documentSection
dict | hasResults
bool 2
classes | protocolSection
dict |
|---|---|---|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cyclophosphamide"
},
{
"name": "Fludarabine phosphate"
},
{
"name": "Decitabine"
}
]
},
"conditionsModule": {
"conditions": [
"Lymphodepleting Chemotherapy",
"Myeloid Malignancies"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Jeremy Ramdial, MD",
"phone": "713-745-0146",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jeremy Ramdial, 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 a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies",
"nctId": "NCT06383572",
"orgStudyIdInfo": {
"id": "2024-0196",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-03505",
"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": "2029-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lenvatinib and Sintilimab"
}
]
},
"conditionsModule": {
"conditions": [
"Gastric Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tianjin",
"contacts": [
{
"email": "[email protected]",
"name": "Ting Deng, MD",
"phone": "022-23340123",
"phoneExt": "1053",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yi Ba, MD",
"phone": "022-23340123",
"phoneExt": "1053",
"role": "CONTACT"
}
],
"country": "China",
"facility": "Tianjin Medical University Cancer Institute and Hospital",
"geoPoint": {
"lat": 39.14222,
"lon": 117.17667
},
"state": "Tianjin",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (\\>=60kg, 200 mg; \\<60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 39,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients",
"nctId": "NCT06383559",
"orgStudyIdInfo": {
"id": "TJMUCH-GI-GC07",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "AE"
}
],
"primaryOutcomes": [
{
"measure": "ORR"
}
],
"secondaryOutcomes": [
{
"measure": "OS"
},
{
"measure": "PFS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tianjin Medical University Cancer Institute and Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Artificial Intelligence",
"Electrocardiogram",
"Deep Learning",
"Congenital Heart Disease in Children",
"Diagnosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Sun Jing, MD",
"phone": "15618497517",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Congenital heart disease (CHD) is the most common congenital disease in children. The early detection, diagnosis and treatment of CHD in children is of great significance to improve the prognosis and reduce the mortality of children, but the current screening methods have limitations. Electrocardiogram (ECG), as an economical and rapid means of heart disease detection, has a very important value in the auxiliary diagnosis of CHD.Big data and deep learning technologies in artificial intelligence (AI) have shown great potential in the medical field. The advent of the big data era provides rich data resources for the in-depth study of CHD ECG signals in children. The development of deep learning technology, especially the breakthrough in the field of image recognition, provides a strong technical support for the intelligent analysis of electrocardiogram. The particularity of children electrocardiogram requires the development of a special algorithm model. At present, the research on the application of deep learning models to identify children's electrocardiograms is limited, and the training and verification from large data sets are lacking. Based on the Chinese Congenital Heart Disease Collaborative Research Network, this project aims to integrate data and deep learning technology to develop a set of intelligent electrocardiogram assisted diagnosis system (CHD-ECG AI system) suitable for children with CHD, so as to improve the early detection rate of CHD and improve the efficiency of congenital heart disease screening."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 30000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "AI-ECG-CHD",
"briefTitle": "Artificial Intelligence-enabled ECG Detection of Congenital Heart Disease in Children: a Novel Diagnostic Tool",
"nctId": "NCT06383546",
"orgStudyIdInfo": {
"id": "XHEC-C-2024-053-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Large-scale ECG database for children"
},
{
"measure": "Artificial intelligence-assisted electrocardiogram model for CHD in Children"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xinhua Hospital, Shanghai Jiao Tong University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Disitamab Vedotin Plus Cadonilimab"
}
]
},
"conditionsModule": {
"conditions": [
"Bile Duct Adenocarcinoma Non-Resectable",
"HER2 Gene Mutation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Jieer Ying, Doctor",
"phone": "13858195803",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Zhejiang Cancer Hospital",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": "RECRUITING",
"zip": "310022"
}
]
},
"descriptionModule": {
"briefSummary": "It is a single arm, open-label, phase II cinical trial to evaluate the efficacy and safety of Disitamab Vedotin Plus Cadonilimab in second-line treatment of patients with Advanced or Metastatic Bile Duct Adenocarcinoma"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma",
"nctId": "NCT06383533",
"orgStudyIdInfo": {
"id": "IRB-2023-385",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective response rate(ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Disease control rate (DCR)"
},
{
"measure": "Incidence of Treatment-Emergent 3/4 Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zhejiang Cancer Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "68Ga-aGPC3-scFv/Fab"
}
]
},
"conditionsModule": {
"conditions": [
"Malignant Neoplasm of Liver"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "Xiaoli Lan, PhD",
"phone": "+86-027-83692633",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "China, Hubei Province",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": "RECRUITING",
"zip": "430022"
}
]
},
"descriptionModule": {
"briefSummary": "This is a diagnostic study. Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PET/or PET/CT imaging targeting a GPC3-specific probe (in the case of 68Ga-NOTA-aGPC3-scFv) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET CT imaging in patients with contraindications. General Information, clinical data, blood routine, liver and renal function, and other imaging data were collected. The final diagnosis was based on the histopathology of biopsy or surgical specimens."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma",
"nctId": "NCT06383520",
"orgStudyIdInfo": {
"id": "XLan-0415",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual and standardized uptake values assessment of lesions and biodistribution"
}
],
"secondaryOutcomes": [
{
"measure": "Radioactivity in the blood and urine samples"
},
{
"measure": "Concentration of tumor markers (e.g., APF) in participants' blood"
},
{
"measure": "Pathological sections of tumour tissue"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Wuhan Union Hospital, China"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CHT101"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Tumor",
"Advanced Solid Tumor",
"Renal Cell Carcinoma",
"Ovarian Cancer",
"Cervix Cancer",
"Head and Neck Squamous Cell Carcinoma",
"Nasopharyngeal Carcinoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 18,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors",
"nctId": "NCT06383507",
"orgStudyIdInfo": {
"id": "CHT101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Adverse events after CD70 UCAR-T cells infusion (Safety and Tolerability)"
}
],
"secondaryOutcomes": [
{
"measure": "Disease control rate (DCR)"
},
{
"measure": "Objective response rate (ORR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LMA supreme group"
},
{
"name": "I-gel group"
},
{
"name": "GMA-Tulip"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Jiangling Wang, Ph. D",
"phone": "+86 571 88122106",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Zhejiang Cancer Hospital",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": "RECRUITING",
"zip": "310022"
}
]
},
"descriptionModule": {
"briefSummary": "Patients were randomly assigned to three extraglottic airway (EGA) devices groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 276,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "GMA-TulipTM, i-gelTM and the LMA-SupremeTM (LMA-S) Devices in Airway Management",
"nctId": "NCT06383494",
"orgStudyIdInfo": {
"id": "IRB-2024-356（IIT）",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Glottic exposure grading"
}
],
"secondaryOutcomes": [
{
"measure": "Peak inspiratory pressures"
},
{
"measure": "Pharyngalgia"
},
{
"measure": "Bleeding"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zhejiang Cancer Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mobile based education"
}
]
},
"conditionsModule": {
"conditions": [
"Thyroid Diseases",
"Healthy Lifestyle",
"Thyroid"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Thyroid diseases constitute one of the most common health problems around the world and in our country. In its treatment; Drug therapy, radioactive iodine therapy and surgical treatment can be applied alone or together. Advances in the diagnosis of thyroid diseases have led to an increase in the number of thyroidectomies. When there are no complications after thyroidectomy, patients are discharged from the hospital on the day of surgery or are hospitalized for only a few days. In this context, since technical care is given priority, discharge training remains incomplete.\n\nPatients who have had thyroidectomy are discharged within 1-2 days after surgery if no problems occur. For this reason, patient education provided by health professionals and especially nurses may be insufficient. Post-discharge patient education in surgical services can sometimes be ignored, and it is noteworthy that this situation is not given importance due to the busy nature of surgical services. Although short hospital stays after surgery are beneficial in many ways, it increases the need for patient education.\n\nIn this study, a mobile application that covers the entire perioperative process and includes education will be developed for patients undergoing thyroidectomy. This developed mobile application aims to manage post-operative problems such as neck pain and discomfort and voice changes experienced by patients, and to improve post-operative recovery, voice quality and, accordingly, quality of life. In this context, it is believed that even in cases where patients cannot access health care professionals, their educational needs will be met, problem management will be provided with applications for the problems they experience, and accordingly, their post-operative recovery, voice and quality of life will increase, starting from the hospital before the surgery until the end of the recovery period, including the home care process after discharge.When the literature on the subject is examined, studies involving education in patients with thyroidectomy are limited. However, no studies have been found on mobile health applications that include training to reduce neck pain and discomfort experienced by thyroidectomy patients, ensure postoperative recovery, and improve voice quality and quality of life."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 92,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Mobile-Based Education on Postoperative Recovery and Quality of Life in Thyroidectomy Patients",
"nctId": "NCT06383481",
"orgStudyIdInfo": {
"id": "TDK-2024-13362",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative Recovery Index (ASII)"
},
{
"measure": "SF-36 Quality of Life Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Visual Comparison Pain Scale(GKAÖ)"
},
{
"measure": "Turkish- Computer System Usability Questionnaire Short Version (TCSUQ- SV)"
},
{
"measure": "Neck Pain and Discomfort Scale (BARÖ)"
},
{
"measure": "Voice Handicap Index (Voice Handicap Index 10)(VHI10)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ataturk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AK120"
}
]
},
"conditionsModule": {
"conditions": [
"Atopic Dermatitis"
]
},
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},
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},
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},
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"phases": [
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],
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},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
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"link": null,
"type": null
},
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},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
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"name": "Akeso"
}
},
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},
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"date": "2024-04-25"
},
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"date": "2025-01-30"
},
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"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-surgical periodontal therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Periodontitis",
"Smoking Habit",
"Subgingival Plaque"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Edirne",
"contacts": null,
"country": "Turkey",
"facility": "Trakya University",
"geoPoint": {
"lat": 41.67719,
"lon": 26.55597
},
"state": null,
"status": null,
"zip": "22030"
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to compare the distribution of subgingival periodontal pathogens following non-surgical periodontal therapy in smoking and non-smoking people with periodontitis. The main question it aims to answer is:\n\n- Does smoking affect the results of non-surgical periodontal treatment on subgingival flora in participants with periodontal disease?\n\nResearchers performed non-surgical periodontal therapy on 48 participants with stage III/IV periodontitis and recorded clinical measurements. They obtained subgingival plaque samples from periodontal pockets at the onset and after four weeks of treatment, determining the level of periodontopathogens using a polymerase chain reaction-based method."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 48,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "35 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Smoking on Clinical and Microbiological Response in Individuals With Periodontitis",
"nctId": "NCT06383455",
"orgStudyIdInfo": {
"id": "Observational",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis"
}
],
"secondaryOutcomes": [
{
"measure": "Change in clinical attachment level (CAL)"
},
{
"measure": "Change in probing depth (PD)"
},
{
"measure": "Change in gingival index (GI) scores"
},
{
"measure": "Change in plaque index (PI) scores"
},
{
"measure": "Change in Bleeding on Probing (BOP)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Trakya University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2019-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-09-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "L-HIIT"
},
{
"name": "M-HIIT"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight or Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": null,
"country": "Taiwan",
"facility": "Taipei Medical University",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null,
"status": null,
"zip": "110"
}
]
},
"descriptionModule": {
"briefSummary": "36 middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week) and the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants were evenly distributed according to a counterbalanced design and divided into three different groups by the body fat percentage of subjects: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest), 3. Control group. Target intensities of each interval bout, exercise and rest (Ex./R.), were 85-90% VO2peak/65-70% VO2peak zones, respectively.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HIIT",
"briefTitle": "HIIT on Overweight Middle-aged Adults",
"nctId": "NCT06383442",
"orgStudyIdInfo": {
"id": "N202103041",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Aerobic Capacity Test"
},
{
"measure": "Aerobic Capacity Test"
},
{
"measure": "Anti-fatigue performance"
},
{
"measure": "skinfold thickness"
},
{
"measure": "Body composition_body fat"
}
],
"secondaryOutcomes": [
{
"measure": "Glucose"
},
{
"measure": "Triglycerides"
},
{
"measure": "low-density lipoprotein (LDL)"
},
{
"measure": "high-density lipoprotein (HDL)"
},
{
"measure": "creatine kinase (CK) level"
},
{
"measure": "C-reactive protein (CRP)"
},
{
"measure": "tumor necrosis factor (TNF)-R1"
},
{
"measure": "TNF-R2"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Taipei Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "forward head posture by using mobile application. And patients will fill out headache disability index."
}
]
},
"conditionsModule": {
"conditions": [
"Obese",
"Headache",
"Neck Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Banī Suwayf",
"contacts": null,
"country": "Egypt",
"facility": "Ababa physical therapy center",
"geoPoint": {
"lat": 29.07441,
"lon": 31.09785
},
"state": "Beni- Suaf",
"status": null,
"zip": "2711860"
}
]
},
"descriptionModule": {
"briefSummary": "Cross sectional study to detect relation between forward head posture and headache. We will take information from the patient about:\n\n* Detailed history of patient\n* Forward head posture by using mobile application\n* Headache disability index"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Relation Between Forward Head Posture and Incidence of Headache in Obese Adults",
"nctId": "NCT06383429",
"orgStudyIdInfo": {
"id": "P.T-WH-10/2023-521",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "forward head posture"
},
{
"measure": "BMI"
},
{
"measure": "headache disability index"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ahram Canadian University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neck pain by VAS"
}
]
},
"conditionsModule": {
"conditions": [
"Geriatric Patients With Neck Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Banī Suwayf",
"contacts": null,
"country": "Egypt",
"facility": "Ababa physical therapy center",
"geoPoint": {
"lat": 29.07441,
"lon": 31.09785
},
"state": null,
"status": null,
"zip": "2711860"
}
]
},
"descriptionModule": {
"briefSummary": "cross sectional study to detect the incidence of headache and its effect on quality of life in geriatric patients with chronic neck pain. Patients will fill out quality of life questionnaire and headache disability index. We will take information from the patients about:\n\n* The frequency of headache occurrence.\n* Visual analogue scale of chronic neck pain. Main measures: chronic neck pain will be assessed by visual analogue scale. Patients will fill out quality of life questionnaire and headache disability index."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Incidence of Headache and Its Effect on Quality of Life in Geriatric Patients With Chronic Neck Pain",
"nctId": "NCT06383416",
"orgStudyIdInfo": {
"id": "P.T-INT-10/2023-522",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual analogue scale"
},
{
"measure": "headache disability index"
},
{
"measure": "SF-36 quality of life questionare"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ahram Canadian University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Elafibranor"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Biliary Cholangitis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.\n\nPrimary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.\n\nMany patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).\n\nThe main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.\n\nThere will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.\n\nParticipants will be twice as likely to receive elafibranor than placebo (2:1 ratio).\n\nParticipants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).\n\nThey will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ELSPIRE",
"briefTitle": "A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.",
"nctId": "NCT06383403",
"orgStudyIdInfo": {
"id": "CLIN-60190-463",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2024-510695-20-00",
"link": null,
"type": "CTIS"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of participants with normalisation of Alkaline Phosphate (ALP) Levels"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of participants with normalisation of ALP Levels"
},
{
"measure": "Change from baseline in ALP levels"
},
{
"measure": "Percentage of participants with normalisation of ALP Levels and ≥15% decrease from Baseline"
},
{
"measure": "Percentage of participants with ≥40% decrease from Baseline in ALP Levels"
},
{
"measure": "Percentage of participants with ALP <0.5 × Upper Limit of Normal (ULN)"
},
{
"measure": "Changes from baseline in Total Bilirubin (TB) Levels"
},
{
"measure": "Percentage of participants with TB <0.7 × ULN"
},
{
"measure": "Percentage of participants with normalisation of ALP and TB <0.7 × ULN"
},
{
"measure": "Percentage of participants with normalisation of TB and ALP Levels"
},
{
"measure": "Percentage of participants with complete biochemical response"
},
{
"measure": "Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score"
},
{
"measure": "Percentage of participants with moderate to severe pruritus at baseline (i.e. score ≥4) with a clinically meaningful response in PBC Worst Itch NRS"
},
{
"measure": "Change from baseline in 5-D itch score"
},
{
"measure": "Change from baseline in Patient Global Impression of Severity (PGI-S) scores"
},
{
"measure": "Patient Global Impression of Change (PGI-C) scores"
},
{
"measure": "Change from baseline in PBC-40 Quality of Life (QoL) scores"
},
{
"measure": "Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a scores"
},
{
"measure": "Percentage of participants experiencing Treatment- Emergent Adverse Events (TEAEs), treatment- related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)."
