documentSection
dict | hasResults
bool 2
classes | protocolSection
dict |
|---|---|---|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Music therapy based on piano learning"
}
]
},
"conditionsModule": {
"conditions": [
"Dementia of Alzheimer Type",
"Dementia",
"Dementia, Vascular",
"Dementia, Mixed",
"Dementia Frontal",
"Dementia With Lewy Bodies",
"Cognitive Decline",
"Neurologic Disorder",
"Neurologic Dysfunction",
"Neurologic Deficits"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "León",
"contacts": null,
"country": "Spain",
"facility": "Universidad de León",
"geoPoint": {
"lat": 42.60003,
"lon": -5.57032
},
"state": "Castilla Y León",
"status": null,
"zip": "24004"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease.\n\nThe key question is: Can pianistic practice influence the development of Alzheimer's disease?\n\nParticipants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "An intervention based on teaching the piano in an individualized way",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "How Does Pianistic Musical Training Influence the Development of Alzheimer's Disease?",
"nctId": "NCT06378372",
"orgStudyIdInfo": {
"id": "ETICA-ULE-064-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "State of global deterioration"
},
{
"measure": "Minimental Test"
},
{
"measure": "RDRS-2 Rapid Disability Assessment Scale"
},
{
"measure": "MONTREAL COGNITIVE ASSESSMENT (MOCA)"
},
{
"measure": "WAIS-IV"
},
{
"measure": "Behavioral disorders: BEHAVE-AD"
},
{
"measure": "NPI - CUMMINGS"
},
{
"measure": "Evaluation of the caregiver's burden (Zarit test)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Jesús Ángel Seco Calvo"
},
{
"name": "Javier Tejada Garcia"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "David Franco Castellanos"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Screening and decolonization for SA carriers with the 3 drug bundle"
},
{
"name": "No screening for SA"
},
{
"name": "no screening"
},
{
"name": "Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening."
},
{
"name": "Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening"
}
]
},
"conditionsModule": {
"conditions": [
"Staphylococcus Aureus Colonization",
"Surgical Site Infections",
"Healthcare Associated Infections"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Minneapolis",
"contacts": [
{
"email": "[email protected]",
"name": "Pragya Karki, MD",
"phone": "612-301-6316",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Minnesota Medical Center and Clinics",
"geoPoint": {
"lat": 44.97997,
"lon": -93.26384
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55414"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent.\n\nThe study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap.\n\nThe primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients",
"nctId": "NCT06378359",
"orgStudyIdInfo": {
"id": "IDIM-2023-32364",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy in eradicating Staphylococcus aureus (SA)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Minnesota"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Glycyrrhizin"
},
{
"name": "Glycyrrhizin"
},
{
"name": "Observation"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Natalie Reizine, MD",
"phone": "312-996-1581",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Omer Qazi, MBBS",
"phone": "312-413-1069",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Illinois",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "60612"
}
]
},
"descriptionModule": {
"briefSummary": "This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GU-01",
"briefTitle": "GU-01: Glycyrrhizin in Prostate Cancer",
"nctId": "NCT06378346",
"orgStudyIdInfo": {
"id": "2023-077",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration"
},
{
"measure": "Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy"
}
],
"secondaryOutcomes": [
{
"measure": "The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0)."
},
{
"measure": "Assessment of plasma GLY levels after GLY administration"
},
{
"measure": "Assessment of blood sodium levels after GLY administration"
},
{
"measure": "Assessment of blood potassium after GLY administration"
},
{
"measure": "Assessment of serum creatinine after GLY administration"
},
{
"measure": "Assessment of serum testosterone levels after GLY administration"
},
{
"measure": "Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration"
},
{
"measure": "Assessment of interleukin-1β (IL-1β) after GLY administration"
},
{
"measure": "Assessment of Tumor necrosis factor α (TNFα) after GLY administration"
},
{
"measure": "Assessment of interleukin 6 (IL-6) after GLY administration"
},
{
"measure": "Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration"
},
{
"measure": "Assessment of Hepatocyte Growth Factor (HGF) after GLY"
},
{
"measure": "Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY"
},
{
"measure": "Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration"
},
{
"measure": "Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration"
},
{
"measure": "Gene expression analysis in tumor specimens obtained before administration of GLY"
},
{
"measure": "Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Illinois at Chicago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "patients who underwent coronary angiography"
}
]
},
"conditionsModule": {
"conditions": [
"Unstable Angina"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montpellier",
"contacts": null,
"country": "France",
"facility": "University Hospital of Montpellier",
"geoPoint": {
"lat": 43.61092,
"lon": 3.87723
},
"state": null,
"status": null,
"zip": "34295"
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations \\< 99 percentile (undetectable: \\<5ng/l or non-elevated: \\<14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 210,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ICAR",
"briefTitle": "Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area.",
"nctId": "NCT06378333",
"orgStudyIdInfo": {
"id": "2024-01-023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hospitalisation for of unstable Angina"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Montpellier"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-27"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "App access and Text message"
},
{
"name": "App access only"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Feeding"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cleveland",
"contacts": null,
"country": "United States",
"facility": "Ahuja Rainbow Center for Women and Children",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio",
"status": null,
"zip": "44103"
},
{
"city": "Cleveland",
"contacts": [
{
"email": "[email protected]",
"name": "Lydia Furman MD",
"phone": "216-675-6691",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Passages, Inc.",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio",
"status": null,
"zip": "44103"
},
{
"city": "Cleveland",
"contacts": null,
"country": "United States",
"facility": "University Hospital MacDonald Women's Hospital",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio",
"status": null,
"zip": "44106"
}
]
},
"descriptionModule": {
"briefSummary": "This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a \"pilot\" study because the app is still in development. The goal of this research is to see if mothers use the app more when they receive text \"nudges\" to look at it compared to not getting those \"nudges\". The research project is being conducted by Lydia Furman MD.\n\nThe purpose of the app (which is currently in clickable \"wireframe\" status, a \"pre\" app phase) is to support and promote breastfeeding specifically for mothers and fathers/partners who are African American or Black. Other breastfeeding apps have pictures mainly of White or Asian mothers and information that is not oriented toward African American mothers. This app aims to provide accurate and needed breastfeeding information that is culturally attuned.\n\nUp to 24 participants will be enrolled at UHCMC, including up to 20 mothers. Other participants will include up to 4 African American or Black fathers/partners whose partners are interested in breastfeeding."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This will be a prospective randomized two arm study for expectant women and a prospective randomized two arm study for fathers/partners. All participants receive access to the wireframe app. Maternal participants will be randomized to nudge or no nudge via text with those in the app \"nudge\" group receiving questions weekly prior to delivery and biweekly (every 2 weeks) after delivery through 3 months postpartum. The purpose of these \"nudges\" is to assess whether participants are more likely to access and benefit from the app if they are encouraged to explore it. Father/partner participants will also be randomized to either a nudge or no nudge group with those in the \"nudge\" group receiving questions weekly for the first two months and then biweekly (every 2 weeks) for another two months.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "eHealth for Breastfeeding Support - the HOTSPOT Trial",
"nctId": "NCT06378320",
"orgStudyIdInfo": {
"id": "STUDY20240287",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maternal participants app usability score"
},
{
"measure": "Father/partner participants app usability score"
},
{
"measure": "Maternal participants app engagement score"
},
{
"measure": "Father/partner participants app engagement score"
}
],
"secondaryOutcomes": [
{
"measure": "Maternal participants breastfeeding knowledge at enrollment"
},
{
"measure": "Maternal participants breastfeeding knowledge after app exposure"
},
{
"measure": "Father/partner participants breastfeeding knowledge at enrollment"
},
{
"measure": "Father/partner participants breastfeeding knowledge after app exposure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospitals Cleveland Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Inclusive Education"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The investigators are conducting a realist evaluation study with a multi-case and qualitative design. The study aims to identify the conditions that promote successful students with disabilities inclusive education at school. This study is nested in the TIAP research (Research to explore the conditions transfer of innovations in the field of disability, with a view to developing a transfer framework)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 114,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TIAP",
"briefTitle": "A Transferability Study on the Conditions for a Successful Inclusive Education",
"nctId": "NCT06378307",
"orgStudyIdInfo": {
"id": "CHUBX2022-06",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effect of inclusive education on children with disabilities autonomy and social participation at school"
},
{
"measure": "Effect of inclusive education on children with disabilities autonomy and social participation in their proximal living environment (leisures participation)"
},
{
"measure": "Effect of inclusive education on social participation of families with children with disabilities"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Bordeaux"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mastectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ferrol",
"contacts": [
{
"email": "[email protected]",
"name": "EULALIA VIVES",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "EULALIA VIVES",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "MANUEL DÍAZ",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Universitario Ferrol",
"geoPoint": {
"lat": 43.4896,
"lon": -8.21942
},
"state": "A Coruña",
"status": "RECRUITING",
"zip": "15402"
},
{
"city": "Santiago De Compostela",
"contacts": [
{
"email": "[email protected]",
"name": "MARÍA EFIGENIA ARIAS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "MARÍA EFIGENIA ARIAS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Universitario Santiago de Compostela",
"geoPoint": {
"lat": 42.88052,
"lon": -8.54569
},
"state": "A Coruña",
"status": "RECRUITING",
"zip": "15706"
},
{
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}
}
}
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{
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{
"name": "Leiden University"
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{
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}
|
null | false |
{
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"measure": "Number of oocytes retrieved"
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"measure": "Number of mature oocytes"
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"measure": "Number of day 3 embryos"
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{
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"measure": "Number of frozen embryos"
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{
"measure": "Positive ß-hCG test"
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"measure": "Clinical pregnancy"
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"measure": "Ectopic pregnancy"
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{
"measure": "Early miscarriage <12 weeks"
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"measure": "Late miscariage 12-< 22 weeks"
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"measure": "Live birth rate"
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"measure": "Birth weight"
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"measure": "Very low birth weight"
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"measure": "Preterm birth"
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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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{
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},
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},
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{
"measure": "Incidence of Adverse event (Phase I)"
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{
"measure": "Recommended Phase II Dose(RP2D)"
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{
"measure": "Maximum Tolerated Dosage(MTD)"
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"measure": "Disease-free survival (DFS) rates"
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{
"measure": "Duration of response (DOR)"
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{
"measure": "Disitamab Vedotin anti-drug antibody (ADA)"
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{
"measure": "PK of enfortumab vedotin: Maximum concentration (Cmax)"
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{
"measure": "PK of enfortumab vedotin: Trough concentration (Ctrough)"
}
]
},
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},
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}
}
|
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{
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},
"conditionsModule": {
"conditions": [
"Treatment Resistant Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gent",
"contacts": [
{
"email": "[email protected]",
"name": "Cisse Geleyn, dr.",
"phone": "+3293328742",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gilbert Lemmens, prof. dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Ghent University Hospital",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
"state": "Oost-Vlaanderen",
"status": "RECRUITING",
"zip": "9000"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Open label feasibility study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PSIHOS-D",
"briefTitle": "Psilocybin for Hospitalized Patients With Treatment-resistant Depression",
"nctId": "NCT06378229",
"orgStudyIdInfo": {
"id": "ONZ-2023-0157",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2022-501857-35-00",
"link": null,
"type": "CTIS"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Montgomery Asberg Depression Rating Scale (MADRS)"
},
{
"measure": "Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR)"
},
{
"measure": "State-Trait Anxiety Inventory (STAI)"
},
{
"measure": "World Health Organization Quality of Life Inventory-Brief subscale (WHOQOL-BREF)"
},
{
"measure": "Maudsley 3-item Visual Analogue Scale (M3VAS)"
},
{
"measure": "Subjective Emotional Health Visual Analogue Scale (SEHVAS)"
},
{
"measure": "revised Dyadic Adjustment Scale (RDAS)"
},
{
"measure": "Zarit Burden Interview - Short Form (Zarit-12 Burden Scale)"
},
{
"measure": "Client Experiencing Scale (EXP)"
},
{
"measure": "Mystical Experience Questionnaire (MEQ)"
},
{
"measure": "Working Alliance Inventory - Short Revised (WAI-SR)"
},
{
"measure": "Semi-structured interviews."
},
{
"measure": "EEG: sensor level analysis (power) and source level analysis (functional connectivity through amplitude envelope correlation), both in resting state and during an emotional paradigm."
}
],
"primaryOutcomes": [
{
"measure": "Incidence and type of Treatment-Emergent Adverse Events"
},
{
"measure": "Columbia-Suicide Severity Rating Scale (C-SSRS)"
}
],
"secondaryOutcomes": [
{
"measure": "Recruitment and retention rates."
},
{
"measure": "Qualitative data from the semi-structured interviews with the subjects and their partners."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Filament Health"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Ghent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "neurocognitive evaluations"
}
]
},
"conditionsModule": {
"conditions": [
"Myotonic Dystrophy 1"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bosisio Parini",
"contacts": [
{
"email": "[email protected]",
"name": "Maria Grazia D'Angelo",
"phone": "+39031 877870",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Maria Grazia D'Angelo",
"geoPoint": {
"lat": 45.80075,
"lon": 9.29
},
"state": "Lecco",
"status": "RECRUITING",
"zip": "23842"
}
]
},
"descriptionModule": {
"briefSummary": "The rationale of the study is to collect structured data in the neuropsychological, clinical neuroradiologic and neurorehabilitation fields in children/young people affected by congenital and juvenile myotonic dystrophy. Children affected by the congenital form (CDM1) present important brain alterations present since birth while, on the contrary, patients with the adult form of DM1 often present a degenerative, slowly progressive neurocognitive picture. Promising therapies that aim to correct the molecular mechanism underlying the symptoms of adult forms of DM1 are under development, but their potential role at the level of the nervous system and in particular in forms of CDM1 (which appears to be a distinct disorder of neuronal development) is also to be clarified.\n\nTo this end, a better definition of neurocognitive profiles and their evolution is essential for the purposes of evaluating the effectiveness of experimental therapies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "MDCJ-NeuBeRe",
"briefTitle": "Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe]",
"nctId": "NCT06378216",
"orgStudyIdInfo": {
"id": "MEDEA 975",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Motor function evaluation by Muscular Impairment Rating Scale"
},
{
"measure": "cognitive evaluation by Wechsler Intelligence scale"
},
{
"measure": "cognitive evaluation by Raven Matrices"
},
{
"measure": "cognitive evaluation by Continous Performance Test 3"
},
{
"measure": "cognitive evaluation by Trail Making Test A-B"
},
{
"measure": "cognitive evaluation by Digit Span and CORSI Test"
},
{
"measure": "cognitive evaluation by Rey Figure test"
}
],
"secondaryOutcomes": [
{
"measure": "clinical evaluation by Epworth Sleepiness Scale"
},
{
"measure": "cognitive evaluation by Wisconsin Card Sorting Test"
},
{
"measure": "cognitive evaluation by Tower of London test"
},
{
"measure": "cognitive and behavioral evaluation by Minnesota Multiphasic Personality Inventory"
},
{
"measure": "cognitive and behavioral evaluation by Vineland Adaptive Behavior Scales"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Eugenio Medea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA)"
}
]
},
"conditionsModule": {
"conditions": [
"Muscular Dystrophies",
"Limb Girdle Muscular Dystrophy",
"Facio-Scapulo-Humeral Dystrophy",
"Becker Muscular Dystrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bosisio Parini",
"contacts": [
{
"email": "[email protected]",
"name": "Maria G D'Angelo, MD",
"phone": "031877111",
"phoneExt": "+39",
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Scientific Institute IRCCS Eugenio Medea",
"geoPoint": {
"lat": 45.80075,
"lon": 9.29
},
"state": "Lecco",
"status": "RECRUITING",
"zip": "23842"
}
]
},
"descriptionModule": {
"briefSummary": "Until twenty years ago physical exercise in muscular dystrophies was considered harmful to the muscle cells, inducing an acceleration of cell necrosis. In fact, it is now certain and validated that an active lifestyle and the practice of controlled and regular physical activity are to be considered therapeutic in neuromuscular pathologies with the aim of optimizing muscular and cardio-respiratory function and preventing atrophy In particular, it seems that the optimal care is extensive and can be carried out in a safe and controlled manner even at home.\n\nIt is well documented that exercise has beneficial effects on muscle with increased strength and muscular endurance."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Each patient will carry out a series of evaluation and training sessions (15 sessions) with a physiotherapist for the drafting of a personalized treatment plan which will subsequently be carried out \"independently\" at domicile.\n\nThe home therapeutic proposal will include the use of the tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) which allows to perform personalized games at home",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RIMUDI",
"briefTitle": "Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI]",
"nctId": "NCT06378203",
"orgStudyIdInfo": {
"id": "MEDEA 1013",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6 minute walk test (6MWT)"
},
{
"measure": "Motor Function Measure scale (MFM)"
},
{
"measure": "Performance of Upper Limb (PUL)"
},
{
"measure": "Time up and go (TUG)"
}
],
"secondaryOutcomes": [
{
"measure": "Modification of fatigue and quality of life scales from T0 to T6"
},
{
"measure": "Short Form 36 (SF36)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS Eugenio Medea"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CAR-T cells therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Refractory B-Cell Lymphoma",
"B-cell Lymphoma Recurrent"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hospitalet de Llobregat",
"contacts": [
{
"email": "[email protected]",
"name": "Esperanza López-Franco, PhD",
"phone": "923291200",
"phoneExt": "55779",
"role": "CONTACT"
},
{
"email": null,
"name": "Alberto Musetti",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Institut Català d'Oncologia Hospital",
"geoPoint": {
"lat": 41.35967,
"lon": 2.10028
},
"state": "Barcelona",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "El Palmar",
"contacts": [
{
"email": "[email protected]",
"name": "Esperanza López-Franco, PhD",
"phone": "923291200",
"phoneExt": "55779",
"role": "CONTACT"
},
{
"email": null,
"name": "Joaquín Gómez-Espuch",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Virgen de la Arrixaca University Hospital",
"geoPoint": {
"lat": 37.93939,
"lon": -1.16095
},
"state": "Mur",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Pamplona",
"contacts": [
{
"email": "[email protected]",
"name": "Esperanza López-Franco, PhD",
"phone": "923291200",
"phoneExt": "55779",
"role": "CONTACT"
},
{
"email": null,
"name": "Carlos Grande",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Clínica Universidad de Navarra",
"geoPoint": {
"lat": 42.81687,
"lon": -1.64323
},
"state": "Navarra",
"status": "RECRUITING",
"zip": "31008"
},
{
"city": "Pamplona",
"contacts": [
{
"email": "[email protected]",
"name": "Esperanza López-Franco",
"phone": "923291200",
"phoneExt": "55779",
"role": "CONTACT"
},
{
"email": null,
"name": "María Carmen Mateos-Rodríguez",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "University Hospital of Navarra",
"geoPoint": {
"lat": 42.81687,
"lon": -1.64323
},
"state": "Navarra",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Esperanza López-Franco, PhD",
"phone": "923291200",
"phoneExt": "55779",
"role": "CONTACT"
},
{
"email": null,
"name": "Valentín Ortiz-Maldonado",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital Clínic",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Madrid",
"contacts": [
{
"email": "[email protected]",
"name": "Esperanza López-Franco",
"phone": "923291200",
"phoneExt": "55779",
"role": "CONTACT"
},
{
"email": null,
"name": "Javier Cornago-Navascués",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Fundación Jiménez Díaz Hospital",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Salamanca",
"contacts": [
{
"email": "[email protected]",
"name": "Esperanza López-Franco, PhD",
"phone": "923291200",
"phoneExt": "55779",
"role": "CONTACT"
},
{
"email": null,
"name": "Lucía López-Corral, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Salamanca University Health Care Complex",
"geoPoint": {
"lat": 40.96882,
"lon": -5.66388
},
"state": null,
"status": "RECRUITING",
"zip": "37007"
},
{
"city": "Sevilla",
"contacts": [
{
"email": "[email protected]",
"name": "Esperanza López-Franco, PhD",
"phone": "923291200",
"phoneExt": "55779",
"role": "CONTACT"
},
{
"email": null,
"name": "José Antonio Pérez-Simón",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Virgen del Rocio Hospital",
"geoPoint": {
"lat": 37.38283,
"lon": -5.97317
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are:\n\nMaximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Phase I/II, pilot, open, national, prospective, multicentre, non-randomised",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TranspoCART19",
"briefTitle": "Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology",
"nctId": "NCT06378190",
"orgStudyIdInfo": {
"id": "TranspoCART19",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Molecular and cell biology exploratory objectives: Response dynamics"
},
{
"measure": "Molecular and cell biology exploratory objectives: Response dynamics"
},
{
"measure": "Molecular and cell biology exploratory objectives: Response dynamics"
},
{
"measure": "Molecular and cell biology exploratory objectives: In vivo survival of TranspoCART19 cells in peripheral blood"
},
{
"measure": "Molecular and cell biology exploratory objectives: Analysis of molecular markers which are possibly related to the tumor response to TranspoCART19 cells"
},
{
"measure": "Molecular and cell biology exploratory objectives: Evaluation of serum biomarkers of toxicity induced by TranspoCART19 cells (cytokine release syndrome and neurotoxicity)"
},
{
"measure": "Molecular and cell biology exploratory objectives: Epigenetic studies on mononuclear bone marrow cells."
