protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Genetic Counselor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bethesda",
"contacts": [
{
"email": "[email protected]",
"name": "Sara Hull, Ph.D.",
"phone": "301-435-8712",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "National Human Genome Research Institute (NHGRI)",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "20892"
}
]
},
"descriptionModule": {
"briefSummary": "Background:Genetic counselors play a new and evolving role in medical care. Recent advances in genetic testing are changing many health care treatments, and genetic counselors play a key role in teaching people how their genes may affect both health and treatments. Genetic counselors may also help guide people through complex talks about their treatment risks; their chances for recovery; and their social and emotional health and wellbeing. Researchers want to learn more about the role genetic counselors play in health care.Objective:To observe how genetic counselors at NIH manage the social and psychological aspects of patient care.Eligibility:Genetic counselors who work at NIH. People aged 18 years or older who are scheduled to meet with one of these counselors are also needed.Design:An investigator will sit in on the session between the counselor and the participant. The investigator will take notes. The session will not be recorded. The investigator will leave at any point if asked.The investigator will focus on talk about social and psychological care. That person will also listen to talk about risk; diagnosis; odds of recovery; and hope, grief, and loss. That person will note strategies that help the participant manage their emotions and how they perceive their risks.Counselors may later have a 1-hour interview with the investigator. They will answer questions about their experiences as a care provider at NIH.Participants will have only 1 session with the investigator. Counselors may have 4 to 10 sessions with an investigator over 8 months."
},
"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": "115 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Care Choreographies and the Making of the Psychosocial in Genetic Counseling",
"nctId": "NCT06280833",
"orgStudyIdInfo": {
"id": "10001884",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "001884-HG",
"link": null,
"type": null
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Care"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Human Genome Research Institute (NHGRI)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Heart Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bethesda",
"contacts": [
{
"email": "[email protected]",
"name": "Veronique Roger, M.D.",
"phone": "301-402-1715",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "National Heart, Lung and Blood Institute (NHLBI)",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland",
"status": null,
"zip": "20892"
}
]
},
"descriptionModule": {
"briefSummary": "Background:More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF.Objective:To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time.Eligibility:People aged 18 years and older with heart failure.Design:Participants will be asked to join the study based on a review of their medical records.They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein.Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA.Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation.Researchers will follow the participants health by monitoring their medical records for up to 5 years."
},
"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": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)",
"nctId": "NCT06280820",
"orgStudyIdInfo": {
"id": "10001889",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "001889-H",
"link": null,
"type": null
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To study the association between multi-omics signatures with all-cause mortality"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50)NYHA (3-4 vs. 1-2)"
},
{
"measure": "To study the cross-sectional association between multi-omics signatures with clinical sub-phenotypes of heart failure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2034-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Hypogonadism",
"Hypergonadism",
"Precocious Puberty",
"Late Puberty",
"Amenorrhea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Research Triangle Park",
"contacts": [
{
"email": "[email protected]",
"name": "NIH Clinical Center Office of Patient Recruitment (OPR)",
"phone": "800-411-1222",
"phoneExt": "TTY dial 711",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "NIEHS Join A Study Recruitment Group",
"phone": "(855) 696-4347",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "NIEHS Clinical Research Unit (CRU)",
"geoPoint": {
"lat": 35.90567,
"lon": -78.90497
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27709"
}
]
},
"descriptionModule": {
"briefSummary": "Background:Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems.Objective:To learn how environmental factors may affect the endocrine and reproductive systems.Eligibility:Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders.Design:Adult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours.Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis.Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include:Body composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume.Resting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest...."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Observation of Environment and Reproductive-Endocrine Effects",
"nctId": "NCT06280807",
"orgStudyIdInfo": {
"id": "10001617",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "001617-E",
"link": null,
"type": null
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Investigate the relationship between environment, lifestyle, and reproductive neuroendocrinology."
}
],
"secondaryOutcomes": [
{
"measure": "the relationship between nutrition, diet and reproduction"
},
{
"measure": "the impact of stress on reproductive dysfunction"
},
{
"measure": "the influence of behavioral and psychological factors on reproductive function"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Institute of Environmental Health Sciences (NIEHS)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2039-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2039-03-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Laser acupuncture"
},
{
"name": "Steroids"
}
]
},
"conditionsModule": {
"conditions": [
"Bell's Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Beijing TongRen Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Objective:Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy in 8 weeks.Methods:This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Betahistine Mesylate tablet, Vitamin B1 tablet and Prednisolone.Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 336,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy",
"nctId": "NCT06280794",
"orgStudyIdInfo": {
"id": "Laser-Bell-2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "House Brackmann Grading System (HB)"
}
],
"secondaryOutcomes": [
{
"measure": "Sunnybrook Facial Grading Scale (SB Grading)"
},
{
"measure": "Facial Disability Index (FDI)"
},
{
"measure": "Facial Clinimetric Evaluation Scale (FaCE Scale)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Beijing Tongren Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MRI Scans"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories \\[ no visible lesion, diffuse changes, discrete visible lesion\\]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "Current (NICE defined active surveillance):PSA 3 monthly in year 1 and then 6 monthly with rectal exam annually. MRI will be carried out at 12 months (if not had one at diagnosis). A biopsy will be required if indicated due to changes in rectal exam or PSA.Planned (Regular MRI based active surveillance):Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI annually. All other patients will undergo PSA 6 monthly and MRI in years 1, 3 and 5. In all patients, a targeted biopsy will be carried out if the MRI PRECISE score is \\>/=4.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1263,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IP9-ATLAS",
"briefTitle": "Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)",
"nctId": "NCT06280781",
"orgStudyIdInfo": {
"id": "22CX7971",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "National Institute of Health Research - Health Technology Assessment",
"id": "NIHR152027",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Biopsy"
},
{
"measure": "Staging"
}
],
"secondaryOutcomes": [
{
"measure": "Cost-effectiveness"
},
{
"measure": "Biopsy Measurement"
},
{
"measure": "MRI & biopsy-related adverse events"
},
{
"measure": "Treatment"
},
{
"measure": "Compliance"
},
{
"measure": "EPIC Questionnaires"
},
{
"measure": "HADS Questionnaires"
},
{
"measure": "EQ-5D-5L Questionnaires"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "East London NHS Foundation Trust"
},
{
"name": "King's College"
},
{
"name": "University College, London"
},
{
"name": "University of York"
},
{
"name": "University College London Hospitals"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Imperial College Healthcare NHS Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-12-07",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 1231033,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-01-24T08:54"
},
{
"date": "2023-12-07",
"filename": "ICF_001.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 286927,
"typeAbbrev": "ICF",
"uploadDate": "2024-01-24T09:01"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SHR-2004 injection"
}
]
},
"conditionsModule": {
"conditions": [
"Atrial Fibrillation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation",
"nctId": "NCT06280768",
"orgStudyIdInfo": {
"id": "SHR-2004-102",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence and severity of adverse events (including bleeding events)"
}
],
"secondaryOutcomes": [
{
"measure": "Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)"
},
{
"measure": "Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)"
},
{
"measure": "Pharmacokinetics of Dupilumab: Elimination half life (t1/2)"
},
{
"measure": "PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity"
},
{
"measure": "PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT)"
},
{
"measure": "Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Beijing Suncadia Pharmaceuticals Co., Ltd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis",
"NMO Spectrum Disorder",
"Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease",
"Radiologically Isolated Syndrome",
"Clinically Isolated Syndrome"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 7000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RECLAIM",
"briefTitle": "Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.",
"nctId": "NCT06280755",
"orgStudyIdInfo": {
"id": "ICO-S-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The number of patients from each institution who have contributed data to the database."
},
{
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"descriptionModule": {
"briefSummary": "The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks."
},
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},
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{
"measure": "Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) at Week 16 for Mono Cohort"
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{
"measure": "Percentage of Participants Achieving EASI-75 at Week 16 for Combo Cohort"
}
],
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{
"measure": "Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort"
},
{
"measure": "Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 for Combo Cohort"
},
{
"measure": "Percentage of Participants With a Itch Numerical Rating Scale (NRS) Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Combo Cohort"
},
{
"measure": "Percentage Change From Baseline in EASI Score at Week 16 for Combo Cohort"
},
{
"measure": "Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort"
},
{
"measure": "Percentage of Participants Achieving EASI-90 at Week 16 for Mono Cohort"
},
{
"measure": "Percentage of Participants With a Itch NRS Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Mono Cohort"
},
{
"measure": "Percentage Change From Baseline in EASI Score at Week 16 for Mono Cohort"
}
]
},
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"date": "2024-05-06"
},
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"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LY3938577"
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{
"name": "Placebo"
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{
"name": "Insulin Degludec"
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{
"name": "Insulin Lispro"
}
]
},
"conditionsModule": {
"conditions": [
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},
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{
"city": "Neuss",
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{
"email": null,
"name": null,
"phone": "+49 (0) 2131 4018 450",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Oliver Klein",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Profil Institut für Stoffwechselforschung",
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"zip": "41460"
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"type": "ESTIMATED"
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"phases": [
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"maximumAge": "64 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
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"id": "18792",
"link": null,
"type": null
},
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{
"domain": "Eli Lilly and Company",
"id": "J4P-MC-IYAB",
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{
"domain": "Universal Trial Number",
"id": "U1111-1301-8386",
"link": null,
"type": "OTHER"
},
{
"domain": "EU Trial Number",
"id": "2023-510365-10-00",
"link": null,
"type": "OTHER"
}
]
},
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{
"measure": "Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration."
},
{
"measure": "Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration."
},
{
"measure": "Part A: Number of Participants With Clinically Significant Changes in Vital Signs"
},
{
"measure": "Part B: Number of Participants With Clinically Significant Changes in Vital Signs"
},
{
"measure": "Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters"
},
{
"measure": "Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters"
},
{
"measure": "Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577"
},
{
"measure": "Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577"
},
{
"measure": "Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577"
},
{
"measure": "Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577"
},
{
"measure": "Part C: PK: Concentration of LY3938577"
}
],
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{
"measure": "Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577"
},
{
"measure": "Part C: PD: Glucose infusion rate (GIR) of LY3938577"
}
]
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},
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"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SGM-101"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer",
"Image",
"Low Grade Dysplasia of Colon"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leiden",
"contacts": [
{
"email": "[email protected]",
"name": "Mats Warmerdam, Msc",
"phone": "+31715298420",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Leiden University Medical Center",
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"lon": 4.49306
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"state": null,
"status": "RECRUITING",
"zip": "2333ZA"
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]
},
"descriptionModule": {
"briefSummary": "This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "This is a single center prospective, non-randomized phase 2 proof of concept study, on the performance of SGM-101 to discriminate T1RC/HGD from LGD in patients that will be scheduled for endoscopic local en-bloc resection in the Leiden University Medical Centre (LUMC).",
"maskingInfo": {
"masking": "NONE",
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"whoMasked": null
},
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"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
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"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
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},
"identificationModule": {
"acronym": "SGM-T1",
"briefTitle": "SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia",
"nctId": "NCT06280690",
"orgStudyIdInfo": {
"id": "NL83765.058.23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic)."
}
],
"secondaryOutcomes": [
{
"measure": "- Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective)"
},
{
"measure": "- In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope."
},
{
"measure": "- The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo"
},
{
"measure": "-The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo"
},
{
"measure": "- The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3)"
},
{
"measure": "- The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Leiden University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AURORA-Donor"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": null,
"country": "Spain",
"facility": "Fertilab",
"geoPoint": {
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"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08017"
}
]
},
"descriptionModule": {
"briefSummary": "This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \\& hr-FSH with GnRH Agonist trigger, 2) Progesterone \\& hr-FSH with GnRH Agonist trigger."
},
"designModule": {
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"allocation": null,
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"maskingInfo": null,
"observationalModel": "COHORT",
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Aurora Test for ART Donor Patients (AURORA-Donor)",
"nctId": "NCT06280677",
"orgStudyIdInfo": {
"id": "2023.Aurora-Donor",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Ongoing pregnancy rate"
},
{
"measure": "Live birth"
},
{
"measure": "Cumulative pregnancy"
},
{
"measure": "Cumulative live birth"
},
{
"measure": "Miscarriage rate"
}
],
"primaryOutcomes": [
{
"measure": "Basic clinical donor patient and stimulation characteristics: P4"
},
{
"measure": "Basic clinical donor patient and stimulation characteristics: E2"
},
{
"measure": "Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose"
},
{
"measure": "Clinical evaluation: number of Follicles"
},
{
"measure": "Clinical evaluation: number of cumulus-oocyte complex"
},
{
"measure": "Clinical evaluation: Meiosis II oocytes"
},
{
"measure": "Clinical evaluation: Abnormal fertilization"
},
{
"measure": "Clinical evaluation: Normal Fertilization"
},
{
"measure": "Clinical evaluation: Day 3 embryo evaluation"
},
{
"measure": "Clinical evaluation: Day 5/6 embryo evaluation"
},
{
"measure": "Clinical evaluation: Day5/6 good quality blastocyst rate"
},
{
"measure": "Clinical evaluation: Embryo utilization"
},
{
"measure": "Expression profile: blastocyst formation"
}
],
"secondaryOutcomes": [
{
"measure": "Biochemical pregnancy"
},
{
"measure": "Clinical pregnancy with positive fetal heartbeat"
},
{
"measure": "Expression profile: pregnancy prediction"
},
{
"measure": "Normalized messenger ribonucleic acid (mRNA) expression"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fertilab"
},
{
"name": "Ferring Pharmaceuticals"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Fertiga, Belgium"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Gastro Esophageal Reflux"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Carlisa Dixon",
"phone": "773-834-4337",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Leila Yazdanbakhsh",
"phone": "773-834-5087",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of Chicago",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "60637"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy Of Hiatal Closure For GERD",
"nctId": "NCT06280664",
"orgStudyIdInfo": {
"id": "IRB20-1151",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Concentration of pH testing"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Chicago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-10-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "dietary preferences and their implications for oral health in children with Autism Spectrum Disorder"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Caries in Children",
"Autistic Disorder",
"Dietary Habits"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study aims to explore how dietary habits affect oral health in children with autism. By examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. This observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for children with autism."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "OHIDPAP-CS",
"briefTitle": "Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis",
"nctId": "NCT06280651",
"orgStudyIdInfo": {
"id": "RGP 2/348/44",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "kING kHALID UNIVERSITY",
"id": "RGP 2/348/44",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess the association between oral hygiene and periodontal disease severity to identify potential implications of dietary preferences for oral health status"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "King Khalid University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual stent-guided incremental optimization strategy (VIOS)"
},
{
"name": "Standard angiographic strategy"
}
]
},
"conditionsModule": {
"conditions": [
"Percutaneous Coronary Intervention",
"Coronary Physiology",
"Computed Tomography"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": null,
"country": "China",
"facility": "Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": null,
"zip": "100037"
}
]
},
"descriptionModule": {
"briefSummary": "A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable \"after the fact\" given selected stents, site of deployment and procedural technique.Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure.However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of \"Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)\" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 280,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CT-COMPASS",
"briefTitle": "CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS)",
"nctId": "NCT06280638",
"orgStudyIdInfo": {
"id": "2023-2095",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The proportion of patients with a final post-PCI FFR result ≥0.90"
}
],
"secondaryOutcomes": [
{
"measure": "The proportion of patients with final post-PCI FFR ≤0.80"
},
{
"measure": "The rate of target vessel failure (TVF) and its component features at 6 months."
},
{
"measure": "The rate of target vessel failure (TVF) and its component features at 1 year."
},
{
"measure": "Change from baseline in self-reported Health-related quality of life evaluation at 6 months."
},
{
"measure": "Change from baseline in self-reported Health-related quality of life evaluation at 1 year."
},
{
"measure": "Change from baseline in self-reported Angina status evaluation at 6 months."
},
{
"measure": "Change from baseline in self-reported Angina status evaluation at 1 year."