},
{
"measure": "Percentage of participants developing clinically significant changes in physical examination"
},
{
"measure": "Percentage of participants developing clinically significant changes in vital signs"
},
{
"measure": "Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) Readings"
},
{
"measure": "Percentage of participants developing clinically significant changes in laboratory parameters"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Ipsen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Retatrutide"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight and Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Birmingham",
"contacts": [
{
"email": null,
"name": "David D. DeAtkine",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Central Research Associates",
"geoPoint": {
"lat": 33.52066,
"lon": -86.80249
},
"state": "Alabama",
"status": null,
"zip": "35205"
},
{
"city": "Daphne",
"contacts": [
{
"email": null,
"name": "Michael T. Ledet",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Alliance for Multispecialty Research, LLC",
"geoPoint": {
"lat": 30.60353,
"lon": -87.9036
},
"state": "Alabama",
"status": null,
"zip": "36526"
},
{
"city": "Huntsville",
"contacts": [
{
"email": null,
"name": "Michael Quadrini",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Nephrology Consultants",
"geoPoint": {
"lat": 34.7304,
"lon": -86.58594
},
"state": "Alabama",
"status": null,
"zip": "35805"
},
{
"city": "Mobile",
"contacts": [
{
"email": null,
"name": "Harry E Studdard",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Alliance for Multispecialty Research, LLC",
"geoPoint": {
"lat": 30.69436,
"lon": -88.04305
},
"state": "Alabama",
"status": null,
"zip": "36608"
},
{
"city": "Anchorage",
"contacts": [
{
"email": null,
"name": "Suneet Nitin Purohit",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Alaska Heart and Vascular Institute",
"geoPoint": {
"lat": 61.21806,
"lon": -149.90028
},
"state": "Alaska",
"status": null,
"zip": "99508"
},
{
"city": "Paradise Valley",
"contacts": [
{
"email": null,
"name": "Gerald Asin",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Helios Clinical Research - SAZ-PDV-026",
"geoPoint": {
"lat": 33.53115,
"lon": -111.94265
},
"state": "Arizona",
"status": null,
"zip": "85253"
},
{
"city": "Phoenix",
"contacts": [
{
"email": null,
"name": "Brock Adam Merritt",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Phoenix Clinical LLC",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona",
"status": null,
"zip": "85014"
},
{
"city": "Phoenix",
"contacts": [
{
"email": null,
"name": "Vijendra Swarup",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Arizona Cardiovascular Research Center",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona",
"status": null,
"zip": "85016"
},
{
"city": "Tucson",
"contacts": [
{
"email": null,
"name": "Kevin Lee Pounds",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Synexus Clinical Research US, Inc./Orange Grove Family Practice",
"geoPoint": {
"lat": 32.22174,
"lon": -110.92648
},
"state": "Arizona",
"status": null,
"zip": "85741"
},
{
"city": "Little Rock",
"contacts": [
{
"email": null,
"name": "Joe Louis Hargrove",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Cardiology and Medicine Clinic",
"geoPoint": {
"lat": 34.74648,
"lon": -92.28959
},
"state": "Arkansas",
"status": null,
"zip": "72204"
},
{
"city": "Apple Valley",
"contacts": [
{
"email": null,
"name": "Edgard Vera",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Kidney & Hypertension Center - Apple Valley",
"geoPoint": {
"lat": 34.50083,
"lon": -117.18588
},
"state": "California",
"status": null,
"zip": "92307"
},
{
"city": "Beverly Hills",
"contacts": [
{
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"primaryCompletionDateStruct": {
"date": "2029-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tooth extraction and bone graft procedure"
}
]
},
"conditionsModule": {
"conditions": [
"Bone Regeneration",
"Safety Issues"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Louvain-la-Neuve",
"contacts": [
{
"email": "[email protected]",
"name": "Sami El Masri",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Laurane Pansaers",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Clinique de la Source DentalMe",
"geoPoint": {
"lat": 50.66829,
"lon": 4.61443
},
"state": "Brabant Wallon",
"status": "RECRUITING",
"zip": "1348"
},
{
"city": "Aubel",
"contacts": [
{
"email": "[email protected]",
"name": "Bertrand Debaty",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Cabinet Debaty-Techy",
"geoPoint": {
"lat": 50.70189,
"lon": 5.85812
},
"state": "Liège",
"status": "RECRUITING",
"zip": "4880"
},
{
"city": "Chaudfontaine",
"contacts": [
{
"email": "[email protected]",
"name": "Souheil Salem",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Clinique du Faubourg DentalMe",
"geoPoint": {
"lat": 50.5828,
"lon": 5.6341
},
"state": "Liège",
"status": "RECRUITING",
"zip": "4053"
},
{
"city": "Liège",
"contacts": [
{
"email": "mailto:[email protected]",
"name": "Bruno De Carvalho",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lemmy Liegeois",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Gilles Szotek",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Centre Hospitalier Université de Liège",
"geoPoint": {
"lat": 50.63373,
"lon": 5.56749
},
"state": null,
"status": "RECRUITING",
"zip": "4000"
},
{
"city": "Namur",
"contacts": [
{
"email": "[email protected]",
"name": "Adrien Bolette",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Centre Oxalys",
"geoPoint": {
"lat": 50.4669,
"lon": 4.86746
},
"state": null,
"status": "RECRUITING",
"zip": "5020"
}
]
},
"descriptionModule": {
"briefSummary": "This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The parallel group will be treated with the product Bio-Oss® in a 1:1 randomization. Bio- Oss® is a natural bone mineral of bovine origin. Bio-Oss® is available as granules of spongious bone. Sterilization of Bio-Oss® is carried out by irradiation. Bio-Oss® has a macro- and microporous structure similar to human spongious bone. Bio-Oss® supports the in-growth of new bone at the implantation site by serving as a stable scaffold for osteoblasts; over time it is subject to the physiological remodeling process. Bio-Oss® is slowly resorbable, depending on the physiological environment of the individual patient, or integrated into the host bone. The highly purified osteoconductive mineral structure is produced from natural bone in a multistage purification process, adhering to the strictest safety regulations.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Patients will not be informed of their randomization assignment until the 1 year post implant placement follow-up visit. At this timepoint, the primary endpoint will have been achieved (at the implant placement visit) as well as the majority of the secondary endpoints. After the bone grafting surgery, all patients will receive an identic implant cart that does not break the blinding of the study. 1 year after implant placement, the patients will receive their definitive implant cart.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation",
"nctId": "NCT06383377",
"orgStudyIdInfo": {
"id": "Pre-market parallel study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure."
}
],
"secondaryOutcomes": [
{
"measure": "Assessment of the bone density at implant placement."
},
{
"measure": "Evaluation of the implant primary stability."
},
{
"measure": "Assessment of the implant osteointegration after implant placement"
},
{
"measure": "Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement"
},
{
"measure": "Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness"
},
{
"measure": "Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire."
},
{
"measure": "Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement."
},
{
"measure": "Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "EVAMED"
},
{
"name": "Pharmalex"
},
{
"name": "Advimago"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Wishbone SA"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Medication Coordinator"
}
]
},
"conditionsModule": {
"conditions": [
"Medication Administered in Error"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aabenraa",
"contacts": null,
"country": "Denmark",
"facility": "Sygehus Sønderjylland",
"geoPoint": {
"lat": 55.04434,
"lon": 9.41741
},
"state": "Southern Denmark",
"status": null,
"zip": "6200"
}
]
},
"descriptionModule": {
"briefSummary": "To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MEDCOOR",
"briefTitle": "The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment",
"nctId": "NCT06383364",
"orgStudyIdInfo": {
"id": "SHS-Pharm - 1 - 2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Reduction of potentially inappropriate medication according to Potentially Inappropriate Medication List"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of patients experiences quality of life with the EQ-5D and EQ-VAS."
},
{
"measure": "Evaluation of patients experienced quality of life with visual analogue scale (VAS)."
},
{
"measure": "Evaluation of patients experienced treatment burden with the questionnaire Multimorbidity treatment burden questionnaire (MTBQ)."
},
{
"measure": "Evaluation of patients experienced medication burden with visual analogue scale (VAS)."
},
{
"measure": "Patient readmission 30 days after hospital discharge"
},
{
"measure": "Patient contact to the ward 30 days after hospital discharge"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Peri-implant Mucositis",
"Perception",
"Survey",
"Questionnaires",
"Peri-Implantitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Siena",
"contacts": [
{
"email": "[email protected]",
"name": "Nicola Discepoli",
"phone": "3395256148",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "AOUS",
"geoPoint": {
"lat": 43.31822,
"lon": 11.33064
},
"state": null,
"status": "RECRUITING",
"zip": "53100"
}
]
},
"descriptionModule": {
"briefSummary": "Despite extensive research on periodontitis, little attention has been given to the symptoms and perception of peri-implant diseases and their impact on oral health-related quality of life. The study aims to assess patient perception of these diseases and their impact on quality of life through a cross-sectional observational study. Patients will be recruited from the Unit of Periodontics at \"Le Scotte\" University Hospital and will undergo diagnosis followed by questionnaire assessments. No follow-up visits are planned, and validated questionnaires will be administered to evaluate perception and impact on quality of life. Study procedures will include recording biometric peri-implant parameters and administering questionnaires such as the Brief Illness Perception Questionnaire (BIPQ) and Oral Health Impact Profile-14 (OHIP-14)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study",
"nctId": "NCT06383351",
"orgStudyIdInfo": {
"id": "BQ001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ)"
},
{
"measure": "Assessment of peri-implant disease's impact on the oral health-related quality of life through the Oral Health Impact Profile 14."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Siena"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Omeprazole"
},
{
"name": "Dextromethorphan"
}
]
},
"conditionsModule": {
"conditions": [
"Hodgkin Lymphoma",
"Non Hodgkin Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Melbourne",
"contacts": [
{
"email": null,
"name": "Marliese Alexander, Doctor of Philosophy",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Peter MacCallum Cancer Centre",
"geoPoint": {
"lat": -37.814,
"lon": 144.96332
},
"state": "Victoria",
"status": null,
"zip": "3000"
}
]
},
"descriptionModule": {
"briefSummary": "PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.\n\nThe study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.\n\nThe acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "PEGASUS",
"briefTitle": "A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.",
"nctId": "NCT06383338",
"orgStudyIdInfo": {
"id": "PEGASUS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of patients who consent to study and complete baseline and at least two longitudinal timepoints with successful measurement of probe drug MR (Metabolic ratio)"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of participants completing all required longitudinal blood sampling"
},
{
"measure": "Proportion of participants with successful detection of probe drug overall and at each sampling timepoint"
},
{
"measure": "Proportion of participants where phenotype can be classified according to MR overall at each sampling timepoint"
},
{
"measure": "The level of acceptability of participation in pharmacogenomic & phenoconversion testing using the PEGASUS specific survey tool (based on the Theoretical Framework of Acceptability [TFA])"
},
{
"measure": "Percentage of participants experiencing an adverse event (AE) during probe drug administration"
},
{
"measure": "Incidence of genotype and phenotype mismatch, overall and across longitudinal timepoints"
},
{
"measure": "Proportion of participants with disease staging and biomarkers of extent of disease"
},
{
"measure": "Proportion of participants with a systemic inflammatory state"
},
{
"measure": "Proportion of participants taking medications involving the CYP P450 pathway"
},
{
"measure": "Participant demographic information"
},
{
"measure": "Proportion of participants with other environmental factors"
},
{
"measure": "Longitudinal inflammatory profile of participants with Hodgkin or non-Hodgkin Lymphoma as measured by a panel including serum levels of procalcitonin, c-reactive protein and cytokine analysis."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Murdoch Childrens Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Chemotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Liver Toxicity, Chemically-Induced"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Detection of hepatotoxcicity in acute leukemia and study the outcome of acute leukemia patients that suffer from hepatic toxiciyt"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Livertoxcicity in Acute Leukemia Patients During Chemotherapy Treatment",
"nctId": "NCT06383325",
"orgStudyIdInfo": {
"id": "Livertoxcicity in AL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Detection of hepatotoxcicity in acute leukemia during chemotherapy treatment"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Reflexologic Magnetic Insole Group"
},
{
"name": "Orthopedic Insole Group"
}
]
},
"conditionsModule": {
"conditions": [
"Primary Dysmenorrhea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul Medipol University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34815"
}
]
},
"descriptionModule": {
"briefSummary": "In the study, easy-to-access and easy-to-use reflexologic magnetic insoles were used in women with primary dysmenorrhea who did not want to receive medical treatment; In addition to reducing symptoms such as pain, nausea, dizziness, fainting, vomiting, weakness, constipation/acute gastroenteritis, it is aimed to increase individuals' participation in daily life activities and increase their quality of life by increasing their emotional state."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "two groups; treatment group and sham group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Magnetic Reflexologic Insoles for Primary Dysmenorrhea",
"nctId": "NCT06383312",
"orgStudyIdInfo": {
"id": "E-10840098-772.02-4248",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "McGill Pain Questionnaire-Short Form:"
},
{
"measure": "Menstruation Attitude Questionnaire"
},
{
"measure": "Menstruation Symptom Questionnaire"
},
{
"measure": "Visual Analogue Scale (VAS)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Medipol University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Obstruvtive Sleep Apnea Syndrome (OSAS)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Yildirim Beyazıt University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate its validity and reliability of the questionarre whose original English name was \"Calgary Sleep Apnea Quality of Life Index\" which we plan to translate into Turkish as Sleep Apnea Quality of Life Index."
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},
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"measure": "Calgary Sleep Apnea Quality of Life İndex (C-SAQLI)"
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{
"measure": "Short Form 36"
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{
"measure": "Epworth Sleepiness Scale"
}
],
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},
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}
},
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}
}
}
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{
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"conditions": [
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]
},
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{
"city": "Ankara",
"contacts": null,
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"lon": 32.85427
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}
]
},
"descriptionModule": {
"briefSummary": "It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time"
},
"designModule": {
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},
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"stdAges": [
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]
},
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"id": "AnkaraYBUfby",
"link": null,
"type": null
},
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},
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{
"measure": "State-Trait Anxiety Inventory (STAI)"
},
{
"measure": "The Center for Epidemiological Studies Depression Scale (CES-D)"
},
{
"measure": "Fatigue Severity Scale"
},
{
"measure": "International Physical Activity Questionnaire short form"
},
{
"measure": "Perceived Stress Scale (PSS-14)"
}
],
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},
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},
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}
}
}
|
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{
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"interventions": [
{
"name": "MELT-300 sublingual tablet"
},
{
"name": "Midalozam sublingual tablet"
},
{
"name": "Placebo sublingual tablet"
}
]
},
"conditionsModule": {
"conditions": [
"Cataract"
]
},
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},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult participants undergoing cataract extraction with lens replacement (CELR). It will also learn about the safety of MELT-300. Researchers will compare MELT-300 to a placebo (a look-alike substance that contains no drug) to see if MELT-300 works on procedural sedation in adult participants undergoing CELR. Researchers will also include a comparator SL midazolam to confirm the benefit of inclusion of ketamine in the combined drug product.\n\nThe main questions it aims to answer are:\n\n1. Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery?\n2. To determine the effectiveness of MELT-300 compared with midazolam on procedural sedation (to determine the contribution of ketamine component and inform the risk of ketamine in MELT-300)\n3. To determine the time to achieve preoperative target sedation level with MELT-300\n4. What medical problems do participants have when taking MELT-300 vs placebo\n\nEligible participants will admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to\n\n1. MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine)\n2. Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam)\n3. Placebo (i.e. 1 matching placebo sublingual tablet)\n\nParticipants will receive study medication 30 (± 5) minutes, without food or water, before planned surgery start (defined as instillation of topical ocular anesthetic gel \\[i.e.. 3 drops of chloroprocaine hydrochloride ophthalmic gel)\\].\n\nThe effectiveness of MELT-300 will be performed after study medication is administered before surgery, in the course of surgery, and postoperative on Day 1 (end of surgery defined as just prior to drape removal). The safety of MELT-300 will be performed at baseline, in the course of surgery, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication."
