protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Denneroll cervical traction orthodontic"
}
]
},
"conditionsModule": {
"conditions": [
"Cervical Lordosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sharjah",
"contacts": [
{
"email": "[email protected]",
"name": "Ibrahim Mostafa Abuamr, professor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shima Zadeh, Research Assistant",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ibrahim Mostafa Abuamr, Professor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United Arab Emirates",
"facility": "University of Sharjah",
"geoPoint": {
"lat": 25.33737,
"lon": 55.41206
},
"state": null,
"status": null,
"zip": "0000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this Randomized clinical trial is to learn about how fixing neck curvature and head posture right away affects heart rate, brainwaves, and muscle coordination in college athletes. The main question it aims to answer:- Whether forward head posture (FHP) may play a crucial role in affecting heart rate variability, brainwaves, and muscle coordination."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Permuted block randomization to ensure an equal number of allocations in each of the two groups (intervention and wait list group). Each random block will be stored in opaque sealed envelopes consecutively numbered with a third researcher. Once each participant officially joins the study the researcher will open the subsequent envelop.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration",
"nctId": "NCT06323746",
"orgStudyIdInfo": {
"id": "HR-EEG-CSAR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cervical Sagittal Alignment Radiographs"
},
{
"measure": "Cervical Sagittal Alignment Radiographs"
}
],
"secondaryOutcomes": [
{
"measure": "Heart rate Variability (HRV) physiological parameter"
},
{
"measure": "Corticomuscular Coherence"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Sharjah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Cachexia-Anorexia Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rennes",
"contacts": null,
"country": "France",
"facility": "SPORMED",
"geoPoint": {
"lat": 48.11198,
"lon": -1.67429
},
"state": "Bretagne",
"status": null,
"zip": "35000"
}
]
},
"descriptionModule": {
"briefSummary": "The prevalence of cancer with cachexia is rising sharply. More than 80% of digestive cancer patients are affected by cancer cachexia. Cachexia leads to weight loss, and reduces quality of life (QoL), cancer treatment response and survival. Exercise could counteract the deleterious effects of cachexia. The 2CAPA study aims to assess the effectiveness of a 12-week exercise program on various symptoms associated with cancer cachexia, including Health-Related QoL (HRQoL), fatigue, appetite, body composition, physical fitness, and physical activity levels. Additionally, it seeks to examine compliance with the exercise program, identify barriers to regular exercise and determine how compliance influences physical and psychological effects. Furthermore, this study aims to determine the maintenance of physical activity levels and the effects post-program for one year follow-up on cachexia-related symptoms.Methods: This study will include 31 cancer patients with cachexia. Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training. Outcomes include HRQoL, fatigue, appetite, anthropometric parameters, physical performances, and physical activity levels at baseline, at the end of the 12-week exercise program, and at 3-, 6- and 12- months post-intervention."
},
"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": 31,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "2CAPA",
"briefTitle": "Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up.",
"nctId": "NCT06323733",
"orgStudyIdInfo": {
"id": "2CAPA",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Compliance to exercise intervention"
},
{
"measure": "Reasons for absence"
},
{
"measure": "Timing of absences"
},
{
"measure": "Fidelity to session duration"
},
{
"measure": "Fidelity to session intensity"
},
{
"measure": "Reasons to modify exercise sessions"
},
{
"measure": "Incidence of Adverse Events"
}
],
"primaryOutcomes": [
{
"measure": "Health-Related Quality of Life"
}
],
"secondaryOutcomes": [
{
"measure": "Body weight"
},
{
"measure": "Body mass index"
},
{
"measure": "Lean mass"
},
{
"measure": "Fat mass"
},
{
"measure": "Aerobic fitness"
},
{
"measure": "Muscular strength of the lower limbs"
},
{
"measure": "Handgrip strength"
},
{
"measure": "Static balance ability"
},
{
"measure": "Appetite"
},
{
"measure": "Cancer-related Fatigue"
},
{
"measure": "Physical Activity and Sedentary Levels"
},
{
"measure": "Stages of change for exercise"
},
{
"measure": "Exercise beliefs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peyrachon Romane"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2026-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Quantitative Sensory Testing"
}
]
},
"conditionsModule": {
"conditions": [
"Tension-Type Headache"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ghent",
"contacts": [
{
"email": null,
"name": "Jessica Van Oosterwijck, Prof.",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "Ghent University",
"geoPoint": {
"lat": 51.05,
"lon": 3.71667
},
"state": "East-Flanders",
"status": "RECRUITING",
"zip": "9000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:- Are signs of central sensitization present in tension-type headache?Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 66,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CSTTH",
"briefTitle": "Signs of Central Sensitization in Tension-type Headache",
"nctId": "NCT06323720",
"orgStudyIdInfo": {
"id": "ONZ-2023-0442",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain sensitivity for heat stimuli"
},
{
"measure": "Pain sensitivity for cold stimuli"
},
{
"measure": "Pain sensitivity for electrical stimuli"
},
{
"measure": "Pain sensitivity for pressure"
},
{
"measure": "Function of the pain facilitating pathways"
},
{
"measure": "Function of the pain inhibiting pathways"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Ghent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
},
{
"name": "Self-management e-module"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice.What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment.What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise \\& self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention).In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment.Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 129,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMPACT",
"briefTitle": "The IMPACT Implementation-Effectiveness Trial",
"nctId": "NCT06323707",
"orgStudyIdInfo": {
"id": "IMPACT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Physical activity level"
}
],
"secondaryOutcomes": [
{
"measure": "Physical activity level"
},
{
"measure": "Physical activity level"
},
{
"measure": "Quality of life"
},
{
"measure": "Quality of life"
},
{
"measure": "Quality of life"
},
{
"measure": "Level of exercise knowledge"
},
{
"measure": "Level of exercise knowledge"
},
{
"measure": "Level of exercise knowledge"
},
{
"measure": "Health status"
},
{
"measure": "Health status"
},
{
"measure": "Health status"
},
{
"measure": "Aerobic capacity"
},
{
"measure": "Aerobic capacity"
},
{
"measure": "Aerobic capacity"
},
{
"measure": "Cardiovascular outcomes - Blood pressure"
},
{
"measure": "Cardiovascular outcomes - Blood pressure"
},
{
"measure": "Cardiovascular outcomes - Blood pressure"
},
{
"measure": "Cardiovascular outcomes - Heart rate"
},
{
"measure": "Cardiovascular outcomes - Heart rate"
},
{
"measure": "Cardiovascular outcomes - Heart rate"
},
{
"measure": "Health care utilization"
},
{
"measure": "Health care utilization"
},
{
"measure": "Health care utilization"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Canadian Cancer Society (CCS)"
},
{
"name": "Hamilton Health Sciences Corporation"
},
{
"name": "Niagara Health System"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "McMaster University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "quality of life"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bologna",
"contacts": null,
"country": "Italy",
"facility": "Istituto Ortopedico Rizzoli",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
},
"state": null,
"status": null,
"zip": "40136"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this qualitative prospective observational study is to analyze the cognitive aspect, the emotional-behavioral state and the quality of life of patients during their stay on the waiting list for two categories of lumbar spinal surgery: arthrodesis and percutaneous vertebroplasty.Hypothesis:Considering the existing evidence that associates some peculiar psychological components (expectations, beliefs, fears, coping strategies) of the patient and the outcome of spinal surgery, as well as the importance that the waiting time for the intervention assumes for recovery post-operative, this study aims to investigate the subjective perception of one's condition and the waiting period prior to the expected spinal surgery.This is a qualitative prospective observational study, monocentric with variable sample up to the level of saturation. The blind members are the staff who will listen to the recordings of the interviews and prepare the summary table of the same and the statistical researcher who will perform the analyzes.The selection of the participants will be carried out in such a way as to ensure a heterogeneous sample in terms of age, sex and experience and as representative as possible of the population studied.The number of participants in qualitative studies is usually determined by intentional sampling, based on the need to understand the full range of possible responses, to obtain the so-called data saturation.All patients on the waiting lists of the Department of Spinal Surgery, for vertebral arthrodesis or percutaneous vertebroplasty are considered eligible.The two types of surgery differ both in the surgical procedure and in the duration of the wait before surgery, which is 1-2 months for vertebroplasty and more than one year for spinal arthrodeses which are not of urgency or priority."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 15,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "chirurgia-1",
"briefTitle": "Quality of Life, Expectations, Thoughts and Fears of Patients on the Waiting List for Spinal Surgery",
"nctId": "NCT06323694",
"orgStudyIdInfo": {
"id": "Attesa chirurgia-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Descriptive survey for vertebroplasty patients"
},
{
"measure": "Descriptive survey for spinal arthrodeses patients"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Bologna"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Ortopedico Rizzoli"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Peginterferon α-2b based treatment group"
},
{
"name": "NAs monotherapy group"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Hepatitis b"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "[email protected]",
"name": "Qing Xie, MD, PhD.",
"phone": "0086-021-64370045",
"phoneExt": "680403",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Honglian Gui, MD,PhD",
"phone": "0086-021-64370045",
"phoneExt": "680419",
"role": "CONTACT"
},
{
"email": null,
"name": "Qing Xie, MD, PhD.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy.This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 2016,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study）",
"nctId": "NCT06323681",
"orgStudyIdInfo": {
"id": "Leading Study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of patients with HBsAg below the lower limit of detection."
}
],
"secondaryOutcomes": [
{
"measure": "Decrease of HBV DNA levels at week 48 compared to baseline."
},
{
"measure": "Proportion of patients with HBV DNA below the lower limit of detection."
},
{
"measure": "Decrease of HBsAg levels at week 48 compared to baseline."
},
{
"measure": "Proportion of patients with HBsAg seroconversion."
},
{
"measure": "Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive."
},
{
"measure": "Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive."
},
{
"measure": "Serious adverse events."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Qing XIe"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cardiac implantable electronic device extraction"
},
{
"name": "Empirical antibiotic therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiac Implantable Electronic Device Infection"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection.The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection).The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized open label trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "None (Open Label)",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 180,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CIEDOUT",
"briefTitle": "Cardiac Implantable Electronic Device remOval Versus Full coUrse Medical Treatment",
"nctId": "NCT06323668",
"orgStudyIdInfo": {
"id": "H-23067693",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of death or relapse bacteremia"
}
],
"secondaryOutcomes": [
{
"measure": "Days alive and out-of-hospital"
},
{
"measure": "Rate of death"
},
{
"measure": "Rate of readmission for any cause"
},
{
"measure": "Rate of cardiac implantable electronic device extraction"
},
{
"measure": "Rate of relapse bacteremia (the same microorganism)"
},
{
"measure": "Rate of bacteremia (all species)"
},
{
"measure": "Rate of definite CIED infection"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rigshospitalet, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2038-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tasimelteon"
},
{
"name": "Active Control Placebo"
},
{
"name": "Tasimelteon Placebo"
},
{
"name": "Active Control"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Volunteers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Laval",
"contacts": null,
"country": "Canada",
"facility": "Vanda Investigational Site",
"geoPoint": {
"lat": 45.56995,
"lon": -73.692
},
"state": "Quebec",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects",
"nctId": "NCT06323655",
"orgStudyIdInfo": {
"id": "VP-VEC-162-1201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Vanda Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2018-08-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2018-08-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-07-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "probiotic containing Lactobacillus rhamnosus GG."