},
{
"measure": "Procedure Duration"
},
{
"measure": "Fluoroscopy Dose"
},
{
"measure": "Contrast Material Dose"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "China National Center for Cardiovascular Diseases"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Replacement of wheat flour by soyflour"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight and Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Champaign",
"contacts": [
{
"email": "[email protected]",
"name": "Marta Y Pepino, MSc, RD",
"phone": "217-300-2374",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Stephanie Okoye, Pharm D",
"phone": "2173004709",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Illinois at Urbana Champaign",
"geoPoint": {
"lat": 40.11642,
"lon": -88.24338
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "61820"
}
]
},
"descriptionModule": {
"briefSummary": "Foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. High glycemic index foods are also linked to an increased risk of developing diabetes. The partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety.In many regions of Latin America, as well as in the Middle East and North Africa (MENA) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. Bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. The results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "People will be evaluated with a food product prepared with different % of replacement of wheat flour for soy flour. Each person will be their own control. In other words, in randomized order, they will all be assessed with the food product prepared with the regular wheat flour (either bread, tortillas or arepas) and on two other visits with different percentages of soy flour.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Participants will be given the food product without information on whether it is prepared 100% with wheat flour or with different soy flour %.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of the Inclusion of Soybean Flour on Glycemic Responses",
"nctId": "NCT06280625",
"orgStudyIdInfo": {
"id": "24388",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Plasma glucose"
},
{
"measure": "Plasma insulin"
}
],
"secondaryOutcomes": [
{
"measure": "Hunger-Satiety"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kenneth Dallmier Consulting, LLC"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Illinois at Urbana-Champaign"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pet therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Therapy-Associated Cancer",
"Cancer Patient",
"Happiness",
"Symptoms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gümüşhane",
"contacts": null,
"country": "Turkey",
"facility": "Gümüşhane University",
"geoPoint": {
"lat": 40.46001,
"lon": 39.47176
},
"state": null,
"status": null,
"zip": "29600"
}
]
},
"descriptionModule": {
"briefSummary": "It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The sample number of the research was calculated in the G\\*Power 3.1.9.6 program. While α=0.05 was the error amount, 0.628 was the effect size, and 0.90 (90%) was the targeted test power, it was calculated as 36 patients for three groups (living cat group, robotic cat group, control group). Since there was no previous study on the subject, a study examining happiness levels in a different sample group was used as a reference. Considering situations such as wanting to leave the study or death during the research, each group was increased by 25%, and a total of 45 patients, 15 patients for each group, were included in the study.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Since the possibility of patients being affected by each other was minimal, the study was continued with only one of the live cat groups, the simulation cat group, and the control group. For example, only the live cat group and those who received chemotherapy treatment were studied before Monday afternoon.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients",
"nctId": "NCT06280612",
"orgStudyIdInfo": {
"id": "RCS10042023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Edmonton Symptom Diagnostic Scale"
},
{
"measure": "Oxford Happiness Scale Short Form"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Karadeniz Technical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transitional care model"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kupang",
"contacts": [
{
"email": "[email protected]",
"name": "Sakti Oktaria Batubara",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": null,
"phone": null,
"phoneExt": "Saragih",
"role": "CONTACT"
},
{
"email": null,
"name": "Ita Daryanti Saragih, Doctoral",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Indonesia",
"facility": "RSUD Prof. Dr. W Z Johannes Kupang",
"geoPoint": {
"lat": -10.17083,
"lon": 123.60694
},
"state": null,
"status": "RECRUITING",
"zip": "308"
}
]
},
"descriptionModule": {
"briefSummary": "Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The patients were divided into two groups: intervention (n=40) and contrast (n=40). Both groups received post-stroke usual care. The intervention group received an 8-week transitional care model for stroke patients, which included comprehensive discharge planning and home follow-up",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Transitional Care Model for Patients With Stroke",
"nctId": "NCT06280599",
"orgStudyIdInfo": {
"id": "SON KMU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Self-efficacy"
},
{
"measure": "Activities of daily living"
}
],
"secondaryOutcomes": [
{
"measure": "Instrumental activities of daily living"
},
{
"measure": "Depression symptoms"
},
{
"measure": "Quality of life in stroke patients"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kaohsiung Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Multidisciplinary intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Muscle Strengh",
"Frailty",
"Sarcopenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mataró",
"contacts": null,
"country": "Spain",
"facility": "Consorci Sanitari del Maresme",
"geoPoint": {
"lat": 41.54211,
"lon": 2.4445
},
"state": "Barcelona",
"status": null,
"zip": "08304"
},
{
"city": "Mataró",
"contacts": null,
"country": "Spain",
"facility": "Mateu Serra-Prat",
"geoPoint": {
"lat": 41.54211,
"lon": 2.4445
},
"state": "Barcelona",
"status": null,
"zip": "08304"
}
]
},
"descriptionModule": {
"briefSummary": "Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know \"a priori\" which group you will be in."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 232,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "70 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ESPAI-F",
"briefTitle": "Effectiveness of Intervention in Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Community Elderly",
"nctId": "NCT06280586",
"orgStudyIdInfo": {
"id": "44/21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Muscle Mass"
},
{
"measure": "Muscle strength and/or Muscle function"
},
{
"measure": "Sarcopenia"
},
{
"measure": "Frailty"
}
],
"secondaryOutcomes": [
{
"measure": "Functional Capacity 1"
},
{
"measure": "Functional Capacity 2"
},
{
"measure": "Functional Capacity 3"
},
{
"measure": "Functional Capacity 4"
},
{
"measure": "Functional Capacity 5"
},
{
"measure": "Functional Capacity 6"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Consorci Sanitari del Maresme"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Wim Hoff method"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bratislava",
"contacts": null,
"country": "Slovakia",
"facility": "Derer's University Hospital",
"geoPoint": {
"lat": 48.14816,
"lon": 17.10674
},
"state": null,
"status": null,
"zip": "83305"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.Researchers will compare the effect to control groups of MS patients without intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "COBRAMS",
"briefTitle": "COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)",
"nctId": "NCT06280573",
"orgStudyIdInfo": {
"id": "MS1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "concentration of pro-inflammatory cytokines"
},
{
"measure": "concentration of markers of oxidative stress"
},
{
"measure": "concentration of NfL"
},
{
"measure": "concentration of GFAP"
},
{
"measure": "concentration of ecDNA"
}
],
"secondaryOutcomes": [
{
"measure": "Expanded Disability Status Scale"
},
{
"measure": "Timed 25-Foot Walk"
},
{
"measure": "Nine-Hole Peg Test"
},
{
"measure": "Symbol Digit Modalities Test"
},
{
"measure": "Fatigue Scale for Motor and Cognitive Functions"
},
{
"measure": "General Anxiety Disorder-7"
},
{
"measure": "Patient Health Questionnaire-9"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Comenius University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Controlled Ovarian Stimulation + Luteal Phase Support"
},
{
"name": "Hormonal Replacement Therapy programmed artificial cycle"
},
{
"name": "Natural Cycle (NC)"
},
{
"name": "Endometrial receptivity reference group"
}
]
},
"conditionsModule": {
"conditions": [
"Endometrial Receptivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Valencia",
"contacts": [
{
"email": "[email protected]",
"name": "Laura Caracena, PhD",
"phone": "651791000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "IVI-RMA Valencia Clinic",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": "RECRUITING",
"zip": "46015"
}
]
},
"descriptionModule": {
"briefSummary": "Both controlled ovarian stimulation (COS) and frozen embryo transfer has become an integral part of in vitro fertilization (IVF) treatment. Fresh embryo transfer is usually performed by providing Luteal Phase Support (LPS) with progesterone after COS. Frozen embryo transfer (FET) is usually performed in artificial cycles with hormone replacement treatment (HRT), in which exogenous progesterone is administered, although it can also be performed in a Natural Cycle (without hormone supplementation) (NC). There is evidence that the supraphysiologic levels of estradiol and progesterone during COS+LPS and HRT could lead to morphologic and biochemical endometrial modifications, altering endometrial receptivity and lowering implantation and pregnancy rates.We hypothesize that the supraphysiologic hormone levels required for both COS+LPS, and HRT may be inducing alterations in endometrial composition and function, specifically the chronic accumulation of senescent cells; either due to an excessive hormonal induction, a lack of clearance due to a deficit of uNKs, or a combination of both, ultimately affecting both endometrial receptivity and decidualization, worsening IVF outcomes.The in vitro clearance of endometrial senescent cells by selective induction of apoptosis has been found to enhance the decidualization capacity of the rest of Endometrial Stromal Cells (EnSC), which could represent in a future adjuvant strategy to reduce the potentially deleterious effects of supraphysiologic hormone levels and improve reproductive outcomes in IVF patients.The results derived from this project would have a direct impact on clinical practice. First, the results would allow us to evaluate, based on experimental data, potential endometrial side effects of stimulation protocols commonly used in IVF treatments. In addition, in the case of finding a pathological accumulation of senescent cells affecting endometrial receptivity, we will be able to in vitro evaluate the effectiveness of adjuvant senolytic (drugs designed to specifically remove senescent cells) compounds to in vitro improve the expression of endometrial receptivity markers, as a first step to demonstrate the effectiveness of their use in improving the reproductive outcomes of IVF patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "HormoSenoRec",
"briefTitle": "Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation",
"nctId": "NCT06280560",
"orgStudyIdInfo": {
"id": "2109-FIVI-087-FD",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Instituto de Salud Carlos III, co-funded by European Union",
"id": "PI23/00860",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Endometrial receptivity"
}
],
"secondaryOutcomes": [
{
"measure": "Senescent Cell Pathological Accumulation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto Valenciano de Infertilidad, IVI VALENCIA"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundación IVI"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oral health education"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Caries in Children",
"Knowledge, Attitudes, Practice"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Aim of the study Assessing the effect of an oral health education program on knowledge, attitude, practice, and dental caries among a group of school children in a governmental school in Fayoum, Egypt."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 115,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "KAP",
"briefTitle": "The Effect of Oral Health Education on Knowledge, Attitude, Practice and Dental Caries Among Egyptian School Children",
"nctId": "NCT06280547",
"orgStudyIdInfo": {
"id": "CUP 13-2",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Cairo University",
"id": "Cairo university",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Caries experience"
}
],
"primaryOutcomes": [
{
"measure": "Oral health related attitude"
}
],
"secondaryOutcomes": [
{
"measure": "Change in oral health related Knowledge, attitude and practice"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Test drug XT1061 capsules and placebo,Single dose group"
},
{
"name": "Test drug XT1061 capsules and placebo，Multiple dosing group"
},
{
"name": "Test drug XT1061 capsules and placebo，Food Impact Group"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Hepatitis b"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jilin",
"contacts": [
{
"email": "[email protected]",
"name": "Ding Yanhua, master",
"phone": "18743062721",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The First Hospital of Jilin University",
"geoPoint": {
"lat": 43.85083,
"lon": 126.56028
},
"state": "Changchun",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 128,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "XT1061",
"briefTitle": "Safety, Tolerability Phase Ia Study of XT1061 in Single and Multiple Doses in Healthy Subjects",
"nctId": "NCT06280534",
"orgStudyIdInfo": {
"id": "XT1061-2022-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment-related adverse events"
},
{
"measure": "Cmax"
},
{
"measure": "Tmax"
},
{
"measure": "t1/2"
},
{
"measure": "AUC"
},
{
"measure": "CL/F"
},
{
"measure": "Vz/F"
},
{
"measure": "CLr/F"
}
],
"secondaryOutcomes": [
{
"measure": "Ae0-72 h"
},
{
"measure": "Fe0-72 h"
},
{
"measure": "bioavailability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xi'an Xintong Pharmaceutical Research Co.,Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "fGQ-ASC"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Autism spectrum disorders (ASD) are currently diagnosed at a rate of approximately 3 males per 1 female, while evidence suggests the rate may be 1.8 males per 1.2 females. It has been shown that affected women receive an autism diagnosis on average 5 years later than men. This delay is associated with deleterious consequences on the educational, psychological and physical health levels in these women. Currently, there are a number of obstacles that delay or prevent women with ASD from accessing diagnosis and specialized support. These include, in particular, gendered assumptions about how ASD manifests depending on the gender of the person concerned, a tendency for clinicians to attribute female autistic traits to causes other than ASD, measures of standardized ASD assessments that may not be sensitive enough to identify ASD females, and finally a demonstrated greater tendency among ASD females to camouflage or mask autistic traits in order to blend in in social situations. It is in this context that the Girl Questionnaire for Autism Spectrum Conditions (GQ-ASC) was developped and validated to address these fundamental gaps in the early identification and measurement of female ASD symptoms.The GQ-ASC is presented as a self-questionnaire with 29 items which assess clinical characteristics specific to the adult female presentation of ASD in the dimensions (five) of imagination and play, camouflage, sensoriality, social situations and interests. To date, several studies have relevantly used the GQ-ASC in populations of adult ASD women, but none in French.The main objective of this online study is therefore to measure the predictive validity of the French version of the Girl Questionnaire for Autism Spectrum Conditions (fGQ-ASC) for the diagnosis of ASD in adult women over 18 years of age and speaking French kindergarten. Subjects included in this online study will complete the protocol using any computer, tablet, or cell phone. We will include 400 participants (100 females-ASD, 100 females-nonASD, 100 males-ASD, 100 males-nonASD). This study will validate for the first time a screening tool for the diagnosis of ASD in women of French mother tongue over 18 years of age (the Girls Questionnaire for Autism Spectrum Condition French version - fGQ-ASC). This tool will have particularly significant benefits since it will help reduce the diagnostic delay among adult women with ASD in France and accelerate their access to specialized support."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "fGQ-ASC",
"briefTitle": "Validation of the Girls Questionnaire for Autism Spectrum Condition in French Langage",
"nctId": "NCT06280521",
"orgStudyIdInfo": {
"id": "38RC23.0331",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "VP fGQ-ASC"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Grenoble"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adebrelimab, Apatinib, Gemcitabine, cisplatin"
}
]
},
"conditionsModule": {
"conditions": [
"Resectable Intrahepatic Cholangiocarcinoma With High Risk of Recurrence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Yajin Chen",
"phone": "13719006202",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Changzhen Shang",
"phone": "13711279678",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "China/Guangdong",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer",
"nctId": "NCT06280508",
"orgStudyIdInfo": {
"id": "SYSKY-2024-082-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "1-year EFS rate"
}
],
"secondaryOutcomes": [
{
"measure": "R0 Resection rate"
},
{
"measure": "EFS"
},
{
"measure": "RFS"
},
{
"measure": "OS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oxaliplatin"
},
{
"name": "Fluorouracil"
},
{
"name": "Serplulimab"
},
{
"name": "Bevacizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Colorectal Cancer",
"Liver Metastases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Yu-hong Li, MD, Ph D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yu-hong Li, MD, Ph D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Sun Yat-sen University Cancer Center",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": "RECRUITING",
"zip": "510060"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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},
"enrollmentInfo": {
"count": 156,
"type": "ESTIMATED"
},
"phases": [
"PHASE2",
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients",
"nctId": "NCT06280495",
"orgStudyIdInfo": {
"id": "INTENSIFY-CRC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "3-year Progression-Free Survival Rate"
}
],
"secondaryOutcomes": [
{
"measure": "Median Overall Survival"
},
{
"measure": "Major Pathological Response (MPR)"
},
{
"measure": "Pathologic complete response (pCR)"
},
{
"measure": "Pathological Partial Response"
},
{
"measure": "Disease Free Survival"
},
{
"measure": "Treatment-related adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-04"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
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"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nicotinamide riboside (NR)"
}
]
},
"conditionsModule": {
"conditions": [
"Smooth Muscle Dysfunction Syndrome (SMDS)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "David Murdock, MD",
"phone": "713-500-6735",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Dianna Milewicz, MD, PhD",
"phone": "(713) 500-6725",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of Texas Health Science Center at Houston",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 5,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Nicotinamide Riboside (NR) to Treat Moyamoya-like Cerebrovascular Disease in Smooth Muscle Dysfunction Syndrome (SMDS)",
"nctId": "NCT06280482",
"orgStudyIdInfo": {
"id": "HSC-MS-23-0332",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Fluoro-18-Deoxyglucose (18F-FDG ) uptake in aortic wall as measured by positron emission tomography (PET)/computerized tomography (CT) imaging"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Levels of Nicotinamide adenine dinucleotide (NAD+) in whole blood as measured by high-performance liquid chromatography (HPLC)"
},
{
"measure": "Change in Levels of NR in whole blood as measured by high-performance liquid chromatography (HPLC)"
},
{
"measure": "Change in aortic measurements as assessed by echocardiography"
},
{
"measure": "Safety as assessed by number of participants that show drug toxicity as shown in bloodwork"
},
{
"measure": "Safety as assessed by number of participants that show drug toxicity as shown in bloodwork"
},
{
"measure": "Tolerability as assessed by the number of patients who complete study"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Texas Health Science Center, Houston"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-05"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Single-Balloon Enteroscopy"
}
]
},
"conditionsModule": {
"conditions": [
"Single-balloon Enteroscopy",
"Operation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xi'an",
"contacts": [
{
"email": "[email protected]",
"name": "Shuhui Liang",
"phone": "+862084771536",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xijing Hospital of Digestive Diseases",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SBE",
"briefTitle": "Single-operator Versus Double-operator in Single-Balloon Enteroscopy",
"nctId": "NCT06280469",
"orgStudyIdInfo": {
"id": "KY20232298-C-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum insertion depth"
}
],
"secondaryOutcomes": [
{
"measure": "Total enteroscopy rate"
},
{
"measure": "Positive findings"
},
{
"measure": "Advent events"
},
{
"measure": "procedural time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shuhui Liang"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tranexamic Acid Powder"
}
]
},
"conditionsModule": {
"conditions": [
"Anterior Cruciate Ligament Reconstruction",
"Tranexamic Acid",
"Hemarthrosis, Knee"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taipei",
"contacts": null,
"country": "Taiwan",
"facility": "Taipei Veterans General Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis and a functional deficit. Many antifibrinolytic agents, including tranexamic acid (TXA), have been used in orthopedic surgeries to reduce postoperative bleeding. Moreover, TXA was proved effective to reduced the events of hemarthrosis and increased the post-operative functional outcomes of the patients in several studies. The purpose of this study is to evaluate the efficacy of intra-articular injection of TXA with different drainage clamping time in patients receiving arthroscopic ACLRs. Patients were randomized into four groups. An intra-articular suction drain was placed recorded 24 h postoperatively. Group 1 patients(TXA 4hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 4 hours. Group 2 patients(TXA 8hr group) received the index procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 8 hours. Clinical evaluations using an IKDC functional score and a Visual Analogue Scale (VAS) pain score were performed during admission, at postoperative day 3 and week 4."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction",
"nctId": "NCT06280456",
"orgStudyIdInfo": {
"id": "2023-09-017A",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The volume of drainage"
}
],
"secondaryOutcomes": [
{
"measure": "Visual analog scale (VAS)"
},
{
"measure": "International Knee Documentation Committee (IKDC) functional score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Taipei Veterans General Hospital, Taiwan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-02-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-01-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Sarcopenia",
"COPD",
"Asthma",
"ILD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taichung",
"contacts": [
{
"email": "[email protected]",
"name": "Pin-Kuei Fu, MD, PhD",
"phone": "886-4-23592525",
"phoneExt": "3213",
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Taichung Veterans General Hospital",
"geoPoint": {
"lat": 24.1469,
"lon": 120.6839
},
"state": null,
"status": "RECRUITING",
"zip": "40705"
}
]
},
"descriptionModule": {
"briefSummary": "Inclusion criteria A)Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment.B) Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Sarcopenia in Chronic Lung Diseases",
"nctId": "NCT06280443",
"orgStudyIdInfo": {
"id": "CE22407B",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "sarcopenia rate"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Taichung Veterans General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-13"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Behcet Disease and Vascular Involvement"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "To measure the level of serum elafin in patients with behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Vascular Affection in Behcet Disease",
"nctId": "NCT06280430",
"orgStudyIdInfo": {
"id": "Vascular affection in behcet",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To measure the level of serum elafin in behcet patients and compare it with control group"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Unreamed intramedullary tibial nail"
}
]
},
"conditionsModule": {
"conditions": [
"Tibia Fracture"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome ."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults",
"nctId": "NCT06280417",
"orgStudyIdInfo": {
"id": "Unreamed IMN In IIIa tibia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of non union"
}
],
"secondaryOutcomes": [
{
"measure": "Incidince of fracture related infection"
},
{
"measure": "The rate of reoperation for delayed union or non-union , infection and fasciotomy"
},
{
"measure": "functional evaluation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Lap cholecystectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Cholecystitis, Chronic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this study is to evaluate the body first approach on the rate of conversion to open technique \\& VBI in patients with obscure calot's triangle."