},
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},
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},
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},
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}
],
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"measure": "Percentage of Participants Requiring Rescue Sedation Medication"
},
{
"measure": "Percentage of Participants Achieving Preoperative Procedural Sedation Without Need For Rescue Sedation Medication"
},
{
"measure": "Percentage of Participants Requiring Rescue Sedation Medication Preoperatively"
},
{
"measure": "Percentage of Participants Requiring Rescue Sedation Medication Intraoperatively"
},
{
"measure": "Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication"
},
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"measure": "Percentage of Participants Able to Complete the Surgery"
},
{
"measure": "Percentage of Participants Able to Complete the Surgery Without Intervention (Other Than Rescue Sedation Medication)"
},
{
"measure": "Duration to Achieve Preoperative Target Sedation (RSS level 2 or 3)"
},
{
"measure": "Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs)"
},
{
"measure": "Percentage of Participants Reporting Adverse Events Special Interest (AESIs)"
},
{
"measure": "Mean Change from Baseline in Blood Pressure (mmHg)"
},
{
"measure": "Mean Change from Baseline in Heart Rate [beats per minute (bpm)]"
},
{
"measure": "Mean Change from Baseline in Respiratory Rate (breath per minute)"
},
{
"measure": "Mean Change from Baseline in Body Temperature (degrees Fahrenheit)"
},
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"measure": "Mean Change from Baseline in Pulse Oximetry (%)"
}
]
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{
"name": "Evolution Research Group"
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{
"name": "Catalent"
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{
"name": "Pharmalex"
}
],
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{
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"name": "Behavioral diagnostic"
}
]
},
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]
},
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{
"city": "Karachi",
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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": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "transcranial magnetic stimulation"
}
]
},
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"conditions": [
"Parkinson Disease",
"Transcranial Magenetic Stimualtion",
"Supplementary Motor Area"
]
},
"contactsLocationsModule": {
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{
"city": "Hefei",
"contacts": null,
"country": "China",
"facility": "Cognitive Neuropsychology Lab Anhui Medical University",
"geoPoint": {
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"lon": 117.28083
},
"state": "Anhui",
"status": null,
"zip": "230032"
}
]
},
"descriptionModule": {
"briefSummary": "Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country."
},
"designModule": {
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},
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"phases": [
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],
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"stdAges": [
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]
},
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"id": "AMU-PD-multicenter",
"link": null,
"type": null
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"measure": "Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores"
}
],
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"measure": "Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores"
},
{
"measure": "Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores"
},
{
"measure": "Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores"
}
]
},
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},
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},
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"date": "2028-12-31"
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},
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}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LG-TAP block with local anesthetic"
},
{
"name": "LG-TAP block with saline solution"
},
{
"name": "Port site infiltration"
}
]
},
"conditionsModule": {
"conditions": [
"Pain",
"Postoperative Pain",
"Acute Pain",
"Analgesia",
"Bariatric Surgery Candidate",
"Anesthesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": null,
"country": "Italy",
"facility": "Fondazione Policlinico Universitario Campus Bio-medico",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": "00128"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo)."
},
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],
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"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "REPABS-SG",
"briefTitle": "REduced Pain After Bariatric Surgery - Sleeve Gastrectomy",
"nctId": "NCT06383234",
"orgStudyIdInfo": {
"id": "PAR 89/21",
"link": null,
"type": null
},
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},
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"measure": "Pain Score"
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],
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{
"measure": "Morphine Consumption"
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{
"measure": "Toradol Consumption"
},
{
"measure": "Nausea and/or vomiting"
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{
"measure": "Lenght of Hospital Stay"
},
{
"measure": "Time to walking"
},
{
"measure": "Time to first flatus"
},
{
"measure": "Surgical Complication"
}
]
},
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},
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},
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"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "\"Mental Fitness Boot Camp - Advanced Counseling\" Step-by-Step Care"
}
]
},
"conditionsModule": {
"conditions": [
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"Stepped Care"
]
},
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"descriptionModule": {
"briefSummary": "In this study, pregnant women were screened and managed for depression in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid/late) and randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women in the intervention group attended a three-week \"mental fitness boot camp\" and were assessed at 3 weeks, and if they still screened positive for depression, they were offered 4 times one-on-one counseling sessions by the obstetrician. The control group received routine care."
},
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"type": "ESTIMATED"
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"phases": [
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],
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"sex": "FEMALE",
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]
},
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"briefTitle": "Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy.",
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"id": "83244570",
"link": null,
"type": null
},
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},
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"measure": "Edinburgh Postnatal Depression Scale"
}
],
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"measure": "Generalized Anxiety Disorder"
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{
"measure": "World Health Organization Five-item Well-Being Index"
}
]
},
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"class": "OTHER",
"name": "Fangbiao Tao"
}
},
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},
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"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "lipid metabolomics"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Kidney Diseases",
"Coronary Heart Disease",
"Lipid Metabolism Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Chen Qiang, MD",
"phone": "+86 13882712184",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "China-Japan Friendship Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Coronary heart disease (CHD) combined with chronic kidney disease (CKD) affects a substantial portion of the population and carries a significant disease burden, often leading to poor outcomes. Despite efforts to strictly control traditional risk factors, the efficacy in improving outcomes for patients with both CHD and CKD has been limited. Recent advancements in lipid metabolism research have identified new lipid metabolites associated with the occurrence and prognosis of CHD and CKD. Our preliminary trial has shown that levels of certain lipid metabolites, such as Cer(18:1/16:0), HexCer(18:1/16:0), and PI(18:0/18:1), are notably elevated in patients with CHD and reduced kidney function compared to those with relatively normal kidney function. This suggests that dysregulation of these non-traditional lipid metabolites may contribute to residual risk for adverse outcomes in these patients.\n\nFurthermore, the emerging concept of \"cardiovascular-kidney-metabolic syndrome\" and the availability of new treatment options highlight the urgent need for a risk stratification tool tailored to modern management strategies and treatment goals to guide preventive measures effectively. To address this, we propose to conduct a prospective cohort study focusing on CHD combined with CKD. This study aims to comprehensively understand the clinical characteristics, diagnosis, treatment status, and cardiovascular-kidney prognosis in these patients. Through advanced metabolomics analysis, we seek to identify lipid metabolism profiles and non-traditional lipid metabolites associated with the progression of coronary artery disease in CHD-CKD patients. Leveraging clinical databases and metabolomics data, we will develop a robust risk prediction model for adverse cardiovascular-kidney outcomes, providing valuable guidance for clinical diagnosis, treatment decisions, and ultimately improving patient prognosis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 470,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CRUISE-MET",
"briefTitle": "Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics",
"nctId": "NCT06383208",
"orgStudyIdInfo": {
"id": "2024-ZF-13",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of cardiovascular adverse events"
},
{
"measure": "Incidence of Renal composite endpoint event"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of All-cause mortality"
},
{
"measure": "Incidence of Repeat revascularization"
},
{
"measure": "Incidence of bleeding"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "China-Japan Friendship Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Enthesitis Related Arthritis",
"Enthesitis Related Arthritis, Juvenile"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "[email protected]",
"name": "Sinan Buran, RA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Hacettepe University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis",
"nctId": "NCT06383195",
"orgStudyIdInfo": {
"id": "SBA 24/189",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ankylosing Spondylitis Performance Index (ASPI)"
}
],
"secondaryOutcomes": [
{
"measure": "Childhood Health Assessment Questionnaire (CHAQ)"
},
{
"measure": "Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)"
},
{
"measure": "Bath Ankylosing Spondylitis Functional Index (BASFI)"
},
{
"measure": "Bath Ankylosing Spondylitis Metrology Index (BASMI)"
},
{
"measure": "Modified Paediatric Mini Mental Scale (MPMMS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "endovascular treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Ischemic Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "ShenYang",
"contacts": null,
"country": "China",
"facility": "General Hospital of Northern Theater Command",
"geoPoint": {
"lat": 41.79222,
"lon": 123.43278
},
"state": null,
"status": null,
"zip": "110840"
}
]
},
"descriptionModule": {
"briefSummary": "Acute ischaemic stroke (AIS) results in high rates of neurological morbidity and mortality, especially in patients with large vessel occlusion (LVO). Endovascular therapy (EVT) has been approved as the most effective treatment for patients with LVO , but about half patients undergoing EVT did not achieve good outcome. The mechanisms of poor prognosis are complex. How to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays."
},
"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": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion",
"nctId": "NCT06383182",
"orgStudyIdInfo": {
"id": "Y (2024) 054",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "the association between cerebral circulation time (CCT) and clinical outcomes"
},
{
"measure": "the association between serum biomarkers and clinical outcomes"
},
{
"measure": "the association between serum biomarkers and status of vessel recanalization"
}
],
"primaryOutcomes": [
{
"measure": "Dynamic changes in serum biomarkers after endovascular treatment"
}
],
"secondaryOutcomes": [
{
"measure": "favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2"
},
{
"measure": "excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1"
},
{
"measure": "distribution of modified Rankin Scale (mRS) score"
},
{
"measure": "early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)"
},
{
"measure": "changes in National Institute of Health stroke scale (NIHSS)"
},
{
"measure": "symptomatic intracranial hemorrhage (sICH)"
},
{
"measure": "occurence of new stroke or other vascular events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "General Hospital of Shenyang Military Region"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zhangjiakou",
"contacts": null,
"country": "China",
"facility": "First Hospital of Zhangjiakou City",
"geoPoint": {
"lat": 40.81,
"lon": 114.87944
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 86,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction",
"nctId": "NCT06383169",
"orgStudyIdInfo": {
"id": "wanglizhong",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Comparison of general clinical data"
},
{
"measure": "Comparison of the response rate"
},
{
"measure": "Comparison of GCS scores and intracranial pressure"
},
{
"measure": "Comparison of KPS scores and satisfaction"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Hospital of Zhangjiakou City"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Double lumen endotracheal tube"
}
]
},
"conditionsModule": {
"conditions": [
"Endotracheal Tube Wrongly Placed During Anesthetic Procedure"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Use of Lung US, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT : A Comparative Study",
"nctId": "NCT06383156",
"orgStudyIdInfo": {
"id": "MD157/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope"
}
],
"secondaryOutcomes": [
{
"measure": "sensitivity and accuracy in confirming the position of the LDLT."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "no intervention"
}
]
},
"conditionsModule": {
"conditions": [
"AL Amyloidosis",
"Smoldering Multiple Myeloma",
"Monoclonal Gammopathy of Undetermined Significance"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bari",
"contacts": [
{
"email": "[email protected]",
"name": "PELLEGRINO MUSTO, MD",
"phone": "080 5593471",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "PELLEGRINO MUSTO, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Angela Minervini, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliera Policlinico Consorziale",
"geoPoint": {
"lat": 41.11148,
"lon": 16.8554
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Catania",
"contacts": [
{
"email": "[email protected]",
"name": "Francesco Di Raimondo, MD",
"phone": "095/378.1956",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Francesco Di Raimondo, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Concetta Maria Sebastiana Conticello, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco",
"geoPoint": {
"lat": 37.49223,
"lon": 15.07041
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Pavia",
"contacts": [
{
"email": "[email protected]",
"name": "GIOVANNI PALLADINI, MD, PhD",
"phone": "+390382502994",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "GIOVANNI PALLADINI, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Luca Arcaini, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mario Ulisse Nuvolone, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione Irccs Policlinico San Matteo",
"geoPoint": {
"lat": 45.19205,
"lon": 9.15917
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Torino",
"contacts": [
{
"email": "[email protected]",
"name": "FRANCESCA MARIA GAY, MD, PhD",
"phone": "011.633.5550 - 5935",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "FRANCESCA MARIA GAY, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Stefania Oliva, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "EMATOLOGIA - Città della Scienza e Salute - Torino",
"geoPoint": {
"lat": 45.07049,
"lon": 7.68682
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "We plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to:\n\n1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM)\n2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical/clinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;\n3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 760,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ProDigALIty",
"briefTitle": "Promoting Diagnosis and Management of AL in Italy (ProDigALIty)",
"nctId": "NCT06383143",
"orgStudyIdInfo": {
"id": "AC-020-IT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess proportion of patients with newly diagnosed AL identified through the biomarker-based screening of at-risk patient"
},
{
"measure": "Assess the proportion of patients with deep haematological response after frontline therapy (best response evaluation) in the new enhanced, contemporary, real-world series of AL patients enrolled during the study."
},
{
"measure": "3. Identify associations of clonal light chain features with different clinical features at baseline."
