protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Finger Prick"
},
{
"name": "Venipuncture"
}
]
},
"conditionsModule": {
"conditions": [
"Infection, Bacterial"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rotterdam",
"contacts": [
{
"email": null,
"name": "Birgit Koch, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Erasmus MC",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The Outpatient Parenteral Antibiotic Therapy (OPAT) service consists of providing antimicrobial therapy through parenteral infusion without hospitalization. This service is provided to stable patients otherwise ready for hospital discharge. Generally, the clinical monitoring for this patient population is minimal. However, clinical monitoring of vancomycin, an antibiotic widely used during OPAT, can be intensive primarily due to therapeutic drug monitoring. To ensure optimal treatment and minimize nephrotoxicity and microbial resistance, TDM and monitoring of serum creatinine levels are crucial during vancomycin therapy. TDM of vancomycin with OPAT presents a challenge for patients who must frequently travel to blood sampling facilities or the hospital for measurements. An alternative sampling method for TDM is the dried blood spot (DBS) method, which involves collecting a small drop of capillary blood from a finger prick onto filter paper. By implementing the DBS sampling method, the amount of outpatient visits regarding vancomycin treatment in OPAT can be reduced. Furthermore, the addition of measuring a biochemical parameter, such as renal function with serum creatinine, could lead to even less outpatient visits during OPAT. To date, studies investigating the effectiveness of DBS sampling of vancomycin and creatinine in terms of reducing outpatient visits have not yet been conducted in the OPAT population."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "120 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ADVANCEDOPAT",
"briefTitle": "A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT",
"nctId": "NCT06283433",
"orgStudyIdInfo": {
"id": "NL83813.078.23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To compare the number of outpatient visits in the control group versus the intervention group at day 28"
}
],
"secondaryOutcomes": [
{
"measure": "Outcomes regarding outpatient visit"
},
{
"measure": "Sampling outcomes"
},
{
"measure": "Satisfaction with blood sampling based on the theoretical framework of acceptability questionnaire (TFA)"
},
{
"measure": "Cost outcomes"
},
{
"measure": "Clinical outcomes"
},
{
"measure": "TDM outcomes"
},
{
"measure": "Logistical outcomes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erasmus Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Heart Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Prague",
"contacts": null,
"country": "Czechia",
"facility": "Institute for Clinical end Experimental Medicine - IKEM",
"geoPoint": {
"lat": 50.08804,
"lon": 14.42076
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This protocol is part of the CarDia project - National Institute for Metabolic and Cardiovascular Disease Research (EXCELES Program, ID: LX22NPO5104), funded by the European Union - Next Generation EU. The protocol is part of Work Package 5 (WP5): metabolic disorders in heart failure.The goal of this observational protocol is to monitor the biochemical and metabolomic response to the initiation of therapy for heart failure with standard drugs (SGLT2i, sGC stimulators, ARNI) and whether this early response (within first 3 months) predicts the further course of the disease.The protocol will examine how parameters reflecting neurohumoral activation, response to hypoxia, systemic metabolism of energy substrates, parameters of iron metabolism, HIF1A activation in peripheral blood behave over time after starting standard heart failure terapiy (baseline, 1 day, 1 week, 1 month, 3 month). This project can provide valuable information on how to identify people who respond more poorly to the treatment being introduced and are more at risk of an adverse course of the disease. Patients will be compared to patients who have no change of therapy over early observation period (3 mo), who will serve as controls. This is observational study, so decision to inicialize therapy will be based on medical indication.Patients with heart failure treated at the IKEM Cardiocenter will have blood drawn at several defined intervals before and after the start of clinically indicated treatment. Some patients will also undergo genetic DNA testing to determine the variability of genes regulating the metabolic neurohumoral response to heart failure. Patients will be contacted at intervals of 1 and 2 years and the incidence of clinical events will be monitored. The study is observational in nature and inclusion in the study does not affect the course of care provided or the choice of pharmacotherapy."
},
"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": "GliF",
"briefTitle": "Metabolic Response to Iniciation of Heart Failure Therapy",
"nctId": "NCT06283420",
"orgStudyIdInfo": {
"id": "CarDia_WP5_P1_IRB:25059/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "hematocrit"
}
],
"secondaryOutcomes": [
{
"measure": "HIF response"
},
{
"measure": "hepcidin"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Vojtech Melenovsky, MD, PhD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ICF-based cross-country comparative analysis"
}
]
},
"conditionsModule": {
"conditions": [
"Musculoskeletal Diseases or Conditions"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rzeszów",
"contacts": [
{
"email": null,
"name": "Agnieszka Wiśniowska-Szurlej",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "University of Rzeszow",
"geoPoint": {
"lat": 50.04132,
"lon": 21.99901
},
"state": null,
"status": null,
"zip": "35-959"
}
]
},
"descriptionModule": {
"briefSummary": "Musculoskeletal conditions are a major cause of disability worldwide. These conditions are often associated with chronicity, which is a challenge for healthcare systems to address. Health care must be person-centred and take into account the individual perspective from which the disease is experienced. The lived experience of health conditions depends to a large extent on contextual factors. Comparison between different contexts helps to identify which aspects are most relevant in the experience of the disease. The International Classification of Functioning, Disability and Health (ICF) provides a unified language that allows such comparisons to be made. The aim of this study is to identify differences in musculoskeletal health between the Polish and Spanish populations using the ICF as a frame of reference."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ICF-based Comparison on Musculoskeletal Health in Poland and Spain",
"nctId": "NCT06283407",
"orgStudyIdInfo": {
"id": "ICF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Brief International Classification of Functioning, Disability and Health (ICF) core set for post-acute musculoskeletal conditions"
}
],
"secondaryOutcomes": [
{
"measure": "Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Sanidad de Castilla y León"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Rzeszow"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Storefront Choice Architecture"
},
{
"name": "Fresh Funds"
},
{
"name": "Loss Framing"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity",
"Diabetes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this interventional study is to test ways to improve the effectiveness of a healthy foods prescription program in increasing the purchase of healthy foods for patients who have both obesity (BMI \\> 30) and diabetes (last A1C\\>8 in the last 90 days). The main questions it aims to answer are:Aim 1: Examine feasibility and engagement among participants by assessing percent enrollment among those identified as eligible, rates of Instacart platform use, amount of the subsidy used each week, and amounts of healthy foods ordered.Aim 2: Examine strategies to optimize the user experience of trial participation, including communication strategies and on-boarding, to increase uptake and engagement in this and subsequent studies.Usual Care (Control): Participants in the usual care arm will not receive weekly subsidies on Instacart, and they will not receive any modifications to the virtual storefront on Instacart. They will have access to the standard Instacart platform and Instacart + memberships with $5 per week to cover service and delivery fees and delivery tips for 3 months.Intervention Arms: The four treatment groups will also each receive a $160 subsidy per month for 3 months to be used on produce (fruits and vegetables)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "AHA (American Heart Association) Food is Medicine Test of Choice Architecture and Salience of Incentives",
"nctId": "NCT06283394",
"orgStudyIdInfo": {
"id": "854803",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The primary outcome will be the percentage of food purchasing expenditures spent on eligible healthy foods."
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of the $160 subsidy used each month in the intervention arms."
},
{
"measure": "Change in hemoglobin A1c"
},
{
"measure": "Qualitative results"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Esomeprazole"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "IVO BOSKOSKI",
"phone": "+390630155701",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "IVO BOSKOSKI",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Universitario A. Gemelli IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "RECRUITING",
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:* Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.* Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ESGIS",
"briefTitle": "The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty",
"nctId": "NCT06283381",
"orgStudyIdInfo": {
"id": "4264",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Thyroidectomy, Bilaterally Total"
},
{
"name": "Thyroidectomy, Unilaterally Total"
},
{
"name": "Thyroidectomy, Complementary"
},
{
"name": "Thyroidectomy, Near Total"
}
]
},
"conditionsModule": {
"conditions": [
"Thyroid Neoplasms Benign",
"Thyroid Nodule",
"Thyroid Cancer",
"Thyroid Diseases"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Thyroid surgery is the most common type of surgery among endocrine surgeries. This surgery is performed for patients with suspected malignancy, patients diagnosed with malignancy, and toxic nodular goiter. In addition to vocal cord injury, which is the most important complication of thyroid surgery, hypocalcemia due to hypoparathyroidism and surgical wound complications (such as hematoma, and fistula) can also be observed, and malignancy surgery increases the risk of recurrent laryngeal nerve injury. Therefore, it is important to differentiate these groups using non-invasive methods before surgery.Tumor-related inflammation is activated as a result of bone marrow and inflammation induced by malignancies. Insufficiently controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Lymphocyte monocyte ratio and red blood cell distribution are parameters (RDW, RDW-CW) previously studied in terms of cancers.Our aim in this study is to reveal the RDW, RDW-CW, and LMR calculated from complete blood count parameters in the preoperative period, as an indicator of malignant inflammatory response, in a non-invasive and inexpensive way before surgery or biopsy is performed to distinguish nodular goiter and thyroid malignancy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 172,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Malignant Thyroid Nodules",
"nctId": "NCT06283368",
"orgStudyIdInfo": {
"id": "2021/11-06",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Determining benign thyroid nodules"
},
{
"measure": "Determining malignant thyroid nodules"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kahramanmaras Sutcu Imam University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nasal Microbiota Transplant (NMT)"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Staphylococcus Aureus",
"Microbial Colonization",
"Neonatal Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Danielle Koontz",
"phone": "443-287-9040",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Aaron Milstone",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Johns Hopkins University",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": null,
"zip": "21287"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 175,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "0 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome",
"nctId": "NCT06283355",
"orgStudyIdInfo": {
"id": "IRB00433691",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neonatal nasal microbiome diversity after intervention"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Johns Hopkins University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Iron Deficiency Anemia in Childbirth",
"Infant Nutrition Disorders",
"Iron Deficiencies"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Konya",
"contacts": null,
"country": "Turkey",
"facility": "Konya Training and Research Hospital",
"geoPoint": {
"lat": 37.87135,
"lon": 32.48464
},
"state": null,
"status": null,
"zip": "42090"
}
]
},
"descriptionModule": {
"briefSummary": "This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 2,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Months",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency",
"nctId": "NCT06283342",
"orgStudyIdInfo": {
"id": "Konya Pediatric Hematology",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ferritine level"
}
],
"secondaryOutcomes": [
{
"measure": "Hemoglobin level"
},
{
"measure": "Prophylactic iron use rate"
},
{
"measure": "Iron-sufficient supplementary food intake rate of babies"
},
{
"measure": "Breast milk usage rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Konya Meram State Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2019-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "vocal cords echography"
}
]
},
"conditionsModule": {
"conditions": [
"Residual Curarization"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tunis",
"contacts": null,
"country": "Tunisia",
"facility": "Elaskri Haythem",
"geoPoint": {
"lat": 36.81897,
"lon": 10.16579
},
"state": null,
"status": null,
"zip": "1008"
}
]
},
"descriptionModule": {
"briefSummary": "Through recent studies residual curarization (RC) remains frequent but serious event, that could be easily avoided in the presence of a paraclinical monitoring and by antagonization of curares. However, conventional monitors focus only on peripheral muscles, whereas ultrasonography allows direct visualization of laryngeal muscles, particularly the vocal cords, which are directly influenced by neuromuscular blocking agents. The aim of the study was to evaluate the ultrasound mobility of the vocal cords after awakening and extubation of general anesthesia compared to their preoperative mobility and its correlation with clinical and paraclinical diagnostic criteria (DG) for RC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 70,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints",
"nctId": "NCT06283329",
"orgStudyIdInfo": {
"id": "echographic VC curarization",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Echographic mobility of vocal cords at different times in post extubation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "General Administration of Military Health, Tunisia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Alopecia Areata",
"Alopecia Totalis",
"Alopecia Universalis",
"Hair Loss",
"Hair Diseases",
"Alopecia",
"Alopecia Drugs",
"Autoimmune Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rotterdam",
"contacts": [
{
"email": "[email protected]",
"name": "DirkJan Hijnen, MD, PhD",
"phone": "0031 10 704 01 10",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Erasmus University Medical Center",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STA2R",
"briefTitle": "Systemic Treatments for Alopecia Areata Registry",
"nctId": "NCT06283316",
"orgStudyIdInfo": {
"id": "11347",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effectiveness of systemic treatments"
},
{
"measure": "Safety of systemic treatments"
}
],
"secondaryOutcomes": [
{
"measure": "Epidemiological data"
},
{
"measure": "Physician Reported - Severity of Alopecia Tool (SALT Score)"
},
{
"measure": "Dermatology Life Quality Index (DLQI, 10 items)"
},
{
"measure": "Alopecia Areata Symptom Impact Scale (AASIS, 13 items)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erasmus Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2099-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2099-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-17"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "T3011 hepatic artery infusion"
},
{
"name": "toripalimab"
},
{
"name": "regorafenib"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer Metastatic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer",
"nctId": "NCT06283303",
"orgStudyIdInfo": {
"id": "MVR-T3011-HAI-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment Emergent Adverse Event（TEAE）"
}
],
"secondaryOutcomes": [
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Progression-free survival (PFS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Immvira Co., Limited"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "China Medical University, China"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Severe Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mansoura",
"contacts": null,
"country": "Egypt",
"facility": "Research Site",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
},
"state": "Dakahlia",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Zagazig",
"contacts": null,
"country": "Egypt",
"facility": "Research Site",
"geoPoint": {
"lat": 30.58768,
"lon": 31.502
},
"state": "Sharkia",
"status": "RECRUITING",
"zip": null
},
{
"city": "Alexandria",
"contacts": null,
"country": "Egypt",
"facility": "Research Site",
"geoPoint": {
"lat": 31.21564,
"lon": 29.95527
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Research Site",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Research Site",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Asthma is a syndrome characterized by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness. Patients present clinically with recurrent wheezing, shortness of breath, cough, and chest tightness. Asthma is a leading cause of morbidity with a global prevalence of approximately 300 million; it is estimated that the number of people with asthma may increase to 400 to 450 million people worldwide by 2025.Severe asthma is not considered a single disease; instead, it is divided into several phenotypes, owing to the variety of inflammatory, clinical, and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied by a high concentration of eosinophils require greater healthcare resource use, greater disease management costs, and a much more impaired QoL than those who do not present with raised eosinophilia.While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses, and inflammatory processes involved represent an added challenge for health care professionals. Thus, severe asthma management is a complex endeavor, and a thorough and up-to-date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making.This cross-sectional, multicenter study aims to determine the prevalence of oral corticosteroid (OCS) use among severe asthma patients who attend to different sites specialized in the management of severe asthma across Egypt. In addition, the prevalence of eosinophilic phenotype of blood eosinophil count ≥ 150 cells/mm3, prevalence of atopic phenotype, and asthma control will also be studied."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PROPE Severe Asthma Study in Egypt",
"nctId": "NCT06283290",
"orgStudyIdInfo": {
"id": "D3250R00122",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To describe the prevalence (frequency) of OCS use among severe asthma patients as defined by chronic treatment and/or bursts of OCS use."
}
],
"secondaryOutcomes": [
{
"measure": "To describe the demographic characteristics of severe eosinophilic asthma patients."
},
{
"measure": "To describe the clinical characteristics of severe eosinophilic asthma patients."