},
"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": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle",
"nctId": "NCT06280404",
"orgStudyIdInfo": {
"id": "Body first in lap chole",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Safe laparoscopic cholecystectomy."
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of the body first approach technique"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Itepekimab (SAR440340)"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Bronchiectasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Westminster",
"contacts": null,
"country": "United States",
"facility": "Allianz Research Institute Site Number : 8400013",
"geoPoint": {
"lat": 33.75918,
"lon": -118.00673
},
"state": "California",
"status": "RECRUITING",
"zip": "92683"
},
{
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"zip": "NE29 8NH"
},
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"facility": "Investigational Site Number : 8260001",
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},
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"zip": "NE7 7DN"
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"facility": "Investigational Site Number : 8260005",
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},
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"zip": "RG1 5AN"
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},
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},
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},
{
"measure": "Change From Baseline in FEV1 at Week 8 and Week 24"
},
{
"measure": "Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use"
},
{
"measure": "Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24"
},
{
"measure": "Change from baseline in SGRQ total score at Week 24"
},
{
"measure": "Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24"
},
{
"measure": "Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period"
},
{
"measure": "Serum concentrations of itepekimab from baseline to end of study"
},
{
"measure": "Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study"
}
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},
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"date": "2024-02-28"
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"name": "KL003 Cell Injection Drug Product"
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},
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"name": "Wei Tang, PhD",
"phone": "+86 13472889588",
"phoneExt": null,
"role": "CONTACT"
},
{
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"name": "Saijuan Chen, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"status": null,
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},
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"email": "[email protected]",
"name": "Zhen Gao, Master",
"phone": "+86 15522360862",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jun Shi, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"lon": 117.17667
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},
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},
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"maximumAge": "35 Years",
"minimumAge": "3 Years",
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"stdAges": [
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"ADULT"
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},
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"link": null,
"type": null
},
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"measure": "KL003 engraftment"
},
{
"measure": "Engraftment time of neutrophil and platelet"
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{
"measure": "Overall Survival"
},
{
"measure": "The number, frequency and severity of adverse events (AE) within 1 year after infusion of KL003 drug products"
},
{
"measure": "Clonal dominance or secondary tumors caused by lentiviral vector insertional-mutation"
},
{
"measure": "Numbers of Participants With Vector-Derived Replication-Competent Lentivirus (RCL)"
}
],
"secondaryOutcomes": [
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"measure": "The proportion of participants achieved Transfusion Independence (TI)for at least 6 months"
},
{
"measure": "The proportion of participants achieved TI 12"
},
{
"measure": "The start time of Transfusion Independence (TI) after KL003 infusion"
},
{
"measure": "Total Hb and the vector-derived HbA^T87Q"
}
]
},
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"name": "Kanglin Biotechnology (Hangzhou) Co., Ltd."
}
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"date": "2024-02"
},
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"date": "2024-02-28"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Mulligan Mobilization with Movement Technique"
}
]
},
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"conditions": [
"Mobilization"
]
},
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{
"city": "Tuzla",
"contacts": null,
"country": "Turkey",
"facility": "Emine Atıcı",
"geoPoint": null,
"state": "İstanbul",
"status": null,
"zip": null
}
]
},
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"briefSummary": "The aim of this study is to investigate the effect of the MWM technique on pain, normal joint movement, proprioception and quality of life in patients with knee osteoarthritis (OA)."
},
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],
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"maximumAge": "65 Years",
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"sex": "ALL",
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]
},
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"acronym": null,
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"id": "012",
"link": null,
"type": null
},
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},
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"measure": "Visual Analog Scale (VAS)"
},
{
"measure": "Short form-36 (SF-36)"
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{
"measure": "Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC)"
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{
"measure": "Evaluation of proprioception"
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{
"measure": "The range of motion"
}
],
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},
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"date": "2024-03-15"
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"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Custom made Total Knee Arthroplasty"
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{
"name": "Functionally aligned robotically assisted total knee arthroplasty"
}
]
},
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"conditions": [
"Knee Osteoarthritis"
]
},
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{
"city": "Graz",
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"email": null,
"name": "Antonio Klasan, MD, PHD, EMBA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Austria",
"facility": "AUVA UKH Steiermark Standort Graz",
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"lon": 15.45
},
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"status": "RECRUITING",
"zip": "8020"
},
{
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{
"email": null,
"name": "Antonio Klasan, MD, PhD, EMBA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "AUVA UKH Steiermark Standort Kalwang",
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"lon": 14.75221
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"status": "RECRUITING",
"zip": "8775"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:* Which implant/philosophy yields better clinical outcomes?* Which implant/philosophy yields better satisfaction?* Which system is more OR efficient? Participants will be followed for 2 years postoperatively."
},
"designModule": {
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},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Knieathlon",
"briefTitle": "Robotic Assisted vs Custom Made Total Knee Arthroplasty",
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"id": "AUVA_Knieathlon_2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Clinical Outcome using the Forgotten Joint Score"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical outcomes using the Kujala anterior knee pain Score"
},
{
"measure": "Patient satisfaction"
},
{
"measure": "Visual analog pain (VAS) scale"
},
{
"measure": "Surgical and total theatre time"
},
{
"measure": "Opioid use"
},
{
"measure": "Number of physiotherapy sessions"
},
{
"measure": "Range of motion measurements (in degrees)"
},
{
"measure": "Radiographic data including radiolucent lines"
},
{
"measure": "Revision rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Austrian Workers Compensation Board Styria"
}
},
"statusModule": {
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"date": "2026-12"
},
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"date": "2024-03-12"
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"overallStatus": "RECRUITING",
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"date": "2024-12"
},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | {
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{
"date": "2023-11-27",
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"hasProtocol": true,
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"label": "Study Protocol and Statistical Analysis Plan",
"size": 156436,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-02-05T09:59"
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]
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} |
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"armsInterventionsModule": {
"interventions": [
{
"name": "Test two food cravings strategies during dietary weight loss"
},
{
"name": "Dietary weight loss program +Food cravings strategies"
}
]
},
"conditionsModule": {
"conditions": [
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"Food Cravings",
"Weight Loss"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Urbana",
"contacts": [
{
"email": "[email protected]",
"name": "Nouf Alfouzan",
"phone": "217-898-5480",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Bevier HAll UIUC",
"geoPoint": {
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"lon": -88.20727
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "61801"
},
{
"city": "Urbana",
"contacts": [
{
"email": "[email protected]",
"name": "Nouf Alfouzan",
"phone": "217-898-5480",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Manabu Nakamura",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Bevier HAll UIUC",
"geoPoint": {
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"lon": -88.20727
},
"state": "Illinois",
"status": "RECRUITING",
"zip": "61801"
}
]
},
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},
"designModule": {
"designInfo": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be enrolled in dietary weight loss program. Before the first meeting they will be randomized to one of the two study groups that focus on teaching participants different strategies to cope with food cravings (Inclusion vs. Avoidance).. To ensure balanced representation and meaningful study results, the randomization process will consider specific characteristics, including BMI category, sex, and age. This stratified randomization method helps us compare the effects of the intervention between different groups of participants.",
"maskingInfo": {
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"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "Food Cravings Strategies During Dietary Weight Loss",
"nctId": "NCT06280339",
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"id": "IRB23-0190",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Body weight"
},
{
"measure": "Food Craving Strategies Compliance"
},
{
"measure": "Food Cravings"
},
{
"measure": "Food Cravings"
}
],
"secondaryOutcomes": [
{
"measure": "Dietary intake"
}
]
},
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"class": "OTHER",
"name": "University of Illinois at Urbana-Champaign"
}
},
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"date": "2024-08-01"
},
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"date": "2024-02-28"
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"date": "2024-06-01"
},
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"startDateStruct": {
"date": "2024-01-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sunflower oil"
},
{
"name": "Slicone based spray"
}
]
},
"conditionsModule": {
"conditions": [
"Neonatal Skin Conditions"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Samsun",
"contacts": null,
"country": "Turkey",
"facility": "Hatice Uzşen",
"geoPoint": {
"lat": 41.27976,
"lon": 36.3361
},
"state": "Atakum",
"status": null,
"zip": "55100"
}
]
},
"descriptionModule": {
"briefSummary": "While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage."
},
"designModule": {
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]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
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"count": 86,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "36 Weeks",
"minimumAge": "32 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies",
"nctId": "NCT06280326",
"orgStudyIdInfo": {
"id": "Orogastric Tube Removal",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neonatal Skin Condition Score"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
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"class": "OTHER",
"name": "Ondokuz Mayıs University"
}
},
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"date": "2024-08-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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}
} | false | null |
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]
},
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"Unresectable Hepatocellular Carcinoma"
]
},
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{
"city": "Wuhan",
"contacts": [
{
"email": "[email protected]",
"name": "Zhiyong Huang",
"phone": "86-13995507729",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Erlei Zhang",
"phone": null,
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"role": "CONTACT"
}
],
"country": "China",
"facility": "Tongji Hospital",
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"zip": "430000"
}
]
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"briefSummary": "Currently, the combination of targeted therapy and immunotherapy is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, a subset of HCC patients with severe splenomegaly, splenic hyperfunction, and esophagogastric varices due to liver cirrhosis and portal hypertension may be unable to undergo or sustain the combination therapy, ultimately missing the optimal treatment window. Prior studies have indicated that splenectomy can significantly improve liver function and hepatic reserve in cirrhotic patients. It also addresses splenic hyperfunction and reduces the risk of bleeding from esophagogastric varices by combining splenectomy with devascularization around the cardia. Additionally, splenectomy contributes to the improvement of liver fibrosis and restoration of immune function in cirrhotic patients. This study aims to elucidate the impact of splenectomy on the efficacy of combination targeted and immunotherapy in unresectable HCC patients with cirrhotic portal hypertension, particularly those with poor liver function, significant splenic hyperfunction, and severe esophagogastric varices. The research also seeks to explore whether changes in the tumor immune microenvironment before and after splenectomy can influence the effectiveness of immunotherapy. Ultimately, the goal is to provide therapeutic opportunities for this specific patient population."
},
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{
"name": "Taihe Hospital"
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{
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{
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{
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{
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}
],
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"date": "2027-03-15"
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"date": "2024-03-15"
},
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"date": "2024-02-28"
}
}
} | false | null |
{
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},
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]
},
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"link": null,
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},
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},
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"otherOutcomes": [
{
"measure": "Exploratory survival outcome"
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],
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"measure": "Patient reported outcomes"
}
],
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"measure": "Feasibility"
},
{
"measure": "Patient understanding of prognosis"
},
{
"measure": "survival"
}
]
},
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},
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"date": "2025-11-01"
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"date": "2024-11-01"
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"date": "2023-11-16"
},
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"date": "2024-02-28"
}
}
} | false | null |
{
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"interventions": [
{
"name": "FAPI PET"
}
]
},
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"conditions": [
"Atherosclerosis"
]
},
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"locations": [
{
"city": "Beijing",
"contacts": [
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"email": "[email protected]",
"name": "Li Huo",
"phone": "86-13910801986",
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"role": "CONTACT"
}
],
"country": "China",
"facility": "Peking Union Medical College Hospital",
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"status": "RECRUITING",
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}
]
},
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"briefSummary": "Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome."
},
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"minimumAge": "18 Years",
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"stdAges": [
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]
},
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"acronym": null,
"briefTitle": "PET Imaging of Fibroblast Activation in Atherosclerosis",
"nctId": "NCT06280287",
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"id": "FAPI-PLAQUE",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "SUVmax of atherosclerotic plaque in carotid or coronary arteries"
},
{
"measure": "TBR of atherosclerotic plaque in carotid or coronary arteries"
}
],
"secondaryOutcomes": null
},
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"class": "OTHER",
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}
},
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"date": "2025-12-31"
},
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"date": "2024-02-28"
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"date": "2024-12-31"
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"startDateStruct": {
"date": "2021-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Metformin"
},
{
"name": "Placebo"
}
]
},
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"conditions": [
"Hyperglycemia"
]
},
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"locations": [
{
"city": "Portland",
"contacts": [
{
"email": "[email protected]",
"name": "Ryland Kagan",
"phone": "503-494-5649",
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"role": "CONTACT"
}
],
"country": "United States",
"facility": "Oregon Health & Science University",
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"status": null,
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"briefSummary": "The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial."
},
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"measure": "Rate of appropriate study drug administration"
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{
"measure": "Rate of participant retention to 90-day follow up"
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],
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{
"measure": "Perioperative glycemic variability"
},
{
"measure": "Sliding scale insulin utilization"
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{
"measure": "Hospital length of stay"
},
{
"measure": "90-day Rate of surgical site infection"
},
{
"measure": "90-day Rate of periprosthetic joint infection"
},
{
"measure": "90-day Rate of mortality"
},
{
"measure": "90-day rate of readmission"
}
]
},
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"date": "2024-02-26"
},
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"date": "2024-02-28"
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}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "parenting stress index, Zarit burden scale, Rosenberg self esteem scale, stait trait anxiety inventory, struggles and difficulties questionnaire"
}
]
},
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"conditions": [
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"Caregiver Burden",
"Life Stress"
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},
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{
"city": "Ankara",
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]
},
"descriptionModule": {
"briefSummary": "Objective: To assess the stress levels and life hardships of phenylketonuria patients and their parents."
},
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},
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{
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{
"measure": "Zarit burden scale"
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{
"measure": "Parenting stress index"
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},
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}
}
} | false | {
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"label": "Study Protocol and Statistical Analysis Plan",
"size": 288978,
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]
}
} |
{
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"interventions": [
{
"name": "Endoscopic ultrasound guided cystogastrostomy of symptomatic pancreatic pseudocyst"
}
]
},
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"conditions": [
"Pancreas Pseudocyst"
]
},
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"descriptionModule": {
"briefSummary": "The number as well as the caliber of plastic stents used for EUS-guided PFC drainage are controversial in current practice \\[Lin et al., 2014\\]. The timing of necrosectomy in WOPN drainage continues to be debated. To date, no comparative studies have been conducted to investigate the ideal timing for stent removal. Thus, the aim of our study is to:* Assess the technical success rates, clinical success rates and potential complications of the different techniques for the best drainage of PFCs as regard type, caliber and number of plastic stents and ideal timing for stent removal.* Compare between early vs late intervention for complete endoscopic necrosectomy of WOPN as regard technical success rates, clinical success rates, potential complications and number of sessions needed."