}
],
"secondaryOutcomes": [
{
"measure": "Description of the baseline characteristics and 6-months outcome, as well as the time to AL development for patients with AL identified through the biomarker-based screening"
},
{
"measure": "Description of the baseline characteristics of MGUS/SMM patients with abnormal FLCR"
},
{
"measure": "Identification of clinical and biological correlates of hematological response"
},
{
"measure": "To verify whether implementing a dedicated pipeline for referral of AL patients to the National Referral Center will increase the proportion of patients from spoke centers"
},
{
"measure": "Identification of associations of clonal light chain features with event-free survival"
},
{
"measure": "Validation of existing algorithms for predicting AL amyloidosis status"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Policlinico S. Matteo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oscillometry with reversibility testing"
},
{
"name": "Breath volatile testing"
},
{
"name": "Nasal eosinophil peroxidase"
},
{
"name": "Handheld capnometry"
}
]
},
"conditionsModule": {
"conditions": [
"Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": null,
"country": "United Kingdom",
"facility": "Imperial College Healthcare NHS Trust",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "W2 1PG"
},
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Eleanor Quek, MBBS",
"phone": "07411429994",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Salman Siddiqui, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Salman Siddiqui, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Imperial College Healthcare NHS Trust",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": null,
"zip": "W21NY"
},
{
"city": "Nottingham",
"contacts": [
{
"email": "[email protected]",
"name": "Matthew Martin, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Matthew Martin, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Nottingham University Hospitals NHS Trust",
"geoPoint": {
"lat": 52.9536,
"lon": -1.15047
},
"state": null,
"status": null,
"zip": "NG7 2UH"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is:\n\n- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO?\n\nResearchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results.\n\nParticipants will\n\n* Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit\n* Optionally participate in our sub-studies on new breath and nasal swab tests for asthma\n* Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 225,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LADS",
"briefTitle": "London Asthma Diagnostics Study",
"nctId": "NCT06383130",
"orgStudyIdInfo": {
"id": "24SM8792",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis"
},
{
"measure": "To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX)"
},
{
"measure": "To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device"
}
],
"primaryOutcomes": [
{
"measure": "To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO"
}
],
"secondaryOutcomes": [
{
"measure": "To conduct an analysis comparing the diagnostic accuracy of (i) oscillometry ± reversibility with spirometry ± reversibility, (ii) spirometry±reversibility with FeNO and (iii) oscillometry ±reversibility and FeNO"
},
{
"measure": "To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO)"
},
{
"measure": "To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Asthma UK"
},
{
"name": "General Practitioners Research Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Imperial College London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Calcium carbonate"
},
{
"name": "Placebo Control"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy",
"Adult",
"Calcium",
"Bone Resorption",
"Endocrine; Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Athens",
"contacts": null,
"country": "United States",
"facility": "University of Georgia Clinical and Translational Research Unit",
"geoPoint": {
"lat": 33.96095,
"lon": -83.37794
},
"state": "Georgia",
"status": null,
"zip": "30606"
}
]
},
"descriptionModule": {
"briefSummary": "The study team is inviting 13 healthy people to complete a study to explore how calcium affects hormones and bones after eating. Participants will be asked to complete two study visits within eight weeks. Before each visit, participants will be asked to not eat or drink (except water) for 9 hours. At each visit, participants will eat the same meal provided by the research team. Along with their meal, they will take a pill - in one session, this will be a calcium supplement, and in the other, a placebo (a pill with no calcium), but they won't know which one they are taking at which session. A phlebotomist will draw blood before the meal and pill, then again several times after eating. Blood draws will take place over three hours. During that time, participants will complete questionnaires about health, diet, and physical activity.\n\nBlood will be analyzed to check on various health indicators, like bone health markers and certain hormones, to see how they change after the meal. The difference in these health indicators between the calcium and placebo sessions will help the study team understand the impact of calcium on health after eating. This could help increase knowledge of the impact of calcium on hormones and bone health."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Randomized placebo crossover trial",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Investigator, participants, team distributing pills blinded to treatment arm",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 14,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Understanding Effects of Calcium on the Gut-Bone Axis",
"nctId": "NCT06383117",
"orgStudyIdInfo": {
"id": "UL1TR002378",
"link": "https://reporter.nih.gov/quickSearch/UL1TR002378",
"type": "NIH"
},
"secondaryIdInfos": [
{
"domain": null,
"id": "KL2TR002381",
"link": "https://reporter.nih.gov/quickSearch/KL2TR002381",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Difference in insulin area under the curve between calcium and placebo"
},
{
"measure": "Difference in glucose area under the curve between calcium and placebo"
},
{
"measure": "Difference in PTH (parathyroid hormone) area under the curve between calcium and placebo"
}
],
"primaryOutcomes": [
{
"measure": "Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo"
},
{
"measure": "Difference in GLP-1 (glucagon-like peptide 1) area under the curve between calcium and placebo"
}
],
"secondaryOutcomes": [
{
"measure": "Difference in CTX (carboxy-terminal collagen crosslinks) area under the curve between calcium and placebo"
},
{
"measure": "Difference in P1NP (N-terminal propeptide) area under the curve between calcium and placebo"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Center for Advancing Translational Sciences (NCATS)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Georgia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"System; Lupus Erythematosus"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Murcia",
"contacts": [
{
"email": "[email protected]",
"name": "RUBEN CUESTA-BARRIUSO, PhD",
"phone": "+34 968278545",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Universidad Católica San Antonio, Murcia",
"geoPoint": {
"lat": 37.98704,
"lon": -1.13004
},
"state": null,
"status": "RECRUITING",
"zip": "30107"
}
]
},
"descriptionModule": {
"briefSummary": "Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.\n\nObjective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.\n\nMethods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.\n\nExpected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus.",
"nctId": "NCT06383104",
"orgStudyIdInfo": {
"id": "MyoLupus",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline joint pain after treatment and at 4 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline functional capacity after treatment and at 4 weeks"
},
{
"measure": "Change from baseline functionality after treatment and at 4 weeks"
},
{
"measure": "Change from baseline joint pain after treatment and at 4 weeks"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidad Católica San Antonio de Murcia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Anterior Neck Manual Therapy"
},
{
"name": "Pain Neuroscience Education"
},
{
"name": "Neck Stretches"
},
{
"name": "Scar massage"
},
{
"name": "Voice Exercises"
},
{
"name": "Placebo Anterior Neck Manual Therapy"
},
{
"name": "Placebo Pain Neuroscience Education"
},
{
"name": "Placebo Neck Stretches"
}
]
},
"conditionsModule": {
"conditions": [
"Total Thyroidectomy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Claire Ligon, Masters of Education",
"phone": "434-390-6387",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kristine Pietsch, Masters of Arts",
"phone": "518-461-3610",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Claire Ligon, Masters of Education",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Kristine Pietsch, Masters of Arts",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Michelle Wilson, Masters of Science",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Johns Hopkins Hospital",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": null,
"zip": "21287"
},
{
"city": "Bethesda",
"contacts": [
{
"email": "[email protected]",
"name": "Claire Ligon, Masters of Education",
"phone": "434-390-6387",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Vaninder Dhillon, Medical Doctor",
"phone": "925-360-5939",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Vaninder Dhillon, Medical Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Claire Ligon, Masters of Education",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Michelle Wilson, Masters of Science",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Suburban Hospital",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland",
"status": null,
"zip": "20817"
}
]
},
"descriptionModule": {
"briefSummary": "In this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone.\n\nThe main questions it aims to answer are:\n\nWill neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy?\n\nWill neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy?\n\nWill neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy?\n\nWill neck massage, stretches and pain science education improve quality of life after total thyroidectomy?\n\nParticipants will:\n\nParticipate in 4 visits with the participant's endocrine/laryngology surgeon. One prior and 3 after surgery for endoscopic evaluation and tests.\n\nParticipate in 5 Speech-Language Pathology Sessions for intervention exercises and tests. One prior and 4 after surgery.\n\nComplete a journal of the participant's Home Exercise Practice"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is meant to be a parallel study. However, The Speech Language Pathologists will not be blinded as the Speech Pathologists are providing each regimen. If a participant in either group requires more intensive sessions or a differing regimen given the severity of complaints, the participants will receive it as per the recommendation of the Speech-Language Pathologist so as not to unblind the PI. An intent to treat analysis will be performed to accurately describe the data in the case of crossover and/or dropout.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Man Total Thy",
"briefTitle": "Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy",
"nctId": "NCT06383091",
"orgStudyIdInfo": {
"id": "IRB00380938",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acoustic measures of voice clarity"
},
{
"measure": "Acoustic measures of speaking voice pitch"
},
{
"measure": "Acoustic measures of speaking voice quality subjectively"
},
{
"measure": "Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10"
},
{
"measure": "Laryngeal sensation"
},
{
"measure": "Scar Tethering Distance"
},
{
"measure": "Scar Quality as assessed by The Patient and Observer Scar Assessment Scale"
},
{
"measure": "Voice Quality of Life as measures by the Voice Related Quality of Life - 10"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse Effects in the Experimental Group"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Johns Hopkins University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HR070803"
},
{
"name": "Oxaliplatin"
},
{
"name": "Tegafur"
},
{
"name": "Folinic acid"
},
{
"name": "5-Fluorouracil"
}
]
},
"conditionsModule": {
"conditions": [
"Efficacy and Safety"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer",
"nctId": "NCT06383078",
"orgStudyIdInfo": {
"id": "MA-PC-II-012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "1-year Disease-free survival rate"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "Disease-free survival（DFS）"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital with Nanjing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IMT Group"
}
]
},
"conditionsModule": {
"conditions": [
"Type 2 Diabetes",
"Bariatric Surgery Candidate"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nicosia",
"contacts": null,
"country": "Cyprus",
"facility": "Near East University",
"geoPoint": {
"lat": 35.17531,
"lon": 33.3642
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate the early effects of Inspiratory Muscle Training (IMT) applied before and after bariatric surgery on respiratory function, respiratory muscle strength and functional capacity in individuals with type 2 diabetes.\n\nThe study will be conducted with 40 individuals with type 2 diabetes aged between 25-65. Individuals will be randomly assigned to the IMT (trained at 30% of maximum inspiratory pressure with an IMT threshold device) and control group. As measurement parameters, a 6-minute walk test for functional capacity, a spirometry test for respiratory function, and a portable device (Cosmed Pony FX Desktop Spirometer, USA) will be used for respiratory muscle strength. Hand grip strength will be measured with a Baseline dynamometer. All measurements will be repeated on the first day before surgery and on the fourth day before discharge after surgery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery",
"nctId": "NCT06383065",
"orgStudyIdInfo": {
"id": "YDU/2020/76-1007",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Respiratory Muscle Strength"
},
{
"measure": "Respiratory Function"
},
{
"measure": "Functional Capacity: The 6-minute walk test"
},
{
"measure": "Hand Grip Strength"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Near East University, Turkey"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "177Lu-NYM032 injection"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Castration-resistant Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuxi",
"contacts": [
{
"email": "[email protected]",
"name": "Chunjing Yu",
"phone": "15312238622",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Affliated Hospital of Jiangnan University",
"geoPoint": {
"lat": 31.56887,
"lon": 120.28857
},
"state": null,
"status": "RECRUITING",
"zip": "214000"
}
]
},
"descriptionModule": {
"briefSummary": "177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with strong affinity for PSMA."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC",
"nctId": "NCT06383052",
"orgStudyIdInfo": {
"id": "NYM032Z01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Patients With Dose Limiting Toxicity (DLT)"
},
{
"measure": "Maximum Tolerated Dose (MTD)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Norroy Bioscience Co., LTD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
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"date": "2024-11-30"
},
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"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcranial Direct Current Stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Balance"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul Medipol University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Beykoz",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The study will be carried out at Istanbul Medipol University. 30 healthy individuals between the ages of 18-25 will be included. To each individual Anodal-supplementary motor area tDCS, Anodal-cerebellar tDCS, Sham tDCS applications will be cross-applied. tDCS application will take 20 minutes and each individual will receive 3 sessions in total. There will be a 72-hour rest period between sessions. Individuals assessed with Demographic Information Form for demographic information, Wii-Fit and Balance Error Scoring System for Static Balance Evaluation, Star Balance Test and Timed Get Up and Go Test for Dynamic Balance Assessment. The aim of this study is to investigate the effect of transcranial direct current stimulation applied on the supplementary motor area and cerebellum on static and dynamic balance in healthy individuals."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "All participants received 3 different interventions at different times.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Participants were not informed which type of current was applied.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "tDCS",
"briefTitle": "Transcranial Direct Current Stimulation and Balance",
"nctId": "NCT06383039",
"orgStudyIdInfo": {
"id": "ZSoy",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Demographic Information Form"
},
{
"measure": "Wii-Fit"
},
{
"measure": "balance error scoring system"
},
{
"measure": "star excursion balance test"
},
{
"measure": "Time Up & Go Test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zeynep Soy"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-05-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-09-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Breast Cancer Screening"
},
{
"name": "Survey/Interview"
},
{
"name": "Focus Group"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milwaukee",
"contacts": [
{
"email": "[email protected]",
"name": "Chandler S Cortina, MD, MS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Medical College of Wisconsin",
"geoPoint": {
"lat": 43.0389,
"lon": -87.90647
},
"state": "Wisconsin",
"status": "RECRUITING",
"zip": "53226"
}
]
},
"descriptionModule": {
"briefSummary": "This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 130,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Transgender and Gender-Diverse Breast Cancer Screening Pilot",
"nctId": "NCT06383026",
"orgStudyIdInfo": {
"id": "PRO00047199",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Callback and Biopsy Rates after Breast Cancer Screening"
},
{
"measure": "Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Transgender and Gender Diverse Persons"
},
{
"measure": "Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical College of Wisconsin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BB-101"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetic Foot Ulcer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": [
{
"email": null,
"name": "Shug-Cheng Chang, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase II Study of BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers",
"nctId": "NCT06383013",
"orgStudyIdInfo": {
"id": "BB-101-BBCBB1A",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Exploratory Objectives"
}
],
"primaryOutcomes": [
{
"measure": "Efficacy Evaluation"
}
],
"secondaryOutcomes": [
{
"measure": "Safety Evaluation"
},
{
"measure": "Secondary Efficacy Evaluation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Blue Blood Biotech Corp."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"General Anesthesia",
"Blood Pressure",
"Pulse Rate",
"Arterial Line"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter monitoring.\n\nResearchers will compare blood pressure data derived from MOH200 to the invasive blood pressure (IBP) data to see if the MOH200 is effective to measure the blood pressure of a surgical person. Also, researchers will compare pulse rate data drived from MOH200 to that from the pulse oximeter to see if the MOH200 is effective to measure the pulse rate of a surgical person.\n\nParticipants will be asked to be applied with MOH200 monitoring while IBP monitoring and pulse oximeter are applied. And after 30 minutes of the surgery, researchers will monitor the adverse effects occurred on the skin of participants to assess the safety of MOH200."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
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},
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"count": 55,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of Effectiveness of Continuous Non-invasive Haemodynamic Monitor by Compared to Invasive Blood Pressure and Pulse Oximeter Monitoring on Patients Undergoing General Anesthesia Surgeries for More Than 60 Minutes",
"nctId": "NCT06383000",
"orgStudyIdInfo": {
"id": "BLZ2024MOH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Continuous Non -invasive Blood Pressure Measurement from MOH200"
},
{
"measure": "Invasive Blood Pressure Measurement from Arterial Line"
},
{
"measure": "Pulse Rate Measurement from MOH200"
},
{
"measure": "Pulse Rate Measurement from Pulse Oximeter"
}
],
"secondaryOutcomes": [
{
"measure": "The Occurrence of Pressure Pores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "BLZ Technology (Wuhan) Co.,Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Deucravacitinib"
},
{
"name": "Apremilast"
}
]
},
"conditionsModule": {
"conditions": [
"Plaque Psoriasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Minato-ku",
"contacts": [
{
"email": null,
"name": "Minoru Tonogai, Site 0001",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Japan",
"facility": "Mebix. Inc.",
"geoPoint": {
"lat": 34.2152,
"lon": 135.1501
},
"state": "Tokyo",
"status": "RECRUITING",
"zip": "1070052"
},
{
"city": "Fukuoka",
"contacts": null,
"country": "Japan",
"facility": "Fukuoka University Hospital",
"geoPoint": {
"lat": 33.6,
"lon": 130.41667
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RePhlect",
"briefTitle": "A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)",
"nctId": "NCT06382987",
"orgStudyIdInfo": {
"id": "IM011-1124",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib."
},
{
"measure": "Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up"
},
{
"measure": "Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up"
},
{
"measure": "Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up"
},
{
"measure": "Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast"
},
{
"measure": "Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up"
},
{
"measure": "Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up"
},
{
"measure": "Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up"
},
{
"measure": "Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up"
},
{
"measure": "Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up"
},
{
"measure": "Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up"
},
{
"measure": "Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up"
},
{
"measure": "Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up"
},
{
"measure": "Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up"
},
{
"measure": "Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up"
},
{
"measure": "Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up"
},
{
"measure": "Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up"
},
{
"measure": "Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bristol-Myers Squibb"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cyst enucleation and bone grafting"
}
]
},
"conditionsModule": {
"conditions": [
"Infection",
"Bone Loss"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": "23634965",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Cairo University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "A case series study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP",
"nctId": "NCT06382974",
"orgStudyIdInfo": {
"id": "3-3-14",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Shrinkage Rate"
}
],
"secondaryOutcomes": [
{
"measure": "Inflammation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexmedetomidine injection"
},
{
"name": "Sufentanil injection"
}
]
},
"conditionsModule": {
"conditions": [
"Delirium in Old Age",
"Anesthesia; Adverse Effect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kunming",
"contacts": null,
"country": "China",
"facility": "Kunming Children's Hospital",
"geoPoint": {
"lat": 25.03889,
"lon": 102.71833
},
"state": "Yunnan",
"status": null,
"zip": "650100"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :\n\n1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?\n2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.\n\nParticipants will undergo routine postoperative care:\n\n1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine\n2. Postoperative visit twice a day for at least seven days"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 287,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postoperative Dexmedetomidine in Prevention of Postoperative Delirium",
"nctId": "NCT06382961",
"orgStudyIdInfo": {
"id": "SZUS_231101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of postoperative delirium"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of postoperative nausea and vomiting"
},
{
"measure": "incidence of postoperative complications"
},
{
"measure": "Pain intensities"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shenzhen People's Hospital"
},
{
"name": "Dongyuan People's Hospital"
},
{
"name": "Kunming Children's Hospital"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-25"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Everolimus"
},
{
"name": "Elacestrant"
},
{
"name": "Placebo"
},
{
"name": "Auxiliary Medicinal Product - Dexamethasone"
},
{
"name": "Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Breast Cancer",
"ER-positive Breast Cancer",
"HER2-negative Breast Cancer",
"ESR1 Gene Mutation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.\n\nThe main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.\n\nRigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Double-blind, parallel group (two arms: elacestrant plus everolimus, and elacestrant plus placebo).",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "A blinded, independent IRC will perform a review of radiographic images and clinical information collected on study to determine the protocol-defined endpoints of disease response and progression. Further information on the independent review process will be provided in the BIRC Charter.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ADELA",
"briefTitle": "Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.",
"nctId": "NCT06382948",
"orgStudyIdInfo": {
"id": "MedOPP545",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2024-512926-27-00",
"link": null,
"type": "CTIS"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Exploratory endpoint: protein expression studies using blood samples to investigate the potential association with clinical outcomes."
},
{
"measure": "Exploratory endpoint: analysis of allele mutation frequencies in circulating tumor DNA (ctDNA) in blood samples to investigate the potential association with clinical outcomes."
},
{
"measure": "Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes."
},
{
"measure": "Exploratory endpoint: Analysis of medical imaging (radiomics) to identify potential biomarkers associated with clinical outcomes."
},
{
"measure": "Exploratory endpoint: Pharmacokinetic (PK) parameter of maximum (Peak) Observed Serum Concentration (Cmax)."
},
{
"measure": "Exploratory endpoint: Pharmacokinetic (PK) parameter of Plasma Through Concentration (Ctrough)."
}
],
"primaryOutcomes": [
{
"measure": "To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients)."
}
],
"secondaryOutcomes": [
{
"measure": "To compare overall survival (OS) between treatment groups, in all patients."
},
{
"measure": "To compare investigator-assessed PFS based on local assessment between treatment groups, in all patients."
},
{
"measure": "To compare objective response rate (ORR) between treatment groups, in all patients."
},
{
"measure": "To compare clinical benefit rate (CBR) between treatment groups, in all patients."
},
{
"measure": "To compare overall time to response (TTR) between treatment groups, in all patients."
},
{
"measure": "To compare duration of response (DoR) between treatment groups, in all patients."
},
{
"measure": "To compare best percentage of change in tumor burden between treatment groups, in all patients."
},
{
"measure": "To describe the changes in health-related quality-of-life (HRQoL) from baseline using the EuroQoL 5 Dimension 5 Level (EQ-5D-5L) scale."
},
{
"measure": "To describe the changes in HRQoL from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)."
},
{
"measure": "To describe the changes in HRQoL from baseline using the EORTC Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR45)."
},
{
"measure": "To assess adverse events (AEs) between treatment groups in all patients."
