaga",
"status": null,
"zip": null
},
{
"city": "Talavera de la Reina",
"contacts": null,
"country": "Spain",
"facility": "Hospital Nuestra Señora del Prado",
"geoPoint": {
"lat": 39.96348,
"lon": -4.83076
},
"state": "Toledo",
"status": null,
"zip": null
},
{
"city": "Alava",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Araba",
"geoPoint": {
"lat": 43.36057,
"lon": -6.19946
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Alicante",
"contacts": null,
"country": "Spain",
"facility": "Hospital General Universitario de Alicante",
"geoPoint": {
"lat": 38.34517,
"lon": -0.48149
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Hospital Clínic Universitat de Barcelona",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Hospital del Mar",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Santa Creu i Sant Pau",
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"lat": 41.38879,
"lon": 2.15899
},
"state": null,
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},
{
"city": "Barcelona",
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"country": "Spain",
"facility": "Hospital Universitario Vall d´Hebrón",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Ciudad Real",
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"country": "Spain",
"facility": "Hospital General Universitario de Ciudad Real",
"geoPoint": {
"lat": 38.98626,
"lon": -3.92907
},
"state": null,
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},
{
"city": "Galdakao",
"contacts": null,
"country": "Spain",
"facility": "Hospital de Galdakao-Usansolo",
"geoPoint": {
"lat": 43.23333,
"lon": -2.83333
},
"state": null,
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"zip": null
},
{
"city": "Las Palmas de Gran Canaria",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Insular de Gran Canaria",
"geoPoint": {
"lat": 28.09973,
"lon": -15.41343
},
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},
{
"city": "Las Palmas",
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"country": "Spain",
"facility": "Hospital Universitario de Gran Canaria Doctor Negrín",
"geoPoint": {
"lat": 28.58232,
"lon": -16.16555
},
"state": null,
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},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Hospital de La Princesa",
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"lat": 40.4165,
"lon": -3.70256
},
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},
{
"city": "Madrid",
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"country": "Spain",
"facility": "Hospital Universitario 12 de Octubre",
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"lat": 40.4165,
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},
"state": null,
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},
{
"city": "Madrid",
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"country": "Spain",
"facility": "Hospital Universitario Infanta Leonor",
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"lat": 40.4165,
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},
"state": null,
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},
{
"city": "Madrid",
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"country": "Spain",
"facility": "Hospital Universitario Ramón y Cajal",
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},
"state": null,
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},
{
"city": "Madrid",
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"country": "Spain",
"facility": "Hospital Universitario San Carlos",
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"lat": 40.4165,
"lon": -3.70256
},
"state": null,
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},
{
"city": "Salamanca",
"contacts": null,
"country": "Spain",
"facility": "Complejo Hospitalario de Salamanca",
"geoPoint": {
"lat": 40.96882,
"lon": -5.66388
},
"state": null,
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},
{
"city": "San Sebastián",
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"country": "Spain",
"facility": "Hospital Universitario Donostia",
"geoPoint": {
"lat": 43.31283,
"lon": -1.97499
},
"state": null,
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},
{
"city": "Sevilla",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Virgen Macarena",
"geoPoint": {
"lat": 37.38283,
"lon": -5.97317
},
"state": null,
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},
{
"city": "Valencia",
"contacts": null,
"country": "Spain",
"facility": "Consorcio Hospital General Unidersitario de Valencia",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": null,
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},
{
"city": "Valencia",
"contacts": null,
"country": "Spain",
"facility": "Hospital Clínico Universitario de Valencia",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Valladolid",
"contacts": null,
"country": "Spain",
"facility": "Hospital Clínico de Valladolid",
"geoPoint": {
"lat": 41.65518,
"lon": -4.72372
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Zaragoza",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Miguel Server",
"geoPoint": {
"lat": 41.65606,
"lon": -0.87734
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).It is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up.To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p \\<0.05 (two tails)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 847,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol",
"nctId": "NCT06369194",
"orgStudyIdInfo": {
"id": "POWER5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall Survival"
},
{
"measure": "Disease-free survival"
},
{
"measure": "Time to disease recurrence"
},
{
"measure": "Time to return to intended oncologic treatment (RIOT)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Grupo Español de Rehabilitación Multimodal"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Neuroendocrine Carcinoma",
"Non-small Cell Lung Cancer",
"Histology Transformation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Zhengfei Zhu, MD",
"phone": "+86 18017312901",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fudan University Shanghai Cancer Center",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "Histology transformation from non-small cell lung cancer (NSCLC) to neuroendocrine carcinomas (NEC), especially from epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma (LADC) to small cell lung cancer (SCLC), is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors (TKIs) resistance. The probability of its occurrence is about 3-14% in NSCLC patients who are resistant to TKI treatment. In addition to EGFR mutations, NSCLC patients carrying ALK/ROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformation(NET).In a previous study \\[Pubmed ID: 35609408\\], the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments. This phenomenon could be under-recognized, because re-biopsy was less frequently performed in these patients. The investigators had also shown that p53/Rb inactivation might correlated with NET and should be considered for NET risk prediction. In another retrospective studies, it was found that NSCLC patients with RB1/TP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1/TP53 inactivation mutations (43 times higher than those without mutations). Therefore, the subgroup of NSCLC patients with tumor suppressor gene RB1/TP53 dual inactivation might have elevated risk for NET.In this study, the investigators proposed to prospectively follow up NSCLC patients with dual RB1/TP53 inactivation (approximately 5% of the total NSCLC). Through prospective and systematic collection of baseline pathological information, clinical treatment process, and imaging data, and as much as possible, repeat pathological biopsies will be performed during disease progression."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC",
"nctId": "NCT06369181",
"orgStudyIdInfo": {
"id": "NET 2020",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "neuroendocrine transformation rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "auricular acupuncture"
}
]
},
"conditionsModule": {
"conditions": [
"Hot Flashes"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "With this clinical trial we investigate whether auricular acupuncture during adjuvant endocrine therapy has an improving effect on hot flashes, which are often perceived as psychologically and physically stressful in self-assessment of women with breast cancer.Empirical studies indicate that body acupuncture has positive effects on hot flashes. As auricular acupuncture offers a number of advantages over body acupuncture, a three-armed randomised controlled research design is being used to investigate whether hot flashes caused by endocrine therapy are also reduced by ear acupuncture. Balanced ear acupuncture will be compared with NADA ear acupuncture in terms of efficacy and effectiveness. In addition, the effects of the two forms of therapy on the patients' individual quality of life, fatigue, stress perception and sleep quality will be analysed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized controlled trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 99,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OhrHit",
"briefTitle": "Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy",
"nctId": "NCT06369168",
"orgStudyIdInfo": {
"id": "Kliniken Essen-Mitte",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "subscale somato-vegetative symptoms of the Menopause Rating Scale (MRS)"
}
],
"secondaryOutcomes": [
{
"measure": "Menopause Rating Scale (MRS) total score"
},
{
"measure": "Psychological symptoms and urogenital symptoms subscales of the MRS"
},
{
"measure": "functional assessment of cancer therapy - breast (FACT-B)"
},
{
"measure": "perceived stress questionnaire (PSQ)"
},
{
"measure": "insomnia severity index (ISI)"
},
{
"measure": "big five inventory (BFI)"
},
{
"measure": "Expected effect of the respective intervention on a 100mm visual analogue scale"
},
{
"measure": "intensity and degree of impairment due to hot flashes on a 100mm visual analogue scale"
},
{
"measure": "adverse events (AEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Karl and Veronica Carstens Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kliniken Essen-Mitte"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Azenosertib"
}
]
},
"conditionsModule": {
"conditions": [
"Uterine Serous Carcinoma",
"Uterine Carcinoma",
"Uterine Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Joyce Liu, MD, MPH",
"phone": "617-632-5269",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joyce Liu, MD, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Brigham and Women's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Joyce Liu, MD, MPH",
"phone": "617-632-5269",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joyce Liu, MD, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Dana-Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
}
]
},
"descriptionModule": {
"briefSummary": "This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma.The name of the study drug involved in this study is:-Azenosertib (a type of Wee1 inhibitor)"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Azenosertib in Uterine Serous Carcinoma: Biomarker Study",
"nctId": "NCT06369155",
"orgStudyIdInfo": {
"id": "24-061",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage Change in Replication Fork Speed in Overall Response"
},
{
"measure": "Percentage Change in Replication Fork Speed in 6 Month Progression Free Survival (PFS6)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Response Rate (ORR)"
},
{
"measure": "6-month Progression-Free Survival (PFS6)"
},
{
"measure": "Clinical Benefit Rate (CBR)"
},
{
"measure": "Median Duration of Overall Response (DOR)"
},
{
"measure": "Median Progression-Free Survival (PFS)"
},
{
"measure": "Grade 3-5 Treatment-related Toxicity Rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
},
{
"name": "Zentalis"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Joyce Liu, MD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intravascular lithotripsy (IVL)"
},
{
"name": "Standard non-IVL methods"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Munich",
"contacts": [
{
"email": "[email protected]",
"name": "Salvatore Cassese, MD, PHD",
"phone": "0049891218",
"phoneExt": "2764",
"role": "CONTACT"
},
{
"email": null,
"name": "Salvatore Cassese, MD, PDH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Deutsches Herzzentrum München",
"geoPoint": {
"lat": 48.13743,
"lon": 11.57549
},
"state": "Bavaria",
"status": null,
"zip": "80636"
}
]
},
"descriptionModule": {
"briefSummary": "The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The study participant as well as the follow-up physicians and site personal are blinded.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 666,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ISAR-WAVE",
"briefTitle": "Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy",
"nctId": "NCT06369142",
"orgStudyIdInfo": {
"id": "GE IDE No. L00123",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Combined endpoint of major cardiac and cerebrovascular events"
}
],
"secondaryOutcomes": [
{
"measure": "Mortality"
},
{
"measure": "Cardiac mortality"
},
{
"measure": "Non-fatal myocardial infarction"
},
{
"measure": "Non-fatal stroke"
},
{
"measure": "Clinically indicated target vessel revascularization"
},
{
"measure": "Definite stent thrombosis"
},
{
"measure": "Clinically indicated non-target vessel revascularization"
},
{
"measure": "Hospitalization due to acute coronary syndrome"
},
{
"measure": "Symptoms of coronary heart disease (CHD): physical health status"
},
{
"measure": "Symptoms of CHD: mental health status"
},
{
"measure": "Bleeding during index hospitalization or ≤30 days (BARC 3-5)"
},
{
"measure": "Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure)"
},
{
"measure": "Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Gemeinsamer Bundesaussschuss"
},
{
"name": "EvidentIQ Germany GmbH"
},
{
"name": "Monitoring Services GmbH"
},
{
"name": "Institute of AI and Informatics in Medicine Technical University of Munich"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Deutsches Herzzentrum Muenchen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Orbital floor reconstruction with Patient Specific Zirconia Implant"
},
{
"name": "Orbital floor reconstruction with Patient Specific Titanium Implant"
}
]
},
"conditionsModule": {
"conditions": [
"Blow-Out Fractures",
"Orbital Fractures",
"Orbital Floor Fracture",
"Orbital Trauma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "OLA A. ELMORSY, PHD",
"phone": "00201141234877",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Cairo University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": "11511"
}
]
},
"descriptionModule": {
"briefSummary": "Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures ."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A randomized clinical trial.* Parallel group study.* A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University .* Equal randomization : participants with equal probabilities for intervention.* Positive controlled : Both groups receiving treatment.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction",
"nctId": "NCT06369129",
"orgStudyIdInfo": {
"id": "CEBD-CU-2024-06-16",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Orbital Volume"
}
],
"secondaryOutcomes": [
{
"measure": "Accuracy of the patient specific implant in the orbital floor reconstruction"
},
{
"measure": "Cost effectiveness"
},
{
"measure": "Patient satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "INSTI HCV Self Test"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatitis C"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Parktown",
"contacts": [
{
"email": "[email protected]",
"name": "Vanessa Tiyamike Msolomba",
"phone": "+27 74 830 9063",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "South Africa",
"facility": "Ezintsha, a division of Wits Health Consortium (Pty) Ltd",
"geoPoint": {
"lat": -26.18205,
"lon": 28.02671
},
"state": null,
"status": "RECRUITING",
"zip": "2193"
}
]
},
"descriptionModule": {
"briefSummary": "This is a controlled study intended to evaluate the usability, label comprehension and performance of the INSTI® HCV Self Test in the hands of untrained lay users using fingerstick blood, with instructions for use specifically designed for a lay person who has not used any hepatitis C rapid self test prior to the study and to assess \"lay\" users ability to comprehend key concepts and information provided on the outside of the pouch and in the accompanying Instructions for Use. Comprehension will be assessed without product familiarization (demonstration/training) by a healthcare professional."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Participants are recruited and enrolled to conduct INSTI HCV Self Test and then participate in the usability portion of the study.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users",
"nctId": "NCT06369116",
"orgStudyIdInfo": {
"id": "CLS-017B",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "HSTAR Programme",
"id": "HSTAR012",
"link": null,
"type": "OTHER"
},
{
"domain": "Ezintsha",
"id": "WRHI071",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical sensitivity and specificity of INSTI HCV Self Test"
}
],
"secondaryOutcomes": [
{
"measure": "To assess the usability and label comprehension of the INSTI HCV Self Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "bioLytical Laboratories"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-11-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexmedetomidine"
},
{
"name": "Propofol"
}
]
},
"conditionsModule": {
"conditions": [
"Patient",
"Satisfaction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Banī Suwayf",
"contacts": [
{
"email": "[email protected]",
"name": "Dina M Fakhry, MD",
"phone": "0201289998680",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Dina M Fakhry, MD",
"phone": "+201289998680",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Beni Suef University Hospital",
"geoPoint": {
"lat": 29.07441,
"lon": 31.09785
},
"state": "Beni Suef",
"status": "RECRUITING",
"zip": "62814"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 420,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Sedative Effects of Dexmedetomidine VS Propofol During Peribulbar Anesthesia in Patients Undergoing Vitrectomy Surgery",
"nctId": "NCT06369103",
"orgStudyIdInfo": {
"id": "FMBSUREC/03032024/Fakhry",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient satisfaction"
}
],
"secondaryOutcomes": [
{
"measure": "Visual analogue scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Beni-Suef University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Electrical impedance tomography (EIT)"
}
]
},
"conditionsModule": {
"conditions": [
"Effect of Breast Tissue on EIT Lung Monitoring"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kladno",
"contacts": null,
"country": "Czechia",
"facility": "Faculty of Biomedical Engineering, Czech Technical University in Prague",
"geoPoint": {
"lat": 50.14734,
"lon": 14.10285
},
"state": null,
"status": null,
"zip": "27201"
}
]
},
"descriptionModule": {
"briefSummary": "Twenty-two healthy female volunteers were monitored using electrical impedance tomogprahy (EIT) in two different situations. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue. The EIT measurement was performed with adjunct spirometric measurement. The changes of regional ventilation related to the breast tissue and the size of breast tissue were evaluated."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Monitoring of 22 subjects, each subject was measured twice with electrode belt in two different positions.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Breast Size on the Electrical Impedance Tomography Measurement",
"nctId": "NCT06369090",
"orgStudyIdInfo": {
"id": "JP/1/2013",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Regional ventilation changes possibly caused by the breast tissue"
}
],
"secondaryOutcomes": [
{
"measure": "Female subjects enrollment in EIT studies and clinical applications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Czech Technical University in Prague"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2014-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2014-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "dorzolamide/timolol"
}
]
},
"conditionsModule": {
"conditions": [
"Glaucoma, Open-Angle",
"Glaucoma; Drugs"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Norwalk",
"contacts": [
{
"email": "[email protected]",
"name": "Peter E Libre, MD",
"phone": "203-853-2020",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Faria Mahjabin, BA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "CT Glaucoma Associates",
"geoPoint": {
"lat": 41.1176,
"lon": -73.4079
},
"state": "Connecticut",
"status": "RECRUITING",
"zip": "06851"
}
]
},
"descriptionModule": {
"briefSummary": "IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later.At each study visit, dry eye signs will be assessed and brief dry eye survey will be administered.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure?",
"nctId": "NCT06369077",
"orgStudyIdInfo": {
"id": "CTGlaucoma1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "intraocular pressure"
}
],
"secondaryOutcomes": [
{
"measure": "dry eye"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "CT Glaucoma Associates"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CVVHD Dialysis parameters"
},
{
"name": "CVVHDF Dialysis parameters"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Kidney Injury",