},
{
"measure": "To discover the average OCS dose per year used among severe asthma patients."
},
{
"measure": "To determine the prevalence of the eosinophilic phenotype"
},
{
"measure": "To determine the prevalence of the eosinophilic phenotype"
},
{
"measure": "To determine the prevalence of the total serum IgE"
},
{
"measure": "To determine the annual severe asthma exacerbation rate in the past twelve months among severe asthma patients in Egypt"
},
{
"measure": "To evaluate asthma control of severe asthma patients"
},
{
"measure": "To evaluate comorbidities related to OCS use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AstraZeneca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Obstetric Ultrasound"
}
]
},
"conditionsModule": {
"conditions": [
"Macrosomia, Fetal",
"Large for Gestational Age",
"Shoulder Dystocia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Fetal Clavicular Measurement to Predict Fetal Macrosomia",
"nctId": "NCT06283277",
"orgStudyIdInfo": {
"id": "fetal macrosomia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Third trimester clavicle length measurement"
}
],
"secondaryOutcomes": [
{
"measure": "Establish the relationship between third-trimester clavicle length and shoulder dystocia"
},
{
"measure": "Mode of delivery"
},
{
"measure": "Gestational age at the time of delivery."
},
{
"measure": "Neonatal Apgar score."
},
{
"measure": "Neonatal bi-acromial diameter"
},
{
"measure": "Neonatal birth weight"
},
{
"measure": "Neonatal need for NICU"
},
{
"measure": "Neonatal actual clavicle length"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Celiac Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study aims to screen and diagnose coeliac disease in patients with type 2 diabetes and monitor the effect of gluten-free diet on the metabolic status"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of Coeliac Disease in Patients With Type 2 Diabetes",
"nctId": "NCT06283264",
"orgStudyIdInfo": {
"id": "Coeliac Disease in type2 DM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "1-Prevalence of coeliac disease among diabetic type 2 patient 2-its effect on glycemic control"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PediRISE Resource Program"
}
]
},
"conditionsModule": {
"conditions": [
"Pediatric Cancer",
"Financial Stress",
"Financial Hardship",
"Disparities"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Kira Bona, MD, MPH",
"phone": "617-632-4688",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kira Bona, MD, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Boston Children's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Kira Bona, MD, MPH",
"phone": "617-632-4688",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kira Bona, MD, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Dana Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.The names of the study groups in this research study are:* PediRISE Program Group* Usual Care Group"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PediRISE Feasibility",
"nctId": "NCT06283251",
"orgStudyIdInfo": {
"id": "23-590",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of Participant Consent"
},
{
"measure": "6-Month Follow Up Rate for PediRISE Program Group"
},
{
"measure": "6-Month Follow Up Rate for Usual Care Group"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "American Cancer Society, Inc."
},
{
"name": "Children's Cancer Research Fund"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Dana-Farber Cancer Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Immune checkpoint inhibitor (ICI) or chemotherapy alone"
}
]
},
"conditionsModule": {
"conditions": [
"GastroEsophageal Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Durham",
"contacts": null,
"country": "United States",
"facility": "Duke University",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina",
"status": null,
"zip": "27710"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to examine genetic changes that may contribute to immunotherapy resistance in gastroesophageal cancer. This information can potentially lead to the identification of new immunotherapeutic targets as well as improve the ability to identify those patients more likely to respond to immunotherapy.This study does not include any treatment or investigational drugs.Participants will be asked:* to enroll before beginning standard care of treatment for their cancer* for blood, archived tumor tissue, and fresh tumor tissue Researchers will compare participants who are not getting immunotherapy to identify potential differences in expression levels of a gene."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Biobanking Upper Gastrointestinal Tumors to Evaluate Response (BURGER With BACON)",
"nctId": "NCT06283238",
"orgStudyIdInfo": {
"id": "Pro00115121",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with Complete Response (CR)"
},
{
"measure": "Number of participants with Partial Response (PR)"
},
{
"measure": "Number of participants with Stable Disease"
},
{
"measure": "Number of participants with Progressive Disease"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Duke University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pia-App"
}
]
},
"conditionsModule": {
"conditions": [
"Dysmenorrhea"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "intervention group and control group",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pilot Study to Investigate the Effect of a Dysmenorrhoea App",
"nctId": "NCT06283225",
"orgStudyIdInfo": {
"id": "RCT004_PilotPia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dysmenorrhea Symptom Interference Scale (DSI)"
},
{
"measure": "Moos Menstrual Distress Questionnaire, Form C (MDQ)"
},
{
"measure": "Visual analog scale (VAS)"
},
{
"measure": "Depression Anxiety Stress Scale mit 21 Items (DASS-21)"
},
{
"measure": "German Version of Pain Self-Efficacy Questionnaire (FESS)"
},
{
"measure": "Fatigue Severity Scale (FSS)"
},
{
"measure": "Pain Disability Index (PDI)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Endo Health GmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ETX101"
}
]
},
"conditionsModule": {
"conditions": [
"Dravet Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Glasgow",
"contacts": [
{
"email": "[email protected]",
"name": "Patricia Clark",
"phone": "0141 232 7600",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Queen Elizabeth Hospital",
"geoPoint": {
"lat": 55.86515,
"lon": -4.25763
},
"state": null,
"status": "RECRUITING",
"zip": "G51 4TF"
},
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Helen Cross, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Great Ormond Street Hospital",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "WC1N3JH"
},
{
"city": "Sheffield",
"contacts": [
{
"email": "[email protected]",
"name": "Research Team",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "Sheffield Children's Hospital",
"geoPoint": {
"lat": 53.38297,
"lon": -1.4659
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "S10 2TH"
}
]
},
"descriptionModule": {
"briefSummary": "EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to \\< 48 months. The study follows and open-label, dose-escalation design."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "47 Months",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "UK Only",
"briefTitle": "A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome",
"nctId": "NCT06283212",
"orgStudyIdInfo": {
"id": "ETX-DS-005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportions of participants experiencing any treatment-emergent adverse events (AEs), serious adverse events (SAEs), related AEs, AEs with severity Grade ≥ 3, AEs resulting in study discontinuation, and AEs with fatal outcome."
},
{
"measure": "Change from baseline in the standard score of the Vineland Adaptive Behavior Scales - Third Edition Adaptive Behavior Composite at Week 52."
}
],
"secondaryOutcomes": [
{
"measure": "Percent change in monthly countable seizure frequency (MCSF) to Week 52, with countable seizures defined as generalized tonic-clonic/clonic, focal motor with clearly observable clinical signs, tonic bilateral, and atonic seizures."
},
{
"measure": "Change from baseline in the raw score of the Bayley Scales of Infant and Toddler Development® 4th Edition receptive language sub-domain at Week 52."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Encoded Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Musculoskeletal Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Alessandro Di Martino, MD",
"phone": "0039 051 6366567",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Istituto Ortopedico Rizzoli",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Lugano",
"contacts": [
{
"email": "[email protected]",
"name": "Christian Candrian, Prof.Dr.med",
"phone": "+41 (0) 91 811 61 23",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "EOC - Orthopaedics and Traumatology Service",
"geoPoint": {
"lat": 46.01008,
"lon": 8.96004
},
"state": null,
"status": "RECRUITING",
"zip": "6900"
}
]
},
"descriptionModule": {
"briefSummary": "Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases.",
"nctId": "NCT06283199",
"orgStudyIdInfo": {
"id": "ORL-ORT-025",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in pain level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ente Ospedaliero Cantonale, Bellinzona"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-04-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Aerobic exercise"
},
{
"name": "Aerobic exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Subjects"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "Álvaro Reina-Varona, MSc",
"phone": "0034 + 649001863",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Álvaro Reina-Varona, MSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "CSEU LaSalle",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "RECRUITING",
"zip": "28023"
}
]
},
"descriptionModule": {
"briefSummary": "This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals",
"nctId": "NCT06283186",
"orgStudyIdInfo": {
"id": "CSEULS-PI-004/2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle"
}
],
"secondaryOutcomes": [
{
"measure": "International Physical Activity Questionnaire (IPAQ)"
},
{
"measure": "Fatigue Assessment Scale (FAS)"
},
{
"measure": "Heart rate"
},
{
"measure": "Rate of perceived exertion (RPE)"
},
{
"measure": "Physical Activity Readiness Questionnaire (PAR-Q)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centro Universitario La Salle"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ColActive Plus Collagen Matrix Dressing"
}
]
},
"conditionsModule": {
"conditions": [
"Skin Sensitisation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Torrance",
"contacts": null,
"country": "United States",
"facility": "ALS Beauty and Personal Care",
"geoPoint": {
"lat": 33.83585,
"lon": -118.34063
},
"state": "California",
"status": null,
"zip": "90501"
}
]
},
"descriptionModule": {
"briefSummary": "The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This will be a single center, with no randomization or blinding, study design in 50 healthy adult subjects, age 18-70 years. Based on prior experience approximately 75 subjects will be enrolled to ensure 50 subjects complete the study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 57,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "HRIPT for Collagen Dressing",
"nctId": "NCT06283173",
"orgStudyIdInfo": {
"id": "23-401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Skin sensitization reaction using Berger and Bowman scale"
},
{
"measure": "Skin sensitization reaction using Berger and Bowman scale"
}
],
"primaryOutcomes": [
{
"measure": "Skin sensitization reaction using Berger and Bowman scale"
},
{
"measure": "Skin irritation reaction using Berger and Bowman scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "ALS Beauty and Personal Care"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Covalon Technologies Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Pancreatic Fistula",
"Acute Pancreatitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Besançon",
"contacts": [
{
"email": null,
"name": "Alexandre Doussot, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "University Hospital of Besançon",
"geoPoint": {
"lat": 47.24878,
"lon": 6.01815
},
"state": null,
"status": "RECRUITING",
"zip": "25000"
}
]
},
"descriptionModule": {
"briefSummary": "Pancreaticoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PROMETHEE",
"briefTitle": "Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy",
"nctId": "NCT06283160",
"orgStudyIdInfo": {
"id": "2023/834",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Besancon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Risk assessment and Management Programme - Knee Osteoarthritis"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Cheryl Fung",
"phone": "26095050",
"phoneExt": "+852",
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Lek Yuen GOPC",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):1. RAMP Knee-OA group2. Usual care groupOutcomes will be measured at baseline, week 16, week 32, and week 52."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "All data collection will be performed by trained research assistants blinded to the allocation status of the patients, and statistician will analyse data without referring to allocation information.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 228,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care",
"nctId": "NCT06283147",
"orgStudyIdInfo": {
"id": "2023.530",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Knee pain"
}
],
"secondaryOutcomes": [
{
"measure": "Physical Function"
},
{
"measure": "Physical function"
},
{
"measure": "Lower limb muscle mass"
},
{
"measure": "Level of physical activity"
},
{
"measure": "Self-Management efficacy"
},
{
"measure": "Level of Anxiety"
},
{
"measure": "Level of Depression"
},
{
"measure": "Insomnia"
},
{
"measure": "Loneliness"
},
{
"measure": "Health related Quality of Life"
},
{
"measure": "Demographic data"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chinese University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BioTTT001 hepatic artery infusion"
},
{
"name": "toripalimab"
},
{
"name": "regorafenib"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer Metastatic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer",
"nctId": "NCT06283134",
"orgStudyIdInfo": {
"id": "BJCT-CMU1H-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of adverse events"
},
{
"measure": "MTD"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival(OS)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Plasma adenovirus (ADV) copies"
},
{
"measure": "ADV copies in various sites"
},
{
"measure": "Serum IL-12 level"
},
{
"measure": "Serum neutralizing antibody level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Beijing Bio-Targeting Therapeutics Technology Co., Ltd"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "China Medical University, China"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BioTTT001 intraperitoneal infusion"
},
{
"name": "SOX regimen"
},
{
"name": "toripalimab"
}
]
},
"conditionsModule": {
"conditions": [
"Gastric Cancer, Metastatic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer",
"nctId": "NCT06283121",
"orgStudyIdInfo": {
"id": "BJCT-CMU1H-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective response rate (ORR)"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Overall survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Beijing Bio-Targeting Therapeutics Technology Co., Ltd"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "China Medical University, China"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience)"
},
{
"name": "Standard Child Life Preparation and Support"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Caries in Children",
"Dental Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": [
{
"email": "[email protected]",
"name": "Claire Simonsen, BA",
"phone": "720-777-5313",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joseph Albietz, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Jennifer Staab, MS",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Children's Hospital Colorado",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80045"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 58,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Gurney Journey: Virtual Reality Distraction",
"nctId": "NCT06283108",
"orgStudyIdInfo": {
"id": "23-1183",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Induction Compliance Checklist"
},
{
"measure": "modified Yale Preoperative Anxiety Scale"
}
],
"secondaryOutcomes": [
{
"measure": "The Pediatric Behavioral Induction Assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Children's Hospital Colorado"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "expansion palatoplasty"
}
]
},
"conditionsModule": {
"conditions": [
"Obstructive Sleep Apnea of Adult"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Assuit",
"contacts": [
{
"email": "[email protected]",
"name": "Enas T Zarief, physician",
"phone": "01226270800",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "ASSUIT",
"geoPoint": {
"lat": 27.18096,
"lon": 31.18368
},
"state": null,
"status": "RECRUITING",
"zip": "1"
}
]
},
"descriptionModule": {
"briefSummary": "The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty",
"nctId": "NCT06283095",
"orgStudyIdInfo": {
"id": "OSA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation the outcome of expansion palatoplasty in management of OSAS."