},
{
"measure": "To assess adverse events leading to study treatment withdrawal."
},
{
"measure": "To assess adverse events leading to dose modification."
},
{
"measure": "To assess the number of participants with abnormal hematology and/or chemistry values that are related to treatment."
},
{
"measure": "To assess the number of participants with changes on vital signs and/or AEs that are related to treatment."
},
{
"measure": "To assess the number of participants with changes on cardiac function measured by ECG QT Interval Corrected by Fridericia formula (QTcF) that are related to treatment effect ."
},
{
"measure": "To assess the number of participants with changes on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) that are related to treatment."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Stemline Therapeutics, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "MedSIR"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Probin Pocket Depth reduction"
}
]
},
"conditionsModule": {
"conditions": [
"Periodontitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Catania",
"contacts": [
{
"email": "[email protected]",
"name": "Gaetano Isola, DDS",
"phone": "0953785652",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "AOU Policlinico G. Rodolico",
"geoPoint": {
"lat": 37.49223,
"lon": 15.07041
},
"state": null,
"status": "RECRUITING",
"zip": "95124"
}
]
},
"descriptionModule": {
"briefSummary": "A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Sealed envelopes",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Non-surgical Periodontal Treatment of miRNome",
"nctId": "NCT06382935",
"orgStudyIdInfo": {
"id": "34-24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Probing Pocket Depth"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Catania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Invasive Aspergillosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Maria Ilaria Del Principe",
"phone": "3394080659",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Tor Vergata University",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "RM",
"status": "RECRUITING",
"zip": "00133"
}
]
},
"descriptionModule": {
"briefSummary": "In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a \"real life\" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA \\[43 probable (1.7%) and 13 proven (0.5%)\\]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC).\n\nThe investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course.\n\nIn SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy",
"nctId": "NCT06382922",
"orgStudyIdInfo": {
"id": "PAPAML022019",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients"
}
],
"secondaryOutcomes": [
{
"measure": "overall mortality rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Rome Tor Vergata"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
{
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-03-22",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 369916,
"typeAbbrev": "Prot",
"uploadDate": "2024-04-18T21:12"
},
{
"date": "2024-03-22",
"filename": "ICF_001.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 192688,
"typeAbbrev": "ICF",
"uploadDate": "2024-04-16T10:55"
}
]
}
}
| false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Inflammatory level"
},
{
"name": "Cognitive assessment"
},
{
"name": "Pedagogical assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Vitoria",
"contacts": null,
"country": "Brazil",
"facility": "Gon1 P&D",
"geoPoint": {
"lat": -20.31944,
"lon": -40.33778
},
"state": "ES",
"status": null,
"zip": "29050335"
},
{
"city": "Vitória",
"contacts": null,
"country": "Brazil",
"facility": "Gon1 gestora de Projetos",
"geoPoint": {
"lat": -20.31944,
"lon": -40.33778
},
"state": "ES",
"status": null,
"zip": "29050335"
}
]
},
"descriptionModule": {
"briefSummary": "The research is characterized as a randomized, double-blind clinical trial (phase III) in which administered the probiotic K11-T (with and without added amino acids, fatty acids and vitamins) to children between 3 and 11 years old with Autism Spectrum Disorder - ASD, being subsequently assessed outcomes related to inflammatory markers and neuropsychiatric and sociopedagogical criteria. To this end, the study will create three groups, one of which will be a control group, which will receive a placebo, the other will receive the probiotic without micronutrients and another will receive the probiotic with added nutrients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Double blind, randomized, with placebo control",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 505,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "ASD",
"briefTitle": "Effect of Probiotic Compound K11T e K11TMax in ASD",
"nctId": "NCT06382909",
"orgStudyIdInfo": {
"id": "202302",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax."
}
],
"primaryOutcomes": [
{
"measure": "Inflammation biomarker 1"
},
{
"measure": "Inflammation biomarker 2"
},
{
"measure": "Inflammation biomarker 3"
},
{
"measure": "Inflammation biomarker 4"
},
{
"measure": "Inflammation biomarker 5"
},
{
"measure": "Neuropsychological Assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Psychiatric Assessment"
},
{
"measure": "Psychopedagogical Assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "SENAI CIMATEC"
}
],
"leadSponsor": {
"class": "NETWORK",
"name": "Deivis de Oliveira guimaraes"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Rebound Pain",
"Arthroscopic Knee Surgery",
"Oliceridine"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xiamen",
"contacts": [
{
"email": "[email protected]",
"name": "Bin Yang, doctor",
"phone": "13859986036",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "First Affiliated Hospital of Xiamen University",
"geoPoint": {
"lat": 24.47979,
"lon": 118.08187
},
"state": "Fujian",
"status": "RECRUITING",
"zip": "361000"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 320,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Oliceridine on Rebound Pain",
"nctId": "NCT06382896",
"orgStudyIdInfo": {
"id": "FirstAHXiamenU-YB-2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time of onset of postoperative rebound pain"
},
{
"measure": "The duration of the rebound pain"
},
{
"measure": "The degree of the rebound pain"
},
{
"measure": "age"
},
{
"measure": "sex"
},
{
"measure": "Surgical procedure"
},
{
"measure": "Previous surgical history"
}
],
"secondaryOutcomes": [
{
"measure": "Movement recovery time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital of Xiamen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Individually tailored lifestyle and physical activity intervention"
},
{
"name": "Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS)"
}
]
},
"conditionsModule": {
"conditions": [
"Obstructive Sleep Apnea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jyväskylä",
"contacts": [
{
"email": "[email protected]",
"name": "Merja Perhonen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Antti Saarinen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Finland",
"facility": "Central Finland Hospital District",
"geoPoint": {
"lat": 62.24147,
"lon": 25.72088
},
"state": null,
"status": "RECRUITING",
"zip": "40620"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea (OSA), physical activity (PA) levels and sedentary behavior (SB), as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP. Emphasis of the individually tailored SEMC-intervention (protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland) is on increasing the amount of total physical activity.\n\nThe main questions the trial aims to answer are:\n\n* Can individually tailored lifestyle intervention, in combination with CPAP therapy, alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA?\n* Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life, increase physical functioning, change body composition, and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA?\n* Can enhanced behavioral support (EBS), when integrated with lifestyle intervention and CPAP therapy, lead to more substantial and enduring changes in participants' levels of physical activity or sedentary behavior?\n\nParticipants will be randomized to either SEMC-intervention group, combination of SEMC-intervention and EBS, or to a control group.\n\nIn this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms, improve their quality of life, body composition and physical functioning, as well as increase physical activity levels and decrease their sedentary behavior compared to the control group. In addition, it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels, and decrease their sedentary behavior to a greater extent, and these changes will be more sustained compared to merely SEMC-intervention or control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ELO",
"briefTitle": "Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment",
"nctId": "NCT06382883",
"orgStudyIdInfo": {
"id": "FINELO2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in apnea-hypopnea-index (AHI)"
}
],
"secondaryOutcomes": [
{
"measure": "Change on sleep apnea symptoms"
},
{
"measure": "Change in the mean daily total light physical activity time"
},
{
"measure": "Change in the mean daily total moderate to vigorous (MVPA) physical activity time"
},
{
"measure": "Change in the mean daily total sedentary time"
},
{
"measure": "Change in 6-minute walk distance (6MWD) in meters"
},
{
"measure": "Change in hand grip strength in kilograms"
},
{
"measure": "Change in waist circumference in centimeters"
},
{
"measure": "Change in body weight in kilograms"
},
{
"measure": "Change in visceral fat area (VFA) in square centimeters"
},
{
"measure": "Change in muscle mass in kilograms"
},
{
"measure": "Change in Quality of Life RAND 36-Item Health Survey"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Jyvaskyla"
},
{
"name": "Organisation for Respiratory Health in Finland"
},
{
"name": "Central Finland Hospital District"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Filha ry"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "education"
}
]
},
"conditionsModule": {
"conditions": [
"Simulation-based Training"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Child abuse and neglect is a broad structure that includes physical abuse, sexual abuse, emotional abuse and neglect. Child neglect and abuse is one of the primary areas of responsibility of health professionals, which negatively affects child health and threatens public health in the long term. All healthcare professionals are legally obligated to report known or suspected cases of child abuse and neglect. Health professionals, in particular, play an important role in stopping child abuse by assessing children, identifying risk factors, and reporting suspected child maltreatment to authorities. Early diagnosis of a neglected and abused child is important in reducing the recurrence of maltreatment.\n\nRegarding the evaluation of child neglect and abuse, healthcare professionals should approach a child who presents with suspicious injuries, thinking that he or she may be abused. The key here is to be aware of the problem. Health professionals should carefully examine children and fulfill their responsibilities by identifying possible clues to abuse and neglect. It is recommended that clues to recognize neglect and abuse be taught within the scope of in-service training for healthcare professionals working in hospitals."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Simulation-Based Training for Child Neglect and Abuse",
"nctId": "NCT06382870",
"orgStudyIdInfo": {
"id": "107.2023fbu",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The awareness level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fenerbahce University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MDF"
},
{
"name": "RUTF"
},
{
"name": "RUSF"
}
]
},
"conditionsModule": {
"conditions": [
"Malnutrition, Child"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Maradi",
"contacts": [
{
"email": "[email protected]",
"name": "Ousmane Guindo, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ibrahim Ngoumboute, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Niger",
"facility": "Epicentre Niger",
"geoPoint": {
"lat": 13.5,
"lon": 7.10174
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \\< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 7356,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "23 Months",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition",
"nctId": "NCT06382857",
"orgStudyIdInfo": {
"id": "823779-MDF Niger",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Programmatic recovery by 12 weeks from admission"
},
{
"measure": "Sustained recovery at 24 weeks from admission"
}
],
"secondaryOutcomes": [
{
"measure": "Default"
},
{
"measure": "Non-response"
},
{
"measure": "Time to recovery"
},
{
"measure": "For MAM children: Deterioration to SAM"
},
{
"measure": "Change in weight gain"
},
{
"measure": "Change in weight-for-length Z (WLZ)"
},
{
"measure": "Change in length-for-age Z (LAZ)"
},
{
"measure": "Change in weight-for-age Z (WAZ)"
},
{
"measure": "Change in MUAC"
},
{
"measure": "Serious adverse events"
},
{
"measure": "Hospitalization"
},
{
"measure": "Death"
},
{
"measure": "Motor, cognitive, language, social-emotional, and mental health skills"
},
{
"measure": "Cost effectiveness"
},
{
"measure": "Dietary intake"
},
{
"measure": "Adherence"
},
{
"measure": "Microbiome profile at enrollment, week 4, program discharge, and study discharge"
},
{
"measure": "Plasma proteome profile at enrollment, week 4, program discharge, and study discharge"
},
{
"measure": "Environmental enteric dysfunction at enrollment, program discharge, and study discharge"
},
{
"measure": "Change of fat mass and fat-free mass at program discharge and study discharge"
},
{
"measure": "Micronutrient status at enrollment, program discharge and study discharge"
},
{
"measure": "Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Epicentre, Niger"
},
{
"name": "National Nutrition Direction, Niger"
},
{
"name": "Ministry of Public Health and Social Affairs, Niger"
},
{
"name": "Regional Direction of Public Health, Maradi"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Epicentre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS)."
}
]
},
"conditionsModule": {
"conditions": [
"Cutaneous T-Cell Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salamanca",
"contacts": [
{
"email": "[email protected]",
"name": "Ricardo López Pérez, PhD",
"phone": "+34 923 29 12 00",
"phoneExt": "55144",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Esperanza López Franco, PhD",
"phone": "+34 923 29 12 00",
"phoneExt": "55779",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Instituto de Investigación Biomédica de Salamanca (IBSAL)",
"geoPoint": {
"lat": 40.96882,
"lon": -5.66388
},
"state": null,
"status": "RECRUITING",
"zip": "37007"
}
]
},
"descriptionModule": {
"briefSummary": "Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry)."
},
"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": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL",
"nctId": "NCT06382844",
"orgStudyIdInfo": {
"id": "PI23/00486",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Ethics Committee for Drug Research of the Salamanca Health Area",
"id": "PI2023 08 1416",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Carlos III Health Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Instituto de Investigación Biomédica de Salamanca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexmedetomidine"
},
{
"name": "Fentanyl"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia and Analgesia",
"Anesthesia, Endotracheal"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 104,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery",
"nctId": "NCT06382831",
"orgStudyIdInfo": {
"id": "IndonesiaU240201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative nausea and vomiting (PONV)"
},
{
"measure": "Pain score"
},
{
"measure": "Time to laryngeal mask exertion"
},
{
"measure": "Adverse effect"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "COHORT A"
},
{
"name": "COHORT B"
},
{
"name": "COHORT C"
},
{
"name": "COHORT D"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montpellier",
"contacts": [
{
"email": "[email protected]",
"name": "MOUSSION AURORE",
"phone": "0467613102",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "AZRIA DAVID",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "MEGE ALICE",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "BRETON-CALLU CHRISTEL",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Institut Du Cancer de Montpellier",
"geoPoint": {
"lat": 43.61092,
"lon": 3.87723
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "* COHORT A = Low risk of recurrence / Low risk of breast toxicity\n* COHORT B = Low risk of recurrence / High risk of breast toxicity\n* COHORT C = High risk of recurrence / Low risk of breast toxicity\n* COHORT D = High risk of recurrence / High risk of breast toxicity",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 854,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROBA",
"briefTitle": "Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability",
"nctId": "NCT06382818",
"orgStudyIdInfo": {
"id": "PROICM 2023-10 PRO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma"
}
],
"secondaryOutcomes": [
{
"measure": "Acute toxicity"
},
{
"measure": "Late toxicity"
},
{
"measure": "Local recurrence rate (LRR)"
},
{
"measure": "Relapse-free survival (RFS) rate"
},
{
"measure": "Overall survival (OS) rate"
},
{
"measure": "Radiation-induced Breast Sarcoma prevalence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Institut du Cancer de Montpellier - Val d'Aurelle"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2036-04-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-26"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physiotherapy program"
},
{
"name": "Kinesio Tape"
},
{
"name": "High Intensity Laser therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Tennis Elbow",
"Physical Therapy",
"Kinesiotaping",
"Laser"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gaziantep",
"contacts": null,
"country": "Turkey",
"facility": "Hasan Kalyoncu University",
"geoPoint": {
"lat": 37.05944,
"lon": 37.3825
},
"state": null,
"status": null,
"zip": "27000"
}
]
},
"descriptionModule": {
"briefSummary": "Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "There are three groups in the study. The groups consist of the control group, kinesio tape group and high intensity laser group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis",
"nctId": "NCT06382805",
"orgStudyIdInfo": {
"id": "HasanKU_FTR_AA_02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Measurement"
},
{
"measure": "Hand grip strength"
},
{
"measure": "Patient-Rated Tennis Elbow Evaluation"
}
],
"secondaryOutcomes": [
{
"measure": "Pain Sensitivity Measurement"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hasan Kalyoncu University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "proximal humeral resection for tumor and allograft prosthetic composite reconstruction"
}
]
},
"conditionsModule": {
"conditions": [
"Shoulder Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nancy",
"contacts": null,
"country": "France",
"facility": "Central Hopital",
"geoPoint": {
"lat": 48.68439,
"lon": 6.18496
},
"state": null,
"status": null,
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).\n\nThe results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 6,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors",
"nctId": "NCT06382792",
"orgStudyIdInfo": {
"id": "2024PI059",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Osteolysis (bone stock in cm3)"
}
],
"secondaryOutcomes": [
{
"measure": "Constant score"
},
{
"measure": "Complications"
},
{
"measure": "Revision"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Central Hospital, Nancy, France"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "reverse shoulder arthroplasty"
}
]
},
"conditionsModule": {
"conditions": [
"Shoulder Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nancy",
"contacts": null,
"country": "France",
"facility": "CHRU - Centre chirurgical emile galle",
"geoPoint": {
"lat": 48.68439,
"lon": 6.18496
},
"state": null,
"status": null,
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite",
"nctId": "NCT06382779",
"orgStudyIdInfo": {
"id": "2024PI057",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Constant score"
}
],
"secondaryOutcomes": [
{
"measure": "complication"
},
{
"measure": "mortality"
},
{
"measure": "revision"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Central Hospital, Nancy, France"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Skeletal Muscle Ultrasonography"
}
]
},
"conditionsModule": {
"conditions": [
"Skeletal Muscle Ultrasonography"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "* To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children.\n* To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools ."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Years",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Skeletal Muscle Ultrasonography in Detection of Malnutrition",
"nctId": "NCT06382766",
"orgStudyIdInfo": {
"id": "SMU in malnutrition",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools ."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gingival inflammation"
}
]
},
"conditionsModule": {
"conditions": [
"Gingivitis",
"Periodontitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Catania",
"contacts": [
{
"email": "[email protected]",
"name": "Gaetano Isola, DDS",
"phone": "0953785652",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "AOU Policlinico G. Rodolico",
"geoPoint": {
"lat": 37.49223,
"lon": 15.07041
},
"state": null,
"status": "RECRUITING",
"zip": "95124"
}
]
},
"descriptionModule": {
"briefSummary": "The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis",
"nctId": "NCT06382753",
"orgStudyIdInfo": {
"id": "20-24-PAR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bleeding on Probing"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Catania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Liver transplantation"
}
]
},
"conditionsModule": {
"conditions": [
"End Stage Liver DIsease",
"Liver Transplantation",
"Old Age"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Padova",
"contacts": [
{
"email": "[email protected]",
"name": "Umberto Cillo, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova",
"geoPoint": {
"lat": 45.40797,
"lon": 11.88586
},
"state": null,
"status": "RECRUITING",
"zip": "35128"
}
]
},
"descriptionModule": {
"briefSummary": "Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.\n\nThis study proposes a \"step by step\" algorithm of selection for liver transplant candidates more than 70 years."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 18,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "71 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Over70-LT",
"briefTitle": "Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years",
"nctId": "NCT06382740",
"orgStudyIdInfo": {
"id": "AOP2097",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "1 year patient survival"
}
],
"secondaryOutcomes": [
{
"measure": "1 year graft survival"
},
{
"measure": "3 months mortality and morbidity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Azienda Ospedaliera di Padova"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "EN will be continued up to extubation (EN will not be withheld prior to extubation)"
}
]
},
"conditionsModule": {
"conditions": [
"Critical Illness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Southport",
"contacts": [
{
"email": null,
"name": "James Mccullogh, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Gold Coast University Hospital",
"geoPoint": {
"lat": -27.96724,
"lon": 153.39796
},
"state": "Queensland",
"status": null,
"zip": "4215"
},
{
"city": "Fitzroy",
"contacts": [
{
"email": null,
"name": "Alastair Brown, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "St Vincent's Hospital Melbourne",
"geoPoint": {
"lat": -37.79839,
"lon": 144.97833
},
"state": "Victoria",
"status": null,
"zip": "3065"
},
{
"city": "Melbourne",
"contacts": [
{
"email": null,
"name": "Emma Ridley, A/Prof",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sean Keem, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "The Alfred Hospital",
"geoPoint": {
"lat": -37.814,
"lon": 144.96332
},
"state": "Victoria",
"status": null,
"zip": "3004"
}
]
},
"descriptionModule": {
"briefSummary": "Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally.\n\nThe delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation).\n\nThe practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN.\n\nThis study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "CONTINUE is a multi-centre, open-label, prospective parallel, pilot randomised controlled trial being conducted in Australia.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CONTINUE",
"briefTitle": "CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care",
"nctId": "NCT06382727",
"orgStudyIdInfo": {
"id": "ER008",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fasting time (hours)"
}
],
"secondaryOutcomes": [
{
"measure": "Reintubation rate"
},
{
"measure": "Days alive and free of mechanical ventilation"
},
{
"measure": "Commencement of antibiotics"
},
{
"measure": "Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2)"
},
{
"measure": "ICU length of stay"
},
{
"measure": "In-hospital mortality"
},
{
"measure": "Nutrition delivery"
},
{
"measure": "Recruitment rate"
},
{
"measure": "Protocol compliance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Emma Ridley"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "For the intervention group, a museum visit with virtual reality glasses will be applied."