},
{
"name": "placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Pneumonia",
"Probiotics"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Islamabad",
"contacts": [
{
"email": "[email protected]",
"name": "Nighat Haider, FCPS",
"phone": "03212125768",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "rashiqa saadat, MBBS",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Pakistan Institute of Medical Sciences",
"geoPoint": {
"lat": 33.72148,
"lon": 73.04329
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "12000"
}
]
},
"descriptionModule": {
"briefSummary": "Probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "randomized control trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "2 Years",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia",
"nctId": "NCT06323642",
"orgStudyIdInfo": {
"id": "F.1-1/20ERB/SZABMU/941",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of days in hospital"
}
],
"secondaryOutcomes": [
{
"measure": "Number of days with cough, fever"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shaheed Zulfiqar Ali Bhutto Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adaptive recursive self-feedback procedure"
},
{
"name": "Non-adaptive recursive self-feedback procedure"
}
]
},
"conditionsModule": {
"conditions": [
"Aphasia",
"Stroke"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is:• To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production?Participants will be engaged in the following activities:* They will perform language and cognitive tasks.* Afterwards, they will receive treatments using tablets and headphones at no cost to them.* The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt.* The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity.* Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Recursive Self-feedback on Speech Production in Aphasia",
"nctId": "NCT06323629",
"orgStudyIdInfo": {
"id": "STUDY006201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Speaking rate"
},
{
"measure": "Speech initiation latency in milliseconds"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Center for Smart Use of Technologies to Assess Real-world Outcomes"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of South Florida"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MAC adjustment to PSI between 25 and 50"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia",
"Emergence Delirium",
"Anesthesia Awareness",
"Behavior Child Problems",
"Postoperative Delirium",
"Postoperative Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Meltem Savran Karadeniz, Assoc. Prof.",
"phone": "009005334845563",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Istanbul University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Istanbul University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of \\>12 points for the diagnosis of ED is 100% and the specificity is 94.5%.Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized, Single-Blind, Prospective, Interventional",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 270,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "8 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics",
"nctId": "NCT06323616",
"orgStudyIdInfo": {
"id": "2023/2343",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "ED/EA incidence"
}
],
"secondaryOutcomes": [
{
"measure": "mYPAS"
},
{
"measure": "PSI <25 episode duration"
},
{
"measure": "PSI >50 episode duration"
},
{
"measure": "PSI <25 number of episodes"
},
{
"measure": "PSI >50 number of episodes"
},
{
"measure": "Suppresyon ratio"
},
{
"measure": "SEF95R"
},
{
"measure": "SEF95L"
},
{
"measure": "Mean blood pressure"
},
{
"measure": "Heart rate"
},
{
"measure": "SpO2"
},
{
"measure": "Total amount of sevoflurane used"
},
{
"measure": "Total amount of remifentanil used"
},
{
"measure": "MAC"
},
{
"measure": "Waking up time"
},
{
"measure": "Pupil size"
},
{
"measure": "Anesthesia duration"
},
{
"measure": "Surgery duration"
},
{
"measure": "PHBQ"
},
{
"measure": "Ped-PADS"
},
{
"measure": "Time of discharge from hospital"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Micro and nanoplastic"
}
]
},
"conditionsModule": {
"conditions": [
"Occupational Exposure",
"Genotoxicity",
"Damage Dna"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Helsinki",
"contacts": null,
"country": "Finland",
"facility": "Textile industry",
"geoPoint": {
"lat": 60.16952,
"lon": 24.93545
},
"state": null,
"status": "COMPLETED",
"zip": null
},
{
"city": "Alicante",
"contacts": null,
"country": "Spain",
"facility": "Recycling company",
"geoPoint": {
"lat": 38.34517,
"lon": -0.48149
},
"state": null,
"status": "COMPLETED",
"zip": null
},
{
"city": "Alicante",
"contacts": null,
"country": "Spain",
"facility": "Textile Industry",
"geoPoint": {
"lat": 38.34517,
"lon": -0.48149
},
"state": null,
"status": "COMPLETED",
"zip": null
},
{
"city": "Barcelona",
"contacts": [
{
"email": null,
"name": "Susana Pastor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Control recruitment",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic",
"nctId": "NCT06323603",
"orgStudyIdInfo": {
"id": "3-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Characterization of macro and nanoplastics"
},
{
"measure": "Genotoxic evaluation by the Micronucleus assay"
},
{
"measure": "Genotoxic evaluation by the Comet assay"
},
{
"measure": "Cytokine release"
},
{
"measure": "Microbiota analysis from feces by MinIOn"
}
],
"secondaryOutcomes": [
{
"measure": "Analyses of surrogate biomarkers"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Finnish Institute of Occupational Health"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ricard Marcos"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Acute Myeloid Leukemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Birmingham",
"contacts": [
{
"email": "[email protected]",
"name": "Omer Jamy",
"phone": "205-934-2721",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Omer Jamy",
"phone": "2059342721",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Omer Jamy",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Alabama at Birmingham",
"geoPoint": {
"lat": 33.52066,
"lon": -86.80249
},
"state": "Alabama",
"status": null,
"zip": "35294"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy."
},
"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": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study",
"nctId": "NCT06323590",
"orgStudyIdInfo": {
"id": "UAB 2372",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "UAB",
"id": "UAB",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "rates of complete remission"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Alabama at Birmingham"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-05"
},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Restricted kinematic alignment"
},
{
"name": "Mechanical alignment"
}
]
},
"conditionsModule": {
"conditions": [
"Osteoarthritis, Knee",
"TKA"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Khlong Luang",
"contacts": [
{
"email": "[email protected]",
"name": "Yot Tanariyakul, M.D.",
"phone": "663930257",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nattapol Tammachote, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Thailand",
"facility": "Thammasat University",
"geoPoint": {
"lat": 14.06467,
"lon": 100.64578
},
"state": "Pathum Thani",
"status": "RECRUITING",
"zip": "12120"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.The main question\\[s\\] it aims to answer are:* Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?* Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA."
},
"designModule": {
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"interventionModel": "PARALLEL",
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},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA",
"nctId": "NCT06323577",
"orgStudyIdInfo": {
"id": "TUH rKA vs MA TKA",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Forgotten joint score"
}
],
"secondaryOutcomes": [
{
"measure": "Modified WOMAC score"
},
{
"measure": "Range of motion"
},
{
"measure": "Pain score"
},
{
"measure": "Hip knee ankle angle"
},
{
"measure": "Complications"
},
{
"measure": "Incidence of soft tissue releasing"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Thammasat University Hospital"
}
},
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"date": "2026-05-31"
},
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"date": "2024-03-21"
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"date": "2026-05-31"
},
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"startDateStruct": {
"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neuropsychological tests in PD"
},
{
"name": "Self-report questionnaires in PD"
},
{
"name": "International Affective Picture System (IAPS)"
},
{
"name": "Neuropsychological tests in AN"
},
{
"name": "Self-report questionnaires in AN"
},
{
"name": "Analysis of bio-humoral parameters"
}
]
},
"conditionsModule": {
"conditions": [
"Anorexia Nervosa",
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oggebbio",
"contacts": [
{
"email": null,
"name": "Riccardo Cremascoli, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Istituto Auxologico Italiano",
"geoPoint": {
"lat": 45.99088,
"lon": 8.64663
},
"state": null,
"status": "RECRUITING",
"zip": "28824"
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of this study is to demonstrate how disorders characterized by different types of \"inflexibility\", cognitive-affective type for Anorexia nervosa and motor one for Parkinson's disease, have an impact on how emotional stimuli are processed and on the transition within emotional states."
},
"designModule": {
"designInfo": {
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"observationalModel": "CASE_CONTROL",
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"timePerspective": "PROSPECTIVE"
},
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"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "INTELLEGO",
"briefTitle": "Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease.",
"nctId": "NCT06323564",
"orgStudyIdInfo": {
"id": "21C223",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in International Affective Picture System (IAPS)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in self-report questionnaires - STAI"
},
{
"measure": "Change in self-report questionnaires - BDI"
},
{
"measure": "Change in Heart rate variability"
},
{
"measure": "Change in analysis of bio-humoral parameters"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Auxologico Italiano"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-13"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
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"date": "2024-08-13"
},
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"date": "2023-01-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mother's Smell"
},
{
"name": "Mother's Breast Milk Smell"
}
]
},
"conditionsModule": {
"conditions": [
"Newborn; Vitality",
"Pain",
"Crying"
]
},
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"locations": [
{
"city": "Mersin",
"contacts": [
{
"email": "[email protected]",
"name": "Atiye Karakul, Ass. Prof.",
"phone": "90(324) 600 00 33",
"phoneExt": "2231",
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Tarsus State Hospital",
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},
"state": null,
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"zip": null
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},
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},
"designModule": {
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"interventionModel": "PARALLEL",
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},
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Days",
"minimumAge": "1 Day",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Mother's Smell and Breast Milk Smell on Pain",
"nctId": "NCT06323551",
"orgStudyIdInfo": {
"id": "2023/50",
"link": null,
"type": null
},
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},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Neonatal Infant Pain Scale"
}
],
"secondaryOutcomes": [
{
"measure": "criying time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tarsus University"
}
},
"statusModule": {
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"date": "2024-12-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
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"date": "2024-07-14"
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"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
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"Diabetes Mellitus, Type 2",
"Cardiovascular Diseases",
"Bone Loss",
"Sustainability",
"Exposure",
"Obesity",
"Vitamin Deficiency",
"Mineral Deficiency"
]
},
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{
"city": "Vienna",
"contacts": null,
"country": "Austria",
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{
"city": "Karlsruhe",
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"email": "[email protected]",
"name": "Benedikt Merz, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Max Rubner-Institut",
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"lon": 8.40444
},
"state": "Baden-Württemberg",
"status": null,
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{
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"contacts": [
{
"email": "[email protected]",
"name": "Christine Dawczynski, PhD",
"phone": "+49 3641 949656",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Friedrich-Schiller University",
"geoPoint": {
"lat": 50.92878,
"lon": 11.5899
},
"state": "Thuringia",
"status": null,
"zip": "07743"
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{
"city": "Berlin",
"contacts": [
{
"email": "[email protected]",
"name": "Cornelia Weikert, Prof",
"phone": "+49 30 1841255000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "The German Federal Institut for Risk Assessment",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
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{
"city": "Bonn",
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{
"email": "[email protected]",
"name": "Ute Nöthlings, Prof",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Bonn",
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"lat": 50.73438,
"lon": 7.09549
},
"state": null,
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},
{
"city": "Gießen",
"contacts": [
{
"email": "[email protected]",
"name": "Markus Keller, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Research Institute for Plant-Based Nutrition, Gießen",
"geoPoint": {
"lat": 50.58727,
"lon": 8.67554
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"state": null,
"status": null,
"zip": "35444"
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{
"city": "Heidelberg",
"contacts": [
{
"email": "[email protected]",
"name": "Ina Danquah",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Heidelberg",
"geoPoint": {
"lat": 49.40768,
"lon": 8.69079
},
"state": null,
"status": null,
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{
"city": "Regensburg",
"contacts": [
{
"email": "[email protected]",
"name": "Michael Leitzmann, Prof",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Beate Fischer",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "University Regensburg",
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"lon": 12.10161
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]
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"briefSummary": "The Cohort on Plant-based Diets (COPLANT) study is a multi-centre cohort study that starts baseline recruitment from 2024 to 2027 with approximately 6,000 participants in Germany and Austria. The COPLANT study focuses on vegan (no animal products), vegetarian (no meat and fish, but dairy products and eggs), pescetarian (no meat, but fish) and omnivorous (mixed diet including all possible animal products) diets. The aim of the COPLANT study is to gain new insights on health benefits and risks as well as social, ecological and economic effects of different plant-based diets in comparison to a mixed diet. In addition to a detailed dietary survey using an app adapted to the needs of this study, the baseline examination includes measurements of body composition, bone health, cardiovascular risk factors, diabetes risk, contaminants and lifestyle. For the basic laboratory program, fasting blood, 24-hour urine collection and a stool sample are taken from all study participants. Furthermore, specific aspects of dietary behavior, physical activity and other lifestyle factors are collected via questionnaires. Follow-up studies are planned at intervals of 5, 10 and 20 years after the baseline visit."