"Continuous Renal Replacement Therapy",
"Intensive Care Unit"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nîmes",
"contacts": [
{
"email": "[email protected]",
"name": "Claire Roger, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Claire Roger, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Aurèle Buzancais, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sylvain Garnier, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU de Nimes",
"geoPoint": {
"lat": 43.83333,
"lon": 4.35
},
"state": null,
"status": null,
"zip": "30029"
}
]
},
"descriptionModule": {
"briefSummary": "In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CompEER",
"briefTitle": "Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient",
"nctId": "NCT06369064",
"orgStudyIdInfo": {
"id": "2023A02707-38",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "urea reduction rate (URR)"
}
],
"secondaryOutcomes": [
{
"measure": "Creatinine clearance at H24"
},
{
"measure": "Urea clearance at H24"
},
{
"measure": "Urea clearance at H48"
},
{
"measure": "ICU Mortality"
},
{
"measure": "Mortality at Day 28"
},
{
"measure": "Organ failure-free days at Day 28"
},
{
"measure": "Hypokalemia at Day 28"
},
{
"measure": "Hypophosphatemia at Day 28"
},
{
"measure": "Hypomagnesemia at Day 28"
},
{
"measure": "Hyperkalemia at Day 28"
},
{
"measure": "Medical Cost"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Nīmes"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Self-employment support intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Suzanne Lo",
"phone": "85239434485",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Non-government organisations",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This project will investigate the effects of an 8-week theory-driven online/hybrid Self-employment Skill Building Intervention on the rate of self-employment, self-efficacy, life satisfaction, and psychosocial outcomes among working-age stroke survivors."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 156,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Supporting Self-employment in Young Adults With Stroke",
"nctId": "NCT06369051",
"orgStudyIdInfo": {
"id": "YSEmploy",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Self-employment rate"
}
],
"secondaryOutcomes": [
{
"measure": "Self-efficacy"
},
{
"measure": "Life satisfaction"
},
{
"measure": "Emotional well-being"
},
{
"measure": "Community reintegration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chinese University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "observation of level of dental anxiety in children"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Anxiety"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim in this study is to compare the results of anxiety measurement of the child using the CD:H scale with the long-used Face,Legs,Activity,Cry and Consolability scale (FLACC scale) and pulse oximeter reading, to see if the drawing alone can be a reliable tool to predict the child's behaviour before the dental procedure."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 138,
"type": "ESTIMATED"
},
"phases": null,
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},
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"maximumAge": "12 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Children's Drawing as a Projective Tool to Assess Dental Anxiety",
"nctId": "NCT06369038",
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"id": "CUP3222024",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "FLAAC behavioral scale"
}
],
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},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
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"completionDateStruct": {
"date": "2025-12-30"
},
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"date": "2024-04-16"
},
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"date": "2024-12-30"
},
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"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interaction Competencies with Children"
}
]
},
"conditionsModule": {
"conditions": [
"Violence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Daressalam",
"contacts": [
{
"email": null,
"name": "Mabula Nkuba, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Eliud Kabelege",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Tanzania",
"facility": "Daressalaam University College of Education",
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"lat": -6.82349,
"lon": 39.26951
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "More than 1.7 billion children worldwide experience violence in their upbringing. Prevalence rates are particularly high in Africa. Toxic stress associated with violence impacts the developing brain. This affects behavioral, social, and emotional functioning of children. The present project will test an intervention that simultaneously aims at reducing violence against children at home and at school. Within the project, (1) the feasibility, acceptability, and cost-effectiveness of the Intervention and (2) the initial effectiveness of reducing parental and teacher violence will be tested. To this end, a mixed-methods two-arm school-based pilot cluster-randomized controlled trial (CRCT) in Tanzania will be conducted.One unique and novel aspect of this project is to test a school-based intervention approach that targets both teachers and parents. A school-based approach including both teachers and parents has the following key advantages: (1) parents of different social, economic, and educational backgrounds can be motivated to participate and (2) using the existing infrastructure of schools reduces costs and will later improve the scalability of the program. The project is bringing together the global health, development economy, and psychological perspectives to promote our collaboration within the German global health community and with research and policy partners in Tanzania."
},
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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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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PreVio",
"briefTitle": "Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz)",
"nctId": "NCT06369025",
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"id": "PreVio",
"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "Reduction of children's perceived stress"
},
{
"measure": "Reduction of parents' and teachers' perceived stress"
},
{
"measure": "Improvement of teachers' decision making"
},
{
"measure": "Improvement of teachers' self-efficacy"
}
],
"primaryOutcomes": [
{
"measure": "Reduction of children's exposure to emotional and physical violence by parents and teachers"
},
{
"measure": "Reduction of parents' or teachers' use of emotional and physical violence"
}
],
"secondaryOutcomes": [
{
"measure": "Change of parents' and teachers' attitudes towards emotional and physical violence"
},
{
"measure": "Improvement of children's mental health"
},
{
"measure": "Increase of children's quality of life"
},
{
"measure": "Improvement of school climate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Technical University of Munich"
},
{
"name": "Dar es Salaam University College of Edcuation"
},
{
"name": "Muhimbili University of Health and Allied Sciences"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Bielefeld University"
}
},
"statusModule": {
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"date": "2025-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
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"date": "2025-02-28"
},
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"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mefenamic acid 500 mg"
}
]
},
"conditionsModule": {
"conditions": [
"Abnormal Uterine Bleeding"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Rania Gamal Anwar, M.D",
"phone": "+201283262383",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Ain Shams University Hospitals",
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"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Abnormal uterine bleeding \"AUB\" describes all abnormal forms of menstrual bleeding which may result from several causes including anovulation, problems related to pregnancy, infections, vaginal and cervical abnormalities, uterine pathologies including benign and malignant tumors, coagulopathies, endocrine disorders, trauma, foreign bodies, systemic diseases and iatrogenic causes. AUB may be clinically presented by menorrhagia, metrorrhagia or menometrorrhagia. It's the most common complaint for the reproductive age females and accounts for 33% of female patients referred to gynecologists"
},
"designModule": {
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},
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},
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},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "15 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Management of Abnormal Uterine Bleeding",
"nctId": "NCT06369012",
"orgStudyIdInfo": {
"id": "Rania Gamal",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bleeding Control"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Egymedicalpedia"
}
},
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"date": "2024-09-30"
},
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"date": "2024-04-16"
},
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"primaryCompletionDateStruct": {
"date": "2024-09-01"
},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "EEG"
}
]
},
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"conditions": [
"Stress Disorders, Post-Traumatic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": null,
"country": "Italy",
"facility": "Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico",
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"lon": 9.18951
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"state": null,
"status": null,
"zip": "20122"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "study of brain EEG activity",
"maskingInfo": {
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},
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},
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"count": 40,
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},
"phases": [
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],
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EEGCOV",
"briefTitle": "Neurophysiological and Neuropsychological Evalution in Healthcare Workers",
"nctId": "NCT06368999",
"orgStudyIdInfo": {
"id": "EEGCOV",
"link": null,
"type": null
},
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},
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{
"measure": "EEG activity"
}
],
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},
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},
"statusModule": {
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"date": "2021-01-09"
},
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"date": "2024-04-16"
},
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"primaryCompletionDateStruct": {
"date": "2020-12-21"
},
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"startDateStruct": {
"date": "2020-05-27"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VH4011499"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499."
},
"designModule": {
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants",
"nctId": "NCT06368986",
"orgStudyIdInfo": {
"id": "222420",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499"
},
{
"measure": "Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4011499"
},
{
"measure": "Maximum observed plasma drug concentration (Cmax) of VH4011499"
},
{
"measure": "Time to maximum observed plasma concentration (Tmax) of VH4011499"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with AEs (Adverse Events), by severity"
},
{
"measure": "Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters"
},
{
"measure": "Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter)"
},
{
"measure": "Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter)"
}
]
},
"sponsorCollaboratorsModule": {
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"class": "INDUSTRY",
"name": "ViiV Healthcare"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-06-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
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"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Benha University Hospital",
"geoPoint": {
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"lon": 31.24967
},
"state": null,
"status": null,
"zip": "13511"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications."
},
"designModule": {
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},
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"count": 315,
"type": "ACTUAL"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit",
"nctId": "NCT06368973",
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"id": "RC16-4-2023",
"link": null,
"type": null
},
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},
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"measure": "Adverse events associated with mechanical ventilation"
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],
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},
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},
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},
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},
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"date": "2023-12-01"
},
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"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Radiotherapy"
},
{
"name": "BM201 injection"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Tumors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": "[email protected]",
"name": "Juan L GCP Director",
"phone": "800-555-5555",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Baorui L Chief Physician",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "210008"
}
]
},
"descriptionModule": {
"briefSummary": "This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment."
},
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},
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},
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "BM201-1001",
"briefTitle": "BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors",
"nctId": "NCT06368960",
"orgStudyIdInfo": {
"id": "BM201-1001",
"link": null,
"type": null
},
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{
"domain": "National Medical Products Administration",
"id": "CTR20223162",
"link": null,
"type": "REGISTRY"
}
]
},
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"primaryOutcomes": [
{
"measure": "DLT and MTD"
},
{
"measure": "Pharmacokinetic (PK) parameters"
},
{
"measure": "Number of patients with adverse events (AEs)"
}
],
"secondaryOutcomes": [
{
"measure": "ORR"
},
{
"measure": "Peripheral blood cytokine profiling in study participants."
},
{
"measure": "The variation in peripheral blood tumor biomarker concentrations."
},
{
"measure": "Other exploring outcomes"
}
]
},
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"class": "INDUSTRY",
"name": "InnoBM Pharmaceuticals Co., Ltd."
}
},
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"date": "2024-12-31"
},
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"date": "2024-04-16"
},
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"date": "2024-12-31"
},
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"startDateStruct": {
"date": "2022-11-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Therapeutic Play"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erzurum",
"contacts": [
{
"email": "[email protected]",
"name": "ARZU SARIALİOĞLU, PHD",
"phone": "04422315795",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ataturk University Nursing of Faculty",
"geoPoint": {
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"lon": 41.27694
},
"state": null,
"status": "RECRUITING",
"zip": "25240"
}
]
},
"descriptionModule": {
"briefSummary": "The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment."
},
"designModule": {
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"interventionModelDescription": null,
"maskingInfo": {
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},
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},
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},
"phases": [
"NA"
],
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},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "10 Years",
"sex": "ALL",
"stdAges": [
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"ADULT"
]
},
"identificationModule": {
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"briefTitle": "Therapeutic Play on Pain Tolerance and Emotion Regulation in Children",
"nctId": "NCT06368947",
"orgStudyIdInfo": {
"id": "B.30.2.ATA.0.01.00/172",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
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"measure": "Pain Tolerance Scale for Children with Cancer"
},
{
"measure": "Emotion Regulation Scale for Children and Adolescents"
}
],
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},
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"class": "OTHER",
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}
},
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"date": "2026-12-29"
},
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"date": "2024-04-17"
},
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"date": "2024-12-29"
},
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"startDateStruct": {
"date": "2024-03-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "sub-lobectomy"
},
{
"name": "imaging total resection"
}
]
},
"conditionsModule": {
"conditions": [
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"Glioblastoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Hushan Hospital, Fudan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200040"
}
]
},
"descriptionModule": {
"briefSummary": "Glioblastoma is recognized as the most common and aggressive form of primary malignant brain tumor, with treatment options that are limited and prognosis that is extremely poor, showing median progression-free survival of 12 months and median overall survival of less than 18 months. Surgical resection plays a critical role in the treatment, with the extent of resection significantly impacting patient outcomes. Historical approaches to surgical resection have evolved, moving from radical strategies to more conservative ones that aim to preserve normal brain function while removing the tumor as completely as possible. Recent studies have suggested that increasing the extent of surgical resection, particularly along the T2 FLAIR border rather than the traditional T1-enhanced border, can significantly improve patient prognosis. There is, however, a lack of consensus on the optimal surgical approach, and the heterogeneity of tumors presents challenges in standardizing surgical strategies. Extended resection has been shown to prolong survival, and novel intraoperative molecular diagnostics have emerged to improve accuracy in tumor classification and prognosis. Building on these advancements, a multicenter, prospective, randomized controlled trial is proposed to evaluate the efficacy of sub-lobectomy in treating IDH wild-type/TERTp-mutant glioblastoma, aiming to improve evidence levels and establish standardized surgical practices for this devastating disease."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Type of study: randomized parallel controlled, open-label, multicenter clinical trial.Interventions: the intervention group was to receive frontal, temporal, parietal, and occipital sub-lobotomies that met anatomical criteria, and the control group was to receive imaging total resection (T1-enhanced borders) that met the Response Assessment in Neuro-Oncology (RANO) criteria.Randomization The control group and intervention group were equal in size. Following intraoperative pathological diagnosis, participants were randomly assigned using a centralized randomization system known as the Interactive Web Response System (IWRS). Stratification factors included preoperative age brackets of \\[18-65\\] and (65-80), gender (male or female), and tumor site in the frontal, temporal, parietal, and occipital lobes.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "This study employed a single-blind approach whereby the participants were unaware of the kind of surgical resection they were receiving.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 326,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma",
"nctId": "NCT06368934",
"orgStudyIdInfo": {
"id": "KY2024-011",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Postoperative quality of life"
},
{
"measure": "Adverse effects"
},
{
"measure": "Cognitive function"
},
{
"measure": "Language function"
},
{
"measure": "Limb muscle strength"
}
],
"primaryOutcomes": [
{
"measure": "Progression-free Survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Huashan Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VRT106"
}
]
},
"conditionsModule": {
"conditions": [
"Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Hongyun Zhao",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Sun Yat-sen University Cancer Center",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors",
"nctId": "NCT06368921",
"orgStudyIdInfo": {
"id": "VRT106-C01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106."