}
],
"secondaryOutcomes": [
{
"measure": "Expansion palatoplasty in Obstructive sleep apnea patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "ET Zarief"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lithiasis assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Hyperoxaluria (Disorder)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lyon",
"contacts": [
{
"email": "[email protected]",
"name": "Laurence Derain, MD,PhD",
"phone": "04 72 11 91 17",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "CLIMA, pavillon R, Hôpital Edouard Herriot",
"geoPoint": {
"lat": 45.74848,
"lon": 4.84669
},
"state": null,
"status": null,
"zip": "69003"
}
]
},
"descriptionModule": {
"briefSummary": "Primary hyperoxaluria type I (PH1) is a rare genetic disorder responsible for severe lithiasis leading to progressive deterioration of renal function and end-stage renal failure. PH1 is linked to a deficiency in glyoxylate amino transferase (AGXT), which leads to increased endogenous oxalate synthesis and hyperoxaluria. In the urine, urinary oxalate precipitates with calcium, forming insoluble crystals, leading to lithiasis and the development of nephrocalcinosis.Non-genetic etiologies of oxalic nephropathy are well known, in particular enteric causes (malabsorptions, bypass, calcium deficiencies, etc.) and sometimes linked to increased oxalate intake in the form of nutritional or vitamin supplements, reinforcing the hypothesis of probably underestimated favouring factors of hyperoxaluria.Until now, heterozygous patients with a mutation in the AGXT gene were considered asymptomatic. However, there have been several cases of patients with heterozygous AGXT mutations presenting with lithiasis.Consequently, the characteristics of symptomatic and asymptomatic heterozygous patients will be studied in order to define the elements that would explain the expression of the disease (particularities of the AGXT mutation, presence of another heterozygous mutation or favorable living conditions).The hypothesis is that there is an increase in hepatic oxalate production in heterozygous patients, which explains why they remain asymptomatic under usual conditions, but could favor stone formation under favorable conditions such as severe calcium deficiency or malabsorption."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HETEROX",
"briefTitle": "Oxalate Excretion Profile in Patients With a Heterozygous Mutation of the AGXT (Alanine-glyoxylate Aminotransferase) Gene",
"nctId": "NCT06283082",
"orgStudyIdInfo": {
"id": "69HCL23_0617",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "2023-A01406-39",
"id": "ID-RCB",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Urinary oxalate and glycolate excretion"
}
],
"secondaryOutcomes": [
{
"measure": "The prevalence of stones"
},
{
"measure": "Lithiasis disease severity"
},
{
"measure": "Lithiasis disease severity"
},
{
"measure": "Lithiasis disease severity"
},
{
"measure": "Lithiasis disease severity"
},
{
"measure": "Predisposing conditions for lithiasis disease"
},
{
"measure": "Predisposing conditions for lithiasis disease"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospices Civils de Lyon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "compilation of a questionnaire about LifeStyle"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Lifestyle",
"Nutrition, Healthy",
"Physical Inactivity",
"Stress",
"Sleep"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Luca Giovanelli, MD",
"phone": "+3902619112808",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Daniela Lucini, Prof",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RICH",
"briefTitle": "Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters",
"nctId": "NCT06283069",
"orgStudyIdInfo": {
"id": "45C301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "weekly physical activity volume"
}
],
"secondaryOutcomes": [
{
"measure": "nutrition quality"
},
{
"measure": "weight"
},
{
"measure": "height"
},
{
"measure": "blood pressure"
},
{
"measure": "perception of stress, fatigue, and somatic symptoms"
},
{
"measure": "glycemia"
},
{
"measure": "cholesterol"
},
{
"measure": "creatinine"
},
{
"measure": "waist circumference"
},
{
"measure": "heart rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2033-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Device treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Cellulitis of Leg"
]
},
"contactsLocationsModule": {
"locations": [
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"measure": "Subject assessment of satisfaction"
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},
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},
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"measure": "Investigator assessment of the cellulite following subdermal Morpheus8 treatment"
},
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},
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{
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{
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{
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{
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"measure": "Beck Depression"
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}
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},
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},
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}
]
},
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},
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},
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}
} | false | null |
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]
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"briefSummary": "Chronic obstructive pulmonary disease (COPD) is a disease that continues to generate a great deal of research and this research must continue, both because it is not completely curable and because of the large patient population. The importance and benefits of exercise training in COPD patients are clear. One of the most preferred types of exercise training is the so-called aerobic exercise training, which typically takes the form of walking. A typical walking training does not use a slope or may include an uphill slope. However, recently there have been publications about downhill walking and its benefits in COPD. Walking on a level, uphill, and downhill slope may have the potential to result in different gains by using different muscle groups more. Therefore, this study aimed to compare the effects of walking training on exercise capacity, respiratory functions, muscle strength, and functional status in COPD patients with three different slope types: level, uphill, and downhill."
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{
"measure": "Muscle strength measurements (respiratory muscles)"
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{
"measure": "Functional performance inventory"
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} | false | null |
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{
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},
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},
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"measure": "The treatment pattern from initial diagnosis to current lorlatinib treatment."
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"measure": "overall survival"
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{
"measure": "1-year OS rate"
},
{
"measure": "time-to-treatment failure for all NSCLC"
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{
"measure": "time-to-treatment failure of lorlatinib"
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{
"measure": "The clinical nature, incidence, duration, and severity of lorlatinib-related safety profile"
}
]
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},
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}
}
} | false | null |
{
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{
"name": "Elranatamab (PF-06863135)"
}
]
},
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},
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{
"city": "Santiago De Compostela",
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"email": null,
"name": "Marta Sonia Gonzalez Perez, MD",
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{
"email": null,
"name": "Marta Sonia Gonzalez Perez, MD",
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],
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{
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{
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{
"city": "L'Hospitalet De Llobregat",
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{
"email": null,
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],
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{
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{
"email": null,
"name": "Enrique M Ocio San Miguel, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Universitario Marqués de Valdecilla",
"geoPoint": {
"lat": 43.46472,
"lon": -3.80444
},
"state": "Cantabria",
"status": "NOT_YET_RECRUITING",
"zip": "39008"
},
{
"city": "Jerez De La Frontera",
"contacts": [
{
"email": null,
"name": "Sebastian Garzon Lopez, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sebastian Garzon Lopez, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Universitario de Jerez de la Frontera",
"geoPoint": {
"lat": 36.68645,
"lon": -6.13606
},
"state": "Cádiz",
"status": "NOT_YET_RECRUITING",
"zip": "11407"
},
{
"city": "Palma De Mallorca",
"contacts": [
{
"email": null,
"name": "Joan LL Bargay, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joan LL Bargay, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Son Llàtzer",
"geoPoint": {
"lat": 39.56939,
"lon": 2.65024
},
"state": "Illes Balears",
"status": "NOT_YET_RECRUITING",
"zip": "07198"
},
{
"city": "Las Palmas De Gran Canaria",
"contacts": [
{
"email": null,
"name": "Alexia T Suarez Cabrera, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alexia T Suarez Cabrera, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "CHU de Gran Canaria Doctor Negrín",
"geoPoint": {
"lat": 28.09973,
"lon": -15.41343
},
"state": "Las Palmas",
"status": "NOT_YET_RECRUITING",
"zip": "35010"
},
{
"city": "Sanchinarro",
"contacts": [
{
"email": null,
"name": "Jaime Perez de Oteysa, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jaime Perez de Oteysa, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital HM Sanchinarro",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": "Madrid",
"status": "NOT_YET_RECRUITING",
"zip": "28050"
},
{
"city": "El Palmar",
"contacts": [
{
"email": null,
"name": "Begoña Navarro de Almenzar, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Begoña Navarro de Almenzar, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Clínico Universitario Virgen de la Arrixaca",
"geoPoint": {
"lat": 37.93939,
"lon": -1.16095
},
"state": "Murcia",
"status": "NOT_YET_RECRUITING",
"zip": "30120"
},
{
"city": "Pamplona",
"contacts": [
{
"email": "[email protected]",
"name": "Jesus San Miguel Izquierdo, MD",
"phone": "+34 948 296 296",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Paula Rodriguez Otero, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Clinica Universidad Navarra (CUN)",
"geoPoint": {
"lat": 42.81687,
"lon": -1.64323
},
"state": "Navarra",
"status": "NOT_YET_RECRUITING",
"zip": "31008"
},
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Joan Bladé, MD",
"phone": "+34 932275428",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Laura Rossiñol, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "H. Clínic i Provincial de Barcelona",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "08036"
},
{
"city": "Gijón",
"contacts": [
{
"email": null,
"name": "María Esther González García, MD",
"phone": "+ 34 985 18 50 00",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "María Esther González García, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital de Cabueñes",
"geoPoint": {
"lat": 43.53573,
"lon": -5.66152
},
"state": null,
"status": "RECRUITING",
"zip": "33394"
},
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "Juan Jose Lahuerta, MD",
"phone": "+34 91 779 28 39",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Instituto de Investigación Sanitaria Hospital 12 de Octubre",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "28041"
},
{
"city": "Salamanca",
"contacts": [
{
"email": "[email protected]",
"name": "Mª Victoria Mateos, MD",
"phone": "+34 923 291 100",
"phoneExt": "55384",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Verónica González de la Calle, MD",
"phone": "+34 923 291 100",
"phoneExt": "55629",
"role": "CONTACT"
},
{
"email": null,
"name": "Mª Victoria Mateos, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Clínico Universitario Salamanca",
"geoPoint": {
"lat": 40.96882,
"lon": -5.66388
},
"state": null,
"status": "RECRUITING",
"zip": "37007"
},
{
"city": "Toledo",
"contacts": [
{
"email": null,
"name": "Luis Felipe Casado Montero, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Luis Felipe Casado Montero, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "C.H. de Toledo (Virgen de la Salud)",
"geoPoint": {
"lat": 39.8581,
"lon": -4.02263
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "45005"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.Safety refers to the measurement of:i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests).ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infectionsThe study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is an open label, multicenter, phase II study of Elranatamab as single agent. The primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy as evaluated with the rate of complete Response and Undetectable Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "None (Open Label)",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes",
"nctId": "NCT06282978",
"orgStudyIdInfo": {
"id": "GEM-RANTAB",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2023-504273-21",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma."
}
],
"secondaryOutcomes": [
{
"measure": "To evaluate annually by NGF until loss of response, the rate of Undetectable Measurable Residual Disease (% of patients with MRD negative by NGF method and with a sensitivity level of 10-5) of elranatamab in patients with R/R multiple myeloma."
},
{
"measure": "Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests."
},
{
"measure": "Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in physical examination and ECOG performance status scale (0-5)."
},
{
"measure": "Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements."
},
{
"measure": "Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test."
},
{
"measure": "Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in 12-lead ECG."
},
{
"measure": "Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in Echocardiogram / MUGA."
},
{
"measure": "To determine Circulating Tumor Cells (CTC) at baseline to evaluate its prognostic value."
},
{
"measure": "To determine serum BCMA levels and its correlation with response."
},
{
"measure": "To do gene expression techniques (RNA sequencing and single cell sequencing studies) coupled with intelligent clinical and molecular data analysis (i.e. machine learning) to identify factors that could predict response to elranatamab."
},
{
"measure": "To determine MRD value with alternative methods"
},
{
"measure": "To characterize patients' immune system"
},
{
"measure": "To define genomic determinants of response/resistance"
},
{
"measure": "To evaluate Overall Response Rate of elranatamab in patients with relapsed/refractory multiple myeloma."
},
{
"measure": "To evaluate Duration of Response of elranatamab in patients with relapsed/refractory multiple myeloma."
},
{
"measure": "To evaluate Time to first and best response of elranatamab in patients with relapsed/refractory multiple myeloma."
},
{
"measure": "To evaluate Progression-free survival (PFS) of elranatamab in patients with relapsed/refractory multiple myeloma."
},
{
"measure": "To evaluate Overall survival (OS) of elranatamab in patients with relapsed/refractory multiple myeloma."
},
{
"measure": "To evaluate PFS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma."
},
{
"measure": "To evaluate OS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma."
},
{
"measure": "To evaluate the Incidence of neurologic effects related to elranatamab in patients with relapsed/refractory multiple myeloma."
},
{
"measure": "To evaluate the Incidence of cytopenias and infections related to elranatamab in patients with relapsed/refractory multiple myeloma."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "PETHEMA Foundation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Angiotensin (1-7)"
},
{
"name": "Sterile saline"
}
]
},
"conditionsModule": {
"conditions": [
"Traumatic Brain Injury"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).The main questions this trial aims to answer are:* Is Angiotensin (1-7) safe?* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?Participants will:* Complete 21 days of study treatment consisting of a once-daily injection.* Provide blood samples.* Undergo two magnetic resonance imaging (MRI) scans of the brain.* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Investigators, study site staff, participants, and caregivers will be unaware of the participant treatment assignments for the duration of the study. The pharmacist will prepare the study treatment and will be unmasked.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ANGel T",
"briefTitle": "Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury",
"nctId": "NCT06282965",
"orgStudyIdInfo": {
"id": "AngT-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants with adverse events"
},
{
"measure": "Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)"
}
],
"secondaryOutcomes": [
{
"measure": "Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA)"
},
{
"measure": "Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)"
},
{
"measure": "Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau)"
},
{
"measure": "Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days"
},
{
"measure": "Effects of Angiotensin (1-7) on brain white matter integrity"
},
{
"measure": "Effects of Angiotensin (1-7) on length of hospital stay"
},
{
"measure": "Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM)"
},
{
"measure": "Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "United States Department of Defense"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Arizona"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fecal transplant"
}
]
},
"conditionsModule": {
"conditions": [
"Fecal Microbiota Transplantation",
"Cesarean Section",
"Overweight and Obesity"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section to obese mothers and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:* Could fecal transplant be used improve gut microbiota and prevent overweight or obesity.* Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The eligible women are randomized into two groups in which their newborns receive either fecal microbiota transplant from 1) their own mother (50 newborns) or 2) the Microbiome Biobank (50 newborns). The randomization 1:1 is done in blocks of 4 mothers. The study is double blinded. If mother has Group B streptococcus colonization or other infectious disease described in table 1, and microbiota transplant cannot be given or if mother will have non-elective-CS and the microbiome transplant is not available, the mother is included in 3) the observational cohort, which is \"open\" (not blinded).",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "The research statistician performs the computer-generated randomization. The study nurse prepares the fecal transplant according to the randomization. Study participants or investigators are not aware of study group.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "49 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "NEMO-FMT",
"briefTitle": "NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT",
"nctId": "NCT06282952",
"orgStudyIdInfo": {
"id": "198/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Microbial composition profiles in fecal sample"
},
{
"measure": "Height in centimeters"
},
{
"measure": "Height z-score"
},
{
"measure": "Weight in kilograms"
},
{
"measure": "Weight-for-length (%)"
}
],
"secondaryOutcomes": [
{
"measure": "The source of colonization by exclusively shared genes (ESGs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Oulu"
},
{
"name": "University of Turku"
},
{
"name": "Turku University Hospital"
},
{
"name": "University of Helsinki"
},
{
"name": "Academy of Finland"
},
{
"name": "Biocenter Oulu"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Oulu University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "OPTIMA and OPTIMAX Coils manufactured by Balt USA"
}
]
},
"conditionsModule": {
"conditions": [
"Intracranial Aneurysm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Plano",
"contacts": [
{
"email": "[email protected]",
"name": "Albert Yoo",
"phone": "972-566-5411",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Pauline Matheri",
"phone": "615-329-7274",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Med City Plano",
"geoPoint": {
"lat": 33.01984,
"lon": -96.69889
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75075"
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System.The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"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": "OPTIMA",
"briefTitle": "Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry",
"nctId": "NCT06282939",
"orgStudyIdInfo": {
"id": "20234314",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Primary Safety Endpoint"
},
{
"measure": "Secondary Safety Endpoint"
}
],
"primaryOutcomes": [
{
"measure": "Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score"
},
{
"measure": "Assess coiling alone or in combination with adjunctive devices for approximately 400 patients"
},
{
"measure": "Evaluate Coiling with flow diversion for approximately 200 subjects"
},
{
"measure": "Subgroup analyses will be performed examining:"
},
{
"measure": "Analyze outcomes of small aneurysms defined as smaller than 5mm"
}
],
"secondaryOutcomes": [
{
"measure": "Adequate occlusion"
},
{
"measure": "Packing density"
},
{
"measure": "Complete occlusion"
},
{
"measure": "Complete occlusion"
},
{
"measure": "Recanalization rate"
},
{
"measure": "Retreatment rate"
},
{
"measure": "Change in degree of disability"
},
{
"measure": "The number of coils used in an aneurysm"
},
{
"measure": "Procedural fluoroscopic time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Balt USA"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "HCA Healthcare Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Echocardiography assessment"
}
]
},
"conditionsModule": {
"conditions": [
"Tetralogy of Fallot"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD",
"nctId": "NCT06282926",
"orgStudyIdInfo": {
"id": "324811",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair."
},
{
"measure": "Evaluate the effects of chronic RV volume overload in this population within one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurement of GLS."