}
],
"primaryOutcomes": [
{
"measure": "Maximum tolerated dose (MTD)"
},
{
"measure": "Efficiency"
}
],
"secondaryOutcomes": [
{
"measure": "Procedure-related mortality (PRM)"
},
{
"measure": "Toxicity assessment"
},
{
"measure": "Response (overall and complete)"
},
{
"measure": "Duration of response"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Perceived general well-being"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Spanish Clinical Research Network - SCReN"
},
{
"name": "Fundación Canaria de Investigación Sanitaria"
},
{
"name": "Fundación para la Investigación Biomédica del Hospital 12 de Octubre"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Instituto de Investigación Biomédica de Salamanca"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LVGN6051 Monoclonal Antibody Injection"
},
{
"name": "toripalimab Injection"
},
{
"name": "Paclitaxel injection"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hefei",
"contacts": [
{
"email": "[email protected]",
"name": "Jin Gao",
"phone": "+86 15395005376",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Anhui Cancer Hospital",
"geoPoint": {
"lat": 31.86389,
"lon": 117.28083
},
"state": "Anhui",
"status": null,
"zip": "230000"
},
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Yan Sun",
"phone": "+86 13671370026",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Cancer Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100142"
},
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Shurong Zhang",
"phone": "+86 13501085646",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Tongren Hospital Affiliated to Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100730"
},
{
"city": "Fuzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Sufang Qiu",
"phone": "+86 13609589163",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fujian cancer hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": null,
"zip": "350014"
},
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Xiaoming Huang",
"phone": "+86 13602808820",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Sun Yat-sen Memorial Hospital, Sun Yat-sen University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510120"
},
{
"city": "Nanning",
"contacts": [
{
"email": "[email protected]",
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"role": "CONTACT"
}
],
"country": "China",
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"lat": 38.91222,
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},
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},
{
"city": "Shenyang",
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{
"email": null,
"name": "Aijun Liao",
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"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
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"lat": 41.79222,
"lon": 123.43278
},
"state": "Liaoning",
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"zip": "Liaoning"
},
{
"city": "Jinan",
"contacts": [
{
"email": null,
"name": "Ji Ma",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shandong Cancer Hospital",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong",
"status": null,
"zip": "250117"
},
{
"city": "Linyi",
"contacts": [
{
"email": null,
"name": "Meifang Zheng",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Linyi City Cancer Hospital",
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"lat": 35.06306,
"lon": 118.34278
},
"state": "Shandong",
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},
{
"city": "Shanghai",
"contacts": [
{
"email": null,
"name": "Tong Chen",
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"role": "CONTACT"
}
],
"country": "China",
"facility": "Huashan Hospital",
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"lat": 31.22222,
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},
"state": "Shanghai",
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},
{
"city": "Xi'an",
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{
"email": null,
"name": "Jianli Wang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Second Affiliated Hospital of Xi'an Jiaotong University",
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"lat": 34.25833,
"lon": 108.92861
},
"state": "Shanxi",
"status": null,
"zip": "710004"
},
{
"city": "Chengdu",
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{
"email": null,
"name": "Xiaobing Huang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Sichuan Provincial People's Hospital",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan",
"status": null,
"zip": "610072"
},
{
"city": "Yibin",
"contacts": [
{
"email": null,
"name": "Shihua Huang",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Yibin Second People's Hospital",
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"lat": 28.76667,
"lon": 104.62383
},
"state": "Sichuan",
"status": null,
"zip": "644002"
},
{
"city": "Tianjin",
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{
"email": null,
"name": "Lihua Qiu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Tianjin Medical University Cancer Institute and Hospital",
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"lat": 39.14222,
"lon": 117.17667
},
"state": "Tianjin",
"status": null,
"zip": "300181"
},
{
"city": "Urumqi",
"contacts": [
{
"email": null,
"name": "Shujuan Wen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The Affiliated Cancer Hospital of Xinjiang Medical University",
"geoPoint": {
"lat": 43.80096,
"lon": 87.60046
},
"state": "Xinjiang Uygur Autonomous Region",
"status": null,
"zip": "830000"
},
{
"city": "Kunming",
"contacts": [
{
"email": null,
"name": "Mingxia Shi",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Kunming Medical University",
"geoPoint": {
"lat": 25.03889,
"lon": 102.71833
},
"state": "Yunnan",
"status": null,
"zip": "650032"
},
{
"city": "Hangzhou",
"contacts": [
{
"email": null,
"name": "Wenjuan Yu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Zhejiang University School of Medicine",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": null,
"zip": "310003"
}
]
},
"descriptionModule": {
"briefSummary": "Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 226,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma",
"nctId": "NCT06378138",
"orgStudyIdInfo": {
"id": "ICP-CL-01203",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria"
},
{
"measure": "Changes from baseline in pulse."
},
{
"measure": "Changes from baseline in blood pressure."
},
{
"measure": "Changes from baseline in ECG QRS interval."
},
{
"measure": "Changes from baseline in ECG QT interval."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Beijing InnoCare Pharma Tech Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-07-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-11-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD)"
},
{
"name": "immediate-release nicotinic acid (SAD)"
},
{
"name": "Placebo controlled-ileal-release nicotinic acid (SAD/MAD)"
},
{
"name": "Placebo immediate-release nicotinic acid (SAD)"
}
]
},
"conditionsModule": {
"conditions": [
"Safety Issues",
"Pharmacokinetic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kiel",
"contacts": [
{
"email": "[email protected]",
"name": "Corinna Geisler, PhD",
"phone": "+4943150022243",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Medical Center Schleswig-Holstein, Campus Kiel",
"geoPoint": {
"lat": 54.32133,
"lon": 10.13489
},
"state": "Schleswig-Holstein",
"status": "RECRUITING",
"zip": "24105"
}
]
},
"descriptionModule": {
"briefSummary": "A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Double (Participant, Investigator)",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes",
"nctId": "NCT06378125",
"orgStudyIdInfo": {
"id": "CIR-NA I",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment-Emergent Adverse Events [Safety and Tolerability]"
},
{
"measure": "Treatment-Emergent Serious Adverse Events [Safety and Tolerability]"
},
{
"measure": "Haemoglobin"
},
{
"measure": "White blood cells"
},
{
"measure": "Blood creatinine"
},
{
"measure": "Blood urea"
},
{
"measure": "Blood uric acid"
},
{
"measure": "Glomerular filtration rate"
},
{
"measure": "Blood ALT"
},
{
"measure": "Blood AST"
},
{
"measure": "Blood GGT"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Schleswig-Holstein"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GTO®"
}
]
},
"conditionsModule": {
"conditions": [
"Edentulous Alveolar Ridge With Labial Resorption"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Granada",
"contacts": [
{
"email": "[email protected]",
"name": "Manuel Toledano, Professor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Raquel Osorio",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Manuel Toledano, Professor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Raquel Osorio, Professor",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Cristina Vallecillo, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Marta Vallecillo-Rivas, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Manuel Toledano-Osorio, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Dental School",
"geoPoint": {
"lat": 37.18817,
"lon": -3.60667
},
"state": null,
"status": "RECRUITING",
"zip": "E18071"
}
]
},
"descriptionModule": {
"briefSummary": "Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction, meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction. It is recommended to use in cases where extraction socket anatomy is intact. In contrast definition \"extraction socket augmentation\" defines alveolar ridge restoration when bony walls of the socket are partly or completely lost. In the case of severe loss (\\> 50%) of the buccal bone plate, preservation of hard tissue with a prolonged healing time before implant placement has been suggested.\n\nThe null hypothesis of this experimental work states that: (i) the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure; (i) the two different bone graft materials exhibit similar histological and histomorphometric results Therefore, the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation/ augmentation (hard-tissue preservation)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "* Group 1 (test group): Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer.\n* Group 2 (control): Guided bone regeneration procedure with Apatos Mix® cortico-cancellous heterologous bone mix (OsteoBiol®; Tecnoss srl) as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GTO",
"briefTitle": "Extraction Socket Augmentation. A Clinical Study",
"nctId": "NCT06378112",
"orgStudyIdInfo": {
"id": "2734/CEIH/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dimensional bone changes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidad de Granada"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patient guided and followed by the pharmacist"
}
]
},
"conditionsModule": {
"conditions": [
"Community Pharmacy Services"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Minor ailments are non-serious, short-term health problems, not related to the patient's pathologies or to the desired or undesired effects of the medications they are taking. Pharmaceutical indication is the service provided in response to a patient's request, who comes to the pharmacy asking for a medication recommendation for a health problem; for this purpose, over-the-counter medications are used, which are pharmacological agents that can be acquired without a prescription. The practice of pharmaceutical indication turns self-medication into a safe and responsible practice, but it requires agreed-upon protocols."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "An exploratory clinical trial with a baseline reference period of parallel groups will be conducted. The study will take place over a period of 10 months, during which 5 MA will be analyzed, and for each of them, patients will be followed up on days 3 to 5, and 7 to 10 post-care (intervention). Drugstores and drugstores/pharmacies (groups) will be randomized in a 1:1 ratio to enroll in the intervention group or the control group.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Blinding of the participants and the pharmacists involved in the care is not possible due to the nature of the intervention.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "InFaPro",
"briefTitle": "Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments",
"nctId": "NCT06378099",
"orgStudyIdInfo": {
"id": "InFaPro",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Resolution time of the MA and the frequency of referral to a physician."
}
],
"secondaryOutcomes": [
{
"measure": "Characterization of the population visiting drugstore or drugstore/pharmacy"
},
{
"measure": "Identification of the presence and classification of the MA"
},
{
"measure": "Need to acquire an OTC medication to treat the MA"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Farmacias Pasteur"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universidad de Antioquia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "RHA® Redensity with new anesthetic agent"
},
{
"name": "RHA® Redensity with lidocaine"
}
]
},
"conditionsModule": {
"conditions": [
"Pain",
"Aging"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": null,
"name": null,
"phone": "212-472-2900",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "United States, New York",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": null,
"zip": "10028"
}
]
},
"descriptionModule": {
"briefSummary": "This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection.\n\nAt screening, the Principal Investigator (PI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.\n\nAt Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the PI injecting study devices were blinded.\n\nImmediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant.\n\nSafety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection.\n\nSubjects attended Visit 2 (30 days post-injection) where effectiveness and safety assessments were conducted.\n\nSubjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2.\n\nIf the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Split-face design",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS)",
"nctId": "NCT06378086",
"orgStudyIdInfo": {
"id": "TEO-PAS-2302",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Non-inferiority of RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in terms of reducing pain during device injection into the upper perioral rhytids."
}
],
"secondaryOutcomes": [
{
"measure": "Difference between RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in term of reducing pain at 15, 30, 45 and 60 minutes post-injection in each side of the mouth."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Teoxane SA"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Incentive Spirometer"
},
{
"name": "Numeric Pain Rating Scale"
}
]
},
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"conditions": [
"Surgery-Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
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"country": "Pakistan",
"facility": "Azra Naheed Medical College, Superior University",
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"lon": 74.35071
},
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"zip": null
},
{
"city": "Lahore",
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"lon": 74.35071
},
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},
{
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},
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},
{
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{
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}
]
},
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"briefSummary": "\"A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.\n\nIn 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS\""
},
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"whoMasked": null
},
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},
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"count": 189,
"type": "ACTUAL"
},
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"NA"
],
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},
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"maximumAge": "88 Years",
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"sex": "ALL",
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"ADULT",
"OLDER_ADULT"
]
},
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"acronym": null,
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"id": "DPT/Batch-Fall19/557",
"link": null,
"type": null
},
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},
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{
"measure": "Incentive Spirometer"
},
{
"measure": "Incentive Spirometer"
}
],
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},
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"class": "OTHER",
"name": "Superior University"
}
},
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"date": "2024-09-01"
},
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"date": "2024-04-22"
},
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"date": "2024-06-01"
},
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"date": "2024-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Modified transplantation system"
}
]
},
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"conditions": [
"Severe Aplastic Anemia"
]
},
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"locations": [
{
"city": "Kunming",
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{
"email": "[email protected]",
"name": "Wang PI sanbin, Doctor",
"phone": "0871-64774206",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
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"lon": 102.71833
},
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"status": "RECRUITING",
"zip": "650000"
}
]
},
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"briefSummary": "The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia."
},
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},
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},
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"type": "ESTIMATED"
},
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"PHASE2"
],
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},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
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"id": "KM04",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "overall survival (OS)"
},
{
"measure": "Acute graft-versus-host disease incidence"
}
],
"secondaryOutcomes": [
{
"measure": "Transplantation-related motality"
},
{
"measure": "Chronic graft-versus-host disease incidence"
},
{
"measure": "incidence of Intensive fungal disease"
},
{
"measure": "EB virus reactivation rate"
},
{
"measure": "CMV reactivation rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Hematology department of the 920th hospital"
}
},
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"completionDateStruct": {
"date": "2027-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-01"
},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pembrolizumab"
},
{
"name": "Irreversible Electroporation"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Cancer",
"Locally Advanced Pancreatic Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": [
{
"email": "[email protected]",
"name": "Alicia Chin",
"phone": "813-745-4673",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Victoria Kryliouk",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mokenge Malafa, MD",
"phone": null,
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"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mohammed Al-Jumayli, MD",
"phone": null,
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Junsung Choi, MD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "James Costello, MD, PhD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Aamir Dam, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jason Denbo, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sophie Dessureault, MD, PhD",
"phone": null,
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Martine Extermann, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jessica Frakes, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Pamela Hodul, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sarah Hoffe, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Dae Won Kim, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Richard Kim, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Bela Kis, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Allan Lima Pereira, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Shaffer Mok, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Russell Palm, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jose Pimiento, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Paulo Rodriguez, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Christine Sam, MD",
"phone": null,
"phoneExt": null,
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},
{
"email": null,
"name": "Andrew Sinnamon, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Amalia Stefanou, MD",
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"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jonathan Strosberg, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Moffitt Cancer Center",
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"lat": 27.94752,
"lon": -82.45843
},
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"zip": "33612"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to determine the safety and tolerability of combining sequential therapy of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally advanced unresectable pancreas cancer following first-line treatment with chemotherapy and ablative stereotactic magnetic resonance image-guided adaptive radiation therapy (A-SMART)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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"maskingInfo": {
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"whoMasked": null
},
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},
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"count": 3,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
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},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": null,
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"nctId": "NCT06378047",
"orgStudyIdInfo": {
"id": "MCC-22325",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
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{
"measure": "Safety and Tolerability"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-Free Survival (PFS)"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Objective Response Rate (ORR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Angiodynamics, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "H. Lee Moffitt Cancer Center and Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
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"startDateStruct": {
"date": "2024-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lactium"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Sleep Disorder"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia."
