protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TMS"
},
{
"name": "Sham"
}
]
},
"conditionsModule": {
"conditions": [
"PTSD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": null,
"country": "United States",
"facility": "Rush University Medical Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60612"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD. Specifically, the present study will compare iTBS versus a sham condition during the second week of the 2- week IOP for veterans who have not experienced PTSD symptom reductions over the course of the first week of the Road Home Program intensive PTSD treatment program."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "TMS for Veterans Attending a 2-week Intensive Outpatient Program for PTSD",
"nctId": "NCT06271733",
"orgStudyIdInfo": {
"id": "21110503",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PTSD Checklist for DSM-5 (PCL-5)"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Health Questionnaire-9 (PHQ-9)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rush University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2026-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "visceral manipulation"
},
{
"name": "integrated neuromuscular inhibition"
}
]
},
"conditionsModule": {
"conditions": [
"Shoulder Impingement"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome",
"nctId": "NCT06271720",
"orgStudyIdInfo": {
"id": "faculty of physical therapy",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "pain intensity"
},
{
"measure": "pain pressure threshold"
},
{
"measure": "shoulder range of motion"
},
{
"measure": "shoulder functional level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Noha Elserty"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "0.5% bupivacaine"
},
{
"name": "Saline"
}
]
},
"conditionsModule": {
"conditions": [
"Esophagectomy",
"Pneumonectomy",
"Lobectomy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "This is a double blind randomized prospective controlled trial. Randomization will be 1:1.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Stellate Ganglion Block",
"nctId": "NCT06271707",
"orgStudyIdInfo": {
"id": "ANES-2024-32720",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "an ultrasound guided left stellate ganglion block with 5 mL of saline."
},
{
"measure": "Atrial fibrillation; Other arrhythmias; Adverse events."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Minnesota"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vestibular Rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Vestibular Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Chelsea Behling",
"phone": "412-624-8811",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UPMC-Rehab Institute",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "15206"
}
]
},
"descriptionModule": {
"briefSummary": "This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "APV",
"briefTitle": "Activity and Participation in Vestibular Disorders",
"nctId": "NCT06271694",
"orgStudyIdInfo": {
"id": "STUDY22020027",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1K23DC020215-01",
"link": "https://reporter.nih.gov/quickSearch/1K23DC020215-01",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Late-life Function and Disability Instrument"
},
{
"measure": "Dizziness Handicap Inventory"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Deafness and Other Communication Disorders (NIDCD)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Pittsburgh"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "15-valent pneumococcal conjugate vaccine"
},
{
"name": "23-valent pneumococcal polysaccharide vaccine"
}
]
},
"conditionsModule": {
"conditions": [
"Pneumococcal Vaccines",
"Immunosuppression"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster series of 15-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine 8 weeks later. Immune response will be assessed by opsonophagocytic assay reactivity and IgG Geometric mean concentration changes."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of PCV15 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans",
"nctId": "NCT06271681",
"orgStudyIdInfo": {
"id": "2120135-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in opsonophagocytic assay (OPA) geometric mean titers (GMT)"
},
{
"measure": "Change in Immunoglobulin G (IgG) geometric mean concentrations (GMC)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Merck Sharp & Dohme LLC"
}
],
"leadSponsor": {
"class": "FED",
"name": "VA Sierra Nevada Health Care System"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Naloxone Co-prescribing Clinical Decision Support (CDS)"
}
]
},
"conditionsModule": {
"conditions": [
"Medication Abuse",
"Harm Reduction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Aurora",
"contacts": null,
"country": "United States",
"facility": "University of Colorado Hospital",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado",
"status": null,
"zip": "80045"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "89 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Decision Support to Improve System Naloxone Co-prescribing",
"nctId": "NCT06271668",
"orgStudyIdInfo": {
"id": "23-2356",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R61DA057610",
"link": "https://reporter.nih.gov/quickSearch/R61DA057610",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone"
}
],
"secondaryOutcomes": [
{
"measure": "Clinical decision support (CDS) acceptance rate"
},
{
"measure": "Subsequent opioid overdose/poisonings rates"
},
{
"measure": "Naloxone dispensed rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institutes of Health (NIH)"
},
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Colorado, Denver"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SPOTFIRE R Panel"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Respiratory Infection",
"Viral Infection",
"Upper Respiratory Tract Infections"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Washington",
"contacts": [
{
"email": "[email protected]",
"name": "Ryan Heidish",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Christopher Payette, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christopher Payette, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Andrew Meltzer, MD, MS",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "George Washington University Hospital",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
},
"state": "District of Columbia",
"status": "RECRUITING",
"zip": "20037"
}
]
},
"descriptionModule": {
"briefSummary": "The study titled \" The Effect of Definitive Identification of Viral Etiology in Emergency Department Patients with Acute Respiratory Infection on Antibiotic Utilization (RADIATE)\" aims to investigate the effectiveness of a rapid diagnostic approach in reducing unnecessary antibiotic use in the emergency department (ED) for patients presenting with acute respiratory illness (ARI) due to a virus. Using a prospective design, eligible participants are individuals who visit the ED with complaints related to acute respiratory illness. The study will employ a single-arm consecutive enrollment approach. The intervention involves the implementation of a rapid point-of-care multiplex polymerase chain reaction (PCR) test to promptly identify the viral cause of the infection. By utilizing a rapid diagnostic tool to identify viral etiology, the study aims to provide healthcare professionals in the ED with more accurate information to guide treatment decisions. Ultimately, the goal is to decrease the unnecessary use of antibiotics for ARI's due to a virus, which has several negative outcomes including promotion of antibiotic resistance, exacerbating ED length of stay and encouraging unnecessary additional diagnostic tests."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RADIATE",
"briefTitle": "Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE)",
"nctId": "NCT06271655",
"orgStudyIdInfo": {
"id": "BFD-RST-23-004",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Antibiotic Use"
}
],
"secondaryOutcomes": [
{
"measure": "Emergency Department Length of Stay"
},
{
"measure": "Utilization of Alternative Tests"
},
{
"measure": "Patient Confidence in Diagnosis"
},
{
"measure": "Provider Confidence in Diagnosis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "BioMérieux"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Christopher Payette"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only"
},
{
"name": "Bluetooth Haptic Device (Control Frequency) + Needle Sham only"
}
]
},
"conditionsModule": {
"conditions": [
"Pain",
"Anxiety"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators",
"nctId": "NCT06271642",
"orgStudyIdInfo": {
"id": "73822",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mechanical Pain Threshold"
}
],
"secondaryOutcomes": [
{
"measure": "Mechanical pain sensitivity"
},
{
"measure": "Anxiety scores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Stanford University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Insomnia severity index"
}
]
},
"conditionsModule": {
"conditions": [
"Rectal Cancer",
"Low Anterior Resection Syndrome",
"Insomnia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Seoul National University Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The preservation surgery of the anal sphincter has become a standard procedure for the treatment of rectal cancer and is now possible even when the tumor is close to the anus, thanks to the advancement of surgical techniques. This procedure allows patients to avoid a permanent artificial anus and enables them to evacuate through the anus, maintaining the continuity of the intestine, making it a highly preferred surgical option. Additionally, advancements in tumor treatments have led to improved long-term survival rates.However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel movements, and fecal incontinence, are referred to as Anterior Resection Syndrome (ARS). Particularly, symptoms following low anterior resection surgery for lower rectal cancer are termed Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, persisting up to 1-2 years, with some improvement over time. However, in many patients, LARS can remain a lifelong challenge, significantly impacting their quality of life. Currently, there is no definitive method to treat LARS, and symptom management is achieved through empirical treatment methods or medications.Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients",
"nctId": "NCT06271629",
"orgStudyIdInfo": {
"id": "2204-042-1314",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS)."
}
],
"secondaryOutcomes": [
{
"measure": "European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)"
},
{
"measure": "European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ministry of Health, Republic of Korea"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Seoul National University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biospecimen Collection"
},
{
"name": "Echocardiography"
},
{
"name": "Ibrutinib"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Graft Versus Host Disease",
"Hematopoietic and Lymphatic System Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jacksonville",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mohamed A. Kharfan Dabaja, M.D., M.B.A.",
"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": null,
"zip": "32224-9980"
}
]
},
"descriptionModule": {
"briefSummary": "This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"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": "Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant",
"nctId": "NCT06271616",
"orgStudyIdInfo": {
"id": "MC1873",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01061",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic Institutional Review Board",
"id": "18-008754",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD)"
}
],
"secondaryOutcomes": [
{
"measure": "Cumulative incidence of non-relapse mortality (NRM)"
},
{
"measure": "Cumulative incidence of relapse"
},
{
"measure": "Cumulative incidence of moderate/severe chronic GVHD"
},
{
"measure": "Cumulative incidence of moderate/severe chronic GVHD"
},
{
"measure": "Cumulative incidence of chronic GVHD of all grades"
},
{
"measure": "Cumulative incidence of late acute GVHD"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "NIH moderate/severe GVHD and relapse free survival (CRFS)"
},
{
"measure": "Type and duration of immune suppressive therapy"
},
{
"measure": "Cumulative incidence of complete immune suppression (IS) discontinuation"
},
{
"measure": "Incidence of adverse events (AE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "diagnosis based on deepLive™ LC-OCT device"
},
{
"name": "diagnosis based on skin biopsy"
}
]
},
"conditionsModule": {
"conditions": [
"Basal Cell Carcinoma of the Skin"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boulogne-Billancourt",
"contacts": [
{
"email": "[email protected]",
"name": "Professeur Philippe SAIAG",
"phone": "800-555-5555",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Philippe SAIAG",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Hôpital Ambroise Paré",
"geoPoint": {
"lat": 48.83333,
"lon": 2.25
},
"state": null,
"status": null,
"zip": "92100"
}
]
},
"descriptionModule": {
"briefSummary": "This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 704,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ECOBASO",
"briefTitle": "Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas",
"nctId": "NCT06271603",
"orgStudyIdInfo": {
"id": "23.02645.000357-MS01",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "23.02645.000357-MS01",
"id": "CPP Ile de France III",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management."
},
{
"measure": "The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management."
},
{
"measure": "The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management."
}
],
"secondaryOutcomes": [
{
"measure": "Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm."
},
{
"measure": "Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm."
},
{
"measure": "Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm."
},
{
"measure": "Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm."
},
{
"measure": "Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm"
},
{
"measure": "Estimate the actual cost of conducting the diagnosis with LC-OCT technology."
},
{
"measure": "Compare healthcare consumption between the two groups at 1 year."
},
{
"measure": "Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Damae Medical"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sirolimus Drug Coated Balloon"
},
{
"name": "Drug eluting stents (DES)"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Disease",
"Native Coronary Artery Stenosis",
"Cardiovascular Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \\~50% of enrollees."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "2:1 randomized trial (MagicTouchTM Sirolimus-Coated Balloon VS Drug eluting stent (ZES or EES)",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1605,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MAGICAL-SV",
"briefTitle": "MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels",
"nctId": "NCT06271590",
"orgStudyIdInfo": {
"id": "CM-US-R03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Angina as assessed by SAQ-7 (Seattle Angina Questionnaire)"
}
],
"primaryOutcomes": [
{
"measure": "Target lesion failure (TLF)"
}
],
"secondaryOutcomes": [
{
"measure": "Procedural success"
},
{
"measure": "Target lesion failure (TLF)"
},
{
"measure": "Ischemia driven target vessel revascularization (ID-TVR)"
},
{
"measure": "Target vessel revascularization (TVR)"
},
{
"measure": "Any revascularization"
},
{
"measure": "Target vessel failure (TVF)"
},
{
"measure": "Q-wave myocardial infarction (MI)"
},
{
"measure": "Non Q-wave myocardial infarction (MI)"
},
{
"measure": "Any myocardial infarction (MI)"
},
{
"measure": "Target vessel myocardial infarction (TV MI)"
},
{
"measure": "Spontaneous myocardial infarction (MI)"
},
{
"measure": "Procedural myocardial infarction (MI)"
},
{
"measure": "Cardiovascular mortality"
},
{
"measure": "All-cause mortality"
},
{
"measure": "Cardiovascular mortality or myocardial infarction (MI)"
},
{
"measure": "All-cause mortality or MI"
},
{
"measure": "All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR)"
},
{
"measure": "Any probable or definite stent thrombosis"
},
{
"measure": "Probable stent thrombosis"
},
{
"measure": "Definite stent thrombosis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Cardiovascular Research Foundation, New York"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Concept Medical Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2031-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AliveCor 12-lead ECG"
}
]
},
"conditionsModule": {
"conditions": [
"Myocardial Infarction",
"Ischemia",
"Myocardial Ischemia",
"Heart Diseases",
"Cardiovascular Diseases",
"Vascular Diseases",
"Heart Attack",
"Heart Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Julianne Rumer",
"phone": "507-255-1034",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Anna Pick",
"phone": "507-775-0630",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gregory Barsness, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI).Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"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": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "STLEUISII",
"briefTitle": "Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II",
"nctId": "NCT06271577",
"orgStudyIdInfo": {
"id": "PRO-0013",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Inter-rater variability for Standard 12-lead ECG readings"
},
{
"measure": "Inter-rater variability for AC 12L ECG readings"
},
{
"measure": "Number of standard 12-lead ECG readings requiring a consensus consultation"
},
{
"measure": "Number of AC 12L ECG readings requiring a consensus consultation"
},
{
"measure": "Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI"
},
{
"measure": "Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI"
},
{
"measure": "Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI"
},
{
"measure": "Negative predictive power of the AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI"
},
{
"measure": "Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI"
},
{
"measure": "Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI"
},
{
"measure": "Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AliveCor"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Magnetite ZnO Composite Nanoparticles"
},
{
"name": "Topical Placebo Gel"
}
]
},
"conditionsModule": {
"conditions": [
"Oral Potentially Malignant Lesions"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": null,
"name": "Nourhane Omara, Master's",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of Dentistry Ain shams University",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "ZnO nanoparticles are now being widely researched for their anticancer properties. They show relatively high biocompatibility. They also show selective cytotoxicity against cancerous cells in in vitro condition compared with other nanoparticles. They can be further surface engineered to show increased selective cytotoxicity. The synthesis process of ZnO nanoparticles is relatively easy, with a wide variety of methods. Owing to these different methods of synthesis, their size and size distribution can be easily controlled. One of the novel methods of synthesis of ZnO is Magnetite ZnO-Fe3O4 Composite Nanoparticles.Magnetite ZnO-Fe3O4 conjugated NPs retained inherent selective property of ZnO and magnetic property of Fe3O4 NPs and showed preferential cytotoxicity towards breast cancer cell line MDA-MB-231, with no significant cytotoxicity towards noncancerous Mouse Fibroblast NIH 3T3 cell."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions",
"nctId": "NCT06271564",
"orgStudyIdInfo": {
"id": "FDASU-Rec IM012415",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in the clinical size in Low to Moderate Dysplastic OPLs using Magnetite ZnO-Fe3O4 Composite NPs using standardized photographs of the oral marker lesion for each patient"
}
],
"secondaryOutcomes": [
{
"measure": "Effect of Magnetite ZnO-Fe3O4 Composite NPs on the change of the degree of Dysplasia during histopathological examination using a biopsy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transdermal estrogen"
},
{
"name": "Active Comparator: Androgen deprivation therapy"
},
{
"name": "Resistance training"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients.The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects.Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training.Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants are randomized in a 1:1 fashion to receive transdermal estradiol and androgen deprivation or solely androgen deprivation therapy. In addition subgroup of participants are randomized in a 1:1 fashion to perform resistance training or to be allocated in non-training control group.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 310,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ESTRACISE",
"briefTitle": "Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy",
"nctId": "NCT06271551",
"orgStudyIdInfo": {
"id": "ESTRACISE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy."
}
],
"secondaryOutcomes": [
{
"measure": "The occurrence of androgen deprivation therapy induced adverse effects."
},
{
"measure": "Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events)."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ)."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity)."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity)."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides)."
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content"
},
{
"measure": "Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins)"
},
{
"measure": "Number of participants with resistance training induced adverse events."
},
{
"measure": "The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)."