},
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},
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"acronym": null,
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"id": "EUS in pancreatic fluid",
"link": null,
"type": null
},
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{
"measure": "Complete resolution or a decrease in the sizes of pancreatic fluid collections (PFCs)"
}
],
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},
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"class": "OTHER",
"name": "Assiut University"
}
},
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"date": "2026-06"
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"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BI 1569912"
},
{
"name": "Placebo"
}
]
},
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"conditions": [
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]
},
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"locations": [
{
"city": "Marlton",
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{
"email": "[email protected]",
"name": "Boehringer Ingelheim",
"phone": "833-602-2368",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Hassman Research Institute",
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"lon": -74.92183
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "08053"
},
{
"city": "Cedarhurst",
"contacts": [
{
"email": "[email protected]",
"name": "Boehringer Ingelheim",
"phone": "833-602-2368",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Neurobehavioral Research, Inc.",
"geoPoint": {
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"lon": -73.7243
},
"state": "New York",
"status": "RECRUITING",
"zip": "11516"
},
{
"city": "Oklahoma City",
"contacts": [
{
"email": "[email protected]",
"name": "Boehringer Ingelheim",
"phone": "833-602-2368",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Sooner Clinical Research",
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"lon": -97.51643
},
"state": "Oklahoma",
"status": "RECRUITING",
"zip": "73112"
},
{
"city": "Wichita Falls",
"contacts": [
{
"email": "[email protected]",
"name": "Boehringer Ingelheim",
"phone": "833-602-2368",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Grayline Research Center",
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"lon": -98.49339
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"zip": "76309"
}
]
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},
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},
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},
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"type": "ESTIMATED"
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"phases": [
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],
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"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine",
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"id": "1447-0005",
"link": null,
"type": null
},
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{
"domain": "WHO International Clinical Trials Registry Platform (ICTRP)",
"id": "U1111-1297-3126",
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"type": "REGISTRY"
},
{
"domain": "CTIS",
"id": "2023-507942-10-00",
"link": null,
"type": "REGISTRY"
}
]
},
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"primaryOutcomes": [
{
"measure": "Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 8"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline in MADRS total score at Week 6"
},
{
"measure": "Response defined as ≥50% MADRS reduction from baseline at Day 8"
},
{
"measure": "Response defined as ≥50% MADRS reduction from baseline at Week 6"
},
{
"measure": "Remission defined as MADRS total score ≤10 at Week 6"
},
{
"measure": "Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score at Day 8"
},
{
"measure": "Change from baseline in SMDDS total score at Week 4"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Boehringer Ingelheim"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The VR instrument - Oculus Quest 2"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jerusalem",
"contacts": [
{
"email": "[email protected]",
"name": "Anat Hershko-Klement, M.D",
"phone": "+972549170084",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Israel",
"facility": "Hadassah mound scopus IVF unit",
"geoPoint": {
"lat": 31.76904,
"lon": 35.21633
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level ."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VRFORANXIETY",
"briefTitle": "The Effectiveness of Virtual Reality on Anxiety Reduction in Women Undergoing Elective Egg Cryopreservation.",
"nctId": "NCT06280222",
"orgStudyIdInfo": {
"id": "VR FOR ANXIETY-HMO-CTIL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Vital signs"
},
{
"measure": "Vital signs"
},
{
"measure": "VAS (visual-analogue scale)"
},
{
"measure": "State and Trait Anxiety (STAI) Score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hadassah Medical Organization"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BMN 351"
}
]
},
"conditionsModule": {
"conditions": [
"Duchenne Muscular Dystrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Soraya Peralta",
"phone": "+34 673200068",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Andres Nascimento",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Sant Joan de Deu",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08950"
},
{
"city": "Sevilla",
"contacts": [
{
"email": "[email protected]",
"name": "Carmen Silva",
"phone": "+34 669393637",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Marcos Madruga-Garrido",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Hospital Viamed Santa Angela De la Cruz",
"geoPoint": {
"lat": 37.38283,
"lon": -5.97317
},
"state": null,
"status": "RECRUITING",
"zip": "41013"
},
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Marta Zancolli",
"phone": "+44 (0)20 7905 2188",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Giovanni Baranello",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Kingdom",
"facility": "Great Ormond Street Hospital NHS Foundation Trust",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": "WC1N 3JH"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 18,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "4 Years",
"sex": "MALE",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy",
"nctId": "NCT06280209",
"orgStudyIdInfo": {
"id": "351-201",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "EU CT",
"id": "2023-506737-30-00",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "To evaluate the immune response to BMN 351."
},
{
"measure": "To evaluate the effect of BMN 351 on physical function."
},
{
"measure": "To evaluate the effect of BMN 351 on physical function."
},
{
"measure": "Change from baseline in dystrophin expression measured by Liquid chromatography-mass spectrometry (LC-MS)."
}
],
"primaryOutcomes": [
{
"measure": "To evaluate and safety and tolerability of single and multiple doses of BMN 351 (incidence, severity, and dose-relationship of adverse effects and changes in laboratory parameters)."
}
],
"secondaryOutcomes": [
{
"measure": "Pharmacokinetics (PK) concentration of BMN 351 in plasma, urine and muscle approximately every 8 weeks for up to 48 weeks."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "BioMarin Pharmaceutical"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BAT3306"
},
{
"name": "EU-Keytruda®"
},
{
"name": "US-Keytruda®"
},
{
"name": "Pemetrexed"
},
{
"name": "Carboplatin"
}
]
},
"conditionsModule": {
"conditions": [
"Carcinoma, Non-Small-Cell Lung"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "double-blind, randomized",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 676,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC",
"nctId": "NCT06280196",
"orgStudyIdInfo": {
"id": "BAT-3306-002-CR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "clinical equivalence"
}
],
"secondaryOutcomes": [
{
"measure": "safety of BAT3306-AE"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Bio-Thera Solutions"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Functional Inspiratory Muscle Training"
},
{
"name": "Aerobic+Resistive Exercise Traning"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals.This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a randomized, single-blind study three arm study.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The assessor will be blind to the group allocation, and participants will be blind to group allocation",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Functional Inspiratory Muscle Training in Obese Individuals",
"nctId": "NCT06280183",
"orgStudyIdInfo": {
"id": "323132",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Respiratory Muscle Strength"
},
{
"measure": "Incremental load test (Respiratory Muscle Endurance)"
},
{
"measure": "Forced expiratory volume 1st second (Respiratory Function)"
},
{
"measure": "Forced vital capacity (Respiratory Function)"
}
],
"secondaryOutcomes": [
{
"measure": "Comorbidity Assessment"
},
{
"measure": "Physical Activity Assessment"
},
{
"measure": "Edmonton Obesity Staging System (EOSS)"
},
{
"measure": "Functional Capacity"
},
{
"measure": "Peripheral Muscle Strength"
},
{
"measure": "Waist circumference"
},
{
"measure": "Hip circumference"
},
{
"measure": "Body fat-muscle ratios"
},
{
"measure": "Glucose profile"
},
{
"measure": "Lipid profile"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Istanbul Galata University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Biruni University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Artificial Intelligence platform for case managers"
}
]
},
"conditionsModule": {
"conditions": [
"Depressive Disorder",
"Anxiety Disorders",
"Substance Use Disorders",
"Post Traumatic Stress Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Alton",
"contacts": null,
"country": "United States",
"facility": "Centerstone",
"geoPoint": {
"lat": 38.8906,
"lon": -90.18428
},
"state": "Illinois",
"status": null,
"zip": "62002"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are:1. Is the AI platform acceptable and feasible for case managers?2. Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "This study will follow a stepped-wedge, randomized controlled design, where each provider team will undergo two phases: SAU and the AI platform phase. All teams will initially start with SAU, and the AI platform will be sequentially introduced to teams over time. Teams will be randomly assigned to different time periods for the AI platform phase using simple randomization. The order of implementation will be determined by randomly selecting the number of the team from sealed envelopes every two months. In both phases, the study will enroll new and existing clients. At the end of the trial all teams would have used Eleos for a few months",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "The masking in this study involves a differential approach between providers and clients. Providers will be aware of whether they are in the Services-As-Usual (SAU) or Artificial Intelligence (AI) phase. However, participating clients will not be informed about the platform their provider is using to document their therapy sessions.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 280,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "AI to Support Mental Health Case Management Providers",
"nctId": "NCT06280170",
"orgStudyIdInfo": {
"id": "ST11480",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Case manager satisfaction"
},
{
"measure": "Case manager productivity"
},
{
"measure": "Case manager note completion time"
}
],
"secondaryOutcomes": [
{
"measure": "Clients' crisis services utilization"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Centerstone Research Institute"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Eleos Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GBS-NN/NN2"
}
]
},
"conditionsModule": {
"conditions": [
"Group B Streptococcus Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Merthyr Tydfil",
"contacts": null,
"country": "United Kingdom",
"facility": "Simbec-Orion Clinical Pharmacology",
"geoPoint": {
"lat": 51.74794,
"lon": -3.37779
},
"state": "Pentrebach Merthyr Tydfil CF48 4DR",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations.Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 55,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Follow up Study of Group B Streptococcus Vaccine (GBS-NN/NN2 Vaccine) in Healthy Volunteers",
"nctId": "NCT06280157",
"orgStudyIdInfo": {
"id": "MVX0007",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IRAS",
"id": "332126",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Antibody Concentration Specific for GBS-NN and GBS-NN2"
},
{
"measure": "Antibody Responses Specific to AlpCN, RibN, Alp1N and Alp2-3N"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Simbec-Orion Group"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Minervax ApS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2028-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Influenza Vaccine, Live, Nasal, Freeze-dried"
},
{
"name": "Sterile water for inhalation"
}
]
},
"conditionsModule": {
"conditions": [
"Influenza Prevention"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chi Feng",
"contacts": [
{
"email": "[email protected]",
"name": "Xiaoling Tian",
"phone": "13848710296",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": null,
"geoPoint": null,
"state": "Inner Mongolia Autonomous Region",
"status": "RECRUITING",
"zip": "024000"
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6080,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine",
"nctId": "NCT06280144",
"orgStudyIdInfo": {
"id": "PF20230428",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Protective effect of COVID-19 cases."
}
],
"primaryOutcomes": [
{
"measure": "Primary influenza protective effect endpoint"
},
{
"measure": "Primary influenza protective effect endpoint"
}
],
"secondaryOutcomes": [
{
"measure": "Secondary protective efficacy endpoint"
},
{
"measure": "Secondary protective efficacy endpoint"
},
{
"measure": "Secondary protective efficacy endpoint"
},
{
"measure": "Safety"
},
{
"measure": "Study on detoxification"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hu Bei province Center for Disease control and prevention"
},
{
"name": "The Inner Mongolia Autonomous Region Center for Disease Control and Prevention"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Changchun BCHT Biotechnology Co."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Multiple Sclerosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This work is aimed to assess the short term effect of pulse therapy on clinical and neurophysiological course before and after pulse therapy in order to understand the possible mechanism of action of steroid therapy on RRMS patients low-dose oral treatment should also be retained for patients in whom this approach seems appropriate"
},
"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": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients:",
"nctId": "NCT06280131",
"orgStudyIdInfo": {
"id": "multiple sclerosis and pulse",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "to evaluate efficacy of a pulse therapy on clinical outcome"
}
],
"secondaryOutcomes": [
{
"measure": "clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional"
},
{
"measure": "clinical correlation between clinical scales scores and neurophysiological changes( cortical exitability parameters)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fatigue"
}
]
},
"conditionsModule": {
"conditions": [
"Resuscitation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Artvin",
"contacts": null,
"country": "Turkey",
"facility": "Resuscitation simulation laboratory of Artvin Çoruh University Health Services Vocational School",
"geoPoint": {
"lat": 41.18161,
"lon": 41.82172
},
"state": null,
"status": null,
"zip": "08000"
}
]
},
"descriptionModule": {
"briefSummary": "Background: This study, in contrast to the previous studies, generated a scenario of fatigue in an earthquake scenario and aimed to measure the effect of fatigue on the quality of cardiopulmonary resuscitation (CPR) performed by paramedics in a debris course.Methods: The study was designed as a randomized controlled trial. The sample, consisting of 84 paramedic students, was randomly assigned as 42 control and 42 experimental groups. Fatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track. A personal information form and a CPR measurement form were used to obtain the data. The simulator was used to evaluate the accuracy of CPR. The collected data were analysed with the statistical program."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Fatigue on CPR",
"nctId": "NCT06280118",
"orgStudyIdInfo": {
"id": "EFCPR008",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Correct number of ventilations"
},
{
"measure": "Correct number of compression"
}
],
"secondaryOutcomes": [
{
"measure": "CPR duration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Artvin Coruh University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-10-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cadonilimab+regorafenib"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fuzhou",
"contacts": null,
"country": "China",
"facility": "Mengchao Hepatobiliary Hospital, Fujian Medical University",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib."