}
]
},
"conditionsModule": {
"conditions": [
"DIALYSIS SYMPTOMS AND ANXIETY"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mollaoğlu",
"contacts": [
{
"email": "[email protected]",
"name": "Mukadder Mollaoğlu, Prof Dr.",
"phone": "90 5055723985",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Songül Mollaoğlu, Assoc Prof",
"phone": "90 532 480 08 32",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Mukadder",
"geoPoint": {
"lat": 39.70028,
"lon": 30.28306
},
"state": "Sivas",
"status": null,
"zip": "58140"
}
]
},
"descriptionModule": {
"briefSummary": "The main purpose of dialysis used in the treatment of end-stage renal failure is; By relieving the patient from uremic symptoms, controlling excess fluid, electrolyte and acid base disorders, improving the well-being of the patients and also improving the quality of life of the patients. In addition to its contribution to the continuation of life, dialysis can significantly affect the biological and physiological balance and normal life order of patients. Some of these effects may be negative on patients. During this process, patients may frequently experience symptoms such as changes in fluid-electrolyte balance, increased fatigue, and weakness, as well as psychopathological conditions such as anxiety. In this context, it is extremely important to handle patients from a holistic perspective and keep their homeostatic balance under control during the hemodialysis process. In addition to pharmacological treatments, many integrative methods are used in the management of symptoms for reasons such as being low in cost, having fewer side effects than pharmacological treatments, and strengthening the immune system. Museum visit, one of these integrative treatment methods, has become an area of art therapy where help is received for various reasons such as coping with the symptoms of chronic diseases, reducing the side effects of medications, preventing mental depression, strengthening healthy behaviors, and avoiding tension and loss of control. In this context, the research was planned as a randomized controlled study investigating the effect of virtual museum tour on dialysis symptom index and anxiety in hemodialysis patients..T.R. The \"https://sanalmuze.gov.tr\" site belonging to the Ministry of Culture and Tourism will be shown to the patients five times and the virtual museum visit will be made by showing the patient's preferred museum five times among the 53 museums prepared by the General Directorate of Information Technologies of the Ministry of Culture and Tourism, and the Initiative Group, Control It will be compared with its group. Research data; It will be collected using the Patient Information Form, Dialysis Symptom Index and Beck Anxiety Scale (BAI). At the end of the study, the data will be evaluated in the SPSS program. The museum visit applied to the Intervention Group will also be applied to the control group after the study is completed, taking into account the ethical dimension."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
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},
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},
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],
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},
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]
},
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"acronym": null,
"briefTitle": "Virtual Museum Visit on Dialysis Symptoms and Anxiety in Hemodialysis Patients",
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},
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},
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"measure": "Dialysis Symptom Index (DSI)"
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{
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}
],
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},
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},
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"date": "2024-05-15"
},
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"date": "2024-04-24"
}
}
}
|
null | false |
{
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"interventions": [
{
"name": "aromatherapy"
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{
"name": "placebo"
}
]
},
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]
},
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{
"city": "Melikgazi",
"contacts": null,
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}
]
},
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"briefSummary": "The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety."
},
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"designInfo": {
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]
},
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},
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},
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"measure": "Visual Analog Scale (VAS)"
}
],
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"measure": "State and Trait Anxiety Inventory (STAI)"
}
]
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"date": "2021-09-06"
},
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"date": "2024-04-24"
}
}
}
|
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{
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{
"name": "NAD+ (nicotinamide adenine dinucleotide) IV"
},
{
"name": "Niagen® (nicotinamide riboside) IV"
},
{
"name": "Niagen® (nicotinamide riboside) oral"
},
{
"name": "Placebo"
}
]
},
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]
},
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{
"city": "Franklin",
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}
]
},
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"briefSummary": "This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV."
},
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]
},
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"link": null,
"type": null
},
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},
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"measure": "Subjective Experience"
}
],
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{
"measure": "Blood Pressure"
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{
"measure": "Heart rate"
},
{
"measure": "Total NAD measured through dried blood spot testing"
},
{
"measure": "Glucose"
},
{
"measure": "Insulin Levels"
},
{
"measure": "total NAD measured through blood and plasma"
},
{
"measure": "Tolerable Infusion Rate"
}
],
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"measure": "Complete Blood Count"
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{
"measure": "Comprehensive Metabolic Panel"
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]
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}
]
},
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},
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],
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"name": "Gabriele Eden, Dr. med.",
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}
],
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},
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}
]
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"briefSummary": "The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.\n\nThe investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment."
},
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]
},
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"acronym": "plasmaFlux",
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|
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{
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{
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}
]
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]
},
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"name": "Study Investigator",
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}
],
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},
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"zip": "85381"
}
]
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"briefSummary": "Every participant will receive active study drug and (tone) 1 comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be (four) 4 visits."
},
"designModule": {
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},
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"id": "PMDAC-01",
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"type": null
},
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},
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{
"measure": "Change from baseline, Standard Deviation of Lateral Position"
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{
"measure": "Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes"
}
],
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{
"measure": "Change from baseline of participants' subjective report of drowsiness on a 10-point scale"
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{
"measure": "Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test)"
},
{
"measure": "The number of product related adverse events experienced by participants from Visit 1 through Visit 4"
}
]
},
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},
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"date": "2024-04-26"
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}
}
}
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{
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"name": "Rivastigmine"
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{
"name": "Placebo"
}
]
},
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]
},
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{
"city": "Saint Louis",
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"email": "[email protected]",
"name": "Kevin Baumgartner",
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],
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]
},
"descriptionModule": {
"briefSummary": "Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production.\n\nRecent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo."
},
"designModule": {
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},
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]
},
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"acronym": "RIVA-AM",
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"id": "202403051",
"link": null,
"type": null
},
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{
"measure": "Time to control of agitation and delirium"
}
],
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"measure": "Duration of agitation and delirium"
},
{
"measure": "Total amount of sedatives administered"
},
{
"measure": "Use of sedative infusions"
},
{
"measure": "Use of physical restraints"
},
{
"measure": "Disposition"
},
{
"measure": "Time to medical clearance"
},
{
"measure": "Oversedation"
},
{
"measure": "Intubation"
},
{
"measure": "Seizure"
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{
"measure": "Gastrointestinal upset"
},
{
"measure": "Bradycardia"
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]
},
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"name": "American Academy of Clinical Toxicology"
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},
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"date": "2026-07"
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"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Standard Care"
},
{
"name": "Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot"
}
]
},
"conditionsModule": {
"conditions": [
"Prenatal Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cleveland",
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{
"email": "[email protected]",
"name": "Heidi Gullett, MD",
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"phoneExt": null,
"role": "CONTACT"
}
],
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},
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"status": null,
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},
{
"city": "Cleveland",
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{
"email": "[email protected]",
"name": "Angela Ranzini, MD",
"phone": "216-778-3513",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "MetroHealth Medical Center",
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},
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"status": null,
"zip": "44109"
},
{
"city": "Cleveland",
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{
"email": "[email protected]",
"name": "Ruth Farrell, MD, MA",
"phone": "216-445-7085",
"phoneExt": null,
"role": "CONTACT"
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{
"email": "[email protected]",
"name": "Christina Collart, MEd",
"phone": "216-470-9796",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
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"status": null,
"zip": "44195"
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]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \\& Diagnostic Testing (PS\\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\\&D and decreases decisional conflict associated with those decisions.\n\nUsing data from NEST (Ensuring Patients Informed Access to NIPT \\[non-invasive prenatal testing\\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\\&D options, and resources to learn about insurance coverage for PS\\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer."
},
"designModule": {
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"allocation": "RANDOMIZED",
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"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "OPUS",
"briefTitle": "Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes",
"nctId": "NCT06382636",
"orgStudyIdInfo": {
"id": "23-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient activation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Cleveland Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The percutaneous A1 pulley release"
},
{
"name": "The peritendinous Betamethasone group"
}
]
},
"conditionsModule": {
"conditions": [
"Trigger Finger"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger."
},
"designModule": {
"designInfo": {
"allocation": null,
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"observationalModel": "OTHER",
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"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacies of Different Managements in Patients With Trigger Finger",
"nctId": "NCT06382623",
"orgStudyIdInfo": {
"id": "43",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Stage of the disease"
}
],
"secondaryOutcomes": [
{
"measure": "Pain intensity"
},
{
"measure": "severity of triggering"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Gaziler Physical Medicine and Rehabilitation Education and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Melatonin"
}
]
},
"conditionsModule": {
"conditions": [
"Sleep"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Redlands",
"contacts": null,
"country": "United States",
"facility": "University of Redlands",
"geoPoint": {
"lat": 34.05557,
"lon": -117.18254
},
"state": "California",
"status": null,
"zip": "92373"
}
]
},
"descriptionModule": {
"briefSummary": "Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Repeated measures crossover trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "22 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations",
"nctId": "NCT06382610",
"orgStudyIdInfo": {
"id": "2024-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Salivary melatonin level"
}
],
"secondaryOutcomes": [
{
"measure": "Side effects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Redlands"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nordic hamstring exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Hamstring Injury"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of the study is to assess the impact of 4 weeks of eccentric Nordic Hamstring Exercise training on changes in the hamstring muscle group, as well as to analyze parameters such as maximum muscle strength of the knee flexors, RFD (rate of force development) and static balance, dynamics for the dominant leg."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
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"count": 2,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "26 Years",
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Four Weeks of Nordic Hamstring Exercises Impact the Strength and Balance of the Hamstring Muscle Group",
"nctId": "NCT06382597",
"orgStudyIdInfo": {
"id": "AWFiS/2024_2_P-GM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Biodex Balance System"
}
],
"secondaryOutcomes": [
{
"measure": "Biodex System"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Gdansk University of Physical Education and Sport"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Femoral fracture surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Direct Oral Anticoagulants (DOACs)",
"Femoral Fractures",
"Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nimes",
"contacts": null,
"country": "France",
"facility": "CHU de NIMES",
"geoPoint": {
"lat": 43.83333,
"lon": 4.35
},
"state": null,
"status": null,
"zip": "30029"
}
]
},
"descriptionModule": {
"briefSummary": "In 2023, oral anticoagulant treatments (anti Xa: apixaban , rivaroxaban, etc.) are tending to replace anti vitamin K treatments in many medical indications. Their prescription is increasing rapidly in the elderly.\n\nIn this context, the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugs.To avoid massive intra- and post-operative haemorrhage, surgical management is postponed because of the need to suspend the treatment, allowing a return to near-normal biological haemostasis within a few days. No consensus has been reached on the withdrawal period required to authorise surgery, as the elimination kinetics of the drug are altered in this context (elderly patients, dehydration, hypovolaemia, impaired renal function). A plasma assay (threshold of \\<30 to 60 ng/mL) has been proposed without any real justification. This waiting period exposes the elderly to excess mortality. Reversing these treatments by adding coagulation factors would be an attractive alternative, as it would allow surgery to be performed earlier, but this would expose patients to an increased thrombotic risk.\n\nBefore considering a prospective randomised study (early vs delayed surgery on AOD), we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 610,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ANTI_XA",
"briefTitle": "Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur",
"nctId": "NCT06382584",
"orgStudyIdInfo": {
"id": "IRB_23.09.01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hospital Mortality"
}
],
"secondaryOutcomes": [
{
"measure": "Duration of the surgery"
},
{
"measure": "Transfusion"
},
{
"measure": "Postoperative comorbidities"
},
{
"measure": "Hospital stay"
},
{
"measure": "Anti Xa assay"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Nīmes"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Renin-Angiotensin System Inhibitor"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure With Reduced Ejection Fraction"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).\n\nMethods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 396,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients",
"nctId": "NCT06382571",
"orgStudyIdInfo": {
"id": "026/66",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "factors associated with sub - target dose of ACEIs,ARBs,ARNI"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chulalongkorn University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leuven",
"contacts": [
{
"email": null,
"name": "Geert Verheyden, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "KU Leuven",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": null,
"status": "RECRUITING",
"zip": "3001"
}
]
},
"descriptionModule": {
"briefSummary": "Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal assessment for sensory processing, one of the most important sensory functions, does not exists. However, our research team has developed a novel assessment paradigm using the KINARM End-Point robot to assess the level of sensory processing of the upper limb. Within a previous study, the investigators examined the validity within 20 chronic stroke patients and 80 age-matched healthy controls by comparing the novel robotic assessment with a set of existing clinical and robotic assessments for the upper limb. The investigators hypothesize that the stroke patients will show a poorer performance on this novel assessment compared to the healthy controls, that the novel assessment will show better correlation coefficients with other sensory tests compared to motor tests, that the novel assessment can differentiate between different motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Validity and Reliability of Sensorimotor Processing Paradigm",
"nctId": "NCT06382558",
"orgStudyIdInfo": {
"id": "s68470",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "KU Leuven",
"id": "C2M/23/060",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Kinarm: Passive and active discrimination task"
}
],
"secondaryOutcomes": [
{
"measure": "Kinarm: Arm position matching task"
},
{
"measure": "Kinarm: Visually guided reaching task"
},
{
"measure": "Erasmus modified Nottingham sensory assessment"
},
{
"measure": "Tactile discrimination test"
},
{
"measure": "Tactile functional object recognition"
},
{
"measure": "Stereognosis section of the original Nottingham sensory assessment"
},
{
"measure": "Wrist position sense test"
},
{
"measure": "Perceptual threshold of touch"
},
{
"measure": "Fugl-Meyer upper extremity assessment"
},
{
"measure": "Action research arm test"
},
{
"measure": "Barthel index"
},
{
"measure": "Montreal cognitive assessment"
},
{
"measure": "Star cancellation test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fanta (Pepsi gold) (FPG)"
},
{
"name": "M3-pro+ Gold (assorted) (MPG)"
}
]
},
"conditionsModule": {
"conditions": [
"Endodontic Treatment"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": null,
"country": "Egypt",
"facility": "Faculty of Oral and Dental medicine, Ahram Canadian University",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": null,
"zip": "12573"
}
]
},
"descriptionModule": {
"briefSummary": "Comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems",
"nctId": "NCT06382545",
"orgStudyIdInfo": {
"id": "Approval number 36.3.22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "comparing the intensity of post-instrumentation pain"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ahram Canadian University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Niacin skin reaction test"
}
]
},
"conditionsModule": {
"conditions": [
"Depressive Disorder",
"Malingering"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": null,
"name": "Jin Wang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Air Force Medical Center",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100142"
}
]
},
"descriptionModule": {
"briefSummary": "This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger. The investigators expect that depressive disorder malinger can be discriminated by the niacin skin reaction test."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 410,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT)",
"nctId": "NCT06382532",
"orgStudyIdInfo": {
"id": "AFMMUChina_NSRT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Niacin reaction test"
}
],
"secondaryOutcomes": [
{
"measure": "Model specificity and sensitivity"
},
{
"measure": "The F Scale in Minnesota Multiphasic Personality Inventory"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Air Force Military Medical University, China"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Thalidomide"
}
]
},
"conditionsModule": {
"conditions": [
"Inflammatory Bowel Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "6 Years",
"minimumAge": "28 Days",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Thalidomide Therapy for VEOIBD",
"nctId": "NCT06382519",
"orgStudyIdInfo": {
"id": "Thal in VEOIBD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "endoscopic response rate"
}
],
"secondaryOutcomes": [
{
"measure": "clinical response rate"
},
{
"measure": "biomarker remission rate"
},
{
"measure": "growth development"
},
{
"measure": "clinical remission rate with steroid-free"
},
{
"measure": "adverse event"
},
{
"measure": "treatment persistence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Children's Hospital of Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Consumption of Cornbread with Hazelnut Bread"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity",
"Celiac Disease",
"Blood Glucose",
"Flour Sensitivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trabzon",
"contacts": null,
"country": "Turkey",
"facility": "Avrasya University",
"geoPoint": {
"lat": 41.005,
"lon": 39.72694
},
"state": null,
"status": null,
"zip": "61000"
}
]
},
"descriptionModule": {
"briefSummary": "One of the factors affecting human health is nutrition. The effects of foods on blood glucose are still under investigation. The Glycemic Index (GI), which is associated with many diseases today, is a value that measures the rate at which carbohydrate-containing foods raise blood glucose. It is thought that the loaves of bread produced will be a product with low GI value and can be consumed by celiacs and diabetics. It is aimed to investigate the effect of adding different amounts of hazelnut flour to bread recipes using gluten-free corn flour on blood glucose."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Hazelnut",
"briefTitle": "The Effect of Hazelnut Flour on Blood Glucose",
"nctId": "NCT06382506",
"orgStudyIdInfo": {
"id": "2024/138",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "One loaf of bread was consumed each week and the study will continue for a month. Blood glucose measurements were performed with a glucometer at 0 (fasting), 15, 30, 45, 60, 90, and 120 minutes after each bread consumption."