},
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"type": "ESTIMATED"
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"eligibilityModule": {
"maximumAge": "69 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "COPLANT",
"briefTitle": "Cohort Study on Plant-based Diets (COPLANT Study)",
"nctId": "NCT06323538",
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"id": "01",
"link": null,
"type": null
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"otherOutcomes": [
{
"measure": "Heavy metals"
},
{
"measure": "Halogenated, polycyclic aromatic hydrocarbons (dioxins)"
},
{
"measure": "Mycotoxins"
},
{
"measure": "Per- and polyfluoroalkyl substances (PFAS)"
},
{
"measure": "Microbiome"
}
],
"primaryOutcomes": [
{
"measure": "Incidence of diabetes type 2"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of cardiovascular diseases"
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{
"measure": "Incidence of cancer"
},
{
"measure": "Vitamin B12"
},
{
"measure": "Holo-transcobalamine"
},
{
"measure": "Homocysteine"
},
{
"measure": "Methylmalonic acid"
},
{
"measure": "Vitamin B1 status"
},
{
"measure": "Vitamin B2 status"
},
{
"measure": "Vitamin B6 status"
},
{
"measure": "Vitamin C status"
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{
"measure": "Vitamin D status"
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{
"measure": "Vitamin E status"
},
{
"measure": "Iron"
},
{
"measure": "Ferritin"
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{
"measure": "Transferrin"
},
{
"measure": "Zinc status"
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{
"measure": "Selenium status"
},
{
"measure": "Iodine status"
},
{
"measure": "Blood pressure"
},
{
"measure": "Blood lipids"
},
{
"measure": "Fasting insulin"
},
{
"measure": "Fasting glucose"
},
{
"measure": "Glycated hemoglobin (HbA1c)"
},
{
"measure": "C-peptide"
},
{
"measure": "Osteocalcin"
},
{
"measure": "Ostase"
},
{
"measure": "Parathormone"
},
{
"measure": "N-terminal propeptide of type I procollagen (PINP)"
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{
"measure": "C-terminal telopeptide of type I collagen (CTX)"
},
{
"measure": "Creatinine"
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{
"measure": "Uric acid"
},
{
"measure": "Cytstatin C"
},
{
"measure": "Thyroid stimulating hormone (TSH)"
},
{
"measure": "Free triiodothyronine (fT3)"
},
{
"measure": "Free thyroxine (fT4)"
},
{
"measure": "Body fat"
},
{
"measure": "Skeletal muscle mass"
},
{
"measure": "Total Body Water"
},
{
"measure": "Energy intake"
},
{
"measure": "Nutrient intake"
},
{
"measure": "Intake of dietary supplements"
},
{
"measure": "Intake of medication"
}
]
},
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"collaborators": [
{
"name": "Max Rubner-Institut"
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{
"name": "University of Bonn"
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{
"name": "Research Institute for Plant-Based Nutrition"
},
{
"name": "University of Jena"
},
{
"name": "University of Regensburg"
},
{
"name": "Heidelberg University"
},
{
"name": "University of Vienna"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "German Federal Institute for Risk Assessment"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2047-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
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"date": "2023-11-20",
"filename": "Prot_000.pdf",
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"label": "Study Protocol",
"size": 1528917,
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{
"armsInterventionsModule": {
"interventions": [
{
"name": "TCR reserved and Power3 gene knock-out allogeneic CD19-targeting CAR-T cell (ATHENA-2 CAR-T)"
},
{
"name": "Fludarabine"
},
{
"name": "Cyclophosphamide"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Weidong Han, M.D",
"phone": "+86-010-66937463",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Qingming Yang, M.D",
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"phoneExt": null,
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{
"email": null,
"name": "Yang Liu, M.D",
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{
"email": null,
"name": "Jinhong Shi, M.S",
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{
"email": null,
"name": "Chunmeng Wang, M.S",
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"facility": "Biotherapeutic Department of Chinese PLA General Hospital",
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"zip": "100853"
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{
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"email": "[email protected]",
"name": "Weidong Han, Ph.D",
"phone": "+86-010-55499341",
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"role": "CONTACT"
}
],
"country": "China",
"facility": "Biotherapeutic Department of Chinese PLA General Hospital",
"geoPoint": {
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{
"city": "Beijing",
"contacts": [
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"email": "[email protected]",
"name": "Zixuan Pang, Ph.D",
"phone": "010-80733899",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "EdiGene Inc",
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},
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Wensheng Wei, Ph.D",
"phone": "010-62757794",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "School of Life Sciences, Peking University",
"geoPoint": {
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"lon": 116.39723
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"status": "RECRUITING",
"zip": null
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]
},
"descriptionModule": {
"briefSummary": "The safety and efficacy of the chimeric antigen receptor (CAR)-T, a CD19-targeting, TRAC and Power3 double genes deleted allogeneic CAR-T cell product, are undergoing rigorous evaluation in non-Hodgkin's lymphoma (NHL) subjects from our ATHENA trial (NCT06014073). Unexpectedly, expansion of the initial residual CD3-positive CAR T from products were measured in patients' peripheral blood (PB) without exception. Accompanying with host immune reconstitution and appearance of the detectable B cells, the CD3-positive allogenic CAR T cells exhibited a compelling amplification advantage over CD3-negative CAR T cells. The amplification of CD3-positive CAR T cell population dynamically suppressed host B cell recovery, and presumably surveilled the recurrence or progression of tumors, but did not induce typical Graft-versus-host-disease (GvHD). Additionally, a series of in vitro experiments illustrated that the HLA-mismatched fratricide between host T cells and TCR-reserved Power3-deleted allogenic CAR T cells was markedly slashed, which in combination with our observed clinical safety date supported the notion that only genomic deletion of Power3 gene in allo-CAR T cells is sufficient to overcome GvHD and host T cell-mediated rejection response.In the ATHENA-2 study, our design is to preserve the expression of the TCR on T cells from healthy donors while selectively disabling the Power3 gene to prepare ATHENA-2 CAR T cells. This approach harnesses the tonic signaling of CAR T cells, resulting in enhanced persistence and improved response to treatment. The purpose of this study is to evaluate the safety and efficacy of ATHENA-2 in B-cell NHL."
},
"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": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "TCR Reserved and Power3 Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma",
"nctId": "NCT06323525",
"orgStudyIdInfo": {
"id": "CHN-PLAGH-BT-083",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Phase 1: Level of donor-specific antibody (DSA) in blood."
},
{
"measure": "Phase 1: Level of human anti-mouse antibodies (HAMA)"
}
],
"primaryOutcomes": [
{
"measure": "Phase 1: Incidence of adverse events (AEs) defined as DLT"
},
{
"measure": "Phase 1: Recommended phase 2 dose (RP2D)"
},
{
"measure": "Phase 2: 3-month objective response rate (ORR)"
},
{
"measure": "Phase 2: Complete response (CR) rate"
},
{
"measure": "Phase 2: Duration of Response (DOR)"
},
{
"measure": "Phase 2: Overall Survival (OS)"
},
{
"measure": "Phase 2: Progression Free Survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Phase 1 and phase 2: Pharmacokinetics: Level of ATHENA-2 CAR-positive T cells circulating in blood over time"
},
{
"measure": "Phase 1 and phase 2: Pharmacodynamics: Level of CD19+ cells in peripheral blood"
},
{
"measure": "Phase 1 and phase 2: Level of serum cytokines in peripheral blood"
},
{
"measure": "Phase 1: 3-month ORR"
},
{
"measure": "Phase 1: OS"
},
{
"measure": "Phase 1: PFS"
},
{
"measure": "Phase 2: Incidence of AEs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chinese PLA General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pulmonary artery denervation (PADN)"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean pulmonary arterial pressure \\> 20 mmHg and pulmonary artery wedge pressure \\>15 mmHg at rest, as determined by right heart catheterization. Pulmonary hypertension secondary to heart failure (PH-HF) is further stratified into isolated post-capillary pulmonary hypertension (Ipc-PH, pulmonary vascular resistance (PVR) is ≤2 Woods Unit) and combined pre- and post-capillary pulmonary hypertension (Cpc-PH, PVR \\> 2 Woods Unit), the later reflecting additional pulmonary vascular constriction or remodeling in addition to passive PH. While medications tailored for World Health Organization defined Group I pulmonary arterial hypertension are not endorsed for PH-HF according to current guidelines, the coexistence of pulmonary hypertension exacerbates the severity of heart failure. Given the presence of pulmonary arterial vasoconstrictor and heightened sympathetic nervous activity in patients with heart failure, the PADN-5 study has demonstrated the safety and efficacy of pulmonary artery denervation (PADN) for patients with CpcPH, characterized by the improvements in left ventricular ejection fraction, cardiac output, clinical outcome, and reductions in left atrial pressure, pulmonary arterial pressure, and PVR. Our objective is to assess the feasibility, safety, and efficacy of PADN for patients with heart failure independent of left ventricular ejection fraction (HFrEF or HFpEF) without pulmonary hypertension (N=30, 15 with HFrEF and another 15 with HFpEF)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pulmonary Arteyr Denervation for Heart Failure",
"nctId": "NCT06323512",
"orgStudyIdInfo": {
"id": "Nanjing",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "All outcomes will be stratified by HFrEF and HFpEF"
}
],
"primaryOutcomes": [
{
"measure": "Left ventricular ejection fraction"
},
{
"measure": "Tricuspid annuls peak systolic excursion (TAPSE)"
},
{
"measure": "6 minute walk distance changes"
}
],
"secondaryOutcomes": [
{
"measure": "All-cause death"
},
{
"measure": "Rehospitalization"
},
{
"measure": "NT-proBNP"
},
{
"measure": "Superoxide dismutase (SOD) 3"
},
{
"measure": "Plasma noradrenaline"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nanjing First Hospital, Nanjing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Induction of atypical atrial flutter"
}
]
},
"conditionsModule": {
"conditions": [
"Tachyarrhythmia",
"Atypical Atrial Flutter",
"Induction of Arryhthmia",
"Clinical Outcome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Essen",
"contacts": null,
"country": "Germany",
"facility": "University Hospital Essen",
"geoPoint": {
"lat": 51.45657,
"lon": 7.01228
},
"state": "Nordrhein-Westfalen",
"status": null,
"zip": "45147"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Atypical atrial flutter (AAF) is an increasingly relevant clinical problem. Despite advancements in mapping and ablation techniques, the general management of these patients remain challenging especially when mapping cannot be performed during ongoing arrhythmia. There are no data whether induction of AAF is a feasible approach in these cases.Methods: The investigators retrospectively analyzed patients who underwent catheter ablation of AAF and compared procedural results between patients with ongoing tachycardia when starting the procedure and patients with induced AAF.For this retrospective study, the investigators analyzed patients undergoing ablation of AAF between April 2018 and January 2021 that were identified from the ablation database at the West German Heart and Vascular Center, Essen. All patients were followed up in the outpatient clinic as part of the clinical standard routine or contacted by telephone to assess the occurrence of clinical recurrence of any arrhythmia. In case the documentation was not performed at the institution, relevant documents and ECGs were requested and reviewed.This single-center cohort study was conducted at the University Hospital Essen, Germany, in accordance with the Declaration of Helsinki and its amendments and was approved by the institutional review board of the University of Essen (number 21-10341-BO). Written informed consent was obtained from all study participants.The primary study endpoint was to evaluate the outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. Furthermore, the investigators analyzed the type of recurrence during follow-up as well as the occurrence and results of repeat ablations at the institution. The investigators also evaluated if the recurrent AAF form was the same or de-novo compared to the AAF during previous procedure."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 76,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Outcome of Induced Atypical Atrial Flutter",
"nctId": "NCT06323499",
"orgStudyIdInfo": {
"id": "UK Essen",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure."