},
"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": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib",
"nctId": "NCT06280105",
"orgStudyIdInfo": {
"id": "2023_148_01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "objective response rate (ORR) per RECIST1.1"
}
],
"secondaryOutcomes": [
{
"measure": "Progression-free survival（PFS）"
},
{
"measure": "Overall survival（OS）"
},
{
"measure": "Duration of response (DOR)"
},
{
"measure": "Occurence of AE and SAE"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Meng Chao Hepatobiliary Hospital of Fujian Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AMSCs"
}
]
},
"conditionsModule": {
"conditions": [
"Epilepsy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is a non-randomized, open label, phase 1 clinical trial to evaluate the fesibility and safety of intrathalamic delivery of MSCs during standard of care DBS surgery for epilepsy.Subjects will be screened at our outpatient clinic and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients will undergo a standard preoperative evaluation which includes baseline laboratory values and a high-definition MRI. Patients will then undergo a stereotactic procedure for bilateral thalamic implantation of DBS leads through the ClearPoint® system. After the thalamic target for DBS is identified, cells will be infused directly into the anterior nucleus of the thalamus previous to lead implantation.Patients will be followed in the outpatient setting for up to a year after therapy application.Surgical, clinical, and radiographic data will be obtained during these visits"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "A single dose of 5x10\\^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "This is an unmasked study",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 5,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery",
"nctId": "NCT06280092",
"orgStudyIdInfo": {
"id": "23-009133",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary Objective"
},
{
"measure": "Secondary Objective"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sanjeet S. Grewal"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultra-high-caloric fatty diet"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Amyotrophic Lateral Sclerosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aachen",
"contacts": null,
"country": "Germany",
"facility": "RWTH Aachen",
"geoPoint": {
"lat": 50.77664,
"lon": 6.08342
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Berlin",
"contacts": [
{
"email": null,
"name": "André Maier, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Charité Universitätsmedizin Berlin",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
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"zip": null
},
{
"city": "Bochum",
"contacts": null,
"country": "Germany",
"facility": "University Clinic Bochum",
"geoPoint": {
"lat": 51.48165,
"lon": 7.21648
},
"state": null,
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},
{
"city": "Bonn",
"contacts": [
{
"email": null,
"name": "Patrick Weydt, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Bonn",
"geoPoint": {
"lat": 50.73438,
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},
"state": null,
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},
{
"city": "Dresden",
"contacts": [
{
"email": null,
"name": "René Günther, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Technical University Dresden",
"geoPoint": {
"lat": 51.05089,
"lon": 13.73832
},
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},
{
"city": "Erlangen",
"contacts": [
{
"email": null,
"name": "Jürgen Winkler, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Erlangen",
"geoPoint": {
"lat": 49.59099,
"lon": 11.00783
},
"state": null,
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},
{
"city": "Essen",
"contacts": [
{
"email": null,
"name": "Torsten Grehl, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Alfried Krupp Krankenhaus Essen",
"geoPoint": {
"lat": 51.45657,
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},
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},
{
"city": "Göttingen",
"contacts": [
{
"email": null,
"name": "Jan C Koch, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Göttingen",
"geoPoint": {
"lat": 51.53443,
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"state": null,
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{
"city": "Halle",
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{
"email": null,
"name": "Elena Schlapakow, Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Halle",
"geoPoint": {
"lat": 51.48159,
"lon": 11.97948
},
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{
"city": "Hannover",
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{
"email": null,
"name": "Susanne Petri, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Hannover Medical School",
"geoPoint": {
"lat": 52.37052,
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},
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{
"city": "Jena",
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{
"email": null,
"name": "Annekathrin Rödiger, Dr.",
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"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Jena",
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{
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{
"email": null,
"name": "Clemens Eickhoff, Dr.",
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}
],
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"facility": "DRK Clinic Kassel",
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"lon": 9.5
},
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{
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{
"email": null,
"name": "Elmar Pinkhardt, Dr.",
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"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Klinikum Kempten",
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{
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{
"email": null,
"name": "Moritz Metelmann, Dr.",
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"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Leipzig",
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"lat": 51.33962,
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},
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{
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{
"email": null,
"name": "Julian Großkreutz, Prof. Dr.",
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"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Lübeck",
"geoPoint": {
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{
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}
],
"country": "Germany",
"facility": "University Clinic Mannheim",
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"lat": 49.4891,
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{
"email": null,
"name": "Paul Lingor, Prof. Dr.",
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"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Technical University Munich",
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{
"email": null,
"name": "Matthias Böntert, Dr.",
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"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Münster",
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}
],
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"facility": "University Clinic Regensburg",
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{
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},
{
"email": null,
"name": "Andreas Herrmann",
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "University Clinic Rostock",
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{
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{
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],
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"facility": "University of Ulm",
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{
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{
"email": null,
"name": "Bertold Schrank, Dr.",
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"role": "CONTACT"
}
],
"country": "Germany",
"facility": "DKD HELIOS Clinic Wiesbaden",
"geoPoint": {
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{
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{
"email": null,
"name": "Daniel Zeller, Dr.",
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"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Clinic Würzburg",
"geoPoint": {
"lat": 49.79391,
"lon": 9.95121
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}
]
},
"descriptionModule": {
"briefSummary": "This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 392,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LIPCAL-ALS II",
"briefTitle": "Ultra-high-caloric, Fatty Diet in ALS",
"nctId": "NCT06280079",
"orgStudyIdInfo": {
"id": "LIPCAL-ALS II 1.1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Microtubule-associated protein 2 in serum"
},
{
"measure": "Microtubule-associated protein 2 in cerebrospinal fluid"
},
{
"measure": "Ubiquitin carboxy-terminal hydrolase L1 in serum"
},
{
"measure": "Ubiquitin carboxy-terminal hydrolase L1 in cerebrospinal fluid"
},
{
"measure": "Transmembrane glycoprotein NMB in serum"
},
{
"measure": "Transmembrane glycoprotein NMB in cerebrospinal fluid"
},
{
"measure": "Human cartilage glycoprotein 39 in serum"
},
{
"measure": "Human cartilage glycoprotein 39 in cerebrospinal fluid"
},
{
"measure": "SNAP-25 in serum"
},
{
"measure": "SNAP-25 in cerebrospinal fluid"
},
{
"measure": "Beta-synuclein in serum"
},
{
"measure": "Beta-synuclein in cerebrospinal fluid"
},
{
"measure": "Aquaporin-4 in serum"
},
{
"measure": "Aquaporin-4 in cerebrospinal fluid"
},
{
"measure": "Glial fibrillary acidic protein in serum"
},
{
"measure": "Glial fibrillary acidic protein in cerebrospinal fluid"
},
{
"measure": "Soluble triggering receptor expressed on myeloid cell-1 in serum"
},
{
"measure": "Soluble triggering receptor expressed on myeloid cell-1 in cerebrospinal fluid"
},
{
"measure": "CC-chemokine ligand 2 in serum"
},
{
"measure": "CC-chemokine ligand 2 in cerebrospinal fluid"
},
{
"measure": "interleukin-1b in serum"
},
{
"measure": "interleukin-1b in cerebrospinal fluid"
},
{
"measure": "interleukin-2 in serum"
},
{
"measure": "interleukin-2 in cerebrospinal fluid"
},
{
"measure": "interleukin-4 in serum"
},
{
"measure": "interleukin-4 in cerebrospinal fluid"
},
{
"measure": "interleukin-6 in serum"
},
{
"measure": "interleukin-6 in cerebrospinal fluid"
},
{
"measure": "interleukin-10 in serum"
},
{
"measure": "interleukin-10 in cerebrospinal fluid"
},
{
"measure": "interleukin-12p70 in serum"
},
{
"measure": "interleukin-12p70 in cerebrospinal fluid"
},
{
"measure": "interleukin-17 in serum"
},
{
"measure": "interleukin-17 in cerebrospinal fluid"
},
{
"measure": "Tumor necrosis factor alpha in serum"
},
{
"measure": "Tumor necrosis factor alpha in cerebrospinal fluid"
}
],
"primaryOutcomes": [
{
"measure": "Survival"
}
],
"secondaryOutcomes": [
{
"measure": "Amyotrophic Lateral Sclerosis Functional Rating Scale Revised"
},
{
"measure": "Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale"
},
{
"measure": "Individual Quality of Life"
},
{
"measure": "Slow vital capacity"
},
{
"measure": "Survival"
},
{
"measure": "Survival"
},
{
"measure": "Time to death"
},
{
"measure": "Time to tracheostomy"
},
{
"measure": "Time to permanent continous ventilator dependence"
},
{
"measure": "Ventilation assistance-free survival"
},
{
"measure": "Body Mass Index"
},
{
"measure": "Council of Nutrition Appetite Questionnaire"
},
{
"measure": "Eating Habits"
},
{
"measure": "Neurofilament light chain"
},
{
"measure": "Amyotrophic Lateral Sclerosis Functional Rating Scale Revised Prediction Model"
},
{
"measure": "Neurofilament Assess Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Ulm"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-01"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers"
}
]
},
"conditionsModule": {
"conditions": [
"Cystic Fibrosis",
"Children",
"Resilience,Psychological",
"Laughter Yoga",
"Laughter Therapy",
"Mothers",
"Psychological Health",
"Lung Functions"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kayseri",
"contacts": [
{
"email": "[email protected]",
"name": "Selin Söyünmez",
"phone": "+905319762180",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Yağmur Sezer Efe, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Selin Söyünmez, PhD Student",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mehmet Köse, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Erciyes University",
"geoPoint": {
"lat": 38.73222,
"lon": 35.48528
},
"state": null,
"status": null,
"zip": "38000"
}
]
},
"descriptionModule": {
"briefSummary": "Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, prepared for children with CF (8-12 years old) and their mothers.In the first stage, the CF experiences of children with cystic fibrosis and how they perceive these experiences will be examined with visual phenomenology, and their mothers' CF experiences and perceptions will be examined with phenomenology. In this regard, 10 children will be asked to draw pictures and their pictures will be analyzed. In-depth individual interviews will be held with mothers.In the 2nd stage, the effectiveness of the Intervention Program Based on Strengthening Psychological Resilience for Children Diagnosed with Cystic Fibrosis and Their Mothers will be determined with a pre-test-post-test randomized controlled experimental design.In the literature review, Gpower analysis was performed (α: 0.05, β: 0.99, d: 1.88) based on the results of studies conducted with children diagnosed with CF and their parents, similar to this study, and 15 samples were used for each group. It is planned to recruit people. Considering the possibility of data loss in the study, it was always deemed appropriate to include 22 people for the group. It was planned to sample a total of 88 children with CF and their mothers, 44 in the intervention group and 44 in the control group. In the 3rd stage, after the experiment, the participants' experiences regarding the intervention program will be examined through interviews and qualitative research method. Thus, qualitative interviews will be conducted before and after the experiment. Data will be collected using these tools: Children; Child and Mother Descriptive Characteristics Form, Semi-Structured Interview Form,Respiratory Function Test, Reorganized Cystic Fibrosis Questionnaire, Psychological Resilience Attitude and Skills Scale and Functional Disability Inventory; Mothers; The Revised Cystic Fibrosis Questionnaire, The Depression Anxiety and Stress Scale, Post-Traumatic Growth Scale and Brief Psychological Resilience Scale. Measurements will be taken before the intervention, after the intervention, at the 1st and 3rd months."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 88,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers",
"nctId": "NCT06280066",
"orgStudyIdInfo": {
"id": "2023/607",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Respiratory Function Test"
},
{
"measure": "The Revised Cystic Fibrosis Questionnaire Child Form"
},
{
"measure": "Psychological Resilience Attitude and Skills Scale Child Form"
},
{
"measure": "Functional Disability Inventory Child"
},
{
"measure": "The Revised Cystic Fibrosis Questionnaire Parent Form"
},
{
"measure": "Depression Anxiety and Stress Scale"
},
{
"measure": "Post-Traumatic Growth Scale"
},
{
"measure": "Brief Psychological Resilience Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "TC Erciyes University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kirsehir Ahi Evran Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HealiAid Collagen Wound Dressing"
}
]
},
"conditionsModule": {
"conditions": [
"Venous Ulcers",
"Bedsores",
"Diabetic Foot Wound",
"Burn Wound"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds.The main questions it aims to answer are:1. The wound healing which was defined as the percentage of area change.2. The duration of wound healing.3. The granulation tissue growth of the wound.4. The wound exudate.5. Safety Indicators of which incidences after treatment.HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The patients' wound conditions were divided into four types: venous ulcers, bedsores, diabetic foot wounds and burn wounds.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 18,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "HealiAid in the Treatment of Different Wounds",
"nctId": "NCT06280053",
"orgStudyIdInfo": {
"id": "103-3024A3",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Wound Healing"
}
],
"secondaryOutcomes": [
{
"measure": "Wound Healing"
},
{
"measure": "Duration of Wound Healing"
},
{
"measure": "Granulation Tissue Growth"
},
{
"measure": "Wound Exudate"
},
{
"measure": "Incidence of Safety Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Maxigen Biotech Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2018-10-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2018-04-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-03-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Clinical examination and multimodal ocular imaging"
}
]
},
"conditionsModule": {
"conditions": [
"Uveal Melanoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Vienna",
"contacts": [
{
"email": "[email protected]",
"name": "Judith Kreminger, MD",
"phone": "0043 1 40400 48470",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Reinhard Told, MD, PhD, Priv.-Doz.",
"phone": "0043 1 40400 48470",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Adrian Reumueller, MD, Priv.-Doz",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Roman Dunavoelgyi, MD, Assoc.-Prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Austria",
"facility": "Department of Ophthalmology and Optometry, Medical University Vienna",
"geoPoint": {
"lat": 48.20849,
"lon": 16.37208
},
"state": null,
"status": "RECRUITING",
"zip": "1090"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma",
"nctId": "NCT06280040",
"orgStudyIdInfo": {
"id": "UM Longitudinal 1942/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence and Severity of Retinopathy"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence and Severity of Opticopathy"
},
{
"measure": "Functional Outcome"
},
{
"measure": "Incidence and Severity of Retinopathy and Opticopathy in oximeter"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Vienna"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-06"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "survey"
}
]
},
"conditionsModule": {
"conditions": [
"Esthetics, Dental"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "İstanbul",
"contacts": null,
"country": "Turkey",
"facility": "Marmara University Faculty of Dentistry",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": "34854"
}
]
},
"descriptionModule": {
"briefSummary": "In the web-based cross-sectional study 180 participants were included. Half of them (n = 90) were patients (laypeople) of the university clinic and the remaining half were restorative dentists and prosthodontists with similar levels of clinical experience (at least 3 years of academic training).A frontal view full-face portrait image of a 25-year-old female was selected as a model for the study, with a smile exhibiting good dental alignment, a quite good midline position, and tooth size symmetry.The original image was digitally modified by a single restorative instructor using Photoshop CC (Adobe, USA) software program. The modifications were divided into three parts. The first part was the generation of midline discrepancy at different levels. The midline was digitally moved to the right side of the patient 1 - 4 millimeters, gradually. The midline movement was performed together with the whole maxillary arch.The second part was the generation of individual crown width disproportions. Accordingly, the mesiodistal width of the left central, lateral, and canine was digitally decreased one by one, gradually, while the width of the symmetrical teeth on the right side was simultaneously increased.The third part was the generation of distributed crown width disproportions. Accordingly, the total mesiodistal width of the left central, lateral, and canine was equally decreased, gradually, while the total width of the symmetrical teeth on the right side was simultaneously increased.In total, 15 images were displayed in random order to the participants including the original image. An online survey was generated to quantitatively evaluate the level of esthetic perception. Subsequently, the participants were asked to evaluate the level of smile esthetics of the presented random images, without being informed about the digital manipulations of the images. The participants were even not informed about the original image. They were expected to answer the question \"How esthetic do you consider this smile?\" The evaluation of each image was performed via a Visual analog scale VAS, ranging from point 0 (extremely not esthetic) to point 100 (extremely esthetic)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 180,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Midline Discrepancy and Crown Width Disporportion on Esthetics",
"nctId": "NCT06280027",
"orgStudyIdInfo": {
"id": "MUDHF_BK1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "survey on midline discrepancy at different levels"
},
{
"measure": "survey on individual crown width disproportions"
},
{
"measure": "survey on distributed crown width disproportions"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Marmara University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Surgery of impacted mandibular wisdom teeth"
},
{
"name": "Surgery of impacted mandibular wisdom teeth"
}
]
},
"conditionsModule": {
"conditions": [
"Tooth, Impacted",
"Tooth Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Van",
"contacts": null,
"country": "Turkey",
"facility": "Serap Keskin Tunc",
"geoPoint": {
"lat": 38.49457,
"lon": 43.38323
},
"state": null,
"status": null,
"zip": "65100"
}
]
},
"descriptionModule": {
"briefSummary": "This study was administered to 22 female and 8 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After impacted tooth extraction, the patient used mefenamic acid on one side and dexketoprofen on the other side for postoperative pain relief. The effects of these two materials on patient comfort were investigated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Effects of Mefenamic Acid and Dexketoprofen on Postoperative Wisdom Dental Surgery",
"nctId": "NCT06280014",
"orgStudyIdInfo": {
"id": "YYU-09/15.12.2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mouth opening measurements"
},
{
"measure": "Facial edema"
},
{
"measure": "Visual Analog Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Yuzuncu Yıl University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-02-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Acquired Immunodeficiency Syndrome",
"HIV Infections"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to determine the incidence and spectrum of opportunistic infections among Chinese HIV/AIDS patients at this stage, to find intervention targets, to construct an early warning prediction model, and to give an individualized program with integrated immune function to obtain salvage opportunities for patients.The main questions it aims to answer are:* Describe the populations and characteristics of pathogenic microorganisms involved in HIV co-infection, map the spatial and temporal changes in the infection system of pathogenic microorganisms, and evaluate their impact on disease regression.* Explore the mechanism of interaction between pathogenic microorganisms and host autoimmune deficiencies.* Discover early warning and predictive markers and immunological indicators of pathogenic microorganisms, and explore new technologies and programs to reduce the mortality rate of infection."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
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},
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]
},
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"acronym": "BRING-UP3HF",
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}
],
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{
"measure": "Rate of patient achieving appropriate dosages of GDMTs"
},
{
"measure": "Treatment patterns of patients with Heart failure with mildly reduced ejection fraction (HFmrEF) and Heart failure with preserved ejection fraction (HFpEF)"
},
{
"measure": "Treatment patterns of patients with Acute Heart Failure (AHF) irrespective of the level of EF"
},
{
"measure": "All cause and specific causes of death and hospitalization (Exploratory endpoint)"
}
]
},
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},
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"date": "2023-09-15"
},
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"date": "2024-02-28"
}
}
} | false | null |
{
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},
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},
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"email": "[email protected]",
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{
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"email": "[email protected]",
"name": "Raoul Sutter, Prof.",
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{
"email": "[email protected]",
"name": "Pascale Grzonka, MD",
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}
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"zip": null
}
]
},
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},
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},
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"acronym": "INSPECT",
"briefTitle": "Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study",
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"orgStudyIdInfo": {
"id": "Req-2023-01275; am23Sutter2",
"link": null,
"type": null
},
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},
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{
"measure": "Reliability of clinical examination of pupils in patients with suspected brain death"
}
],
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},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Basel, Switzerland"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-12"
},
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"date": "2024-02-28"
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"date": "2029-12"
},
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"date": "2023-12-18"
},
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"date": "2024-02-28"
}
}
} | false | null |
{
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"name": "Survey questionnaire"
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"Stigma, Social"
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},
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"locations": [
{
"city": "Iganga",
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"facility": "Empowerment to Heal - Uganda",
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"lon": 33.46861
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"status": null,
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}
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},
"descriptionModule": {
"briefSummary": "This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness."
},
"designModule": {
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"allocation": "RANDOMIZED",
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},
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},
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"count": 379,
"type": "ACTUAL"
},
"phases": [
"NA"
],
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Survey Experiment to Estimate Level of Mental Illness Stigma Based on Condition and Gender",
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"id": "2000034620",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE"
},
{
"measure": "Level of acceptance for the individual depicted in the vignette as measured by BROAD ACCEPTANCE SCALE"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Empower Through Health"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Yale University"
}
},
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"date": "2023-09-15"
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"date": "2024-02-28"
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"date": "2023-09-15"
},
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"startDateStruct": {
"date": "2023-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Provider training"
},
{
"name": "Clinic protocols"
}
]
},
"conditionsModule": {
"conditions": [
"Hiv"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess the feasibility and acceptability of structural intervention components to increase adolescent HIV testing uptake by improving the implementation of confidential care as standard practice in pediatric primary care."