},
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"designInfo": {
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"whoMasked": [
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]
},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
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"acronym": null,
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"nctId": "NCT06378034",
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"id": "2023-A01926-39",
"link": null,
"type": null
},
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},
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{
"measure": "Sleep efficiency"
}
],
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{
"measure": "Sleep diary"
},
{
"measure": "Insomnia Severity Index"
},
{
"measure": "PSQI"
},
{
"measure": "Sleep quality by cctigraphy"
}
]
},
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"class": "INDUSTRY",
"name": "Ingredia S.A."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-30"
},
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"date": "2024-04-22"
},
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"date": "2024-07-15"
},
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"startDateStruct": {
"date": "2024-06-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Calcium Chloride"
},
{
"name": "Sodium Chloride 0.9% Inj"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": null,
"name": "Mohamed A Gamal, Ass prof",
"phone": "010080827060",
"phoneExt": "02",
"role": "CONTACT"
},
{
"email": null,
"name": "Abdelhameed I Ebid, Prof",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Ain shams university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": "Abassia Cairo",
"status": "RECRUITING",
"zip": "02"
}
]
},
"descriptionModule": {
"briefSummary": "This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient.\n\nThe intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"masking": "NONE",
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"whoMasked": null
},
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"timePerspective": null
},
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"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "74 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG",
"nctId": "NCT06378021",
"orgStudyIdInfo": {
"id": "Calcium chloride in CABG",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in number of patients who developed Atrial fibrillation"
}
],
"secondaryOutcomes": [
{
"measure": "Change in length of hospital stay"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Helwan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CSPS toothpaste"
},
{
"name": "Regular fluoride toothpaste (Crest Cavity Protection)"
}
]
},
"conditionsModule": {
"conditions": [
"Dentin Sensitivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mississauga",
"contacts": [
{
"email": null,
"name": "C R Goyal, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "All Sum Research",
"geoPoint": {
"lat": 43.5789,
"lon": -79.6583
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "L5N 6J2"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate (CSPS) toothpaste."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
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},
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"count": 234,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers",
"nctId": "NCT06378008",
"orgStudyIdInfo": {
"id": "300100",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from Baseline in Schiff Sensitivity Score at Day 56"
}
],
"secondaryOutcomes": [
{
"measure": "Change from Baseline in Tactile Threshold at Day 56"
},
{
"measure": "Change from Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28"
},
{
"measure": "Change from Baseline in Tactile Threshold at Days 3, 7, 14 and 28"
},
{
"measure": "Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56"
},
{
"measure": "Change from Baseline in DHEQ Total Score (Section 2, Question Q1-34) at Days 28 and 56"
},
{
"measure": "Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56"
},
{
"measure": "Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56"
},
{
"measure": "Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56"
},
{
"measure": "Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56"
},
{
"measure": "Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56"
},
{
"measure": "Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56"
},
{
"measure": "Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "HALEON"
}
},
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}
}
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{
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"name": "Placebo technique"
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{
"name": "Diaphragm protocol"
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},
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{
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{
"email": "[email protected]",
"name": "Natália MO Campelo, PhD",
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"measure": "Changes in range of motion after applying the diaphragm targeted protocol"
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"measure": "Changes in pain level one week after the intervention"
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"measure": "Changes in range of motion one week later"
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}
}
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{
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"name": "hUCB"
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"briefSummary": "A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy"
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"ADULT"
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}
}
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null | false |
{
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]
},
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"briefSummary": "Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord."
},
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},
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"id": "75269",
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{
"measure": "Patient Global Impression Change"
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{
"measure": "Change in Quality of Life"
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{
"measure": "Change in Pain Catastrophizing Scale"
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{
"measure": "Change in sleep quality"
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{
"measure": "Change in Social Functioning"
}
]
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"date": "2027-06-30"
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},
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}
}
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{
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"name": "Observation without intervention"
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"email": "[email protected]",
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"measure": "Fecal calorie"
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{
"measure": "Urine calorie"
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{
"measure": "Weight"
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{
"measure": "Height"
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{
"measure": "Waist circumferences"
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{
"measure": "Bone mass"
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{
"measure": "Fat mass"
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{
"measure": "Fat free mass"
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{
"measure": "Blood pressure"
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{
"measure": "Heart rate"
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{
"measure": "Resting energy expenditure"
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{
"measure": "Thermic effect of food"
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{
"measure": "Body shape"
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{
"measure": "Microbiome"
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{
"measure": "Metabolites"
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{
"measure": "Gut transit time"
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{
"measure": "Food macronutrient content"
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{
"measure": "Feces macronutrient content"
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{
"measure": "Total daily water volume"
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{
"measure": "Total daily urine volume"
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{
"measure": "Physical activity"
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{
"measure": "Bristol Stool Scale"
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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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"measure": "Measurement of Clinical Seizure Frequency"
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"measure": "Change in seizure severity"
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{
"measure": "Global Impression of Change"
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{
"measure": "Pharmacokinetic parameters"
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}
}
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null | false |
{
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"name": "Laser Assisted Hatching"
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]
},
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"conditions": [
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},
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"locations": [
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"city": "Marlton",
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"email": "[email protected]",
"name": "Christine V Whitehead, MS, BSN, RN",
"phone": "973-656-2841",
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},
{
"email": "[email protected]",
"name": "Caroline Zuckerman, BS, RN",
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"role": "CONTACT"
},
{
"email": null,
"name": "Jason Fransiak, MD",
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"role": "PRINCIPAL_INVESTIGATOR"
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"email": null,
"name": "Kevin Lambrese, PhD",
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],
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"stdAges": [
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},
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"briefTitle": "Investigating Micro-Manipulation Procedures for Assisted Hatching Timing",
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"link": null,
"type": null
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"measure": "Blastulation Rate"
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"measure": "Embryo morphologic grade"
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{
"measure": "Timing of blastulation"
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{
"measure": "Aneuploidy rate"
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{
"measure": "Positive pregnancy rate"
},
{
"measure": "Sustained implantation rate"
},
{
"measure": "Pregnancy loss rate"
},
{
"measure": "Live birth rate"
}
]
},
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},
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"date": "2024-04-22"
}
}
}
|
null | false |
{
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},
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"locations": null
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"briefSummary": "This retrospective (between April 2020 and December 2023) then prospective (between January 2024 and August 2026), non-interventional cohort study has as its main objective to evaluate the clinical and therapeutic characteristics of patients aged 75 and over hospitalized in geriatrics for heart failure and also to evaluate the clinical characteristics and triggering factor(s) of acute heart failure."
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"minimumAge": "75 Years",
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},
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"acronym": "AGING HF",
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"id": "2023-A02125-40",
"link": null,
"type": null
},
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},
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"measure": "Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure"
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],
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"measure": "Factors associated with patients hospitalization or rehospitalization"
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"leadSponsor": {
"class": "OTHER",
"name": "Gérond'if"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Emotional Resilience training"
}
]
},
"conditionsModule": {
"conditions": [
"Fear of Childbirth",
"Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bayburt",
"contacts": null,
"country": "Turkey",
"facility": "Bayburt State Hospital",
"geoPoint": {
"lat": 40.25631,
"lon": 40.22289
},
"state": null,
"status": null,
"zip": "69000"
}
]
},
"descriptionModule": {
"briefSummary": "Although birth has a great place in a woman's life, factors such as the woman's education level, personal experiences, social support status, whether the pregnancy is planned or not, the family's attitude towards pregnancy, and socioeconomic status increase the burden of pregnancy and can create a stressful situation for the woman. While the pain that may be experienced during birth, thoughts about the baby's health and postpartum baby care further increase this fear, primiparous women who will give birth for the first time experience many emotions that they cannot define and cannot predict the situations they will encounter during birth. The most important situation that will cause pain during birth is fear. So much so that fear of birth may cause women to avoid pregnancy and increase optional abortions.In particular, fear of birth may increase cesarean delivery rates and also lead to negative maternal outcomes such as poor mental health after birth. Fear experienced during the antenatal period can lead to difficult births, mother-baby attachment problems, and depression. While fear of birth causes depression and anxiety disorders in the postpartum period, it is stated that depression experienced during pregnancy may increase the fear of birth, or fear of birth may be a hidden symptom of depression. It is noted that emotional regulation skills and resilience in pregnant women can be effective strategies in minimizing and managing fear, anxiety, stress, and anxiety. Emotional resilience is defined as the style of coping with stress, the ability to repair oneself, the ability to recover from adverse events quickly, and the state of adapting to a new environment. In particular, individuals with high emotional resilience can protect their physical and mental health and increase their life satisfaction by reducing the negative consequences they experience. With the emotional resilience training given during pregnancy, pregnant women's stress, fear, and anxiety will be reduced, and they will be able to cope better with the difficulties they experience. This research will be conducted to examine the effect of emotional resilience training given to primiparous pregnant women on fear of childbirth and depression."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women",
"nctId": "NCT06377891",
"orgStudyIdInfo": {
"id": "TDK-2024-13563",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The effect of emotional resilience on fear of birth and depression in primiparous pregnant women."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Atatürk University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ataturk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Preeclampsia",
"Eclampsia",
"HELLP Syndrome",
"Toxemia",
"Hypertensive Disorder of Pregnancy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Melbourne",
"contacts": [
{
"email": "[email protected]",
"name": "VeeAnn Argyle",
"phone": "321-421-6957",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Eleni Z Tsigas, BA",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Hilary Gammill, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "James Roberts, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Preeclampsia Foundation",
"geoPoint": {
"lat": 28.08363,
"lon": -80.60811
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32940"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 20000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TPR",
"briefTitle": "The Preeclampsia Registry",
"nctId": "NCT06377878",
"orgStudyIdInfo": {
"id": "Pro00008369",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Preeclampsia Foundation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2040-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2040-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2013-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"B Thalassemia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "to evaluate thyroid function ,HbA1C,\\&lipid profile in thalassemic patient to correlate thyroid function , Hba1c , lipid profile e ferritin level in thalassemic patient"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia",
"nctId": "NCT06377865",
"orgStudyIdInfo": {
"id": "endocrine dis & B thalassemia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Palbociclib"
},
{
"name": "Ribociclib"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with MBC (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.\n\nThe primary objective of the CDK Study is to compare TTD on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (AI or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors.\n\nTogether with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "500 patients will be enrolled, 250 per arm (Arm 1 being indicated dose, Arm 2 being titrated dose).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study",
"nctId": "NCT06377852",
"orgStudyIdInfo": {
"id": "Pro00075309",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time to Treatment Discontinuation (TTD)"
}
],
"secondaryOutcomes": [
{
"measure": "Toxicity (grade 3-4 AEs)"
},
{
"measure": "Event-Free survival (EFS)"
},
{
"measure": "Quality of life assessed by patient reported outcomes"
},
{
"measure": "Time to dose reduction and escalation"
},
{
"measure": "Reason for not escalating"
},
{
"measure": "Treatment received (missed doses, cumulative dose, etc.)"
},
{
"measure": "Healthcare utilization (ED visits, hospital admissions, etc.)"
},
{
"measure": "Body Mass Index"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Patient-Centered Outcomes Research Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "American Society of Clinical Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Advanced platelet-rich fibrin in the ekstraction socket"
}
]
},
"conditionsModule": {
"conditions": [
"Pain Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aalborg",
"contacts": [
{
"email": "[email protected]",
"name": "Thomas Starch-Jensen, Professor",
"phone": "+45 23266370",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Department of Oral and Maxillofacial surgery, Aalborg University Hospital",
"geoPoint": {
"lat": 57.048,
"lon": 9.9187
},
"state": "Nordjylland",
"status": "RECRUITING",
"zip": "9000"
}
]
},
"descriptionModule": {
"briefSummary": "Pain is the most common complication following surgical removal of an impacted mandibular third molar. Several risk factors may increase the intensity and duration of pain following removal of mandibular third molars. Acute postoperative pain can transcript into postoperative chronic pain without an explainable reason or a specific risk factor. The use of advanced platelet-rich fibrin in the extraction socket following surgical removal of mandibular third molar have diminished the intensity and duration of acute postoperative pain and facilitated improved wound healing. The objective of the present study is therefore to identified specific risk factors and predictors for developing postoperative chronic pain following surgical removal of mandibular third molars with or without advanced platelet-rich fibrin applied in the extraction socket using epigenetic modulation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pain After Removal of Mandibular Third Molars With or Without Advanced Platelet-rich Fibrin",
"nctId": "NCT06377839",
"orgStudyIdInfo": {
"id": "N-20230048",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assessment of postoperative pain by using Visual Analoque scale"
}
],
"secondaryOutcomes": [
{
"measure": "Assessment of quality of life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Aalborg University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Aalborg University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "aerobic exercises"
},
{
"name": "resistance training"
},
{
"name": "medication"
}
]
},
"conditionsModule": {
"conditions": [
"Comparison of Aerobic Exercise and Resistance Training"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Abbottābād",
"contacts": [
{
"email": "[email protected]",
"name": "saira jahan, MS",
"phone": "031591289095",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Usama Iqbal",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Abbottabad medical complex",
"geoPoint": {
"lat": 34.1463,
"lon": 73.21168
},
"state": "Khyber Pakhtunkhwa",
"status": "RECRUITING",
"zip": "21300"
}
]
},
"descriptionModule": {
"briefSummary": "the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 66,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism.",
"nctId": "NCT06377826",
"orgStudyIdInfo": {
"id": "RCRAHS-ISB/REC/MS-PT/01813",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "6 Minute Walk Test"
},
{
"measure": "The Beck Depression Inventory Scale"
},
{
"measure": "SF- 36 SF-36"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mode-Kinetic Chain Exercise With Core Stability Exercises"
},
{
"name": "Mode-Kinetic Chain Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "Muhammad Sanaullah, MS",
"phone": "03224819253",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Maryam Maqsood, DPT",
"phone": "03314815652",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Riphah International University",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this \\[type of study: Randomized control trial\\] is to \\[ see the effects of Combined Mode Kinetic Chain Exercises along with or without core stability exercises on pain, range of motion and disability \\] in \\[ in patients with Knee Osteoarthritis\\].The main question it aims to answer is:\n\nWether core stability exercises is effective if performed along with Combined chain kinetic exercises to improves the condition of Knee Osteoarthritis? Group A will receive Core Stability Exercises along with Combined Chain Kinetic Exercises and Group B will receive combined Chain Kinetic Exercises."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Assignment",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Combined Mode-Kinetic Chain Exercise With and Without Core Stability Exercises on Patients With Knee Osteoarthritis",
"nctId": "NCT06377813",
"orgStudyIdInfo": {
"id": "REC/RCR& AHS/23/01100/Maryam",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numeric pain rating scale"
},
{
"measure": "Kellgren and Lawrence system for classification of Osteoarthritis"
},
{
"measure": "Knee Injury and Osteoarthritic outcome score (KOOS)"
},
{
"measure": "Goniometer"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "navicular mobilization along conventional therapy."
},
{
"name": "conventional therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Plantar Fascitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Faisalābad",
"contacts": [
{
"email": "[email protected]",
"name": "Maria Khalid, MSOMPT",
"phone": "03315369768",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kainat Fatima, MSOMPT*",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kainat Fatima, MSOMPT*",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "DHQ Hospital",
"geoPoint": {
"lat": 31.41554,
"lon": 73.08969
},
"state": "Punjab",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. Understanding how this therapy impacts navicular height, pain and disability of the foot can lead to improved clinical outcomes and a better understanding of the biomechanical factors contributing to plantar fasciitis. Ultimately, this research may help refine treatment strategies and enhance the quality of life for individuals suffering from this condition"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects Of Navicular Mobilization In Patients With Planter Fasciitis",
"nctId": "NCT06377800",
"orgStudyIdInfo": {
"id": "REC 01801 Kainat Fatima",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numeric Pain Rating Scale"
},
{
"measure": "(Foot Function Index)"
},
{
"measure": "Navicular drop test"
},
{
"measure": "Foot print analysis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ELDOA and conventional therapy"
},
{
"name": "conventional therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Cervicogenic Headache"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Islamabad",
"contacts": [
{
"email": "[email protected]",
"name": "Maria Khalid, MSOMPT",
"phone": "03315369768",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Aneeqa Zaheer, MSOMPT*",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Aneeqa Zaheer, MSOMPT*",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Alkhidmat Raazi Hospital CBR Town",
"geoPoint": {
"lat": 33.72148,
"lon": 73.04329
},
"state": "Punjab",
"status": null,
"zip": "46000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of our study is to determine the effect of ELDOA in relieving pain, improving ROM and functional disability in patients with cervicogenic headache. This study will add to the growing body of knowledge that if this technique yields comparable outcomes, it would be the alternative therapy. Moreover, it would add to the society as no literature is available on the effect of ELDOA technique in the management of Cervicogenic headache."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of ELDOA in Patients With Cervicogenic Headache",
"nctId": "NCT06377787",
"orgStudyIdInfo": {
"id": "REC 01732 Aneeqa Zaheer",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "(Numeric Pain Rating Scale)."
},
{
"measure": "NDI (U) (Neck Disability Index)"
},
{
"measure": "Inclinometer"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No intervention in this study"
}
]
},
"conditionsModule": {
"conditions": [
"Acute-On-Chronic Liver Failure"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and two specific adsorption membranes dedicating to remove bilirubin and the middle molecular toxins respectively. The efficiency of DMPAS treatment in liver failure patients remains controversial. Previous study indicate that liver failure patients with DPMAS therapy improve the short-term mortality and prevent the diseases progression within 28 days (PADSTONE Study). Thus, this single-arm, multicenter and prospective study is to further validate and optimize the therapeutic procedures of DPMAS therapy in ACLF patients."