},
{
"measure": "The Patient Health Questionnaire score (PHQ-9) overall and subdomain score."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Tampere University"
},
{
"name": "University of Jyvaskyla"
},
{
"name": "Tampere University Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Central Finland Hospital District"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Skal Pro"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Irritable Bowel Syndrome",
"Gastrointestinal Diseases",
"Colonic Diseases, Functional",
"Intestinal Disease",
"Digestive System Disease",
"Pathologic Processes",
"Colonic Disease",
"Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kubang Kerian",
"contacts": [
{
"email": "[email protected]",
"name": "Yeong Yeh Lee, MD, PhD",
"phone": "+6097676846",
"phoneExt": "6845",
"role": "CONTACT"
},
{
"email": null,
"name": "Yeong Yeh Lee, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Thai Hau Koo, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Malaysia",
"facility": "Hospital Universiti Sains Malaysia",
"geoPoint": {
"lat": 6.09123,
"lon": 102.27938
},
"state": "Kelantan",
"status": null,
"zip": "16150"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome",
"nctId": "NCT06271538",
"orgStudyIdInfo": {
"id": "EP-USM-122023-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary"
},
{
"measure": "Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary"
},
{
"measure": "Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ)"
},
{
"measure": "Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire"
},
{
"measure": "Change in Visceral Sensitivity Index"
},
{
"measure": "Assessment of psychological dysfunction suing Catastrophizing Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "EP Plus Group Sdn Bhd"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "cupping therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Spondylosis"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "cupping therapy",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "24 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CT",
"briefTitle": "Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis",
"nctId": "NCT06271525",
"orgStudyIdInfo": {
"id": "P.T.REC/012/002532",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the nitric oxide level"
}
],
"secondaryOutcomes": [
{
"measure": "cervical range of motion"
},
{
"measure": "pain intensity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shady Abdelsattar Refaat"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Beta-Thalassemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oakland",
"contacts": null,
"country": "United States",
"facility": "UCSF Benioff Children's Hospitals",
"geoPoint": {
"lat": 37.80437,
"lon": -122.2708
},
"state": "California",
"status": "RECRUITING",
"zip": "94609"
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. To assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of Participants With β-Thalassemia Treated With Betibeglogene Autotemcel",
"nctId": "NCT06271512",
"orgStudyIdInfo": {
"id": "REG-501",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants who Experience Each Individual Adverse Events of Interest (AEIs)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants with Serious Adverse Events (SAEs)"
},
{
"measure": "Number of Participants with beti-cel related AEs"
},
{
"measure": "Event-Free Survival"
},
{
"measure": "Percentage of Participants Achieving Transfusion Independence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Center for International Blood and Marrow Transplant Research"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "bluebird bio"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2043-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2043-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Radial artery catheterization with USG"
},
{
"name": "Radial artery catheterization with smart glasses integrated UGG"
}
]
},
"conditionsModule": {
"conditions": [
"Catheterization",
"Cannulation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara University Medical Faculty",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The use of Ultrasonography (USG) in arterial catheterization, in which the comfort of the practitioner and hand-eye coordination become very important, is frequently needed by anesthesiologists in their daily practice. The aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization",
"nctId": "NCT06271499",
"orgStudyIdInfo": {
"id": "AnkaraU-Smart-cannulation",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The success rate"
},
{
"measure": "The anesthesiologist's satisfaction"
}
],
"secondaryOutcomes": [
{
"measure": "The cannulation time"
},
{
"measure": "Complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ayşegül Güven"
},
{
"name": "Bengi Safak"
},
{
"name": "Ahmet Onat Bermede"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ankara University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-02-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pregabalin 75mg"
},
{
"name": "An epidural blood patch (EBP)"
},
{
"name": "conservative treatment."
}
]
},
"conditionsModule": {
"conditions": [
"Postdural Puncture Headache"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tanta",
"contacts": [
{
"email": "[email protected]",
"name": "Neveen Kohaf",
"phone": "+201060383012",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nahed F. Abo-Elmatey, M.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Hany Bauiomy, M.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Ahmed M. Abosakaya, M.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Neveen Kohaf",
"geoPoint": {
"lat": 30.78847,
"lon": 31.00192
},
"state": null,
"status": "RECRUITING",
"zip": "11865"
}
]
},
"descriptionModule": {
"briefSummary": "Lumbar puncture (LP), often known as a \"spinal tap,\" is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pregabalin in Treatment of Postdural Puncture Headache",
"nctId": "NCT06271486",
"orgStudyIdInfo": {
"id": "RC. 40.5.2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the incidence of complete relief"
}
],
"secondaryOutcomes": [
{
"measure": "The intensity of the headache"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Benha University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Al-Azhar University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution."
}
]
},
"conditionsModule": {
"conditions": [
"Efficacy",
"Safety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Ain Shams university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "ACTIVE_NOT_RECRUITING",
"zip": null
},
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Azza MA Said, MD",
"phone": "+201006228992",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "David G Samuel, Msc",
"phone": "+201064442469",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Ain Shams university",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "20 eyes of 20 patients will be divided randomly into 2 groups:* Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only* Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME",
"nctId": "NCT06271473",
"orgStudyIdInfo": {
"id": "AinShamsU3",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "any surgical complication or recurrence of DME"
}
],
"primaryOutcomes": [
{
"measure": "change in CMT by OCT at final visit"
}
],
"secondaryOutcomes": [
{
"measure": "change in BCVA at final visit"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Traditional physiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Nonspecific Low Back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Elif E Safran, asst. prof.",
"phone": "500 4047",
"phoneExt": "216",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Irmak Çavuşoğlu, asst. prof.",
"phone": "500 4184",
"phoneExt": "216",
"role": "CONTACT"
},
{
"email": null,
"name": "Elif E Safran, asst. prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Irmak Çavuşoğlu, asst. prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Nuray Alaca, assoc. prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Acıbadem Health Group",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "None Selected",
"status": "RECRUITING",
"zip": "34752"
}
]
},
"descriptionModule": {
"briefSummary": "To investigate the reliability and sensitivity of the Turkish versions of the Roland-Morris Disability Questionnaire, The Quebec Back Pain Disability Scale, and the Oswestry Disability Index in patients with chronic non-specific low back pain and to increase confidence in their use in clinical practice and research by determining the most appropriate minimal clinically significant difference values for this patient population."
},
"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": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Disability in Patients With Non-specific Chronic Low Back Pain",
"nctId": "NCT06271460",
"orgStudyIdInfo": {
"id": "2023-21-728",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analog Scale"
},
{
"measure": "The Roland-Morris Disability Questionnaire"
},
{
"measure": "The Quebec Back Pain Disability Scale"
},
{
"measure": "The Oswestry Disability Index"
},
{
"measure": "The Perceived Global Impact"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Acibadem University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Traditional therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Low-back Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Elif E Safran, asst. prof.",
"phone": "500 4047",
"phoneExt": "216",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Nuray N Alaca, assoc. prof.",
"phone": "500 4184",
"phoneExt": "Safran",
"role": "CONTACT"
},
{
"email": null,
"name": "Elif E Safran, asst. prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Irmak I Çavuşoğlu, asst. prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Nuray N Alaca, assoc. prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Elif Esma Safran",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "None Selected",
"status": "RECRUITING",
"zip": "34752"
}
]
},
"descriptionModule": {
"briefSummary": "To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation."
},
"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": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Answerability and Minimal Clinical Significance of the Pain Questionnaires",
"nctId": "NCT06271447",
"orgStudyIdInfo": {
"id": "2023-21-705",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analog Scale"
},
{
"measure": "Fear-Avoidance Beliefs Questionnaire"
},
{
"measure": "Tampa Scale for Kinesiophobia"
},
{
"measure": "The Pain Catastrophizing Scale"
},
{
"measure": "The Perceived Global Impact"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Acibadem University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "THYROX (Atlantic krill oil"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Endothelial Dysfunction"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.Hypotesis:The krill oil will infleunce the gut barier integrity."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "All competitors will be randomly divided into two groups (double-blind):A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day.B. control (n = 15) receiving placebo. The supplementation period will be six weeks.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Triple",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers.",
"nctId": "NCT06271434",
"orgStudyIdInfo": {
"id": "Olej z kryla/jelita",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "I-FABP (intestinal fatty acid binding protein)"
},
{
"measure": "CLDN-3"
},
{
"measure": "LBP (lipopolysaccharide binding protein)"
},
{
"measure": "Catechyloamines, cortisol"
},
{
"measure": "CD14"
}
],
"secondaryOutcomes": [
{
"measure": "Food intake"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Poznan University of Physical Education"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NanoTherm therapy"
},
{
"name": "Glioma Resection"
},
{
"name": "radiotherapy according to Stupp protocol"
},
{
"name": "chemotherapy according to Stupp protocol"
}
]
},
"conditionsModule": {
"conditions": [
"Glioblastoma Multiforme"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Poznań",
"contacts": [
{
"email": "[email protected]",
"name": "Slawomir Michalak, Prof.",
"phone": "+4861 8691 535",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jakub Moskal, MD, PhD",
"phone": "+4861 8691 422",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "University Hospital",
"geoPoint": {
"lat": 52.40692,
"lon": 16.92993
},
"state": null,
"status": "RECRUITING",
"zip": "60-355"
}
]
},
"descriptionModule": {
"briefSummary": "Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study.The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM.The main questions it aims to answer are:1. how NanoTherm therapy influences overall survival, and progression free survival;2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life.Participants will undergo:* initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life;* standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field;* between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation;* after the first activation (10th day), the catheter will be removed;* subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day;* for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed;* during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted.Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A prospective longitudinal study will be performed recurrent glioblastoma multiforme patients who:1. are included for NanoTherm therapy (group A),2. are included for standard Stupp protocol (surgery/chemo-radiotherapy) (group B)",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "ANCHIALE is open-label study",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ANCHIALE",
"briefTitle": "NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme",
"nctId": "NCT06271421",
"orgStudyIdInfo": {
"id": "01/24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Survival following the surgery [units months 1-24]"
},
{
"measure": "Progression free survival [units months 1-24]"
}
],
"secondaryOutcomes": [
{
"measure": "Response Assessment in Neuro-oncology [1 - complete response; 4 -progressive disease]"
},
{
"measure": "EuroQuality of Life 5-dimensions-5 levels scale (EQ-5D-5L) [arbitraty units 0- worst ; 100 - best]"
},
{
"measure": "Neurologic Assessment in Neuro-Oncology (NanoScale 2) [0-best; 23-worst]"
},
{
"measure": "modified Rankin scale [0-best; 6-worst]"
},
{
"measure": "Barthel index [range 0-100; 0-best, 100-worst]"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "MagForce USA"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Poznan University of Medical Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution"
},
{
"name": "Vibrating Mesh Nebulizer"
},
{
"name": "Metered Dose Inhaler"
},
{
"name": "Jet Nebulizer"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Obstructive Pulmonary Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Charlottesville",
"contacts": [
{
"email": "[email protected]",
"name": "Roselove Roselove Nunoo-Asare",
"phone": "434-243-6074",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Virginia Sheridan Snyder Translational Fontaine Research Unit",
"geoPoint": {
"lat": 38.02931,
"lon": -78.47668
},
"state": "Virginia",
"status": "RECRUITING",
"zip": "22947"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is whether there are differences in lung ventilation following treatment with each of the three methods as measured using hyperpolarized Xe 129 with MRI.Participants will:Receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices. In total, participants will receive three treatments separated by at least 1 week each.Following each treatment, participants will have inhale an MRI contrast agent called hyperpolarized Xe 129 and will have images of their lungs taken with an MRI.Researchers will compare the different lung images taken after each treatment to see if there are differences in the distribution of air in the lungs (known as ventilation)."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging",
"nctId": "NCT06271408",
"orgStudyIdInfo": {
"id": "POL-Xe-005",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ventilation Defect Percent"
}
],
"secondaryOutcomes": [
{
"measure": "Distribution of ventilated space"
},
{
"measure": "Membrane uptake of Xe 129"
},
{
"measure": "Red blood cell Xe 129 transfer"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Aerogen"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Polarean, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Injectable Type A Botulinum Toxin"
}
]
},
"conditionsModule": {
"conditions": [
"Cricopharyngeal Achalasia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Xinzhu",
"contacts": [
{
"email": null,
"name": "Haim Liu",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Xinzhu Rehabilitation Hospital",
"geoPoint": {
"lat": 22.46205,
"lon": 120.47335
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction",
"nctId": "NCT06271395",
"orgStudyIdInfo": {
"id": "Chaoshengqiunang",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "functional oral intake scale"
}
],
"secondaryOutcomes": [
{
"measure": "Penetration-Aspiration Scale"
},
{
"measure": "The Fiberoptic Endoscopic Dysphagia Severity Scale"
},
{
"measure": "Murray secretion scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Zeng Changhao"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acupressure Group"
},
{
"name": "Sham Acupressure Group"
},
{
"name": "Foot Ankle Exercise Group"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes Mellitus, Type 2"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 66,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes",
"nctId": "NCT06271382",
"orgStudyIdInfo": {
"id": "AIBU-SBF-SA-05",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ankle Brachial Index"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Abant Izzet Baysal University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Diffuse Large B-cell Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "East Hanover",
"contacts": null,
"country": "United States",
"facility": "Novartis",
"geoPoint": {
"lat": 40.8201,
"lon": -74.36487
},
"state": "New Jersey",
"status": null,
"zip": "07936"
}
]
},
"descriptionModule": {
"briefSummary": "This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 613,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.",
"nctId": "NCT06271369",
"orgStudyIdInfo": {
"id": "CCTL019CUS13",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of patients with IP admission"
},
{
"measure": "Number of IP admissions"
},
{
"measure": "IP days"
},
{
"measure": "Number of ICU stays"
},
{
"measure": "ICU days"
},
{
"measure": "Number of patients with OP visit"
},
{
"measure": "Number of OP visits"
},
{
"measure": "Number of patients with ER visit"
},
{
"measure": "Number of ER visits"
},
{
"measure": "Healthcare reimbursement costs"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Time to next treatment (TTNT) or death"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novartis Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-08-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BC-Navigate"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Quality of Life",
"Chemotherapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Diana Buitrago",
"phone": "312-503-2866",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Northwestern University",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60611"
}
]
},
"descriptionModule": {
"briefSummary": "The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Breast Cancer - Navigate - Prospective Cohort",
"nctId": "NCT06271356",
"orgStudyIdInfo": {
"id": "STU00220278",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Demand of BC-Navi: Recruitment Rate"
},
{
"measure": "Demand of BC-Navi: Rentention Rate"
},
{
"measure": "Acceptability of BC-Navi"
},
{
"measure": "Preliminary Efficacy: Chemotherapy Initiation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Chrysalis Initiative"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Northwestern University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Kidney Transplant Tolerance"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nantes",
"contacts": [
{
"email": "[email protected]",
"name": "Christophe MASSET, PH",
"phone": "33 2 76 64 39 61",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Nantes University Hospital",
"geoPoint": {
"lat": 47.21725,
"lon": -1.55336
},
"state": "Loire-Atlantique",
"status": "RECRUITING",
"zip": "44093"
}
]
},
"descriptionModule": {
"briefSummary": "Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "KTOL",
"briefTitle": "Kidney Graft Tolerance KTOL",
"nctId": "NCT06271343",
"orgStudyIdInfo": {
"id": "RC23_0394",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection."
}
],
"secondaryOutcomes": [
{
"measure": "Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones."
},
{
"measure": "Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Institut National de la Santé Et de la Recherche Médicale, France"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Nantes University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Faricimab"
}
]
},
"conditionsModule": {
"conditions": [
"AMD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nantes",
"contacts": [
{
"email": "[email protected]",
"name": "Jean-Baptiste Ducloyer, MD",
"phone": "02 40 08 46 51",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yann Maucourant, MD",
"phone": "85 658",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Ducloyer",
"geoPoint": {
"lat": 47.21725,
"lon": -1.55336
},
"state": null,
"status": null,
"zip": "44000"
}
]
},
"descriptionModule": {
"briefSummary": "Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \\[1\\] and aflibercept \\[2\\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \\[3\\] is that it extends the injection interval in the Treat and Extend (T\\&E) protocol, which is more extensive than with previous anti-VEGF agents.The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FAR-WEST",
"briefTitle": "Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.",
"nctId": "NCT06271330",
"orgStudyIdInfo": {
"id": "AP_JBD_FarWest_004",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment."