}
],
"secondaryOutcomes": [
{
"measure": "Type of recurrence during follow-up"
},
{
"measure": "Occurrence and results of repeat ablations at our institution"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Essen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-10-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "active accelerated bilateral sequential theta burst stimulation and sham treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Depressive Disorder, Treatment-Resistant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Amer M. Burhan, MBChB, MSc",
"phone": "905.430.4055",
"phoneExt": "4019",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Adrian I. Espiritu, MD",
"phone": "905.430.4055",
"phoneExt": "6271",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Ontario Shores Centre for Mental Health Sciences",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "L1N 5S9"
}
]
},
"descriptionModule": {
"briefSummary": "The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "We will enroll patients who are willing to be randomized to either the accelerated bilateral sequential theta burst stimulation (absTBS)-sham or sham-absTBS treatment sequence arms. In the absTBS-sham sequence, participants shall receive the active absTBS treatment at Week 1, followed by sham treatment at Week 3, while in the sham-absTBS sequence, participants shall receive sham treatment at Week 1, followed by the active absTBS treatment at Week 3. The primary rationale for employing this sequential treatment strategy for both arms in this trial is to ensure that those assigned to the sham-absTBS group do not have to wait for longer periods to begin receiving the active absTBS therapy and to maintain blinding continuity.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "We shall perform a double-blinding system where the participants, study investigators, transcranial magnetic stimulation (TMS) technicians (those who operate and administer TMS procedures), and research assistants (outcome assessors) are masked to the assignment of the enrolled participants.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CogniTReaD",
"briefTitle": "Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression",
"nctId": "NCT06323486",
"orgStudyIdInfo": {
"id": "23-015-B",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Dual-task Cost"
},
{
"measure": "Change in Hamilton Depression Rating Scale 17 (HAMD-17) score"
},
{
"measure": "Adverse events (AE)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score"
},
{
"measure": "Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score"
},
{
"measure": "Change in Trail Making A (TMT-A) score"
},
{
"measure": "Change in Trail Making B (TMT-B) score"
},
{
"measure": "Change in Digit Symbol Substitution Test (DSST) score"
},
{
"measure": "Change in Digit Span Forward (DSF) score"
},
{
"measure": "Change in Digit Span Backward (DSB) score"
},
{
"measure": "Change in Category Verbal Fluency (CVF) score"
},
{
"measure": "Change in Montreal Cognitive Assessment (MoCA) score"
},
{
"measure": "Change in Colour Word Interference Test (CWIT) score"
},
{
"measure": "Change in Patient Health Questionnaire-9 (PHQ-9) score"
},
{
"measure": "Change in Geriatric Depression Scale 30 (GDS-30) score"
},
{
"measure": "Change in Generalized Anxiety Disorder 7 (GAD-7) score"
},
{
"measure": "Change in Short Form 36 (SF-36) score"
},
{
"measure": "Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score"
},
{
"measure": "Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score"
},
{
"measure": "Change in Clinical Global Impression (CGI) score"
},
{
"measure": "Change in Short Physical Performance Battery (SPPB) score"
},
{
"measure": "Change in Timed Up & Go (TUG) score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Sunnybrook Health Sciences Centre"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ontario Shores Centre for Mental Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Black Maitake Prothera"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ottawa",
"contacts": [
{
"email": "[email protected]",
"name": "Mark Legacy",
"phone": "613-792-1222",
"phoneExt": "1",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "The Centre for Health Innovation",
"geoPoint": {
"lat": 45.41117,
"lon": -75.69812
},
"state": "Ontario",
"status": null,
"zip": "K2P 0M7"
},
{
"city": "Toronto",
"contacts": [
{
"email": "[email protected]",
"name": "Daniel Lander",
"phone": "416-498-1255",
"phoneExt": "280",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Canadian College of Naturopathic Medicine - Integrative Cancer Centre",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": "M2K 1E2"
}
]
},
"descriptionModule": {
"briefSummary": "Maitake is an edible mushroom that is used for both its nutritional and medicinal properties. Human and animal studies have shown Maitake may help improve immune function; however, its effectiveness in people with cancer is not clear. The investigators aim to measure if Maitake has any immunomodulatory effects when given alongside conventional systemic cancer therapy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Uncontrolled single arm clinical trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Maitake",
"briefTitle": "Maitake for Integrative Cancer Care",
"nctId": "NCT06323473",
"orgStudyIdInfo": {
"id": "Maitake001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in absolute neutrophil count"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of febrile neutropenia"
},
{
"measure": "Change in neutrophil to lymphocyte ratio (NLR)"
},
{
"measure": "Change in platelet to lymphocyte ratio (PLR)"
},
{
"measure": "Change in high-sensitivity C-reactive protein (CRP)"
},
{
"measure": "Changes in Quality of Life"
},
{
"measure": "Changes in hemoglobin A1c (HbA1c)"
},
{
"measure": "Incidence of adverse events"
},
{
"measure": "Incidence of dose reductions or delays in systemic therapy"
},
{
"measure": "Addition of new medications to combat neutropenia"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Canadian College of Naturopathic Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biospecimen Collection"
},
{
"name": "Carboplatin"
},
{
"name": "Cisplatin"
},
{
"name": "Computed Tomography"
},
{
"name": "External Beam Radiation Therapy"
},
{
"name": "Paclitaxel"
},
{
"name": "Positron Emission Tomography"
},
{
"name": "Questionnaire Administration"
}
]
},
"conditionsModule": {
"conditions": [
"Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8",
"Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8",
"Oropharyngeal Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Columbus",
"contacts": [
{
"email": "[email protected]",
"name": "Sujith Baliga",
"phone": "614-293-5066",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sujith Baliga",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Ohio State University Comprehensive Cancer Center",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43210"
}
]
},
"descriptionModule": {
"briefSummary": "This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer",
"nctId": "NCT06323460",
"orgStudyIdInfo": {
"id": "OSU-23083",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-00904",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Positron emission tomography complete response"
}
],
"secondaryOutcomes": [
{
"measure": "Progression free survival"
},
{
"measure": "Incidence of adverse events"
},
{
"measure": "Quality of life (QOL)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ohio State University Comprehensive Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PointCheck"
}
]
},
"conditionsModule": {
"conditions": [
"Diffuse Large B Cell Lymphoma",
"Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 210,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "10 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PC002",
"briefTitle": "Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia",
"nctId": "NCT06323447",
"orgStudyIdInfo": {
"id": "PC002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PointCheck Accuracy"
}
],
"secondaryOutcomes": [
{
"measure": "PointCheck Precision"
},
{
"measure": "PointCheck Usability"
},
{
"measure": "PointCheck Errors"
},
{
"measure": "PointCheck Safety"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Leuko Labs, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Chronic Subdural Hematoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Freiburg",
"contacts": [
{
"email": "[email protected]",
"name": "Katharina Wolf, Dr.",
"phone": "+4076127093556",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jürgen Beck, Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Amir El Rahal, Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Niklas Lützen, Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Horst Urbach, Prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Mukesch J Shah, Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Christian Taschner, Prof.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Marco Reisert, Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Manou Overstijns",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Katharina Wolf, Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Florian Volz, Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "University of Freiburg",
"geoPoint": {
"lat": 47.9959,
"lon": 7.85222
},
"state": "Baden-Württemberg",
"status": null,
"zip": "79106"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population.The spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks.Currently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH.Objective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures."
},
"designModule": {
"designInfo": {
"allocation": null,
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"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
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"count": 220,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SPICE",
"briefTitle": "Spinal CSF Leaks in Chronic Subdural Hematoma",
"nctId": "NCT06323434",
"orgStudyIdInfo": {
"id": "spice1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "evidence of a spinal CSF leak (yes/no)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of identified CSF leak types:"
},
{
"measure": "Number of diagnostic procedures performed:"
},
{
"measure": "Number, and site of interventions needed for cSDH:"
},
{
"measure": "Color of hematoma evacuated:"
},
{
"measure": "Age"
},
{
"measure": "body height"
},
{
"measure": "body weight"
},
{
"measure": "Body mass index (BMI)"
},
{
"measure": "sex"
},
{
"measure": "Karnofsky Index"
},
{
"measure": "Anti-platelet therapy intake"
},
{
"measure": "Anticoagulation intake"
},
{
"measure": "Blood pressure medication intake"
},
{
"measure": "Lipid regulation medication intake"
},
{
"measure": "Hormonal regulation medication intake"
},
{
"measure": "Immunotherapeutic medication intake"
},
{
"measure": "other medication intake"
},
{
"measure": "history of trauma"
},
{
"measure": "national institutes of health stroke scale (NIHSS)"
},
{
"measure": "gait disorder"
},
{
"measure": "Modified Rankin Scale (mRS)"
},
{
"measure": "Headache-Impact-Test (HIT)-6"
},
{
"measure": "current working capacity,"
},
{
"measure": "complaints"
},
{
"measure": "headache severity"
},
{
"measure": "Days within the last month"
},
{
"measure": "maximum duration being continuously upright"
},
{
"measure": "severeness of dizziness"
},
{
"measure": "Severeness of shoulder- and neck pain"
},
{
"measure": "severeness of nausea"
},
{
"measure": "severeness of hearing disturbances and tinnitus"
},
{
"measure": "severeness of cognitive deficits"
},
{
"measure": "severeness of visual disturbances"
},
{
"measure": "exhaustion"
},
{
"measure": "ability to focus and concentrate"
},
{
"measure": "Patient's Global Impression of Change (PGIC)"
},
{
"measure": "Self-Administered Comorbidity Questionnaire (SCQ)"
},
{
"measure": "5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) Index"
},
{
"measure": "5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) visual analogue scale"
},
{
"measure": "Hematocrit"
},
{
"measure": "Size of the chronic subdural hematoma"
},
{
"measure": "Volumetry of the cranial compartments"
},
{
"measure": "Bern-Score according to Dobrocky et al"
},
{
"measure": "Spinal longitudinal extradural fluid collection (SLEC)"
},
{
"measure": "DiverTICula (TIC)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Freiburg"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mindfulness"
}
]
},
"conditionsModule": {
"conditions": [
"Mindfulness",
"Colon Cancer",
"Females"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Lisa Tussing-Humphreys, PhD",
"phone": "312-355-5521",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Illinois at Chicago",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60612"
}
]
},
"descriptionModule": {
"briefSummary": "Many neighborhoods in Chicago experience daily exposure to stressors including economic inopportunity and violent crime in public spaces. There is mounting evidence that chronic psychosocial stress can facilitate carcinogenesis by modulating the gut microbiome and immune system. The proposed research aims to study the practice of mindfulness to mitigate CPS and reduce colorectal cancer risk factors among Black American women at elevated risk."