}
],
"secondaryOutcomes": [
{
"measure": "Compare TTE-3DKBR evaluation to the conventional 2D echocardiography measurements used in routine clinical practice (TAPSE, TDI, FAC, and GLS)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Manchester Metropolitan University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Guy's and St Thomas' NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mindfulness Meditation"
}
]
},
"conditionsModule": {
"conditions": [
"Burnout",
"Compassion Fatigue",
"Psychological Well-Being"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"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 Mindfulness Meditation",
"nctId": "NCT06282913",
"orgStudyIdInfo": {
"id": "---Oncology-Nursing-2024---",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "compassion fatigue"
},
{
"measure": "burnout"
},
{
"measure": "psychological well-being"
}
],
"secondaryOutcomes": [
{
"measure": "compassion fatigue"
},
{
"measure": "burnout"
},
{
"measure": "psychological well-being"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Gulhane Training and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "University students"
}
]
},
"conditionsModule": {
"conditions": [
"Student"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Elif E Safran, asst. prof.",
"phone": "500 4047",
"phoneExt": "216",
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Acibadem University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "None Selected",
"status": "RECRUITING",
"zip": "34752"
}
]
},
"descriptionModule": {
"briefSummary": "One of the most important factors why young people spend inactive time is the time they spend in front of the screen. Sedentary screen time refers to time spent using a screen-based device, such as a computer, television, smartphone, or tablet while being sedentary in any environment. The last decade has seen a disturbing increase in the amount of time young people spend in front of screens. Research shows that musculoskeletal disorders in the hand, wrist, arm, and neck occur at a high rate due to long-term and repetitive use of the smartphone, one of the electronic devices. People with musculoskeletal pain often complain of more than one area of pain.The primary purpose of this study is to investigate the relationship between university students' use of various screen-based devices, the time they spend in front of the screen, and the number of painful areas they report on the body. Our secondary aim is to evaluate the relationship between pain, and screen time, and physical activity level."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pain and Screen Addiction in University Students",
"nctId": "NCT06282900",
"orgStudyIdInfo": {
"id": "2024-1/15",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Investigating the use of screen-based devices"
},
{
"measure": "Musculoskeletal system evaluation"
}
],
"secondaryOutcomes": [
{
"measure": "Physical activity assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Acibadem University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Music therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Psycho-Oncology"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": null,
"name": "Juan Nie, Masters",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "GuangZhou Concord Cancer Center",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "510700"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "All participants will be wearing a headphone, and they will not know if there will be music until they experience and finish the scan process.Radiographers are blinding to avoid biases.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and A Relevant Mediator",
"nctId": "NCT06282887",
"orgStudyIdInfo": {
"id": "2021-IIT-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Anxiety"
},
{
"measure": "Symptom distress"
},
{
"measure": "Relaxation"
}
],
"secondaryOutcomes": [
{
"measure": "Pulse rates"
},
{
"measure": "Respiration rate"
},
{
"measure": "Scanning efficiency"
},
{
"measure": "Patient satisfaction level"
},
{
"measure": "Patient attention to music (only for the music therapy group)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Guangzhou Concord Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-11-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lorlatinib"
}
]
},
"conditionsModule": {
"conditions": [
"Carcinoma, Non-Small-Cell Lung",
"Brain Metastases",
"Leptomeningeal Metastasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Chang Lu",
"phone": "02083827812",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jin-Ji Yang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Guangdong Provincial Perople's Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Other (Non U.s.)",
"status": null,
"zip": "510080"
}
]
},
"descriptionModule": {
"briefSummary": "This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases",
"nctId": "NCT06282874",
"orgStudyIdInfo": {
"id": "CTONG2303",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "intracranial objective response rate（iORR）"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-free survival (PFS) and intracranial PFS（iPFS）"
},
{
"measure": "Obiective response rate (ORR)"
},
{
"measure": "Disease control rate (DCR) and intracranial disease control rate (iDCR)"
},
{
"measure": "Overall survival"
},
{
"measure": "Number of participants with adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Guangdong Association of Clinical Trials"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Trelegy Ellipta 100/62.5/25Mcg Inh 30D"
},
{
"name": "Brimica"
},
{
"name": "Duaklir"
},
{
"name": "Ultibro"
},
{
"name": "Ulunar"
},
{
"name": "Xoterna"
},
{
"name": "Anoro"
},
{
"name": "Laventair"
},
{
"name": "Spiolto Respimat"
},
{
"name": "Yanimo"
},
{
"name": "Foradil"
},
{
"name": "Broncoral"
},
{
"name": "Formoterol stada"
},
{
"name": "Oxis"
},
{
"name": "Formatris"
},
{
"name": "Formoterol Aldo"
},
{
"name": "Onbrez"
},
{
"name": "Oslif"
},
{
"name": "Hirobriz"
},
{
"name": "Striverdi"
},
{
"name": "Beglan"
},
{
"name": "Betamican"
},
{
"name": "Inaspir"
},
{
"name": "Serevent"
},
{
"name": "Soltel"
},
{
"name": "Eklira"
},
{
"name": "Bretaris"
},
{
"name": "Seebri"
},
{
"name": "Tovanor"
},
{
"name": "Enurev"
},
{
"name": "Spiriva"
},
{
"name": "Tavulus"
},
{
"name": "Sirkava"
},
{
"name": "Braltus"
},
{
"name": "Gregal"
},
{
"name": "Incruse"
},
{
"name": "Rolufta"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Obstructive Pulmonary Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Àlvar Agustí",
"phone": "93 227 57 79",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nestor Soler",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital Clínic Barcelona",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": "Catalunya",
"status": "RECRUITING",
"zip": "08036"
}
]
},
"descriptionModule": {
"briefSummary": "Current guidelines recommend initial treatment with dual long-acting bronchodilator therapy (LABA-LAMA) in patients with Chronic Obstructive Pulmonary Disease (COPD) of group B (defined by CAT≥10 and none or 1 moderate exacerbation). However, the investigators hypothesize that there is a subgroup of B patients (B+) at a particularly high risk for poor clinical control, characterized by the following:* 1 moderate exacerbation in the previous year* CAT≥10 despite current treatment with LABA -LAMA* Blood eosinophil levels of ≥150 cells/mlthe investigators further hypothesize that B+ patients could benefit from triple therapy treatment (LABA-LAMA + Inhaled Corticosteroids). Therefore, the main goal of this clinical trial is to compare the efficacy of Trelegy (triple therapy) in improving clinical control in GOLD B+ patients with chronic obstructive disease when compared to standard double therapy (LABA -LAMA).The clinical control is a validated composite endpoint that includes two domains, the patient's stability, and the impact of the disease.1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month follow-up trial.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1028,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ANTES B+",
"briefTitle": "ANTES B+ Clinical Trial",
"nctId": "NCT06282861",
"orgStudyIdInfo": {
"id": "ANTES B+",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2023-507304-32",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical Control (CC)"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical Important Deterioration (CID)"
},
{
"measure": "Patients persistently controlled"
},
{
"measure": "Time to deterioration"
},
{
"measure": "Time to no control event of CC - Stability Domain"
},
{
"measure": "Time to no control event of CC - Impact Domain"
},
{
"measure": "Time to deterioration event of CID-CAT Exacerbations"
},
{
"measure": "Time to deterioration event of CID-CAT Spirometry"
},
{
"measure": "Exacerbation rate"
},
{
"measure": "Time to first Exacerbation"
},
{
"measure": "Spirometry changes"
},
{
"measure": "Independent predictors"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "GlaxoSmithKline"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundacio Privada Mon Clinic Barcelona"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
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"date": "2025-09"
},
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"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Atropine 0.05%"
},
{
"name": "DIMS lens"
}
]
},
"conditionsModule": {
"conditions": [
"Myopia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Henry HL Chan, PhD",
"phone": "85227667937",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kaiyip Choi, PhD",
"phone": "85234002934",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "School of Optometry, Hong Kong Polytechnic University",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": "00000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:* the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates* the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized clinical trial",
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"masking": "DOUBLE",
"maskingDescription": "Double-blinded",
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"INVESTIGATOR"
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"timePerspective": null
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "9 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate",
"nctId": "NCT06282848",
"orgStudyIdInfo": {
"id": "HongKongPU_Optometry4",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Subjective refraction"
},
{
"measure": "Axial length"
}
],
"secondaryOutcomes": [
{
"measure": "mfERG responses"
},
{
"measure": "Retinal and choroidal thickness"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The University of Hong Kong"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The Hong Kong Polytechnic University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
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"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-03-02",
"filename": "ICF_000.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 234773,
"typeAbbrev": "ICF",
"uploadDate": "2024-02-21T22:59"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Eravacycline Injection"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Infection",
"Pneumonia, Bacterial",
"Acinetobacter Baumannii"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fuzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Hui Zhang, Phd",
"phone": "13015723860",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fujian Medical University Union hospital",
"geoPoint": {
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"lon": 119.30611
},
"state": "Fujian",
"status": "RECRUITING",
"zip": "350000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time"
},
"designModule": {
"designInfo": {
"allocation": null,
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"maskingInfo": null,
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},
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},
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Eravacycline Combination Therapy for MRAB",
"nctId": "NCT06282835",
"orgStudyIdInfo": {
"id": "2023KY242",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical Responded Rate"
}
],
"secondaryOutcomes": [
{
"measure": "The microbiological clearance rate"
},
{
"measure": "The all-cause mortality rate within 28 days"
},
{
"measure": "\"Incidence Rate of Adverse Event"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fujian Medical University Union Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
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"date": "2024-10-31"
},
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"startDateStruct": {
"date": "2024-01-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transthoracic echocardiography"
}
]
},
"conditionsModule": {
"conditions": [
"Shear Wave Elastography",
"Heart Failure With Preserved Ejection Fraction"
]
},
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"descriptionModule": {
"briefSummary": "The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF."
},
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},
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"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction",
"nctId": "NCT06282822",
"orgStudyIdInfo": {
"id": "HFpEF-SWE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Shear wave velocity"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "First Hospital of China Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreas Cancer",
"Adenocarcinoma of the Pancreas",
"Pancreatic Cancer",
"Tumor of Pancreas"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Hospital de la Santa Creu i Sant Pau",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective multi-center, single-arm, feasibility trial.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GANNON",
"briefTitle": "The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy",
"nctId": "NCT06282809",
"orgStudyIdInfo": {
"id": "CSP3325",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "HistoSonics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Echocardiography"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fuzhou",
"contacts": [
{
"email": null,
"name": "Weiqin Huang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fujian Cancer Hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": "RECRUITING",
"zip": null
},
{
"city": "Dalian",
"contacts": [
{
"email": null,
"name": "Bo Zhang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Dalian Friendship Hospital",
"geoPoint": {
"lat": 38.91222,
"lon": 121.60222
},
"state": "Liaoning",
"status": "RECRUITING",
"zip": null
},
{
"city": "Dalian",
"contacts": [
{
"email": null,
"name": "Qingxiong Yue",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Dalian Municipal Central Hospital",
"geoPoint": {
"lat": 38.91222,
"lon": 121.60222
},
"state": "Liaoning",
"status": "RECRUITING",
"zip": null
},
{
"city": "Shenyang",
"contacts": [
{
"email": null,
"name": "Xiaoxue Zhang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Liaoning Cancer Hospital & Institute",
"geoPoint": {
"lat": 41.79222,
"lon": 123.43278
},
"state": "Liaoning",
"status": "RECRUITING",
"zip": null
},
{
"city": "Chengdu",
"contacts": [
{
"email": null,
"name": "Min Xu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Third People's Hospital Of Chengdu",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis."
},
"designModule": {
"designInfo": {
"allocation": null,
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
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"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy",
"nctId": "NCT06282796",
"orgStudyIdInfo": {
"id": "EPW-CABC-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy."
}
],
"secondaryOutcomes": [
{
"measure": "Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "First Hospital of China Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Topiramate"
}
]
},
"conditionsModule": {
"conditions": [
"HIV-1-infection",
"Hiv",
"HIV Infections",
"HIV I Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rotterdam",
"contacts": null,
"country": "Netherlands",
"facility": "Erasmus Medical Centre",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Even with current HIV treatments, HIV is still a lifelong disease because it hides in some long-lasting cells in the body. One of the strategies to find a cure for HIV works by finding the virus in these cells, making it visible, and then getting rid of it. This is called the 'shock and kill' approach.So far, the drugs tested can find the virus, but they don't get rid of it completely. That's why there need to be new drugs that can do this more effectively. The Erasmus MC HIV Eradication Group (EHEG) has been testing new drugs in the lab and found a drug called topiramate can wake up the virus without harming the cells. The aim of this study is to test topiramate in people living with HIV.Most of the people that participate in HIV cure studies are men, even though most people living with HIV around the world are women. Previous research has shown that men and women might respond differently to these treatments. So, in this study, topiramate will be investigated in both men and women. This could help us find a cure that works for everyone."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STAR",
"briefTitle": "Studying Topiramate for Re-Activating the HIV-1 Reservoir",
"nctId": "NCT06282783",
"orgStudyIdInfo": {
"id": "2024-511532-27-00",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effect of topiramate as measured by cell-associated HIV RNA"
},
{
"measure": "Number of treatment-related adverse events as assessed by CTCAE v4.0"
}
],
"secondaryOutcomes": [
{
"measure": "Influence of sex on the primary outcome measures"
},
{
"measure": "The effect of topiramate on the size of the HIV reservoir measured by relevant assays"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erasmus Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Laser Diode Brace"
},
{
"name": "Sham Laser Diode Brace"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Fusion",
"Chronic Lower Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Daniel Lu, MD, PhD",
"phone": "310-267-2975",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Mark Yamamoto, BS",
"phone": "424-535-9634",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Semel Institute of Neuroscience at UCLA",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": "RECRUITING",
"zip": "90024"
},
{
"city": "Los Angeles",
"contacts": [
{
"email": "[email protected]",
"name": "Daniel Lu, MD, PhD",
"phone": "310-267-2975",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Adreanne Rivera, BS",
"phone": "424-946-5712",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UCLA Clinical and Translational Research Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California",
"status": "RECRUITING",
"zip": "90095"
}
]
},
"descriptionModule": {
"briefSummary": "After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Patients will come into clinic for consultation and enrollment in the study. They will have their first study visit where they will be given either and laser diode brace or a placebo brace. They will follow up with the physician after 2 weeks and then at 3, 6, 9 months and at 1 year to evaluate function and symptoms .",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Participants in this study will not be told which belt is the sham diode brace or which is the functional diode brace. The assessor of the study will also be blinded to which belt each subject has, and data will be analyzed blindly based on patient ID alone.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery",
"nctId": "NCT06282770",
"orgStudyIdInfo": {
"id": "IRB#23-000444",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS"
},
{
"measure": "Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI"
}
],
"secondaryOutcomes": [
{
"measure": "Stony Brook Scar Evaluation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Los Angeles"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Video placebo communication"
},
{
"name": "Video nocebo communication"
}
]
},
"conditionsModule": {
"conditions": [
"Communication",
"Chronic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nijmegen",
"contacts": [
{
"email": "[email protected]",
"name": "Syl Slatman, MSc",
"phone": "+31629684200",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "HAN University of Applied Sciences",
"geoPoint": {
"lat": 51.8425,
"lon": 5.85278
},
"state": "Overijssel",
"status": null,
"zip": "6525EN"
}
]
},
"descriptionModule": {
"briefSummary": "Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMPStudy design: Web-based randomized controlled trial.Study population: 100 participantsIntervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP",
"nctId": "NCT06282757",
"orgStudyIdInfo": {
"id": "202302",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ)"
},
{
"measure": "Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in openness to VR measured using a single question"
},
{
"measure": "Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "HAN University of Applied Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Outpatient physical therapy improvement in movement assessment log"
}
]
},
"conditionsModule": {
"conditions": [
"Physical Performance",
"Outpatients"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Purpose of the study:To translate, culturally adapt, and to test the validity and reliability of the Outpatient Physical Therapy Improvement in Movement Assessment Log in Arabic speaking language."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 880,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OPTIMAL",
"briefTitle": "Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log",
"nctId": "NCT06282744",
"orgStudyIdInfo": {
"id": "OPTIMAL Arabic version",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "validity and reliability of the Egyptian Arabic language version of Outpatient Physical Therapy Improvement Movement Assessment Log on physical therapy outpatients."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Silodosin"
}
]
},
"conditionsModule": {
"conditions": [
"Benign Prostatic Hyperplasia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New Taipei City",
"contacts": null,
"country": "Taiwan",
"facility": "En Chu Kong Hospital",
"geoPoint": {
"lat": 25.01111,
"lon": 121.44583
},
"state": null,
"status": null,
"zip": "23702"
}
]
},
"descriptionModule": {
"briefSummary": "The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 74,
"type": "ACTUAL"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "50 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Changes of Urine Growth Factors Level",
"nctId": "NCT06282731",
"orgStudyIdInfo": {
"id": "ECKIRB1020407",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Urine growth factors level"
}
],
"primaryOutcomes": [
{
"measure": "Urine growth factors level"
}
],
"secondaryOutcomes": [
{
"measure": "Urine growth factors level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "En Chu Kong Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2017-04-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2016-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-05-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Acute Respiratory Tract Infection"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC). The POS-ARI-PC study is a long-term study, with the aim of describing the nature of ARI in adults and children presenting to PC across Europe. The POS-ARI-PC study will provide critically important data on the presentation and management of ARI, and build a research-ready infrastructure for studies related to the treatment, diagnosis, and prevention of ARI in primary care settings. Additional observational studies will be embedded and use the infrastructure developed in POS-ARI-PC."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 2000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "POS-ARI-PC",
"briefTitle": "A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe",
"nctId": "NCT06282718",
"orgStudyIdInfo": {
"id": "POS-ARI-PC CORE and AUDIT",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "European Union",
"id": "965313",
"link": null,
"type": "OTHER_GRANT"
},
{
"domain": "ISRCTN",
"id": "10204126",
"link": null,
"type": "REGISTRY"
},
{
"domain": "NIHR CPMS",
"id": "55487",
"link": null,
"type": "OTHER"
},
{
"domain": "IRAS",
"id": "324504",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Age Bands"
},
{
"measure": "The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI)"
},
{
"measure": "Overall illness severity rating"
},
{
"measure": "Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens."