},
"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": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "To Optimize Therapeutic Procedures of DPMAS in ACLF Patients: a Prospective, Sigle Arm and Multicenter Study",
"nctId": "NCT06377774",
"orgStudyIdInfo": {
"id": "NFEC-2024-096",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "28-day transplantation-free mortality"
},
{
"measure": "The disease progression rate"
}
],
"secondaryOutcomes": [
{
"measure": "the 90-day transplantation-free mortality"
},
{
"measure": "the disease progression"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nanfang Hospital, Southern Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Qishen Granules"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure With Preserved Ejection Fraction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Lei Wang, M.D",
"phone": "8620-81887233-32801",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Guangdong Provincial Hospital of Chinese Medicine",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "510120"
},
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Lei Wang, doctorate",
"phone": "+8613724078381",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Shuai Mao, doctorate",
"phone": "86-20-81887233-32801",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "WangLei",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "510120"
}
]
},
"descriptionModule": {
"briefSummary": "With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Random parallel grouping",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study on Heart Failure With Preserved Ejection Fraction With Qishen Granules",
"nctId": "NCT06377761",
"orgStudyIdInfo": {
"id": "BF-2022-121",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Changes in Aspartate aminotransferase(AST) compared to baseline on day 90"
},
{
"measure": "Changes in Alanine aminotransferase(ALT) compared to baseline on day 90"
},
{
"measure": "Number of participants with treatment-related adverse events"
}
],
"primaryOutcomes": [
{
"measure": "Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90"
},
{
"measure": "Changes in E/e' ratio compared to baseline on day 90"
},
{
"measure": "Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90"
},
{
"measure": "Changes in Left ventricular mass index (LVMI) compared to baseline on day 90"
},
{
"measure": "Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90"
},
{
"measure": "Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90"
},
{
"measure": "Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90"
},
{
"measure": "Changes in blood urea compared to baseline on day 90"
},
{
"measure": "Changes in blood creatinine compared to baseline on day 90"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Guangdong Provincial Hospital of Traditional Chinese Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Facilitated tucking position"
},
{
"name": "ShotBlocker"
},
{
"name": "Combined facilitated tucking and ShotBlocker"
}
]
},
"conditionsModule": {
"conditions": [
"Procedural Pain",
"Pain, Acute",
"Nursing Caries"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": null,
"name": "Aynur Aytekin Özdemir, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Istanbul Medeniyet University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Kadıköy",
"status": null,
"zip": "34720"
}
]
},
"descriptionModule": {
"briefSummary": "This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be assigned to experimental and control groups using block randomization method. Birth weight (2500-3000 g, 3001-3500 g, 3501 g and above), gender (male and female) and mode of delivery (vaginal and cesarean section) variables will be used for block randomization.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Using the block randomization technique, participants will be divided into 4 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B, C and D using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each baby is in just before the application (researcher blinding).\n\nParents will know which group the baby is in within the scope of the research. By the nature of the sample group, babies are blind.\n\nResearch data will be entered into the computer database by coding the group name as A, B, C and D, and statistical analysis will be performed using this coding (statistician blinding).",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 144,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "42 Weeks",
"minimumAge": "38 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants",
"nctId": "NCT06377748",
"orgStudyIdInfo": {
"id": "2023/02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neonatal Infant Pain Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Crying time during the procedure"
},
{
"measure": "Procedure time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul Medeniyet University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BAI-BACE"
}
]
},
"conditionsModule": {
"conditions": [
"Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Qunfang Zhou, MD",
"phone": "8619868000115",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Feng Duan, MD",
"phone": "8613910984586",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Chinese PLA General hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100853"
}
]
},
"descriptionModule": {
"briefSummary": "Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported as non-first-line therapy to treat lung cancer in many hospitals in China. BAI, which uses chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. In this study, we aim to describe the efficacy and safety of BAI-BACE as non-first-line for advanced lung squamous cell carcinoma."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI) procedure was performed as follows: Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, paclitaxel (300 mg) was infused slowly at least 30 min. BAI (bronchial arterial infusion) chemotherapy was followed by BACE (Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with cis-platinum (30 mg) were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 85,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "BAI-BACE for Advanced Lung Squamous Cell Carcinoma",
"nctId": "NCT06377735",
"orgStudyIdInfo": {
"id": "CHEST-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-Free-Survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cabozantinib"
}
]
},
"conditionsModule": {
"conditions": [
"Renal Cell Carcinoma Metastatic",
"Renal Cell Carcinoma Stage IV",
"Renal Cell Carcinoma Stage III"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oviedo",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Central de Asturias",
"geoPoint": {
"lat": 43.36029,
"lon": -5.84476
},
"state": "Asturias",
"status": null,
"zip": null
},
{
"city": "L'Hospitalet de Llobregat",
"contacts": null,
"country": "Spain",
"facility": "Institut Català d'Oncologia. Idibell",
"geoPoint": {
"lat": 41.35967,
"lon": 2.10028
},
"state": "Barcelona",
"status": null,
"zip": null
},
{
"city": "Santander",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario de Valdecilla",
"geoPoint": {
"lat": 43.46472,
"lon": -3.80444
},
"state": "Cantabria",
"status": null,
"zip": null
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Hospital Univeristario 12 de Octubre",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": "28041"
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Centro Oncológico Clara Campal - HM CIOCC",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario La Paz",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Ramón y Cajal",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Hospital Universitario Severo Ochoa",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 18,
"type": "ACTUAL"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer",
"nctId": "NCT06377722",
"orgStudyIdInfo": {
"id": "CABOPRE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Radiological response rate prior to cytoreductive nephrectomy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "Fundacion Oncosur"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-08-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "TERMINATED",
"primaryCompletionDateStruct": {
"date": "2022-08-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ProACTive™"
}
]
},
"conditionsModule": {
"conditions": [
"Burn Injuries",
"Burns",
"Emotional Distress",
"Adjustment"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This mixed-methods acceptability study aims to investigate whether an early acceptance and commitment therapy (ACT) based intervention called ProACTive™, aimed at supporting burns patients' adjustment to a changed appearance and preventing distress, is acceptable. This will be measured by descriptive data, questionnaire data and semi-structured interviews.\n\nPreliminary data on the potential clinical effectiveness of the intervention will also be gathered. This will be measured by scores on standardised questionnaires."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Mixed-methods Acceptability Study of ProACTive™ to Help Burns Patients Adjust to Changes to Appearance",
"nctId": "NCT06377709",
"orgStudyIdInfo": {
"id": "24CP001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A)"
}
],
"secondaryOutcomes": [
{
"measure": "Positive and Negative Affect Schedule (PANAS-GEN)"
},
{
"measure": "Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)"
},
{
"measure": "Self-Compassion Scale - Short Form (SCS-SF)"
},
{
"measure": "Helpful Aspects of Therapy Form (HAT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nottingham University Hospitals NHS Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Best Practice"
},
{
"name": "Medical Device Usage and Evaluation"
},
{
"name": "Metformin"
},
{
"name": "Neurocognitive Assessment"
},
{
"name": "Questionnaire Administration"
}
]
},
"conditionsModule": {
"conditions": [
"Malignant Brain Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ugur T. Sener, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": null,
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essential component of brain tumor treatment, can result in significant negative effects on cognitive (the ability to clearly think, learn, and remember) function. Wearable devices have been used in the field of neurology for seizure detection and assessment of patients with movement disorders. Wearable device technology has also been implemented for remote monitoring of cancer patients and for cancer clinical trials. Metformin is the active ingredient in a drug used to treat type 2 diabetes mellitus (a condition in which the body cannot control the level of sugar in the blood). It is also being studied in the treatment of cancer. Use of metformin may reduce risk of cognitive decline following radiation therapy within the skull (intracranial). These effects may be further strengthen by addition of device-based physical activity promotion. Mayo Test Drive is a web-based platform for remote self-administered cognitive assessment. Using Mayo Test Drive may help determine whether patient care can be done remotely, while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy",
"nctId": "NCT06377696",
"orgStudyIdInfo": {
"id": "MC230713",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-02980",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic in Rochester",
"id": "MC230713",
"link": null,
"type": "OTHER"
},
{
"domain": "Mayo Clinic Institutional Review Board",
"id": "23-005512",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall completion rates and compliance (Feasibility)"
},
{
"measure": "Overall satisfaction"
},
{
"measure": "Adherence (Feasibility)"
},
{
"measure": "Neurocognitive scores"
},
{
"measure": "Incidence of adverse events (AEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "177Lu-Dansyl-PSMA radioligand therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Castration-resistant Prostate Cancer, mCRPC"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xiamen",
"contacts": [
{
"email": "[email protected]",
"name": "Haojun Chen, MD, PhD",
"phone": "+8618659285282",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Hao Fu, MD, PhD",
"phone": "+8615959230059",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Haojun Chen, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Hao Fu, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "China",
"facility": "The First Affiliated Hospital of Xiamen University",
"geoPoint": {
"lat": 24.47979,
"lon": 118.08187
},
"state": "Fujian",
"status": "RECRUITING",
"zip": "361003"
}
]
},
"descriptionModule": {
"briefSummary": "Ten to 20% of patients with prostate cancer (PC) experience progression in their disease, even after undergoing pharmaceutical or surgical castration, leading to metastatic CRPC (mCRPC). Prostate-specific membrane antigen (PSMA) is a membrane-bound glycoprotein mostly specific to the prostate. While PSMA is expressed at low levels in normal prostate, this expression increased by 100-1000-fold in PC, which makes it a favorable target for therapy. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled ligand 177Lu-Dansyl-PSMA in mCRPC patients."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "classic 3+3 dose escalation",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer",
"nctId": "NCT06377683",
"orgStudyIdInfo": {
"id": "XMYY-2023KY122",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of treatment-related adverse events (safety and tolerability)"
},
{
"measure": "To determine the maximum tolerated dose (MTD)"
}
],
"secondaryOutcomes": [
{
"measure": "Dosimetry"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital of Xiamen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Wassel IV Thumb Duplication Surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Wassel IV Thumb Duplication"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year",
"nctId": "NCT06377670",
"orgStudyIdInfo": {
"id": "38RC24.0012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Functional and Aesthetic Outcomes"
}
],
"secondaryOutcomes": [
{
"measure": "Comparison of Surgical Techniques"
},
{
"measure": "Efficacy of Skin Flap Types"
},
{
"measure": "Immobilization Method Analysis"
},
{
"measure": "Preoperative Angle Decision Model"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Grenoble"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
},
{
"name": "Aloe vera"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Type 2"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amol",
"contacts": null,
"country": "Iran, Islamic Republic of",
"facility": "Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran",
"geoPoint": {
"lat": 36.46961,
"lon": 52.35072
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Diabetes is a prevalent metabolic disease that leads to increased blood sugar levels due to insulin shortage or resistance. Type 2 diabetes is often linked to obesity, which can increase insulin resistance. Meteorin-like protein (METRNL) is a new secreted protein that affects insulin sensitivity and has been found to be negatively related to serum glucose levels in people with diabetes.\n\nOxidative stress in diabetics can stimulate the production of inflammatory mediators, increasing the activity of the antioxidant system. Aloe vera, a widely used plant, has been used for treating diabetes, wound healing, tumors, and inflammatory bowel disease. It has anti-inflammatory, antioxidant, neuroprotective, antidepressant, and memory-enhancing effects.\n\nExercise can improve diabetic patients' conditions by increasing the expression of GLUT4 protein and skeletal muscle. High-intensity interval training has been shown to increase the expression of the METORIN gene in human subjects and decrease MDA in type 2 diabetic patients. However, no studies have examined the simultaneous effect of exercise and Aloe vera on diabetes indicators.\n\nThe present study aims to investigate the response of METRNL and some oxidative and antioxidant plasma indicators to high-intensity interval training and Aloe vera supplementation in type 2 diabetic men. The findings indicate that exercise and consumption of plants with anti-inflammatory and antioxidant properties can be effective in modulating the pathological effects of diabetes and increasing insulin sensitivity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The participants were blinded for the supplementation.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "25 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM",
"nctId": "NCT06377657",
"orgStudyIdInfo": {
"id": "DONT4GET",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "METRNL - Meteorin Like, Glial Cell Differentiation Regulator"
}
],
"secondaryOutcomes": [
{
"measure": "Glutathione peroxidase (GPx)"
},
{
"measure": "Serum superoxide dismutase (SOD)"
},
{
"measure": "Total antioxidant blood capacity (TAD)"
},
{
"measure": "Plasma malondialdehyde (MDA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Nis"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Kinesio taping"
},
{
"name": "Dry Needling"
}
]
},
"conditionsModule": {
"conditions": [
"Frozen Shoulder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": null,
"country": "Pakistan",
"facility": "Pain away Physical Therapy",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "\"Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "35 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparing the Efficacy of KT vs DN With Conventional Treatment for Improving QOL and Alleviating Pain in Frozen Shoulder",
"nctId": "NCT06377644",
"orgStudyIdInfo": {
"id": "DPT/Batch-Fall19/560",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "VAS"
},
{
"measure": "SPADI"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Superior University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Visceral Obesity",
"Non-alcoholic Fatty Liver",
"Postmenopausal"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Reus",
"contacts": [
{
"email": "[email protected]",
"name": "Anna Crescenti, PhD",
"phone": "977770958",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Anna Crescenti",
"geoPoint": {
"lat": 41.15612,
"lon": 1.10687
},
"state": "Catalonia. Spain",
"status": null,
"zip": "43204"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat, as well as their associated comorbidities, in postmenopausal women with abdominal obesity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingDescription": null,
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"INVESTIGATOR",
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]
},
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"timePerspective": null
},
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"type": "ESTIMATED"
},
"phases": [
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],
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},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "50 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FATHIS+",
"briefTitle": "Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women With Abdominal Obesity",
"nctId": "NCT06377631",
"orgStudyIdInfo": {
"id": "FATHIS+",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Visceral Adiposity"
}
],
"secondaryOutcomes": [
{
"measure": "Height (cm)"
},
{
"measure": "Age"
},
{
"measure": "Ethnicity"
},
{
"measure": "Change in Body Weight (kg)"
},
{
"measure": "Change in Body Mass Index (BMI) (Kg/m^2)"
},
{
"measure": "Change in Neck circumference (cm)"
},
{
"measure": "Change in Arm circumference (cm)"
},
{
"measure": "Change in Waist circumference (cm)"
},
{
"measure": "Change in Hip circumference (cm)"
},
{
"measure": "Change in Conicity Index"
},
{
"measure": "Change in Waist-to-Hip ratio"
},
{
"measure": "Change in Lipid Accumulation Product (LAP)"
},
{
"measure": "Change in Systolic Blood Pressure (mm Hg)"
},
{
"measure": "Change in Diastolic Blood Pressure (mm Hg)"
},
{
"measure": "Change in heart rate (bpm)"
},
{
"measure": "Change in serum glucose levels (mg/dL)"
},
{
"measure": "Change in serum total cholesterol (mg/dL)"
},
{
"measure": "Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL)"
},
{
"measure": "Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL)"
},
{
"measure": "Change in serum triglycerides (TG, mg/dL)"
},
{
"measure": "Change in serum alanine aminotransferase (ALT, U/L)"
},
{
"measure": "Change in serum aspartate aminotransferase (AST, U/L)"
},
{
"measure": "Change in serum gamma glutamyl transferase (GGT, U/L)"
},
{
"measure": "Change in serum insulin levels (mU/L)"
},
{
"measure": "Change in serum leptin levels (pg/mL)"
},
{
"measure": "Change in serum adiponectin levels (ng/mL)"
},
{
"measure": "Change in Adiponectin/Leptin ratio (numerical ratio)"
},
{
"measure": "Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL)"
},
{
"measure": "Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL)"
},
{
"measure": "Change in plasma Interleukin 6 (IL-6) levels (pg/mL)"
},
{
"measure": "Change in plasma Interleukin 10 (IL-10) levels (pg/mL)"
},
{
"measure": "Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL)"
},
{
"measure": "Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL)"
},
{
"measure": "Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L)"
},
{
"measure": "Change in serum C-Reactive protein levels (mg/L)"
},
{
"measure": "Change in Histidine levels in blood (umol/L)"
},
{
"measure": "Change in Acylcarnitine levels in blood (umol/L)"
},
{
"measure": "Change in 17-beta-estradiol (E2) levels in blood (pg/mL)"
},
{
"measure": "Change in Follicle-stimulating hormone (FSH) levels in blood (mU/mL)"
},
{
"measure": "Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR)"
},
{
"measure": "Change in Fatty Liver Index (FLI)"
},
{
"measure": "Change in Triglyceride glucose index (TyG)"
},
{
"measure": "Change in Plasma atherogenic index"
},
{
"measure": "Change in lipidomic profile"
},
{
"measure": "Change in intestinal microbiota composition"
},
{
"measure": "Change in the expression of lipid-metabolism genes in PBMC"
},
{
"measure": "Change in Dietary habits"
},
{
"measure": "Change in Physical activity"
},
{
"measure": "Concomitant medication"
},
{
"measure": "Consumption of dietary supplements"
},
{
"measure": "Change in the Supraclavicular skin temperature"
},
{
"measure": "Change in postmenopausal symptoms"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Centre de Diagnosi per la Imatge"
},
{
"name": "Instituto de Investigación Biomédica de Girona (IDIBGI)"
},
{
"name": "Laboratorio de Referencia de Cataluña"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundació Eurecat"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-05"
},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Resistance Training and Core Strengthening Exercises Group"
},
{
"name": "Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation"
}
]
},
"conditionsModule": {
"conditions": [
"Menopausal",
"Pain, Low Back"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": null,
"country": "Pakistan",
"facility": "Azra Naheed Medical College, Superior University",
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"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women."