},
"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": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "45 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MindCRC",
"briefTitle": "Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer",
"nctId": "NCT06323421",
"orgStudyIdInfo": {
"id": "STUDY2023-1359",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Body mass index"
},
{
"measure": "Stress measure"
},
{
"measure": "Fasting glucose"
},
{
"measure": "Gut microbiota composition"
},
{
"measure": "Gut inflammation"
},
{
"measure": "Adiposity"
},
{
"measure": "Epinephrine"
},
{
"measure": "Norepinephrine"
},
{
"measure": "Cortisol"
},
{
"measure": "Resting heart rate"
},
{
"measure": "Blood lipids"
},
{
"measure": "Fasting insulin"
},
{
"measure": "Hemoglobin A1c"
},
{
"measure": "Systemic inflammation"
}
],
"primaryOutcomes": [
{
"measure": "Feasibility measures"
},
{
"measure": "Acceptability"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Illinois at Chicago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tissue, blood, cerebrospinal-spinal fluid"
}
]
},
"conditionsModule": {
"conditions": [
"Glioma, Malignant",
"Embryonal Tumor",
"Medulloblastoma",
"Ependymoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 72,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "39 Years",
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "BZKF-AYA",
"briefTitle": "Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas",
"nctId": "NCT06323408",
"orgStudyIdInfo": {
"id": "BZKF-AYA_1.0",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "AI processing of MRI fand PET or diagnosis"
},
{
"measure": "AI processing of MRI and PET for evaluation of response and relapse"
},
{
"measure": "Quality control analysis in radiotherapy"
},
{
"measure": "Analysis of response in liquid biopsies"
},
{
"measure": "Target molecules in tissue and liquid biopsies"
},
{
"measure": "Evaluation of progression free survival"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital Regensburg"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vizol S LIPID BALANCE eye drops"
},
{
"name": "ophthalmic saline eye drops"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Belgrad",
"contacts": null,
"country": "Serbia",
"facility": "Special eye hospital - Beogradski oftalmološki centar",
"geoPoint": {
"lat": 44.80401,
"lon": 20.46513
},
"state": null,
"status": null,
"zip": "11000"
},
{
"city": "Niš",
"contacts": null,
"country": "Serbia",
"facility": "Specialized clinic for eye desease - klinika Veselinović",
"geoPoint": {
"lat": 43.32472,
"lon": 21.90333
},
"state": null,
"status": null,
"zip": "18000"
}
]
},
"descriptionModule": {
"briefSummary": "The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S Lipid Balance, a new eye drops, emulsion developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 30 days."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "As the clinical trial will be conducted in a double-blind way, both investigators and patients will be blind with respect to the treatment administered. For the purpose of individual unblinding of a patient's treatment the investigator will receive a sealed emergency envelope for each patient containing the treatment code (Only in case of medical emergency it is permitted to open the emergency envelope).",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 64,
"type": "ACTUAL"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye",
"nctId": "NCT06323395",
"orgStudyIdInfo": {
"id": "JGL-DED-VIZ-SLB 21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "The presence of Adverse Event/ /Serious Adverse Event (AE/ /SAE) throughout the investigation period"
},
{
"measure": "BCVA"
},
{
"measure": "Frequency of ocular signs"
}
],
"primaryOutcomes": [
{
"measure": "Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30)"
}
],
"secondaryOutcomes": [
{
"measure": "Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15)"
},
{
"measure": "percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) and from Visit 1 (baseline) to Visit 3 (day 30)"
},
{
"measure": "Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30)"
},
{
"measure": "Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30)"
},
{
"measure": "Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Poseidon CRO"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Jadran Galenski laboratorij d.d."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Locoregional therapy"
},
{
"name": "Bevacizumab"
},
{
"name": "Atezolizumab"
},
{
"name": "Tislelizumab"
},
{
"name": "Toripalimab"
},
{
"name": "Sintilimab"
},
{
"name": "Camrelizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Hepatocellular Carcinoma",
"Anti-PD1/PDL1 Antibody",
"Bevacizumab"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Qunfang Zhou, Md",
"phone": "8619868000115",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "MD",
"phone": "8613910984586",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Feng Duan, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Chinese PLA hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100853"
}
]
},
"descriptionModule": {
"briefSummary": "Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 240,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma",
"nctId": "NCT06323382",
"orgStudyIdInfo": {
"id": "Liver Project 6",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression-Free-Survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tislelizumab（neoadjuvant）"
},
{
"name": "Cisplatin （neoadjuvant）"
},
{
"name": "Nab-paclitaxel （neoadjuvant）"
},
{
"name": "Surgical resection"
},
{
"name": "Cisplatin（adjuvant）"
},
{
"name": "Tislelizumab（adjuvant）"
},
{
"name": "Radiation"
},
{
"name": "Carboplatin（neoadjuvant）"
},
{
"name": "Carboplatin（adjuvant）"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Song Fan, Doctor",
"phone": "13570536658",
"phoneExt": "+86",
"role": "CONTACT"
},
{
"email": null,
"name": "Song Fan, Doctor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Medical Ethics Committee of Sun Yat-sen Memorial Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Yuexiu",
"status": "RECRUITING",
"zip": "510120"
}
]
},
"descriptionModule": {
"briefSummary": "A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable clinically node-negative head and neck squamous cell carcinoma."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 154,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma",
"nctId": "NCT06323369",
"orgStudyIdInfo": {
"id": "SYSKY-2023-1283-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease-Free Survival(DFS )"
},
{
"measure": "Lymph node positivity rate"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Adverse Events"
},
{
"measure": "Pathological complete response (pCR) rate"
},
{
"measure": "Major Pathological Response (MPR) rate"
},
{
"measure": "lymph node division"
},
{
"measure": "Event-free Survival (EFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Disease-Free Survival(DFS )"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-09-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-03-25"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TAK-279"
}
]
},
"conditionsModule": {
"conditions": [
"Generalized Pustular Psoriasis",
"Erythrodermic Psoriasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nagoya",
"contacts": null,
"country": "Japan",
"facility": "Nagoya City University Hospital",
"geoPoint": {
"lat": 35.18147,
"lon": 136.90641
},
"state": "Aichi",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Toyoake",
"contacts": null,
"country": "Japan",
"facility": "Fujita Health University Hospital",
"geoPoint": {
"lat": 35.038,
"lon": 136.99931
},
"state": "Aichi",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Kisarazu",
"contacts": null,
"country": "Japan",
"facility": "Kimitsu Chuo Hospital",
"geoPoint": {
"lat": 35.38329,
"lon": 139.93254
},
"state": "Chiba",
"status": "RECRUITING",
"zip": null
},
{
"city": "Urayasu",
"contacts": null,
"country": "Japan",
"facility": "Juntendo University Urayasu Hospital",
"geoPoint": {
"lat": 35.67054,
"lon": 139.88862
},
"state": "Chiba",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Kitakyushu",
"contacts": null,
"country": "Japan",
"facility": "Hospital of the University of Occupational and Environmental Health, Japan",
"geoPoint": {
"lat": 33.85181,
"lon": 130.85034
},
"state": "Fukuoka",
"status": "RECRUITING",
"zip": null
},
{
"city": "Isesaki",
"contacts": null,
"country": "Japan",
"facility": "Isesaki Municipal Hospital",
"geoPoint": {
"lat": 36.31667,
"lon": 139.2
},
"state": "Gunma",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Kobe",
"contacts": null,
"country": "Japan",
"facility": "Kobe University Hospital",
"geoPoint": {
"lat": 34.6913,
"lon": 135.183
},
"state": "Hyogo",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Isehara",
"contacts": null,
"country": "Japan",
"facility": "Tokai University Hospital",
"geoPoint": {
"lat": 35.39932,
"lon": 139.31019
},
"state": "Kanagawa",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Tsu",
"contacts": null,
"country": "Japan",
"facility": "Mie University Hospital",
"geoPoint": {
"lat": 34.73333,
"lon": 136.51667
},
"state": "Mie",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Hirakata",
"contacts": null,
"country": "Japan",
"facility": "Kansai Medical University Hospital",
"geoPoint": {
"lat": 34.81352,
"lon": 135.64914
},
"state": "Osaka",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Iruma",
"contacts": null,
"country": "Japan",
"facility": "Saitama Medical University Hospital",
"geoPoint": null,
"state": "Saitama",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Chuo City",
"contacts": null,
"country": "Japan",
"facility": "St.Luke's International Hospital",
"geoPoint": {
"lat": 35.57779,
"lon": 139.71685
},
"state": "Tokyo",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Itabashi-ku",
"contacts": null,
"country": "Japan",
"facility": "Teikyo University Hospital",
"geoPoint": {
"lat": 35.74893,
"lon": 139.71497
},
"state": "Tokyo",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Minato-ku",
"contacts": null,
"country": "Japan",
"facility": "The Jikei University Hospital",
"geoPoint": {
"lat": 34.2152,
"lon": 135.1501
},
"state": "Tokyo",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Shinjuku-ku",
"contacts": null,
"country": "Japan",
"facility": "Tokyo Medical University Hospital",
"geoPoint": {
"lat": 35.2946,
"lon": 139.57059
},
"state": "Tokyo",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Fukuoka",
"contacts": null,
"country": "Japan",
"facility": "Fukuoka University Hospital",
"geoPoint": {
"lat": 33.6,
"lon": 130.41667
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Kyoto",
"contacts": null,
"country": "Japan",
"facility": "University Hospital, Kyoto Prefectural University of Medicine",
"geoPoint": {
"lat": 35.02107,
"lon": 135.75385
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Okayama",
"contacts": null,
"country": "Japan",
"facility": "Okayama University Hospital",
"geoPoint": {
"lat": 34.65,
"lon": 133.93333
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Osaka",
"contacts": null,
"country": "Japan",
"facility": "Nippon Life Hospital",
"geoPoint": {
"lat": 34.69374,
"lon": 135.50218
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Osaka",
"contacts": null,
"country": "Japan",
"facility": "Osaka Metropolitan University Hospital",
"geoPoint": {
"lat": 34.69374,
"lon": 135.50218
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279.All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.Participants will be in the study for up to 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis",
"nctId": "NCT06323356",
"orgStudyIdInfo": {
"id": "TAK-279-PsO-3005",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "jRCT",
"id": "jRCT2031230714",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16"
},
{
"measure": "Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52"
},
{
"measure": "Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Both Week 16 and Week 52 Visits"
},
{
"measure": "Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52"
},
{
"measure": "Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52"
},
{
"measure": "Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits"
},
{
"measure": "Percentage of Participants Achieving PASI-75 at Week 52"
},
{
"measure": "Percentage of Participants Achieving PASI-90 at Week 16 and Week 52"
},
{
"measure": "Percentage of Participants Achieving PASI-100 at Week 16 and Week 52"
},
{
"measure": "Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits"
},
{
"measure": "Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits"
},
{
"measure": "Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 and Week 52"
},
{
"measure": "Change from baseline in ssPGA at Weeks 16 and 52"
},
{
"measure": "Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 16 and Week 52"
},
{
"measure": "Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 and Week 52"