},
{
"measure": "Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels."
}
],
"secondaryOutcomes": [
{
"measure": "Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106."
},
{
"measure": "Assess the immunogenicity of intratumoral injection of VRT106."
},
{
"measure": "Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators."
},
{
"measure": "Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Guangzhou Virotech Pharmaceutical Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcutaneous Functional Magnetic Muscle Stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Critical Illness Myopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Celje",
"contacts": null,
"country": "Slovenia",
"facility": "General Hospital Celje",
"geoPoint": {
"lat": 46.23092,
"lon": 15.26044
},
"state": null,
"status": "RECRUITING",
"zip": "300"
}
]
},
"descriptionModule": {
"briefSummary": "ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The myopathy causes persistent functional impairment, endangering patients long after hospital discharge.Magnetic stimulation prevents inactivation atrophy of skeletal muscles, as demonstrated in the mobilized limb of rats. Transcutaneous magnetic stimulation of the quadriceps via the femoral nerve is a safe and painless method even when applied to humans.In patients with chronic obstructive pulmonary disease (COPD), quadriceps magnetic stimulation increased spontaneous contraction force compared to the control group and improved quality of life. Patients with COPD tolerate quadriceps magnetic stimulation well, as it does not affect oxidative stress in muscles but does increase the size of slow-twitch muscle fibers.In intensive care medicine, magnetic stimulation has been primarily used for diagnostic purposes in assessing diaphragm function, peripheral muscle strength assessment, and transcranial electrical stimulation as a diagnostic tool and therapeutic stimulation of brain cells. With the development of modern transcutaneous magnetic stimulators, the possibility arises for their use in intensive care medicine for therapeutic purposes such as preventing critical illness myopathy.To date, no research has been conducted on the use and effectiveness of magnetic stimulation of peripheral muscles in critically ill individuals.The aim of the study is to investigate the effect of Functional Muscle Magnetic Stimulation (FMS) on the development of ICU-AW."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "One of legs is randomised to be stimulated by trans-cutaneous functional magnetic stimulation (Arm 1), the other leg is control (Arm 2)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FMS_ICU",
"briefTitle": "Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill",
"nctId": "NCT06368908",
"orgStudyIdInfo": {
"id": "6I/2023/3",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Measurement of Thickness of Thigh Muscles"
}
],
"secondaryOutcomes": [
{
"measure": "Measurement of Thigh Circumference"
},
{
"measure": "Assessment of Muscle Strength and Communication Ability"
},
{
"measure": "Body composition measurement by bioimpedance- Extracellular water"
},
{
"measure": "Body composition measurement by bioimpedance- Intracellular water"
},
{
"measure": "Body composition measurement by bioimpedance- skeletal muscle mass"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "General and Teaching Hospital Celje"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fecal microbiota transplantation delivery through colonoscopy"
},
{
"name": "Fecal microbiota transplantation delivery through oral capsules"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatic Encephalopathy",
"Dysbiosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": [
{
"email": "[email protected]",
"name": "Francesca Ponziani, MD",
"phone": "+390630156018",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Agostino Gemelli IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "RECRUITING",
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.The aims of the study are:To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment",
"nctId": "NCT06368895",
"orgStudyIdInfo": {
"id": "2188",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of safety of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy"
},
{
"measure": "Evaluation of efficacy of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of changes in the gut microbiota composition following the fecal microbiota transplantation"
},
{
"measure": "Evaluation of changes in the systemic inflammatory following the fecal microbiota transplantation"
},
{
"measure": "Evaluation of changes in the intestinal inflammatory following the fecal microbiota transplantation"
},
{
"measure": "Comparison between protein metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation"
},
{
"measure": "Comparison between lipid metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation"
},
{
"measure": "Comparison between carbohydrates metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-04-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Peg-Interferon α"
}
]
},
"conditionsModule": {
"conditions": [
"Nonalcoholic Fatty Liver Disease",
"Chronic Hepatitis b"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ningbo",
"contacts": [
{
"email": null,
"name": "Hongshan Li",
"phone": "13738865021",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Ningbo No.2 Hospital",
"geoPoint": {
"lat": 29.87819,
"lon": 121.54945
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Rui'an",
"contacts": [
{
"email": null,
"name": "Liang Hong",
"phone": "13958805550",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Ruian People's Hospital",
"geoPoint": null,
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Wenzhou",
"contacts": [
{
"email": null,
"name": "Chenwei Pan",
"phone": "13587655994",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Wenzhou Medical University",
"geoPoint": {
"lat": 27.99942,
"lon": 120.66682
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Wenzhou",
"contacts": [
{
"email": null,
"name": "Ran Ding",
"phone": "18057788513",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Wenzhou People's Hospital",
"geoPoint": {
"lat": 27.99942,
"lon": 120.66682
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Yueqing",
"contacts": [
{
"email": null,
"name": "Hui Zhao",
"phone": "13968713322",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Yueqing People's Hospital",
"geoPoint": null,
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.The security assessment includes adverse events, vital signs, and imaging."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）",
"nctId": "NCT06368882",
"orgStudyIdInfo": {
"id": "Yongping _Chen",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "HBsAg clearance"
}
],
"secondaryOutcomes": [
{
"measure": "HBsAg clearance at 96 weeks"
},
{
"measure": "Cumulative HBsAg clearance rate"
},
{
"measure": "Liver Function Tests"
},
{
"measure": "The incidence of liver cirrhosis and liver cancer"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Affiliated Hospital of Wenzhou Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Livento press veneers luted with dual cured resin cement"
},
{
"name": "Livento press veneers luted with light cured resin cement"
},
{
"name": "Celtra duo veneers luted with dual cured resin cement"
},
{
"name": "Celtra duo veneers luted with light cured resin cement"
}
]
},
"conditionsModule": {
"conditions": [
"Color; Change Teeth, Posteruptive"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Alexandria",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Dentistry, Alexandria University",
"geoPoint": {
"lat": 31.21564,
"lon": 29.95527
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers",
"nctId": "NCT06368869",
"orgStudyIdInfo": {
"id": "#1/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Color stability assessment"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "amr elshimy"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mupirocin (50 mg)"
},
{
"name": "Mupirocin (500 mg)"
},
{
"name": "blood samples after Single dose part"
},
{
"name": "nasal swab after Single dose part"
},
{
"name": "Collection of urine after Single dose part"
},
{
"name": "nasal swab during Repeated dose part"
},
{
"name": "Collection of urine during Repeated dose part"
},
{
"name": "nasal swab after Repeated dose part"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy",
"Staphylococcus Aureus Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint-Étienne",
"contacts": [
{
"email": null,
"name": "Kasra AZARNOUSH, MD PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Elisabeth BOTELHO-NEVERS, MD PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Anne CARRICAJO, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Philippe BERTHELOT, MD PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "CHU de SAINT-ETIENNE",
"geoPoint": {
"lat": 45.43389,
"lon": 4.39
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively.As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule.Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of \"a match head\", i.e. 50 mg, to 500 mg per nostril.Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application.It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Single-center, randomized, open-label pharmacokinetic study of mupirocin in 40 healthy subjects with 2 randomization :* first randomization - single dose part : 50mg or 500mg of mupirocin* wash-out: one month* second randomization - repeated doses part: 50mg mupirocin twice a day or 50 mg 3 times a day 500mg mupirocin twice a day or 500mg mupirocin 3 times a day",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MUPIPHARM",
"briefTitle": "Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study",
"nctId": "NCT06368856",
"orgStudyIdInfo": {
"id": "20CH024",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2020-006105-30",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "plasma concentrations of mupirocin"
},
{
"measure": "plasma concentrations of mupirocin"
},
{
"measure": "plasma concentrations of mupirocin"
},
{
"measure": "intranasal concentrations of mupirocin"
},
{
"measure": "intranasal concentrations of mupirocin"
},
{
"measure": "intranasal concentrations of mupirocin"
},
{
"measure": "intranasal concentrations of mupirocin"
},
{
"measure": "intranasal concentrations of mupirocin"
},
{
"measure": "intranasal concentrations of mupirocin"
}
],
"secondaryOutcomes": [
{
"measure": "presence of Staphylococcus aureus"
},
{
"measure": "presence of Staphylococcus aureus"
},
{
"measure": "presence of Staphylococcus aureus"
},
{
"measure": "presence of Staphylococcus aureus"
},
{
"measure": "urinary concentrations of monic acid"
},
{
"measure": "urinary concentrations of monic acid"
},
{
"measure": "urinary concentrations of monic acid"
},
{
"measure": "urinary concentrations of monic acid"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Saint Etienne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gargle with ketamine"
}
]
},
"conditionsModule": {
"conditions": [
"Postoperative Sore Throat"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baghdad",
"contacts": null,
"country": "Iraq",
"facility": "Ministry of Health",
"geoPoint": {
"lat": 33.34058,
"lon": 44.40088
},
"state": "Thi-Qar",
"status": null,
"zip": "00964"
}
]
},
"descriptionModule": {
"briefSummary": "Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat",
"nctId": "NCT06368843",
"orgStudyIdInfo": {
"id": "Ketamine for POST",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sore throat"
}
],
"secondaryOutcomes": [
{
"measure": "Cough"
},
{
"measure": "Hoarseness of voice"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Al-Azhar University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "3-ounce water swallow test"
},
{
"name": "Kayser-Jones Brief Oral Health Status Examination (BOHSE)"
},
{
"name": "Tongue pressure"
},
{
"name": "Test of Masticating and Swallowing Solids (TOMASS)"
},
{
"name": "Respiratory function tests"
}
]
},
"conditionsModule": {
"conditions": [
"Oropharyngeal Dysphagia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Oral and Swallowing Function in Older Adults",
"nctId": "NCT06368830",
"orgStudyIdInfo": {
"id": "2024-0337",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "UW Madison",
"id": "A534100",
"link": null,
"type": "OTHER"
},
{
"domain": "UW Madison",
"id": "Protocol Version 3/4/24",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Positive oropharyngeal dysphagia screen prevalence"
}
],
"secondaryOutcomes": [
{
"measure": "Mean brief oral health status examination (BOHSE) score"
},
{
"measure": "Oral dryness prevalence"
},
{
"measure": "Decreased tongue pressure prevalence"
},
{
"measure": "Decreased masticatory function prevalence"
},
{
"measure": "pH of saliva sample"
},
{
"measure": "Extensional viscosity of saliva sample"
},
{
"measure": "Salivary Substance P Concentration"
},
{
"measure": "Oral microbiome"
},
{
"measure": "Cell barrier function"
},
{
"measure": "Protein composition"
},
{
"measure": "Gene expression"
},
{
"measure": "Immunofluorescent staining"
},
{
"measure": "Immune cell trafficking"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Wisconsin, Madison"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "3-Dimensional Conformal Radiation Therapy"
},
{
"name": "Carboplatin"
},
{
"name": "Etoposide"
},
{
"name": "Intensity-Modulated Radiation Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Intracranial Germ Cell Tumor",
"Childhood Central Nervous System Germinoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "A phase II trial that is attempting to build upon the excellent results of ACNS1123 stratum 2 by reducing the Radiotherapy (RT) dose for patients in a Complete Response (CR) after chemotherapy. The trial will be testing a further reduction in the whole ventricular irradiation (WVI) dose. Additionally, patients with metastatic disease and basal ganglia and thalamic germinoma will be included, and they will be treated with craniospinal irradiation (CSI) or whole brain irradiation (WBI) respectively."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas",
"nctId": "NCT06368817",
"orgStudyIdInfo": {
"id": "ACNS2321",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "EFS distribution for eligible and evaluable patients in Stratum 4 and Stratum 5."
},
{
"measure": "EFS distribution for eligible and evaluable patients in Stratum 6 and Stratum 7."
},
{
"measure": "prospectively collect blood, cerebrospinal fluid, and tumor tissue at diagnosis and second-look surgery (if feasible) for future biology studies."
},
{
"measure": "Incidence of cerebral vascular events (stroke or transient ischemic attacks) of children and young adults with CNS germinoma through the COG Standardized assessment battery: Patient-reported outcome measures"
},
{
"measure": "Incidence of cerebral vascular events (stroke or transient ischemic attacks) of children and young adults with CNS germinoma through the COG Standardized assessment battery: Health-reported quality of life"
}
],
"primaryOutcomes": [
{
"measure": "Event-free survival (EFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Estimate the EFS distribution for eligible and evaluable patients in Stratum 2"
},
{
"measure": "To estimate the EFS distribution for eligible and evaluable patients in Stratum 3"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Determine the impact of tumor location, treatment regimen and treatment modalities on the long-term neuroendocrine function for patients with CNS germinomas."