}
],
"secondaryOutcomes": [
{
"measure": "This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ege University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-04-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tegoprazan-containing sequential H. pylori eradication therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Helicobacter Pylori Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seongnam-si",
"contacts": [
{
"email": null,
"name": "Nayoung Kim, M.D.,Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Korea, Republic of",
"facility": "Seoul National University Bundang Hospital",
"geoPoint": {
"lat": 37.43861,
"lon": 127.13778
},
"state": "Gyeonggi-do",
"status": "RECRUITING",
"zip": "463-707"
}
]
},
"descriptionModule": {
"briefSummary": "As H. pylori eradication, we prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tegoprazan-containing Sequential for H. Pylori",
"nctId": "NCT06382493",
"orgStudyIdInfo": {
"id": "B-2011-648-005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Eradication rate"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Seoul National University Bundang Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diet with specific macronutrient composition."
}
]
},
"conditionsModule": {
"conditions": [
"Overweight",
"Obesity",
"Prediabetes",
"Type 2 Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Potsdam",
"contacts": [
{
"email": "[email protected]",
"name": "Olga Ramich, PD Dr.",
"phone": "+4933200882749",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Marina D'Urso",
"phone": "+4933200882690",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Olga Ramich",
"geoPoint": {
"lat": 52.39886,
"lon": 13.06566
},
"state": "Potsdam-Rehbrücke",
"status": "RECRUITING",
"zip": "14558"
}
]
},
"descriptionModule": {
"briefSummary": "The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake divided by a 4-week wash-out phase.",
"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": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROTIME",
"briefTitle": "PROTeIn-rich Meals to Control Glucose",
"nctId": "NCT06382480",
"orgStudyIdInfo": {
"id": "90/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean 24-hour glucose"
}
],
"secondaryOutcomes": [
{
"measure": "Measurement of height"
},
{
"measure": "Measurement of body weight"
},
{
"measure": "Waist and hip circumference / waist to hip ratio"
},
{
"measure": "Systolic and diastolic blood pressure"
},
{
"measure": "Body fat and lean mass"
},
{
"measure": "Energy expenditure and substrate oxidation rates"
},
{
"measure": "Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))"
},
{
"measure": "Renal values (creatinine, urea, uric acid)"
},
{
"measure": "Intra- und inter-day glycemic variability"
},
{
"measure": "Glucose levels in meal tolerance test (MTT)"
},
{
"measure": "Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)"
},
{
"measure": "Inflammatory markers and T cell populations analyses"
},
{
"measure": "Satiety and hunger scores"
},
{
"measure": "Sleep/wake timing and sleep quality"
},
{
"measure": "Physical activity"
},
{
"measure": "Adipose tissue transcriptome"
},
{
"measure": "Gene expression in peripheral blood mononuclear cells (PBMC)"
},
{
"measure": "Gut microbiota and microbiome-derived metabolites"
},
{
"measure": "Determination of decision behavior"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Charite University, Berlin, Germany"
},
{
"name": "Helmholtz Center Munich"
},
{
"name": "Hasso Plattner Institute, Potsdam, Germany"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "German Institute of Human Nutrition"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remimazolam besylate + propofol MCT"
},
{
"name": "Propofol MCT"
}
]
},
"conditionsModule": {
"conditions": [
"Neurologic Disorder"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements."
},
"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": 56,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM",
"nctId": "NCT06382467",
"orgStudyIdInfo": {
"id": "2401-136-016",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of intraoperative hypotension"
}
],
"secondaryOutcomes": [
{
"measure": "Amount and number of inotropic agents"
},
{
"measure": "Incidence of participants' intraoperative involuntary movement"
},
{
"measure": "scores of neurophysiologic monitoring quality"
},
{
"measure": "onset time of study drugs"
},
{
"measure": "The administration number of rescue anti-emetic agents"
},
{
"measure": "Time-weighted average of intraoperative hypotension"
},
{
"measure": "recovery time of study drugs (remimazolam+propofol or propofol)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chung-Ang University Gwangmyeong Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Assist-On Arm Robot Group"
},
{
"name": "Control Group"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Upper Extremity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Hacettepe University, Faculty of Physical Therapy and Rehabilitation",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Altındağ, Ankara",
"status": null,
"zip": "06100"
}
]
},
"descriptionModule": {
"briefSummary": "Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke 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": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Upper Extremity Robot-Assisted Therapy in Stroke Patients",
"nctId": "NCT06382454",
"orgStudyIdInfo": {
"id": "E2-23-5921",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Modified Ashworth Scale"
},
{
"measure": "Fugl-Meyer Assessment Upper Extremity"
},
{
"measure": "Action Research Arm Test"
},
{
"measure": "Box and Block Test"
},
{
"measure": "Nine Hole Peg Test"
}
],
"secondaryOutcomes": [
{
"measure": "ACTIVLIM"
},
{
"measure": "ABILHAND Assessment"
},
{
"measure": "Stroke Impact Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Interact Medical Technologies Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Hacettepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "tele-exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Behavior, Health"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kowloon Tong",
"contacts": null,
"country": "Hong Kong",
"facility": "Xiong Zhennan",
"geoPoint": {
"lat": 22.33312,
"lon": 114.17969
},
"state": "Kowloon",
"status": null,
"zip": null
},
{
"city": "Kowloon Tong",
"contacts": null,
"country": "Hong Kong",
"facility": "Yan SUN",
"geoPoint": {
"lat": 22.33312,
"lon": 114.17969
},
"state": "Kowloon",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself.\n\nBreast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health.\n\nThe study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits.\n\nThe study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health.\n\nThe training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "40 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Tele-exercise Program for Breast Cancer Survivors",
"nctId": "NCT06382441",
"orgStudyIdInfo": {
"id": "KC/KE-23-0122/ER-4",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acceptability (quantitative)"
},
{
"measure": "Acceptability (qualitative)"
},
{
"measure": "Recruitment rate"
},
{
"measure": "Retention rate"
},
{
"measure": "Attendance rate"
},
{
"measure": "Compliance rate"
}
],
"secondaryOutcomes": [
{
"measure": "Cardiorespiratory fitness"
},
{
"measure": "muscle strength"
},
{
"measure": "balance"
},
{
"measure": "% body fat"
},
{
"measure": "skeletal muscle mass"
},
{
"measure": "height"
},
{
"measure": "Shoulder joint range of motion (ROM) of affected side"
},
{
"measure": "Limb circumference and lymphedema"
},
{
"measure": "Health-related quality of life"
},
{
"measure": "Physical activity level (min/week)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hong Kong Baptist University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pelvic floor muscle training"
}
]
},
"conditionsModule": {
"conditions": [
"Pelvic Floor Disorders",
"Postpartum Disorder",
"Quality of Life",
"Mothers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Yeditepe University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34010"
}
]
},
"descriptionModule": {
"briefSummary": "Pelvic floor muscle training (PFMT) is routinely recommended to treat and prevent pelvic floor symptoms in the postpartum period. However, due to the high cost, remoteness of the location, and responsibilities of the baby, women cannot participate in PFMT whenever and wherever they want. Telerehabilitation (TR) may be an effective method to facilitate women's access to PFMT. Therefore, our study aims to compare the short and medium-term effects of PFMT applied with the TR method on pelvic floor symptoms, symptom-related quality of life and pelvic floor muscle function with supervised PFMT. This randomized controlled study was conducted at Yeditepe University Hospital Bağdat Street Polyclinic Pelvic Floor Center and online synchronous platform on women aged 18-35 and between the 6th and 8th weeks postpartum. Participants were randomly assigned to the synchronized PFMT performed with the telerehabilitation method (TR-PFMT) group and the supervised PFMT (S-PFMT) group. The same PFMT program was carried out in both groups for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program was carried out via a synchronous online platform (Skype™ program) in the TR-PFMT group, and as a face-to-face session in the S-PFMT group. Participants' pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20), symptom-related quality of life was evaluated with the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pelvic floor muscle function was evaluated with superficial electromyography. Evaluations were made 3 times in total: before the exercise program, after the exercise program and at the 8th week after the exercise program (6th month postpartum)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 58,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period",
"nctId": "NCT06382428",
"orgStudyIdInfo": {
"id": "T-DAYICAN-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pelvic Floor Distress Inventory-20 to measure the total pelvic floor symptoms"
},
{
"measure": "Pelvic Floor Distress Inventory-20 to measure the pelvic organ prolapse symptoms"
},
{
"measure": "Pelvic Floor Distress Inventory-20 to measure the colorectal-anal symptoms"
},
{
"measure": "Pelvic Floor Distress Inventory-20 to measure the urinary symptoms"
},
{
"measure": "Pelvic Floor Impact Questionnaire-7 to measure the total pelvic floor symptoms related quality of life"
},
{
"measure": "Pelvic Floor Impact Questionnaire-7 to measure the pelvic organ prolapse symptoms related quality of life"
},
{
"measure": "Pelvic Floor Impact Questionnaire-7 to measure the colorectal-anal symptoms related quality of life"
},
{
"measure": "Pelvic Floor Impact Questionnaire-7 to measure the urinary symptoms related quality of life"
},
{
"measure": "Surface electromyography (EMG) to measure the pre-basal activity of the pelvic floor muscles"
},
{
"measure": "Surface electromyography (EMG) to measure the phasic activity of the pelvic floor muscles"
},
{
"measure": "Surface electromyography (EMG) to measure the tonic activity of the pelvic floor muscles"
},
{
"measure": "Surface electromyography (EMG) to measure the endurance activity of the pelvic floor muscles"
},
{
"measure": "Surface electromyography (EMG) to measure the post-baseline rest activity of the pelvic floor muscles"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Biruni University"
},
{
"name": "Yeditepe University"
},
{
"name": "Fenerbahce University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Izmir Tinaztepe University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Rectal Cancer",
"Organ-Space Surgical Site Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Granollers",
"contacts": null,
"country": "Spain",
"facility": "Hospital General de Granollers",
"geoPoint": {
"lat": 41.60797,
"lon": 2.28773
},
"state": "Barcelona",
"status": null,
"zip": "08402"
}
]
},
"descriptionModule": {
"briefSummary": "In rectal cancer surgery, the organ/space surgical site infection (O/S-SSI) has an impact on patient's prognosis. Its influence in the oncologic outcomes remains controversial. The main objective is to assess the possible effect of O/S-SSI on long-term overall survival and cancer recurrence."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 3826,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VINCat_PDO_2",
"briefTitle": "Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery",
"nctId": "NCT06382415",
"orgStudyIdInfo": {
"id": "VINCat_PDO_2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of overall cancer recurrence"
},
{
"measure": "Overall survival"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of Organ-space surgical site infection"
},
{
"measure": "Rate of surgical complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospital de Granollers"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2016-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2011-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CCTA scan"
}
]
},
"conditionsModule": {
"conditions": [
"Myocardial Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Louisville",
"contacts": [
{
"email": "[email protected]",
"name": "Dinesh Kalra, MD",
"phone": "502-588-7010",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Rongras Damrongwatanasuk, MD",
"phone": "502-588-7010",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Louisville School of Medicine, Division of Cardiovascular Diseases",
"geoPoint": {
"lat": 38.25424,
"lon": -85.75941
},
"state": "Kentucky",
"status": null,
"zip": "40202"
}
]
},
"descriptionModule": {
"briefSummary": "This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 700,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI",
"nctId": "NCT06382402",
"orgStudyIdInfo": {
"id": "23.0924",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "MACE"
},
{
"measure": "Cardiovascular (CV) mortality"
},
{
"measure": "Nonfatal MI, stroke"
},
{
"measure": "Hospitalization for unstable angina"
},
{
"measure": "Hospitalization for heart failure"
},
{
"measure": "Unplanned revascularization"
}
],
"secondaryOutcomes": [
{
"measure": "All-cause mortality"
},
{
"measure": "In-hospital and 90-day costs"
},
{
"measure": "Patient quality of life at 90 days"
},
{
"measure": "Diagnostic certainty scores"
},
{
"measure": "Individual components of the primary endpoint"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Louisville"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "EMONO"
},
{
"name": "Medical air"
}
]
},
"conditionsModule": {
"conditions": [
"Depression",
"Neurocognitive Disorders"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects.\n\nRecent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes.\n\nThe principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel assignement",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROTO-EHPAD",
"briefTitle": "Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial-",
"nctId": "NCT06382389",
"orgStudyIdInfo": {
"id": "DR220204",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2023-504691-18-00",
"link": null,
"type": "CTIS"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline)."