},
{
"measure": "Change from Baseline in DLQI at Week 16 and Week 52"
},
{
"measure": "Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline"
},
{
"measure": "Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52"
},
{
"measure": "Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Week 16 and Week 52"
},
{
"measure": "Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52"
},
{
"measure": "Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52"
},
{
"measure": "Percentage of Participants with Generalized Pustular Psoriasis Who Achieve ≥75% Improvement from Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Week 16 and Week 52"
},
{
"measure": "Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Takeda"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Video Intervention"
},
{
"name": "Webpage links"
}
]
},
"conditionsModule": {
"conditions": [
"Patient Empowerment"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test an animated video delivered by text message in patients whose pregnancies are complicated with fetal anomalies. The main question it aims to answer is: Does the video intervention prepare parents to talk to the doctors during prenatal appointments?Participants will be randomized to receive either the video intervention or links to the clinic's webpages. They will complete an enrollment survey before their appointment and a follow up survey after their appointment.The researchers will compare the video and webpage groups to see which group reports engaging in more of the identified best-practices of communication."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 114,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits",
"nctId": "NCT06323343",
"orgStudyIdInfo": {
"id": "00040976",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Parents' communication behaviors measure"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical College of Wisconsin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Speech rehabilitation"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke Rehabilitation",
"Aphasia, Broca"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this Interventional Study is to develop and test the Indian Adaptation of Melodic Intonation Therapy (MIT) for Indian patients in with post-stroke Non-Fluent Aphasia (PSNFA). The main question\\[s\\] it aims to answer are: • To develop the MIT Indian Adaptation tool and check its feasibility • To compare the MIT with standard speech rehabilitation in patient with PSNFA. Participants will undergo Speech Rehabilitation according to the developed module and the standard treatment will be given in the comparator arm. The speech recovery at 12 weeks will be compared in both treatment arms."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The MIT- Indian Adaptation will be tested and compared with standard speech rehabilitation in post-stroke non-fluent aphasia",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The outcome assessor will be blinded to the intervention",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation",
"nctId": "NCT06323330",
"orgStudyIdInfo": {
"id": "I-1623",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Western Aphasia Battery Score"
}
],
"secondaryOutcomes": [
{
"measure": "Western Aphasia Battery Score"
},
{
"measure": "functional Near Red Spectroscopy measures"
},
{
"measure": "modified Rankin Score"
},
{
"measure": "Fugl Meyer Assessment Scores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Institute of Human Behavior and Allied Sciences"
},
{
"name": "Indian Institute of Technology, New Delhi"
},
{
"name": "Vardhman Mahavir Medical College And Safdarjung Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "All India Institute of Medical Sciences, New Delhi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Multi-component exercise programme"
},
{
"name": "Attention Placebo"
},
{
"name": "Structured preoperative education"
},
{
"name": "Nutritional optimization"
},
{
"name": "Stress management"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Artery Bypass Grafting",
"Heart Valve Replacement",
"Transcatheter Aortic Valve Implantation",
"Frailty"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Polly Wai Chi Li, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "Polly Wai Chi",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": "Please Select",
"status": "RECRUITING",
"zip": "00000"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures. The program aims to improve functional capacity, frailty level, cardiac-related physical functioning, health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE), hospital length of stay, and readmission rates.Cardiovascular disease is a leading cause of disability and morbidity globally, particularly in older adults. Frailty, a geriatric syndrome commonly seen in cardiac patients, complicates their perioperative care and leads to worse outcomes.Prehabilitation, which optimizes patients' physiological and functional capacities before surgery, has shown promise in general cardiac patients but requires a more comprehensive approach for frail individuals. This randomized controlled trial will recruit 50 Chinese adults awaiting elective cardiac surgeries/procedures in Hong Kong. Participants will be randomly assigned to either the intervention group, receiving a comprehensive prehabilitation program, or the control group, receiving routine preoperative care. Assessments will be conducted at baseline and at three postoperative time points.The findings will contribute to our understanding of the impact of frailty on postoperative outcomes and help develop strategies to improve patient care. Ultimately, this study aims to reduce healthcare burdens associated with cardiac disease-related morbidity and disability."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The post-intervention data collector (research assistant) will be blinded to the group allocation to avoid performance and detection biases.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PREHAB",
"briefTitle": "A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures",
"nctId": "NCT06323317",
"orgStudyIdInfo": {
"id": "UW 21-405",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Short Physical Performance Battery (SPPB)"
},
{
"measure": "Weakness/ Grip Strength (Fried Phenotype Frailty Assessment)"
},
{
"measure": "Slowness (Fried Phenotype Frailty Assessment)"
},
{
"measure": "Low Physical Activity (Fried Phenotype Frailty Assessment)"
},
{
"measure": "Self-reported Exhaustion (Fried Phenotype Frailty Assessment)"
},
{
"measure": "Unintentional Weight Loss (Fried Phenotype Frailty Assessment)"
},
{
"measure": "The Seattle Angina Questionnaire (SAQ)"
},
{
"measure": "The MacNew Heart Disease Health-Related Quality of Life Questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "The Hospital Anxiety and Depression Scale (HADS)"
},
{
"measure": "Biomarkers-Serum albumin"
},
{
"measure": "Biomarkers- C-reactive protein"
},
{
"measure": "Major adverse cardiac and cerebrovascular events (MACCE)"
},
{
"measure": "Hospital Length of stay"
},
{
"measure": "Hospital Readmissions"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Auricular acupressure"
},
{
"name": "Sham acupressure"
},
{
"name": "Standard treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Itching",
"Runny Nose",
"Sneezing",
"Nasal Congestion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ho Chi Minh",
"contacts": [
{
"email": "[email protected]",
"name": "Chau Ngoc Le, MD",
"phone": "+84942831722",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Minh-Man Pham Bui, MD",
"phone": "+84916080803",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Vietnam",
"facility": "University of Medical Center HCMC - Branch no.3",
"geoPoint": {
"lat": 10.82302,
"lon": 106.62965
},
"state": null,
"status": "RECRUITING",
"zip": "700000"
}
]
},
"descriptionModule": {
"briefSummary": "Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Current treatments for AR include allergen avoidance, symptom-relieving medications, anti-inflammatory therapy, and allergen-specific immunotherapy. However, many patients still experience uncontrolled symptoms despite these approaches, either as monotherapy or in combination, along with medication side effects such as drowsiness, dry eyes, nasal mucosal damage, and immunosuppression.Auricular acupressure therapy (AAT) utilizes ear acupoints by applying pressure with ear seeds. The neurobiological mechanisms of AAT on the human body have gained increasing attention in clinical and experimental studies, involving anti-inflammatory, antioxidant, and immunomodulatory effects. Its efficacy has been recognized, becoming a potential alternative therapy for various conditions such as sleep disorders, obesity, and chronic pain. Previous clinical studies have reported the efficacy and safety of AAT in treating AR. However, the primary outcomes of these studies remain inconsistent and lack specific criteria for evaluating AR treatment efficacy.This study aims to investigate the efficacy and safety of AAT in treating AR based on the ARIA guideline 2019 treatment efficacy criteria. It will provide a basis for applying AAT as a complementary approach in the multimodal treatment of AR."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Triple-blind method (Participant, Investigator, Outcome assessor) Participants will be blinded to their randomization assignment, either to the intervention group or the control group. Sham acupressure therapy will be performed at acupoints that have no therapeutic effect on allergic rhinitis, and the procedures will be similar to auricular pressure therapy. Both groups will be treated with fluticasone propionate nasal spray, which is the standard treatment.The physician who perform auricular acupressure therapy or sham acupressure therapy will be aware of the intervention assignment for each group, but they will not be involved in data analysis or outcome assessment. The data analysts and outcome assessors will be blinded to the treatment assignment.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis",
"nctId": "NCT06323304",
"orgStudyIdInfo": {
"id": "701/HDDD-DHYD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The change of nasal and non nasal symptom scores"
}
],
"secondaryOutcomes": [
{
"measure": "The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score"
},
{
"measure": "The change of relief medication usage"
},
{
"measure": "Proportion of intervention-related adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Medicine and Pharmacy at Ho Chi Minh City"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Coaching Sessions"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": [
{
"email": "[email protected]",
"name": "Emma Hume",
"phone": "813-745-6426",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kea Turner, MPH, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Pamela Hodul, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Moffitt Cancer Center",
"geoPoint": {
"lat": 27.94752,
"lon": -82.45843
},
"state": "Florida",
"status": "RECRUITING",
"zip": "33612"
}
]
},
"descriptionModule": {
"briefSummary": "This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study",
"nctId": "NCT06323291",
"orgStudyIdInfo": {
"id": "MCC-23077",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recruitment Rate"
},
{
"measure": "Participant Acceptance of the Digital Health Coaching Program"
},
{
"measure": "Participant Ease of Usability of the Digital Health Coaching Program"
},
{
"measure": "Feasibility of Utilizing the Digital Health Coaching Program"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Canopy Cancer Collective"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "H. Lee Moffitt Cancer Center and Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cognitive training"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "[email protected]",
"name": "Fabiana Ruggiero, MSc in Psychology",
"phone": "+390255033621",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment.Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 68,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease",
"nctId": "NCT06323278",
"orgStudyIdInfo": {
"id": "PD&REHAB",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Efficacy of the cognitive training on cognitive function in PD patients with GBA mutation compared to a control group of PD patients without genetic mutations."
}
],
"secondaryOutcomes": [
{
"measure": "The effect of cognitive training on behavioural aspects in PD patients."
},
{
"measure": "The effect of cognitive training on behavioural aspects in PD patients."
},
{
"measure": "The effect of cognitive training on behavioural aspects in PD patients."
},
{
"measure": "The effect of cognitive training on behavioural aspects in PD patients."
},
{
"measure": "The effect of cognitive training on behavioural aspects in PD patients."