},
{
"measure": "Proportion undergoing POC (with results) and lab-based investigations"
},
{
"measure": "Details of prescriptions given on presentation of ARI"
},
{
"measure": "Details of tests ordered on presentation of ARI"
},
{
"measure": "Return to usual daily activities"
},
{
"measure": "Feeling recovered from RTI"
},
{
"measure": "Use of prescription medication"
},
{
"measure": "Use of over the counter medications"
},
{
"measure": "Complications reported associated to ARI presentation"
},
{
"measure": "Variation in practice and advice from national guidelines, to be fed back to national teams"
}
],
"secondaryOutcomes": [
{
"measure": "Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients."
},
{
"measure": "An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings."
},
{
"measure": "An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials"
},
{
"measure": "Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "UMC Utrecht"
},
{
"name": "University of Oxford"
},
{
"name": "Universiteit Antwerpen"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "European Clinical Research Alliance for Infectious Diseases (ECRAID)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diagonal Drop Jumps 0cm"
},
{
"name": "Diagonal Drop Jumps 40cm"
},
{
"name": "Diagonal Drop Jumps 60cm"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Participants",
"Low Activity Level"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nottingham",
"contacts": null,
"country": "United Kingdom",
"facility": "Nottingham Trent University",
"geoPoint": {
"lat": 52.9536,
"lon": -1.15047
},
"state": "Nottinghamshire",
"status": null,
"zip": "Ng11 8NS"
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Estimated load being applied to the bone, will be assessed using non-invasive biomechanical procedures (Inertial Measurement Units, motion analysis, force plates) during drop jumps. Participants will be assigned a drop jump height of 0 cm, 30 cm or 60 cm based on a significant difference in external load at these heights or assigned to a control group where no jumps will be performed. Groups will be matched for body mass to ensure that jump height produces the load. The participants will be asked to perform 40 jumps (20 each side), 4 times per week ensuring jumping bouts are separated by 24 hours. Bone characteristics will be assessed via whole body dual-energy X-ray absorptiometry (DXA) scans and bilateral peripheral Quantitative Computed Tomography (pQCT) scans. Lab based jumping will take place on week 0, week 6, week 12, and week 16 to understand the loading applied during the different jump height groups. pQCT scans will take place on week 0, week 12, week 16 and DXA scans will take place week 0 and week 16. The reasoning of week 12 for pQCT being it may show a significant timepoint for bone formation during the remodelling cycle. During visits participants will complete a health screen, the Bone specific Physical Activity Questionnaire (BPAQ), a food frequency questionnaire and Pittsburgh sleep quality questionnaire alongside consent as tools to monitor any changes to participant lifestyle across the study. Differences in bone characteristics, lab measures and jump heights will be analysed between and within participants.The present study aims to use varied drop jump heights to identify an osteogenic dose response effect. Drop jumps have been previously used to expose osteogenic effects in research due to the load produced at impact. Is it possible to identify an optimum height for bone response during impact? If so do we then find anything above this height actually has negative or no effect on a group of individuals?"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Semi-randomised, matched model.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dose Response Effect of Drop Jumps on Bone Characteristics",
"nctId": "NCT06282705",
"orgStudyIdInfo": {
"id": "306347",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "BMD as assessed by whole body dual-energy X-ray absorptiometry (DXA)."
},
{
"measure": "BMC as assessed by whole body dual-energy X-ray absorptiometry (DXA)."
},
{
"measure": "Total bone area as assessed by whole body dual-energy X-ray absorptiometry (DXA)."
},
{
"measure": "Trabecular density as assessed by peripheral quantitative tomography (pQCT) of tibia."
},
{
"measure": "Cortical thickness as assessed by peripheral quantitative tomography (pQCT) of tibia."
},
{
"measure": "Periosteal circumference as assessed by peripheral quantitative tomography (pQCT) of tibia."
},
{
"measure": "Axial bone strength (SSIX) as assessed by peripheral quantitative tomography (pQCT) of tibia."
},
{
"measure": "Axial bone strength (SSIY) as assessed by peripheral quantitative tomography (pQCT) of tibia."
},
{
"measure": "Polar bone strength (SSIPOL) as assessed by peripheral quantitative tomography (pQCT) of tibia."
},
{
"measure": "Cortical density as assessed by peripheral quantitative tomography (pQCT) of tibia."
}
],
"secondaryOutcomes": [
{
"measure": "Peak impact load as assessed by force plates."
},
{
"measure": "Impulse as assessed by force plates."
},
{
"measure": "Load rate as assessed by force plates."
},
{
"measure": "Jump height as assessed by force plates."
},
{
"measure": "Centre of Mass (CoM) velocity as assessed by force plates."
},
{
"measure": "Peak acceleration as assessed by Inertial measurement units (IMU)."
},
{
"measure": "Stiffness as assessed by motion capture."
},
{
"measure": "Moments as assessed by motion capture."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nottingham Trent University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg"
}
]
},
"conditionsModule": {
"conditions": [
"COVID-19 Pandemic",
"COVID-19 Vaccines"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Surabaya",
"contacts": [
{
"email": "[email protected]",
"name": "Dominicus Husada, MD",
"phone": "+6281232266377",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Damayanti Tinduh, MD",
"phone": "+6281703293335",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dominicus Husada, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Damayanti Tinduh, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Gatot Soegiarto, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Leny Kartina, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Laksmi Wulandari, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Deasy Fetarayani, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Novira Widajanti, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Yudi H Oktaviano, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Aryati Aryati, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Fitriah Munawaroh, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Neneng D Kurniati, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Budi Utomo, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Eko B Khoendori, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jusak Nugroho, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Maria I Lusida, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Indonesia",
"facility": "Dr. Soetomo General Hospital",
"geoPoint": {
"lat": -7.24917,
"lon": 112.75083
},
"state": "Jawa Timur",
"status": "RECRUITING",
"zip": "67161"
}
]
},
"descriptionModule": {
"briefSummary": "This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose.The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "12 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old",
"nctId": "NCT06282692",
"orgStudyIdInfo": {
"id": "UNAIR-MP-INAKTIF-R-005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Vaccine Neutralizing Antibody Profile"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of Adverse Events"
},
{
"measure": "Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum"
},
{
"measure": "Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA"
},
{
"measure": "Cellular Immunogenicity Profile"
},
{
"measure": "Persistence of Antibody Level"
},
{
"measure": "Whole Genome Sequencing (WGS) of SARS-CoV-2"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Indonesia-MoH"
},
{
"name": "Universitas Airlangga"
},
{
"name": "PT Biotis Pharmaceuticals, Indonesia"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Dr. Soetomo General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Botulinum Toxin Type A Injection [Botox]"
}
]
},
"conditionsModule": {
"conditions": [
"Rosacea",
"Botulinum Toxin"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": "[email protected]",
"name": "jie dai",
"phone": "02552271117",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Jie Dai",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "210006"
}
]
},
"descriptionModule": {
"briefSummary": "the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea",
"nctId": "NCT06282679",
"orgStudyIdInfo": {
"id": "KY20220701-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "VISIA red zone score"
},
{
"measure": "Dermatology Quality of Life Score (DLQI)"
}
],
"primaryOutcomes": [
{
"measure": "CEA score"
}
],
"secondaryOutcomes": [
{
"measure": "GAIS score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nanjing First Hospital, Nanjing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Spinal anesthesia"
},
{
"name": "lumbar erector spinae plane block"
},
{
"name": "Epidural analgesia"
},
{
"name": "patient-controlled analgesia"
},
{
"name": "Timed Up and Go test"
},
{
"name": "neuropathic pain symptom inventory"
},
{
"name": "Lovett test"
},
{
"name": "Visual analog scale"
},
{
"name": "Quality of Recovery 40"
},
{
"name": "Ability to sit, stand upright, and walk"
}
]
},
"conditionsModule": {
"conditions": [
"Coxarthrosis",
"Pain, Postoperative",
"Pain, Acute",
"Pain, Chronic",
"Postoperative Pain, Chronic",
"Analgesia",
"Quality of Life",
"Anesthesia",
"Spinal"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lublin",
"contacts": [
{
"email": "[email protected]",
"name": "Michał A Borys, M.D. Ph.D",
"phone": "506350569",
"phoneExt": "+48",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Paweł Kutnik, M.D.",
"phone": "608769410",
"phoneExt": "+48",
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "II Department of Anesthesia and Intensive Care",
"geoPoint": {
"lat": 51.25,
"lon": 22.56667
},
"state": null,
"status": null,
"zip": "20-081"
}
]
},
"descriptionModule": {
"briefSummary": "In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two groups will be randomly allocated to Epidural and ESPB (1:1)",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation.Physiotherapists assessing outcomes will not be aware of patient allocation.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ESPB_HIP",
"briefTitle": "Lumbar ESPB in Hip Replacement Surgery",
"nctId": "NCT06282666",
"orgStudyIdInfo": {
"id": "KE-0254/150/2019",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Opiod consumtion with PCA"
}
],
"secondaryOutcomes": [
{
"measure": "Pain at rest"
},
{
"measure": "Pain upon activity"
},
{
"measure": "Lovett test"
},
{
"measure": "TUG"
},
{
"measure": "QoR-40"
},
{
"measure": "NPSI"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Lublin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Musculoskeletal System Disease",
"Position Sense Disorders",
"Symptoms and Signs",
"Postural; Defect",
"Endodontic Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Villaviciosa De Odón",
"contacts": [
{
"email": null,
"name": "Antonio Conde, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Universidad Europea de Madrid",
"geoPoint": {
"lat": 40.35692,
"lon": -3.90011
},
"state": "Madrid",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Musculoskeletal disorders (MSDs) are a significant occupational health problem for dentists and have been linked to a decline in quality of life, often leading to stress-related illnesses and early retirement. Poor posture, poor movement or imbalances in the neck or shoulders can lead to the three most common pain syndromes in dentistry. The objectives of this study were to evaluate the working position adopted during an endodontic procedure and to determine the perception of symptoms of musculoskeletal disorders in first and second year students of the Master in Advanced Endodontics at the European University of Madrid (UEM), using the standardised Nordic Kuorinka questionnaire supplemented by a form with socio-demographic variables. This study has a descriptive cross-sectional observational design and included 10 students selected by convenience sampling. A video camera was used to record the procedures from three different angles for a maximum of 5 minutes. The information was processed using Microsoft Excel spreadsheet software, and the video recordings were assessed using Rodgers' Muscular Fatigue Analysis (RMFA) and Rapid Upper Limb Assessment (RULA)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postural and Muscle Fatigue Analysis of Endodontic Residents",
"nctId": "NCT06282653",
"orgStudyIdInfo": {
"id": "Endo-ergonomics",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Symptom Perception"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidad Europea de Madrid"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2024-02-20",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 96217,
"typeAbbrev": "Prot",
"uploadDate": "2024-02-20T05:22"
},
{
"date": "2024-02-20",
"filename": "ICF_001.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 77805,
"typeAbbrev": "ICF",
"uploadDate": "2024-02-20T05:30"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin D"
}
]
},
"conditionsModule": {
"conditions": [
"Carpal Tunnel Syndrome",
"Vitamin D Deficiency"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kayseri",
"contacts": null,
"country": "Turkey",
"facility": "Kayseri City Hospital",
"geoPoint": {
"lat": 38.73222,
"lon": 35.48528
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 87,
"type": "ACTUAL"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome",
"nctId": "NCT06282640",
"orgStudyIdInfo": {
"id": "567",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Boston symptom severity scale"
}
],
"primaryOutcomes": [
{
"measure": "electrophysiological scale."