},
{
"measure": "Prospectively evaluate processing speed of children and young adults with CNS germinoma through the Children's Oncology Group (COG) Standardized assessment battery."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "Children's Oncology Group"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2033-11-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2033-11-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Antibiotic monotherapy treatment and follow-up"
},
{
"name": "Antibiotic bitherapy treatment and follow-up"
}
]
},
"conditionsModule": {
"conditions": [
"Bronchiectasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amiens",
"contacts": [
{
"email": null,
"name": "Damien BASILLE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Amiens-Picardie",
"geoPoint": {
"lat": 49.9,
"lon": 2.3
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Bordeaux",
"contacts": [
{
"email": null,
"name": "Julie MACEY",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Haut Leveque, Bordeaux",
"geoPoint": {
"lat": 44.84044,
"lon": -0.5805
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Brest",
"contacts": [
{
"email": null,
"name": "Francis COUTURAUD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHRU Brest",
"geoPoint": {
"lat": 48.3903,
"lon": -4.48628
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Cergy-Pontoise",
"contacts": [
{
"email": null,
"name": "Bruno PHILIPPE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CH Pontoise",
"geoPoint": {
"lat": 49.03894,
"lon": 2.07805
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Créteil",
"contacts": [
{
"email": null,
"name": "Bernard MAITRE",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Centre hospitalier intercommunal de Créteil",
"geoPoint": {
"lat": 48.78333,
"lon": 2.46667
},
"state": null,
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"zip": "94010"
},
{
"city": "Créteil",
"contacts": [
{
"email": null,
"name": "Fréderic SCHLEMMER",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "APHP, Henri Mondor",
"geoPoint": {
"lat": 48.78333,
"lon": 2.46667
},
"state": null,
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},
{
"city": "Lyon",
"contacts": [
{
"email": null,
"name": "Gilles DEVOUASSOUX",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital de la Croix Rousse, HCL, Lyon",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
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},
{
"city": "Nantes",
"contacts": [
{
"email": null,
"name": "François-Xavier BLANC",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU Nantes",
"geoPoint": {
"lat": 47.21725,
"lon": -1.55336
},
"state": null,
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},
{
"city": "Nice",
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{
"email": null,
"name": "Sylvie LEROY",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU H. Pasteur, Nice",
"geoPoint": {
"lat": 43.70313,
"lon": 7.26608
},
"state": null,
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},
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Clémence MARTIN",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "APHP, Cochin",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Abdellatif TAZI",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "APHP, Saint Louis",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Nathalie ROZENSTAJ",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "APHP, Tenon",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Suresnes",
"contacts": [
{
"email": null,
"name": "Emilie CATHERINOT",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Foch, Suresnes",
"geoPoint": {
"lat": 48.87143,
"lon": 2.22929
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Toulouse",
"contacts": [
{
"email": null,
"name": "Marlene MURIS-ESPIN",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU H. Larrey, Toulouse",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Versailles",
"contacts": [
{
"email": null,
"name": "Charlotte COLIN",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CH Versailles",
"geoPoint": {
"lat": 48.8,
"lon": 2.13333
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Villefranche-sur-Saône",
"contacts": [
{
"email": null,
"name": "Sonia BLANDIN",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CH Villefranche s/Saône",
"geoPoint": {
"lat": 45.98333,
"lon": 4.71667
},
"state": null,
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"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 196,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ANTEIPA",
"briefTitle": "Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis",
"nctId": "NCT06368804",
"orgStudyIdInfo": {
"id": "ANTEIPA",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ID-RCB",
"id": "2022-A01575-38",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PA-eradication rate"
}
],
"secondaryOutcomes": [
{
"measure": "Time to first exacerbation"
},
{
"measure": "1 year-exacerbation rate"
},
{
"measure": "Quality-of-life using questionnaires"
},
{
"measure": "Quality-of-life using questionnaires"
},
{
"measure": "Treatment burden assessment using questionnaires"
},
{
"measure": "Quality-of-life using questionnaires"
},
{
"measure": "Detection of PA at 3-month and 1 year"
},
{
"measure": "Time to first PA-recurrence"
},
{
"measure": "Emergence of FQ-resistant strains of (PA or other bacteria)"
},
{
"measure": "Adverse event (AE) and serious AE at 12 months follow-up"
},
{
"measure": "Number of premature ending of one of the treatment in study due to any AE"
},
{
"measure": "Number of premature ending of one of the treatment in study"
},
{
"measure": "Proportion of non-administered doses of nebulized colistin"
},
{
"measure": "Cost and incremental cost effectiveness ratio at 1 year"
},
{
"measure": "Cost and incremental cost effectiveness ratio at 1 year"
},
{
"measure": "Cost and incremental cost effectiveness ratio at 1 year"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Assistance Publique - Hôpitaux de Paris"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Intercommunal Creteil"
}
},
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"completionDateStruct": {
"date": "2028-06-01"
},
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"date": "2024-04-18"
},
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"date": "2024-11-01"
},
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"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Box Breathing"
},
{
"name": "Breathing and Mindfulness Exercise"
},
{
"name": "Everyday life control"
}
]
},
"conditionsModule": {
"conditions": [
"Stress, Psychological",
"Burnout, Psychological",
"Subjective Stress",
"Occupational Stress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Berlin",
"contacts": [
{
"email": "[email protected]",
"name": "Valentin M Vetter, MD",
"phone": "0049 30 450 566 298",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Charité - Universitätsmedizin Berlin",
"geoPoint": {
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"lon": 13.41053
},
"state": null,
"status": "RECRUITING",
"zip": "10117"
}
]
},
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"briefSummary": "Medical practice often comes with high stress. Stress negatively affects our health and well-being and is linked to doctors making mistakes, some of which can be deadly.In this study, the effect of two quick stress-relief methods on daily stress levels is estimated. The two anti-stress exercises are designed to easily fit into daily routines:1. Box breathing (6 minutes) is known to reduce stress and lower the heart rate. It is used by the military and law enforcement, among others, to manage stress.2. Breathing and mindfulness exercise (10 minutes): This guided breathing and mindfulness intervention combines mindful breathing with simple body movements, developed to reduce the perceived level of stress.The effectiveness of these interventions is being examined in a series of N-of-1 trials. Each participant can choose between the interventions. After being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. Participants record their stress levels daily over the four-week study period. The intervention is only performed in the intervention phases. Upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. Each participant will receive an individual analysis based on the collected data. In addition, the investigators will estimate the effects at the population level.Three months after the study, a survey will be sent to the participants to check if the benefits have persisted."
},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ASIP",
"briefTitle": "Anti-Stress Intervention Among Physicians Study",
"nctId": "NCT06368791",
"orgStudyIdInfo": {
"id": "30001479",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Daily perceived stress"
},
{
"measure": "Daily expectation of perceived stress level on the following day"
}
],
"secondaryOutcomes": [
{
"measure": "Level of agreement between expected and actually perceived level of stress"
},
{
"measure": "Compliance with the study protocol: number of participant reported outcomes"
},
{
"measure": "Compliance with the study protocol: number of performed anti-stress interventions"
},
{
"measure": "Successful study completion"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Charite University, Berlin, Germany"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Verbal Advice"
},
{
"name": "Bathroom Scale"
},
{
"name": "Loadsol Biofeedback"
}
]
},
"conditionsModule": {
"conditions": [
"Physical Therapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salt Lake City",
"contacts": null,
"country": "United States",
"facility": "University of Utah Orthopaedic Center",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": null,
"zip": "84108"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to investigate the effectiveness of a biofeedback device (Loadsol) in training healthy subjects to comply with partial weightbearing, and to compare its outcomes with the standard of care training. Partial weightbearing is an essential component of rehabilitation and recovery for many orthopedic patients, yet it remains challenging for individuals to accurately gauge their weightbearing restrictions without proper guidance and feedback.The primary objective of the study is to determine whether the use of the biofeedback device (Loadsol) can reduce the time it takes for healthy subjects to learn and comply with partial weightbearing, compared to traditional training methods. The Loadsol device provides real-time auditory feedback on the individual's weightbearing status, potentially enhancing the learning process and adherence to weightbearing restrictions.Secondary objectives of the study include:Assessing the compliance of subjects with weightbearing restrictions in both the biofeedback and standard of care training groups, and comparing the results to identify any significant differences in adherence to the prescribed weightbearing limitations.Evaluating subject satisfaction with the training methods, as measured through questionnaires and the use of Patient-Reported Outcomes Measurement Information System (PROMIS) tools. This evaluation will help determine if the biofeedback device (Loadsol) leads to higher levels of satisfaction among subjects compared to the standard of care training.By examining these objectives, this study aims to provide valuable insights into the potential benefits of using a biofeedback device in partial weightbearing training, and to establish whether its implementation can lead to improved outcomes in learning, compliance, and overall patient satisfaction."
},
"designModule": {
"designInfo": {
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},
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"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Real-Time Biofeedback on Partial Weightbearing Training",
"nctId": "NCT06368778",
"orgStudyIdInfo": {
"id": "166591",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Average peak force (Newtons, (N))"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Utah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-13"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral Rehydration Solution (ORS)"
},
{
"name": "Water"
}
]
},
"conditionsModule": {
"conditions": [
"Dehydration"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a prospective, randomized, controlled, blinded, crossover, study to evaluate the effects of an oral hydration solution."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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},
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},
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"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
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"briefTitle": "Oral Rehydration Solution and Dehydration Recovery",
"nctId": "NCT06368765",
"orgStudyIdInfo": {
"id": "BL72",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Body Composition"
},
{
"measure": "Reaction Time"
},
{
"measure": "Handgrip Strength"
},
{
"measure": "Urine Volume"
},
{
"measure": "Hydration Status Saliva"
},
{
"measure": "Heart Rate"
},
{
"measure": "Blood Pressure"
},
{
"measure": "Thirst Sensation Scale"
},
{
"measure": "Gagge Thermal Scale"
},
{
"measure": "Urine Color"
},
{
"measure": "Palatability"
},
{
"measure": "Adverse Events"
}
],
"primaryOutcomes": [
{
"measure": "Plasma Volume"
}
],
"secondaryOutcomes": [
{
"measure": "Body Mass"
},
{
"measure": "Hydration Status Urine"
},
{
"measure": "Blood Biomarker - Plasma Osmolality"
},
{
"measure": "Blood Biomarker - Plasma Electrolyte Concentration"
},
{
"measure": "Blood Biomarker - Plasma Glucose Concentration"
},
{
"measure": "Body Temperature"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Abbott Nutrition"
}
},
"statusModule": {
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"date": "2024-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
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},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GIP[3-30]NH2"
},
{
"name": "Saline"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hellerup",
"contacts": null,
"country": "Denmark",
"facility": "Gentofte Hospital",
"geoPoint": {
"lat": 55.73204,
"lon": 12.57093
},
"state": null,
"status": null,
"zip": "2900"
}
]
},
"descriptionModule": {
"briefSummary": "This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP\\[3-30\\]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The trial is a randomized, double-blind, crossover study. We give intravenous infusion of GIP\\[3-30\\]NH2, and thus describe the effects of GIP by comparing with what happens during a saline infusion (placebo).",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The infusion is mixed by an external coordinator. Neither the investigator or the participants knows whether is the GIP\\[3-30\\]NH2 infusion or saline infusion that is being given. Which infusion that is given on each trial day is randomized for each participant.",
"whoMasked": [
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"INVESTIGATOR"
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},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
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},
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"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Role of Endogenous GIP in Glycosis Metabolism During Fasting",
"nctId": "NCT06368752",
"orgStudyIdInfo": {
"id": "H-22063621",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Plasma glucagon concentrations"
}
],
"secondaryOutcomes": [
{
"measure": "Plasma levels of C-peptide"
},
{
"measure": "Plasma levels of insulin"
},
{
"measure": "Resting metabolic rate"
},
{
"measure": "Activity in brown adipose tissue"
},
{
"measure": "Appetite"
},
{
"measure": "Blood pressure"
},
{
"measure": "Puls"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Frederikke Koefoed-Hansen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2023-12-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | {
"largeDocumentModule": {
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"label": "Study Protocol and Statistical Analysis Plan",
"size": 120286,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-04-11T04:12"
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} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nurture program"
},
{
"name": "Regular benefits"
}
]
},
"conditionsModule": {
"conditions": [
"Pregnancy Related",
"Financial Gift",
"Nutrition, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Corpus Christi",
"contacts": null,
"country": "United States",
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"status": null,
"zip": "78415"
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]
},
"descriptionModule": {
"briefSummary": "With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "From the eligible population, DHP randomly selected a subset of approximately 500 women during the pilot period, from which approximately 200 were in the program, the \"exposed group.\" The women who were covered during the same period but were not selected were not exposed to the program and will compose the \"comparison group.\"",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
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"minimumAge": "30 Years",
"sex": "FEMALE",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women",
"nctId": "NCT06368739",
"orgStudyIdInfo": {
"id": "STUDY00005622",
"link": null,
"type": null
},
"secondaryIdInfos": null
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"otherOutcomes": [
{
"measure": "Emergency Department visits"
},
{
"measure": "Cost (outpatient)"
},
{
"measure": "Cost (inpatient)"
},
{
"measure": "Cost (pharmacy/medication)"
},
{
"measure": "Cost (total)"
},
{
"measure": "Delivery mode (vaginal, C-section)"
},
{
"measure": "Birthweight"
}
],
"primaryOutcomes": [
{
"measure": "Composite outcome 1: Adverse health events during pregnancy"
},
{
"measure": "Composite outcome 2: Adverse health events at birth and newborn-related"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Driscoll Health Plan"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Texas at Austin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | {
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{
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"label": "Study Protocol and Statistical Analysis Plan",
"size": 630078,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-02-12T16:26"
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]
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} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "tDCS or Transcranial Direct Current Stimulation"
},
{
"name": "Risperidone"
}
]
},
"conditionsModule": {
"conditions": [
"Attention",
"Visual Perceptual Weakness",
"Social Behavior",
"Fluency Disorder",
"EEG With Periodic Abnormalities"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Liverpool",
"contacts": null,
"country": "United Kingdom",
"facility": "New Remedies Ltd",
"geoPoint": {
"lat": 53.41058,
"lon": -2.97794
},
"state": "Merseyside",
"status": null,
"zip": "L1 0AH"
}
]
},
"descriptionModule": {
"briefSummary": "Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two groups of childs: 90 childs receive tDCS treatment and 90 traditional treatments with Risperidone educational training, speech therapy and visual training.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation.",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"count": 180,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "tDCS&ASD",
"briefTitle": "Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders",
"nctId": "NCT06368726",
"orgStudyIdInfo": {
"id": "SFND04042024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "FFT"
},
{
"measure": "Power Density Spectrum Changes or PSD"
},
{
"measure": "ERP MMN changes"
},
{
"measure": "ERP MMN Changes"
}
],
"secondaryOutcomes": [
{
"measure": "Attention"
},
{
"measure": "Social Skills"
},
{
"measure": "Language"
},
{
"measure": "Visual Contact"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fundacion para la Salud Materno Infantil"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Spanish Foundation for Neurometrics Development"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-01"
},
"lastUpdatePostDateStruct": {
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},
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"date": "2025-05-01"
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"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Peritoneal Dialysis",
"Exercise",
"Gastrointestinal Function",
"Quality of Life",
"Chronic Kidney Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chengdu",
"contacts": [
{
"email": null,
"name": "Jin Chen, Doctor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": "RECRUITING",
"zip": "610000"
}
]
},
"descriptionModule": {
"briefSummary": "This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 132,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients",
"nctId": "NCT06368713",
"orgStudyIdInfo": {
"id": "PD-GIEX",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in GIQLI"
}
],
"secondaryOutcomes": [
{
"measure": "Change in GSRS"
},
{
"measure": "Change in PAC-SYM"
},
{
"measure": "Change in 6-MWT"
},
{
"measure": "Change in SGA"
},
{
"measure": "Change in measured Gastrointestinal Hormones"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sichuan Academy of Medical Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hyalex Knee Cartilage System"
}
]
},
"conditionsModule": {
"conditions": [
"Cartilage Injury",
"Cartilage Damage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Ava Neijna",
"phone": "917-260-3677",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Morgan Rizy",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sabrina Strickland, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Andreas Gomoll, M.D.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Hospital for Special Surgery",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10021"
},
{
"city": "Portland",
"contacts": [
{
"email": "[email protected]",
"name": "Jessica Ballin",
"phone": "503-418-9580",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dennis Crawford, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Oregon Health & Science University",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
},
"state": "Oregon",
"status": "RECRUITING",
"zip": "97239"
}
]
},
"descriptionModule": {
"briefSummary": "The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DEVICE_FEASIBILITY",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Hyalex Early Feasibility Study (EFS)",
"nctId": "NCT06368700",
"orgStudyIdInfo": {
"id": "CL-00001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Freedom from implant rejection and infection."