},
{
"measure": "The effect of cognitive training on behavioural aspects in PD patients."
},
{
"measure": "The effect of cognitive training on behavioural aspects in PD patients."
},
{
"measure": "The effect of cognitive training on behavioural aspects in PD patients."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-12-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Adebrelimab + chemotherapy"
},
{
"name": "±chest radiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Extensive Stage Small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shijiazhuang",
"contacts": [
{
"email": "[email protected]",
"name": "Jun Wang",
"phone": "13931182128",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Jun Wang",
"geoPoint": {
"lat": 38.04139,
"lon": 114.47861
},
"state": "Hebei",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer",
"nctId": "NCT06323265",
"orgStudyIdInfo": {
"id": "ARL-SCLC-001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Progression free survival (PFS)"
}
],
"secondaryOutcomes": [
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Disease control rate (DCR)"
},
{
"measure": "Duration of Overall Response（DoR）"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hebei Medical University Fourth Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MastihaOil"
},
{
"name": "nutritional counsel"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertriglyceridemia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. The aim of this study is to determine the effect of Mastiha oil in adults with Hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.The effects of the intervention will be evaluated via clinical and laboratory markers."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia",
"nctId": "NCT06323252",
"orgStudyIdInfo": {
"id": "MastihaOil-HT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in blood triglycerides"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Harokopio University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SBRT"
},
{
"name": "Low-dose Radiotherapy (LDRT)"
},
{
"name": "Toripalimab"
},
{
"name": "Gemcitabine"
},
{
"name": "Cisplatin"
},
{
"name": "IMRT"
}
]
},
"conditionsModule": {
"conditions": [
"Nasopharyngeal Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": null,
"country": "China",
"facility": "Sun Yat-sen University Cancer Center",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 148,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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]
},
"identificationModule": {
"acronym": null,
"briefTitle": "SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma",
"nctId": "NCT06323239",
"orgStudyIdInfo": {
"id": "SBRT/LDRT+PD-1+GP for r/mNPC",
"link": null,
"type": null
},
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},
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{
"measure": "Progression-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall Survival"
},
{
"measure": "Objective Response Rate"
},
{
"measure": "Disease Control Rate"
},
{
"measure": "Adverse Events"
},
{
"measure": "QoL"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
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"completionDateStruct": {
"date": "2028-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
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"date": "2026-04-01"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Sepsis",
"Children, Only"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chendu",
"contacts": [
{
"email": null,
"name": "Ji Yi, Doctor",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
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"facility": "West China Hospital of Sichuan University",
"geoPoint": null,
"state": "Sichuan",
"status": "RECRUITING",
"zip": null
}
]
},
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"briefSummary": "This study is conducted in critically ill children with sepsis with a five years follow-up. We aim to investigate the impact of sepsis on long-term outcomes including growth, neurodevelopment, survival rate, quality of life."
},
"designModule": {
"designInfo": {
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},
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},
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},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "0 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis",
"nctId": "NCT06323226",
"orgStudyIdInfo": {
"id": "2024-312-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mortality"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "West China Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
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"date": "2025-01-01"
},
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"startDateStruct": {
"date": "2019-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "610"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Asthma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"whoMasked": [
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"INVESTIGATOR"
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 480,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy and Safety Study of 610 in Patients With Severe Asthma",
"nctId": "NCT06323213",
"orgStudyIdInfo": {
"id": "SSGJ-610-BA-III-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Annualized rate of severe exacerbation events"
}
],
"secondaryOutcomes": [
{
"measure": "Time to first severe exacerbation event"
},
{
"measure": "Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit"
},
{
"measure": "Change from baseline in ACQ score"
},
{
"measure": "Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ)"
},
{
"measure": "Change in pre-bronchodilator forced expiratory volume (FEV1)"
},
{
"measure": "Assessment of adverse events (AEs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd."
}
},
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"completionDateStruct": {
"date": "2026-09"
},
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"date": "2024-03-21"
},
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"date": "2026-06"
},
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"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "lymphaticovenous anastomosis"
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]
},
"conditionsModule": {
"conditions": [
"Lymphedema"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"count": 189,
"type": "ACTUAL"
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},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
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"acronym": "LVA",
"briefTitle": "Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA",
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"orgStudyIdInfo": {
"id": "202400221B0",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Volume change after LVA."
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],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chang Gung Memorial Hospital"
}
},
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"completionDateStruct": {
"date": "2023-03"
},
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"date": "2023-03"
},
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"startDateStruct": {
"date": "2015-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Cervical Sampling"
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]
},
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"conditions": [
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"Preeclampsia",
"Fetal Growth Retardation"
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},
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},
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"briefSummary": "Fetal cells are not easily obtained from pregnant patients; this curtails testing to assess the health of the fetus and the mother. Currently, the only way of diagnosing fetal genetic or chromosomal abnormalities is by invasive techniques, such as chorionic villous sampling (CVS) and amniocentesis performed at 10 to 13 weeks and after 15 weeks of gestation, respectively. Although small, there is a risk for fetal loss with these procedures. Transcervical cell sampling (TCS), similar to a Pap smear, is a platform that meets the requirements for prenatal genetic testing (genetic testing with fetal cells obtained before birth), as well as diagnosis of maternal pregnancy complication, at a very early stage of pregnancy (as early as 5 weeks) and carries low risk for the mother and the developing fetus.This study will examine cervical fluid collected using various noninvasive methods for TCS in pregnant women. The number of placental cells will be assessed against similarly obtained samples from nonpregnant women of reproductive age who lack cells derived from a placenta. Participating volunteers will provide written informed consent. Only standard medical procedures and approved devices will be used for collection of cervical fluid, minimizing risk to the participants and their fetuses. No test results or other benefits will be available to the participants."
},
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"phases": null,
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"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
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},
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"acronym": "OCCP",
"briefTitle": "Optimization of Cervical Collections in Pregnancy",
"nctId": "NCT06323187",
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"id": "4656",
"link": null,
"type": null
},
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},
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{
"measure": "Cellular content"
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{
"measure": "Cell-free content"
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},
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"collaborators": null,
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"date": "2031-02-28"
},
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"startDateStruct": {
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},
"studyFirstPostDateStruct": {
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}
}
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{
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{
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{
"name": "Placebo"
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{
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"facility": "Arcturus Healthcare, PLC",
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{
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"contacts": null,
"country": "United States",
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{
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"facility": "Velocity Clinical Res-Dallas",
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"lon": -96.80667
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"status": "RECRUITING",
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{
"city": "San Antonio",
"contacts": null,
"country": "United States",
"facility": "Northeast Clinical Research of San Antonio",
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"lon": -98.49363
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"state": "Texas",
"status": "RECRUITING",
"zip": "78233"
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"city": "Shavano Park",
"contacts": null,
"country": "United States",
"facility": "Consano Clinical Research, LLC",
"geoPoint": {
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"zip": "78231"
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{
"city": "Shavano Park",
"contacts": null,
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"state": "Texas",
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"zip": "78231"
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{
"city": "Newport News",
"contacts": null,
"country": "United States",
"facility": "TPMG Clinical Research",
"geoPoint": {
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{
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"country": "China",
"facility": "Chinese People's Liberation Army General Hospital",
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"lon": 116.39723
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"state": "Beijing",
"status": "NOT_YET_RECRUITING",
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{
"city": "Nanjing",
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"country": "China",
"facility": "The Second Affiliated Hospital of Nanjing Medical University_Nanjing",
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"state": "Jiangsu",
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{
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"facility": "The Affiliated Hospital of Jiangsu University_Zhenjiang",
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{
"city": "Ji'Nan",
"contacts": null,
"country": "China",
"facility": "Jinan Central Hospital",
"geoPoint": {
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"lon": 116.99722
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"state": "Shandong",
"status": "NOT_YET_RECRUITING",
"zip": "250000"
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{
"city": "Debrecen",
"contacts": null,
"country": "Hungary",
"facility": "Belinus Bt.",
"geoPoint": {
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"lon": 21.63333
},
"state": "Hajdu-Bihar Varmegye",
"status": "NOT_YET_RECRUITING",
"zip": "4025"
},
{
"city": "Nyíregyháza",
"contacts": null,
"country": "Hungary",
"facility": "Borbánya Praxis E.Ü. Kft.",
"geoPoint": {
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"lon": 21.71671
},
"state": "Szabolcs-Szatmar Varmegye",
"status": "NOT_YET_RECRUITING",
"zip": "4405"
},
{
"city": "Bergamo",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospedaliera Papa Giovanni XXIII",
"geoPoint": {
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"lon": 9.66721
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "24127"
},
{
"city": "Catanzaro",
"contacts": null,
"country": "Italy",
"facility": "Policlinico Mater Domini Università di Catanzaro",
"geoPoint": {
"lat": 38.88247,
"lon": 16.60086
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "88100"
},
{
"city": "Milano",
"contacts": null,
"country": "Italy",
"facility": "IRCCS Ospedale San Raffaele Milano",
"geoPoint": {
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"lon": 9.18951
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "20132"
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{
"city": "Roma",
"contacts": null,
"country": "Italy",
"facility": "Azienda Ospealiero Universitaria Policlinico Umberto I",
"geoPoint": {
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"lon": 12.51133
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "00161"
},
{
"city": "Rzeszow",
"contacts": null,
"country": "Poland",
"facility": "Centrum Medyczne Medyk Sp. z o.o.",
"geoPoint": {
"lat": 50.04132,
"lon": 21.99901
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"state": "Podkarpackie",
"status": "NOT_YET_RECRUITING",
"zip": "35-055"
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{
"city": "Białystok",
"contacts": null,
"country": "Poland",
"facility": "Renew Clinic Bialystok",
"geoPoint": {
"lat": 53.13333,
"lon": 23.16433
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "15-794"
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{
"city": "Lodz",
"contacts": null,
"country": "Poland",
"facility": "Centrum Terapii Wspolczesnej",
"geoPoint": {
"lat": 51.75,
"lon": 19.46667
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "90-338"
},
{
"city": "Warszawa",
"contacts": null,
"country": "Poland",
"facility": "NBR Polska Tomasz Klodawski",
"geoPoint": {
"lat": 52.22977,
"lon": 21.01178
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "00-710"
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{
"city": "Al Ahsa",
"contacts": null,
"country": "Saudi Arabia",
"facility": "King Abdulaziz Hospital-Al Ahsa-National Guard",
"geoPoint": null,
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "36428"
},
{
"city": "Jeddah",
"contacts": null,
"country": "Saudi Arabia",
"facility": "National Guard Hospital - Jeddah",
"geoPoint": {
"lat": 21.54238,
"lon": 39.19797
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "21423"
},
{
"city": "Riyadh",
"contacts": null,
"country": "Saudi Arabia",
"facility": "King Fahad Medical City",
"geoPoint": {
"lat": 24.68773,
"lon": 46.72185
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "11525"
},
{
"city": "Riyadh",
"contacts": null,
"country": "Saudi Arabia",
"facility": "King Khaled University Hospital,King Saud Univ. Med. City",
"geoPoint": {
"lat": 24.68773,
"lon": 46.72185
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "12372"
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{
"city": "Riyadh",
"contacts": null,
"country": "Saudi Arabia",
"facility": "King Salman Bin Abdulaziz Hospital",
"geoPoint": {
"lat": 24.68773,
"lon": 46.72185
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "12769"
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{
"city": "Belgrade",
"contacts": null,
"country": "Serbia",
"facility": "CHC Zvezdara, Clinical department for endocrinology",
"geoPoint": {
"lat": 44.80401,
"lon": 20.46513
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "11000"
},
{
"city": "Belgrade",
"contacts": null,
"country": "Serbia",
"facility": "Clinical Hospital Center Bezanijska Kosa",
"geoPoint": {
"lat": 44.80401,
"lon": 20.46513
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "11080"
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{
"city": "Belgrade",
"contacts": null,
"country": "Serbia",
"facility": "Clinical Hospital Centre Zemun",
"geoPoint": {
"lat": 44.80401,
"lon": 20.46513
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"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "11080"
}
]
},
"descriptionModule": {
"briefSummary": "This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a \"dummy\" medicine (also called \"placebo\") that has no effect on the body. Participants will get either CagriSema or \"dummy\" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year."