}
],
"secondaryOutcomes": [
{
"measure": "Difference between time to recurrence before switch and after switch."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Rennes University Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Nantes University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Obesity"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study",
"nctId": "NCT06271317",
"orgStudyIdInfo": {
"id": "AP_CL_001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Study postoperative morbidity after nissen sleeve gastrectomy in Nantes"
},
{
"measure": "postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nantes University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blue blocking eyewear"
},
{
"name": "Low filtration eyewear"
}
]
},
"conditionsModule": {
"conditions": [
"Bipolar Disorder"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.When in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days.After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Outcome assessors will be blinded to the treatment assignment. At the beginning of each assessment, participants will be instructed not to describe or discuss their glasses with the assessor. Because the two types of glasses are of different color (clear (LF) and orange (BB)), we cannot guarantee a full blinding of the participants. Participants will be informed that we are studying the effects of two different types of light filters without more detail so they will not be provided with certain knowledge of which condition is expected to yield the largest effect. We will assess the integrity of the blind by asking participants whether they think they received glasses with high or low filtration lenses at the end of the study. Participants will be discouraged from actively seeking information about sleep glasses during the study",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participants are instructed not to discuss the appearance of their designated eyewear with their care providers or the investigator or outcome assessor. Participants are not informed of the exact filtration level of their eyewear.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "BLUES",
"briefTitle": "Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder",
"nctId": "NCT06271304",
"orgStudyIdInfo": {
"id": "BLUES",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Manic symptoms"
}
],
"secondaryOutcomes": [
{
"measure": "Mood instability"
},
{
"measure": "Objective sleep quality"
},
{
"measure": "Objective sleep quality"
},
{
"measure": "Subjective sleep quality"
},
{
"measure": "Subjective sleep quality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mental Health Services in the Capital Region, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Interventional Study"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Duarte",
"contacts": [
{
"email": null,
"name": "Ajay Goel, Ph.D.",
"phone": "626-256-4673",
"phoneExt": "85200",
"role": "CONTACT"
},
{
"email": null,
"name": "Ajay Goel, Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "City of Hope",
"geoPoint": {
"lat": 34.13945,
"lon": -117.97729
},
"state": "California",
"status": null,
"zip": "91010"
},
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shounak Majumder, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": null,
"zip": "55905"
},
{
"city": "Pittsburgh",
"contacts": [
{
"email": null,
"name": "Randall Brand, M.D.",
"phone": "412-864-7516",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Pittsburgh",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15232"
}
]
},
"descriptionModule": {
"briefSummary": "This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 15000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts",
"nctId": "NCT06271291",
"orgStudyIdInfo": {
"id": "23-000161",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-00504",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic in Rochester",
"id": "23-000161",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "P30CA015083",
"link": "https://reporter.nih.gov/quickSearch/P30CA015083",
"type": "NIH"
},
{
"domain": null,
"id": "U01CA210138",
"link": "https://reporter.nih.gov/quickSearch/U01CA210138",
"type": "NIH"
},
{
"domain": null,
"id": "U24CA274496",
"link": "https://reporter.nih.gov/quickSearch/U24CA274496",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer"
},
{
"measure": "Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-20"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Emotional Freedom Technique"
}
]
},
"conditionsModule": {
"conditions": [
"Occupational Stress",
"Alert Fatigue, Health Personnel"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Malatya",
"contacts": [
{
"email": "[email protected]",
"name": "Turgut Ozal Medical Center",
"phone": "+904223770100",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": null,
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gurkan Kapikiran, Ph.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Seher Çevik Aktura, Ph.D",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Şerafettin Okutan, Ph.D",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Remziye Cici, Ph.D",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Inonu University Turgut OzaL Medical Center",
"geoPoint": {
"lat": 38.35018,
"lon": 38.31667
},
"state": null,
"status": "RECRUITING",
"zip": "44090"
}
]
},
"descriptionModule": {
"briefSummary": "Nurses working in surgical intensive care units face numerous health and safety stressors. The introduction of new health technologies, medical devices (such as bedside monitors, pump and perfuser devices, and mechanical ventilators), and changing health environments have contributed to increased work stress among nurses. This, in turn, has had negative effects on their physical and mental health outcomes. One of the hazards associated with medical devices is alarm fatigue. Noise pollution caused by bells, beeps, and horns in intensive care units can lead to alarm fatigue, defined as desensitisation to monitor alarms. Nurses are particularly susceptible to this due to their constant exposure to these sounds, which can also cause stress. Occupational stress is a recognised issue in this demanding field, characterised by disproportionate workloads and negative effects on performance.Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study was conducted as a randomised controlled study with experimental and control groups.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Participants will be blinded to their group assignment. The subjects will be selected in a randomized order using software. Data collection will be conducted without involvement from research analysts.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 144,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Emotional Freedom Techniques Application on Nurses",
"nctId": "NCT06271278",
"orgStudyIdInfo": {
"id": "2023-17",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Subjective Units of Disturbance Scale"
},
{
"measure": "Alarm Fatigue Scale"
},
{
"measure": "The General Work Stress Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Gurkan KAPIKIRAN"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "EXPAREL"
},
{
"name": "bupivacaine"
}
]
},
"conditionsModule": {
"conditions": [
"Postoperative Pain"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"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": "6 Years",
"minimumAge": "0 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery",
"nctId": "NCT06271265",
"orgStudyIdInfo": {
"id": "402-C-125",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The following model-predicted PK endpoint will be determined:"
},
{
"measure": "The following model-predicted PK endpoint will be determined:"
},
{
"measure": "The following model-predicted PK endpoint will be determined:"
},
{
"measure": "The following model-predicted PK endpoint will be determined:"
},
{
"measure": "The following model-predicted PK endpoint will be determined:"
},
{
"measure": "The following model-predicted PK endpoint will be determined:"
}
],
"secondaryOutcomes": [
{
"measure": "Vitals change from Baseline:"
},
{
"measure": "Vitals change from Baseline:"
},
{
"measure": "Vitals change from Baseline:"
},
{
"measure": "Vitals change from Baseline:"
},
{
"measure": "Vitals change from Baseline:"
},
{
"measure": "Incidence of treatment-emergent adverse events (TEAEs)"
},
{
"measure": "Incidence of adverse events of special interest (AESIs)"
},
{
"measure": "Incidence of serious adverse events (SAEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Pacira Pharmaceuticals, Inc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "OriCAR-017"
}
]
},
"conditionsModule": {
"conditions": [
"Neoplasms, Plasma Cell",
"Neoplasms by Histologic Type",
"Neoplasms",
"Hemostatic Disorders",
"Vascular Diseases",
"Cardiovascular Diseases",
"Paraproteinemias",
"Blood Protein Disorders",
"Hematologic Diseases",
"Hemorrhagic Disorders",
"Lymphoproliferative Disorders",
"Immunoproliferative Disorders",
"Immune System Diseases",
"Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Atlanta",
"contacts": [
{
"email": "[email protected]",
"name": "Melhem Solh",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Caitlin Guzowski",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Northside Hospital",
"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia",
"status": null,
"zip": "30342"
}
]
},
"descriptionModule": {
"briefSummary": "The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.RIGEL Study"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 81,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study",
"nctId": "NCT06271252",
"orgStudyIdInfo": {
"id": "OriCAR-017 US-P1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum tolerated dose (MTD) of OriCAR-017 US-P1"
},
{
"measure": "Dose-limiting toxicity (DLT)"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM"
},
{
"measure": "Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM"
},
{
"measure": "Assessment of Duration of Response (DOR) of treatment in patients with RR/MM"
},
{
"measure": "Progress-Free Survival (PFS) of treatment in patients with RR/MM"
},
{
"measure": "Assessment of Overall Survival (OS) of treatment in patients with RR/MM"
},
{
"measure": "Assessment of MRD negative Rate"
},
{
"measure": "Assessment of Overall Response Rate (ORR)"
},
{
"measure": "Assessment of Disease Control Rate (DCR)"
},
{
"measure": "Assessment of Clinical Benefit Rate (CBR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "OriCell Therapeutics Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intervention group (ViviFrail)"
},
{
"name": "Group Suggestions for a Healthy Life (CG)"
}
]
},
"conditionsModule": {
"conditions": [
"Frailty",
"Aging",
"Physical Disability"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "In the Intervention Group (ViviFrail), participants will perform a six-month VIVIFRAIL® protocol-based exercise, adapted to their clinical profile.The Group Suggestions for a Healthy Life (CG) will receive exercise suggestions and guidance for maintaining a healthy routine for three months. After, they will undergo a three-month intervention using the VIVIFRAIL® protocol.Sample size determination was based on Casas-Herrero et al. (2022). The study assessed the impact of multicomponent training on intrinsic functional capacity, utilizing the Short Physical Performance Battery (SPPB) to gauge balance, gait speed, and lower limb strength on a 0 to 12 scale. Control group: -0.33±1.60 point difference; Treatment group: 1.07±1.52 point difference.Considering a 5% alpha and 80% power, 20 participants per group are required. Anticipating a 25% dropout rate, as observed by Tiecker (2021), we plan to enroll 25 participants per group.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The assessments will be conducted by trained researchers",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults",
"nctId": "NCT06271239",
"orgStudyIdInfo": {
"id": "U1111-1299-9167",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IRB-Pontifical Catholic University of Rio Grande do Sul",
"id": "65318722.0.0000.5336",
"link": null,
"type": "OTHER"
},
{
"domain": "The Brazilian Registry of Clinical Trials (ReBEC)",
"id": "RBR-2tq2jky",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Short physical performance battery"
}
],
"secondaryOutcomes": [
{
"measure": "Barthel Index"
},
{
"measure": "ICOPE questionnaire"
},
{
"measure": "Lawton Scale"
},
{
"measure": "4-meter gait speed"
},
{
"measure": "Five Times Sit-to-Stand"
},
{
"measure": "Balance test in three positions"
},
{
"measure": "Self-perceived health"
},
{
"measure": "Adverse health outcomes - falls"
},
{
"measure": "Adverse health outcomes - hospitalization"
},
{
"measure": "Adverse health outcomes - institutionalization"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Coordenação de Aperfeiçoamento de Pessoal de Nível Superior."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Pontificia Universidade Católica do Rio Grande do Sul"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "acupressure"
},
{
"name": "placebo acupressure"
},
{
"name": "control group"
}
]
},
"conditionsModule": {
"conditions": [
"Intensive Care Patients",
"Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giresun",
"contacts": [
{
"email": "[email protected]",
"name": "emine yaman lezki",
"phone": "+9005458026622",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Giresun Eğitim Araştırma Hastanesi",
"geoPoint": {
"lat": 40.91698,
"lon": 38.38741
},
"state": null,
"status": "RECRUITING",
"zip": "28000"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this experimental study is to determine the effect of acupressure applied to intensive care patients on pain and physiological parameters (blood pressure, heart rate, respiration and oxygen saturation).The main questions that the study aims to answer are:Acupressure applied to intensive care patients has no effect on pain. Acupressure applied to intensive care patients has an effect on pain. Acupressure applied to intensive care patients has no effect on physiological parameters.Acupressure applied to intensive care patients has an effect on physiological parameters.Participants will be included in the study after obtaining consent from patients who were treated in the intensive care unit, who scored 9 and above on the glaskow coma scale by evaluating their consciousness status, and had pain after evaluating their pain."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Since there will be variability in patient admissions to intensive care units, block randomization will be used. Three different groups will be coded with different letters (A,B,C) and blocks will be created. Then randomization will be performed by assigning random numbers on the computer. The letters determined in the randomization will be written in closed envelopes and stored, and the randomization process will be carried out by an independent researcher. After the patient who meets the inclusion criteria is identified, the independent researcher will be contacted to find out which group the patient is in.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "participant and statistical analysis expert is blind.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EFFECTOFACU",
"briefTitle": "The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters",
"nctId": "NCT06271226",
"orgStudyIdInfo": {
"id": "OMUKAEK 2022/75",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ONDOKUZ MAYIS UNIVERSTY",
"id": "OMUKAEK 2022/75",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "neurological evaluation"
},
{
"measure": "evaluation of pain"
},
{
"measure": "evaluation of physiological parameters"
}
],
"secondaryOutcomes": [
{
"measure": "evaluation of physiological parameters"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ondokuz Mayıs University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "observational only - no interventions as part of study"
}
]
},
"conditionsModule": {
"conditions": [
"Respiration Disorders",
"Respiratory Disease",
"Asthma in Children",
"Wheezing",
"Gastro-Intestinal Disorder",
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Glasgow",
"contacts": [
{
"email": "[email protected]",
"name": "Ross J Langley, MRCPCH",
"phone": "0141 451 6683",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow",
"geoPoint": {
"lat": 55.86515,
"lon": -4.25763
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the \"gut-lung axis\" in health and disease.Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are:* What does a healthy gut-lung axis look like?* Do children with respiratory issues show an altered gut microbiome?* Do children with GI issues show an altered lung microbiome?Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control).Participants will provide:* airway samples (to investigate the lung microbiome)* blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care* stool samples (to assess gut microbiome)* dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "0 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Gut-Lung Axis and Respiratory Illness in Children",
"nctId": "NCT06271213",
"orgStudyIdInfo": {
"id": "303841",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess differences in gut and lung microbiota diversity between groups"
},
{
"measure": "Assess changes in gut and lung microbiota in children with asthma receiving biologics"
},
{
"measure": "Determine mediators of gut-lung axis in health and disease"
}
],
"secondaryOutcomes": [
{
"measure": "Nutritional influence in gut-lung axis"
},
{
"measure": "Multi-omics integration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Glasgow"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "NHS Greater Glasgow and Clyde"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intermittent fasting and 10,000 steps per day"
}
]
},
"conditionsModule": {
"conditions": [
"Metabolic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zhunan",
"contacts": [
{
"email": "[email protected]",
"name": "Vivian Wang, Master",
"phone": "+886-37-206166",
"phoneExt": "35374",
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes",
"geoPoint": {
"lat": 22.57358,
"lon": 120.54147
},
"state": "Miaoli County",
"status": null,
"zip": "350"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction \\> 5% body weight over 24 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intervention on Metabolism and Related Chronic Diseases",
"nctId": "NCT06271200",
"orgStudyIdInfo": {
"id": "MG-113-GP-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Tri-Service General Hospital"
},
{
"name": "Chang Gung Memorial Hospital"
},
{
"name": "National Taiwan University Hospital Hsin-Chu Branch"
},
{
"name": "Taichung Armed Forces General Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "National Health Research Institutes, Taiwan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dynamic-orthosis"
},
{
"name": "Traditional stroke occupational therapy training"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tainan",
"contacts": [
{
"email": "[email protected]",
"name": "JER-HAO CHANG, PH.D.",
"phone": "886-6-2353535",
"phoneExt": "5912",
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "National Cheng Kung University",
"geoPoint": {
"lat": 22.99083,
"lon": 120.21333
},
"state": null,
"status": "RECRUITING",
"zip": "701"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dynamic-orthosis Programs for Stroke Hand Function",
"nctId": "NCT06271187",
"orgStudyIdInfo": {
"id": "A-ER-110-507",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fugl-Meyer Assessment- Upper Extremity"
},
{
"measure": "Box and Block Test"
},
{
"measure": "Motor Activity Log"
}
],
"secondaryOutcomes": [
{
"measure": "Modified Ashworth scale"
},
{
"measure": "Upper limb joint range of motion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Cheng-Kung University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Carbocaine"
},
{
"name": "Profofol and/or Suxaméthonium and/or Sévoflurane"
}
]
},
"conditionsModule": {
"conditions": [
"Persistent Postoperative Pain"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.The goal is to show the decrease of the incidence of the persistent postoperative pain in the group \"locoregional analgesia\"."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 208,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "183 Months",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "AWA3PASIC",
"briefTitle": "Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children",
"nctId": "NCT06271174",
"orgStudyIdInfo": {
"id": "RC23_0009",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Persistent Postoperative Pain"
}
],
"secondaryOutcomes": [
{
"measure": "Screening of neuropathic pain if persistent postoperative pain - 3 months"
},
{
"measure": "Screening of neuropathic pain if persistent postoperative pain - 6 months"
},
{
"measure": "Screening of neuropathic pain if persistent postoperative pain - 12 months"
},
{
"measure": "1st EN score in immediate post-operative ICU before morphine titration"
},
{
"measure": "Persistent postoperative pain at 6 months."