}
],
"secondaryOutcomes": [
{
"measure": "monofilament test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kayseri City Hospital"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Dr. Ayşe Güç"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-12-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Observational study"
}
]
},
"conditionsModule": {
"conditions": [
"COVID-19",
"Post-COVID-19 Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Groningen",
"contacts": null,
"country": "Netherlands",
"facility": "University Medical Center Groningen",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null,
"status": null,
"zip": "9713 GZ"
}
]
},
"descriptionModule": {
"briefSummary": "Background. Guidelines on COVID-19 management are developed as we learn from this pandemic. However, most research has been done on hospitalised patients and the impact of the disease on non-hospitalised and their role in transmission are not yet well understood.The COVID HOME study conducts research among COVID-19 patients and their family members who were not hospitalised during acute disease, to guide patient care and inform public health guidelines for infection prevention and control in the community and household.Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatients was established in March 2020 at the beginning of the COVID-19 pandemic in the Netherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that did not merit hospitalisation, and their household (HH) members, were enrolled after written informed consent. Enrolled participants were visited at home within 48 hours after initial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a blood sample for biochemical parameters/cytokines and serological determination; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (if consenting) to test for SARS-CoV-2 by RT-PCR (viral shedding) and for viral culturing. Weekly nasopharyngeal/throat swabs and stool samples, plus a blood sample on days 0 and 21 were also taken from HH members to determine whether and when they became infected. All participants were invited to continue follow-up at 3-, 6-, 12- and 18-months post-infection to assess long-term sequelae and immunological status."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 256,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "COVID-HOME",
"briefTitle": "The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients",
"nctId": "NCT06282627",
"orgStudyIdInfo": {
"id": "10430012010023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "SARS-CoV-2 infection"
}
],
"secondaryOutcomes": [
{
"measure": "Long-term sequelae"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "ZonMw: The Netherlands Organisation for Health Research and Development"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Medical Center Groningen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mucogyne Ovule"
}
]
},
"conditionsModule": {
"conditions": [
"Vaginal Dryness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nogent-sur-Marne",
"contacts": null,
"country": "France",
"facility": "JEAN Christian's medical office",
"geoPoint": {
"lat": 48.83333,
"lon": 2.48333
},
"state": null,
"status": null,
"zip": "94130"
},
{
"city": "Orléans",
"contacts": [
{
"email": null,
"name": "Ramez GHADRI, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ramez GHADRI, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Dr Ramez GHADRI's medical office",
"geoPoint": {
"lat": 47.90289,
"lon": 1.90389
},
"state": null,
"status": null,
"zip": "45100"
},
{
"city": "Rennes",
"contacts": [
{
"email": null,
"name": "Raïssa APERANO-MAS, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Raïssa APERANO-MAS, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Dr Raïssa APERANO-MAS's medical office",
"geoPoint": {
"lat": 48.11198,
"lon": -1.67429
},
"state": null,
"status": null,
"zip": "35000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective, multicenter (France), open label without comparator study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MOVHYDA",
"briefTitle": "Performance and Safety of MUCOGYNE® Ovule as a Moisturizer",
"nctId": "NCT06282614",
"orgStudyIdInfo": {
"id": "MUCO245",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ID-RCB",
"id": "2023-A02081-44",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use"
}
],
"secondaryOutcomes": [
{
"measure": "Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation"
},
{
"measure": "Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort"
},
{
"measure": "Assessment of the local performance of MUCOGYNE® Ovule in reducing itching"
},
{
"measure": "Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness"
},
{
"measure": "Assessment of the patient's sexual function"
},
{
"measure": "Assessment of the patient's satisfaction"
},
{
"measure": "Assessment of changes in patient's clinical status"
},
{
"measure": "Assessment by investigator of changes in patient's clinical status"
},
{
"measure": "Assessment of the safety of MUCOGYNE® Ovule"
},
{
"measure": "Assessment of the device deficiencies of MUCOGYNE® Ovule"
},
{
"measure": "Assessment of the usability of MUCOGYNE® Ovule"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Voisin Consulting Life Science (VCLS)"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Biocodex"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Audiogram"
},
{
"name": "Musical priming for the syntax test"
},
{
"name": "Test MMSE"
},
{
"name": "Barcelona Music Reward Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Presbyacousie"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "70 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AMORCAGE MUSIC",
"briefTitle": "STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS",
"nctId": "NCT06282601",
"orgStudyIdInfo": {
"id": "GUIGOU - Defaye 2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "linguistic performance test focusing on syntax."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire Dijon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Darolutamide"
},
{
"name": "Darolutamide matched placebo"
},
{
"name": "Radiotherapy"
},
{
"name": "Zoladex 3.6Mg Implant"
},
{
"name": "Zoladex LA"
},
{
"name": "Decapeptyl sustained release 22.5 mg"
},
{
"name": "Decapeptyl sustained release 11.25 mg"
},
{
"name": "Depo-Eligard 45 mg"
},
{
"name": "Depo-Eligard 22.5 mg"
},
{
"name": "Depo-Eligard 7.5 mg"
},
{
"name": "Firmagon 120 MG Injection"
},
{
"name": "Firmagon 80 MG Injection"
},
{
"name": "Docetaxel"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wilrijk",
"contacts": [
{
"email": "[email protected]",
"name": "Piet Ost, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Piet Ost",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "GZA Sint-Augustinus",
"geoPoint": {
"lat": 51.16734,
"lon": 4.39513
},
"state": "Antwerp",
"status": "RECRUITING",
"zip": "2610"
},
{
"city": "Aalst",
"contacts": [
{
"email": null,
"name": "Samuel Br",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Samuel Bral",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "OLVZ Aalst",
"geoPoint": {
"lat": 50.93604,
"lon": 4.0355
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "9300"
},
{
"city": "Brugge",
"contacts": [
{
"email": null,
"name": "Sabine Meersschout",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sabine Meersschout",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "AZ Sint-Jan",
"geoPoint": {
"lat": 51.20892,
"lon": 3.22424
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "8000"
},
{
"city": "Bruxelles",
"contacts": [
{
"email": null,
"name": "Ad Vanderm",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ad Vandermeulen",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Saint Luc",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "1200"
},
{
"city": "Edegem",
"contacts": [
{
"email": null,
"name": "Karen Fransis",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Karen Fran",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "UZA",
"geoPoint": {
"lat": 51.15662,
"lon": 4.44504
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "2600"
},
{
"city": "Gent",
"contacts": [
{
"email": null,
"name": "Valérie Fonteyne",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Valérie Fonteyne",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "UZ Gent",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "9000"
},
{
"city": "Gent",
"contacts": [
{
"email": null,
"name": "Lien Van De Voorde",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lien Van De Voor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "AZ Sint-Lucas",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "900"
},
{
"city": "Kortrijk",
"contacts": [
{
"email": null,
"name": "Nick Liefhooghe",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nick Liefhooghe",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "AZ Groeninge",
"geoPoint": {
"lat": 50.82803,
"lon": 3.26487
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "8500"
},
{
"city": "Liège",
"contacts": [
{
"email": null,
"name": "Brieuc Suatois",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Brieuc Sautois",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "CHU Liège",
"geoPoint": {
"lat": 50.63373,
"lon": 5.56749
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "4000"
},
{
"city": "Roeselare",
"contacts": [
{
"email": null,
"name": "Benedikt Engels",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Benedikt Enge",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "AZ Delta",
"geoPoint": {
"lat": 50.94653,
"lon": 3.12269
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "8800"
},
{
"city": "Sint-Niklaas",
"contacts": [
{
"email": null,
"name": "Bart De Troyer",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Bart De Troyer",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "VITAZ",
"geoPoint": {
"lat": 51.16509,
"lon": 4.1437
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "9100"
}
]
},
"descriptionModule": {
"briefSummary": "This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity.The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (\\> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome.The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase 2: non randomised, 1 treatment arm, open label Phase 3: randomized 1:1 between two treatment arms, blinded",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Phase 3 trial: blinded Phase 2 trial: open label",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 493,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "THUNDER",
"briefTitle": "Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers",
"nctId": "NCT06282588",
"orgStudyIdInfo": {
"id": "CTO21042GZA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Phase 3: PSMA PET metastasis free survival (ppMFS)"
},
{
"measure": "Phase 2: quality of life (sexual subdomain)"
},
{
"measure": "Phase 2: quality of life (hormonal subdomain)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Prostate-cancer specific survival"
},
{
"measure": "Biochemical progression-free survival"
},
{
"measure": "Time to next systemic therapy"
},
{
"measure": "Frequency and severity of adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bayer"
},
{
"name": "Veracyte, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Cancer Research Antwerp"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Zanidatamab"
},
{
"name": "Cisplatin"
},
{
"name": "Gemcitabine"
},
{
"name": "Pembrolizumab"
},
{
"name": "Durvalumab"
}
]
},
"conditionsModule": {
"conditions": [
"Biliary Tract Cancer",
"HER2 Gene Mutation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lone Tree",
"contacts": null,
"country": "United States",
"facility": "Rocky Mountain Cancer Centers, LLP",
"geoPoint": {
"lat": 39.55171,
"lon": -104.8863
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80124"
},
{
"city": "Louisville",
"contacts": null,
"country": "United States",
"facility": "Norton Cancer Institute - Audubon",
"geoPoint": {
"lat": 38.25424,
"lon": -85.75941
},
"state": "Kentucky",
"status": "NOT_YET_RECRUITING",
"zip": "40217"
},
{
"city": "Maple Grove",
"contacts": null,
"country": "United States",
"facility": "Minnesota Oncology Hematology, P.A.",
"geoPoint": {
"lat": 45.07246,
"lon": -93.45579
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55369"
},
{
"city": "Nashville",
"contacts": null,
"country": "United States",
"facility": "SCRI Oncology Partners",
"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee",
"status": "RECRUITING",
"zip": "37203"
},
{
"city": "Dallas",
"contacts": null,
"country": "United States",
"facility": "Texas Oncology - DFW",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75246"
},
{
"city": "Rio Piedras",
"contacts": null,
"country": "Puerto Rico",
"facility": "Hospital Oncologico, Puerto Rico Medical Center",
"geoPoint": {
"lat": 18.39745,
"lon": -66.04989
},
"state": null,
"status": "RECRUITING",
"zip": "00935"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 286,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer",
"nctId": "NCT06282575",
"orgStudyIdInfo": {
"id": "JZP598-302",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTIS",
"id": "2023-508219-21-00",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS) in participants with IHC 3+ tumors"
},
{
"measure": "Progression Free Survival for all participants"
},
{
"measure": "OS for all participants"
},
{
"measure": "Number of participants achieving Confirmed objective response rate (cORR)"
},
{
"measure": "Duration of response (DOR)"
},
{
"measure": "Number of Patients reporting Treatment-Emergent Adverse Events (TEAE)"
},
{
"measure": "Maximum serum concentration of Zanidatamab"
},
{
"measure": "Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab"
},
{
"measure": "Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30"
},
{
"measure": "TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30"
},
{
"measure": "TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis)"
},
{
"measure": "TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Jazz Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High-Intensity Interval Training (HIIT)"
}
]
},
"conditionsModule": {
"conditions": [
"Brain Tumor, Primary",
"Exercise"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amsterdam",
"contacts": [
{
"email": "[email protected]",
"name": "Marieke Blom, Msc",
"phone": "+31621522442",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "VU University Medical Centers, location VUmc",
"geoPoint": {
"lat": 52.37403,
"lon": 4.88969
},
"state": null,
"status": "RECRUITING",
"zip": "1081 HV"
}
]
},
"descriptionModule": {
"briefSummary": "The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
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},
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"acronym": "FeelFit",
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},
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"measure": "Daily physical activity"
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{
"measure": "Health-related quality of life questionnaire"
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{
"measure": "Perceived functional impairments"
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{
"measure": "Self-efficacy"
},
{
"measure": "Mastery"
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{
"measure": "Brain tumor specific quality of life questionnaire"
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{
"measure": "Subjective Happiness"
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{
"measure": "Subjective cognitive functioning"
},
{
"measure": "Subjective cognitive failure"
},
{
"measure": "Fatigue questionnaire"
},
{
"measure": "Sleep questionnaire"
},
{
"measure": "Anxiety questionnaire"
},
{
"measure": "Self-reported depression questionnaire"
},
{
"measure": "Depression questionnaire"
},
{
"measure": "Muscle strength"
},
{
"measure": "Subjective physical fitness"
},
{
"measure": "Objective neurocognitive functioning"
},
{
"measure": "Objective neurological functioning"
},
{
"measure": "Brain imaging (optional)"
},
{
"measure": "Brain activity (optional)"
}
],
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"measure": "Self-reported physical fitness"
}
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{
"measure": "VO2max"
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},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
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"name": "Telmisartan/Amlodipine/Chlorthalidone(Truset)"
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]
},
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]
},
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{
"city": "Busan",
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{
"email": null,
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}
],
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},
{
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"email": null,
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}
],
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"zip": "42835"
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{
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"email": null,
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}
],
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"zip": "62284"
},
{
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{
"email": null,
"name": "Chanhee Kwon",
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}
],
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"facility": "Konkuk University Medical Center",
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"zip": "05030"
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{
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{
"email": null,
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}
],
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"facility": "Veterans Health Service Medical Center",
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"zip": "05368"
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},
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"id": "YMC046",
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"type": null
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{
"measure": "Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)"
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],
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"measure": "Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage"
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{
"measure": "Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP)"
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{
"measure": "Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP)"
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{
"measure": "Percentage of patients who terminated the treatment"
}
]
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}
}
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{
"name": "surgery"
}
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},
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"briefSummary": "Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer."
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"id": "LungMate-018",
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"measure": "Objective response rate (ORR)"
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"measure": "Pathologic complete response (PCR) rate"
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"measure": "Major pathologic response (MPR) rate"
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"measure": "Overall survival (OS)"
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{
"measure": "Event-free survival (EFS)"
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{
"measure": "Treatment-related adverse event (TRAE)"
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{
"measure": "5-year overall survival (OS)"
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{
"measure": "1-year event-free survival (EFS) rate"
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{
"measure": "Health related quality of life (HRQol)"
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]
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}
} | false | null |
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"name": "HMP app"
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{
"name": "HMRP web app"
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},
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{
"email": "[email protected]",
"name": "Simon Goldberg, PhD",
"phone": "608-265-8986",
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"role": "CONTACT"
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{
"email": null,
"name": "Simon Goldberg, PhD",
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],
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"lon": -89.40123
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"zip": "53705"
}
]
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},
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},
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},
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"domain": "UW- Madison",
"id": "A171600",
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{
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"id": "EDUC/COUNSELING PSYCH",
"link": null,
"type": "OTHER"
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{
"domain": "UW- Madison",
"id": "Protocol Version 12/27/23",
"link": null,
"type": "OTHER"
}
]
},
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"measure": "Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety"
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{
"measure": "HMP App Utilization: Days"
},
{
"measure": "HMP App Utilization: Number of Activities"
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{
"measure": "HMP App Utilization: Minutes"
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{
"measure": "Change in Healthy Minds Index (HM Index): Awareness"
},
{
"measure": "Change in Healthy Minds Index (HM Index): Connection"
},
{
"measure": "Change in Healthy Minds Index (HM Index): Purpose"
},
{
"measure": "Change in Healthy Minds Index (HM Index): Insight"
},
{
"measure": "Change in Subjective Happiness Scale"
},
{
"measure": "Change in Satisfaction with Life Scale (SWLS)"
},
{
"measure": "Change in Perceived Stress Scale (PSS-10)"
},
{
"measure": "Change in Flourishing Measure"
},
{
"measure": "Change in Digital Working Alliance Inventory (DWAI)"
},
{
"measure": "Change in Experiences Questionnaire (EQ) Decentering Subscale"
},
{
"measure": "Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale"
},
{
"measure": "Change in NIH Toolbox Loneliness"
},
{
"measure": "Change in Wellbeing Growth Mindset"
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{
"measure": "Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose"
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]
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},
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}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Povidone Iodine Topical"
}
]
},
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"conditions": [
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"Colonization, Asymptomatic"
]
},
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{
"city": "Chicago",
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{
"email": "[email protected]",
"name": "Sarah E Sansom, DO",
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{
"email": "[email protected]",
"name": "Mary K Hayden, MD",
"phone": "312-942-8727",
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}
],
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"zip": "60612"
},
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Nidhi Undevia, MD",
"phone": "630-286-4000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Lisa Duffner",
"phone": "630-286-4000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "RML Specialty Hospital",
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},
"state": "Illinois",
"status": "RECRUITING",
"zip": "60624"
},
{
"city": "Hinsdale",
"contacts": [
{
"email": "[email protected]",
"name": "Nidhi Undevia, MD",
"phone": "630-286-4000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Lisa Duffner",
"phone": "(630) 286-4000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
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"state": "Illinois",
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"zip": "60521"
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]
},
"descriptionModule": {
"briefSummary": "This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris."