},
{
"measure": "Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hyalex Orthopaedics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Anorexia nervosa plus autism"
}
]
},
"conditionsModule": {
"conditions": [
"Anorexia Nervosa",
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In a pilot study, we will validate a so-called autism care location in an inpatient ward. The care location will be adapted for patients with anorexia nervosa (AN) and concurrent autism (AN+autism). In order to investigate the effect of a tailored care location for patients with AN + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. The overall aim is to improve treatment for this specific AN subgroup, that otherwise has a worse prognosis regarding AN recovery."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Pilot study. Ten consecutive patients with anorexia nervosa (AN) plus autism will be admitted to the autism care location at an inpatient ward for eating disorders. The planned period of care for each patient is 12 weeks. The patient will be assessed (including weight, height, self-report questionnaires and interviews) before admission, at discharge and 6 months later.",
"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": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TRANPAS",
"briefTitle": "TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum",
"nctId": "NCT06368687",
"orgStudyIdInfo": {
"id": "2023-06112-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "BMI change between baseline and discharge 12 weeks later"
}
],
"secondaryOutcomes": [
{
"measure": "Change of level of anxiety between baseline and discharge 12 weeks later"
},
{
"measure": "Change of Quality of life between baseline and discharge 12 weeks later"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Göteborg University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention group Case Manager (CM)"
},
{
"name": "Control Group"
}
]
},
"conditionsModule": {
"conditions": [
"Frailty",
"Dependence",
"Integrated Care"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward.This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need.The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Clinical control study",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "75 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bridging the Gap: Creating a Continuum of Care",
"nctId": "NCT06368674",
"orgStudyIdInfo": {
"id": "2023-00363",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dependency in Activities of Daily Living (ADL)"
}
],
"secondaryOutcomes": [
{
"measure": "Self-rated health"
},
{
"measure": "Life satisfaction"
},
{
"measure": "Satisfaction with quality of care"
},
{
"measure": "Health economics"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Vastra Gotaland Region"
},
{
"name": "Narhalsan Reasearch and Development primary care Region Vastra Gotaland"
},
{
"name": "Sahlgrenska University Hospital, Sweden"
},
{
"name": "Forte"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Göteborg University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Nutrition Related Neoplasm/Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Vigo",
"contacts": [
{
"email": "[email protected]",
"name": "Ciro Cabezas Checchi, MD",
"phone": "+34 986 82 11 00",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Ciro Cabezas Checchi",
"geoPoint": {
"lat": 42.23282,
"lon": -8.72264
},
"state": "Pontevedra",
"status": "RECRUITING",
"zip": "36206"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CROSSOVER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1)",
"nctId": "NCT06368661",
"orgStudyIdInfo": {
"id": "23.79 Colo-MAR 1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dietary habits registry from participants: the dietary intake"
},
{
"measure": "Biomarkers in colon mucosa, precancerous lesions and colorectal cancer"
},
{
"measure": "Gut microbiota profile"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "CEU San Pablo University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundación Vithas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Intracranial Pressure",
"Intracranial Pressure Changes",
"Traumatic Brain Injury",
"Intracerebral Hemorrhage",
"Encephalitis",
"Encephalopathy",
"Hydrocephalus",
"Stroke",
"Autoregulation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 581,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CoMind EFS",
"briefTitle": "CoMind Early Feasibility Study",
"nctId": "NCT06368648",
"orgStudyIdInfo": {
"id": "CP-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and ABP."
}
],
"primaryOutcomes": [
{
"measure": "A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP"
},
{
"measure": "Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP."
}
],
"secondaryOutcomes": [
{
"measure": "Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population."
},
{
"measure": "Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg)."
},
{
"measure": "Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform."
},
{
"measure": "Demonstration of an non-invasive ICP model that can predict trends in ICP"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Lindus Health"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "CoMind Technologies Limited"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Coronary angiography"
}
]
},
"conditionsModule": {
"conditions": [
"Microcirculation",
"Coronary Artery Disease",
"Cerebrovascular Circulation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Weijing Wang, PhD",
"phone": "+8601088326200",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100000"
}
]
},
"descriptionModule": {
"briefSummary": "Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds.Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown.The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CCMD",
"briefTitle": "The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study",
"nctId": "NCT06368635",
"orgStudyIdInfo": {
"id": "2022-GSP-QN-8",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MACE"
},
{
"measure": "MACE"
}
],
"secondaryOutcomes": [
{
"measure": "Cerebral microcirculation"
},
{
"measure": "Cerebral microcirculation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Chinese Academy of Medical Sciences, Fuwai Hospital"
}
],
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"name": "Weijing Wang"
}
},
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"date": "2025-03-31"
},
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},
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"date": "2024-12-31"
},
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"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Surpass Evolve Flow Diverter System"
}
]
},
"conditionsModule": {
"conditions": [
"Intracranial Aneurysm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Xuanwu Hospital Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
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"status": null,
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}
]
},
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},
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},
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},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evolve China PMCF Study",
"nctId": "NCT06368622",
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"id": "CDM10001814",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Neurological death or disabling stroke"
},
{
"measure": "100% occlusion without significant parent artery stenosis"
}
],
"secondaryOutcomes": [
{
"measure": "Procedure- and device-related serious adverse events"
},
{
"measure": "Key neurological events"
},
{
"measure": "Procedural success"
},
{
"measure": "Device success"
},
{
"measure": "Re-sheathing success"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Stryker (Beijing) Healthcare Products Co., Ltd"
}
],
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"class": "INDUSTRY",
"name": "Stryker Neurovascular"
}
},
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"date": "2031-08"
},
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},
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"date": "2027-11"
},
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"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IgG RDT"
},
{
"name": "IgG4 RDT"
}
]
},
"conditionsModule": {
"conditions": [
"Strongyloides Stercoralis Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Negrar",
"contacts": [
{
"email": "[email protected]",
"name": "Dora Buonfrate",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dora Buonfrate",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRCCS Sacro Cuore Don Calabria hospital",
"geoPoint": {
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"lon": 10.93899
},
"state": "Verona",
"status": null,
"zip": "37024"
}
]
},
"descriptionModule": {
"briefSummary": "Single center, no profit experimental study on sera available in the Tropica Biobank."
},
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},
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},
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},
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],
"studyType": "INTERVENTIONAL"
},
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"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROTOSS",
"briefTitle": "Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection",
"nctId": "NCT06368609",
"orgStudyIdInfo": {
"id": "2024-09",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "RDTs IgG results: positive or negative"
},
{
"measure": "RDTs IgG4 results: positive or negative"
}
],
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{
"measure": "Agreement between readers"
}
]
},
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}
},
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"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fusobacterium detection"
}
]
},
"conditionsModule": {
"conditions": [
"Endometriosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Negrar",
"contacts": [
{
"email": "[email protected]",
"name": "Marcello Ceccaroni, Doctor",
"phone": null,
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"role": "CONTACT"
},
{
"email": null,
"name": null,
"phone": "0456013111",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marcello Ceccaroni",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Dora Buonfrate",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRCCS Sacro Cuore Don Calabria di Negrar",
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},
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"status": null,
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}
]
},
"descriptionModule": {
"briefSummary": "This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation.A control group would however be recruited for secondary objective 1 and 2.The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice."
},
"designModule": {
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},
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},
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],
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},
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"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ENDS",
"briefTitle": "ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis",
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"id": "2024-04",
"link": null,
"type": null
},
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},
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{
"measure": "Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis"
}
],
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"measure": "Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis"
},
{
"measure": "Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled"
},
{
"measure": "Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis ."
},
{
"measure": "Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present"
},
{
"measure": "Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis"
},
{
"measure": "Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis"
}
]
},
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}
},
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},
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},
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"date": "2024-04"
},
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}
}
} | false | null |
{
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{
"name": "Interview"
}
]
},
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"conditions": [
"Well-Being, Psychological"
]
},
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{
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{
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"name": "Sabine Nabecker, MD",
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{
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},
{
"email": null,
"name": "Kristi Downey, MSc",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sunti Barahi, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ratesh Bassi, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Afsheen Nasir, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
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"facility": "Mount Sinai Hospital",
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},
"descriptionModule": {
"briefSummary": "During the process of labour and delivery, patients may experience a wide range of events in a short time frame. This study focuses on exploring these experiences and aims to incorporate the improvements from these experiences so that in future, the expectations of patients delivering can be met as much as possible. Since every patient and encounter is unique, they might have a variety of experiences, be it during the labour epidural placement or during the delivery of the baby. Our study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience and to then use this information to enhance the quality of future anesthesia care during labour and delivery.Patients who underwent labour and delivery and received labour epidural for pain management will be approached the day following the delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of the obstetricians, anesthesiologists, and nurses with the goals of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice, a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during labour and delivery."
},
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},
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},
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"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PAS-EDU-NLA",
"briefTitle": "The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia",
"nctId": "NCT06368583",
"orgStudyIdInfo": {
"id": "24-05",
"link": null,
"type": null
},
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},
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{
"measure": "Patient questionnaire"
},
{
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}
],
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},
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}
},
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},
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"date": "2024-04-23"
},
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},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interview"
}
]
},
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"conditions": [
"Well-Being, Psychological"
]
},
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"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Sabine Nabecker, MD",
"phone": "416-586-4800",
"phoneExt": "5270",
"role": "CONTACT"
},
{
"email": null,
"name": "Ron George, MD",
"phone": null,
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Kristi Downey, MSc",
"phone": null,
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Fernanda Septimio Lanza Oliveira, MD",
"phone": null,
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Lada Kordich, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Afsheen Nasir, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
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"facility": "Mount Sinai Hospital",
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},
"state": "Ontario",
"status": "RECRUITING",
"zip": "M5G1X5"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD.Patients who have undergone a routine CD will be approached the day following their delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study, which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of obstetricians, anesthesiologists and nurses with the goal of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during elective CD."
},
"designModule": {
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},
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},
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},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PAS-EDU-RCD",
"briefTitle": "The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery",
"nctId": "NCT06368570",
"orgStudyIdInfo": {
"id": "24-04",
"link": null,
"type": null
},
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},
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{
"measure": "Patient questionnaire"
},
{
"measure": "Patient interview"
}
],
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},
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"collaborators": null,
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"class": "OTHER",
"name": "Samuel Lunenfeld Research Institute, Mount Sinai Hospital"
}
},
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},
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"date": "2024-04-26"
},
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"date": "2024-12"
},
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"startDateStruct": {
"date": "2024-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CoolMinds: Internet-based cognitive behavioral therapy (iCBT)"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Odense",
"contacts": [
{
"email": "[email protected]",
"name": "Helene Skaarnes, MSc (psych))",
"phone": "+4529649702",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kim Mathiasen, Ph.d.",
"phone": "+4561677747",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Centre for Digital Psychiatry",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
},
"state": "Region Of Southern Denmark",
"status": "RECRUITING",
"zip": "5000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to theDiagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.2. What effect different degrees of therapist support have on the treatment.Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "The RCT is designed as a superiority RCT with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally upon completing session 8 in the program, participants will be randomized to receive or not receive a booster session 12 weeks after finishing the intervention with an allocation ratio of 1:1. The design of the randomized trial is thus factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). Data will be collected with parent and adolescent questionnaires at five time points: pre-treatment, post-treatment and at follow-ups after 3, 6 and 12 months.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "As the study concerns itself with psychotherapy and examines the difference in therapist support, it is practically impossible to blind participants and clinicians, and thus they are not blinded. The research team is involved in the day-to-day operation of the project, including the screening for suicidality, why blinding of the research team is also practically impossible with the current setup. However the analyzes of the trial results will be pseudo-anonymized, so that only the ID number appears on the data sheet in order to get as close to blinding as possible in relation to the research design.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 168,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders",
"nctId": "NCT06368557",
"orgStudyIdInfo": {
"id": "22/59602",
"link": null,
"type": null
},
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},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Children´s Anxiety Scale"
},
{
"measure": "The Short Mood and Feelings questionnaire"
},
{
"measure": "EuroQol-5 Dimension Youth"
},
{
"measure": "Client Satisfaction Questionnaire-8"
},
{
"measure": "Systems Usability Scale"
},
{
"measure": "Negative Effects Questionnaire"
},
{
"measure": "Sociodemographic measures"
},
{
"measure": "Engagement"
},
{
"measure": "Cost-effectiveness"
},
{
"measure": "Cost-effectiveness"
},
{
"measure": "The Anxiety Disorders Interview Schedule for Children"
}
],
"primaryOutcomes": [
{
"measure": "The Youth Online Diagnostic Assessment - Child and Parent Versions"
},
{
"measure": "Spence Children's Anxiety Scale- Child and Parent Versions"
}
],
"secondaryOutcomes": [
{
"measure": "Child Anxiety Life Interference Scale- Child and Parent Version"
},
{
"measure": "The Mood and Feelings Questionnaire- Child and Parent Version"
},
{
"measure": "Working Alliance Inventory - Short Form"
},
{
"measure": "Working Alliance Inventory for Online Interventions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Aarhus"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Region of Southern Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "lower-body positive-pressure"
}
]
},
"conditionsModule": {
"conditions": [
"Anterior Cruciate Ligament Injuries",
"Cartilage Degeneration"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "ren shuang",
"phone": "[email protected]",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Peking University Third Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction",
"nctId": "NCT06368544",
"orgStudyIdInfo": {
"id": "M2023816",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gait biomechanical data"
},
{
"measure": "Gait biomechanical data"
},
{
"measure": "Gait biomechanical data"
},
{
"measure": "Gait biomechanical data"
},
{
"measure": "Gait biomechanical data"
},
{
"measure": "Biochemical characteristics of knee cartilage"
},
{
"measure": "Biochemical characteristics of knee cartilage"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking University Third Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-02-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-02-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Chronic Pain",
"Insomnia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Odense",
"contacts": [
{
"email": null,
"name": "Henrik B Vaegter, PhD",
"phone": "004565413869",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
},
"state": null,
"status": "RECRUITING",
"zip": "5000"
}
]
},
"descriptionModule": {
"briefSummary": "Insomnia is reported by more than 50% of patients with chronic pain. In this study, the investigators aim to advance the understanding of physiological sleep in individuals with chronic pain. To do this the investigators will monitor at-home sleep with an ear-EEG over 20 nights in patients with chronic pain and collect self-reported measures of sleep and pain. The collected data will be used to explore and characterize intra-individual variations in sleep metrics (e.g. total sleep time, time in each sleep stage (N1, N2, N3, REM), sleep latency, REM stage latency, wake after sleep onset, sleep efficiency, number of arousals and arousal index) over 20 nights."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Long-term Monitoring of Sleep With Ear-EEG in Patients With Chronic Pain",
"nctId": "NCT06368531",
"orgStudyIdInfo": {
"id": "2314270",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Sleep quality"
},
{
"measure": "Insomnia"
},
{
"measure": "The Graded Chronic Pain Scale Revised"
},
{
"measure": "Age"
},
{
"measure": "Sex"
},
{
"measure": "Ethnicity"
},
{
"measure": "Height"
},
{
"measure": "Weight"
},
{
"measure": "Level of education"
},
{
"measure": "Obstructive sleep apnea"
}
],
"primaryOutcomes": [
{
"measure": "sleep period time (SPT) from Ear EEG"
},
{
"measure": "Qualitative sleep parameters obtained from sleep diary."