}
],
"secondaryOutcomes": [
{
"measure": "CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8"
},
{
"measure": "CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8"
},
{
"measure": "The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8"
},
{
"measure": "Collection of adverse events at all study visits"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Tours"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group"
}
]
},
"conditionsModule": {
"conditions": [
"Gynecological Cancer Surgery",
"Regional Anesthesia Morbidity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Başakşehir Çam and Sakura City Hospital",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Basaksehir",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries.\n\nThe key question(s) it aims to answer are:\n\n\\[Is intrathecal morphine more effective in postoperative analgesia?\\] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 71,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Analgesia Methods Applied in Gynecological Cancer Surgeries on Postoperative Analgesia",
"nctId": "NCT06382376",
"orgStudyIdInfo": {
"id": "2024-60",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "postoperative numerical rating scale"
}
],
"secondaryOutcomes": [
{
"measure": "postoperative opioid use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Bakirkoy Dr. Sadi Konuk Research and Training Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "POC-cHbA1c testing"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus",
"Pre-diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Chan",
"phone": "25185657",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Aberdeen Jockey Club General Out-Patient Clinic",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Chan",
"phone": "25185657",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Kwun Tong Community Health Centre",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Chan",
"phone": "25185657",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Lek Yuen General Out-Patient Clinic",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Chan",
"phone": "25185657",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Li Po Chun General Out-Patient Clinic",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Chan",
"phone": "25185657",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Ma On Shan Family Medicine Centre",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Chan",
"phone": "25185657",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Sai Ying Pun Jockey Club General Out-patient Clinic",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Chan",
"phone": "25185657",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Tseung Kwan O (Po Ning Road) General Out-patient Clinic",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Linda Chan",
"phone": "25185657",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Yau Ma Tei Jockey Club Specialist Clinic",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Objectives: To evaluate the effectiveness of active opportunistic screening using point-of-care capillary Hemoglobin-A1c (POC-cHbA1c) testing, compared to venous HbA1c (vHbA1c) testing, in improving detection of type 2 diabetes mellitus (T2DM) among at-risk primary care patients.\n\nDesign: Pragmatic cluster randomized controlled trial.\n\nSetting: 8 public primary care clinics in Hong Kong.\n\nParticipants: A minimum of 776 patients (97 per clinic) who have ≥1 risk factor for T2DM, but no known diagnosis of DM or DM screening in the past 12 months.\n\nIntervention: Participants at intervention clinics (n=4) will be offered free POC-cHbA1c testing on-site, immediately informed of test results and DM risk, and scheduled for confirmatory oral glucose tolerance test (OGTT) if screened positive (i.e. HbA1c≥5.6%). Participants at control clinics will be offered free vHbA1c testing scheduled on a separate day, informed of test results and DM risk via phone, and scheduled for confirmatory OGTT if screened positive.\n\nMain outcome measures: Primary outcomes are uptake rate of POC-cHbA1c versus vHba1c testing, and difference in proportion of T2DM detected between intervention and control groups.\n\nSecondary outcomes include number-needed-to-screen to detect one more T2DM case.\n\nData analysis: Participants' characteristics and test uptake rates will be summarized by descriptive statistics. Difference in the proportion of T2DM detected between groups will be compared using Chi-squared test. Number-needed-to screen to identify one additional patient with DM will be calculated.\n\nExpected results: A greater proportion of T2DM patients will be detected by POC-cHbA1c than vHbA1c due to a higher screening test uptake rate among the studied population."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 776,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DM-REACH",
"briefTitle": "Improving T2DM Detection Using Spot cHbA1c Test - a Cluster RCT",
"nctId": "NCT06382363",
"orgStudyIdInfo": {
"id": "UW21-363",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportional difference in detection of T2DM"
},
{
"measure": "Uptake rate"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of high-risk HbA1c concentration"
},
{
"measure": "Difference in uptake rate of OGTT"
},
{
"measure": "Number-needed-to-screen to detect one more T2DM case"
},
{
"measure": "Proportion of patients who refuse to join the study"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hospital Authority, Hong Kong"
},
{
"name": "Food and Health Bureau, Hong Kong"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MiniMed 780 G"
}
]
},
"conditionsModule": {
"conditions": [
"Type 1 Diabetes Mellitus",
"Type 1 Diabetes Mellitus With Hypoglycemia",
"Drive"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SAFEDRIVE",
"briefTitle": "Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems",
"nctId": "NCT06382350",
"orgStudyIdInfo": {
"id": "KHL-002-2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Specific CGM analysis in relation to recorded the daily activities"
}
],
"primaryOutcomes": [
{
"measure": "The frequency of hypoglycemia (<3.9 mmol/l) during the driving periods"
}
],
"secondaryOutcomes": [
{
"measure": "Period of time spent in a range between 3.9 and 4.5 mmol/l (a risky period) during driving."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Motol"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Group A : ice cream cone technique"
},
{
"name": "Group B : the vestibular socket therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Teeth Loss",
"Alveolar Bone Resorption"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mansoura",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": "050 2248512",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mohamed Fa Shoeib, demonstrator",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Faculty of Dentistry Mansoura University",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": null,
"status": null,
"zip": "7650001"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Immediate Dental Implants in The Upper Anterior Region",
"nctId": "NCT06382337",
"orgStudyIdInfo": {
"id": "A03010240S",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bone changes"
}
],
"secondaryOutcomes": [
{
"measure": "soft tissue changes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "mindfulness practice of body scan"
},
{
"name": "listening to light music"
}
]
},
"conditionsModule": {
"conditions": [
"Anterior Cruciate Ligament (Acl) Reconstruction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Keelung",
"contacts": [
{
"email": "[email protected]",
"name": "Jian-Hong Chen",
"phone": "096-130-7506",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Chang Gung Memorial Hospital",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Taiwan",
"facility": "ChangGungMH",
"geoPoint": {
"lat": 25.12825,
"lon": 121.7419
},
"state": null,
"status": "RECRUITING",
"zip": "204004"
}
]
},
"descriptionModule": {
"briefSummary": "Anterior cruciate ligament (ACL) reconstruction surgery is a common procedure performed by orthopedic surgeons. Postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. These factors influence the recovery and return to sports capabilities of ACL patients. According to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. Psychological factors during the recovery process may explain this disparity. ACL injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. A study by Lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. This suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports.\n\nMindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. Mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. Good sleep quality contributes to emotional stability and physical recovery. Even short daytime naps can be beneficial for athletes. A review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep.\n\nTherefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after ACL reconstruction."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Intervention method:\n\n* Mindfulness napping group: listening to a record of mindfulness meditation practice for 40 minutes.\n* Control group: listening to light music for 40 minutes.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The outcome assessor of polysomnography did not know the data belongs which group",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction",
"nctId": "NCT06382324",
"orgStudyIdInfo": {
"id": "202301280B0",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Electroencephalogram (EEG)"
},
{
"measure": "Electrooculography (EOG)"
},
{
"measure": "Electromyography (EMG)"
},
{
"measure": "ECG (Electrocardiography)"
},
{
"measure": "Nasal/Oral airflow"
},
{
"measure": "Thermistor"
},
{
"measure": "Chest and abdominal belt"
},
{
"measure": "Oximetry"
},
{
"measure": "Snoring"
}
],
"secondaryOutcomes": [
{
"measure": "Karolinska Sleepiness Scale (KSS)"
},
{
"measure": "Five Facet Mindfulness Questionnaire (FFMQ)"
},
{
"measure": "State-Trait Anxiety Inventory (STAIS)"
},
{
"measure": "Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) (Short Version)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chang Gung Memorial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Flu Pandemic mRNA_Dose level 1"
},
{
"name": "Flu Pandemic mRNA_Dose level 2"
},
{
"name": "Flu Pandemic mRNA_ Dose level 3."
},
{
"name": "Flu Pandemic mRNA_ Dose level 4"
},
{
"name": "Flu Pandemic mRNA_Dose level 5"
},
{
"name": "Flu Pandemic mRNA_Dose level 6"
},
{
"name": "Flu Pandemic mRNA_Dose level 7"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Influenza, Human"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Anniston",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Almena L Free",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
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},
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"status": "NOT_YET_RECRUITING",
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},
{
"city": "Little Rock",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Derek Lewis",
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
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},
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},
{
"city": "Fort Collins",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael Thakor",
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}
],
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},
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},
{
"city": "Fort Myers",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Pedro P Ylisastigui",
"phone": null,
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
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},
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},
{
"city": "West Palm Beach",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mira Baron",
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}
],
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},
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},
{
"city": "Chamblee",
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{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Adebowale Akintayo",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
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},
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},
{
"city": "El Dorado",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael Rausch",
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}
],
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"city": "Lenexa",
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{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
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"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Carlos A Fierro",
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}
],
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},
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},
{
"city": "Lexington",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mark S Adams",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
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},
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"status": "NOT_YET_RECRUITING",
"zip": "40509"
},
{
"city": "Kansas City",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Martha Sue Fanning",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
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"lon": -94.57857
},
"state": "Missouri",
"status": "NOT_YET_RECRUITING",
"zip": "64114"
},
{
"city": "Omaha",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Tamara Doehner",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
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},
"state": "Nebraska",
"status": "NOT_YET_RECRUITING",
"zip": "68144"
},
{
"city": "Las Vegas",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Raj Singh",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 36.17497,
"lon": -115.13722
},
"state": "Nevada",
"status": "NOT_YET_RECRUITING",
"zip": "89102"
},
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Matthew G Davis",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York",
"status": "NOT_YET_RECRUITING",
"zip": "14609"
},
{
"city": "Greensboro",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alexander Vance Murray",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 36.07264,
"lon": -79.79198
},
"state": "North Carolina",
"status": "NOT_YET_RECRUITING",
"zip": "27408"
},
{
"city": "Winston-Salem",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Robert Dean Rosen",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 36.09986,
"lon": -80.24422
},
"state": "North Carolina",
"status": "NOT_YET_RECRUITING",
"zip": "27103"
},
{
"city": "Edmond",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kyle Rickner",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 35.65283,
"lon": -97.4781
},
"state": "Oklahoma",
"status": "NOT_YET_RECRUITING",
"zip": "73013"
},
{
"city": "Yukon",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Robert J. Lockwood",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 35.50672,
"lon": -97.76254
},
"state": "Oklahoma",
"status": "RECRUITING",
"zip": "73099"
},
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Max Mercado",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": "NOT_YET_RECRUITING",
"zip": "19111"
},
{
"city": "Austin",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Laurence Chu",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 30.26715,
"lon": -97.74306
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78705"
},
{
"city": "Norfolk",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mary Bailey",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 36.84681,
"lon": -76.28522
},
"state": "Virginia",
"status": "NOT_YET_RECRUITING",
"zip": "23502"
},
{
"city": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "US GSK Clinical Trials Call Center",
"phone": "877-379-3718",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "EU GSK Clinical Trials Call Centre",
"phone": "+44 (0) 20 8990 4466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ashley Fuller",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": "NOT_YET_RECRUITING",
"zip": "98015"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered healthy adults 18 to 85 years of age."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Data will be collected in an observer-blind manner in Phase 1 and Phase 2.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1080,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults",
"nctId": "NCT06382311",
"orgStudyIdInfo": {
"id": "221824",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Phase 1: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8"
},
{
"measure": "Phase 1: Percentage of participants with increased in FDA toxicity grading in hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29"
},
{
"measure": "Phase 1: Percentage of participants with increased in haematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8"
},
{
"measure": "Phase 1: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29"
},
{
"measure": "Percentage of participants with anti- hemagglutinin inhibition (HI) titers >= 1:40 at Day 43 [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with solicited administration site events [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with solicited systemic events [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with unsolicited AEs [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with MAAEs [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with SAEs [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with AESIs [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with anti-HI titers >= 1:40 at Day 22 [Phase 2 Part B]"
}
],
"secondaryOutcomes": [
{
"measure": "Geometric mean titers (GMTs) of HA antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Geometric mean increase (GMI) of HA antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with HA antibody Seroconversion rate (SCR) [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of participants with anti-HI antibody titers >= 1:40 [Phase 1 and Phase 2 Part A]"
},
{
"measure": "Percentage of seropositive participants for the HA antibody titers [Phase 1 and Phase 2 Part A]"
},
{
"measure": "GMT of Anti-HI antibody titers [Phase 2 Part B]"
},
{
"measure": "GMI of anti-HI antibody titers [Phase 2 Part B]"
},
{
"measure": "GMI of anti-HI antibody titers [Phase 2 Part B]"
},
{
"measure": "GMI of anti-HI antibody titers [Phase 2 Part B]"
},
{
"measure": "Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B]"
},
{
"measure": "Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B]"
},
{
"measure": "Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with anti-HI antibody >= 1:40 [Phase 2 Part B]"
},
{
"measure": "Percentage of participants with seropositivity of anti-HI antibody titers [Phase 2 Part B]"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "GlaxoSmithKline"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-18"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "COTTONSEED OIL"
},
{
"name": "MATCHED PUFA DIET"
},
{
"name": "CONTROL"
}
]
},
"conditionsModule": {
"conditions": [
"Dyslipidemia",
"Overweight and Obesity",
"Nutrition, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Athens",
"contacts": null,
"country": "United States",
"facility": "University of Georgia",
"geoPoint": {
"lat": 33.96095,
"lon": -83.37794
},
"state": "Georgia",
"status": null,
"zip": "30602"
}
]
},
"descriptionModule": {
"briefSummary": "Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk.\n\nThe specific aims are:\n\n* Examine the impact of CSO vs. PUFA on fasting and postprandial lipids.\n* Examine the impact of CSO on other markers of chronic disease risk.\n\nParticipants will be asked to:\n\n* Consume provided meal replacement shakes daily for 28-days.\n* Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials,\n* Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast.\n\nResearchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Three groups of 28-day parallel feeding trials with two groups receiving 20% of energy needs from CSO, or matched PUFA diet, and one group serving as control receiving 20% of energy needs as a mixture of oils that match the fatty acid profile of the average American intake.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participants are blinded to oil intervention group. Investigator blinded to participant's oil intervention group.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cottonseed Oil Versus Matched PUFA Effects",
"nctId": "NCT06382298",
"orgStudyIdInfo": {
"id": "PROJECT00009332",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Change in blood pressure"
},
{
"measure": "Change in body weight"
},
{
"measure": "Change in body composition"
},
{
"measure": "Change in diet composition"
},
{
"measure": "Change in fasting tocopherol concentrations"
},
{
"measure": "Change in anthropometric circumferences"
},
{
"measure": "Change in resting metabolic rate"
},
{
"measure": "Change in Perceived Stress"
},
{
"measure": "Change in anxiety"
},
{
"measure": "Change in self reported physical activity levels"
},
{
"measure": "Change in Body Mass Index (BMI)"
}
],
"primaryOutcomes": [
{
"measure": "Change in fasting serum lipoprotein and cholesterol concentrations"
},
{
"measure": "Change in fasting serum lipoprotein particle numbers"
},
{
"measure": "Change in fasting and postprandial plasma triglyceride concentrations"
},
{
"measure": "Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations"
},
{
"measure": "Change in fasting and postprandial plasma glucose concentrations"
},
{
"measure": "Change in fasting and postprandial plasma insulin concentrations"
},
{
"measure": "Change in fasting and postprandial plasma appetite control hormones concentrations"
},
{
"measure": "Change in fasting and postprandial subjective feelings related to appetite"
},
{
"measure": "Change in fasting and postprandial plasma Malondialdehyde (MDA)"
},
{
"measure": "Change in fasting and postprandial plasma total antioxidant capacity"
},
{
"measure": "Change in fasting inflammatory cytokine concentrations"
},
{
"measure": "Change in fasting plasma markers of coagulation potential"
},
{
"measure": "Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins"
},
{
"measure": "Change in fasting insulin resistance metrics"
},
{
"measure": "Desaturation index"
}
],
"secondaryOutcomes": [
{
"measure": "Change in fasting serum hepatic enzymes"
},
{
"measure": "Change in fasting serum hepatic proteins"
},
{
"measure": "Change in fasting serum bilirubin"
},
{
"measure": "Change in additional fasting plasma inflammatory cytokine concentrations"
},
{
"measure": "Change in additional fasting plasma markers of coagulation potential"
},
{
"measure": "Change in acute dietary intake"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "United States Department of Agriculture (USDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Georgia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Continues peripheral block"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Replacement Surgery"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study will include 50 patients who underwent a knee replacement surgery, who will be randomized to 2 groups. 6 hours after surgery the two groups will be connected to a prolonged block pump. One group will receive the peripheral block ropivacaine 0.2% according to the protocol of 8-10 cc per hour up to 24 hours after surgery. The second group will receive saline according to the same protocol",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement",
"nctId": "NCT06382285",
"orgStudyIdInfo": {
"id": "0206-22-ASF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain level"
},
{
"measure": "Analgesic use"
}
],
"secondaryOutcomes": [
{
"measure": "Physiotherapy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Assaf-Harofeh Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-24"
}
}
}
|
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