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Nasal Antisepsis for C. Auris Prevention",
"nctId": "NCT06282510",
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"id": "23053003",
"link": null,
"type": null
},
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},
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{
"measure": "Non-susceptibility of C. auris to povidone iodine"
},
{
"measure": "Change in microbiome community"
}
],
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"measure": "Detection of C. auris from the anterior nares"
}
],
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{
"measure": "Detection of C. auris from body sites other than anterior nares"
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{
"measure": "Detection of C. auris from environmental surfaces"
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{
"measure": "Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares"
},
{
"measure": "Detection of MRSA from environmental surfaces"
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},
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{
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},
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}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
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"name": "Optimised neck CTV"
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{
"name": "standard neck CTV"
}
]
},
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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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},
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"stdAges": [
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},
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"id": "ZSCPH-003",
"link": null,
"type": null
},
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},
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"measure": "Regional recurrence free survival"
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{
"measure": "Local recurrence free survival"
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{
"measure": "Distant metastasis-free survival"
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{
"measure": "Progression free survival"
},
{
"measure": "Acute toxicities"
},
{
"measure": "Late toxicities"
}
]
},
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},
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"date": "2026-10-23"
},
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"startDateStruct": {
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},
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}
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},
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{
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{
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"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I)",
"nctId": "NCT06282432",
"orgStudyIdInfo": {
"id": "RP-L201-0121-LTFU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hematopoietic stem cell transplant (HSCT) free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of hospitalizations"
},
{
"measure": "Incidence of significant infections"
},
{
"measure": "Resolution of LAD-I-related skin rash"
},
{
"measure": "Resolution of LAD-I-related periodontal abnormalities"
},
{
"measure": "Event free survival"
},
{
"measure": "Overall Survival"
},
{
"measure": "Long-term genetic correction in peripheral blood mononuclear cells (PBMCs)"
},
{
"measure": "Long-term genetic correction in PB CD15+ granulocytes"
},
{
"measure": "Long-term CD18 neutrophil expression by flow cytometry"
},
{
"measure": "Long-term CD11 neutrophil expression by flow cytometry"
},
{
"measure": "Improvement or resolution of LAD-I related neutrophilia"
},
{
"measure": "Improvement or resolution of LAD-I-related leukocytosis."
},
{
"measure": "Incidence of Investigational Product (IP) related serious adverse events (SAEs)"
},
{
"measure": "Incidence of hematologic malignancy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Rocket Pharmaceuticals Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2037-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2037-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "USE OF MOBILE ULTRASOUND"
},
{
"name": "ultrasound image taken from the internet"
}
]
},
"conditionsModule": {
"conditions": [
"Ultrasonography Prenatal"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erzurum",
"contacts": [
{
"email": "[email protected]",
"name": "Merve Çakıl",
"phone": "+905310854245",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ayla KANBUR",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Atatürk University",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a study that evaluates the effects on mothers by involving fathers in the pregnancy follow-up process through the use of mobile ultrasound.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 132,
"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 Visual and Audio Stimulus Offered to Father-to-be",
"nctId": "NCT06282419",
"orgStudyIdInfo": {
"id": "B.30.2.ATA.0.01.00/542",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Introductory Information Form (For Women)"
},
{
"measure": "Spouse Support Scale Perceived by Women During Early Postpartum Period"
},
{
"measure": "Breastfeeding Self-Efficacy Scale-Short Form"
},
{
"measure": "Breastfeeding Adaptation Scale"
},
{
"measure": "Edinburgh Postpartum Depression Scale"
},
{
"measure": "Introductory Information Form (For Men)"
},
{
"measure": "Fathers' Breastfeeding Attitude and Participation Scale"
},
{
"measure": "Edinburgh Postpartum Depression Scale for Men"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ataturk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-21"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcutaneous Electrical Stimulation"
},
{
"name": "Sham"
}
]
},
"conditionsModule": {
"conditions": [
"Paresis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Elizabeth B Toth, BA",
"phone": "412-954-5382",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kimberly A Toland",
"phone": "(412) 215-5084",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael A. Urbin, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15240"
}
]
},
"descriptionModule": {
"briefSummary": "Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pupil-Indexed Noninvasive Neuromodulation",
"nctId": "NCT06282406",
"orgStudyIdInfo": {
"id": "N4532-R",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "U.S. Department of Veterans Affairs",
"id": "I0X1RX004532",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Force Control Change"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "VA Office of Research and Development"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-08-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-04-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "FibriCheck recordings"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Arrhythmia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Genk",
"contacts": [
{
"email": "[email protected]",
"name": "Pieter Vandervoort, MD",
"phone": "089/325050",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Ziekenhuis Oost Limburg",
"geoPoint": {
"lat": 50.965,
"lon": 5.50082
},
"state": "Limburg",
"status": "RECRUITING",
"zip": "3600"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FDR",
"briefTitle": "FibriCheck Data Registry",
"nctId": "NCT06282393",
"orgStudyIdInfo": {
"id": "Z-2023072",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Alignment PPG measurement"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Qompium NV"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "FibriCheck Mobile Application"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FDA-AF",
"briefTitle": "Fibricheck Detection cApabilities for Atrial Fibrillation",
"nctId": "NCT06282380",
"orgStudyIdInfo": {
"id": "FDA-AF study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Accuracy of the FibriCheck Mobile Application"
}
],
"secondaryOutcomes": [
{
"measure": "Sensitivity of the FibriCheck Mobile Application"
},
{
"measure": "Specificity of the FibriCheck Mobile Application"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Qompium NV"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Colonoscopy",
"Colonoscopy Preparation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lima",
"contacts": null,
"country": "Peru",
"facility": "Jose Agurto Tello Hospital",
"geoPoint": {
"lat": -12.04318,
"lon": -77.02824
},
"state": null,
"status": null,
"zip": "05001"
}
]
},
"descriptionModule": {
"briefSummary": "Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 222,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bowel Preparation for Colonoscopy With Oral Lactulose",
"nctId": "NCT06282367",
"orgStudyIdInfo": {
"id": "JOSE AGURTO TELLO HOSPITAL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Degree of bowel cleansing using the Boston score"
}
],
"secondaryOutcomes": [
{
"measure": "adenomas detection rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Josue Aliaga"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Type of post-operative appointment"
}
]
},
"conditionsModule": {
"conditions": [
"Urologic Cancer",
"Satisfaction, Patient",
"Surgery",
"Postoperative Adhesion"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Telemedicine for Postoperative Follow-up After Oncological Surgeries",
"nctId": "NCT06282354",
"orgStudyIdInfo": {
"id": "NP4035/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient satisfaction in the post-operative return"
}
],
"secondaryOutcomes": [
{
"measure": "unattended arrivals at the institution"
},
{
"measure": "Postoperative complications"
},
{
"measure": "Appointment's time"
},
{
"measure": "Number of exams requested"
},
{
"measure": "Total cost involved per service"
},
{
"measure": "Environmental impact"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Instituto do Cancer do Estado de São Paulo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Race: Simulated marathon"
},
{
"name": "Race: Simulated trail"
},
{
"name": "Race: Trail in nature"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Saint-Étienne",
"contacts": [
{
"email": "[email protected]",
"name": "Léonard FEASSON, Phd",
"phone": "04 77 12 03 83",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Diana RIMAUD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Clément FOSCHIA, Dr",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Pascal EDOUARD, Dr",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "France",
"facility": "Unités de Myologie et de Médecine du Sport",
"geoPoint": {
"lat": 45.43389,
"lon": 4.39
},
"state": null,
"status": "RECRUITING",
"zip": "42055"
}
]
},
"descriptionModule": {
"briefSummary": "Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert...) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective study on healthy volunteers, comparing the neurophysiological, physiological and biomechanical effects at the end of a marathon compared with an equivalent effort trail in the open air, or simulated on a treadmill, in runners specialising in each of the 2 disciplines",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "MARA-TRAIL",
"briefTitle": "Fatigue and Recovery: a Comparison Between Trail and Marathon",
"nctId": "NCT06282341",
"orgStudyIdInfo": {
"id": "23CH132",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in knee extensors maximal isometric torque output"
}
],
"secondaryOutcomes": [
{
"measure": "Change in plantar flexor maximal isometric torque output"
},
{
"measure": "Recovery of quadriceps maximal isometric torque output the month after the race"
},
{
"measure": "Voluntary activation level"
},
{
"measure": "Force assessed in dynamic"
},
{
"measure": "Velocity assessed in dynamic"
},
{
"measure": "Power assessed in dynamic"
},
{
"measure": "Muscular power and stretch-shortening cycle assessed through squat jumps"
},
{
"measure": "Muscular power and stretch-shortening cycle assessed through countermovement jump"
},
{
"measure": "Muscular power and stretch-shortening cycle assessed through drop jump"
},
{
"measure": "Muscle electrical activity"
},
{
"measure": "The kinetics of energy cost"
},
{
"measure": "Racing kinematics"
},
{
"measure": "Ground reaction force (in Newton)"
},
{
"measure": "Center of pressure (in Newton)"
},
{
"measure": "Muscle damage blood markers"
},
{
"measure": "Resting heart rate variability parameters"
},
{
"measure": "Effort perception"
},
{
"measure": "fatigue assessment"
},
{
"measure": "Muscular pain"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Universitaire de Saint Etienne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HIV test"
}
]
},
"conditionsModule": {
"conditions": [
"Hiv",
"HIV Infections",
"AIDS"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Elisabetta Carini",
"phone": "+0039 0226437934",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS San Raffaele Scientific Institute",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": "20127"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors.This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason.The overall study duration is 24 months, with recruitment lasting 20 months. Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization.Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside.In case of a positive rapid capillary HIV test result, antigen/antibody testing and Western Blot for HIV confirmation will be performed on venous blood samples on the same day."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "14 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HIV-HOTE",
"briefTitle": "HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting",
"nctId": "NCT06282328",
"orgStudyIdInfo": {
"id": "CET 26-2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prevalence of HIV infection"
}
],
"secondaryOutcomes": [
{
"measure": "Number of HIV-IC"
},
{
"measure": "Number of Behavioral Risk Factors"
},
{
"measure": "CD4+ lymphocytes"
},
{
"measure": "HIV-RNA"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Castagna Antonella"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-14"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pre-screening Phase"
},
{
"name": "Screenig Phase"
},
{
"name": "Randomization"
},
{
"name": "Baseline Effectiveness Cohort"
},
{
"name": "Day 0 Trial Intervention"
},
{
"name": "Active Surveillance (study visit Day 1, Day 2 and Day 7)"
},
{
"name": "Passive Surveillance"
},
{
"name": "Post-Treatment Effectiveness Evaluation"
}
]
},
"conditionsModule": {
"conditions": [
"Soil-Transmitted Helminths"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Accra",
"contacts": [
{
"email": "[email protected]",
"name": "Abraham Oduro, PM",
"phone": "+233 (0) 50 469 8534",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Joseph Opare, PI",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Ghana",
"facility": "Ghana Health Service (GHS)",
"geoPoint": {
"lat": 5.55602,
"lon": -0.1969
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Nairobi",
"contacts": [
{
"email": "[email protected]/[email protected]",
"name": "Benson Singa, PI",
"phone": "+254-720018880",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Stella Kepha, PM",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Kenya",
"facility": "Kenya Medical Research Institution (KEMRI)",
"geoPoint": {
"lat": -1.28333,
"lon": 36.81667
},
"state": null,
"status": null,
"zip": "00200"
}
]
},
"descriptionModule": {
"briefSummary": "An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Open-label, randomized at the school level, and each eligible participant within a school will receive only one of the study treatments (ALB or IVM).",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "This is an open study. Participants and the study investigators assessing drug safety will not be blinded to treatment arms. Only the laboratory-based effectiveness measurement will be performed by blinded operators.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20000,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness",
"nctId": "NCT06282315",
"orgStudyIdInfo": {
"id": "REALISE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Exploratory 1: Reduction in Strongyloides stercoralis seroprevalence in participants treated with FDC compared with ALB."
},
{
"measure": "Exploratory 2: Reduction in hookworms and A. lumbricoides prevalence in participants treated with FDC compared with ALB."
},
{
"measure": "Exploratory 3: Reduction in A. lumbricoides prevalence in participants treated with FDC compared with ALB."
},
{
"measure": "Exploratory 4: Describe the frequency of scabies before and after the intervention in the two treatment arms."
},
{
"measure": "Exploratory 5: (i) Genetic diversity within and between T. trichiura populations, relative to the FDC or ALB study participants."
},
{
"measure": "Exploratory 5: (ii) Genetic diversity in candidate genes and identification of genes and/or regions in the genome of T. trichiura under selective pressure due to the treatment with FDC and/or ALB;"
},
{
"measure": "Exploratory 5: (iii) Relative abundance of mixed parasite species within and between populations and in response to treatment in the FDC or ALB study participants."
},
{
"measure": "Exploratory 6: (i) Characterization of the microbiome composition at baseline and its implication in MDA effectiveness"
},
{
"measure": "Exploratory 6: (ii) Determine the Impact of MDA with ALB or FDC on the microbiome composition at population level"
},
{
"measure": "Exploratory 6: (iii) Measure the Recovery of the baseline microbiome composition at 11 months post-treatment and its role in reinfection with STH."
}
],
"primaryOutcomes": [
{
"measure": "AEs and SAEs record of participants treated with FDC compared to ALB."