},
{
"measure": "Pain intensity rating"
},
{
"measure": "Time from sleep onset until final awakening (TST) from Ear EEG"
},
{
"measure": "Sleep efficiency (SE) from Ear EEG"
},
{
"measure": "Sleep onset latency (SOL) from Ear EEG"
},
{
"measure": "Wake after sleep onset (WASO) from Ear EEG"
},
{
"measure": "REM sleep latency from Ear EEG"
},
{
"measure": "Time from sleep onset until first epoch of REM stage sleep from Ear EEG"
},
{
"measure": "Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG"
},
{
"measure": "Number of awakenings within TST from Ear EEG"
},
{
"measure": "Arousal index which is number of arousals per hour from Ear EEG"
}
],
"secondaryOutcomes": [
{
"measure": "Ease-of-use and Comfort with ear EEG"
},
{
"measure": "Adverse device effects"
},
{
"measure": "Polysomnography"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Aarhus"
},
{
"name": "T&W Engineering A/S"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Odense University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Hypertrophic Cardiomyopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Graz",
"contacts": [
{
"email": "[email protected]",
"name": "Nicolas Verheyen, MD, PHD",
"phone": "004331638530173",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Viktoria Santner, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nicolas Verheyen, MD, PHD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Austria",
"facility": "Medical University of Graz",
"geoPoint": {
"lat": 47.06667,
"lon": 15.45
},
"state": "Styria",
"status": "RECRUITING",
"zip": "8036"
}
]
},
"descriptionModule": {
"briefSummary": "The Austrian Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across Austria including academic and non-academic centers. Patients will undergo a structured examination process including assessment for symptoms of HCM, past medical history, concomitant medication, family history and the presence of HCM-specific red flags. Furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. All data are entered into an electronic case report form (eCRF) (Phoenix Clinical Trial Management System). In order to perform multicenter analyses, data can be extracted from the eCRF after approval by the steering committee."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Austrian HCM Registry",
"nctId": "NCT06368518",
"orgStudyIdInfo": {
"id": "ID01/2024/MZHCM-Reg/NV",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "All cause mortality"
},
{
"measure": "Cardiovascular events"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Graz"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2034-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ultrasound guided PRP injection"
},
{
"name": "ultrasound guided hydrodissection"
}
]
},
"conditionsModule": {
"conditions": [
"Carpal Tunnel Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mansoura",
"contacts": [
{
"email": "[email protected]",
"name": "osama elshafei, MD PHD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Dena El-Ghzzawy",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dena El-Ghzzawy, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "OSAMA ELSHAFEI, MD PHD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Mansoura University",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": null,
"status": "RECRUITING",
"zip": "35511"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:* Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome* Asses safety profile of both methodsParticipants will:* Randomized to one of the two arms* Visit the clinic 1 and 3 months after intervention* Assessed for efficacy and safety of the intervention"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome",
"nctId": "NCT06368505",
"orgStudyIdInfo": {
"id": "R.24.02.2506.R1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)"
},
{
"measure": "The visual analog scale (VAS)"
}
],
"secondaryOutcomes": [
{
"measure": "The cross-sectional area (CSA) of the Median nerve"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Osama Ahmed Elshafei"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Psilocybin"
},
{
"name": "Hypnosis script"
}
]
},
"conditionsModule": {
"conditions": [
"Fibromyalgia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Maastricht",
"contacts": [
{
"email": "[email protected]",
"name": "Mauro Cavarra, MSc",
"phone": "+313494438261",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Maastricht University",
"geoPoint": {
"lat": 50.84833,
"lon": 5.68889
},
"state": "Limburg",
"status": null,
"zip": "6226AK"
},
{
"city": "Leiden",
"contacts": [
{
"email": "[email protected]",
"name": "Monique van Velzen, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Leiden University Medical Center",
"geoPoint": {
"lat": 52.15833,
"lon": 4.49306
},
"state": "South Holland",
"status": null,
"zip": "2333"
}
]
},
"descriptionModule": {
"briefSummary": "Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "double-blind, randomized, within-subjects, placebo-controlled design.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Blinding will be handled by one of the study pharmacies and order and allocation of the treatment to each participant will be completely randomized. This setup ensures that neither the participant nor the experimenter running the test day will be aware of the contents of the capsule.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PsiloFM",
"briefTitle": "The Impact of Psilocybin on Pain in Fibromyalgia Patients",
"nctId": "NCT06368492",
"orgStudyIdInfo": {
"id": "P137",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2021-002909-10",
"link": null,
"type": "EUDRACT_NUMBER"
},
{
"domain": "METC azM/Maastricht University",
"id": "NL78008.068.21",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ischemic Pain perception"
},
{
"measure": "Pressure-evoked Pain perception"
},
{
"measure": "Self-reported pain"
}
],
"secondaryOutcomes": [
{
"measure": "Subjective effects: psychedelic phenomenology"
},
{
"measure": "Subjective effects: mood"
},
{
"measure": "Subjective effects: intensity of effects"
},
{
"measure": "Subjective effects: Ego dissolution"
},
{
"measure": "Subjective effects: Dissociation"
},
{
"measure": "Psychiatric symptoms"
},
{
"measure": "Cognitive performance"
},
{
"measure": "Vigilance"
},
{
"measure": "Empathy"
},
{
"measure": "Creativity"
},
{
"measure": "Creativity"
},
{
"measure": "Autobiographical memory"
},
{
"measure": "Autobiographical memory"
},
{
"measure": "Treatment expectancy"
},
{
"measure": "Treatment expectancy"
},
{
"measure": "Fibromyalgia-related pain"
},
{
"measure": "Personality"
},
{
"measure": "Absorption"
},
{
"measure": "Interpersonal Reactivity"
},
{
"measure": "Depression"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Leiden University Medical Center"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Maastricht University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-09-08",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 673739,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2023-10-30T07:36"
},
{
"date": "2023-10-10",
"filename": "ICF_001.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 451492,
"typeAbbrev": "ICF",
"uploadDate": "2023-10-30T07:38"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "iStatis HBsAg Test"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatitis B",
"Hepatitis B Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hillcrest",
"contacts": [
{
"email": "[email protected]",
"name": "Cherie Cawood",
"phone": "+27828202955",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "South Africa",
"facility": "Epicentre Health Research",
"geoPoint": null,
"state": "Kwazulu Natal",
"status": "RECRUITING",
"zip": "3650"
}
]
},
"descriptionModule": {
"briefSummary": "A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings",
"nctId": "NCT06368479",
"orgStudyIdInfo": {
"id": "CLS-016B",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
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"primaryOutcomes": [
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"measure": "iStatis Performance"
}
],
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},
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"class": "INDUSTRY",
"name": "bioLytical Laboratories"
}
},
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"date": "2024-07-01"
},
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"date": "2024-04-16"
},
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"date": "2024-07-01"
},
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"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "iStatis HBsAg Test"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatitis B",
"Hepatitis B Infection"
]
},
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{
"city": "Melbourne",
"contacts": [
{
"email": null,
"name": "Alex Thompson",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "St. Vincent's Hospital, Melbourne",
"geoPoint": {
"lat": -37.814,
"lon": 144.96332
},
"state": "Fitzroy Victoria",
"status": null,
"zip": "3065"
}
]
},
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"briefSummary": "A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions."
},
"designModule": {
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},
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},
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"type": "ESTIMATED"
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"phases": [
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],
"studyType": "INTERVENTIONAL"
},
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]
},
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"id": "CLS-016A",
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"type": null
},
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},
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"measure": "Performance"
},
{
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],
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{
"name": "St Vincent's Hospital Melbourne"
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],
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"date": "2024-09-01"
},
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},
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"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
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"interventions": [
{
"name": "INSTI® HIV Self-Test"
}
]
},
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"Human Immunodeficiency Virus II Infection"
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},
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"minimumAge": "18 Years",
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},
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"id": "CLS-003",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
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"measure": "Clinical sensitivity and specificity of the INSTI® HIV Self-Test"
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],
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"measure": "The INSTI® HIV Self-Test usability and result interpretation"
}
]
},
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"date": "2024-05-01"
},
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"date": "2024-04-16"
}
}
} | false | null |
{
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"name": "AZD6793"
},
{
"name": "AZD6793"
},
{
"name": "Placebo"
}
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]
},
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{
"city": "Glendale",
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"status": null,
"zip": "91206"
}
]
},
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"studyType": "INTERVENTIONAL"
},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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]
},
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"nctId": "NCT06368440",
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"id": "D7860C00003",
"link": null,
"type": null
},
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},
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{
"measure": "Part 1 (SAD): Number of Participants with Adverse Events"
},
{
"measure": "Part 2 (MAD): Number of Participants with Adverse Events"
}
],
"secondaryOutcomes": [
{
"measure": "Part 1 (SAD) : Maximum Observed Plasma Drug Concentration"
},
{
"measure": "Part 1 (SAD): Time to Reach Peak Concentration (tmax)"
},
{
"measure": "Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz)"
},
{
"measure": "Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz)"
},
{
"measure": "Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12])"
},
{
"measure": "Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24])"
},
{
"measure": "Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast)"
},
{
"measure": "Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf)"
},
{
"measure": "Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F)"
},
{
"measure": "Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F)"
},
{
"measure": "Part 1 (SAD): Dose Normalized AUClast"
},
{
"measure": "Part 1 (SAD): Dose Normalized AUCinf"
},
{
"measure": "Part 1 (SAD): Dose Normalized Cmax"
},
{
"measure": "Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax)"
},
{
"measure": "Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough)"
},
{
"measure": "Part 2 (MAD): Temporal Change Parameter (TCP)"
},
{
"measure": "Part 2 (MAD): Time to Reach Peak Concentration (tmax)"
},
{
"measure": "Part 2 (MAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz)"
},
{
"measure": "Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz)"
},
{
"measure": "Part 2 (MAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24])"
},
{
"measure": "Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast)"
},
{
"measure": "Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf)"
},
{
"measure": "Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau)"
},
{
"measure": "Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F)"
},
{
"measure": "Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F)"
},
{
"measure": "Part 2 (MAD): Dose Normalized AUClast"
},
{
"measure": "Part 2 (MAD): Dose Normalized AUCtau"
},
{
"measure": "Part 2 (MAD): Dose Normalized Cmax"
},
{
"measure": "Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC)"
},
{
"measure": "Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax)"
},
{
"measure": "Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2])"
},
{
"measure": "Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf)"
},
{
"measure": "Part 2 (MAD): Renal Clearance (CLR)"
}
]
},
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}
},
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},
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},
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"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
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"interventions": [
{
"name": "budesonide / glycopyrronium / formoterol"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
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},
"designModule": {
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},
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},
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"acronym": "COnCORD",
"briefTitle": "Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD",
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"link": null,
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"measure": "Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score"
}
],
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"measure": "Change from baseline to 6 months in the CAT score"
},
{
"measure": "Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment"
},
{
"measure": "Percent responders of the CAT [MID=2] after 12 weeks of treatment"
},
{
"measure": "Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation"
},
{
"measure": "Drivers for initiation or switch to BGF MDI via physician questionnaire"
}
]
},
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},
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}
} | false | null |
{
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"interventions": [
{
"name": "Asciminib"
}
]
},
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"conditions": [
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]
},
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},
"descriptionModule": {
"briefSummary": "To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI"
},
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},
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},
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},
"phases": [
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AsterA",
"briefTitle": "A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia",
"nctId": "NCT06368414",
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"id": "KCMLWP-2021-04",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "MR3.0 or less by 1 year"
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],
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},
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"name": "Korean Society of Hematology"
}
},
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"date": "2028-08-31"
},
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},
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"date": "2028-08-31"
},
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"studyFirstPostDateStruct": {
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}
}
} | false | {
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} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Versa Implant"
}
]
},
"conditionsModule": {
"conditions": [
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},
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{
"city": "Auckland",
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{
"email": null,
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}
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]
},
"descriptionModule": {
"briefSummary": "This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates."