},
"designModule": {
"designInfo": {
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"interventionModel": "PARALLEL",
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"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "50 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison Of Resistance Training And Core Strengthening Exercises Vitamin D In Postmenopausal Women With Low Back Pain",
"nctId": "NCT06377618",
"orgStudyIdInfo": {
"id": "DPT/Batch-Fall19/556",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analog Scale (VAS)"
},
{
"measure": "Oswestry Disability Index (ODI)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Superior University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2024-05-20"
},
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"startDateStruct": {
"date": "2024-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ESPB"
},
{
"name": "local anaesthetic infiltration"
},
{
"name": "midazolam and lidocaine"
},
{
"name": "Bupivacain"
}
]
},
"conditionsModule": {
"conditions": [
"Erector Spinae Plane Block",
"Super Obese Patients",
"Bariatric Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "amany ahmea eissa, lecturer",
"phone": "01001807207",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "marwa saeed zayed, ass. professor",
"phone": "01003347560",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Kasr Al Ainy Hospitals",
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"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. \\[1\\] Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing \\[2\\].\n\nPostoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity. With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the availability of other pain management modalities is essential \\[14\\].\n\nUltrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially. It is supposed to provide both visceral and somatic abdominal analgesia \\[3\\].\n\nESPB is effective, easy to perform, and can be performed in a short time. \\[4\\] It has been shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery, breast surgery, and abdominal surgery \\[5\\]. However, the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.\n\nPeripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient positioning and landmark identification. However, Ultrasound guidance may help overcome many difficulties in regional techniques. But as expected, targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient. \\[15\\] Few studies examined the use of ESPB in bariatric surgery \\[3,6,7\\], all indicating potential benefits of the technique in terms of opioid sparing and pain control. To date, the efficacy of ESPB has not been examined in superobese patient.\n\nSo we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized controlled trial- single blinded",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial.",
"nctId": "NCT06377605",
"orgStudyIdInfo": {
"id": "MD-15-2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total opioid consumption"
}
],
"secondaryOutcomes": [
{
"measure": "VAS score during first 24 hour postoperative"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Amany Ahmed Eissa"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sample collection without intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Bacterial Infections"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Suita",
"contacts": [
{
"email": null,
"name": "Go Yamamoto",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Japan",
"facility": "Osaka University Hospital",
"geoPoint": {
"lat": 34.76143,
"lon": 135.51567
},
"state": "Osaka",
"status": "RECRUITING",
"zip": "5650871"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI"
},
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},
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"count": 18000,
"type": "ESTIMATED"
},
"phases": null,
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},
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"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Development and Accuracy Evaluation of Gram Staining Analysis AI",
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"orgStudyIdInfo": {
"id": "G22396",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Advanced level of blood culture Gram stain analysis AI accuracy"
},
{
"measure": "Ordinary level of blood culture Gram stain analysis AI accuracy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "GramEye"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
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"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
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},
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]
},
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{
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"lon": 2.3
},
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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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},
{
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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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"lon": 0.2
},
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},
{
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"geoPoint": {
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},
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},
{
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"facility": "Marseille IPC",
"geoPoint": {
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},
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},
{
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},
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},
{
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"facility": "Montpellier - Chu Saint Eloi",
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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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},
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},
{
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},
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},
{
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},
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},
{
"city": "Strasbourg",
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"facility": "ICANS - Institut de cancérologie de strasbourg europe",
"geoPoint": {
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},
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},
{
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"facility": "Toulouse - IUCT Oncopole - Service d'Hématologie",
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},
"descriptionModule": {
"briefSummary": "Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)/αKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosis\n\nIvosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R/R) AML (DiNardo et al. 2018) and in front line settings (Montesinos et al. 2022). In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R/R settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R/R. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R/R patients and March 2022 for first line treatment.\n\nIn this multicentric retrospective study, we aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R/R disease. Our results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R/R IDH1mut AML."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia",
"nctId": "NCT06377579",
"orgStudyIdInfo": {
"id": "FILObsLAM_IVOOBS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "characterize the Overall survival (OS) in the both cohort : 1st line and Relapsed/Refractory (R/R)"
}
],
"secondaryOutcomes": [
{
"measure": "characterize the composite response rate (CRc) at any time during follow-up, for the both cohort : 1st line and Relapsed/Refractory (R/R)"
},
{
"measure": "characterize the Event Free Survival (EFS) in both cohorts : 1st line and Relapsed/Refractory (R/R)"
},
{
"measure": "characterize the incidence and relatedness of serious adverse events (SAE), for patients treated by Ivosidenib, for both cohorts : 1st line and Relapsed/Refractory (R/R)"
},
{
"measure": "describe the management of treatment by Ivosidenib in both cohorts : 1st line and Relapsed/Refractory (R/R)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Acute Leukemia French Association"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "French Innovative Leukemia Organisation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Brentuximab vedotin"
},
{
"name": "Doxorubicin"
},
{
"name": "Vinblastine"
},
{
"name": "Dacarbazine"
},
{
"name": "Pembrolizumab"
},
{
"name": "Gemcitabine"
},
{
"name": "Vinorelbine"
},
{
"name": "FDG-PET/CT scan"
}
]
},
"conditionsModule": {
"conditions": [
"Hodgkin Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Miami",
"contacts": [
{
"email": null,
"name": "Craig Moskowitz, MD",
"phone": "305-243-5302",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Miami",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida",
"status": "NOT_YET_RECRUITING",
"zip": "33136"
},
{
"city": "Basking Ridge",
"contacts": [
{
"email": null,
"name": "Robert Stuver, MD",
"phone": "646-608-4308",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Basking Ridge (All Protocol Activities)",
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"lat": 40.70621,
"lon": -74.54932
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07920"
},
{
"city": "Middletown",
"contacts": [
{
"email": null,
"name": "Robert Stuver, MD",
"phone": "646-608-4308",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Monmouth (All Protocol Activities)",
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"lat": 40.39652,
"lon": -74.09211
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07748"
},
{
"city": "Montvale",
"contacts": [
{
"email": null,
"name": "Robert Stuver, MD",
"phone": "646-608-4308",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Bergen (All Protocol Activities)",
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"lat": 41.04676,
"lon": -74.02292
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07645"
},
{
"city": "Commack",
"contacts": [
{
"email": null,
"name": "Robert Stuver, MD",
"phone": "646-608-4308",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)",
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"lat": 40.84288,
"lon": -73.29289
},
"state": "New York",
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"zip": "11725"
},
{
"city": "Harrison",
"contacts": [
{
"email": null,
"name": "Robert Stuver, MD",
"phone": "646-608-4308",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Westchester (All Protocol Activities)",
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"lat": 40.96899,
"lon": -73.71263
},
"state": "New York",
"status": "RECRUITING",
"zip": "10604"
},
{
"city": "New York",
"contacts": [
{
"email": null,
"name": "Robert Stuver, MD",
"phone": "646-608-4308",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Cancer Center (All Protocol Activities)",
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"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10065"
},
{
"city": "Uniondale",
"contacts": [
{
"email": null,
"name": "Robert Stuver, MD",
"phone": "646-608-4308",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Memorial Sloan Kettering Nassau (All Protocol Activities)",
"geoPoint": {
"lat": 40.70038,
"lon": -73.59291
},
"state": "New York",
"status": "RECRUITING",
"zip": "11553"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease.\n\nBV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is a multicenter, investigator-initiated, single-arm phase II trial.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 71,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of BV-AVD in People With Bulky Hodgkin Lymphoma",
"nctId": "NCT06377566",
"orgStudyIdInfo": {
"id": "24-039",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "progression-free survival"
}
],
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"measure": "overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Seagen Inc."
}
],
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"class": "OTHER",
"name": "Memorial Sloan Kettering Cancer Center"
}
},
"statusModule": {
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"date": "2027-04"
},
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},
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"date": "2027-04"
},
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"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Radiotracer Injection"
},
{
"name": "Imaging"
},
{
"name": "Rectal Ultrasound Gel Injection"
}
]
},
"conditionsModule": {
"conditions": [
"Endometriosis",
"Endometrioma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Charlestown",
"contacts": [
{
"email": "[email protected]",
"name": "Onforio Catalano, MD, Ph.D",
"phone": "617-724-4030",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Diandrea Galloway",
"phone": "617-643-1407",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School",
"geoPoint": {
"lat": 42.37787,
"lon": -71.062
},
"state": "Massachusetts",
"status": null,
"zip": "02129"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as inflammatory peritoneal lesions, fibrotic deep infiltrating endometriosis lesions (DIE), and ovarian endometriomas. The authors will compare \\[68Ga\\]CBP8 or \\[18F\\]-FAPI-74 PET/MRI imaging versus the current gold standard diagnostic methods, including laparoscopic surgery, clinical follow-up, and follow-up imaging."
},
"designModule": {
"designInfo": {
"allocation": null,
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"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PET/MRI for Evaluation of Endometriosis",
"nctId": "NCT06377553",
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"id": "2023P000955",
"link": null,
"type": null
},
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},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection"
},
{
"measure": "Diagnostic Performance of PET/MRI vs. Conventional Imaging"
}
],
"secondaryOutcomes": [
{
"measure": "Impact of [18F]-FAPI-74 and [68Ga]CBP8 PET/MRI on Diagnosis and Management in Endometriosis"
},
{
"measure": "Correlation of Pre-Treatment PET Uptake and Post-Treatment Response in Endometriosis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Massachusetts General Hospital"
}
},
"statusModule": {
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"date": "2026-05-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-05-03"
},
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"startDateStruct": {
"date": "2024-05-03"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pembrolizumab"
},
{
"name": "Autologous stem cell transplant"
},
{
"name": "Carmustine"
},
{
"name": "Etoposide"
},
{
"name": "Cytarabine"
},
{
"name": "Melphalan"
}
]
},
"conditionsModule": {
"conditions": [
"Autologous Stem Cell Transplant",
"Classic Hodgkin Lymphoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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"masking": "NONE",
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"whoMasked": null
},
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"timePerspective": null
},
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"count": 28,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma",
"nctId": "NCT06377540",
"orgStudyIdInfo": {
"id": "2022LS174",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression free survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Non-relapse mortality (NRM)"
},
{
"measure": "Overall Survival (OS)"
},
{
"measure": "Rate of Complete Metabolic Response"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Masonic Cancer Center, University of Minnesota"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-01"
},
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"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Mesonephric-like Adenocarcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": null,
"name": "Jeffrey How, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jeffrey How, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma."
},
"designModule": {
"designInfo": {
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},
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"count": 2000,
"type": "ESTIMATED"
},
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},
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"minimumAge": "18 Years",
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"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA)",
"nctId": "NCT06377527",
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"id": "2023-0945",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-03342",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Tumor Registry"
}
],
"secondaryOutcomes": null
},
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"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2037-12-28"
},
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"date": "2024-04-22"
},
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"date": "2035-12-28"
},
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"startDateStruct": {
"date": "2024-10-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Test IOL Model DEN00V"
},
{
"name": "Control IOL Model DCB00"
}
]
},
"conditionsModule": {
"conditions": [
"Cataracts"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
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},
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"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"minimumAge": "22 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens",
"nctId": "NCT06377514",
"orgStudyIdInfo": {
"id": "PCOL109PHNG",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Monocular photopic DCIVA (first eyes) at 66 cm"
},
{
"measure": "Monocular Depth of Focus"
},
{
"measure": "Monocular Photopic BCDVA at 4m"
},
{
"measure": "Monocular Photopic DCVA at 100 cm"
}
],
"secondaryOutcomes": [
{
"measure": "Monocular photopic DCNVA at 40 cm (first eyes)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Johnson & Johnson Surgical Vision, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-31"
},
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"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
{
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-02-23",
"filename": "ICF_000.pdf",
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"measure": "Concentration of iron"
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{
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{
"measure": "Rotational Stability"
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{
"measure": "Absolute Rotation Error"
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"measure": "Incidence of Unacceptable Lens Fit"
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{
"measure": "Slit Lamp Findings"
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"measure": "Subjective Handling Scores"
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{
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},
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},
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{
"measure": "Wax vs JIG Registration"
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"measure": "Questionnaire"
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},
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"date": "2025-12"
},
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"date": "2024-03-08"
},
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"date": "2024-04-22"
}
}
}
|
null | false |
{
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]
},
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{
"city": "Dresden",
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"email": null,
"name": "Katja Sockel, Dr. med.",
"phone": null,
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"role": "CONTACT"
}
],
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"facility": "Universitätsklinikum Carl Gustav Carus",
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},
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}
]
},
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},
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},
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"OLDER_ADULT"
]
},
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"id": "VEXAS-Registry",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Collection of epidemiological data on VEXAS"
},
{
"measure": "Collection and monitoring of initial disease manifestations"
},
{
"measure": "Documentation of the treatment approaches and therapy sequences"
},
{
"measure": "Analysis of clinical-relevant clinical endpoints"
}
],
"secondaryOutcomes": [
{
"measure": "Describe disease cluster"
},
{
"measure": "Laboratory diagnostics"
},
{
"measure": "Correlation clinical endpoints with treatment approaches"
},
{
"measure": "Quality of life data (QoL), fatigue questionnaire (Facit-F)"
},
{
"measure": "Accompanying translational research"
},
{
"measure": "Collection of Biospecimens"
}
]
},
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"collaborators": [
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"name": "Bristol-Myers Squibb"
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{
"name": "University Hospital Munich"
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],
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"name": "Technische Universität Dresden"
}
},
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"date": "2030-12-31"
},
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"date": "2024-04-22"
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"date": "2029-12-31"
},
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"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound examination of the lungs"
}
]
},
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"conditions": [
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"Aortic Stenosis, Severe",
"Aortic Insufficiency",
"Mitral Stenosis",
"Mitral Insufficiency",
"Mitral Stenosis With Insufficiency",
"Tricuspid Insufficiency",
"Ascending Aortic Aneurysm"
]
},
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"locations": [
{
"city": "Saint Petersburg",
"contacts": [
{
"email": "[email protected]",
"name": "Sergei M Efremov, MD, PhD",
"phone": "+79137946090",
"phoneExt": null,
"role": "CONTACT"
}
],
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"lat": 59.93863,
"lon": 30.31413
},
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}
]
},
"descriptionModule": {
"briefSummary": "The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\\[s\\] it aims to answer are:\n\n* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.\n* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.\n\nResearchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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},
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},
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],
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},
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]
},
"identificationModule": {
"acronym": null,
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"id": "UIL-CSP-18052023",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative pulmonary complications"
},
{
"measure": "Cumulative dosage of diuretics"
},
{
"measure": "Number of nights at home after hospital discharge"
}
]
},
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"class": "OTHER",
"name": "Saint Petersburg State University, Russia"
}
},
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"date": "2026-01-01"
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},
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"date": "2025-05-15"
},
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"date": "2024-05-15"
},
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"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
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"name": "Experimental training"
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]
},
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"conditions": [
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]
},
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"locations": [
{
"city": "Milano",
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{
"email": "[email protected]",
"name": "Gabriella GC CERRI, Full Professor",
"phone": "+393402527675",
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"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Gabriella CERRI",
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"lon": 9.18951
},
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}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to implement a personalized training program to prevent functional decline in frail subjects but not yet disable. The purpose of the project is to test the training in a subject at particularly high risk of entering the disabled condition. A total of 80 frail subjects, divide the participants into two groups \"Divida Senso Group\" (experimental group) and \"Standard of care Group\" (Control group) will be recruited.\n\nThe expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program."
},
"designModule": {
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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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},
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"acronym": "PRAISE",
"briefTitle": "Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme",
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"measure": "Changes in the Functional decline"
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{
"measure": "Intrinsic Capacity (IC)"
},
{
"measure": "Intreaction between IC and cardiac autonomic control (CAC)"
}
],
"secondaryOutcomes": null
},
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}
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},
"descriptionModule": {
"briefSummary": "Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years."
},
"designModule": {
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"stdAges": [
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},
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},
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},
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{
"measure": "Percentage % of patients with marginal staining"
}
],
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},
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"class": "OTHER",
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},
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"date": "2024-01-10"
},
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"date": "2021-08-01"
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{
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{
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}
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},
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]
},
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{
"city": "Cheras",
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"email": "[email protected]",
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},
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"briefSummary": "As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial.\n\nMucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation.\n\nMucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency ."
},
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"sex": "ALL",
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"OLDER_ADULT"
]
},
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"acronym": "SyProNAC",
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"id": "FF-2023-433",
"link": null,
"type": null
},
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},
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{
"measure": "To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact."
}
],
"secondaryOutcomes": [
{
"measure": "to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life."
},
{
"measure": "to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry"
},
{
"measure": "to determine change of Forced Vital Capacity in litres/minute using spirometry"
},
{
"measure": "to determine adverse effects of Syrup Prospan (in %)"
},
{
"measure": "to determine adverse effects of N-Acetylcysteine (in %)"
},
{
"measure": "To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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}
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]
},
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},
"designModule": {
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"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Project staff, nurses and resident doctors looking after the neonate will not be blinded. The assessment of the primary outcome will be performed by a blinded adjudicator, who is not involved in the recruitment and monitoring of subjects. A part of the case report form (CRF) containing relevant details of all episodes of sickness in the 1st week of life will be detached from the main form and will be sent to the blinded adjudicator. This part will be linked to the main form only by a unique identification number. No patient identifiers or allocation group will be mentioned on the part sent to the blinded adjudicator.",
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},
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"id": "IIRPIG-2023-0000070",
"link": null,
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"measure": "Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization"
},
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"measure": "Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization"
}
],
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"measure": "All-cause Mortality within 1st 7 days after randomization"
},
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"measure": "Blood culture-positive sepsis of any severity within 1st 7 days after randomization"
},
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"measure": "Episode of severe sepsis within 1st 7 days after randomization"
},
{
"measure": "Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization"
},
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"measure": "Individual components of composite outcome within 1st 72 hours after randomization"
},
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"measure": "Composite of mortality/blood culture positive sepsis/severe sepsis during hospital stay"
},
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"measure": "Individual components of composite outcome during hospital stay"
},
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"measure": "Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay"
},
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"measure": "Composite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomization"
},
{
"measure": "Individual components of composite outcome during 1st 30 days"
},
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},
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"measure": "Sepsis-related mortality within 1st 72 hours after randomization"
},
{
"measure": "Sepsis-related mortality within 7 day after randomization"
},
{
"measure": "Sepsis-related mortality during hospital stay after randomization"
},
{
"measure": "Sepsis-related mortality during 1st 30 days after randomization"
},
{
"measure": "Clinical sepsis within 1st 72 hours after randomization"
},
{
"measure": "Clinical sepsis within 7 days after randomization"
},
{
"measure": "Clinical sepsis during hospital stay"
},
{
"measure": "Clinical sepsis within 1st 30 days after randomization"
},
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"measure": "Episode of Probable EONS within 72 hours after randomization"
},
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"measure": "Episode of asymptomatic proven EONS within 72 hours after randomization"
},
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"measure": "Need for sepsis workup during 1st 72 hours after randomization"
},
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"measure": "Need for sepsis workup during 1st 7 days after randomization"
},
{
"measure": "Need for sepsis workup during 1st 30 days after randomization"
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"measure": "Need for sepsis workup during hospital stay"
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"measure": "Cumulative duration of antibiotic therapy during 1st 7 days after randomization"
},
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"measure": "Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization"
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"measure": "Cumulative duration of antibiotic therapy during hospital stay"
},
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"measure": "Duration of hospitalization"
},
{
"measure": "Episodes of healthcare associated infection during hospital stay."