},
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"designInfo": {
"allocation": "RANDOMIZED",
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},
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"phases": [
"NA"
],
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},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Confidential Care and Adolescent HIV Testing",
"nctId": "NCT06279949",
"orgStudyIdInfo": {
"id": "2000036999",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NIMH *ID not yet added",
"id": "1K01MH136929-01",
"link": null,
"type": "OTHER"
}
]
},
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"primaryOutcomes": [
{
"measure": "Feasibility, defined as the extent to which structural intervention components to improve confidential care implementation can be successfully carried out in pediatric primary care settings"
},
{
"measure": "Acceptability, defined as the perception among pediatric primary care clinic leadership and providers that structural intervention components to improve confidential care implementation are agreeable or satisfactory"
},
{
"measure": "Change in HIV testing uptake"
}
],
"secondaryOutcomes": [
{
"measure": "Reach, defined as the number of adolescent patients who receive confidential care"
},
{
"measure": "Adoption, defined as the proportion of pediatric primary care providers who have time alone with and/or provide confidentiality assurances to adolescent patients"
},
{
"measure": "Implementation, defined as pediatric primary care provider fidelity to confidential care provision"
},
{
"measure": "Maintenance, defined as the extent to which confidential care is provided and adolescent patients are screened for, accept, and receive results of HIV testing 6-months post-intervention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Mental Health (NIMH)"
}
],
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"name": "Yale University"
}
},
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"date": "2027-10"
},
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"date": "2027-10"
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"startDateStruct": {
"date": "2026-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neuropsychological battery"
},
{
"name": "Surveys and symptom severity questionnaires"
},
{
"name": "Blood withdrawal"
},
{
"name": "Saliva swabs"
}
]
},
"conditionsModule": {
"conditions": [
"Long COVID"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Duffel",
"contacts": null,
"country": "Belgium",
"facility": "SINAPS",
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"lon": 4.50903
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"state": "Antwerp",
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"zip": "2570"
}
]
},
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},
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},
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"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": "Cov-N-Psy",
"briefTitle": "Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID",
"nctId": "NCT06279936",
"orgStudyIdInfo": {
"id": "B3002021000171",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Concentration of immunological and HPA-axis markers"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of psychopathological and neurocognitive function of long COVID patients with neuropsychiatric complaints"
},
{
"measure": "Cross-sectional and longitudinal association between long COVID NP symptoms (BDI, HDRS, STAI, ISI, KEDS, FSS, NP battery ...) and immunological and cortisol measures (CAR, cytokines, serology, WBC, CRP, mitochondrial markers, TRYCATS, ...)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "UZA Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universiteit Antwerpen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2022-10-01",
"filename": "Prot_SAP_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 1140716,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2024-02-08T04:56"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CD19-BAFF Targeted CAR T-cells"
}
]
},
"conditionsModule": {
"conditions": [
"Autoimmune Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "He Huang, MD",
"phone": "86-13605714822",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yongxian Hu, MD",
"phone": "+8615957162012",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "The first affiliated hospital of medical college of zhejiang university",
"geoPoint": {
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"lon": 120.16142
},
"state": "Zhejiang",
"status": "RECRUITING",
"zip": "310000"
}
]
},
"descriptionModule": {
"briefSummary": "Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases."
},
"designModule": {
"designInfo": {
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"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases",
"nctId": "NCT06279923",
"orgStudyIdInfo": {
"id": "TXB2023023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dose-limiting toxicity (DLT)"
},
{
"measure": "Incidence of treatment-emergent adverse events (TEAEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Multiple Myeloma (MM), Overall response rate (ORR)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Duration of remission,DOR"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shanghai YaKe Biotechnology Ltd."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Calcifediol"
}
]
},
"conditionsModule": {
"conditions": [
"SARS-CoV 2 Pneumonia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Albacete",
"contacts": [
{
"email": "[email protected]",
"name": "Jose A Blazquez, MD",
"phone": "+34967597100",
"phoneExt": "37214",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Laura Navarro, MD",
"phone": "+34967597460",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Javier Torres, PhD.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Spain",
"facility": "Complejo Hospitalario Universitario de la Gerencia de Atención Integrada (GAI) de Albacete",
"geoPoint": {
"lat": 38.99424,
"lon": -1.85643
},
"state": null,
"status": "RECRUITING",
"zip": "02008"
},
{
"city": "Cordoba",
"contacts": null,
"country": "Spain",
"facility": "Maimónides Biomedical Research Institute of Córdoba (IMIBIC).",
"geoPoint": {
"lat": 37.89155,
"lon": -4.77275
},
"state": null,
"status": "WITHDRAWN",
"zip": "14004"
}
]
},
"descriptionModule": {
"briefSummary": "Descriptive, retrospective, observational, anonymous, study to evaluate the potential effect of incorporating calcifediol into the therapeutic protocol of patients hospitalized for COVID-19 on mortality and other outcome variables, such as admission to the Intensive Care Unit (ICU), to \"Gerencia de Atención Integrada (GAI) de Albacete\". \"Complejo Hospitalario Universitario de Albacete\". Albacete (Spain)\", based on the files of the MXXI medical records, Information System of the Laboratory (ISL) and Pharmacy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 275,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "COVIDIOL",
"briefTitle": "Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).",
"nctId": "NCT06279910",
"orgStudyIdInfo": {
"id": "2021 36 (EOm)",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Measure mortality by differentiating groups: calcifediol yes/no."
},
{
"measure": "Measure the need for ICU admission by differentiating the groups calcifediol yes/no."
}
],
"secondaryOutcomes": [
{
"measure": "Measure mortality in relation to baseline 25(OH)D levels"
},
{
"measure": "To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency"
},
{
"measure": "Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Complejo Hospitalario Universitario de Albacete"
}
},
"statusModule": {
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"date": "2024-04-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
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"date": "2024-03-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Skin Surface Rewarming"
},
{
"name": "Skin Surface Warming"
},
{
"name": "Skin Surface Heating"
},
{
"name": "Skin Surface Cooling"
}
]
},
"conditionsModule": {
"conditions": [
"Blood Pressure",
"Blood Loss"
]
},
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"locations": [
{
"city": "Colorado Springs",
"contacts": [
{
"email": "[email protected]",
"name": "James Pearson, PhD",
"phone": "719-255-3806",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Colorado Colorado Springs",
"geoPoint": {
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"lon": -104.82136
},
"state": "Colorado",
"status": "RECRUITING",
"zip": "80918"
}
]
},
"descriptionModule": {
"briefSummary": "Assess the effect of skin rewarming during lower body negative pressure upon arterial blood pressure and tolerance to simulated blood loss after exercise in the cold."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Participants will complete trial 1 at the beginning of the study. Participants will then complete trials 2 through 5 in a random, counterbalanced order.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Participants are blinded to the skin temperature control.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "LBNP Tolerance With Skin Warming After Exercise Cold Stress",
"nctId": "NCT06279897",
"orgStudyIdInfo": {
"id": "2023-068",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Arterial blood pressure"
},
{
"measure": "Tolerance to simulated blood loss"
}
],
"secondaryOutcomes": [
{
"measure": "Core temperature"
},
{
"measure": "Cutaneous Vascular Conductance"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Colorado, Colorado Springs"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
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"startDateStruct": {
"date": "2022-01-24"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-01-03",
"filename": "Prot_ICF_000.pdf",
"hasIcf": true,
"hasProtocol": true,
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"label": "Study Protocol and Informed Consent Form",
"size": 315418,
"typeAbbrev": "Prot_ICF",
"uploadDate": "2024-02-22T15:33"
}
]
}
} |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Liver Transplantation",
"Transplant Recipients"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are:* Characterize the distribution of pathogenic bacteria infecting liver transplant recipients.* Establish a monitoring and early warning system for secondary infections."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
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},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection",
"nctId": "NCT06279884",
"orgStudyIdInfo": {
"id": "2023YFC2308802-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Secondary Infections in liver transplant recipients at 4 weeks"
},
{
"measure": "quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Occurrence of secondary infections in liver transplant recipients at 8 weeks, including site of infection, pathogen of infection"
},
{
"measure": "Occurrence of secondary infections in liver transplant recipients at 12 weeks, including site of infection, pathogen of infection"
},
{
"measure": "qSOFA score at 8 weeks"
},
{
"measure": "qSOFA score at 12 weeks"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Beijing Ditan Hospital"
},
{
"name": "Beijing YouAn Hospital"
},
{
"name": "Huashan Hospital"
},
{
"name": "Qilu Hospital of Shandong University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-04"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ARCT-2303"
},
{
"name": "Influenza vaccine"
},
{
"name": "Influenza vaccine, adjuvanted"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"COVID-19"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine."
},
"designModule": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 1680,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults",
"nctId": "NCT06279871",
"orgStudyIdInfo": {
"id": "ARCT-2303-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "SARS-CoV-2 neutralizing antibody titers"
},
{
"measure": "SARS-CoV-2 neutralizing antibody seroconversion rates"
},
{
"measure": "Hemagglutination Inhibition (HI) titers"
},
{
"measure": "SARS-CoV-2 neutralizing antibody titers"
}
],
"secondaryOutcomes": [
{
"measure": "SARS-CoV-2 neutralizing antibody titers"
},
{
"measure": "SARS-CoV-2 neutralizing antibody seroconversion rates"
},
{
"measure": "SARS-CoV-2 neutralizing antibody response (Group 1a; Group 2a)"
},
{
"measure": "Hemagglutination Inhibition (HI) titers"
},
{
"measure": "SARS-CoV-2 neutralizing antibody responses"
},
{
"measure": "Hemagglutination Inhibition (HI) assay titers"
},
{
"measure": "Local and systemic adverse events (AEs)"
},
{
"measure": "Unsolicited AEs"
},
{
"measure": "SAE, Medically Attended Adverse Events (MAAE), Adverse Events of Special Interest (AESI), and AE leading to early termination"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Seqirus"
},
{
"name": "Novotech (Australia) Pty Limited"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Arcturus Therapeutics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-10"
},
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"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Probiotics"
}
]
},
"conditionsModule": {
"conditions": [
"Fragile X Syndrome"
]
},
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"locations": [
{
"city": "Belgrade",
"contacts": [
{
"email": "[email protected]",
"name": "Dragana Protic, Prof.",
"phone": "+381640667466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Sanja Dimitrijevic, PhD",
"phone": "+381640667466",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Serbia",
"facility": "Special Hospital for Cerebral Palsy and Developmental Neurology",
"geoPoint": {
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"lon": 20.46513
},
"state": null,
"status": "RECRUITING",
"zip": "11000"
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this clinical trial is to evaluate efficacy of probiotic mixture which contains Lactobacillus casei, Lactobacillus salivarius and Bifidobacterium breve, in children with Fragile X aged 3-18 years. Specifically, links between microbiome modifications by probiotic mixture and behavioral manifestations and brain processing (eye tracker, EEG analysis) will be assessed. Exploratory objects of this trial are analyses of microbiome composition and assessment of its alterations and modifications (by probiotic mixture) that may lead to clinical improvement and prediction which patients with FXS may be likely to benefit from probiotics treatment.This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. The study plans to enroll 15 participants with FXS, aged 3-18 years, both sexes, during 1-year period and complete all study-related activities by January 2025. During the 3-month study period, subjects will attend three visits (screening/baseline, 6-week, and 3-month visits) to the Fragile X Clinic at the Special Hospital for Cerebral Palsy and Developmental Neurology, Belgrade, Serbia. The primary outcome measureswill be Vineland Adaptive Behavior Scales-Third Edition (VABS-III) and eye tracking measures (social gaze and pupillometry). Exploratory endpoint will be microbiome analyses. Secondary outcome measures will be: CGI-S and CGI-I scores, ABC-CFX score, quality of life, sleep habits and EEG analyses."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is open label trial without masking, where each participant receives probiotic for 3 months (12 weeks). It will be single group assignment. In this approach, participants act as their own controls by measuring the microbiome and other parameters before and after taking the probiotics. This design was chosen because individual's microbiome is highly personalized. Even within a family, individuals can have distinct microbiomes. The unique composition of an individual's microbiome can have implications for the effectiveness of probiotics. Thus, changes in analyses and scores between baseline and 3-month study period will be assessed for everyone. Specifically, microbiome modifications that may be associated with changes in behavior and brain processing will be examined.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Probiotic Intervention for Microbiome Modifications and Clinical Improvements in Fragile X Syndrome",
"nctId": "NCT06279858",
"orgStudyIdInfo": {
"id": "1-2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Microbiome analyses"
}
],
"primaryOutcomes": [
{
"measure": "1. Vineland Adaptive Behavior Scales-Third Edition (VABS-III)"
},
{
"measure": "Eye tracking"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical Global Impression Scales of Severity (CGI-S) and Improvement (CGI-I) -"
},
{
"measure": "The Aberrant Behavior Checklist - Community Edition (ABC-C), scored using the FXS-specific factoring system (ABC-CFX)"
},
{
"measure": "Pediatric Quality of Life Questionnaire (PedsQL) Parent Proxy"
},
{
"measure": "Child Sleep Habits Questionnaire (CSHQ)"
},
{
"measure": "EEG analyses"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "FRAXA Research Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Specila hospital for cerebral palsy and developmental neurology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
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"date": "2024-12-31"
},
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"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Liver Cirrhosis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are:* Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis.* Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression."
},
"designModule": {
"designInfo": {
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},
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"count": 2000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection",
"nctId": "NCT06279845",
"orgStudyIdInfo": {
"id": "2023YFC2308802-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Secondary infection in patients at 4 weeks"
},
{
"measure": "quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Survival rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Beijing Ditan Hospital"
},
{
"name": "Beijing YouAn Hospital"
},
{
"name": "Huashan Hospital"
},
{
"name": "Qilu Hospital of Shandong University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Zhejiang University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-04"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "trascriptomic profiling"
}
]
},
"conditionsModule": {
"conditions": [
"Endometrial Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": [
{
"email": "[email protected]",
"name": "francesco fanfani",
"phone": "0630151",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione Policlinico Agostino Gemelli IRCSS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "Lazio",
"status": "RECRUITING",
"zip": "00118"
}
]
},
"descriptionModule": {
"briefSummary": "The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "As far as the sample size concerns, the number of images required for the analysis are a figure of at least 100 positive cases (15). We considered as positive patients with a favorable prognostic profile according to PORTEC-4a and also low and intermediate risk class according to ESGO/ESTRO/ESP 2020 recommendations.Therefore, we estimate to enroll at least 1000 patients in order to reach the 100 positive cases.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Romantic",
"briefTitle": "Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.",
"nctId": "NCT06279832",
"orgStudyIdInfo": {
"id": "3994",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Predictive value of the model"
}
],
"secondaryOutcomes": [
{
"measure": "Validity of the model"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
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"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "gut microbiota-targeted dietary intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Hiv",
"Cardiovascular Diseases",
"Diet, Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Junwen Yu",
"phone": "13320178333",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Fudan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:* Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.* Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.* Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 106,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients",
"nctId": "NCT06279819",
"orgStudyIdInfo": {
"id": "2024-008",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ASCVD risk estimated by the PCE"
},
{
"measure": "The composition of gut microbiota"
}
],
"secondaryOutcomes": [
{
"measure": "fasting blood lipids"
},
{
"measure": "blood pressure"
},
{
"measure": "BMI"
},
{
"measure": "ASCVD symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fudan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mobile health application use"
},
{
"name": "Information of the breast cancer survivor period booklet"
}
]
},
"conditionsModule": {
"conditions": [
"Posttraumatic Growth",
"Grief"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Treatments are aimed at prolonging survival from breast cancer and enabling patients to live better. Women repeatedly experience many vital crises such as the diagnosis of cancer, the difficulties of the treatment process and the fear of recurrence in the post-treatment period. In the face of these crises, post-traumatic growth occurs when the individual's efforts to cope are transformed into positive psychological experiences. Positive experiences lead to improvement in women's life, while negative experiences make it difficult to cope and adapt. In order for post-traumatic growth to take place, women should be supported to cope with these negative emotions. The care given to patients during cancer treatment should be such as to support the change process that will help individuals adapt to the new lifestyle.This information and supportive care content should include the topics that women will need in the long term after the treatment, in addition to the diagnosis and treatment process. Generally, the education and counseling given to the patient at the last treatment appointment may be limited. Due to the long period from the last treatment appointment to the control appointment, patients cannot interact with healthcare professionals for a long time. Long-term side effects and needs of people may differ after breast cancer treatment. For this reason, the need for information and consultancy services of healthcare professionals continues in this process as well.Today, the use of remotely accessible mechanisms in the treatment of breast cancer and in the follow-up of women after treatment is increasing. It is thought that the mobile application to be developed within the scope of the project will increase the quality and efficiency of health services with an R\\&D and innovative approach and make these services accessible to everyone through digital technologies. In addition, our study will set an example for nursing care to be presented in one of the priority areas of health, such as cancer, through digital technologies. In our study, it is aimed to evaluate the effect of mobile health application based on Mezirow's Transformational Learning Theory on post-traumatic development in women with breast cancer. The research is a single center, parallel group, stratified block randomized controlled experimental study. It is planned to be conducted with 56 (intervention: 28, control: 28) women at Gazi University Health Research and Practice Center. The training content to be included in the mobile application has been determined by considering the results of the studies in the literature and the recommendations of international guides to determine the problems experienced by women with breast cancer during the post-treatment period. After receiving expert opinions on the subject content, the development process of the mobile application will be started. In the implementation phase of the study, the women in the intervention group will start using the mobile application 1 week after completing the active treatment chemotherapy and radiotherapy) process.The implementation of the study will last 8 weeks. At the end of eight weeks, data collection tools will be applied to the women. The final tests will be repeated 4 weeks after the end of the application. Starting from this period, women in the control group who want to use the application will also be included in the mobile application system. After completing the data collection tools, the analysis and reporting part will be started. Statistical analyzes will be made using SPSS Package Program (IBM SPSS Statistics 27). Student t test, Pearson Chi-square test, Independent Sample t test, Mann Whitney U test, One-Way Analysis of Variance or Friedman test will be used in the analyses."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In order to ensure similarity between the groups, stratified block randomization will be used to assign the women in the sample group to the experimental and control groups. In this method, after stratification according to risk factors, block randomization is performed within each stratum. Since the type of treatment applied in breast cancer and marital status will significantly affect posttraumatic development, stratification was made in terms of these parameters. Stratum 1 in terms of treatment type: Mastectomy, 2nd stratum: Breast conserving surgery or reconstructive surgery during mastectomy; Stratum 1 in terms of partner presence: Has a partner, Stratum 2: No partner. In order to determine which stratum group the women who were found to meet the research criteria and who agreed to participate in the study were in, blocks will be formed with a combination of 4 and the assignment list will be determined through the www.randomizer.org website.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The data obtained from the research will be coded as A and B by an independent researcher and transferred to the SPSS program. The data will also be analyzed by an independent statistician.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 56,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer",
"nctId": "NCT06279806",
"orgStudyIdInfo": {
"id": "SerapAlkas",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Women's progression through the stages of grief"
}
],
"secondaryOutcomes": [
{
"measure": "Women's increased level of posttraumatic development"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Gazi University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Long-chain n-3 fatty acids"
},
{
"name": "Intravenous 0.9% Sodium Chloride"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Surgery",
"High Risk Patients",
"Intensive Care Unit",
"Cardiopulmonary Bypass",
"Valve Surgeries"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aachen",
"contacts": [
{
"email": "[email protected]",
"name": "Moritz Immohr, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Aileen Hill, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "RWTH Aachen University",
"geoPoint": {
"lat": 50.77664,
"lon": 6.08342
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Berlin",
"contacts": [
{
"email": "[email protected]",
"name": "Sascha Ott, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Maren Kleine-Brüggeney, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Charité Universitätsmedizin Berlin",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Bonn",
"contacts": [
{
"email": "[email protected]",
"name": "Markus Velten, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Maria Wittmann, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University of Bonn",
"geoPoint": {
"lat": 50.73438,
"lon": 7.09549
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Göttingen",
"contacts": [
{
"email": "[email protected]",
"name": "Reiner Wäschle, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Anselm Bräuer, M.D.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Universität Göttingen",
"geoPoint": {
"lat": 51.53443,
"lon": 9.93228
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Kiel",
"contacts": [
{
"email": "[email protected]",
"name": "Elke Gunnar, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Matthias Lindner, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Medical Center Schleswig-Holstein",
"geoPoint": {
"lat": 54.32133,
"lon": 10.13489
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Münster",
"contacts": [
{
"email": "[email protected]",
"name": "Alexander Zarbock, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Carola Wempe, M.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University of Muenster",
"geoPoint": {
"lat": 51.96236,
"lon": 7.62571
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only.In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous FO- based lipid emulsion (Omegaven®), or placebo.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Researchers and clinical staff will be blinded to study intervention allocation. Unblinded delegate at each site will be able to prepare and dispense the investigational drug or placebo.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MODIFYCSX",
"briefTitle": "Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients.",
"nctId": "NCT06279793",
"orgStudyIdInfo": {
"id": "MODIFYCSX",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Optional-Ultrasound measurement"
},
{
"measure": "Optional-Functional Status Score for Intensive Care Unit"
},
{
"measure": "Optional-Short Physical Performance Battery test"
},
{
"measure": "Optional-Hand grip dynamometer"
},
{
"measure": "Optional-Hand held dynamometer"
},
{
"measure": "Optional-Manual Muscle Testing"
},
{
"measure": "Optional-Left ventricular ejection function"
},
{
"measure": "Optional-Markers of inflammation"
},
{
"measure": "Optional-Hemodynamics"
},
{
"measure": "Sub-study"
}
],
"primaryOutcomes": [
{
"measure": "Atrial fibrillation"
}
],
"secondaryOutcomes": [
{
"measure": "Weaning from cardiopulmonary bypass (CPB)"
},
{
"measure": "Time to discharge alive"
},
{
"measure": "Persistent Organ Dysfunction + Death"
},
{
"measure": "Days alive and out of hospital"
},
{
"measure": "Hospital length of stay"
},
{
"measure": "ICU length of stay"
},
{
"measure": "Simplified Acute Physiology Score"
},
{
"measure": "Therapeutic Intervention Scoring System"
},
{
"measure": "ICU and Hospital Readmission rates"
},
{
"measure": "Delta Sequential Organ Failure Assessment Score (SOFA) Score"
},
{
"measure": "Mechanical ventilation"
},
{
"measure": "Stroke"
},
{
"measure": "Acute Kidney Injury"
},
{
"measure": "Infections rate"
},
{
"measure": "Clinical frailty scale"
},
{
"measure": "Development of delirium"
},
{
"measure": "Survival status"
},
{
"measure": "Physical activity assessment"
},
{
"measure": "Quality of Life (SF-36)"
},
{
"measure": "Adverse Events"
},
{
"measure": "Postoperative bleeding"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Charite University, Berlin, Germany"
},
{
"name": "Wuerzburg University Hospital"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "GCP-Service International West GmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "very low-calorie diet"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity Adult Onset"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Valencia",
"contacts": null,
"country": "Spain",
"facility": "FISABIO",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": null,
"zip": "46020"
}
]
},
"descriptionModule": {
"briefSummary": "It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI\\>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function \\[total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry\\], markers of mitochondrial dynamics \\[Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot\\], markers of inflammation \\[Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 109,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity",
"nctId": "NCT06279780",
"orgStudyIdInfo": {
"id": "PI18/00932",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Analyze the changes in the diversity of the intestinal microbiota after dietetic intervention."