},
"designModule": {
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},
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]
},
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"briefTitle": "A First in Human Study for the Versa Device for Tricuspid Regurgitation",
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"link": null,
"type": null
},
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},
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"primaryOutcomes": [
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"measure": "Acute Procedural Success"
},
{
"measure": "Incidence of major adverse events (MAE)"
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"measure": "Tricuspid Regurgitation Severity Change"
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]
},
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},
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"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
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}
}
} | false | null |
{
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"name": "Prospective data collection"
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{
"name": "Prospective data collection"
}
]
},
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"Sepsis",
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"Hidradenitis Suppurativa"
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},
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"email": "[email protected]",
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{
"email": "[email protected]",
"name": "Willem-Jan Metsemakers, MD, PhD",
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},
{
"email": null,
"name": "Willem-Jan Metsemakers, MD, PhD",
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"country": "Belgium",
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},
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{
"measure": "Rate of exacerbations"
},
{
"measure": "Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR)"
},
{
"measure": "Lund-Mackay CT score"
},
{
"measure": "Lund Kennedy endoscopy score"
},
{
"measure": "Modified Davos score"
}
],
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"measure": "Disease free period"
},
{
"measure": "Bacterial eradication"
}
],
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"measure": "PROMIS global health (patient-reported outcome measurement information system)"
},
{
"measure": "PROMIS (patient-reported outcome measurement information system) physical function"
},
{
"measure": "PROMIS (patient-reported outcome measurement information system) pain interference"
},
{
"measure": "Sino-nasal outcome test (SNOT)-22"
},
{
"measure": "Visual Analogue Scale (VAS) score"
},
{
"measure": "Cystic fibrosis questionnaire (CF-Q-R)"
},
{
"measure": "Dermatology Life Quality Index (DLQI)"
},
{
"measure": "Hidradenitis Suppurativa Quality of Life (HiSQoL)"
}
]
},
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"collaborators": [
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"name": "KU Leuven"
}
],
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} | false | null |
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]
},
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{
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},
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},
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},
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"measure": "Fundus Photography (FP)"
},
{
"measure": "Optos"
},
{
"measure": "Autofluorescence (AF)"
},
{
"measure": "Optical Coherence Tomography (OCT)"
},
{
"measure": "Full-Field Electroretinogram (ff-ERG)"
}
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},
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},
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}
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},
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} | false | null |
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},
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"measure": "T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient"
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{
"measure": "Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use"
}
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{
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"name": "Choir singing"
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]
},
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],
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"email": "[email protected]",
"name": "Anna Zumbansen, PhD",
"phone": "613-562-5800",
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"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Narges Bayat, Master",
"phone": "613-562-5800",
"phoneExt": "8393",
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],
"country": "Canada",
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"name": "Arla Good, Ph.D.",
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],
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"facility": "Toronto Metropolitan University",
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"zip": "M5B 0C3"
},
{
"city": "Montréal",
"contacts": [
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"email": "[email protected]",
"name": "Carole Anglade, Ph.D.",
"phone": null,
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],
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"state": "Quebec",
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"zip": "H3C 3J7"
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},
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"measure": "Voice - Pitch"
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{
"measure": "Voice - Maximum Phonation Time"
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{
"measure": "Mood"
},
{
"measure": "Biosocial indexes"
},
{
"measure": "Expectations on a 100-scale"
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"measure": "Satisfaction on a 100-scale"
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],
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"measure": "Communication Index"
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"measure": "Level of confidence in communication"
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"measure": "Aphasia severity index"
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"measure": "Speech and language in functional communication"
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{
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{
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{
"measure": "Social participation"
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{
"measure": "Generic measure of health"
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"measure": "Appetence to music"
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"measure": "Singing voice abilities"
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{
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{
"name": "Université du Québec à Trois-Rivières"
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{
"name": "University of South Florida"
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},
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "FIH Clinical Investigation of Graphene Electrodes for Brain Mapping",
"nctId": "NCT06368310",
"orgStudyIdInfo": {
"id": "R124807",
"link": null,
"type": null
},
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{
"domain": "NHS Research Ethics Committee Reference",
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"link": null,
"type": "OTHER"
}
]
},
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"measure": "Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory)"
},
{
"measure": "Assess the quality of the recorded baseline brain activity - sensing part B (exploratory)"
},
{
"measure": "Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory)"
},
{
"measure": "Evaluate decoding capability from data recorded during language task (exploratory)"
},
{
"measure": "Evaluate signal characteristics of tumour infiltrated brain regions (exploratory)"
}
],
"primaryOutcomes": [
{
"measure": "To evaluate the preliminary safety of the investigational device for its intended use"
}
],
"secondaryOutcomes": [
{
"measure": "Assess the ability of the device to record signals from the brain"
},
{
"measure": "Evaluate the ability of the device to provide functional stimulation of the brain"
},
{
"measure": "Assess stability of sensing and stimulating electrodes"
},
{
"measure": "Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Northern Care Alliance NHS Foundation Trust"
},
{
"name": "European Commission"
},
{
"name": "Inbrain Neuroelectronics"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Manchester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-31"
},
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"date": "2024-04-16"
},
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"date": "2025-01-31"
},
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"startDateStruct": {
"date": "2024-05-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ketone Monoester Supplementation"
},
{
"name": "Ketogenic diet"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight and Obesity",
"Cognitive Change",
"Psychophysiologic Reaction"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses."
},
"designModule": {
"designInfo": {
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"interventionModel": "PARALLEL",
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"masking": "QUADRUPLE",
"maskingDescription": null,
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"timePerspective": null
},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults",
"nctId": "NCT06368297",
"orgStudyIdInfo": {
"id": "BSERE22-APP007-FED",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Brain Plasticity"
},
{
"measure": "Grey Matter Volume"
},
{
"measure": "Cortical Thickness"
},
{
"measure": "Blood-Oxygen-Level-Dependent (BOLD) Signal Changes"
}
],
"secondaryOutcomes": [
{
"measure": "Blood Glucose"
},
{
"measure": "Blood Beta-Hydroxybutyrate"
},
{
"measure": "Blood Insulin"
},
{
"measure": "Leptin"
},
{
"measure": "Ghrelin"
},
{
"measure": "Brain-Derived Neurotrophic Factor"
},
{
"measure": "Reaction Time of Attention Network Test"
},
{
"measure": "Accuracy of Attention Network Test"
},
{
"measure": "Reaction Time of Stroop Task"
},
{
"measure": "Accuracy of Stroop Task"
},
{
"measure": "Reaction Time of N-back Task"
},
{
"measure": "Accuracy of N-back Task"
},
{
"measure": "Cerebral Hemoglobin Concentration"
},
{
"measure": "Height in Kilograms"
},
{
"measure": "Weight in Meters"
},
{
"measure": "Body Fat Percentage"
},
{
"measure": "Fat Mass"
},
{
"measure": "Muscle Mass"
},
{
"measure": "Body Water"
},
{
"measure": "Body Mass Index"
},
{
"measure": "Skinfold Thickness"
},
{
"measure": "Maximal Oxygen Uptake"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Macau"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident"
}
]
},
"conditionsModule": {
"conditions": [
"Perineum; Tear, Traumatic",
"Anal Tear",
"Anal Incontinence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montpellier",
"contacts": [
{
"email": "[email protected]",
"name": "Thomas BARDOL, MD",
"phone": "04 67 33 90 69",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Chu Montpellier",
"geoPoint": {
"lat": 43.61092,
"lon": 3.87723
},
"state": null,
"status": "RECRUITING",
"zip": "34295"
}
]
},
"descriptionModule": {
"briefSummary": "French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023.Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice."
},
"designModule": {
"designInfo": {
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},
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"type": "ESTIMATED"
},
"phases": null,
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},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TP-JET",
"briefTitle": "Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results",
"nctId": "NCT06368284",
"orgStudyIdInfo": {
"id": "IRB-MTP_2022_09_202201170",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of fecal incontinence"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of permanent stoma"
},
{
"measure": "Rate of acontractile bladder"
},
{
"measure": "Rate of sexual dysfunction"
},
{
"measure": "Rate of impact on quality of life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Montpellier"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lipidomics"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Nutrition",
"Diet, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": null,
"country": "Denmark",
"facility": "University of Copenhagen",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": null,
"zip": "2100"
},
{
"city": "Copenhagen",
"contacts": null,
"country": "Denmark",
"facility": "Department of Nutrition, Exercise and Sports",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "20 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Lipidomix",
"briefTitle": "Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile",
"nctId": "NCT06368271",
"orgStudyIdInfo": {
"id": "Lipidomix",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Meal test including medium-chain fatty acids"
}
],
"secondaryOutcomes": [
{
"measure": "Resting metabolic rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Copenhagen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Red yeast rice"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Hypercholesterolemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": null,
"country": "Italy",
"facility": "AOU Policlinico S.Orsola-Malpighi",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk\\>1% but \\< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \\>115 mg/dL, \\< 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia",
"nctId": "NCT06368258",
"orgStudyIdInfo": {
"id": "Curr-RYR2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment-dependent change in LDL-C"
}
],
"secondaryOutcomes": [
{
"measure": "Treatment-dependent change in Total Cholesterol"
},
{
"measure": "Treatment-dependent change in Non-HDL-C"
},
{
"measure": "Treatment-dependent change in liver parameters"
},
{
"measure": "Treatment-dependent change in CPK plasma levels"
},
{
"measure": "Treatment-dependent change in plasma proteomic pattern"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Bologna"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "long-segment posterior TL instrumented fusion"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Fusion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Minneapolis",
"contacts": [
{
"email": "[email protected]",
"name": "David Polly, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Minnesota Medical Center",
"geoPoint": {
"lat": 44.97997,
"lon": -93.26384
},
"state": "Minnesota",
"status": null,
"zip": "55454"
},
{
"city": "Charlottesville",
"contacts": [
{
"email": "[email protected]",
"name": "Justin S Smith, MD, PhD",
"phone": "434-243-6339",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Judith G Beenhakker",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Virginia",
"geoPoint": {
"lat": 38.02931,
"lon": -78.47668
},
"state": "Virginia",
"status": null,
"zip": "22908"
}
]
},
"descriptionModule": {
"briefSummary": "This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 1244,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions",
"nctId": "NCT06368245",
"orgStudyIdInfo": {
"id": "SMART",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rod fracture (RF)"
}
],
"secondaryOutcomes": [
{
"measure": "Time to rod fracture"
},
{
"measure": "Time to rod fracture"
},
{
"measure": "Configurations of supplementary rod constructs"
},
{
"measure": "Treatment for rod fracture"
},
{
"measure": "Recurrent RFs"
},
{
"measure": "Other mechanical failures"
},
{
"measure": "Surgical complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "AO Foundation, AO Spine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "püPatients undergoing bariatric surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Bariatric Surgery Candidate",
"Gastrostomy",
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Yıldırım Beyazıt University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06760"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. Data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. Preoperative and postoperative biochemical parameters along with anthropometric measurements will assess."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 76,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study",
"nctId": "NCT06368232",
"orgStudyIdInfo": {
"id": "19.036.123.125",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Body Weight"
},
{
"measure": "BMI (Body Mass Index)"
},
{
"measure": "Lean Mass"
},
{
"measure": "Fat Mass"
},
{
"measure": "Fasting Blood Glucose"
},
{
"measure": "HbA1c"
},
{
"measure": "Iron levels"
},
{
"measure": "Vitamin D level"
},
{
"measure": "Lipid Profile (Triglycerides, LDL, HDL)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara Yildirim Beyazıt University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ketamine- midazolam versus ketamine- propofol"
}
]
},
"conditionsModule": {
"conditions": [
"Procedural Sedation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)* Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting",
"nctId": "NCT06368219",
"orgStudyIdInfo": {
"id": "0108161",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Induction and recovery time for both combinations"
}
],
"secondaryOutcomes": [
{
"measure": "incidence and severity of adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Alexandria University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Investigational device Aktiia G2C"
},
{
"name": "Marketed device used as reference for blood pressure monitoring: double auscultation cuff"
},
{
"name": "Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2"
},
{
"name": "Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff"
},
{
"name": "Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff"
},
{
"name": "Marketed device used as reference for pulse rate monitoring: pulse finger oximeter"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lausanne",
"contacts": null,
"country": "Switzerland",
"facility": "CHUV",
"geoPoint": {
"lat": 46.516,
"lon": 6.63282
},
"state": null,
"status": null,
"zip": "1011"
}
]
},
"descriptionModule": {
"briefSummary": "The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to evaluate the performances and safety of the Aktiia.product-G2C that doesn't require any calibrations, as compared against double auscultation for BP reference measurements, and finger pulse oximeter for pulse rate reference measurements, for a cohort of subjects characterized by a wide variety of phenotypes."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 85,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device at Fingertip (Aktiia G2C) Against Double Auscultation, and Comparison With Oscillometry and Aktiia Bracelet G2",
"nctId": "NCT06368206",
"orgStudyIdInfo": {
"id": "OBPM_Calfree2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Blood pressure mean value of differences"
},
{
"measure": "Blood pressure standard deviation of differences"
}
],
"secondaryOutcomes": [
{
"measure": "Pulse rate root-mean-square error"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Aktiia SA"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neuralert Monitor"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Stephanie Cummings",
"phone": "215-662-3363",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Scott Kasner, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Hospital of the University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": null,
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, clinical usability, and tolerability."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Neuralert Stroke Monitor Pilot Trial",
"nctId": "NCT06368193",
"orgStudyIdInfo": {
"id": "Neuralert 001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Data Aggregation"
}
],
"secondaryOutcomes": [
{
"measure": "Time to alarm reception"
},
{
"measure": "Time to alarm reponse"
},
{
"measure": "Stroke detection"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Neuralert Technologies LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Robotic assisted gait training"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Riyadh",
"contacts": null,
"country": "Saudi Arabia",
"facility": "King Abdu Aziz Medical City",
"geoPoint": {
"lat": 24.68773,
"lon": 46.72185
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study compared the effects of RAGT and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral CP"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Robotic-assisted gait training Body weight-supported treadmill training",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of a RAGT & BWSTT on Children With CP",
"nctId": "NCT06368180",
"orgStudyIdInfo": {
"id": "439106274",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gait spatio-temporal parameters"
}
],
"secondaryOutcomes": [
{
"measure": "Six-minute walk test (6MWT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "King Saud University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-03-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-02-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-08-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SHR2554"
}
]
},
"conditionsModule": {
"conditions": [
"Follicular Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Yuqin Song",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Peking University Cancer Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100142"
}
]
},
"descriptionModule": {
"briefSummary": "The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 105,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma",
"nctId": "NCT06368167",
"orgStudyIdInfo": {
"id": "SHR2554-202",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective response rate (ORR) assessed by independent review committee (IRC)"
}
],
"secondaryOutcomes": [
{
"measure": "ORR assessed by investigator"
},
{
"measure": "Progression free survival"
},
{
"measure": "Time to Response"
},
{
"measure": "Duration of response"
},
{
"measure": "Overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Jiangsu HengRui Medicine Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Exosomes",
"Newborn",
"Bone Diseases, Metabolic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Changsha",
"contacts": [
{
"email": "[email protected]",
"name": "yinzhi y liu, master",
"phone": "13467532228",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Hunan Children's Hospital",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan",
"status": "RECRUITING",
"zip": "410007"
}
]
},
"descriptionModule": {
"briefSummary": "Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "72 Hours",
"minimumAge": "0 Hours",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity",
"nctId": "NCT06368154",
"orgStudyIdInfo": {
"id": "HCHLL-2019-08",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "exosomes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Hunan Children's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Serplulimab"
},
{
"name": "Capecitabine"
},
{
"name": "Oxaliplatin"
}
]
},
"conditionsModule": {
"conditions": [
"Colon Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Ruijin Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200025"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are:* Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer?* Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer?Participants will receive:* a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen.* a sequential CAPEOX plus Serplulimab regimen.* a standard complete mesocolic excision (CME) operation."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 56,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NeoCHIC",
"briefTitle": "Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer",
"nctId": "NCT06368141",
"orgStudyIdInfo": {
"id": "2023294",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "pathologic complete response"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ruijin Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Indoor Rock Climbing Exercise Training Program"
}
]
},
"conditionsModule": {
"conditions": [
"Lifestyle Factors",
"Physical Inactivity",
"Quality of Life"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Marquette",
"contacts": [
{
"email": "[email protected]",
"name": "Lisa Eckert, PhD",
"phone": "906-227-1291",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Megan C Nelson, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Northern Michigan University",
"geoPoint": {
"lat": 46.54354,
"lon": -87.39542
},
"state": "Michigan",
"status": "RECRUITING",
"zip": "49855"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled trial with participants allocated to either a control or intervention group; comparison between groups and within groups",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "CLIMB",
"briefTitle": "Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study",
"nctId": "NCT06368128",
"orgStudyIdInfo": {
"id": "HS-24_51",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fasting lipids"
},
{
"measure": "Fasting glucose"
},
{
"measure": "Hemoglobin a1c"
}
],
"secondaryOutcomes": [
{
"measure": "Physical activity and sedentary behavior"
},
{
"measure": "Sedentary behavior bouts (30 min, 60 min, >60 min)"
},
{
"measure": "Cardiorespiratory fitness"
},
{
"measure": "Muscular fitness"
},
{
"measure": "Handgrip strength asymmetry"
},
{
"measure": "Lower-body dynamic balance"
},
{
"measure": "Health-related quality of life using CDC Health-Related Quality of Life Scale"
},
{
"measure": "Exercise self-efficacy measured via Self-efficacy for exercise scale"
},
{
"measure": "Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale"
},
{
"measure": "Perceived stress"
},
{
"measure": "Blood pressure"
},
{
"measure": "Body composition"
},
{
"measure": "Bone density"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Northern Michigan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Educational Materials"
}
]
},
"conditionsModule": {
"conditions": [
"Alzheimer Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Worcester",
"contacts": [
{
"email": "[email protected]",
"name": "Cassie L Saphirak",
"phone": "508-856-3493",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UMass Chan Medical School",
"geoPoint": {
"lat": 42.26259,
"lon": -71.80229
},
"state": "Massachusetts",
"status": null,
"zip": "01605"
}
]
},
"descriptionModule": {
"briefSummary": "Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study design will be a prospective, randomized, \"open-label\" educational intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention mailed one time; (2) a combined patient/caregiver and provider educational intervention mailed two times; and (3) usual care.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DPRESCRIBE-AD2",
"briefTitle": "A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2",
"nctId": "NCT06368115",
"orgStudyIdInfo": {
"id": "00023453",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "4R33AG069794",
"link": "https://reporter.nih.gov/quickSearch/4R33AG069794",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Absence of Inappropriate Medication Prescription Dispensing"
}
],
"secondaryOutcomes": [
{
"measure": "Dose Change"
},
{
"measure": "Polypharmacy"
},
{
"measure": "Rates of Health Care and Emergency Care Utilization"
},
{
"measure": "Mortality"
},
{
"measure": "Switching within Classes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Aging (NIA)"
},
{
"name": "Harvard Pilgrim Health Care"
},
{
"name": "Humana Healthcare Research, Inc."