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{
"measure": "Adverse effects until day 30 after randomization"
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"measure": "Serious adverse effects until day 30 after randomization"
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{
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{
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{
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],
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},
{
"measure": "Children's Sleep Habits Questionnaire (CSHQ)"
},
{
"measure": "Vineland Adaptive Behavior Scale"
},
{
"measure": "Sensory Profile 2"
},
{
"measure": "Quick Environmental Exposure and Sensitivity Inventory (QEESI)"
},
{
"measure": "Hayward Environmental Illness Severity Scale"
},
{
"measure": "Parenting Stress Index, 4th edition (PSI-4)"
},
{
"measure": "Beck Anxiety Inventory (BAI)"
}
]
},
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{
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]
},
"descriptionModule": {
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},
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},
{
"measure": "2nd Post-operative [Cu64]DOTATATE PET SUV"
},
{
"measure": "MRI Size Measurements"
},
{
"measure": "GTR vs STR Assessment"
},
{
"measure": "MRI Progression Assessment"
},
{
"measure": "Target Lesion Neoprobe Count"
},
{
"measure": "Subtotal Neoprobe Count"
},
{
"measure": "Reference Background Neoprobe Count"
}
],
"secondaryOutcomes": [
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"measure": "SSTR2 expression"
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"measure": "WHO grade"
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"measure": "Ki67 Proliferation Index"
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]
},
"conditionsModule": {
"conditions": [
"Obesity, Visceral",
"Obesity; Endocrine"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Inneo Terapia Despi",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The Scope of this study is to assess the visceral and subcutaneous fat loss in patients having Tecar (Radiofrequency) Therapy and its effects on other anthropometric variables, adipokines and inflammation.\n\n20 obese patients will be treated with Tecar Therapy (Radiofrequency). Each patient will have 4 active, automatic plates placed on the abdomen (200 cm2 per plate), two on the right side of the midline and two on the left side. Energy will be applied for 50 minutes, controlling the temperature. Subsequently, 15 minutes of Capacitive and Resistive manual electrodes will be applied to the abdomen, simultaneously, 20 minutes of Lymphatic Drainage placing one active plate in the foot and the other in the lumbo-dorsal area. Patients will be informed that they will only feel comfortable warmth. Five sessions will be applied from Monday to Friday resting Saturday and Sunday, for 2 weeks. Total 10 sessions.\n\nSubcutaneous and visceral fat will be measured by MRI. Anthropometric variables (Body Mass Index, Waist to Hip ratio and skinfold) will be also measured.\n\nMetabolic and inflammatory effects of the RF treatment will be evaluated measuring adipokines (Leptin, adiponectin and resistin) as well as citokines (IL-6, TNF-a and C reactive Protein).\n\nResults will be analyzed using the SPSS statistics package. A Kolmogorov-Smirnov test will be applied, if the data behaves normally, parametric tests will be applied. If not, non-parametric tests will be performed. The differences between proportions will be analyzed using Fischer's exact test. The differences between the medians will be assessed using the Student's t-test for paired samples and independent samples."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Tecar Theraty was applied to 20 obese patients in order to assess the effect on the body fat loss, serum adipocytokines and imflammation. It was an interventional study in one group of patients. No controls. No masking.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy.",
"nctId": "NCT06377358",
"orgStudyIdInfo": {
"id": "CEEAH CA31",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visceral fat loss (cm3)"
},
{
"measure": "Visceral fat loss (g)"
},
{
"measure": "Subcutaneous fat loss (cm3)"
},
{
"measure": "Subcutaneous fat loss (g)"
},
{
"measure": "Tumor Necrosis Factor alfa"
},
{
"measure": "Interleukin 6 levels"
},
{
"measure": "C reactive Protein levels"
},
{
"measure": "Leptin levels"
},
{
"measure": "Adiponectin levels"
},
{
"measure": "Resistin levels"
},
{
"measure": "Total cholesterol changes"
},
{
"measure": "Total triglycerides changes"
},
{
"measure": "LDL Cholesterol changes"
},
{
"measure": "HDL Cholesterol changes"
},
{
"measure": "Glucose"
}
],
"secondaryOutcomes": [
{
"measure": "Body Mass Index loss"
},
{
"measure": "Waist to Hip Index loss"
},
{
"measure": "Skinfold Thickness (cm)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Malaga"
},
{
"name": "Alfonso X El Sabio University"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "CAPENERGY MEDICAL, SL"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-07-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AeviceMD device"
},
{
"name": "Standard care"
}
]
},
"conditionsModule": {
"conditions": [
"Asthma",
"Asthma Attack",
"Asthma in Children",
"Asthma Acute",
"Asthma Chronic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Aim: To evaluate the use of AeviceMD Monitoring System (AeviceMD) asthma in reducing acute exacerbation.\n\nMethodology: Using a randomized controlled trial design, this project aims evaluate the effectiveness of AeviceMD in improving patients' outcomes in terms of reducing exacerbation, healthcare utilization, improving quality of life, self-efficacy, and cost effectiveness. Paediatric patients above age 7 and adults will be recruited. The data follow-up period is 3 months. It will also evaluate the usability of the device from both patients' and clinicians' perspective. 180 patients (124 adults, 56 pediatrics) and 120 clinicians will be recruited.\n\nImportance of study: This study will evaluate if the AeviceMD can help improve disease management and reduce recurrence of asthma exacerbation.\n\nPotential benefits and risk: AeviceMD allows for remote monitoring and tracking of patients' lung sounds, which could be used by patients to monitor their lung condition and prevent an episode of exacerbation or worsening exacerbations culminating in an admission which who further utilize already limited healthcare resources. An exacerbation is an episode of severe shortness of breath, cough, and chest tightening which warrants a visit to a healthcare institution. Through self-monitoring, patients can be empowered to self-manage their asthma, with aid of the asthma action plan which is given to all patients with asthma. AeviceMD can also help provide clinicians with patients' objective lung data. In the primary care setting, care is also fragmented as patients are often followed-up by a different doctor or healthcare providers. Clinicians have no objective data to track patients, and is dependent on patients' self-report and possible recall bias. There is no expected risk with the use of the device."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A two-group randomized controlled trial (RCT) design will be used. The control group will receive the usual care, and the intervention group will receive the Aevice device on top of usual care. Outcomes will be measured at baseline, week 4, and week 12. This is to evaluate the long-term impacts of the Aevice device. Clinicians who have interacted with participants using Aevice will also be invited to participate in an interview and clinician perception survey. A convenience sampling will be used for the recruitment of clinicians.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The outcomes assessor will not be aware of the participants' group",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Remote Patient Monitoring Solution for Chronic Respiratory Disease Management",
"nctId": "NCT06377345",
"orgStudyIdInfo": {
"id": "202312-00011",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rescue therapy"
},
{
"measure": "Dose of oral Prednisolone use"
},
{
"measure": "Visit to hospital emergency department"
},
{
"measure": "Hospitalisation"
},
{
"measure": "Euro Quality of Life 5 dimensions (EQ5D)"
},
{
"measure": "Asthma quality of life questionnaire (AQLQ)"
},
{
"measure": "Pediatric asthma quality of life questionnaire (PAQLQ)"
}
],
"secondaryOutcomes": [
{
"measure": "Self-efficacy"
},
{
"measure": "Usability"
},
{
"measure": "Heart rate"
},
{
"measure": "Respiratory rate"
},
{
"measure": "Wheeze detection trend"
},
{
"measure": "Medication log"
},
{
"measure": "Duration of device usage"
},
{
"measure": "Payment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "SingHealth Polyclinics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High density electroencephalogram (HdEEG)"
},
{
"name": "Functional near infrared spectroscopy (fNIRS)"
},
{
"name": "Magnetic resonance imaging (MRI)"
},
{
"name": "Blood collection"
},
{
"name": "Neuropsychological battery"
},
{
"name": "Questionnaires"
},
{
"name": "Pulmonary Function Test (PFT)"
},
{
"name": "Cognitive Assessment"
},
{
"name": "Polysomnogram (PSG)"
}
]
},
"conditionsModule": {
"conditions": [
"COPD",
"Overlap Syndrome",
"OSA"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sydney",
"contacts": [
{
"email": "[email protected]",
"name": "Angela D'Rozario, PhD",
"phone": "02 9850 3246",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Laura Harris, MScMed",
"phone": "02 9805 3194",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "The Woolcock Institute of Medical Research",
"geoPoint": {
"lat": -33.86785,
"lon": 151.20732
},
"state": "New South Wales",
"status": "RECRUITING",
"zip": "2113"
}
]
},
"descriptionModule": {
"briefSummary": "Chronic obstructive pulmonary disease (COPD), obstructive sleep apnoea (OSA) and overlap syndrome are associated with obstructions in breathing and disturbed sleep.\n\nChronic breathing disruptions and poor sleep may lead to cognitive impairment and brain changes linked with early neurodegenerative processes. As such, identifying early markers of cognitive impairment and dementia risk in individuals with chronic respiratory and sleep breathing disorders is crucial for understanding how these diseases may contribute to accelerated brain ageing. This study will comprehensively measure sleep, lung function, cognitive performance and blood-based markers of dementia risk and inflammation. The investigators will use innovative technologies to identify biomarkers of cognitive impairment and dementia risk in people with chronic sleep and breathing disorders. The investigators will also investigate the relationships between disrupted sleep and abnormal breathing and the brain. This research may also inform future early interventions to improve cognition and brain health in chronic sleep and respiratory disease."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 104,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ORACLE",
"briefTitle": "Biomarkers of Dementia in Chronic Sleep and Breathing Disorders",
"nctId": "NCT06377332",
"orgStudyIdInfo": {
"id": "X23-0330",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Brain structure: cortical thickness and volumetric brain maps"
},
{
"measure": "Brain structure: diffusion-weighted imaging"
},
{
"measure": "Brain function: resting-state BOLD fMRI"
},
{
"measure": "Brain pathology: T1-weighted, T2-weighted, diffusion-weighted imaging, and FLAIR"
},
{
"measure": "Assessment of sensorimotor function and comprehension through the Motor Screening Task (MOT) of CANTAB."
},
{
"measure": "Assessment of processing and psychomotor speed through the Reaction Time (RTI) test of CANTAB."
},
{
"measure": "Assessment of working memory and strategy through the Spatial Working Memory (SWM) test of CANTAB."
},
{
"measure": "Assessment of visual episodic memory through the Paired Associate Learning (PAL) test of CANTAB."
},
{
"measure": "Sleep Spindles During Non-Rapid Eye Movement (NREM) Sleep"
},
{
"measure": "Traditional sleep staging."
},
{
"measure": "Absolute Electroencephalography (EEG) Power During Rapid Eye Movement (REM) Sleep."
},
{
"measure": "Obstructive sleep apnoea (OSA) severity metrics"
},
{
"measure": "Lung function as measured by clinical pulmonary function tests (PFT)"
}
],
"primaryOutcomes": [
{
"measure": "Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk."
},
{
"measure": "Blood levels of amyloid beta (Aβ40/Aβ42 ratio)."
}
],
"secondaryOutcomes": [
{
"measure": "Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep."
},
{
"measure": "Brain tissue oxygenation during cognitive tasks and sleep."
},
{
"measure": "Hypoxemia as measured by pulse oximetry."
},
{
"measure": "Sleep Fragmentation"
},
{
"measure": "Assessment of premorbid functioning and preinjury through the Test of Premorbid Functioning (TOPF)."
},
{
"measure": "Assessment of verbal learning and memory through the Rey Auditory Verbal Learning Test (RAVLT)."
},
{
"measure": "Assessment of mild forms of cognitive dysfunction through Delis Kaplan Executive Functioning System (D-CEFS) neuropsychological assessment."
},
{
"measure": "Assessment of speed of processing and executive functioning through the Trail Making Test (TMT)."
},
{
"measure": "Assessment of verbal fluency through the Controlled Oral Word Association Test (COWAT)."
},
{
"measure": "Assessment of attention, perceptual speed, motor speed and visual scanning through the Symbol Digits Modalities Test (SDMT)."
},
{
"measure": "Blood levels of fibrinogen."
},
{
"measure": "Blood levels of clusterin."
},
{
"measure": "Blood levels of 8-isoprostane"
},
{
"measure": "Blood levels of C-reactive protein (CRP)"
},
{
"measure": "Blood levels of erythrocyte sedimentation rate (ESR)."
},
{
"measure": "Blood levels of plasma tau."
},
{
"measure": "Blood levels of neurofilament light chain (NFL)."
},
{
"measure": "Blood levels of Glial fibrillary acidic protein (GFAP)."
},
{
"measure": "Blood levels of Apolipoprotein E gene (APOE-4)."
},
{
"measure": "Blood levels of interleukin-8 (IL-8)."
},
{
"measure": "Blood levels of interleukin-6 (IL-6)."
},
{
"measure": "Blood levels of tumor necrosis factor alpha (TNFα)."
},
{
"measure": "Blood levels of amyloid beta (Aβ40/Aβ42 ratio)."
},
{
"measure": "Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Woolcock Institute of Medical Research"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cardiac Output Response to Stress (CORS) test"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to support clinical validation of an artificial intelligence (AI)-driven decision support system (DSS) and mobile application for risk prediction, diagnosis, and progression of HF to enhance patients' quality of life and lead to more cost-effective health care."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STRATIFYHF",
"briefTitle": "Decision Support System for Diagnosis and Progression of Heart Failure",
"nctId": "NCT06377319",
"orgStudyIdInfo": {
"id": "101080905",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic accuracy of the DSS"
}
],
"secondaryOutcomes": [
{
"measure": "Demographic and clinical predictors of risk, diagnosis, and progression of heart failure."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Newcastle University"
},
{
"name": "University of Cambridge"
},
{
"name": "University of Novi Sad"
},
{
"name": "University of Florence"
},
{
"name": "University of Regensburg"
},
{
"name": "Utrecht University"
},
{
"name": "Servicio Madrileño de Salud, Madrid, Spain"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Coventry University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Effect of training loads and sport performance level on health and sport performance"
}
]
},
"conditionsModule": {
"conditions": [
"Menstrual Cycle",
"Athletes",
"Physical Activity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Netanya",
"contacts": [
{
"email": "[email protected]",
"name": "Yotam Shribman, B.Sc",
"phone": "+972-54-5723401",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Israel",
"facility": "Wingate Institute",
"geoPoint": {
"lat": 32.33291,
"lon": 34.85992
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential \"noise\" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking.\n\nThe investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes.\n\n200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC.\n\nFinding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes",
"nctId": "NCT06377306",
"orgStudyIdInfo": {
"id": "MC study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Psychological questionnaire (The Sport Emotion Questionnaire (SEQ)"
}
],
"primaryOutcomes": [
{
"measure": "Stool Microbiome"
},
{
"measure": "Serum metabolomics"
},
{
"measure": "VO2max"
},
{
"measure": "Countermovement jump"
},
{
"measure": "Flexibility"
},
{
"measure": "Grip Strength"
},
{
"measure": "Lower leg Strength"
},
{
"measure": "Blood tests"
},
{
"measure": "Knee valgus"
}
],
"secondaryOutcomes": [
{
"measure": "Anthropometric (Height)"
},
{
"measure": "Psychological questionnaire (Positive-Affect Negative-Affect scale - PANAS)"
},
{
"measure": "Anthropometric (Weight)"
},
{
"measure": "Percentage body fat (%)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Weizmann Institute of Science"
},
{
"name": "Kaplan Medical Center"
},
{
"name": "Ministry of Innovation, Science and Technology of Israel"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Wingate Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dialysis-specific therapeutic diet"
}
]
},
"conditionsModule": {
"conditions": [
"End-Stage Kidney Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "A randomized, active-controlled trial with cross-over design",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Laboratory technicians who assess the study outcomes will be masked",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients",
"nctId": "NCT06377293",
"orgStudyIdInfo": {
"id": "FEMH-IRB-TSAI2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Concentrations of intact fibroblast growth factor 23 (pg/mL)"
}
],
"secondaryOutcomes": [
{
"measure": "Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)"
},
{
"measure": "Concentrations of phosphate (mg/dL)"
},
{
"measure": "Concentrations of calcium (mg/dL)"
},
{
"measure": "Concentrations of intact parathyroid hormone (pg/mL)"
},
{
"measure": "Concentrations of bone-specific alkaline phosphatase (μg/L)"
},
{
"measure": "Concentrations of procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL)"
},
{
"measure": "Concentrations of tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml)"
},
{
"measure": "Concentrations of alkaline phosphatase (ALP) (IU/L)"
},
{
"measure": "Concentrations of free indoxyl sulfate (mg/L)"
},
{
"measure": "Concentrations of free p-cresol sulfate (mg/L)"
},
{
"measure": "Concentrations of pre-albumin (g/dL)"
},
{
"measure": "Concentrations of albumin (g/dL)"
},
{
"measure": "Concentrations of C-reactive protein (mg/dL)"
},
{
"measure": "Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells"
},
{
"measure": "Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells"
},
{
"measure": "Absolute number (per μl blood) of monocytes"
},
{
"measure": "Concentrations of fetuin-A (μg/ml)"
},
{
"measure": "Concentrations of trimethylamine-N-oxide (TMAO) (μM)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Far Eastern Memorial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-11"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Navina Mini"
}
]
},
"conditionsModule": {
"conditions": [
"Bowel Dysfunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Malmö",
"contacts": [
{
"email": "[email protected]",
"name": "Louis Banka Johnson, MD",
"phone": "+4640336557",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Sara Strandberg",
"phone": "+4640336377",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Skåne University Hospital",
"geoPoint": {
"lat": 55.60587,
"lon": 13.00073
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.\n\nParticipating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.",
"nctId": "NCT06377280",
"orgStudyIdInfo": {
"id": "NAV-0011",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient satisfaction"
}
],
"secondaryOutcomes": [
{
"measure": "Assessment of clinical benefit"
},
{
"measure": "Ease of handling"
},
{
"measure": "Safety Outcome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Wellspect HealthCare"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-18"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bevacizumab"
},
{
"name": "Olaparib"
}
]
},
"conditionsModule": {
"conditions": [
"Ovarian Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": null,
"name": "Ana Oaknin",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Vall d'Hebron Institute of Oncology",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Background:\n\nThe study aims to address the challenge of accurately identifying patients with ovarian cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown significant benefits from PARPi treatment, the efficacy in homologous recombination deficient (HRD) patients remains inconclusive. Current assays used to estimate HR status do not effectively differentiate between patients who benefit most from PARPi and those who do not, making it inefficient to treat all patients. There is a need for a more accurate HR status testing method to optimize PARPi benefit. This study aims to assess the performance of the VHIO-CARD-300 test in determining HR status compared to SOPHiA DDM™ Dx HRD Solution.\n\nSummary:\n\nThe study is a prospective, non-randomized trial designed to evaluate the concordance of the VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution. Additionally, it aims to assess the association between HRD status determined by the VHIO-CARD-300 test and treatment efficacy. Patients with advanced FIGO stage III-IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be invited to participate. Those eligible will undergo testing with both VHIO-CARD-300 and SOPHiA DDM™ Dx HRD Solution. Patients classified as HRD positive will receive olaparib in combination with bevacizumab, while others will receive bevacizumab alone. Treatment will be administered according to approved doses, with follow-up evaluations conducted until RECIST progression."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STROBE",
"briefTitle": "Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial)",
"nctId": "NCT06377267",
"orgStudyIdInfo": {
"id": "ESR-20-21103",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution"
}
],
"secondaryOutcomes": [
{
"measure": "Performance Assessment of VHIO-CARD-300 Test for HR Status Identification"
},
{
"measure": "Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes."