},
{
"measure": "Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present metabolically healthy obesity (MHO) or metabolically unhealthy obesity (MUHO)."
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate significant changes in body fat mass percentage after the dietetic intervention."
},
{
"measure": "Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietetic intervention."
},
{
"measure": "Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention."
},
{
"measure": "Assess significant changes in plasmatic homocysteine as an inflammatory parameter after the dietetic intervention."
},
{
"measure": "Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention."
},
{
"measure": "Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention."
},
{
"measure": "Evaluate significant changes in tumor necrosis factor alpha (TNF-alpha) levels as a pro-inflammatory molecule after the dietetic intervention."
},
{
"measure": "Assess significant changes in superoxide dismutase (SOD) levels after the dietetic intervention."
},
{
"measure": "Analyze the significant differences between metabolomic profile before and after the dietetic intervention."
},
{
"measure": "Evaluate if there is a significant reduction after the dietetic intervention in total ROS levels."
},
{
"measure": "Assess if there is a significant reduction after the dietetic intervention in glutathione levels."
},
{
"measure": "Analyze if there is a significant change after the dietetic intervention in total free radicals and superoxide levels."
},
{
"measure": "Analyze if there is a significant reduction after the dietetic intervention in mitochondrial ROS production."
},
{
"measure": "Evaluate if there is a significant improvement after the dietetic intervention in mitochondrial membrane potential."
},
{
"measure": "Analyze the proportion of subjects achieving at least 10% reduction in weight compared with baseline."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto de Salud Carlos III"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Celia Bañuls"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "6-mercaptopurine"
}
]
},
"conditionsModule": {
"conditions": [
"Glioblastoma",
"Cancer",
"Temozolomide"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": "[email protected]",
"name": "Yongping You, PhD",
"phone": "13770694258",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Department of Neurosurgery of The First Affiliated Hospital of Nanjing Medical University",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "210029"
}
]
},
"descriptionModule": {
"briefSummary": "Glioblastoma, the most prevalent malignant tumor in the central nervous system, is characterized by high invasiveness and a propensity to recur, contributing to a relatively elevated mortality rate. Patients diagnosed with high-grade glioblastomas typically experience a median survival period of less than 14 months. Presently, the standard treatment for glioblastoma involves surgical resection combined with postoperative radiotherapy and chemotherapy, with postoperative chemotherapy playing a pivotal role in enhancing patient prognosis. Temozolomide (TMZ), a cutting-edge oral alkylating agent known for its advantageous properties, including easy traversal of the blood-brain barrier, induces DNA alkylation in tumor cells, fostering apoptosis. Currently, it serves as a frontline medication for postoperative chemotherapy in glioblastoma. However, clinical resistance to TMZ chemotherapy significantly hampers its efficacy in later stages. We have recently discovered and validated that 5-aminoimidazole-4-carboxamide (AICA), derived from TMZ, can transform into 5-aminoimidazole-4-carboxamide ribonucleotide-5-phosphate (AICAR) in GBM cells. Hypoxanthine phosphoribosyltransferase 1 (HPRT1) has been identified as the catalyst for the AICA reaction, generating AICAR. AICAR acts as an endogenous activator of AMP-activated protein kinase (AMPK), fostering chemoresistance in glioblastoma through the activation of the AMPK signaling pathway. 6-mercaptopurine (6-MP) competes effectively to inhibit HPRT1 activity, thereby impeding TMZ-induced AMPK activation and significantly heightening glioblastoma cell sensitivity to TMZ. In this project, we propose an innovative strategy involving the combination of 6-MP with TMZ for the treatment of glioblastoma."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 27,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma",
"nctId": "NCT06279767",
"orgStudyIdInfo": {
"id": "2022-SR-557",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PFS"
}
],
"secondaryOutcomes": [
{
"measure": "OS"
},
{
"measure": "Safety evaluation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital with Nanjing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Recombinant Human Endostatin Injection"
}
]
},
"conditionsModule": {
"conditions": [
"Locally Advanced Squamous Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy",
"nctId": "NCT06279754",
"orgStudyIdInfo": {
"id": "ZLXGBXKYXM-031-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "objective response rate"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Progression-free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital of Xinxiang Medical College"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-18"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Endotracheopulmonary Instillation, Suspension"
}
]
},
"conditionsModule": {
"conditions": [
"Bronchopulmonary Dysplasia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Brussels",
"contacts": [
{
"email": "[email protected]",
"name": "Olivier Danhaive, M.D.",
"phone": "+32 2 764 79 00",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Olivier Danhaive, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Cliniques Universitaires Saint-Luc (UCLouvain)",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "1200"
},
{
"city": "Charleroi",
"contacts": [
{
"email": "[email protected]",
"name": "Serge Vanden Eijnden, M.D.",
"phone": "+32 7 192 12 43",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Serge Vanden Eijnden, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "ISPPC CHU Charleroi",
"geoPoint": {
"lat": 50.41136,
"lon": 4.44448
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "6000"
},
{
"city": "Liège",
"contacts": [
{
"email": "[email protected]",
"name": "Pierre Maton, M.D.",
"phone": "+32 4 355 56 17",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Pierre Maton, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Belgium",
"facility": "Clinique CHC Montlégia",
"geoPoint": {
"lat": 50.63373,
"lon": 5.56749
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "4000"
},
{
"city": "Florence",
"contacts": [
{
"email": "[email protected]",
"name": "Carlo Dani, M.D.",
"phone": "+39 055 7948421",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Carlo Dani, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "AOU Careggi",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Genova",
"contacts": [
{
"email": "[email protected]",
"name": "Giorgia Brigati, M.D.",
"phone": "+39 010 56362218",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Giorgia Brigati, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "IRCCS Instituto Giannina Gaslini",
"geoPoint": {
"lat": 44.40478,
"lon": 8.94438
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Anna Lavizzari, M.D.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": null,
"phone": "+39 025 5032907",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anna Lavizzari, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Modena",
"contacts": [
{
"email": "[email protected]",
"name": "Alberto Berardi, M.D.",
"phone": "+39 333 1053301",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alberto Berardi, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "AOU Policlinico di Modena",
"geoPoint": {
"lat": 44.64783,
"lon": 10.92539
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Padua",
"contacts": [
{
"email": "[email protected]",
"name": "Eugenio Baraldi, Prof",
"phone": "+39 049 8213578",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Eugenio Baraldi, Prof",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Unità di Fase I della UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale (TINI) dell'Azienda Ospedale Università di Padova",
"geoPoint": {
"lat": 45.40797,
"lon": 11.88586
},
"state": null,
"status": "RECRUITING",
"zip": "35128"
}
]
},
"descriptionModule": {
"briefSummary": "The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution).Infants will be followed up to 2 years of corrected age (end of study)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Phase 1 is an open-labelled, dose-escalated, and single-arm of EXOB-001. Phase 2 is a randomised, double-blind, placebo-controlled, and dose-finding of EXOB-001.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Phase 1 is an open-label, dose-escalation and single-arm study. In phase 2, Investigators will remain blinded to each subject's assigned treatment throughout the study. The Sponsor will put in place procedures to maintain this blind. Indeed, to ensure the blinding of the groups, the preparation and administration of the test product will be organized by different teams. In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded study treatment records at the site(s) to verify that randomisation/dispensing has been done accurately. Blinding will be broken by the Investigator for emergency purposes only, where knowledge of the blinded treatment could influence further subject care. In addition, subjects will be unblinded for safety reports, as per regulatory requirements. Study blind will be broken after the database lock.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 265,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Days",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "EVENEW",
"briefTitle": "Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants",
"nctId": "NCT06279741",
"orgStudyIdInfo": {
"id": "EVENEW",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2022-500293-34",
"link": null,
"type": "EUDRACT_NUMBER"
},
{
"domain": "Universal Trial Number",
"id": "U1111-1291-0283",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of subjects with treatment-emergent adverse events (phase 1)"
},
{
"measure": "Number of subjects with BPD grade II-III incidence rate per groups (phase 2)."
}
],
"secondaryOutcomes": [
{
"measure": "Assessment of medium-term safety of EXOB-001 (phase 1/2)"
},
{
"measure": "Number of subjects with dose-limiting toxicity (DLT) (phase 1)"
},
{
"measure": "Number of subjects needing for oxygen and ventilation for BPD incidence (phase 1/2)"
},
{
"measure": "Assessment of immune markers (phase 2)"
},
{
"measure": "Assessment of BPD incidence and severity (phase 1/2)"
},
{
"measure": "Safety evaluation (phase 1/2)"
},
{
"measure": "Assessment of lung ultrasound score (phase 1/2)"
},
{
"measure": "Number of subjects with complications of prematurity (phase 1/2)"
},
{
"measure": "Assessment of the respiratory morbidity (phase 1/2)"
},
{
"measure": "Assessment of neurodevelopment (phase 1/2)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "EXO Biologics S.A."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Datopotamab deruxtecan"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Non-Small Cell Lung Cancer",
"Metastatic Non Small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Honolulu",
"contacts": [
{
"email": null,
"name": "Principal Investigator",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Queen's Medical Center",
"geoPoint": {
"lat": 21.30694,
"lon": -157.85833
},
"state": "Hawaii",
"status": "AVAILABLE",
"zip": "96813"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial."
},
"designModule": {
"designInfo": null,
"enrollmentInfo": null,
"phases": null,
"studyType": "EXPANDED_ACCESS"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients",
"nctId": "NCT06279728",
"orgStudyIdInfo": {
"id": "DS1062-0003-EAP-MA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": null,
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "AstraZeneca"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Daiichi Sankyo"
}
},
"statusModule": {
"completionDateStruct": null,
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "AVAILABLE",
"primaryCompletionDateStruct": null,
"resultsFirstPostDateStruct": null,
"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Preimplantation Genetic Testing for Aneuploidy"
}
]
},
"conditionsModule": {
"conditions": [
"Embryo Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montreal",
"contacts": null,
"country": "Canada",
"facility": "Clinique ovo",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H4P 2S4"
}
]
},
"descriptionModule": {
"briefSummary": "IVF is the most commonly employed form of assisted reproductive technologies (ART) for the 10-15% of couples who face difficulties becoming pregnant. Many individuals elect to have their IVF-derived embryos analyzed using pregenetic implantation testing for aneuploidies (PGT-A). The use of PGT-A is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure.Segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (CN) changes. The frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. This can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 800,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "43 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "DFI and Aneuploidies",
"nctId": "NCT06279715",
"orgStudyIdInfo": {
"id": "3437",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "DFI association and aneuploidy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Clinique Ovo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SERIOUS GAME"
},
{
"name": "COMICS"
}
]
},
"conditionsModule": {
"conditions": [
"First Aid"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aksaray",
"contacts": null,
"country": "Turkey",
"facility": "Özlem Çalışır",
"geoPoint": {
"lat": 38.37255,
"lon": 34.02537
},
"state": "Center",
"status": null,
"zip": "68200"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to determine the effect of first aid training for injuries given to secondary school students through serious game simulation and comic books on knowledge, skills and motivation.Hypotheses:H1: First aid training given through simulation applications affects the level of knowledge.H2: First aid training given through simulation applications affects the skill level.H3: First aid training given with simulation application affects motivation.H4: First aid training given with comics affects the level of knowledge.H5: First aid training given with comic books affects the skill level.H6: First aid training given with comics affects motivation.METHOD: The research will be conducted as a randomized controlled experimental study with a pre-test-post-test design with children studying in the 5th and 6th grades of schools in the central district of Aksaray. One group will be given first aid training for injuries prepared with serious games, the other group will be given first aid training for injuries prepared with comic books. No intervention will be made to the control group. Serious game scenario software prepared based on the literature will be integrated into the computer. Appropriate statistics will be made after the research by applying the prepared data collection tools. With this research, the gap in the literature will be filled, children's first aid knowledge and skills in injuries will be increased, and school health nurses will be provided with up-to-date teaching material."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "serious game and comics",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "9 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Serious Game Simulation and Comics in School Students",
"nctId": "NCT06279702",
"orgStudyIdInfo": {
"id": "OCalisir",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Motivation Scale for Teaching Materials"
},
{
"measure": "Student Knowledge Level Evaluation Form for First Aid Application in Injuries"
},
{
"measure": "Student Skill Level Evaluation Form for First Aid Application in Injuries"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "TC Erciyes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ultrasound scans"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Subjects"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no investigational product injection during this study The exploratory objective of this study is to evaluate the anatomical characteristics of both anterolateral thighs in healthy adult and healthy pediatric populations (2 to 17 years old) by ultrasound scan before and while applying a force similar to the ZENEO® triggering force.In the healthy adult population, anatomical characteristics of one shoulder (deltoid) and one upper arm (biceps and triceps) will also be evaluated by ultrasound scan before and while applying a force similar to ZENEO® triggering force.Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Echography Study_Anthropometric Measurements",
"nctId": "NCT06279689",
"orgStudyIdInfo": {
"id": "CJTCDZ2301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "STBD : Skin To Bone Distance"
},
{
"measure": "STMD: Skin To Muscle Distance"
},
{
"measure": "Thickness of skin layers (dermis, hypodermis)"
},
{
"measure": "Thickness of muscle layers"
}
],
"secondaryOutcomes": [
{
"measure": "Circumferences measurements (thigh, upper arm, waist, hip)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Crossject"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"GVHD, Chronic"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women."