},
{
"measure": "Persistent postoperative pain at 12 months."
},
{
"measure": "Postoperative nausea and vomiting"
},
{
"measure": "Time in Post Interventional Care Unit"
},
{
"measure": "Opioïd dose received - Per-operative"
},
{
"measure": "Opioïd dose received - in Post Interventional Care Unit"
},
{
"measure": "Opioïd dose received"
},
{
"measure": "Intravenous Morphine dose received in Post Interventional Care Unit"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fondation Apicil"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Nantes University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Postoperative Pain",
"Postoperative Nausea and Vomiting",
"Throat, Sore",
"Anesthesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Selçuklu",
"contacts": null,
"country": "Turkey",
"facility": "Funda Arun",
"geoPoint": {
"lat": 37.8842,
"lon": 32.49222
},
"state": "Konya",
"status": null,
"zip": "42000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to to evaluate the effects of a throat pack soaked with saline at +4 ºC on postoperative throat pain (POTP) and postoperative nausea and vomiting (PONV) in dental surgical procedures performed under general anesthesia. The main questions it aims to answer are: 1. How long can we keep the pharyngeal mucosa cold using tampons and cold wash solutions? 2. Does cooling the pharyngeal mucosa reduce the incidence of postoperative sore throat and nausea and vomiting?"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 84,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting",
"nctId": "NCT06271161",
"orgStudyIdInfo": {
"id": "F002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The incidence of postoperative sore throat and noise vomiting was investigated in dental surgery involving the application of cooling to the pharyngeal area, particularly when a throat pack was used."
}
],
"secondaryOutcomes": [
{
"measure": "Intraoperative change in nasopharyngeal temperature from baseline (ºC ), intraoperative opioid usage (mcg), postoperative analgesic usage (mg),antiemetic usage(mg) and any adverse events due to throat pack were recorded."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Selcuk University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Interview"
}
]
},
"conditionsModule": {
"conditions": [
"Surgery",
"Lifestyle"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Al-Karak",
"contacts": null,
"country": "Jordan",
"facility": "Mutah University",
"geoPoint": {
"lat": 31.16368,
"lon": 35.76204
},
"state": null,
"status": null,
"zip": "61710"
}
]
},
"descriptionModule": {
"briefSummary": "A study conducted to evaluate the female surgeons in Jordan from different lifestyle"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 224,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Career and Lifestyle Among Female Surgeons in Jordan",
"nctId": "NCT06271148",
"orgStudyIdInfo": {
"id": "Mutah University",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Mutah university school of medicine",
"id": "Myah REC/133/2023",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Career and Lifestyle Among Female Surgeons in Jordan"
},
{
"measure": "Working Hours"
},
{
"measure": "Sex Bias"
},
{
"measure": "inadequate mentorship"
},
{
"measure": "having 30 days of leave"
},
{
"measure": "salary"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mohammad Abu-Jeyyab"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CAPILLARY REPAIR SERUM 30ml"
}
]
},
"conditionsModule": {
"conditions": [
"Rosacea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Białystok",
"contacts": null,
"country": "Poland",
"facility": "Medical University of Bialystok",
"geoPoint": {
"lat": 53.13333,
"lon": 23.16433
},
"state": null,
"status": null,
"zip": "15-089"
}
]
},
"descriptionModule": {
"briefSummary": "The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessing the Quality of Life of Patients With Rosacea",
"nctId": "NCT06271135",
"orgStudyIdInfo": {
"id": "LU20170508",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Elements influenced on quality of life of participants with rosacea"
}
],
"secondaryOutcomes": [
{
"measure": "Self-reported questionnaire"
},
{
"measure": "Dietary Questionnaire"
},
{
"measure": "The Physical Activity Questionnaire"
},
{
"measure": "DLQI (Dermatology Life Quality Index)"
},
{
"measure": "SWLS (Satisfaction With Life Scale)"
},
{
"measure": "BDI (Beck Depression Inventory)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Lomza"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Bialystok"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2018-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2018-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-05-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Voluntary activation assessed by magnetic stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Obstructive Pulmonary Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lodève",
"contacts": [
{
"email": "[email protected]",
"name": "Nelly Heraud, PhD",
"phone": "+33467888491",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nicolas Oliver, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "France",
"facility": "Clinique du Souffle La Vallonie",
"geoPoint": {
"lat": 43.71667,
"lon": 3.31667
},
"state": null,
"status": "RECRUITING",
"zip": "34700"
}
]
},
"descriptionModule": {
"briefSummary": "Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease associated with various comorbidities, including muscle weakness (MW), which is very worrying due to its negative impact on patients' quality of life and survival. To address this issue, muscle strengthening is incorporated into pulmonary rehabilitation programs. However, its effectiveness is unclear, as although there is an average improvement in muscle strength, one in two patients does not show a clinically relevant improvement. To understand this non-response, it is crucial to examine the effect of muscle strengthening programs on the two main determinants of force production: the muscle and the central command. Muscle adaptations following a muscle strengthening program are well-documented, showing improvements in muscle function (cross-sectional area, lean mass, etc.). Conversely, only one study has investigated central adaptations after a muscle strengthening program, clearly demonstrating a lack of effect.The investigators hypothesize that patients showing no improvement in muscle strength after pulmonary rehabilitation (non-responders) have a significantly lower level of voluntary activation before starting the program compared to responding patients (responders)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients",
"nctId": "NCT06271122",
"orgStudyIdInfo": {
"id": "COMPET-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Central voluntary activation assessed by transcranial magnetic stimulation (TMS)"
}
],
"secondaryOutcomes": [
{
"measure": "Muscle excitability assessed by femoral magnetic stimulation (FMS)"
},
{
"measure": "Contractile properties assessed by femoral magnetic stimulation (FMS)"
},
{
"measure": "Corticospinal excitability assessed by transcranial magnetic stimulation (TMS)"
},
{
"measure": "Intra-cortical inhibitions transcranial magnetic stimulation (TMS)"
},
{
"measure": "Voluntary activation assessed by femoral magnetic stimulation (FMS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Korian"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-18"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Anatomical laparoscopic liver resection for liver neoplasms"
},
{
"name": "Non-Anatomical laparoscopic liver resection for liver neoplasms"
}
]
},
"conditionsModule": {
"conditions": [
"Liver Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sohag",
"contacts": null,
"country": "Egypt",
"facility": "Sohag University",
"geoPoint": {
"lat": 26.55695,
"lon": 31.69478
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors",
"nctId": "NCT06271109",
"orgStudyIdInfo": {
"id": "Soh-Med-24-01-04MD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "complete resection of the neoplasm"
}
],
"secondaryOutcomes": [
{
"measure": "residual liver tissue"
},
{
"measure": "recurrence rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sohag University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
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"startDateStruct": {
"date": "2021-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intra muscular Midazolam"
},
{
"name": "Intravascular Diazepam"
}
]
},
"conditionsModule": {
"conditions": [
"Seizures"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Peshawar",
"contacts": null,
"country": "Pakistan",
"facility": "Khyber Teaching Hospital",
"geoPoint": {
"lat": 34.008,
"lon": 71.57849
},
"state": null,
"status": null,
"zip": "25000"
}
]
},
"descriptionModule": {
"briefSummary": "IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study was a randomized controlled trial carried out between November 2019 to November 2022 in the Pediatric department of Khyber Teaching Hospital. A total of 150 children who presented to the emergency department with seizures were enrolled in this study via consecutive sampling. This study was approved by the Ethical Review",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ACTUAL"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Years",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children",
"nctId": "NCT06271096",
"orgStudyIdInfo": {
"id": "638/ADR/KMC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fits Controlled"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Arooj Khan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exposure with response prevention"
},
{
"name": "Brief psychoeducation with general psychological support"
}
]
},
"conditionsModule": {
"conditions": [
"Tourette Syndrome",
"Chronic Tic Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Stockholm",
"contacts": [
{
"email": "[email protected]",
"name": "Ekaterina Ivanova, PhD",
"phone": "0046765807416",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Karolinska Institutet",
"geoPoint": {
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"lon": 18.0649
},
"state": null,
"status": "RECRUITING",
"zip": "14157"
}
]
},
"descriptionModule": {
"briefSummary": "This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 110,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TICNET",
"briefTitle": "Internet-based Behavior Therapy for Adults With Tourette Syndrome",
"nctId": "NCT06271083",
"orgStudyIdInfo": {
"id": "2023-06541-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS)"
},
{
"measure": "Credibility/Expectancy Questionnaire (CEQ)"
},
{
"measure": "Working Alliance Inventory-Short Form Revised (WAI-SR)"
},
{
"measure": "Checklist for negative events"
},
{
"measure": "Events during treatment and adverse events"
}
],
"primaryOutcomes": [
{
"measure": "Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS)"
}
],
"secondaryOutcomes": [
{
"measure": "Yale Global Tic Severity Scale (YGTSS) - impairment scale"
},
{
"measure": "Clinical Global Impression (CGI)"
},
{
"measure": "Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL)"
},
{
"measure": "Montgomery-Asberg Depression Rating Scale (MADRS)"
},
{
"measure": "Adult Tic Questionnaire (ATQ)"
},
{
"measure": "Work and social adjustment scale (WSAS)"
},
{
"measure": "Treatment Inventory of Costs in Psychiatric Patients (TIC-P)"
},
{
"measure": "Assessing Quality of Life 6 Dimensions (AQoL-6D)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Karolinska Institutet"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Lifestyle Risk Reduction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hanoi",
"contacts": [
{
"email": null,
"name": "Nguyen Thuy Lan, Doctor",
"phone": "+84 243 622 7799",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Vietnam",
"facility": "Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited",
"geoPoint": {
"lat": 21.0245,
"lon": 105.84117
},
"state": null,
"status": "RECRUITING",
"zip": "11612"
}
]
},
"descriptionModule": {
"briefSummary": "To clarify the relationship between vegetable intake and lifestyle-related disease in Vietnam, we measure skin carotenoid levels and basic indicators of health status related to lifestyle and analyze the correlation between them. This is an important study that can lead to dietary suggestions for preventing lifestyle-related diseases in Vietnam."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Analysis of Correlation Between Skin Carotenoid Level and Basic Indicators of Health Status Related to Lifestyle in Vietnamese: An Observational Study",
"nctId": "NCT06271070",
"orgStudyIdInfo": {
"id": "2023-R23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Skin carotenoid level"
},
{
"measure": "Blood markers of lifestyle-related diseases"
},
{
"measure": "BMI"
},
{
"measure": "Body fat percentage"
},
{
"measure": "Blood pressure"
}
],
"secondaryOutcomes": [
{
"measure": "Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "KAGOME CO., LTD."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "golcadomide"
}
]
},
"conditionsModule": {
"conditions": [
"Diffuse Large B-cell Lymphoma Refractory",
"Refractory Primary Mediastinal Large B-Cell Lymphoma",
"Refractory Transformed B-cell Non-Hodgkin Lymphoma",
"Refractory High Grade B-Cell Lymphoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Créteil",
"contacts": null,
"country": "France",
"facility": "Hopital Henri Mondor",
"geoPoint": {
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"lon": 2.46667
},
"state": null,
"status": null,
"zip": "94010"
},
{
"city": "Dijon",
"contacts": null,
"country": "France",
"facility": "Chu Dijon Bourgogne",
"geoPoint": {
"lat": 47.31667,
"lon": 5.01667
},
"state": null,
"status": null,
"zip": "21000"
},
{
"city": "La Tronche",
"contacts": null,
"country": "France",
"facility": "Chu de Grenoble",
"geoPoint": {
"lat": 45.20429,
"lon": 5.73645
},
"state": null,
"status": null,
"zip": "38700"
},
{
"city": "Lille",
"contacts": null,
"country": "France",
"facility": "Chru de Lille",
"geoPoint": {
"lat": 50.63297,
"lon": 3.05858
},
"state": null,
"status": null,
"zip": "59037"
},
{
"city": "Marseille",
"contacts": null,
"country": "France",
"facility": "Institut Paoli Calmettes",
"geoPoint": {
"lat": 43.29551,
"lon": 5.38958
},
"state": null,
"status": null,
"zip": "13273"
},
{
"city": "Montpellier",
"contacts": null,
"country": "France",
"facility": "Chu de Montpellier",
"geoPoint": {
"lat": 43.61092,
"lon": 3.87723
},
"state": null,
"status": null,
"zip": "34090"
},
{
"city": "Nantes",
"contacts": null,
"country": "France",
"facility": "Chu de Nantes",
"geoPoint": {
"lat": 47.21725,
"lon": -1.55336
},
"state": null,
"status": null,
"zip": "44093"
},
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hopital Saint-Louis",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": "75475"
},
{
"city": "Pessac",
"contacts": null,
"country": "France",
"facility": "Chu de Bordeaux",
"geoPoint": {
"lat": 44.81011,
"lon": -0.64129
},
"state": null,
"status": null,
"zip": "33604"
},
{
"city": "Rennes",
"contacts": null,
"country": "France",
"facility": "Chu Pontchaillou",
"geoPoint": {
"lat": 48.11198,
"lon": -1.67429
},
"state": null,
"status": null,
"zip": "35033"
},
{
"city": "Rouen",
"contacts": null,
"country": "France",
"facility": "Centre Henri Becquerel",
"geoPoint": {
"lat": 49.44313,
"lon": 1.09932
},
"state": null,
"status": null,
"zip": "76038"
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{
"city": "Toulouse",
"contacts": null,
"country": "France",
"facility": "Iuct Oncopole",
"geoPoint": {
"lat": 43.60426,
"lon": 1.44367
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"state": null,
"status": null,
"zip": "31059"
},
{
"city": "Vandœuvre-lès-Nancy",
"contacts": null,
"country": "France",
"facility": "Chu Brabois",
"geoPoint": {
"lat": 48.65,
"lon": 6.18333
},
"state": null,
"status": null,
"zip": "54511"
}
]
},
"descriptionModule": {
"briefSummary": "This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator."
},
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},
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"sex": "ALL",
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},
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"acronym": null,
"briefTitle": "Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse",
"nctId": "NCT06271057",
"orgStudyIdInfo": {
"id": "CARMOD",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Complete metabolic response rate (CMR rate)"
}
],
"secondaryOutcomes": [
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Complete response rate (CRR)"
},
{
"measure": "Duration of response (DR)"
},
{
"measure": "Event-free survival (EFS)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Time To Next anti-Lymphoma Treatment (TTNLT)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Incidence of Adverse Events and Serious Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
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"name": "Lymphoma Study Association"
}
],
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"class": "OTHER",
"name": "The Lymphoma Academic Research Organisation"
}
},
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"date": "2027-10-20"
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"lastUpdatePostDateStruct": {
"date": "2024-02-21"
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"date": "2026-01-15"
},
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"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
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"interventions": [
{
"name": "With radioiodine treatment"
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{
"name": "With postoperative radioiodine treatment"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To study if its is safe to reduce the amount of postoperative treatments in those patients, who have been operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level."
},
"designModule": {
"designInfo": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients with low risk papillary thyroid cancer either received a radioiodine treatment according to the normal Finnish treatment schedule or were schedulded for only follow-up .",
"maskingInfo": {
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"whoMasked": null
},
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"count": 61,
"type": "ACTUAL"
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],
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"minimumAge": "18 Years",
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},
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"acronym": null,
"briefTitle": "a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS",
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"id": "RAILESS",
"link": null,
"type": null
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{
"measure": "Event free situation during follow-up event free /disease free"
}
],
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Helsinki University Central Hospital"
}
},
"statusModule": {
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"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
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"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2024-12"
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"startDateStruct": {
"date": "2014-10"
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"studyFirstPostDateStruct": {
"date": "2024-02-21"
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}
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"conditions": [
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]
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"descriptionModule": {
"briefSummary": "The goal of this study is to create a computer simulation of patients with bloodstream infection to understand how changes in healthcare policies and resources affect patient treatment. This simulation will help doctors and health-care decision makers make better choices in treating these patients and avoid overusing antibiotics that can lead to antibiotic resistance. Antibiotic resistance is when bacteria can't be killed by antibiotics anymore. Participants will not receive treatments as this is an observational study, but the study will involve:* Interviews with healthcare staff to understand patient care pathways.* Analysis of historical data on bacteria causing infections and antibiotic treatments.* A 30-day observational study to observe patient treatment for bloodstream infections."