},
{
"measure": "Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases"
},
{
"measure": "Safety and Tolerability of Olaparib Plus Bevacizumab"
},
{
"measure": "To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Vall d'Hebron Institute of Oncology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-06"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Decreased Physical Activity"
},
{
"name": "Increased Physical activity"
}
]
},
"conditionsModule": {
"conditions": [
"Sedentary Behavior",
"Metabolic Syndrome",
"Age-related Cognitive Decline",
"Age-Related Sarcopenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nottingham",
"contacts": [
{
"email": "[email protected]",
"name": "Sara Brown",
"phone": "+44(0)115 8230434",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Joanne Mallinson, PhD",
"phone": "+44(0)1158230434",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Paul Greenhaff, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Liz Simpson, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Joanne Mallinson, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Abhishek Sheth, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Penny Gowland, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sue Francis, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Rosemary Nicholls, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Aline Nixon",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sara Brown",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Donald Peden, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "David Greenfield Human Physiology Unit",
"geoPoint": {
"lat": 52.9536,
"lon": -1.15047
},
"state": "Notts",
"status": "RECRUITING",
"zip": "NG72UH"
}
]
},
"descriptionModule": {
"briefSummary": "Life expectancy has been increasing for the last 150 years, but the maintenance of health has not kept pace with increased lifespan, and on average, UK adults spend the last decade of life in poor-health, with major consequences for society and the individual.\n\nPersistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \\>8hrs/day being sedentary, with average step count of 3000-4000 steps/day.\n\nTo be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised.\n\nThe goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for six months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months.\n\nBefore and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include;\n\n* fitness, muscle strength and function tests,\n* completion of questionnaires and computer-based brain puzzles\n* having muscle and fat tissue biopsies and blood samples taken.\n* The study also involves having MRI scans.\n\nThis 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Non-randomised, parallel design lifestyle intervention",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Those undertaking analysis of biological samples and MRI data will be masked as to the group the participant is allocated to.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CHAIN",
"briefTitle": "Multi-organ Responses to CHronic Physical Activity and INactivity",
"nctId": "NCT06377254",
"orgStudyIdInfo": {
"id": "BB/X015173/1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Fasting blood lipid concentration"
},
{
"measure": "Fasting blood lipid concentration"
},
{
"measure": "Fasting blood lipid concentration"
},
{
"measure": "Fasting blood lipid concentration"
},
{
"measure": "Fasting blood lipid concentration"
},
{
"measure": "liver function test: alanine transaminase (ALT)"
},
{
"measure": "liver function test: alanine transaminase (ALT)"
},
{
"measure": "liver function test: alanine transaminase (ALT)"
},
{
"measure": "liver function test: alanine transaminase (ALT)"
},
{
"measure": "liver function test: alanine transaminase (ALT)"
},
{
"measure": "liver function test: aspartate aminotransferase (AST)"
},
{
"measure": "liver function test: aspartate aminotransferase (AST)"
},
{
"measure": "liver function test: aspartate aminotransferase (AST)"
},
{
"measure": "liver function test: aspartate aminotransferase (AST)"
},
{
"measure": "liver function test: aspartate aminotransferase (AST)"
},
{
"measure": "liver function test: Bilirubin"
},
{
"measure": "liver function test: Bilirubin"
},
{
"measure": "liver function test: Bilirubin"
},
{
"measure": "liver function test: Bilirubin"
},
{
"measure": "liver function test: Bilirubin"
},
{
"measure": "liver function test: Albumin"
},
{
"measure": "liver function test: Albumin"
},
{
"measure": "liver function test: Albumin"
},
{
"measure": "liver function test: Albumin"
},
{
"measure": "liver function test: Albumin"
},
{
"measure": "liver function test: Gamma glutamyl transferase (GGT)"
},
{
"measure": "liver function test: Gamma glutamyl transferase (GGT)"
},
{
"measure": "liver function test: Gamma glutamyl transferase (GGT)"
},
{
"measure": "liver function test: Gamma glutamyl transferase (GGT)"
},
{
"measure": "liver function test: Gamma glutamyl transferase (GGT)"
},
{
"measure": "Blood Haemoglobin concentration"
},
{
"measure": "Blood Haemoglobin concentration"
},
{
"measure": "Blood Haemoglobin concentration"
},
{
"measure": "Blood Haemoglobin concentration"
},
{
"measure": "Blood Haemoglobin concentration"
}
],
"primaryOutcomes": [
{
"measure": "Change in Cardiorespiratory fitness (VO2 max)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Isometric leg strength"
},
{
"measure": "Change in time to leg fatigue"
},
{
"measure": "Change in incremental area under the curve (iAUC) for blood glucose concentration"
},
{
"measure": "Change in iAUC for serum insulin concentration"
},
{
"measure": "Change in fasting glucose oxidation rate"
},
{
"measure": "Change in 'fed' glucose oxidation rate"
},
{
"measure": "Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score"
},
{
"measure": "Change in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score"
},
{
"measure": "Change in World Health Organisation Quality of Life (WHOQoL) score"
},
{
"measure": "Change in Pittsburgh Sleep Quality Index (PSQI)"
},
{
"measure": "Change in Stroop test; % Accuracy"
},
{
"measure": "Change in Stroop test; reaction time"
},
{
"measure": "Change in four-choice reaction time test; % Accuracy"
},
{
"measure": "Change in four-choice reaction time test; reaction time"
},
{
"measure": "Change in card sort test; % Accuracy"
},
{
"measure": "Change in card sort test; reaction time"
},
{
"measure": "Change in Logical reasoning test; % accuracy"
},
{
"measure": "Change in Logical reasoning test; reaction time"
},
{
"measure": "Change in serial subtractions test; number of responses in 2 minutes"
},
{
"measure": "Change in Corsi blocks test; score"
},
{
"measure": "Change in Muscle protein synthesis rate"
},
{
"measure": "Change in Muscle protein breakdown rate"
},
{
"measure": "Change in whole body fat volumes"
},
{
"measure": "Change in liver fat volumes"
},
{
"measure": "Change in thigh muscle fat volumes"
},
{
"measure": "Change in whole body muscle volumes"
},
{
"measure": "Change in muscle phosphocreatine synthesis rate"
},
{
"measure": "Change in cerebral volume"
},
{
"measure": "Change in cortical thickness"
},
{
"measure": "Change in plasma metabolome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Biotechnology and Biological Sciences Research Council"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Nottingham"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ScentAware"
},
{
"name": "UPSIT"
}
]
},
"conditionsModule": {
"conditions": [
"Alzheimer Disease, Early Onset"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Madison",
"contacts": [
{
"email": "[email protected]",
"name": "Amy Remm",
"phone": "608-262-3377",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Wisconsin",
"geoPoint": {
"lat": 43.07305,
"lon": -89.40123
},
"state": "Wisconsin",
"status": "RECRUITING",
"zip": "53705"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. The main questions it aims to answer are:\n\n* Whether the test is as effective and reliable as the standard test\n* Whether there is a link between the results of the smell test and the structure of the back of the eye\n\nParticipants will:\n\n* complete a short questionnaire\n* have pictures of the inside of their eyes taken\n* perform two smell tests"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ScentAware and OCT in MCI vs HC",
"nctId": "NCT06377241",
"orgStudyIdInfo": {
"id": "2023-1436",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "UW Madison",
"id": "A536000",
"link": null,
"type": "OTHER"
},
{
"domain": "UW Madison",
"id": "SMPH/OPHTHAL&VIS SCI/GEN",
"link": null,
"type": "OTHER"
},
{
"domain": "UW Madison",
"id": "Protocol Version 2/23/2024",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting"
},
{
"measure": "Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently"
},
{
"measure": "Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently"
}
],
"secondaryOutcomes": [
{
"measure": "Compare baseline ScentAware test scores between cohorts"
},
{
"measure": "Compare baseline UPSIT test scores between cohorts"
},
{
"measure": "Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness"
},
{
"measure": "Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness"
},
{
"measure": "Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness"
},
{
"measure": "Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Wisconsin, Madison"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TAK-007"
},
{
"name": "Chemotherapy Agents"
}
]
},
"conditionsModule": {
"conditions": [
"Refractory Lupus Nephritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ann Arbor",
"contacts": [
{
"email": "[email protected]",
"name": "Site Contact",
"phone": "888-229-3065",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jacqueline Madison",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Michigan",
"geoPoint": {
"lat": 42.27756,
"lon": -83.74088
},
"state": "Michigan",
"status": null,
"zip": "48109"
},
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Site Contact",
"phone": "585-486-0901",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christopher Palma",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Rochester",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York",
"status": null,
"zip": "14642"
},
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Site Contact",
"phone": "713-486-3100",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Meera Subash",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UT Health Houston",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of the study is to learn how well adults with refractory lupus nephritis (LN) tolerate TAK-007 and to check for side effects (adverse events).\n\nOther aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN)",
"nctId": "NCT06377228",
"orgStudyIdInfo": {
"id": "TAK-007-1001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants With Treatment-Emergent Adverse Events (TEAEs)"
},
{
"measure": "Number of Participants With Dose Limiting Toxicities (DLTs)"
}
],
"secondaryOutcomes": [
{
"measure": "Cmax: Maximum Observed Plasma Concentration for TAK-007"
},
{
"measure": "Tmax: Time to Reach the Cmax for TAK-007"
},
{
"measure": "Tlast: Time of Last Measurable Concentration Above the Lower Limit of Quantitation for TAK-007"
},
{
"measure": "AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-007"
},
{
"measure": "Change From Baseline in CD19+ B Cell Counts"
},
{
"measure": "Duration of B Cell Depletion"
},
{
"measure": "Change From Baseline in Plasma Cytokine Levels"
},
{
"measure": "Change From Baseline in Physician's Global Assessment (PGA) Score"
},
{
"measure": "Percentage of Participants Achieving a Reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Relative to Baseline"
},
{
"measure": "Percentage of Participants Achieving Complete Renal Response (CRR)"
},
{
"measure": "Time to CRR"
},
{
"measure": "Duration of CRR"
},
{
"measure": "Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)"
},
{
"measure": "Time to LLDAS"
},
{
"measure": "Duration of LLDAS"
},
{
"measure": "Percentage of Participants Meeting the Definition of Remission in SLE (DORIS) Criteria"
},
{
"measure": "Time to DORIS Remission"
},
{
"measure": "Duration of DORIS Remission"
},
{
"measure": "Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Levels"
},
{
"measure": "Change From Baseline in Antinuclear Antibody (ANA) Levels"
},
{
"measure": "Change From Baseline in Proteinuria Levels"
},
{
"measure": "Change From Baseline in Creatinine Levels"
},
{
"measure": "Change From Baseline in eGFR"
},
{
"measure": "Change From Baseline in Complement (C3, C4) Levels"
},
{
"measure": "Percentage of Participants With Antidrug Antibodies Categorized as Anti-Human Leukocyte Antigen (HLA) and Anti- Chimeric Antigen Receptor (CAR)"
},
{
"measure": "Percentage of Participants With Replication Competent Retrovirus (RCR) in Blood"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Takeda"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-04-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-04-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Open-source master hearing aid"
}
]
},
"conditionsModule": {
"conditions": [
"Hearing Impairment, Sensorineural",
"Spatial Perception",
"Aging",
"Hearing Aids"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": [
{
"email": "[email protected]",
"name": "Erol Ozmeral, Ph.D.",
"phone": "813-974-9778",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Carrie Secor, Au.D.",
"phone": "813-974-4148",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Erol Ozmeral, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210C",
"geoPoint": {
"lat": 27.94752,
"lon": -82.45843
},
"state": "Florida",
"status": null,
"zip": "33612"
}
]
},
"descriptionModule": {
"briefSummary": "The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 121,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Understanding Aided Speech Perception in Noise",
"nctId": "NCT06377215",
"orgStudyIdInfo": {
"id": "Pro00041729",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01DC020514",
"link": "https://reporter.nih.gov/quickSearch/R01DC020514",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Pure-tone Air Threshold (PTac)"
},
{
"measure": "Bone Conduction Threshold (PTbc)"
},
{
"measure": "Wideband Tympanometry (Equivalent Ear Canal Volume)"
},
{
"measure": "Wideband Tympanometry (Static Peak Pressure)"
},
{
"measure": "Wideband Tympanometry (Resonant Frequency)"
}
],
"primaryOutcomes": [
{
"measure": "Digit Identification"
},
{
"measure": "Neural Segregation"
}
],
"secondaryOutcomes": [
{
"measure": "Minimum Audible Angle (MAA)"
},
{
"measure": "Speech Localization Error"
},
{
"measure": "Fixed Spatial Release from Masking"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Deafness and Other Communication Disorders (NIDCD)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of South Florida"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Katie Elkins",
"phone": "215-615-6740",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Janos Tanyi, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies",
"nctId": "NCT06377202",
"orgStudyIdInfo": {
"id": "SynKIR-110 LTFU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of subjects with treatment related adverse events as assessed by CTCAE v5.0"
}
],
"secondaryOutcomes": [
{
"measure": "Number of subjects with persistence of SynKIR-110 modified cells"
},
{
"measure": "Number of subjects with potential/suspected RCL"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Verismo Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2038-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2038-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings"
},
{
"name": "Control Arm - Treatment As Usual (TAU)"
}
]
},
"conditionsModule": {
"conditions": [
"Mental Health Issue",
"Depression/Anxiety",
"Quality of Life",
"Psychosomatic Disorders",
"Patients Lived Experiences",
"Doctor-Patient Relation",
"Collaboration"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lausanne",
"contacts": null,
"country": "Switzerland",
"facility": "Center for Primary Care and Public Health (Unisanté) - Sponsorship / Not recruiting site",
"geoPoint": {
"lat": 46.516,
"lon": 6.63282
},
"state": "Vaud",
"status": null,
"zip": "1010"
},
{
"city": "Yverdon-les-Bains",
"contacts": [
{
"email": "[email protected]",
"name": "Julien Elowe, MD",
"phone": "0041 21 314 54 38",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Julien Elowe, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Gerrit Weber, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "Service de psychiatrie de l'adulte nord ouest (SPANO) Département de psychiatrie - CHUV (DP-CHUV)",
"geoPoint": {
"lat": 46.77852,
"lon": 6.64115
},
"state": "Vaud",
"status": null,
"zip": "1400"
},
{
"city": "Neuchâtel",
"contacts": [
{
"email": "[email protected]",
"name": "Stéphane Saillant, PD",
"phone": "0041 32 755 15 15",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Stéphane Saillant, PD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Julie Gavin-Ramain, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Switzerland",
"facility": "Centre Neuchâtelois de Psychiatrie (CNP)",
"geoPoint": {
"lat": 46.99179,
"lon": 6.931
},
"state": null,
"status": null,
"zip": "2000"
}
]
},
"descriptionModule": {
"briefSummary": "The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland (PLIMeC-P), is a mixed method randomized controlled trial. The investigated health-related intervention is a brief Consultation-Liaison (CL) psychiatry intervention in primary care.\n\nPrimary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care, CL psychiatry being one such type of intervention. Therefore, community CL-psychiatry, for example in private primary care group practices, are rare. The impact of such community, primary care CL-psychiatry interventions, should be investigated.\n\nThe mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provided to patients suffering from mental health problems, a group of patients generally under-treated. The CL-psychiatrist will receive and discuss PCPs' referrals for patients with mental distress, who don't have a psychiatric follow-up. After a brief intervention (1-4 sessions), feedback conjoint (PCP-psychiatrist) session will be organized, to complete the intervention and provide proposals.\n\nThe pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligible participants are expected for each group, 30 participants in total. They will be recruited in three private primary care group practices. After eligibility and randomization 15 participants will be included for the intervention arm (brief CL-psychiatric intervention) and 15 for the control arm (TAU). The expected number of participants for the main trial (PLIMeC) will be estimated through analysis of the initial results of the PLIMeC-P."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In order to answer the research question of the PLIMeC-P (pilot study), aiming to determine the feasibility and practicability of the main PLIMeC study, in the initial phase, the statistical procedures will be limited to questions of practicability and quality.\n\nFor the main PLIMeC study we will use a mixed method approach, combining various data collection and analysis methods (qualitative and quantitative). Quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest, and qualitative methods will be used to explore and obtain depth of this understanding. More specifically, the combination of methods will be used for complementarity, using qualitative data to examine how the participants, patients and healthcare providers, experience this specific CL-psychiatric intervention and quantitative methods to examine the impact of such an intervention on patients. In data analysis, the priority among the two methods will be equal.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PLIMeC-P",
"briefTitle": "Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study",
"nctId": "NCT06377189",
"orgStudyIdInfo": {
"id": "2023-01910",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Healthcare system complexity - Quantitative assessment"
},
{
"measure": "Healthcare system complexity - qualitative assessment"
},
{
"measure": "Access to mental healthcare"
}
],
"primaryOutcomes": [
{
"measure": "Evaluate the feasibility of the main PLIMeC study"
},
{
"measure": "Mental health - psychiatric symptoms"
},
{
"measure": "Mental health - Quality of life"
},
{
"measure": "Mental health - Self-report questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "The lived experience of the participants"
},
{
"measure": "The lived experience of the implicated clinicians"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Neuchâtel Psychiatry Centre (CNP)"
},
{
"name": "University of Lausanne Hospitals"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Massage therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Postpartum Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sleman",
"contacts": null,
"country": "Indonesia",
"facility": "Community Health Center",
"geoPoint": {
"lat": -7.71556,
"lon": 110.35556
},
"state": "Yogyakarta",
"status": null,
"zip": "55584"
}
]
},
"descriptionModule": {
"briefSummary": "Mother and infant massage, a type of complementary therapy, possesses the capacity to ameliorate maternal depression, stress, fatigue, and also infant temperaments and convert them into more manageable ones. The objective of this study was to determine the effect of mother and infant massage therapy on maternal depression, stress, fatigue, and infant temperament. In this quasi-experimental study, a total of 102 participants were allocated into two groups based on a pretest and posttest. During a period of five weeks, the experimental groups were subjected to ten massages per week, twice every week. On the data, a generalized estimating equation (GEE) was implemented. This study's hypothesis was an improvement in maternal depression, stress, fatigue, and infant temperament."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A quasi-experimental design was utilized in this investigation; it comprised a pre-test and a post-test administered to two distinct groups. The intervention group was subjected to pre-testing before receiving the intervention, and after the intervention, mother and infant massage treatment was delivered to the intervention group. Post-testing was performed on both groups, with the control group receiving mother and infant massage.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 102,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament",