}
],
"secondaryOutcomes": [
{
"measure": "Reduction in T. trichiura prevalence in participants treated with FDC compared with ALB."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ghana Health Services"
},
{
"name": "Kenya Medical Research Institute"
},
{
"name": "Bridges to Development"
},
{
"name": "Sanger Institute"
},
{
"name": "Barcelona Institute for Global Health"
},
{
"name": "European Union"
},
{
"name": "Swiss Confederation"
},
{
"name": "Mundo Sano"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Insud Pharma"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Group control"
},
{
"name": "Isometric Exercise"
},
{
"name": "Aerobic Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension,Essential",
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Porto Alegre",
"contacts": [
{
"email": "[email protected]",
"name": "Lidiane P Stochero",
"phone": "5554981301920",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Brazil",
"facility": "Institute of Cardiology",
"geoPoint": {
"lat": -30.03306,
"lon": -51.23
},
"state": "RS",
"status": "RECRUITING",
"zip": "900.620-000"
}
]
},
"descriptionModule": {
"briefSummary": "Introduction: Adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. The effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. Objective: To verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The RCT will involve thirty-six elderly volunteers (≥ 60 years of age) with systemic arterial hypertension, aiming to compare two types of physical exercise sessions, isometric wall squats and an aerobic exercise session on an exercise bike, on the 24-hour blood pressure levels.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People",
"nctId": "NCT06282302",
"orgStudyIdInfo": {
"id": "6030/22",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "24-hour Ambulatory Blood Pressure Monitoring"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Instituto de Cardiologia do Rio Grande do Sul"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Magnetoencephalography (MEG)"
},
{
"name": "Cognition development questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Speech"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this study is to investigate the preferential responses of speech neural systems in infants.The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary).Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Months",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "AV-SSR-I",
"briefTitle": "Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants",
"nctId": "NCT06282289",
"orgStudyIdInfo": {
"id": "2023-077",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ID RCB",
"id": "2023-A01798-37",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Significance of correlation between the delta (i.e. difference) of synchronization power estimated at 10- and 6-months of age and the delta of vocabulary level measured at 18months of age."
}
],
"secondaryOutcomes": [
{
"measure": "The equation for linear regression analysis used to estimate the amount of neuronal synchronization between auditory and visual perception systems according to the Coherence and the Synchrony of AV inputs"
},
{
"measure": "The equation for linear regression analysis used to estimate the variation in the amount of neuronal synchronization between 4 experimental conditions according to the Coherence and the Synchrony of AV inputs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Institut de l'Audition"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Institut Pasteur"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "cross sectional survey"
}
]
},
"conditionsModule": {
"conditions": [
"Weight Stigma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hadera",
"contacts": null,
"country": "Israel",
"facility": "Hillel Yaffe Medical Center",
"geoPoint": {
"lat": 32.44192,
"lon": 34.9039
},
"state": null,
"status": null,
"zip": "38000"
}
]
},
"descriptionModule": {
"briefSummary": "Evidence shows that anti-fat attitudes and weight stigma are prevalent among healthcare professionals and may affect treatment decisions regarding patients with obesity. The present study aimed to examine the presence of anti-fat attitudes and weight stigma among orthopedic surgeons and their correlation to the therapeutic approach to patients with obesity. In this cross-sectional survey, 150 orthopedic surgeons will complete a web-based questionnaire. the questionnaire is based on Antifat Attitudes Questionnaire (AFA), developed by Crandall in 1994. In addition, the questionnaire will include a questionnaire developed by Bocquier in 200521 to explore weight stigma among physicians."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 150,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "72 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Anti-fat Attitudes and Weight Stigma Among Orthopedic Surgeons",
"nctId": "NCT06282276",
"orgStudyIdInfo": {
"id": "012922HYMC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "anti fat attitudes"
},
{
"measure": "Weight stigma"
},
{
"measure": "Therapeutic approach"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Hillel Yaffe Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "\"Awareness Development Program on Suicide Prevention for Oncology Nurses\""
}
]
},
"conditionsModule": {
"conditions": [
"Suicide Prevention",
"Nurses"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Hacettepe University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": "06100"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to investigate the effect of the Awareness Development Programme on Suicide Prevention for Oncology Nurses on the levels of knowledge, stigma and perception of efficacy towards suicide in oncology nurses. The main questions it aims to answer are:1. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the knowledge levels of nurses about suicide according to the pre-programme and control group?2. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the perception of efficacy levels of nurses regarding suicide according to the pre-programme and control group.3. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the stigma levels of nurses towards suicide according to the pre-programme and control group.4. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test and post-test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology.5. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test-follow-up test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology.Participants will participate the Awareness Development Programme on Suicide Prevention for Oncology Nurses. Oncology Nurses are expected to complete the pre-test, post-test and follow-up tests.Researchers will compare control group to see if effect of \"the Awareness Development Programme on Suicide Prevention\""
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study was a pre-test, post-test, follow-up design and control group intervention study conducted to examine the effect of \"Awareness Development Programme on Suicide Prevention for Oncology Nurses\" on oncology nurses' knowledge, stigma and perception of efficacy regarding suicide risk management.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 86,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RCT",
"briefTitle": "The Effect of the Awareness Development Program on Suicide Prevention for Oncology Nurses",
"nctId": "NCT06282263",
"orgStudyIdInfo": {
"id": "1292",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the Literacy of Suicide Scale"
},
{
"measure": "Efficacy Perception Scale For Suicide Risk Management"
},
{
"measure": "The Stigma of Suicide Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sevda Ozturk"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy"
},
{
"name": "Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy"
},
{
"name": "Psycho-education + Imagery focused Cognitive Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Bipolar Disorder",
"Mood Swing",
"Prodromal Symptoms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Eindhoven",
"contacts": [
{
"email": "[email protected]",
"name": "Else Treffers, MSc",
"phone": "+31622559192",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Geestelijke Gezondheidszorg Eindhoven (GGzE)",
"geoPoint": {
"lat": 51.44083,
"lon": 5.47778
},
"state": "Noord-Brabant",
"status": "RECRUITING",
"zip": "5626ND"
}
]
},
"descriptionModule": {
"briefSummary": "In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied.Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder",
"nctId": "NCT06282250",
"orgStudyIdInfo": {
"id": "in progress",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in depressive symptom scores on the IDS-SR"
},
{
"measure": "Change in hyperactive symptom scores on the ASRM"
},
{
"measure": "Change in anxiety symptom scores on the BAI"
},
{
"measure": "Change in sleep quality subjective rating on 11-point Likert scale"
},
{
"measure": "Change in activity levels subjective rating on 11-point Likert scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Geestelijke Gezondheidszorg Eindhoven (GGzE)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "survey"
}
]
},
"conditionsModule": {
"conditions": [
"Sarcoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Roma",
"contacts": [
{
"email": "[email protected]",
"name": "Sergio Valeri, MD",
"phone": "06225411626",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Campus Biomedico",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "RECRUITING",
"zip": "00128"
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.Primary objectives:* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;* Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;* Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).Secondary endpoints will be:1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);• The change in walking performance before and after the rehabilitation treatment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 13,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "1206",
"briefTitle": "Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study",
"nctId": "NCT06282237",
"orgStudyIdInfo": {
"id": "2022.143",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Improvement in the Toronto Extremity Salvage Score (TESS)"
}
],
"secondaryOutcomes": [
{
"measure": "Pain evaluation"
},
{
"measure": "Motor performance evaluation"
},
{
"measure": "Evaluation of Quality of Life"
},
{
"measure": "Pain evaluation"
},
{
"measure": "Pain evaluation"
},
{
"measure": "Evaluation of Quality of Life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fondazione Don Carlo Gnocchi Onlus"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Campus Bio-Medico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Performing endoscopic transnasal skull base surgery with AR-integrated endoscope"
}
]
},
"conditionsModule": {
"conditions": [
"Pituitary Neoplasms"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "\"For lesions in the skull base, including meningiomas, chordomas and pituitary tumors, endoscopic surgery has replaced traditional microscopes as the mainstream procedure. Although neurosurgeons can enlarge the surgical area using a neuroendoscope, it does not provide any information on the morphology and location of anatomical structures beneath visible surfaces. Due to the complex anatomical relationships of adjacent structures in the skull base, lesions occurring here are often located deep within anatomy that is difficult to fully expose and remove with endoscopic surgery alone. Especially when dealing with larger tumors that surround major arteries and nerves, limited visibility at surface level can easily damage blood vessels or nerves causing complications such as bleeding during or after surgery, deformities or functional impairments. The purpose of this study is to explore how augmented reality (AR) technology can highlight important anatomical structures in a neuroendoscope's field of view to optimize surgical visibility beyond what is possible with just an endoscope alone. This will make it easier for surgeons to distinguish deeper anatomical structures and reduce intraoperative and postoperative complications associated with endoscopic surgery.\""
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DEVICE_FEASIBILITY",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery",
"nctId": "NCT06282224",
"orgStudyIdInfo": {
"id": "XMFHIIT-2023SL066",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Postoperative Recovery of Transnasal Surgery"
},
{
"measure": "Postoperative complication"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital of Xiamen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ondansetron Oral Soluble Pellicles"
}
]
},
"conditionsModule": {
"conditions": [
"Nausea and Vomiting"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Weihui",
"contacts": [
{
"email": "[email protected]",
"name": "Yana Zhang",
"phone": "15093230340",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Keya Zhi",
"geoPoint": {
"lat": 34.79333,
"lon": 108.93833
},
"state": "None Selected",
"status": "RECRUITING",
"zip": "453100"
}
]
},
"descriptionModule": {
"briefSummary": "The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 184,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "the Efficacy and Safety of Ondansetron Oral Soluble Pellicles",
"nctId": "NCT06282211",
"orgStudyIdInfo": {
"id": "CHASE 005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Incidence of adverse events and serious adverse reactions throughout the study period"
}
],
"primaryOutcomes": [
{
"measure": "Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups"
},
{
"measure": "Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital of Xinxiang Medical College"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Distal Femoral Musculoskeletal Tumors"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Valencia",
"contacts": [
{
"email": null,
"name": "JF Lisón, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Universidad CEU Cardenal Herrera",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The primary aim of this study is to compare spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals without prostheses."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMU-DFM",
"briefTitle": "Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses",
"nctId": "NCT06282198",
"orgStudyIdInfo": {
"id": "UCHCEU-13/02/24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gait Symmetry index measured in percentage (%)"
}
],
"secondaryOutcomes": [
{
"measure": "Sagittal range of movement of the knee measured with a goniometer"
},
{
"measure": "Muscular strength"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cardenal Herrera University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Prostatic Neoplasms",
"Metastasis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\\[s\\] it aims to answer are:* What is the impact of exercise on quality of life* What is the impact of exercise on physical fitnessParticipants will have an individual training program with supervised training by physiotherapists.Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized controlled trial with an intervention arm and an usual care group",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Superman",
"briefTitle": "SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy",
"nctId": "NCT06282185",
"orgStudyIdInfo": {
"id": "CanisiusWH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "change of quality of life assessed with EPIC26 (0-100 points)"
},
{
"measure": "change of quality of life assessed with EPIC26 (0-100 points)"
},
{
"measure": "change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)"
},
{
"measure": "change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale)"
}
],
"secondaryOutcomes": [
{
"measure": "change of physical fitness in maximum uptake of oxygen in ml/kg/min"
},
{
"measure": "change of physical fitness in maximum uptake of oxygen in ml/kg/min"
},
{
"measure": "change of physical fitness in fat percentage"
},
{
"measure": "change of physical fitness in fat percentage"
},
{
"measure": "change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))"
},
{
"measure": "change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes))"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Canisius-Wilhelmina Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Treatment with BTL-785-7"
}
]
},
"conditionsModule": {
"conditions": [
"Fat Burn"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hackensack",
"contacts": null,
"country": "United States",
"facility": "Schweiger Dermatology PC, Research Division",
"geoPoint": {
"lat": 40.88593,
"lon": -74.04347
},
"state": "New Jersey",
"status": null,
"zip": "07601"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue",
"nctId": "NCT06282172",
"orgStudyIdInfo": {
"id": "BTL-785_CTUS1600",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Investigation of the effect of the BTL-785F device (with BTL-785-7 applicator) on submental subcutaneous fat tissue."
}
],
"secondaryOutcomes": [
{
"measure": "Investigation of post-treatment adipocyte apoptosis"
},
{
"measure": "Incidence of Treatment-related Adverse Events"
},
{
"measure": "Comfort Evaluation Assessed by Therapy Comfort Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "BTL Industries Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DNTH103"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Myasthenia Gravis, Generalized"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bradenton",
"contacts": [
{
"email": "[email protected]",
"name": "Gloria Carlbert",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Bradenton Research Center",
"geoPoint": {
"lat": 27.49893,
"lon": -82.57482
},
"state": "Florida",
"status": "RECRUITING",
"zip": "34205"
},
{
"city": "Dallas",
"contacts": [
{
"email": "[email protected]",
"name": "Haley Rucker",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Texas Neurology",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75206"
},
{
"city": "Lubbock",
"contacts": [
{
"email": "[email protected]",
"name": "Christie Long",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "West Texas Neurology Clinic",
"geoPoint": {
"lat": 33.57786,
"lon": -101.85517
},
"state": "Texas",
"status": "RECRUITING",
"zip": "79414"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MAGIC",
"briefTitle": "A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)",
"nctId": "NCT06282159",
"orgStudyIdInfo": {
"id": "DNTH103-MG-201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence, severity, and relationship of TEAEs (including treatment discontinuation due to adverse events [AEs]) [Time Frame: Baseline (Day 1) to Safety Follow-Up Visit (up to Week 40)]"
},
{
"measure": "Incidence, severity, and relationship of adverse events of special interest (AESI)"
},
{
"measure": "Number of participants with changes from baseline in ECG parameters"
},
{
"measure": "Number of participants with changes in clinical laboratory values over time"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score"
},
{
"measure": "Change from baseline in Quantitative Myasthenia Gravis (QMG) scale score"
},
{
"measure": "Serum concentrations of DNTH103"
},
{
"measure": "Change from baseline in complement total blood test (CH50)"
},
{
"measure": "Antidrug antibody (ADA) levels against DNTH103"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Dianthus Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "transcranial magnetic stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Major Depressive Disorder",
"Depression",
"Psychiatric Disorder",
"Mood Disorders",
"Mental Disorder",
"Anxiety Disorders",
"OCD",
"PTSD"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "T5",
"briefTitle": "Testing a Transdiagnostic TMS Treatment Target",
"nctId": "NCT06282146",
"orgStudyIdInfo": {
"id": "2024P000252",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Beck Depression Inventory (BDI)"
},
{
"measure": "Beck Anxiety Inventory (BAI)"
},
{
"measure": "Adult Attention Deficit/Hyperactivity Disorder Self-Report Scale (AARS)"
},
{
"measure": "Clinical Global Impression Scale (CGI)"
},
{
"measure": "Illness Intrusiveness Rating Scale (IIRS)"
},
{
"measure": "Perceived Stress Scale (PSS)"
},
{
"measure": "Positive and Negative Symptom Scale (PANSS)"
},
{
"measure": "Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)"
},
{
"measure": "Social Readjustment Rating Scale (SRRS)"
},
{
"measure": "Yale Brown Obsessive-Compulsive Scale (Y-BOCS)"
},
{
"measure": "Temperament and Character Inventory, Revised 140-item"
},
{
"measure": "Emotional Conflict Resolution Test"
},
{
"measure": "Learning, Multi-Source Interference Task (MSIT)"
},
{
"measure": "Penn Emotion Recognition Task (ER-40)"
},
{
"measure": "Death Suicide IAT"
},
{
"measure": "Young Mania Rating Scale (YMRS)"
}
],
"primaryOutcomes": [
{
"measure": "Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire"
},
{
"measure": "Feasibility as measured by number of the 50 treatments completed"
}
],
"secondaryOutcomes": [
{
"measure": "Montgomery-Åsberg Depression Rating Scale (MADRS)"
},
{
"measure": "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC)"
},
{
"measure": "World Health Organization Disability Assessment Schedule II (WHODAS 2.0)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Brigham and Women's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
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