},
"designModule": {
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"allocation": null,
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"type": "ESTIMATED"
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},
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"minimumAge": "18 Years",
"sex": "ALL",
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"OLDER_ADULT"
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},
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"acronym": "CSM-BSI",
"briefTitle": "Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection",
"nctId": "NCT06271031",
"orgStudyIdInfo": {
"id": "LHS0211",
"link": null,
"type": null
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"measure": "Generation of a software simulation model that is fine tuned to the observed data."
}
],
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"measure": "Exploration of the performance of the model in different hypothesised scenarios."
}
]
},
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"leadSponsor": {
"class": "OTHER_GOV",
"name": "Liverpool University Hospitals NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
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"date": "2023-10-10",
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"label": "Study Protocol and Informed Consent Form",
"size": 2058603,
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"uploadDate": "2023-11-14T09:05"
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{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Giant Cell Arteritis",
"Aortitis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).Giant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.Multiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.The GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.Following the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.However, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.This observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA."
},
"designModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TILT",
"briefTitle": "TocILizumab in aorTitis in GCA (TILT)",
"nctId": "NCT06271018",
"orgStudyIdInfo": {
"id": "GMIO-2024-0001",
"link": null,
"type": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To evaluate the proportion of patients with remission of GCA"
}
],
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{
"measure": "To assess the cumulative incidence of relapse"
},
{
"measure": "To assess the proportion of GCA in remission (according to EULAR consensus definitions) after treatment start"
},
{
"measure": "To assess the cumulative dose of prednisone"
},
{
"measure": "To assess the cumulative incidence of severe adverse events"
},
{
"measure": "To assess the proportion of radiological vascular progression"
},
{
"measure": "To assess the cumulative incidence of vascular revascularization procedures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "UNKNOWN",
"name": "GMIOFrance"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NeuroTears"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye Disease",
"Dry Eye"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
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},
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},
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"count": 75,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves",
"nctId": "NCT06271005",
"orgStudyIdInfo": {
"id": "000824",
"link": null,
"type": null
},
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"primaryOutcomes": [
{
"measure": "OSDI"
}
],
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},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Genetic Disease Investigators"
}
},
"statusModule": {
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"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
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"date": "2024-10-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NCCN (National Comprehensive Cancer Network) diagnosis"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kayseri",
"contacts": [
{
"email": "[email protected]",
"name": "Aycan Gundogdu, PhD",
"phone": "+90 352 207 6666",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Erciyes University Hospital",
"geoPoint": {
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"lon": 35.48528
},
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"status": "RECRUITING",
"zip": "38039"
}
]
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"descriptionModule": {
"briefSummary": "The study aims to develop a deep learning-based diagnostic method for lung cancer using the oral microbiome. This innovative approach involves establishing an observational cohort of 576 individuals, including lung cancer patients, non-cancerous benign lung disease patients, and healthy controls, to collect tongue swab samples for 16S rRNA sequencing. Additionally, an international cohort of approximately 1700 individuals will be formed using in silico data. The project will utilize deep learning methods to analyze all data integratively and develop an AI diagnostic algorithm capable of distinguishing lung cancer patients from others. The diagnostic method's performance will be tested in a pilot clinical trial with 96 individuals using a PRoBE design. Led by experts in chest surgery, molecular microbiology, and bioinformatics, the project spans over 30 months and aims to create a non-invasive, easily accessible lung cancer screening method that could lead to significant diagnostic advancements and potential spin-off companies in the field of liquid biopsy/molecular diagnosis."
},
"designModule": {
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"maximumAge": "65 Years",
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"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Oral Microbiome Diagnostics of Lung Cancer",
"nctId": "NCT06270992",
"orgStudyIdInfo": {
"id": "123R030",
"link": null,
"type": null
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"primaryOutcomes": [
{
"measure": "Diagnostics accuracy assessment"
}
],
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"collaborators": [
{
"name": "THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "TC Erciyes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
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"overallStatus": "RECRUITING",
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"date": "2025-02-15"
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"startDateStruct": {
"date": "2023-11-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
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}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ISHA"
}
]
},
"conditionsModule": {
"conditions": [
"Frailty"
]
},
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"locations": null
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"descriptionModule": {
"briefSummary": "In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.The aims of the study are:1. to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the ISHA system in rehabilitation and nursing home settings.2. to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.3. to explore individual trajectories of intrinsic capacity with the ISHA system."
},
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"timePerspective": "CROSS_SECTIONAL"
},
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"count": 120,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
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"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ISHA",
"briefTitle": "Intrinsic Capacity and Functional Ability Monitoring With an Integrated Data Eco-System for Healthy Ageing.",
"nctId": "NCT06270979",
"orgStudyIdInfo": {
"id": "ISHA",
"link": null,
"type": null
},
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{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Potential technical problems of the ISHA system"
},
{
"measure": "Experiences with ISHA (usability, feasibility and acceptability outcome)"
}
],
"secondaryOutcomes": [
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in quality of life (Qol) measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)"
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol)"
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)."
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)."
},
{
"measure": "The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)."
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)."
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)."
},
{
"measure": "The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Leiehome vzw"
},
{
"name": "University Hospital, Antwerp"
},
{
"name": "Universiteit Antwerpen"
},
{
"name": "INNOVIRIS"
},
{
"name": "AAL"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Prof. Ivan Bautmans"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Virtual Reality Cognitive Remediation"
}
]
},
"conditionsModule": {
"conditions": [
"Mild Cognitive Impairment",
"Cognitive Remediation",
"Virtual Reality",
"Psychiatric Rehabilitation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cagliari",
"contacts": null,
"country": "Italy",
"facility": "San Giovanni di Dio Hospital",
"geoPoint": {
"lat": 39.23054,
"lon": 9.11917
},
"state": "CA",
"status": null,
"zip": "09100"
}
]
},
"descriptionModule": {
"briefSummary": "The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized Controlled Trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT",
"nctId": "NCT06270966",
"orgStudyIdInfo": {
"id": "28287 08/11/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Side effects; Dropout rates; Proportion of recruited participants among those considered eligible"
}
],
"secondaryOutcomes": [
{
"measure": "Short Form Health Survey, 12 items (SF-12)"
},
{
"measure": "Brief Social Rhythms Scale (BSRS)"
},
{
"measure": "Patient Health Questionnaire (PHQ-9)"
},
{
"measure": "Generalized Anxiety Disorder-7 item (GAD-7)"
},
{
"measure": "Addenbrooke's Cognitive Examination (ACE-R)"
},
{
"measure": "Matrix test"
},
{
"measure": "Rey's Word Test"
},
{
"measure": "Trail Making Test (TMT)"
},
{
"measure": "Digit Span"
},
{
"measure": "Stroop Test"
},
{
"measure": "Frontal Assessment Battery (FAB)"
},
{
"measure": "Cognitive Estimates Test (CET)"
},
{
"measure": "Rey Figure Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Cagliari"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dozee Pro NX"
}
]
},
"conditionsModule": {
"conditions": [
"No Specific Medical Conditions or Disease States"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lake Jackson",
"contacts": [
{
"email": "[email protected]",
"name": "Lindsay Darthard, LNFA",
"phone": "979-319-2306",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lindsay Darthard, LNFA",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Marc A Wilson, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Oak Village Healthcare",
"geoPoint": {
"lat": 29.03386,
"lon": -95.43439
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77566"
}
]
},
"descriptionModule": {
"briefSummary": "Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "120 Years",
"minimumAge": "18 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non-invasive Monitoring: Impact on Patient Management and Outcomes",
"nctId": "NCT06270953",
"orgStudyIdInfo": {
"id": "DZ_NX_US",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),"
}
],
"secondaryOutcomes": [
{
"measure": "HCP experience response data"
},
{
"measure": "Care pathway mapping"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Turtle Shell Technologies Pvt. Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pulsed Radiofrequency (PRF) Treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Neuropathic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Amsterdam",
"contacts": [
{
"email": "[email protected]",
"name": "Katrin Stoecklein, Dr",
"phone": "0031 20 444 386",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Amsterdam UMC",
"geoPoint": {
"lat": 52.37403,
"lon": 4.88969
},
"state": null,
"status": "RECRUITING",
"zip": "1081 HV"
}
]
},
"descriptionModule": {
"briefSummary": "Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PURPOSE",
"briefTitle": "Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy",
"nctId": "NCT06270940",
"orgStudyIdInfo": {
"id": "2023.0922",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Duration PRF"
},
{
"measure": "Type of PRF"
},
{
"measure": "Pain intensity"
},
{
"measure": "Health Related Quality of life"
},
{
"measure": "Patient Global Impression of Change: PGIC"
},
{
"measure": "Use of opioids"
},
{
"measure": "PROMIS-29"
},
{
"measure": "PROMIS Global-10"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Amsterdam UMC, location VUmc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MRI"
},
{
"name": "CT"
}
]
},
"conditionsModule": {
"conditions": [
"Brain Ischemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Austin",
"contacts": [
{
"email": "[email protected]",
"name": "Adrienne N Dula, PhD",
"phone": "512-495-5922",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Karinne Berstis, MA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Ascension Seton",
"geoPoint": {
"lat": 30.26715,
"lon": -97.74306
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78712"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an \"intent-to-scan\" basis and all qualifying patients will be included in their assigned cohort."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 600,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "120 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CSI",
"briefTitle": "A Feasibility Study for Randomization of Code Stroke Imaging Strategies",
"nctId": "NCT06270927",
"orgStudyIdInfo": {
"id": "00003830",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "compliance"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Lone Star Stroke Research Consortium"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Texas at Austin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Inclusive Positive Behavior Interventions and Supports"
}
]
},
"conditionsModule": {
"conditions": [
"Behavior Problem",
"Social Skills"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Uppsala",
"contacts": [
{
"email": "[email protected]",
"name": "Martin Karlberg, PhD",
"phone": "018-471 1669",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Nina Klang, PhD",
"phone": "018-471 1674",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Department of Education",
"geoPoint": {
"lat": 59.85882,
"lon": 17.63889
},
"state": "Uppland",
"status": "RECRUITING",
"zip": "752 37"
}
]
},
"descriptionModule": {
"briefSummary": "Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. School-Wide Positive Behavioral Interventions and Supports (SW-PBIS) have shown positive effects on school climate, but fewer studies have been conducted in the European context. Aim: The present project aims to investigate the effectiveness of SW-PBIS programs for students' social-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment. Furthermore, the study intends to evaluate how school-level factors mediate or moderate the effects of the intervention. In addition, the study includes a qualitative evaluation of the dynamic interaction processes that occur during program implementation in local school contexts. Methods: Data on school- and individual-level measures are collected in intervention and control schools. With regard to challenges in retaining control groups over extended time periods, two waves of recruitment are used. In the first wave, an active control group is used, and data are collected during three time points. In the second wave, a wait-list control group is used, and data are collected during two time points during one school year. Hierarchical regression analyses will be conducted to explore the effects of SW-PBIS on the outcomes of the study. An ethnomethodological approach will be applied to provide a detailed examination of the social interactional and meaning-making practices of different school implementation teams, and the negotiation of normative expectations and rules of conduct in peer-teacher-student interactions in different classrooms. Discussion: The study is expected to contribute knowledge on the effects of the SWPBIS program and how these effects may be mediated or moderated by school-level factors. Combining quantitative and qualitative methods to explore the significance of school contexts in the implementation of the SWPBIS program constitutes the strength of the study. The challenge in the study is the extended period of implementation of SWPBIS, which entails difficulties in retaining a control group over the required time period. Therefore, two waves of recruitment are used, encompassing different procedures of allocation to intervention or control groups."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This study utilizes quasi-experimental non-randomized design, including two waves of participant recruitment. Two waves of recruitment are used. In the first wave of recruitment, intervention and active control group are used and outcomes will be measured at three time points. In addition to quantitative data, qualitative observations and interviews are conducted to get a deeper understanding of the process of implementation of SWPIS. In the second wave of data recruitment, intervention and wait-list control group are used and outcomes will be measured at two time points (pre- and post).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 5000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "9 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "IBIS",
"briefTitle": "Inclusive Positive Behaviour Supports",
"nctId": "NCT06270914",
"orgStudyIdInfo": {
"id": "IBIS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Implementation fidelity"
}
],
"primaryOutcomes": [
{
"measure": "Social emotional skills"
},
{
"measure": "Classroom environment"
},
{
"measure": "Students' achievement"
}
],
"secondaryOutcomes": [
{
"measure": "Collective self-efficacy"
},
{
"measure": "Problem behavior in classroom and school"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "The Swedish Research Council"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Uppsala University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-25"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High Protein Planetary Health Diet"
},
{
"name": "Low Protein Planetary Health Diet"
},
{
"name": "High Protein Western Diet"
},
{
"name": "Low Protein Western Diet"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Metabolic Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bonn",
"contacts": [
{
"email": "[email protected]",
"name": "Sarah Egert, Prof. Dr.",
"phone": "+ 49 (0) 228 / 73 59",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology",
"geoPoint": {
"lat": 50.73438,
"lon": 7.09549
},
"state": "North-Rhine Westphalia",
"status": "RECRUITING",
"zip": "53115"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LeguPlan_1",
"briefTitle": "Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants With Increased Cardiometabolic Risk",
"nctId": "NCT06270901",
"orgStudyIdInfo": {
"id": "BMEL: 2822EPS008",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Parameters of lipid metabolism in blood"
}
],
"secondaryOutcomes": [
{
"measure": "Parameters of lipid metabolism in blood"
},
{
"measure": "Parameters of lipid metabolism in blood"
},
{
"measure": "Parameters of lipid metabolism in blood"
},
{
"measure": "Parameters of lipid metabolism in blood"
},
{
"measure": "Parameters of glucose metabolism in blood"
},
{
"measure": "Parameters of glucose metabolism in blood"
},
{
"measure": "Parameters of glucose metabolism in blood"
},
{
"measure": "Parameters of glucose metabolism in blood"
},
{
"measure": "Parameters of glucose metabolism in blood"
},
{
"measure": "Blood amino acid profile"
},
{
"measure": "Blood urea"
},
{
"measure": "Uric acid in blood"
},
{
"measure": "Parameters of hunger and satiety in blood"
},
{
"measure": "Parameters of endothelial function in blood"
},
{
"measure": "Parameters of inflammation in blood"
},
{
"measure": "Endothelial function"
},
{
"measure": "Neuropsychological parameters"
},
{
"measure": "Neuropsychological parameters"
},
{
"measure": "Neuropsychological parameters"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Federal Ministry of Food and Agriculture (BMEL)"
},
{
"name": "Federal Office for Agriculture and Food (BLE)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Bonn"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Radiation"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": null,
"country": "United States",
"facility": "The University of Chicago Comprehensive Cancer Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60637"
}
]
},
"descriptionModule": {
"briefSummary": "This study if for people who have been diagnosed with multiple myeloma and their doctors are recommending radiation to help treat it. Typically, radiation consists of 2-3 weeks of external beam radiation therapy. Doctors leading this study would like to see if a shorter radiation course (i.e., hypofractionation) for pelvic radiation is safe for multiple myeloma. Because participants in this study will receive a shortened radiation course, each daily treatment dose that is delivered would be slightly higher than normal. This higher daily dose would be delivered because the study team would like to see if higher doses of radiation are as safe given over a shorter number of days compared to 2-3 weeks. The purpose of this study is to make sure that hypofractionation is safe and effective for individuals with multiple myeloma."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hypofractionation (Radiation) Trial for Multiple Myeloma",
"nctId": "NCT06270888",
"orgStudyIdInfo": {
"id": "IRB23-1011",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum Tolerated Dose of Radiation of Per Fraction"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of Grade 3 or Higher Adverse Events"
},
{
"measure": "Rate of Long-Term Adverse Events"
},
{
"measure": "Overall Response Rate"
},
{
"measure": "Progression-free Survival"
},
{
"measure": "Local Control of the treated Lesion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Chicago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ADAPT HF"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure NYHA Class III",
"Heart Failure NYHA Class IV",
"Chronic Illness"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age \\> 18) with advanced HF. Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the palliative care coach involved in delivering the intervention.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ADAPT HF",
"briefTitle": "Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF)",
"nctId": "NCT06270875",
"orgStudyIdInfo": {
"id": "PROJECT ADAPT-HF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility of Intervention Delivery and Data Collection"
},
{
"measure": "Acceptability of Intervention Measure (AIM)"
},
{
"measure": "PROMIS Pain Intensity Scale"
},
{
"measure": "Pain Interference Scale Short Form 6b"
},
{
"measure": "Feasibility of Intervention Measure"
}
],
"secondaryOutcomes": [
{
"measure": "Edmonton Symptom Assessment Scale (ESES-r)"
},
{
"measure": "Kansas City Cardiomyopathy Questionnaire- Short Form"
},
{
"measure": "Hospital Anxiety and Depression Scale (HADS)"
},
{
"measure": "PROMIS General Self-efficacy"
},
{
"measure": "Self-care of Heart Failure Index"
},
{
"measure": "Multidimensional Scale of Perceived Social Support (MSPSS)"
},
{
"measure": "Patient Activation Measure (PAM) Short Form"
},
{
"measure": "Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q"
},
{
"measure": "Connor-Davidson Resilience Scale (CD-RISC-10)"
},
{
"measure": "Discrimination in Medical Settings Scale Scale"
},
{
"measure": "Cost/Resource Utilization Form"
},
{
"measure": "SF Global Health Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Alabama at Birmingham"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-07"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Resilience training"
},
{
"name": "cognitive training"
},
{
"name": "physical exercise"
},
{
"name": "social interaction"
},
{
"name": "workshop series"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Aging",
"Cognitive Change",
"Psychological Stress",
"Loneliness",
"Social Interaction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Lixia Yang, PhD",
"phone": "416-979-5000",
"phoneExt": "556522",
"role": "CONTACT"
},
{
"email": null,
"name": "Lixia Yang, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Cognitive Aging Lab",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "M5B 2K3"
}
]
},
"descriptionModule": {
"briefSummary": "The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.In the \"active aging with resilience (AR)\" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional \"active aging\" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The \"workshop training\" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AAT",
"briefTitle": "A Digital Active Aging Training Program for Older Adults",
"nctId": "NCT06270862",
"orgStudyIdInfo": {
"id": "SSHRC-PEG2023-AAT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Exercise Self-efficacy level (ESES)"
},
{
"measure": "the 5-item World Health Organization WellBeing Index (WHO-5)"
},
{
"measure": "Kessler Psychological Distress Scale (K10)"
},
{
"measure": "Multidimensional Scale of Perceived Social Support (MSPSS)"
},
{
"measure": "Conner-Davidson Resilience Scale 10-item (CD RISC-10)"
},
{
"measure": "Emotional regulation Questionnaire (ERQ)"
},
{
"measure": "Positive and Negative Affect Schedule (PANAS)"
},
{
"measure": "Visual working memory test"
},
{
"measure": "Divided attention test"
},
{
"measure": "Visual memory test"
},
{
"measure": "Stroop test"
},
{
"measure": "Sustained attention to response test"
}
],
"secondaryOutcomes": [
{
"measure": "Satisfaction with life scale (SWLS)"
},
{
"measure": "Instrumental Activities of Daily Living(IADL)"
},
{
"measure": "The 6-item De Jong Gierveld Loneliness Scale"
},
{
"measure": "The Brief Approach/Avoidance Coping Questionnaire (BACQ)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Social Sciences and Humanities Research Council of Canada"
},
{
"name": "AGE-WELL and the Canadian Frailty Network"
},
{
"name": "Cogniciti"
},
{
"name": "Cognifit"
},
{
"name": "Aging in Cloud"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Toronto Metropolitan University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire",
"Reliability of Thai Version of the ICIQ-FLUTS LF"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Khlong Luang",
"contacts": null,
"country": "Thailand",
"facility": "Thammasat University Hospital",
"geoPoint": {
"lat": 14.06467,
"lon": 100.64578
},
"state": "Pathumthani",
"status": null,
"zip": "12120"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 130,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With IPSS",
"nctId": "NCT06270849",
"orgStudyIdInfo": {
"id": "MTU-EC-SU-0-002/66",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity."