},
{
"name": "Carelon Research"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Massachusetts, Worcester"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ampicillin"
}
]
},
"conditionsModule": {
"conditions": [
"Surgical Site Infection"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery",
"nctId": "NCT06368102",
"orgStudyIdInfo": {
"id": "R6-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Occurrence of surgical site infection"
}
],
"secondaryOutcomes": [
{
"measure": "Occurrence of alveolar osteitis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Uji Takeda Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Inspiratory muscle training (IMT) group"
},
{
"name": "Early mobilization (EM) group"
}
]
},
"conditionsModule": {
"conditions": [
"Ventilator Dependent"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Songkhla",
"contacts": null,
"country": "Thailand",
"facility": "Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital",
"geoPoint": {
"lat": 7.19882,
"lon": 100.5951
},
"state": null,
"status": null,
"zip": "90110"
}
]
},
"descriptionModule": {
"briefSummary": "Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to:1. Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period.2. Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomization",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients",
"nctId": "NCT06368089",
"orgStudyIdInfo": {
"id": "REC.66-474-30-2",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Faculty of Medicine, Prince of Songkla University",
"id": "MR-PSU:66-30-21-406",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum inspiratory pressure (MIP)"
},
{
"measure": "Dynamic lung compliance (Cdyn)"
}
],
"secondaryOutcomes": [
{
"measure": "Weaning time"
},
{
"measure": "Weaning outcome"
},
{
"measure": "Grip strength"
},
{
"measure": "chest wall expansion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Prince of Songkla University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Muscular Atrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": [
{
"email": "[email protected]",
"name": "Sophia Frølich, stud.med",
"phone": "+ 45 3545 3561",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Noémie Receveur, stud.med",
"phone": "+4535453561",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Rigshospitalet",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": "RECRUITING",
"zip": "2100"
}
]
},
"descriptionModule": {
"briefSummary": "Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy."
},
"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": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High-intensity Interval Training in Patients With Spinal Muscular Atrophy",
"nctId": "NCT06368076",
"orgStudyIdInfo": {
"id": "H-23065096",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Questionnaire on fatigue"
},
{
"measure": "Questionnaire on pain."
},
{
"measure": "Questionnaire on constipation"
},
{
"measure": "Questionnaire on quality of life"
},
{
"measure": "Questionnaire on sleep quality"
}
],
"secondaryOutcomes": [
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "Blood sample"
},
{
"measure": "MRI scan liver size"
},
{
"measure": "MR-elastography"
},
{
"measure": "MRI scan liver steatosis"
},
{
"measure": "Ultrasound scan"
},
{
"measure": "MRI scan"
},
{
"measure": "MRI scan"
},
{
"measure": "Exercise test"
},
{
"measure": "Motorscore"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rigshospitalet, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Huaier granule"
},
{
"name": "chemotherapy drugs"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Cancer Resectable"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 642,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer",
"nctId": "NCT06368063",
"orgStudyIdInfo": {
"id": "HE-202301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Progression-free survival"
},
{
"measure": "The incidence and severity of adverse events (AE) and severe adverse events (SAE)"
},
{
"measure": "The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "LinkDoc Technology (Beijing) Co. Ltd."
},
{
"name": "Huazhong University of Science and Technology"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Health Science Center of Xi'an Jiaotong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "practice structure intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Head Injury",
"Sport Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Winston-Salem",
"contacts": [
{
"email": "[email protected]",
"name": "Jill Urban, PhD, MPH",
"phone": "336-716-0947",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Konstantia Strates",
"phone": "336-713-1263",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jill Urban, PhD, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Wake Forest University Health Sciences",
"geoPoint": {
"lat": 36.09986,
"lon": -80.24422
},
"state": "North Carolina",
"status": null,
"zip": "27157"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "11 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football",
"nctId": "NCT06368050",
"orgStudyIdInfo": {
"id": "IRB00067187.2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of practice head impacts"
},
{
"measure": "Number of practice head acceleration events"
},
{
"measure": "Practice head impact rate"
},
{
"measure": "Practice head acceleration even rate"
},
{
"measure": "Median linear acceleration"
},
{
"measure": "Median rotational acceleration"
},
{
"measure": "Median rotational velocity"
},
{
"measure": "95th percentile linear acceleration"
},
{
"measure": "95th percentile rotational acceleration"
},
{
"measure": "95th percentile rotational velocity"
}
],
"secondaryOutcomes": [
{
"measure": "Feasibility of Intervention Measure (FIM) Values"
},
{
"measure": "Acceptability of Intervention Measure (AIM) Values"
},
{
"measure": "Number of practices the intervention was implemented as prescribed"
},
{
"measure": "Average minutes per practice of live time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Childress Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Wake Forest University Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DragonFire Transcatheter Myocardial Radiofrequency Ablation System"
}
]
},
"conditionsModule": {
"conditions": [
"Obstructive Hypertrophic Cardiomyopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shenyang",
"contacts": null,
"country": "China",
"facility": "Northern Theater Command General Hospital of the Chinese People's Liberation Army",
"geoPoint": {
"lat": 41.79222,
"lon": 123.43278
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively."
},
"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": "Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy",
"nctId": "NCT06368037",
"orgStudyIdInfo": {
"id": "DragonFire-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The rate of freedom from major adverse events at 30 days postoperatively"
},
{
"measure": "The success rate of treatment at 6 months postoperatively"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Hangzhou Valgen Medtech Co., Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "This is a retrospective analysis study of data collected with a diagnostic medical device"
}
]
},
"conditionsModule": {
"conditions": [
"Neurologic Disorder",
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kfar Saba",
"contacts": null,
"country": "Israel",
"facility": "QuantalX Neuroscience Ltd.",
"geoPoint": {
"lat": 32.175,
"lon": 34.90694
},
"state": "Center",
"status": null,
"zip": "4453001"
}
]
},
"descriptionModule": {
"briefSummary": "A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 263,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Establishment of Delphi-MD Safety Performance and Reliability",
"nctId": "NCT06368024",
"orgStudyIdInfo": {
"id": "CL-12-600",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cortical Excitability"
},
{
"measure": "Specific Peak Amplitudes"
},
{
"measure": "GMFP"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "QuantalX Neuroscience"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "acceptance and commitment therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Stigmatization"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hatay",
"contacts": null,
"country": "Turkey",
"facility": "Hatay Mustafa Kemal Üniversitesi",
"geoPoint": {
"lat": 38.40227,
"lon": 27.10486
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of study is to determine the effect of acceptance and commitment therapy-based psychoeducation on the level of stigmatization applied to relatives of schizophrenia patients.Type of study: This study was planned as a pretest-posttest quasi-experimental design with an observation and control group.Participants: The population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Community Mental Health Center in a state hospital in Ankara.Intervention: Before the psychoeducation process started, personal information form and scales were applied to the relatives of the patients in the experimental and control groups. An ACT-based psychoeducation program consisting of 8 sessions was applied to the experimental group. each session lasted approximately 90 minutes. The control group did not receive any intervention. After the psychoeducation, the scales were reapplied to the experimental and control groups. In addition, the experimental group was asked to fill out the psychoeducation evaluation form. The scales were reapplied to the experimental group after the 1-month follow-up study and evaluated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Impact of Acceptance and Commitment Therapy on Stigmatization",
"nctId": "NCT06368011",
"orgStudyIdInfo": {
"id": "MustafaKU-CINCINOGLU-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Stigma Scale for Relatives of Patients with Schizophrenia"
},
{
"measure": "Stigma Scale for Relatives of Patients with Schizophrenia"
},
{
"measure": "Stigma Scale for Relatives of Patients with Schizophrenia"
}
],
"secondaryOutcomes": [
{
"measure": "Stigmatization Scale"
},
{
"measure": "Stigmatization Scale"
},
{
"measure": "Stigmatization Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mustafa Kemal University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2023-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pregabalin"
}
]
},
"conditionsModule": {
"conditions": [
"Rotator Cuff Tears",
"Central Sensitisation",
"Neuropathic Pain"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair.The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 76,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "69 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Pregabalin on Shoulder Pain of Patients With Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair",
"nctId": "NCT06367998",
"orgStudyIdInfo": {
"id": "PC24MISV0017",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "VAS pain score"
}
],
"secondaryOutcomes": [
{
"measure": "Constant shoulder score"
},
{
"measure": "American shouler and elbow surgeons (ASES) score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Viatris Korea"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The Catholic University of Korea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Air Oxygen Concentration CAPA-IVM culture"
},
{
"name": "Low Oxygen Concentration CAPA-IVM culture"
}
]
},
"conditionsModule": {
"conditions": [
"In Vitro Fertilization"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ho Chi Minh City",
"contacts": [
{
"email": "[email protected]",
"name": "Tuong M Ho, MSc, MD",
"phone": "+84 90 3633377",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Vietnam",
"facility": "My Duc Hospital",
"geoPoint": {
"lat": 10.82302,
"lon": 106.62965
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Capacitation in-vitro maturation (CAPA-IVM) has recently been advanced in culturing oocytes from the germinal vesicle (GV) stage following mild or no controlled ovarian stimulation. Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor (HIF). Nonetheless, it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen (O2) concentration index in the IVM culture environment has not been reached. Based on the outcomes of atmospheric O2 concentration (20%) and low O2 concentration (5%) during CAPA-IVM culture in mice, it has been hypothesized that a 5% O2 was the optimal culture condition for the pre-IVM step. A 20% O2 was more suitable for the IVM culture step. Therefore, this study is designed to enhance the CAPA-IVM culture system, improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Sibling oocytes",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "42 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "CAPA-IVM Culture With Low Oxygen Tension",
"nctId": "NCT06367985",
"orgStudyIdInfo": {
"id": "03/24/DD-BVMD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maturation rate"
}
],
"secondaryOutcomes": [
{
"measure": "Total number of oocytes retrieval"
},
{
"measure": "Number of patients with no oocyte retrieved"
},
{
"measure": "Number of MII oocytes"
},
{
"measure": "Number of GV oocytes"
},
{
"measure": "Number of patients with no matured oocyte"
},
{
"measure": "Number of 2PN oocytes"
},
{
"measure": "Fertilization rate"
},
{
"measure": "Abnormal fertilization rate"
},
{
"measure": "Number of patients with no day-3 embryo"
},
{
"measure": "Number of day-3 embryos"
},
{
"measure": "Number of good quality Day-3 embryos"
},
{
"measure": "Number of frozen day-3 embryos"
},
{
"measure": "Number of blastocyst (day 5 or day 6 embryo)"
},
{
"measure": "Number of patients with no blastocyst"
},
{
"measure": "Number of good quality blastocysts"
},
{
"measure": "Number of frozen blastocysts"
},
{
"measure": "Number of embryos transferred"
},
{
"measure": "Quality of embryos transferred (Grade 1, Grade 2, Grade 3)"
},
{
"measure": "Positive pregnancy test rate"
},
{
"measure": "Implantation rate"
},
{
"measure": "Clinical pregnancy rate"
},
{
"measure": "Ectopic pregnancy rate"
},
{
"measure": "Ongoing pregnancy rate"
},
{
"measure": "Miscarriage <12 weeks rate (Early miscarriage)"
},
{
"measure": "Miscarriage <22 weeks rate (late miscarriage)"
},
{
"measure": "Live birth rate"
},
{
"measure": "Multiple pregnancy rate"
},
{
"measure": "Multiple delivery rate"
},
{
"measure": "Mode of delivery"
},
{
"measure": "Gestational age at birth"
},
{
"measure": "Birth weight"
},
{
"measure": "Very low birth weight rate"
},
{
"measure": "Low birth weight rate"
},
{
"measure": "High birth weight rate"
},
{
"measure": "Very high birth weight rate"
},
{
"measure": "Small for gestational age rate"
},
{
"measure": "Large for gestational age rate"
},
{
"measure": "Hypertension in pregnancy rate"
},
{
"measure": "Gestational diabetes mellitus rate"
},
{
"measure": "Still birth rate"
},
{
"measure": "Premature birth rate"
},
{
"measure": "Antepartum haemorrhage rate"
},
{
"measure": "Major congenital abnormalities rate"
},
{
"measure": "Neonatal mortality rate"
},
{
"measure": "NICU admission rate"
},
{
"measure": "Reason for NICU admission"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Vrije Universiteit Brussel"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Mỹ Đức Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Local Consolidation Therapy"
},
{
"name": "Next-line Systemic Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"OligoProgressive Metastatic Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Ethan Ludmir, MD",
"phone": "832-729-0998",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ethan Ludmir, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation \\[the removal or destruction of a body part or tissue or its function\\], or embolization \\[a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel\\]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP)",
"nctId": "NCT06367972",
"orgStudyIdInfo": {
"id": "2024-0070",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-03278",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safety and adverse events (AEs)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-10-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-10-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-16"
}
}
} | false | null |
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