"nctId": "NCT06377176",
"orgStudyIdInfo": {
"id": "NTUNHSEN",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Depression"
}
],
"secondaryOutcomes": [
{
"measure": "Stress"
},
{
"measure": "Fatigue"
},
{
"measure": "Infant temperament"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Taipei University of Nursing and Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-10-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-10-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-06-16"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Children Pneumonia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gamasa",
"contacts": null,
"country": "Egypt",
"facility": "Amira Hussin Mohammed",
"geoPoint": {
"lat": 31.44112,
"lon": 31.53675
},
"state": null,
"status": null,
"zip": "35712"
}
]
},
"descriptionModule": {
"briefSummary": "Pediatric community acquired pneumonia (CAP) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features.\n\nThis study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "28 Days",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bacterial Pathogens Associated With Community-acquired Pneumonia in Children",
"nctId": "NCT06377163",
"orgStudyIdInfo": {
"id": "acquired pneumonia in children",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Complete blood count"
},
{
"measure": "C-reactive protein (CRP)"
},
{
"measure": "Blood culture and sensitivity on admission"
},
{
"measure": "Gastric lavage culture or sputum culture on admission"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Delta University for Science and Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Stargardt Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tuebingen",
"contacts": null,
"country": "Germany",
"facility": "University Hospital Tuebingen",
"geoPoint": {
"lat": 48.52266,
"lon": 9.05222
},
"state": "Baden-Wuerttemberg, Germany",
"status": null,
"zip": "72076"
}
]
},
"descriptionModule": {
"briefSummary": "Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 39,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Stargardt Disease in Childhood",
"nctId": "NCT06377150",
"orgStudyIdInfo": {
"id": "ABCA4-1382022BO2",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Best Corrected Visual Acuity (BCVA)"
},
{
"measure": "Visual Field (VF)"
},
{
"measure": "Fundus Photography (FP)"
},
{
"measure": "Fundus Autofluorescence (AF)"
},
{
"measure": "Optical Coherence Tomography (OCT)"
},
{
"measure": "Full-Field Electroretinography (ff-ERG)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Tuebingen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Small-sided soccer games groups (SSSG)"
},
{
"name": "Traditional soccer training groups (TSG)"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity, Adolescent",
"Metabolic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Porto",
"contacts": null,
"country": "Portugal",
"facility": "Faculty of Sport of the University of Porto",
"geoPoint": {
"lat": 41.14961,
"lon": -8.61099
},
"state": null,
"status": null,
"zip": "4200-450"
}
]
},
"descriptionModule": {
"briefSummary": "Pediatric obesity is considered one of the most important public health problems worldwide due to its high prevalence and associated comorbidities. Physical exercise has been shown to have an important role in the treatment of obesity and associated cardiometabolic dysfunction. Small-sided soccer games (SSSG) have been explored as a promising way of increasing physical exercise due to its benefits on cardiometabolic health and high degree of enjoyment, which favors long-term adherence.\n\nThe objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors, physical fitness, adherence to 24-hour movement patterns, enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the effects of a traditional soccer intervention.\n\nThe investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training.\n\nA parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age. The inclusion criteria are: (i) age between 11-15 years at the time of intervention start; (ii) overweight or obesity (BMI\\> 85th percentile); (iii) Abdominal obesity ≥90th percentile as assessed by waist circumference or a waist-to-height ratio ≥ 0.5; (iv) willing to participate in the study regardless of possible group allocation; (v) informed consent given by participant and legal representatives. Exclusion criteria: (i) health condition not compatible with participation in physical exercise; (ii) history of recent musculoskeletal injury hindering exercise participation; (iii) concurrent participation in a structured weight loss or exercise program.\n\nThose eligible to participate in the study will be randomly assigned to one of three groups: i) SSSG group, ii) traditional soccer play group (TSG), or, iii) non-exercise intervention control group (CG). Participants in both exercise intervention groups will undergo a 16-week intervention. The SSSG group will participate in a high-intensity small-sided soccer games training, while the TSG will undergo a technical and tactical skills training program and traditional soccer training. The CG participants will continue with regular school physical education classes without any additional intervention. Before and after the intervention, all participants will be assessed for cardiometabolic and hepatic biochemical markers, physical fitness, anthropometry and body composition, blood pressure, objective daily physical activity and sleep quality, and perceived enjoyment of participation in SSSG and TSG. The primary outcomes of the study will be waist circumference and cardiorespiratory fitness.\n\nThe study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 51,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "11 Years",
"sex": "MALE",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction",
"nctId": "NCT06377137",
"orgStudyIdInfo": {
"id": "University of the Porto",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Waist circumference"
},
{
"measure": "Cardiorespiratory fitness"
}
],
"secondaryOutcomes": [
{
"measure": "Variation in fasting blood glucose concentration (mg/dL)"
},
{
"measure": "Variation in serum insulin concentration (mU/L)"
},
{
"measure": "Variation in HOMA-IR"
},
{
"measure": "Variation in glycosylated hemoglobin concentration (mg/dL)"
},
{
"measure": "Variation in high-density lipoprotein cholesterol concentration (mg/dL)"
},
{
"measure": "Variation in low-density lipoprotein cholesterol concentration (mg/dL)"
},
{
"measure": "Variation in total cholesterol concentration (mg/dL)"
},
{
"measure": "Variation in blood triglycerides concentration (mg/dL)"
},
{
"measure": "Variation in blood Alanine aminotransferase concentration (U/L)"
},
{
"measure": "Variation in blood Aspartate aminotransferase concentration (U/L)"
},
{
"measure": "Variation in blood Gamma glutamyl transferase concentration (U/L)"
},
{
"measure": "6-minute walk test"
},
{
"measure": "Hand grip strength"
},
{
"measure": "Lower limb strength"
},
{
"measure": "Body composition"
},
{
"measure": "Body mass index"
},
{
"measure": "Neck circumference"
},
{
"measure": "Blood Pressure (mmHg)"
},
{
"measure": "Physical activity"
},
{
"measure": "Sleep quality"
},
{
"measure": "Perceived enjoyment of physical activity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universidade do Porto"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-04-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "3S intervention"
},
{
"name": "GH information"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Agnes YK Lai, PhD",
"phone": "3970-2903",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Agnes Yuen Kwan Lai, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Hong Kong",
"facility": "Queen Mary Hospital",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Lung cancers patients often experience multiple symptoms (e.g. fatigue, dyspnea, distress, depression, sleep disturbance). The current study attempts to explore the efficacy of the Smart Self-Management Support Programme (3S) in improving quality of life of patients using self-management support programme with mobile devices."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The 3S intervention includes an individual session, messaging and phone contact related to lung cancer self-management, and hotline services.\n\nThe general health information includes an individual session, messaging and phone contact related to general health information, and hotline services.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The outcome assessor was not aware of which groups the patients belonged to.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 320,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients",
"nctId": "NCT06377124",
"orgStudyIdInfo": {
"id": "UW21-507",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in health-related quality of life"
}
],
"secondaryOutcomes": [
{
"measure": "Change in health-related quality of life"
},
{
"measure": "Change in patient activation"
},
{
"measure": "Change in general self-efficacy"
},
{
"measure": "Change in acceptance of illness"
},
{
"measure": "Change in physical activity level"
},
{
"measure": "Change in diet habit"
},
{
"measure": "Change in smoking and drinking habits"
},
{
"measure": "Change in health status"
},
{
"measure": "Change in anxiety symptoms of patients"
},
{
"measure": "Change in depression symptoms of patients"
},
{
"measure": "Change in social and family support"
},
{
"measure": "Change in adherence to agreed preset health-related goals"
},
{
"measure": "Change in symptom severity"
},
{
"measure": "Change in functional exercise capacity"
},
{
"measure": "Change in lower limb strength"
},
{
"measure": "Change in hand grip strength"
},
{
"measure": "Change in flexibility"
},
{
"measure": "Change in balance"
},
{
"measure": "Change in body composition"
},
{
"measure": "Change in objective physical activity level"
},
{
"measure": "Change in objective sleep quality"
},
{
"measure": "Change in burden of family caregivers (For FCGs)"
},
{
"measure": "Change in quality of life of family caregivers (For FCGs)"
},
{
"measure": "Change in anxiety symptoms of family caregivers (For FCGs)"
},
{
"measure": "Change in depression symptoms of family caregivers (For FCGs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Queen Mary Hospital, Hong Kong"
},
{
"name": "The Queen Elizabeth Hospital"
},
{
"name": "United Christian Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "C-PAN"
},
{
"name": "Nivolumab"
},
{
"name": "Ipilimumab"
}
]
},
"conditionsModule": {
"conditions": [
"Melanoma (Skin)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Minge Xu",
"phone": "416-946-4501",
"phoneExt": "7754",
"role": "CONTACT"
},
{
"email": null,
"name": "Samuel Saibil",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "University Health Network- Princess Margaret Cancer Centre",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M5G 2M9"
}
]
},
"descriptionModule": {
"briefSummary": "This study is open to patients with a type of cancer called melanoma. Patients can join the study if their tumor cannot be removed by surgery or has spread to other organs, and are planned to receive immunotherapy as treatment for their cancer. This study is looking at whether taking calcium pantothenate supplement (a type of Vitamin B5) can increase its levels in the blood and have an effect in the immune system, when its used in combination with the immunotherapy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma",
"nctId": "NCT06377111",
"orgStudyIdInfo": {
"id": "PANTHEON-IO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Correlation between change in pantothenic acid plasmatic level in mcMol/L between baseline and first day of ICI, and ORR by RECIST and iRECIST."
},
{
"measure": "Correlation between change in plasmatic pantothenic acid level between baseline and week 9 assessment, and immune profiling."
}
],
"primaryOutcomes": [
{
"measure": "To determine if the dose of 2000 mg daily of pantothenic acid achieves an increase in plasmatic concentration of pantothenic acid by at least a 50% between baseline and week 9, in 9 or more of the patients treated with combined ICI."
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate the overall response rate (ORR) of the enrolled cohort."
},
{
"measure": "Evaluate the progression free survival (PFS) of the enrolled cohort."
},
{
"measure": "Incidence of immune-related colitis."
},
{
"measure": "Correlation between baseline intestinal microbiome composition to the development of immune-related colitis."
},
{
"measure": "Correlation between the early changes in composition of intestinal microbiome and the development of immune-related colitis."
},
{
"measure": "The incidence of treatment-related adverse events."
},
{
"measure": "The incidence of treatment-related adverse events"
},
{
"measure": "Correlation between change in plasmatic pantothenic acid level between baseline and at first day of ICI, and ORR."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Health Network, Toronto"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sildenafil 50 mg Oral Tablet"
},
{
"name": "Placebo Oral Tablet"
}
]
},
"conditionsModule": {
"conditions": [
"Neonatal Asphyxia",
"Intrapartum Fetal Distress",
"Development, Infant",
"Intrapartum Asphyxia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Douala",
"contacts": [
{
"email": "[email protected]",
"name": "Pius Tih Muffih, PhD",
"phone": "677764781",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Rahel Kyeng Mbah",
"phone": "370 371378",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Akila Subramaniam, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Pius Tih Miffih, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Cameroon",
"facility": "Cameroon Baptist Convention Health Services",
"geoPoint": {
"lat": 4.04827,
"lon": 9.70428
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Nakuru",
"contacts": [
{
"email": "[email protected]",
"name": "Amos Otara, MD",
"phone": "254 7222 7470",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Elizabeth G Kibaru, MbchB, Mmed",
"phone": "072 942 394",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nora Switchenko, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Amos Otara, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Kenya",
"facility": "Egerton University/Nakuru County Referral Hospital",
"geoPoint": {
"lat": -0.28333,
"lon": 36.06667
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Lusaka",
"contacts": [
{
"email": "[email protected]",
"name": "Elwyn Chomba, MD",
"phone": "0211 254 655",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Musaku Mwenechanya, MD",
"phone": "+260966722966",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Elwyn Chomba, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Musaku Mwenechanya, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Zambia",
"facility": "University Teaching Hospital",
"geoPoint": {
"lat": -15.40669,
"lon": 28.28713
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.\n\nThe main questions it aims to answer are:\n\n* What are the fetal heart rate monitoring practices in a low-resource setting?\n* What are the indications for operative delivery in a low-resource?\n* What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?\n* What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?\n\nResearchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.\n\nParticipants will:\n\n* Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor\n* Have the (mothers \\& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \\& mask ventilation, Apgar scores, and seizures.\n* Have a neonatal neurological assessment prior to discharge\n* Have phone call assessments for re-hospitalization or mortality 7 days post-delivery\n* Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call\n\nThe results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Double blinded, placebo-controlled, 1:1 parallel allocation, randomized feasibility trial",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "The only person who will be unmasked will be the pharmacist who will dispense the study medication--either sildenafil 50mg or identical placebo",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "0 Days",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "PRISM",
"briefTitle": "Intrapartum Sildenafil in Laboring Mothers",
"nctId": "NCT06377098",
"orgStudyIdInfo": {
"id": "UAB-300010901",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "UAB Dixon Endowed Chair",
"id": "UAB Dixon Endowed Ch/3102800",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of perinatal mortality"
},
{
"measure": "Percentage of operative delivery"
},
{
"measure": "Indication for operative delivery"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of mothers who received fetal heart rate monitoring"
},
{
"measure": "Indication for fetal heart rate monitoring"
},
{
"measure": "Apgar Score"
},
{
"measure": "Percentage of use of bag and mask ventilation in neonates"
},
{
"measure": "Percentage of neonates with neonatal encephalopathy"
},
{
"measure": "Percentage of neonates with neonatal encephalopathy"
},
{
"measure": "Percentage of neonates with hypoxemia"
},
{
"measure": "Percentage of infants with neonatal hypoxic-ischemic encephalopathy"
},
{
"measure": "Percentage of neonatal ICU admissions"
},
{
"measure": "Percentage of maternal rehospitalization"
},
{
"measure": "Percentage of neonatal rehospitalization"
},
{
"measure": "Infant/child developmental assessment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Teaching Hospital, Lusaka, Zambia"
},
{
"name": "Egerton University"
},
{
"name": "Cameroon Baptist Convention Health"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Alabama at Birmingham"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
null | false |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Placebo for the AZA 10mg/m^2"
},
{
"name": "Placebo for the AZA 20mg/m^2"
},
{
"name": "Placebo for the AZA 35mg/m^2"
},
{
"name": "Placebo for the AZA 75mg/m^2"
},
{
"name": "5-Azacytidine 10mg/m^2"
},
{
"name": "5-Azacytidine 20mg/m^2"
},
{
"name": "5-Azacytidine 35mg/m^2"
},
{
"name": "5-Azacytidine 75mg/m^2"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy",
"Contracture"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In this controlled dose-escalation study, we will study the initial safety, biological properties, and potential efficacy of 5-azacytidine (AZA). Our overarching aspiration is for AZA to evolve into an approved pharmacological treatment, fostering muscle growth and enhancing body movement, ultimately contributing to an improved quality of life in children with CP.\n\nThe main questions this study aims to answer are:\n\n1. What is the optimal dose of AZA injection that can be used safely in children with CP?\n2. Can the optimal safe dose of AZA improve the function of muscle-generating stem cells in children with CP?\n\nEach participant will have up to five research visits over the course of the study duration, in which they will participate in: blood draws, pregnancy test(s) (if applicable), medical assessments, and a muscle biopsy during a surgery for muscle contractures.\n\nResearchers will compare participants with four different dosages of AZA injections to those with four different dosages of placebo injections. A placebo is a look-alike substance that contains no active drug. They will see if a single injection of AZA at a standard concentration currently approved by the FDA to treat myelodysplastic syndromes, can also safely improve muscle growth and function in children with CP."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "For this Phase 1 trial, we will conduct a dose-escalation study in children having CP who receive 5-Azacytidine (AZA) via a single subcutaneous (SQ) injection two weeks before their surgery, already scheduled to release their contractures. We will use a \"3 + 3\" dose-escalation design where decisions are based on the rate of toxicity at the current dose level independently from prior dose levels. The primary goal of this study is to determine a Maximum Tolerated Dose (MTD), which will be the highest dose level at which less or equal of 33% of patients experience Dose-Limiting Toxicity (DLT).",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Repurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy",
"nctId": "NCT06377085",
"orgStudyIdInfo": {
"id": "809325",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Chromatin immunoprecipitation sequencing (ChIP-seq), and assay for transposase-accessible chromatin sequencing (ATAC-seq)"
}
],
"primaryOutcomes": [
{
"measure": "Dose-limiting toxicity (DLT)."
}
],
"secondaryOutcomes": [
{
"measure": "Satellite Cell Fusion Index."
},
{
"measure": "DNA methylation quantification in Satellite Cells and Blood Mononucleated Cells."
},
{
"measure": "DNA methylation profiling in Satellite Cells."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Rady Children's Hospital, San Diego"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Shirley Ryan AbilityLab"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-22"
}
}
}
|
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