},
{
"measure": "The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency."
},
{
"measure": "The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability."
}
],
"secondaryOutcomes": [
{
"measure": "The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Thammasat University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-24"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tarcocimab"
},
{
"name": "Sham injection"
}
]
},
"conditionsModule": {
"conditions": [
"Non-proliferative Diabetic Retinopathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fullerton",
"contacts": null,
"country": "United States",
"facility": "Retina Consultants of Orange County",
"geoPoint": {
"lat": 33.87029,
"lon": -117.92534
},
"state": "California",
"status": "NOT_YET_RECRUITING",
"zip": "92835"
},
{
"city": "Glendale",
"contacts": null,
"country": "United States",
"facility": "Global Research Management, Inc. - Lugene Eye Institute",
"geoPoint": {
"lat": 34.14251,
"lon": -118.25508
},
"state": "California",
"status": "NOT_YET_RECRUITING",
"zip": "91204"
},
{
"city": "Mountain View",
"contacts": null,
"country": "United States",
"facility": "Northern California Retina Vitreous Associates",
"geoPoint": {
"lat": 37.38605,
"lon": -122.08385
},
"state": "California",
"status": "NOT_YET_RECRUITING",
"zip": "94040"
},
{
"city": "Redlands",
"contacts": null,
"country": "United States",
"facility": "Retina Consultants of Southern California",
"geoPoint": {
"lat": 34.05557,
"lon": -117.18254
},
"state": "California",
"status": "NOT_YET_RECRUITING",
"zip": "92374"
},
{
"city": "Clearwater",
"contacts": null,
"country": "United States",
"facility": "Blue Ocean Clinical Research",
"geoPoint": {
"lat": 27.96585,
"lon": -82.8001
},
"state": "Florida",
"status": "NOT_YET_RECRUITING",
"zip": "33761"
},
{
"city": "Melbourne",
"contacts": null,
"country": "United States",
"facility": "Florida Eye Associates",
"geoPoint": {
"lat": 28.08363,
"lon": -80.60811
},
"state": "Florida",
"status": "NOT_YET_RECRUITING",
"zip": "32901"
},
{
"city": "Winter Haven",
"contacts": null,
"country": "United States",
"facility": "Center for Retina and Macular Disease",
"geoPoint": {
"lat": 28.02224,
"lon": -81.73286
},
"state": "Florida",
"status": "NOT_YET_RECRUITING",
"zip": "33880"
},
{
"city": "Augusta",
"contacts": null,
"country": "United States",
"facility": "Southeast Retina Center",
"geoPoint": {
"lat": 33.47097,
"lon": -81.97484
},
"state": "Georgia",
"status": "NOT_YET_RECRUITING",
"zip": "30909"
},
{
"city": "Springfield",
"contacts": null,
"country": "United States",
"facility": "Springfield Clinic LLP",
"geoPoint": {
"lat": 39.80172,
"lon": -89.64371
},
"state": "Illinois",
"status": "NOT_YET_RECRUITING",
"zip": "62703"
},
{
"city": "Hagerstown",
"contacts": null,
"country": "United States",
"facility": "Cumberland Valley Retina Consultants",
"geoPoint": {
"lat": 39.64176,
"lon": -77.71999
},
"state": "Maryland",
"status": "NOT_YET_RECRUITING",
"zip": "21740"
},
{
"city": "Bloomfield",
"contacts": null,
"country": "United States",
"facility": "Envision Ocular, LLC",
"geoPoint": {
"lat": 40.80677,
"lon": -74.18542
},
"state": "New Jersey",
"status": "NOT_YET_RECRUITING",
"zip": "07003"
},
{
"city": "Springfield",
"contacts": null,
"country": "United States",
"facility": "Cascade Medical Research Institute",
"geoPoint": {
"lat": 44.04624,
"lon": -123.02203
},
"state": "Oregon",
"status": "NOT_YET_RECRUITING",
"zip": "97477"
},
{
"city": "Bethlehem",
"contacts": null,
"country": "United States",
"facility": "Mid Atlantic Retina",
"geoPoint": {
"lat": 40.62593,
"lon": -75.37046
},
"state": "Pennsylvania",
"status": "NOT_YET_RECRUITING",
"zip": "18017"
},
{
"city": "Knoxville",
"contacts": null,
"country": "United States",
"facility": "Southeastern Retina Associates PC",
"geoPoint": {
"lat": 35.96064,
"lon": -83.92074
},
"state": "Tennessee",
"status": "NOT_YET_RECRUITING",
"zip": "37922"
},
{
"city": "Abilene",
"contacts": null,
"country": "United States",
"facility": "Retina Research Institute of Texas",
"geoPoint": {
"lat": 32.44874,
"lon": -99.73314
},
"state": "Texas",
"status": "RECRUITING",
"zip": "79606"
},
{
"city": "Amarillo",
"contacts": null,
"country": "United States",
"facility": "Panhandle Eye Group, LLP. - Southwest Retina Specialists",
"geoPoint": {
"lat": 35.222,
"lon": -101.8313
},
"state": "Texas",
"status": "NOT_YET_RECRUITING",
"zip": "79106"
},
{
"city": "Burleson",
"contacts": null,
"country": "United States",
"facility": "Star Vision Research",
"geoPoint": {
"lat": 32.54208,
"lon": -97.32085
},
"state": "Texas",
"status": "NOT_YET_RECRUITING",
"zip": "76028"
},
{
"city": "Plano",
"contacts": null,
"country": "United States",
"facility": "Texas Retina Associates",
"geoPoint": {
"lat": 33.01984,
"lon": -96.69889
},
"state": "Texas",
"status": "NOT_YET_RECRUITING",
"zip": "75075"
},
{
"city": "Willow Park",
"contacts": null,
"country": "United States",
"facility": "Strategic Clinical Research Group, LLC",
"geoPoint": {
"lat": 32.76263,
"lon": -97.65058
},
"state": "Texas",
"status": "NOT_YET_RECRUITING",
"zip": "76087"
},
{
"city": "Lynchburg",
"contacts": null,
"country": "United States",
"facility": "Piedmont Eye Center",
"geoPoint": {
"lat": 37.41375,
"lon": -79.14225
},
"state": "Virginia",
"status": "NOT_YET_RECRUITING",
"zip": "24502"
},
{
"city": "Arecibo",
"contacts": null,
"country": "Puerto Rico",
"facility": "Emanuelli Research & Development Center, LLC",
"geoPoint": {
"lat": 18.47245,
"lon": -66.71573
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "00612"
}
]
},
"descriptionModule": {
"briefSummary": "This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomized 1:1 into one of two arms: KSI-301 or sham.",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GLOW2",
"briefTitle": "A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)",
"nctId": "NCT06270836",
"orgStudyIdInfo": {
"id": "KS301P108",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy"
},
{
"measure": "Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Kodiak Sciences Inc"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-27"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Knee-to-chest-flexion manoeuvre"
}
]
},
"conditionsModule": {
"conditions": [
"Transient Tachypnea of the Newborn"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Moshi",
"contacts": [
{
"email": "[email protected]",
"name": "Febronia L Shirima, MD",
"phone": "+255714143368",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Bariki Mchome, PhD",
"phone": "+255784280027",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Febronia L Shirima, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Bariki Mchome, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Blandina T Mmbaga, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Tanzania",
"facility": "Kilimanjaro Christian Medical Centre",
"geoPoint": {
"lat": -3.35,
"lon": 37.33333
},
"state": "Kilimanjaro",
"status": "RECRUITING",
"zip": "P.O.Box 3010"
}
]
},
"descriptionModule": {
"briefSummary": "Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 562,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Minutes",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial",
"nctId": "NCT06270823",
"orgStudyIdInfo": {
"id": "NIMR/HQ/R.8a/Vol.IX/4331",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "respiratory distress"
}
],
"secondaryOutcomes": [
{
"measure": "adverse outcome of knee-to-chest flexion maneuver"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Leiden University Medical Center"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Kilimanjaro Clinical Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-14"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Aerobic Exercise"
},
{
"name": "Increasing non-Exercise Physical Activity"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Çatalzeyti̇n",
"contacts": null,
"country": "Turkey",
"facility": "Kastamonu University, Çatalzeytin Vocational School",
"geoPoint": null,
"state": "Kastamonu",
"status": null,
"zip": "37"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.The main question it aims to answer is:• Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity",
"nctId": "NCT06270810",
"orgStudyIdInfo": {
"id": "Aero-PA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Low Density Lipoprotein (LDL) Cholesterol"
},
{
"measure": "High Density Lipoprotein (HDL) Cholesterol"
},
{
"measure": "Total Cholesterol"
},
{
"measure": "Glycated Hemoglobin (HbA1C)"
},
{
"measure": "Serum Triglycerides"
},
{
"measure": "Maximal Oxygen Consumption"
},
{
"measure": "Systolic Blood Pressure"
},
{
"measure": "Diastolic Blood Pressure"
}
],
"secondaryOutcomes": [
{
"measure": "Body Fat Percentage"
},
{
"measure": "Fat-free Mass"
},
{
"measure": "Waist Circumference"
},
{
"measure": "Hip Circumference"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kastamonu University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "intubation for general anesthesia"
}
]
},
"conditionsModule": {
"conditions": [
"Clinical Decision Support System"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kaohsiung",
"contacts": [
{
"email": "[email protected]",
"name": "Tz Ping Gau, MD",
"phone": "+886912060962",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "Kaohsiung Medical University Chung-Ho Memorial Hospital",
"geoPoint": {
"lat": 22.61626,
"lon": 120.31333
},
"state": "Sanmin Dist",
"status": "RECRUITING",
"zip": "80756"
}
]
},
"descriptionModule": {
"briefSummary": "This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 30000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pre-anesthesia Imaging-based Respiratory Assessment and Analysis",
"nctId": "NCT06270797",
"orgStudyIdInfo": {
"id": "KMUHIRB-E(I)-20230184",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "A pre-anesthesia evaluation"
},
{
"measure": "Perform non-invasive imaging capture."