},
"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": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SaFeGreff",
"briefTitle": "Improvement of Women's Health After Allogeneic Stem Cell Transplantation",
"nctId": "NCT06279676",
"orgStudyIdInfo": {
"id": "SaFeGreff",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice."
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate genital cGVHD treatment response"
},
{
"measure": "Evaluate the frequency of premature ovarian failure"
},
{
"measure": "Measure the incidence and prevalence of HPV infection"
},
{
"measure": "Evaluate the quality of life (QoL) of allografted women"
},
{
"measure": "Evaluate intimacy within relationships of allografted women"
},
{
"measure": "Evaluate sexual function of allografted women"
},
{
"measure": "Evaluate sexual distress of allografted women"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Centre hospitalier de l'Université de Montréal (CHUM)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ciusss de L'Est de l'Île de Montréal"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Revascularization"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Novosibirsk",
"contacts": [
{
"email": "[email protected]",
"name": "Anton Obedinskiy, 1",
"phone": "+73833476099",
"phoneExt": "1",
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Anton",
"geoPoint": {
"lat": 55.0415,
"lon": 82.9346
},
"state": "Novosibirsk Obl",
"status": "RECRUITING",
"zip": "630055"
},
{
"city": "Novosibirsk",
"contacts": [
{
"email": "[email protected]",
"name": "Anton Obedinskiy",
"phone": "89139322885",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Russian Federation",
"facility": "Anton",
"geoPoint": {
"lat": 55.0415,
"lon": 82.9346
},
"state": "Rechkunovskaya Str.",
"status": "RECRUITING",
"zip": "630055"
}
]
},
"descriptionModule": {
"briefSummary": "The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \\> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 460,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NSTE-ACSMT",
"briefTitle": "Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease",
"nctId": "NCT06279663",
"orgStudyIdInfo": {
"id": "NSTE-ACS Multivessel Trial",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Death from any cause"
},
{
"measure": "Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)"
},
{
"measure": "target LDL level"
}
],
"secondaryOutcomes": [
{
"measure": "Myocardial infarction"
},
{
"measure": "Stroke"
},
{
"measure": "Repeated unplanned myocardial revascularization"
},
{
"measure": "Duration of the hospital period"
},
{
"measure": "Intra/perioperative complications"
},
{
"measure": "Significant hemorrhagic complications (grade 3 or more on the BARC scale)"
},
{
"measure": "Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kemerovo Cardiology Center, Tarasov Roman Sergeevich"
},
{
"name": "Tomsk National Research Medical Center of the Russian Academy of Sciences, Ryabov Vyacheslav Valeryevich"
}
],
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Self-hypnosis"
},
{
"name": "Psycho-education and cognitive Bahavioral therapy (CBT)"
}
]
},
"conditionsModule": {
"conditions": [
"Hypnosis, Chronic Pain Management"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "David Ogez",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "5415 Bd de l'Assomption",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": "RECRUITING",
"zip": "H1T 2M4"
}
]
},
"descriptionModule": {
"briefSummary": "Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.Adverse events: none expected."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Self-hypnosis Training for Chronic Pain Management",
"nctId": "NCT06279650",
"orgStudyIdInfo": {
"id": "2022-2741",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Time 3 : Numerical Rating Scale (NRS) from 0 to 10"
},
{
"measure": "Time 3 : Questionnaire Brief Pain Inventory (BPI)"
},
{
"measure": "Time 3 : Hospital anxiety and depression scale (HADS)"
},
{
"measure": "Time 3 : SF-36 (36-Item Short Form Survey)"
},
{
"measure": "Time 4 : Numerical Rating Scale (NRS) from 0 to 10"
},
{
"measure": "Time 4 : Questionnaire Brief Pain Inventory (BPI)"
},
{
"measure": "Time 4 : Hospital anxiety and depression scale (HADS)"
},
{
"measure": "Time 4 : SF-36 (36-Item Short Form Survey)"
},
{
"measure": "Time 5 : Numerical Rating Scale (NRS) from 0 to 10"
},
{
"measure": "Time 5 : Questionnaire Brief Pain Inventory (BPI)"
},
{
"measure": "Time 5 : Hospital anxiety and depression scale (HADS)"
},
{
"measure": "Time 5 : SF-36 (36-Item Short Form Survey)"
}
],
"primaryOutcomes": [
{
"measure": "Time 1 : Numerical Rating Scale (NRS) from 0 to 10"
},
{
"measure": "Time 1 : Questionnaire Brief Pain Inventory (BPI)"
},
{
"measure": "Time 1 : Hospital anxiety and depression scale (HADS)"
},
{
"measure": "Time 1 : SF-36 (36-Item Short Form Survey)"
},
{
"measure": "Time 1 : Questionnaire socio-demographic and clinical"
}
],
"secondaryOutcomes": [
{
"measure": "Time 2 : Numerical Rating Scale (NRS) from 0 to 10"
},
{
"measure": "Time 2 : Questionnaire Brief Pain Inventory (BPI)"
},
{
"measure": "Time 2 : Hospital anxiety and depression scale (HADS)"
},
{
"measure": "Time 2 : SF-36 (36-Item Short Form Survey)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ciusss de L'Est de l'Île de Montréal"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Joint Home-DM-BAT Intervention"
},
{
"name": "Usual Care"
}
]
},
"conditionsModule": {
"conditions": [
"Type 2 Diabetes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.The aims of the study are:Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "120 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes",
"nctId": "NCT06279637",
"orgStudyIdInfo": {
"id": "PRO00046457",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Glycemic Control (Hemoglobin A1C [HbA1C])"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical College of Wisconsin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Community-acquired Pneumonia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is the matched 1:2 case-control study, prospectively collect case and control who are diagnosed with pneumococcal or non-pneumococcal community acquired pneumonia (CAP), accordingly from November 2023 through October 2024. The investigators define a CASE as a person aged ≥60 years due to pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge. While a CONTROL is defined as a person aged ≥60 years due to non-pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge.The goal of this observational study is to evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal CAP in Thai adults aged ≥ 60 years with or without any medical conditions.The main questions it aims to answer is:• What are the effectiveness of PCV13 for preventing all typed, vaccine typed, or non-vaccine typed of pneumococcal CAP among Thai older adults?The investigators retrospectively collect cases and control who are diagnosed with CAP accordingly from January 2012 through October 2023. The investigators define case and control the same as prospective method, but all data were retrieved from archive database.-The investigators select a 1:2 matched control with criteria as follows; 10-year-interval of age, ward (the same patient care such as out or in-patient, or admitted in the same level ward).Participants will be* collated from hospital database regarding their CAP illnesses by pneumococcal and non-pneumococcal pneumonia condition.* explored their vaccine status by either vaccine book checking or hospital database.Researcher will compare the effectiveness of PCV13 to prevent all typed, vaccine typed and non-vaccine typed pneumococcal pneumonia."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 840,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of the PCV13 in Older Thai Adults",
"nctId": "NCT06279624",
"orgStudyIdInfo": {
"id": "NRCT9-4",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Vaccine effectiveness of PCV13 on all types of pneumococcal CAP"
}
],
"secondaryOutcomes": [
{
"measure": "Vaccine effectiveness of PCV13 on PCV13 (vaccine typed) and non-PCV13 (non-vaccine typed) pneumococcal CAP"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Research Council of Thailand"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Mahidol University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "LY007"
}
]
},
"conditionsModule": {
"conditions": [
"B-NHL"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "zhao weili, MD",
"phone": "13512112076",
"phoneExt": "610707",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "yan zixun, MD",
"phone": "+8613482056727",
"phoneExt": "610707",
"role": "CONTACT"
}
],
"country": "China",
"facility": "Ruijin hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 18,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "r/r B-NHL",
"briefTitle": "An Evaluation of LY007 Cell Injection for r/r B-NHL",
"nctId": "NCT06279611",
"orgStudyIdInfo": {
"id": "LY007C1101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Exploratory study endpoint"
}
],
"primaryOutcomes": [
{
"measure": "Maximum tolerated dose or clinically recommended dose"
},
{
"measure": "Dose limiting toxicity"
},
{
"measure": "Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern"
}
],
"secondaryOutcomes": [
{
"measure": "PK aspect"
},
{
"measure": "PK aspect"
},
{
"measure": "PD aspect"
},
{
"measure": "therapeutic effect"
},
{
"measure": "Anti LY007 antibody"
},
{
"measure": "The titer of human anti mouse antibody"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The First Affiliated Hospital with Nanjing Medical University"
},
{
"name": "Ruijin Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Longyao Biotechnology Inc., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-12-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Prolonged Exposure therapy"
},
{
"name": "Eye Movement Desensitization Reprocessing (EMDR)"
},
{
"name": "Interpersonal Psychotherapy (IPT)"
}
]
},
"conditionsModule": {
"conditions": [
"Stress Disorders, Post-Traumatic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Deventer",
"contacts": [
{
"email": "[email protected]",
"name": "Maarten K van Dijk, PhD",
"phone": "+31 0570-604000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Dominique Jonkers, Master",
"phone": "+31 038-4692300",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Dimence",
"geoPoint": {
"lat": 52.255,
"lon": 6.16389
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized.Key questions:1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?Secondary goals:* Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes;* Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes;* Investigating how much the quality of the therapeutic alliance influences outcomes.Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study is a randomized controlled trial (RCT) conducted in two phases. Patients with PTSD will first be randomized to PE or EMDR in the first treatment phase. After this first phase of treatment, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy for PTSD. In both phases (phase 1 and 2) the treatment lasts 8 weeks. Patients receive 14 sessions of 1 hour in 8 weeks.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 442,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PT-STRESS",
"briefTitle": "PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD",
"nctId": "NCT06279598",
"orgStudyIdInfo": {
"id": "UniversityGroningen",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Age"
},
{
"measure": "Gender"
},
{
"measure": "Education"
},
{
"measure": "Employment"
},
{
"measure": "Marital status"
},
{
"measure": "Ethnicity/race"
},
{
"measure": "Medication use"
},
{
"measure": "Treatment history"
},
{
"measure": "Mini-Schedules for Clinical Assessment in Neuropsychiatry (mini-SCAN)"
},
{
"measure": "Life Events Checklist for DSM-5 (LEC-5)"
},
{
"measure": "The Childhood Trauma Questionnaire-Short Form (CTQ-SF)"
},
{
"measure": "Symptom Checklist-90 (SCL-90), Hostility subscale"
},
{
"measure": "Experiences in Close Relationships-Relationship Structures (ECR-RS)"
},
{
"measure": "The Brief Experiental Avoidance Questionnaire (BEAQ)"
},
{
"measure": "Improving Access to Psychological Therapies (IAPT)"
},
{
"measure": "Posttraumatic Cognitions Inventory (PTCI)"
},
{
"measure": "Trauma Related Guilt Inventory (TRGI)"
},
{
"measure": "Trauma Related Shame Iventory (TRSI)"
},
{
"measure": "Working Alliance Questionnaire shortened version (WAV-12)"
},
{
"measure": "Expectancy rating (patients and therapists)"
}
],
"primaryOutcomes": [
{
"measure": "PTSD Checklist for DSM-5 (PCL-5)"
}
],
"secondaryOutcomes": [
{
"measure": "Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)"
},
{
"measure": "International Trauma Questionnaire (ITQ)"
},
{
"measure": "Hospital Anxiety and Depression Scale (HADS)"
},
{
"measure": "Mental Health Continuum Short Form (MHC-SF)"
},
{
"measure": "Positive and Negative Experiences of Psychotherapy questionnaire (PNEP)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Dimence"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Groningen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2031-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physical therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Graft-versus-host-disease",
"Graft Versus Host Disease, Chronic",
"Stem Cell Transplant Complications",
"Hematological Malignancy",
"Hematologic Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seville",
"contacts": [
{
"email": "[email protected]",
"name": "Raquel P Aguilar, Ph.D.cand.",
"phone": "955 013 260",
"phoneExt": "34",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "José Antonio P Simón, PhD",
"phone": "955 013 260",
"phoneExt": "34",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "University of Seville; Manuel Siurot Avenue, no number",
"geoPoint": {
"lat": 37.38283,
"lon": -5.97317
},
"state": null,
"status": null,
"zip": "41013"
}
]
},
"descriptionModule": {
"briefSummary": "Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 108,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD",
"nctId": "NCT06279585",
"orgStudyIdInfo": {
"id": "ECA GVHD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Health-related quality of life"
},
{
"measure": "Chronic Graft-Versus-Host Disease (cGVHD) symptom burden"
}
],
"secondaryOutcomes": [
{
"measure": "Muscular strength"
},
{
"measure": "Cardiorespiratory fitness"
},
{
"measure": "Functional status"
},
{
"measure": "Distress"
},
{
"measure": "Mood"
},
{
"measure": "Anxiety"
},
{
"measure": "Biological markers"
},
{
"measure": "Responses to medical treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Seville"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biospecimen Collection"
},
{
"name": "Bone Marrow Aspirate"
},
{
"name": "Electronic Health Record Review"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Myeloid Leukemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Scottsdale",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Cecilia Y. Arana Yi, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Arizona",
"geoPoint": {
"lat": 33.50921,
"lon": -111.89903
},
"state": "Arizona",
"status": "NOT_YET_RECRUITING",
"zip": "85259"
},
{
"city": "Jacksonville",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Talha Badar, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Florida",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida",
"status": "RECRUITING",
"zip": "32224-9980"
},
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mithun V. Shah, M.D., Ph.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": "NOT_YET_RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy",
"nctId": "NCT06279572",
"orgStudyIdInfo": {
"id": "20-011624",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2022-09618",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic Institutional Review Board",
"id": "20-011624",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Music-therapy"
}
]
},
"conditionsModule": {
"conditions": [
"High Risk Pregnancy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Genova",
"contacts": [
{
"email": "[email protected]",
"name": "Cristina Venturino",
"phone": "010 5636.2346",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Giannina Gaslini",
"geoPoint": {
"lat": 44.40478,
"lon": 8.94438
},
"state": null,
"status": "RECRUITING",
"zip": "16147"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are:1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women?2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?3. How does the risk of preterm birth modulate the future attachment bond between mother and child?Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy).Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond.Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Music Therapy and High-risk Pregnancy",
"nctId": "NCT06279559",
"orgStudyIdInfo": {
"id": "MTinHRP_v1_10/01/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Depressive symptoms"
},
{
"measure": "State anxiety and trait anxiety"
},
{
"measure": "Perceived stress"
},
{
"measure": "Perceived positive and negative feelings"
},
{
"measure": "Mother-fetus attachment bond"
},
{
"measure": "Mother-child attachment bond"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Giannina Gaslini"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Detection of structures"
}
]
},
"conditionsModule": {
"conditions": [
"Gastrointestinal Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guayaquil",
"contacts": null,
"country": "Ecuador",
"facility": "IECED",
"geoPoint": {
"lat": -2.20584,
"lon": -79.90795
},
"state": "Guayas",
"status": null,
"zip": "090505"
}
]
},
"descriptionModule": {
"briefSummary": "Endoscopic ultrasound (EUS) visual impression is operator-dependant and can hinder diagnostic accuracy, especially in less experienced endoscopists. The implementation of artificial intelligence can potentially mitigate operator dependency and interpretation variability, helping or improving the overall accuracy.The investigators therefore aim to compare diagnostic accuracy between artificial intelligence (AI)-based model and the endoscopists when identifying normal anatomical structures in EUS-procedures."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy",
"nctId": "NCT06279546",
"orgStudyIdInfo": {
"id": "IECED-12345",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic accuracy"
}
],
"secondaryOutcomes": [
{
"measure": "Interobserver agreement"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Methodist Hospital Research Institute"
},
{
"name": "Baylor Saint Luke's Medical Center"
},
{
"name": "Beth Israel Deaconess Medical Center"
},
{
"name": "Barra Life Medical Center, Brazil"
},
{
"name": "Hospital Clinico Universitario de Santiago"
},
{
"name": "Universitair Ziekenhuis Brussel"
},
{
"name": "Hospital Civil de Morelia, Michoacan"
},
{
"name": "ELIAS Emergency University Hospital"
},
{
"name": "Larkin Community Hospital"
},
{
"name": "Carol Davila University of Medicine and Pharmacy"
},
{
"name": "mdconsgroup, Guayaquil, Ecuador"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Instituto Ecuatoriano de Enfermedades Digestivas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-28"
}
}
} | false | null |
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