},
{
"measure": "difficult intubation prediction"
}
],
"secondaryOutcomes": [
{
"measure": "time to successfully extubate the nasotracheal tube after anesthesia"
},
{
"measure": "safely discharged from post-anesthesia care unit (postoperative recovery room)"
},
{
"measure": "side effects and adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kaohsiung Medical University Chung-Ho Memorial Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Traditional Extraction"
},
{
"name": "Orthodontic Extraction"
}
]
},
"conditionsModule": {
"conditions": [
"Inferior Alveolar Nerve Injuries"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Senem Askin Ekinci, DDS",
"phone": "+902167775000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Marmara University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": "Basibuyuk",
"status": "RECRUITING",
"zip": "34854"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?Participants will:* undergo either traditional or orthodontic extraction* be monitored for postoperative paresthesia.Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve",
"nctId": "NCT06270784",
"orgStudyIdInfo": {
"id": "09.2024.122",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The effect of the extraction method on nerve injury"
}
],
"secondaryOutcomes": [
{
"measure": "2-point discrimination test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Marmara University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-17"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-17"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "OURA Ring"
}
]
},
"conditionsModule": {
"conditions": [
"MDS",
"Myelodysplastic Syndromes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Rena Buckstein",
"phone": "416-480-5000",
"phoneExt": "689565",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Geetha Yogendran",
"phone": "416-480-5000",
"phoneExt": "689565",
"role": "CONTACT"
},
{
"email": null,
"name": "Rena Buckstein",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Canada",
"facility": "Sunnybrook Health Sciences Research Centre",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M4N 3M5"
}
]
},
"descriptionModule": {
"briefSummary": "A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OURA MDS",
"briefTitle": "OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study",
"nctId": "NCT06270771",
"orgStudyIdInfo": {
"id": "5823",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility of patients with MDS wearing the OURA ring"
}
],
"secondaryOutcomes": [
{
"measure": "Exploratory correlations between physiologic changes captured by the wearable device and physical functioning"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sunnybrook Health Sciences Centre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CT scan at the femur"
}
]
},
"conditionsModule": {
"conditions": [
"Osteoporosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Alessandra Aldieri, PhD",
"phone": "+390516366565",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Fabio Baruffaldi",
"phone": "+390516366850",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Rizzoli Orthopaedic Institute",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": null,
"status": "RECRUITING",
"zip": "40136"
},
{
"city": "Bologna",
"contacts": [
{
"email": "[email protected]",
"name": "Alessandra Aldieri, PhD",
"phone": "+39 051 636 6565",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Fabio Baruffaldi",
"phone": "+ 39 051 6366850",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Rizzoli Orthopaedic Institute",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": null,
"status": "RECRUITING",
"zip": "40136"
}
]
},
"descriptionModule": {
"briefSummary": "The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "65 Years",
"sex": "FEMALE",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ValidaBBCT-hip",
"briefTitle": "Clinical Validation of BBCT-hip",
"nctId": "NCT06270758",
"orgStudyIdInfo": {
"id": "453/2023/Sper/IOR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Femoral fracture event"
},
{
"measure": "BBCT-hip risk prediction"
}
],
"secondaryOutcomes": [
{
"measure": "T-score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Ortopedico Rizzoli"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2030-11-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-11-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "indocyanine green"
}
]
},
"conditionsModule": {
"conditions": [
"Surgical Anastomosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Yantai",
"contacts": [
{
"email": "[email protected]",
"name": "Xuan Qiu, MD",
"phone": "8618354280081",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ni Wang, MD",
"phone": "8618705353551",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Shandong Linglong Yingcheng Hospital",
"geoPoint": {
"lat": 37.47649,
"lon": 121.44081
},
"state": "Shandong",
"status": "RECRUITING",
"zip": "264000"
}
]
},
"descriptionModule": {
"briefSummary": "This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ICG Anastomotic Control in Digestive System Surgery",
"nctId": "NCT06270745",
"orgStudyIdInfo": {
"id": "sdycllyy001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Anastomotic leak at 30 days"
}
],
"secondaryOutcomes": [
{
"measure": "Post-operative morbidity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "Shandong Linglong Yingcheng Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "iMentalize Program (iMentalize)"
},
{
"name": "Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA)"
},
{
"name": "Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU)"
}
]
},
"conditionsModule": {
"conditions": [
"Emotional Intelligence",
"Social Interaction",
"Mental Health Wellness 1",
"Well-Being, Psychological"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Anna Ciraso, Researcher",
"phone": "+34661858272",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ana Carolina Pacheco, Researcher",
"phone": "+573153561564",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Sergi Ballespí",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08193"
},
{
"city": "Barcelona",
"contacts": [
{
"email": "[email protected]",
"name": "Anna Ciraso, Researcher",
"phone": "+34661858272",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Ana Carolina Pacheco, Researcher",
"phone": "+573153561564",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Universitat Autònoma de Barcelona",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08193"
}
]
},
"descriptionModule": {
"briefSummary": "OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:* iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).* iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).* MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Double-blind, parallel group, randomized controlled trial",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 105,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "iMentalize",
"briefTitle": "Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population.",
"nctId": "NCT06270732",
"orgStudyIdInfo": {
"id": "PID2021-125444OB-100-II-iM",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Inventory of Learning Patterns, reduced version (60 items) (ILP-60)"
},
{
"measure": "Relationship Questionnaire (RQ)"
},
{
"measure": "Time with the Child (TC)"
}
],
"primaryOutcomes": [
{
"measure": "Parental Reflective Function Questionnaire (PRFQ)"
},
{
"measure": "Trait Meta-Mood Scale (24 items) (TMMS-24)"
},
{
"measure": "Basic Empathy Scale (BES)"
},
{
"measure": "Movie for the Assessment of Social Cognition (MASC)"
},
{
"measure": "Stirling Children's Wellbeing Scale (SCWBS)"
},
{
"measure": "Child Well-Being Level (CWBL)"
},
{
"measure": "Strengths and Difficulties Questionnaire (SDQ)"
},
{
"measure": "Achenbach System for Empirically Assessment (ASEBA)"
}
],
"secondaryOutcomes": [
{
"measure": "Observing Mediational Interaction (OMI)"
},
{
"measure": "Parental Stress Questionnaire (PSI)"
},
{
"measure": "Goldberg Health Questionnaire (28 items) (GHQ-28)"
},
{
"measure": "Difficulties in Emotional Regulation Scale (DERS)"
},
{
"measure": "Oxford Happiness Questionnaire (OHQ)"
},
{
"measure": "Rosenberg's Self-Esteem Scale (RSES)"
},
{
"measure": "Parental Sense of Competence Scale (PSOC)"
},
{
"measure": "Self-Other Mentalization Scale (SOMS)"
},
{
"measure": "Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5)"
},
{
"measure": "Trait Meta-Mood Scale - Children version (TMMS-C)"
},
{
"measure": "Big Five Questionnaire for Children and Adolescents (BFQ-NA)"
},
{
"measure": "BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn)"
},
{
"measure": "Rosenberg's Self-Esteem Scale - Child version (RSES-C)"
},
{
"measure": "Battery of Socialization (BAS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ministerio de Economía y Competitividad, Spain"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universitat Autonoma de Barcelona"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "delandistrogene moxeparvovec"
},
{
"name": "Standard of Care"
}
]
},
"conditionsModule": {
"conditions": [
"Duchenne Muscular Dystrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Little Rock",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Aravindhan Veerapandiyan, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Arkansas Children's Hospital",
"geoPoint": {
"lat": 34.74648,
"lon": -92.28959
},
"state": "Arkansas",
"status": "RECRUITING",
"zip": "72202"
},
{
"city": "Hershey",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ashutosh Kumar, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Penn State Health Milton S. Hershey Medical Center",
"geoPoint": {
"lat": 40.28592,
"lon": -76.65025
},
"state": "Pennsylvania",
"status": "NOT_YET_RECRUITING",
"zip": "17033"
},
{
"city": "Fort Worth",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Cook Children's Hospital",
"geoPoint": {
"lat": 32.72541,
"lon": -97.32085
},
"state": "Texas",
"status": "RECRUITING",
"zip": "76104"
},
{
"city": "Norfolk",
"contacts": [
{
"email": "[email protected]",
"name": null,
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Crystal Proud, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Children's Hospital of the King's Daughters",
"geoPoint": {
"lat": 36.84681,
"lon": -76.28522
},
"state": "Virginia",
"status": "RECRUITING",
"zip": "23507"
}
]
},
"descriptionModule": {
"briefSummary": "This is a multicenter, prospective, observational Phase 4 study in the United States. The study is designed to collect both medical history and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice. In addition, treatment outcomes will be collected prospectively from post-trial participants who have received delandistrogene moxeparvovec through participation in select SRP-9001 studies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "4 Years",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ENDURE",
"briefTitle": "An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy",
"nctId": "NCT06270719",
"orgStudyIdInfo": {
"id": "SRP-9001-401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "All Cohorts: Mean Change From Baseline in Time to Walk/Run 10 Meters (and Calculated Velocity) at Month 12"
}
],
"secondaryOutcomes": [
{
"measure": "All Cohorts: Time to Rise From Floor (Supine to Stand)"
},
{
"measure": "All Cohorts: Loss of Ambulation (LOA)"
},
{
"measure": "All Cohorts: Performance of Upper Limb (PUL) Version 2.0 Entry Item Score"
},
{
"measure": "All Cohorts: Patient-reported Outcomes Measurement Information (PROMIS) Domain Scores of Mobility, Upper Extremity and Fatigue"
},
{
"measure": "All Cohorts: Pulmonary Function, as Measured Forced Vital Capacity (FVC) (% Predicted)"
},
{
"measure": "All Cohorts: Cardiac Function, Including Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram (ECHO)"
},
{
"measure": "All Cohorts: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)"
},
{
"measure": "Delandistrogene Moxeparvovec Cohorts: Time to Walk/Run 10 Meters (Calculated Velocity)"
},
{
"measure": "Delandistrogene Moxeparvovec Post-trial Cohort: North Star Ambulatory Assessment (NSAA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sarepta Therapeutics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2038-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PLN-101095"
},
{
"name": "Pembrolizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Solid Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Grand Rapids",
"contacts": null,
"country": "United States",
"facility": "South Texas Accelerated Research Therapeutics (START)",
"geoPoint": {
"lat": 42.96336,
"lon": -85.66809
},
"state": "Michigan",
"status": "RECRUITING",
"zip": "49546"
},
{
"city": "Austin",
"contacts": null,
"country": "United States",
"facility": "NEXT Austin",
"geoPoint": {
"lat": 30.26715,
"lon": -97.74306
},
"state": "Texas",
"status": "RECRUITING",
"zip": "78758"
},
{
"city": "Houston",
"contacts": null,
"country": "United States",
"facility": "University of Texas MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77030"
},
{
"city": "Fairfax",
"contacts": null,
"country": "United States",
"facility": "NEXT Virginia",
"geoPoint": {
"lat": 38.84622,
"lon": -77.30637
},
"state": "Virginia",
"status": "RECRUITING",
"zip": "22031"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \\[primary resistance\\]) or relapsed \\[secondary resistance\\]) after at least 3 months from the start of treatment with pembrolizumab.The study will consist of 2 main parts:* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design* Part 2: Dose-expansion cohorts using Simon's 2-stage design"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 77,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors",
"nctId": "NCT06270706",
"orgStudyIdInfo": {
"id": "PLN-101095-ONC-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0."
},
{
"measure": "Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications."
}
],
"secondaryOutcomes": [
{
"measure": "Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK)."
},
{
"measure": "Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK)."
},
{
"measure": "Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK)."
},
{
"measure": "Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1."
},
{
"measure": "Objective response rate (ORR) is defined by the proportion of participants with an iCR or iPR per iRECIST Version 1.1."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Pliant Therapeutics, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-30"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Endodontic treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Apical Periodontitis",
"Coronary Artery Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rohtak",
"contacts": null,
"country": "India",
"facility": "PGIDS",
"geoPoint": {
"lat": 28.89447,
"lon": 76.58917
},
"state": "Haryana",
"status": null,
"zip": "124001"
}
]
},
"descriptionModule": {
"briefSummary": "Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
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"whoMasked": null
},
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},
"enrollmentInfo": {
"count": 70,
"type": "ACTUAL"
},
"phases": [
"NA"
],
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},
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"maximumAge": "75 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis",
"nctId": "NCT06270693",
"orgStudyIdInfo": {
"id": "Dr Sushma",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Serum hsCRP"
},
{
"measure": "complete hemogram indices"
}
],
"secondaryOutcomes": [
{
"measure": "Periapical index SCORE CHANGE"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Postgraduate Institute of Dental Sciences Rohtak"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vision Edge Pro"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Head Injury",
"Carotenoids"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "University Park",
"contacts": [
{
"email": "[email protected]",
"name": "Semyon Slobounov, PhD",
"phone": "814-571-4298",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jonathan Kelly, MS",
"phone": "9495565035",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Semyon Slobounov, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "The Pennsylvania State University",
"geoPoint": {
"lat": 40.80201,
"lon": -77.85639
},
"state": "Pennsylvania",
"status": null,
"zip": "16802"
}
]
},
"descriptionModule": {
"briefSummary": "This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo."
},
"designModule": {
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"interventionModel": "PARALLEL",
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]
},
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},
"enrollmentInfo": {
"count": 52,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Carotenoids for Collision Athletes",
"nctId": "NCT06270680",
"orgStudyIdInfo": {
"id": "STUDY00023019",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Blood and saliva biomarkers via venous blood draw and spitting into sterile cup."
},
{
"measure": "Visual Performance: Speed of visual processing"
},
{
"measure": "Visual Performance: Contrast Sensitivity"
},
{
"measure": "Skin carotenoid concentration"
},
{
"measure": "Retinal Nerve Fiber Layer Thickness"
},
{
"measure": "Macular Pigment Optical Density"
},
{
"measure": "Visual Quality of Life Scores"
},
{
"measure": "Visual Quality of Life Scores"
}
],
"secondaryOutcomes": [
{
"measure": "Demographic information"
},
{
"measure": "Demographic information"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "MacuHealth"
},
{
"name": "Orlando Regional Medical Center"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Penn State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Aerobic Exercise"
},
{
"name": "Combined Aerobic and Resistance Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Lymphoma",
"Physical Exercise",
"Cardiotoxicity",
"Cardiovascular Diseases",
"Chemotherapeutic Toxicity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oslo",
"contacts": [
{
"email": null,
"name": "Tormod S. Nilsen, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Norway",
"facility": "Norweigan School of Sport Sciences",
"geoPoint": {
"lat": 59.91273,
"lon": 10.74609
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Uppsala",
"contacts": [
{
"email": null,
"name": "Helena Igelström, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Anna Henriksson, PhD",
"phone": "709394175",
"phoneExt": "0046",
"role": "CONTACT"
},
{
"email": null,
"name": "Helena Igelström, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Anna Henriksson, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Sweden",
"facility": "Helena Igelström",
"geoPoint": {
"lat": 59.85882,
"lon": 17.63889
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 280,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LYMfit",
"briefTitle": "Effects of Exercise Training in Survivors of Lymphoma",
"nctId": "NCT06270667",
"orgStudyIdInfo": {
"id": "LYMfit",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Muscle genome-wide DNA methylation and gene expression"
},
{
"measure": "Adverse events"
}
],
"primaryOutcomes": [
{
"measure": "VO2peak"
}
],
"secondaryOutcomes": [
{
"measure": "Systolic- and diastolic heart chamber dimensions"
},
{
"measure": "Systolic- and diastolic longitudinal strain"
},
{
"measure": "Lean body mass"
},
{
"measure": "Fat mass"
},
{
"measure": "Forced Vital Capacity"
},
{
"measure": "Forced Expiratory Volume 1 sec"
},
{
"measure": "Maximal voluntary ventilation"
},
{
"measure": "Diffusion capacity"
},
{
"measure": "Physical activity"
},
{
"measure": "Physical activity"
},
{
"measure": "Global Health related Quality of life"
},
{
"measure": "Blood volume"
},
{
"measure": "Muscle fiber area"
},
{
"measure": "Muscle fiber type"
},
{
"measure": "Muscle mitochondria mass"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Uppsala University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Norwegian School of Sport Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Erector spinae plane block"
},
{
"name": "Skin infiltration LA"
}
]
},
"conditionsModule": {
"conditions": [
"Lumbar Spine Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kuala Lumpur",
"contacts": [
{
"email": "[email protected]",
"name": "Wei Keang Tan, M.D.",
"phone": "+60126655489",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Wei Keang Tan, MD.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Tzi Sen Lee, MBBS",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Dharmendra Ganesan, MBBS, FRCS",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Malaysia",
"facility": "Universiti Malaya Medical Centre",
"geoPoint": {
"lat": 3.1412,
"lon": 101.68653
},
"state": "Wilayah Persekutuan",
"status": "RECRUITING",
"zip": "51100"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery",
"nctId": "NCT06270654",
"orgStudyIdInfo": {
"id": "2023322-12280",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery"
},
{
"measure": "Total opioid consumption intraoperative"
},
{
"measure": "Total opioid consumption post-operative"
},
{
"measure": "Timing of first rescue dose of iv morphine"
}
],
"secondaryOutcomes": [
{
"measure": "The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation"
},
{
"measure": "Hemodynamic changes intraoperative"
},
{
"measure": "Hemodynamic changes intraoperative"
},
{
"measure": "Length of hospital stays"
},
{
"measure": "Time to ambulation after surgery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Malaya"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ExerciseRx intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis (MS)",
"Fatigue",
"Physical Inactivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "Laurie Kavanagh, MPH",
"phone": "206-668-4168",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UW Medicine",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": "RECRUITING",
"zip": "98133"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"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": "Increasing Physical Activity for Adults With Multiple Sclerosis (MS)",
"nctId": "NCT06270641",
"orgStudyIdInfo": {
"id": "STUDY00018628",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Physical activity: daily average step count"
}
],
"secondaryOutcomes": [
{
"measure": "Activity volume"
},
{
"measure": "Minutes/week of moderate intensity aerobic activity"
},
{
"measure": "Fatigue - PROMIS Fatigue-MS Short Form 8a"
},
{
"measure": "Pain intensity - PROMIS Pain Intensity Short Form 3a"
},
{
"measure": "Depressive symptom severity - PROMIS Depression Short Form 8a"
},
{
"measure": "Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a"
},
{
"measure": "Physical functioning - PROMIS Physical Function 10a"
},
{
"measure": "Pain interference - PROMIS Pain Interference Scale Short Form 6a"
},
{
"measure": "Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a"
},
{
"measure": "Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Washington"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise group"
}
]
},
"conditionsModule": {
"conditions": [
"Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Utrecht",
"contacts": null,
"country": "Netherlands",
"facility": "University Medical Center Utrecht",
"geoPoint": {
"lat": 52.09083,
"lon": 5.12222
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "BackgroundMany people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.Goal of the study:The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.Design of the studyIn the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.MeasurementsThe main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.Conclusion:This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "RCT with two study arms: exercise group and wait list control group",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 350,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "LION",
"briefTitle": "Personalized Live-remote Exercise Training for Cancer Survivors",
"nctId": "NCT06270628",
"orgStudyIdInfo": {
"id": "NL85029.018.23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Participants experience of sensor-based guidance"
},
{
"measure": "Trainer experience of sensor-based guidance"
},
{
"measure": "Compliance sensor-based guidance"
},
{
"measure": "Technical feasibility of sensor-based guidance"
},
{
"measure": "Aerobic capacity"
},
{
"measure": "Upper body muscle strength"
},
{
"measure": "Lower body muscle strength"
},
{
"measure": "Core muscle strength"
},
{
"measure": "Physical functioning"
},
{
"measure": "Balance"
},
{
"measure": "Socio-demographics"
},
{
"measure": "Self-efficacy"
},
{
"measure": "Social Support"
},
{
"measure": "Medical history"
},
{
"measure": "Concomitant diseases"
},
{
"measure": "Cancer + concomitant medication"
},
{
"measure": "Cancer characteristics"
},
{
"measure": "Cancer treatment history"
}
],
"primaryOutcomes": [
{
"measure": "Health-Related Quality of Life"
},
{
"measure": "A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline"
},
{
"measure": "A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline"
},
{
"measure": "A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline"
},
{
"measure": "A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline"
}
],
"secondaryOutcomes": [
{
"measure": "Health-related quality of life"
},
{
"measure": "Fatigue"
},
{
"measure": "Anxiety and Depression"
},
{
"measure": "CIPN_1"
},
{
"measure": "CIPN_2"
},
{
"measure": "Sleep"
},
{
"measure": "Pain"
},
{
"measure": "Cognitive problems"
},
{
"measure": "Work limitations"
},
{
"measure": "Body image"
},
{
"measure": "Fear of cancer recurrence"
},
{
"measure": "Habitual physical activity"
},
{
"measure": "Aerobic capacity on bike"
},
{
"measure": "Aerobic capacity on step"
},
{
"measure": "Handgrip strength"
},
{
"measure": "Upper body muscle strength"
},
{
"measure": "Lower body muscle strength"
},
{
"measure": "Sit to stand test"
},
{
"measure": "Physical function"
},
{
"measure": "Balance"
},
{
"measure": "Physical activity"
},
{
"measure": "Blood pressure"
},
{
"measure": "Resting heart rate"
},
{
"measure": "Weight"
},
{
"measure": "Height"
},
{
"measure": "Waist circumference"
},
{
"measure": "Hip circumference"
},
{
"measure": "Body composition"
},
{
"measure": "Inflammatory state"
},
{
"measure": "Growth factors"
},
{
"measure": "CRP"
},
{
"measure": "Hemoglobin"
},
{
"measure": "Leucocyte counts"
},
{
"measure": "Quality-adjusted life years"
},
{
"measure": "Health-care, patient and family costs"
},
{
"measure": "Productivity losses"
},
{
"measure": "Exercise-related (serious) adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "German Cancer Research Center (DKFZ), Heidelberg, Germany"
},
{
"name": "German Sport University Cologne (DSHS), Cologne, Germany"
},
{
"name": "Cabrini Health (CAB), Malvern, Australia"
},
{
"name": "Karolinska Institute (KI), Stockholm, Sweden"
},
{
"name": "Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands"
},
{
"name": "Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany"
},
{
"name": "Fundacion Onkologikao (ONK), San Sebastian, Spain"
},
{
"name": "Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal"
}
],
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}
},
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"date": "2027-10-31"
},
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},
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"date": "2026-10-31"
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"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Ambispective validation of machine learning-based predictive model"
}
]
},
"conditionsModule": {
"conditions": [
"Wounds and Injuries",
"Traumatic Shock",
"Hemorrhagic Shock"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Clichy",
"contacts": [
{
"email": "[email protected]",
"name": "Mathilde Holleville, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Beaujon Hospital AP-HP, Anesthesia-Intensive Care Department",
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},
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},
{
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{
"email": "[email protected]",
"name": "Tobias Gauss, MD",
"phone": "+33476769288",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Samia Salah",
"phone": "+33476769288",
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"role": "CONTACT"
}
],
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"facility": "Grenoble Alpes University Hospital",
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"lat": 45.20429,
"lon": 5.73645
},
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"zip": "38700"
},
{
"city": "Le Kremlin-Bicêtre",
"contacts": [
{
"email": "[email protected]",
"name": "Marie Werner, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Bicêtre Hospital AP-HP, Anesthesia-Intensive Care Department",
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"lon": 2.36073
},
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},
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{
"email": "[email protected]",
"name": "Benjamin Bijok, MD",
"phone": null,
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"role": "CONTACT"
}
],
"country": "France",
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},
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}
],
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"name": "Nathalie Delhaye, MD",
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}
],
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}
],
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],
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},
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}
]
},
"descriptionModule": {
"briefSummary": "Management of post-traumatic severe hemorrhage remains a challenge to any trauma care system. Studying integrated and innovative tools designed to predict the risk of early severe hemorrhage (ESH) and resource needs could offer a promising option to improve clinical decisions and then shorten the time of intervention in the context of pre-hospital severe trauma. As evidence seems to be lacking to address this issue, this ambispective validation study proposes to assess on an independent cohort the predictive performance of a newly developed machine learning-based model, as well as the feasibility of its clinical deployment under real-time healthcare conditions."
},
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},
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},
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"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
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"acronym": "SHOCKMATRIX",
"briefTitle": "Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model",
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"id": "CRCBDD1712",
"link": null,
"type": null
},
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},
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{
"measure": "Fβ-score, with β = 4"
}
],
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"measure": "Common binary classification metrics"
}
]
},
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"name": "Traumabase Group"
},
{
"name": "Capgemini Invent"
},
{
"name": "Ecole polytechnique"
},
{
"name": "EHESS (Ecole des hautes études en sciences sociales)"
},
{
"name": "CNRS (Centre national de la recherche scientifique)"
}
],
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"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
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},
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"date": "2022-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
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"name": "Data collection (retrospective)"
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{
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},
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"city": "Casavatore",
"contacts": [
{
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}
],
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},
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"role": "CONTACT"
}
],
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"facility": "Asl Napoli 3 Sud",
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},
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},
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"name": "Cesare Gridelli, M.D.",
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}
],
"country": "Italy",
"facility": "A.O. Moscati",
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},
{
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"email": null,
"name": "Giuseppe Genua, M.D.",
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],
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],
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}
],
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],
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],
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}
],
"country": "Italy",
"facility": "A.O. Cardarelli",
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},
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},
{
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"email": null,
"name": "Vincenzo Montesarchio, M.D.",
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}
],
"country": "Italy",
"facility": "A.O. Dei Colli",
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},
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},
{
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}
],
"country": "Italy",
"facility": "Federico II",
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},
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},
{
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}
],
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},
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},
{
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"name": "Fortunato Ciardiello, M.D.",
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}
],
"country": "Italy",
"facility": "A.O.U. Luigi Vanvitelli",
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},
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},
{
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"email": null,
"name": "Tiziana Spinosa, M.D.",
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}
],
"country": "Italy",
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},
{
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"name": "Bruno Daniele, M.D.",
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],
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},
{
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"email": null,
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}
],
"country": "Italy",
"facility": "Asl Salerno",
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},
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},
{
"city": "Salerno",
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{
"email": null,
"name": "Stefano Pepe, M.D.",
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"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "A.O.U. Ruggi",
"geoPoint": {
"lat": 40.67545,
"lon": 14.79328
},
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"status": "RECRUITING",
"zip": "84126"
}
]
},
"descriptionModule": {
"briefSummary": "The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study."
},
"designModule": {
"designInfo": {
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},
"enrollmentInfo": {
"count": 15000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The ONCOCAMP Study",
"nctId": "NCT06270602",
"orgStudyIdInfo": {
"id": "ONCOCAMP",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "IRCCS I.N.T. \"G. Pascale\"",
"id": "6/23 oss",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence for each tumor of the patients included in the ROC platform"
},
{
"measure": "Evaluation of the time interval between GOM activities"
},
{
"measure": "Evaluation of the time interval between GOM activities"
},
{
"measure": "Evaluation of the time interval between GOM activities"
},
{
"measure": "Evaluation of the time interval between GOM activities"
},
{
"measure": "Evaluation of the time interval between GOM activities"
},
{
"measure": "Frequency of use of the services of the ROC platform"
},
{
"measure": "Descriptive analysis of each subgroup of patients (subdivision by tumor type)"
},
{
"measure": "Spatial analysis for each patient"
},
{
"measure": "Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)"
},
{
"measure": "Percentage of patient included in clinical trial"
},
{
"measure": "Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate"
},
{
"measure": "Prevalence for each tumor of the patients included in the ROC platform"
}
],
"secondaryOutcomes": [
{
"measure": "Description of pharmacological strategies"
},
{
"measure": "Description of diagnostic activities"
},
{
"measure": "Description of surgical strategies"
},
{
"measure": "Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)"
},
{
"measure": "Description of each surgical approach"
},
{
"measure": "Description of the different surgical techniques among the centers"
},
{
"measure": "Patients' quality of life"
},
{
"measure": "Patients' reported outcome"
},
{
"measure": "Patients' satisfaction and evaluation of the diagnostic / therapeutic path"
},
{
"measure": "Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis"
},
{
"measure": "Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit"
},
{
"measure": "Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path"
},
{
"measure": "Survival analysis for each tumor"
},
{
"measure": "Life status assessment for each patient"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "National Cancer Institute, Naples"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
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"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-14"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
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"interventions": [
{
"name": "MF-HIIT"
},
{
"name": "MF-only"
},
{
"name": "HIIT-only"
},
{
"name": "Sitting rest"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteers"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting restQuestion 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting restParticipants will visit the laboratory on 5 separate days (\\> 2-day washout between days) in which they have not previously participated in structured physical activities.Participants will complete the testing and/or receive treatments below:Day 1:* Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient* Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)Days 2-5* Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)* Participants' heart rate and self-reported affect and rating of physical exertion will be measured* Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility* Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performanceResearcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
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"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
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{
"measure": "frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes"
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]
},
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},
{
"measure": "Part B: Plasma Concentration of S-337395"
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]
},
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"date": "2024-03-13"
},
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"date": "2024-02-21"
}
}
} | false | null |
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},
{
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}
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"Left Ventricular Systolic Dysfunction"
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{
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{
"measure": "Ferritin"
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{
"measure": "Serum iron"
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{
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{
"measure": "Hepcidin"
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{
"measure": "Cardiac structure and function 1"
},
{
"measure": "Cardiac structure and function 2"
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{
"measure": "Cardiac structure and function 3"
},
{
"measure": "Cardiac structure and function 4"
},
{
"measure": "Cardiac structure and function 5"
},
{
"measure": "Cardiac structure and function 6"
},
{
"measure": "Clinical outcome"
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],
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"measure": "Exercise capacity"
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},
{
"measure": "6MWT distance improvement"
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{
"measure": "Quality of life improvement"
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{
"measure": "Exercise capacity (peak oxygen consumption)"
},
{
"measure": "F2-isoprostanes"
},
{
"measure": "Soluble NOX2-derived peptide (sNOX2-dp)"
},
{
"measure": "H2O2"
},
{
"measure": "Phosphate"
},
{
"measure": "Fibroblast growth factor (FGF)-23"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Pisa, Italy"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Raffaele De Caterina"
}
},
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"date": "2025-06-01"
},
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"date": "2024-02-21"
},
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"date": "2025-03-01"
},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PEEP"
}
]
},
"conditionsModule": {
"conditions": [
"Ventilation Therapy; Complications",
"Congenital Heart Disease",
"Children, Only",
"Hemodynamic Instability"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Berlin",
"contacts": [
{
"email": "[email protected]",
"name": "Jan Clausen, MD",
"phone": "004917620808764",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael Emeis, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "Deutsches Herzzentrum der Charité",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "RECRUITING",
"zip": "13353"
},
{
"city": "Groningen",
"contacts": [
{
"email": "[email protected]",
"name": "Martin Kneyber, PhD, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Richard Hollander, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "UMCG",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children \\< 5 years of age"
},
"designModule": {
"designInfo": {
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"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 56,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Years",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "IPCOM",
"briefTitle": "Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children",
"nctId": "NCT06270485",
"orgStudyIdInfo": {
"id": "EA2/224/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cardiac Output"
}
],
"secondaryOutcomes": [
{
"measure": "TAPSE (cm)"
},
{
"measure": "respiratory mechanics"
},
{
"measure": "TAPSV (cm/s)"
},
{
"measure": "Global Strain RV (%/sec)"
},
{
"measure": "Lung Compliance (ml/Min/kg)"
},
{
"measure": "Esophageal Pressure (mbar)"
},
{
"measure": "EIT"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Medical Center Groningen"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Charite University, Berlin, Germany"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-27"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "hernioplasty"
}
]
},
"conditionsModule": {
"conditions": [
"Hernia, Inguinal"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals"
},
"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": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Transinguinal Periperitoneal Technique in Inguinal Hernioplasty",
"nctId": "NCT06270472",
"orgStudyIdInfo": {
"id": "tipp technique",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recurrence rate of inguinal hernia 2 years follow up ."
},
{
"measure": "Numerical rating score of pain"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "HMAN Robot"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The study is a multi-site prospective clinical trial, with single-arm study design with independent assessment of outcome measures (i.e., robotic metrics, standardized outcomes, quality of life, subjective measures).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TRUST",
"briefTitle": "Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke",
"nctId": "NCT06270459",
"orgStudyIdInfo": {
"id": "DSRB 2023/00954",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Compliance Rates"
}
],
"secondaryOutcomes": [
{
"measure": "Fugl Meyer Motor Assessment (FMA)"
},
{
"measure": "Action Research Arm Test (ARAT)"
},
{
"measure": "Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)"
},
{
"measure": "System Usability Scale (SUS)"
},
{
"measure": "Intrinsic Motivation Inventory (IMI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National University Hospital, Singapore"
},
{
"name": "Singapore General Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Tan Tock Seng Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Community based physiotherapy"
},
{
"name": "Outpatient physiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Knee Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Singapore",
"contacts": null,
"country": "Singapore",
"facility": "Tan Tock Seng Hospital",
"geoPoint": {
"lat": 1.28967,
"lon": 103.85007
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Data analysis blinded",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 59,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Community Based Rehabilitation Model After Total Knee Replacement",
"nctId": "NCT06270446",
"orgStudyIdInfo": {
"id": "DSRB 2019/01135",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "OKS"
}
],
"primaryOutcomes": [
{
"measure": "TUG"
},
{
"measure": "30 sec chair stand test"
},
{
"measure": "Pain intensity"
}
],
"secondaryOutcomes": [
{
"measure": "Knee flexion and extension"
},
{
"measure": "Passive range of motion"
},
{
"measure": "Presence of lag"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tan Tock Seng Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-21"
}
}
} | false | null |
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