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"measure": "Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol"
},
{
"measure": "Ratio to Baseline in Lipids: Triglycerides"
},
{
"measure": "Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol"
},
{
"measure": "Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol"
},
{
"measure": "Ratio to Baseline in Lipids: HDL Cholesterol"
},
{
"measure": "Ratio to Baseline in Lipids: Total Cholesterol"
},
{
"measure": "Ratio to Baseline in Lipids: Free Fatty Acids"
},
{
"measure": "Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score"
},
{
"measure": "Change in SF-36v2: Physical Component Summary Score"
},
{
"measure": "Change in SF-36v2: Mental Component Summary Core"
},
{
"measure": "Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score"
},
{
"measure": "Change in Leptin"
},
{
"measure": "Change in Soluble Leptin Receptor"
},
{
"measure": "Number of Treatment Emergent Adverse Events (TEAEs)"
},
{
"measure": "Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter)"
},
{
"measure": "Number of Clinically Significant Hypoglycaemic Episodes (level 3)"
}
]
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},
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},
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"date": "2024-03-26"
},
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"date": "2024-03-21"
}
}
} | false | null |
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"name": "Osimertinib"
},
{
"name": "No adjuvant therapy"
}
]
},
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"Lung Cancer",
"EGFR Gene Mutation",
"Minimal Residual Disease"
]
},
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"briefSummary": "This study plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients after radical surgery (R0 resection). Patients with positive ctDNA testing will receive standard treatment according to clinical guidelines, while patients with negative ctDNA testing will be assessed based on comprehensive clinical and pathological characteristics. After receiving or not receiving standard adjuvant chemotherapy, patients will be randomly assigned in a 1:1 ratio to either the observation follow-up group (experimental group) or the osimertinib adjuvant treatment group (control group). The aim is to explore whether observation follow-up for patients with negative ctDNA after surgery has a prognosis non-inferior to osimertinib treatment, and to investigate the disease-free survival rate of EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients with positive ctDNA after surgery receiving osimertinib adjuvant treatment, providing more precise treatment guidance for adjuvant therapy in this specific type of NSCLC patients with EGFR mutation-positive tumors."
},
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},
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},
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"type": "ESTIMATED"
},
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"OLDER_ADULT"
]
},
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"briefTitle": "Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)",
"nctId": "NCT06323148",
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"id": "ECTOP-1022",
"link": null,
"type": null
},
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},
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}
],
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},
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"class": "OTHER",
"name": "Fudan University"
}
},
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},
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},
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},
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"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": null,
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"conditions": [
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"Nutrition Aspect of Cancer",
"Prognostic Cancer Model"
]
},
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{
"city": "Chengdu",
"contacts": null,
"country": "China",
"facility": "West China Hospital, Sichuan Universit",
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"lon": 104.06667
},
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"status": null,
"zip": "610041"
}
]
},
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},
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},
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},
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"minimumAge": "18 Years",
"sex": "ALL",
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Nutrition Assessment in Advanced Cancer Patients",
"nctId": "NCT06323135",
"orgStudyIdInfo": {
"id": "2019-725",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "All-cause mortality"
}
],
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"measure": "length of stay in hospital"
}
]
},
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}
},
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"date": "2023-09-11"
},
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},
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"date": "2023-09-11"
},
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"startDateStruct": {
"date": "2019-09-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "2.0 miniplates"
},
{
"name": "2.3 high profile miniplates"
},
{
"name": "3D miniplates"
}
]
},
"conditionsModule": {
"conditions": [
"Mandibular Fractures"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "October 6U",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": "12566"
}
]
},
"descriptionModule": {
"briefSummary": "The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period."
},
"designModule": {
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},
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"type": "ACTUAL"
},
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},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures.",
"nctId": "NCT06323122",
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"id": "Plating Techniques 2023",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Surgery Time"
}
],
"secondaryOutcomes": [
{
"measure": "complication"
},
{
"measure": "fracture stability"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "October 6 University"
}
},
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"date": "2023-12-01"
},
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},
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"date": "2023-10-01"
},
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"date": "2021-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MRI-UDS; US-UDS; MCUD"
}
]
},
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"conditions": [
"Lower Urinary Tract Symptoms",
"BPH"
]
},
"contactsLocationsModule": {
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{
"city": "Madison",
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{
"email": "[email protected]",
"name": "Gemma Gliori, MS",
"phone": null,
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"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Suzanne Hanson, BS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alejandro Roldan-Alzate, PhD",
"phone": null,
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"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Wade Bushman, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Matt Grimes, MD",
"phone": null,
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Giuseppe Toia, MD",
"phone": null,
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Ivan Rosado-Mendez, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Wisconsin",
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"lon": -89.40123
},
"state": "Wisconsin",
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"zip": "53705"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this research is to develop an ultrasound (US) based urodynamics (UDS) evaluation of voiding based on successful magnetic resonance imaging (MRI)-UDS evaluation. Both US and MRI are non-invasive imaging techniques, but US is a more cost-effective and widely available technology. 80 participants will be enrolled and will be on study for up to 2.5 hours (1.5 hour MRI and 1 hour US)."
},
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"sex": "MALE",
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]
},
"identificationModule": {
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"link": null,
"type": null
},
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{
"domain": "UW Madison",
"id": "A196200",
"link": null,
"type": "OTHER"
},
{
"domain": "UW Madison",
"id": "Protocol Version 12/21/23",
"link": null,
"type": "OTHER"
}
]
},
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{
"measure": "MRI Urodynamics - Change in Bladder Volume"
},
{
"measure": "MRI Urodynamics - Change in Urine Velocity"
},
{
"measure": "MRI Urodynamics - Change in Pressure"
},
{
"measure": "Bladder outlet obstruction index (BOOI)"
},
{
"measure": "Bladder contractility index (BOI)"
},
{
"measure": "International Prostate Symptom Score (IPSS)"
}
],
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"name": "Wisconsin Partnership Program"
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],
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}
},
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"date": "2023-11-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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},
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]
},
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"locations": [
{
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"contacts": [
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"email": "[email protected]",
"name": "Alexander Prokazyuk, MD",
"phone": "+77071891849",
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"role": "CONTACT"
}
],
"country": "Kazakhstan",
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},
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},
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"link": null,
"type": null
},
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},
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"measure": "Prediction of SIRS"
},
{
"measure": "Rate of ATC prediction in the 24 h after admission using the developed CDSS."
},
{
"measure": "Rate of hemorrage prediction in the 24 h after admission using the developed CDSS."
},
{
"measure": "Rate of pneumonia prediction using the developed CDSS."
}
],
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},
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"name": "Ministry of Science and Higher Education of the Republic of Kazakhstan"
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],
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},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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"name": "Emotional Freedom Technique"
}
]
},
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"conditions": [
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"Stress",
"Self Efficacy"
]
},
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"city": "Konya",
"contacts": null,
"country": "Turkey",
"facility": "Selcuk University",
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"lon": 32.48464
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},
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},
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},
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"NA"
],
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"sex": "FEMALE",
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},
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"id": "006",
"link": null,
"type": null
},
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},
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"measure": "General Self-Efficacy Scale"
},
{
"measure": "Perceived Stress Scale"
},
{
"measure": "The Subjective Units of Distress Scale"
}
],
"secondaryOutcomes": null
},
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"name": "Selcuk University"
}
},
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"date": "2023-06-30"
},
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"date": "2024-03-21"
},
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"date": "2022-11-28"
},
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"startDateStruct": {
"date": "2022-11-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Low-fat cookies"
},
{
"name": "Watermelon"
}
]
},
"conditionsModule": {
"conditions": [
"Overweight and Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Diego",
"contacts": [
{
"email": "[email protected]",
"name": "Mee Young Hong, PhD",
"phone": "619-594-2392",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "School of Exercise and Nutritional Sciences",
"geoPoint": {
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"lon": -117.15726
},
"state": "California",
"status": "RECRUITING",
"zip": "92182"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults."
},
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},
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},
"enrollmentInfo": {
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Watermelon or Low-fat Cookie Consumption on Wellness",
"nctId": "NCT06323070",
"orgStudyIdInfo": {
"id": "HS-2023-0281",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Change of sexual health questionnaire scores"
},
{
"measure": "Change of skin hydration scores"
},
{
"measure": "Change of microbiome diversity"
}
],
"secondaryOutcomes": [
{
"measure": "Change of depression questionnaire scores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "San Diego State University"
}
},
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"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
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"date": "2025-12"
},
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"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Single pulse TMS to the frontal cortex"
}
]
},
"conditionsModule": {
"conditions": [
"Behavior"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Newark",
"contacts": [
{
"email": "[email protected]",
"name": "Travis E Baker, PhD",
"phone": "862-250-3351",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Daniel Robles, PhD",
"phone": "973-353-3509",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Rutgers University - Newark",
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"lon": -74.17237
},
"state": "New Jersey",
"status": "RECRUITING",
"zip": "07102"
}
]
},
"descriptionModule": {
"briefSummary": "Our specific aim is to examine the effects of TMS on reward processing during goal-directed behavior. In these experiments the investigators will utilize a scalp-recorded brain oscillation called frontal midline theta that is believed to index the sensitivity of the cingulate cortex to reward feedback. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in decision making tasks, and if so, whether it would affect the encoding of rewards and subsequent choices during task performance."
},
"designModule": {
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]
},
"observationalModel": null,
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"timePerspective": null
},
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"count": 28,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Modulating Reward Learning Using Transcranial Magnetic Stimulation",
"nctId": "NCT06323057",
"orgStudyIdInfo": {
"id": "Pro2022000444_CLFMT",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Event-related Brain Oscillation: Frontal Midline Theta"
},
{
"measure": "Reward learning"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
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"class": "OTHER",
"name": "Rutgers, The State University of New Jersey"
}
},
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"date": "2025-04-30"
},
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"date": "2024-03-22"
},
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"date": "2025-04-30"
},
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"startDateStruct": {
"date": "2024-02-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Best Practice"
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{
"name": "Biospecimen Collection"
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{
"name": "Electronic Health Record Review"
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{
"name": "Interview"
},
{
"name": "Medical Device Usage and Evaluation"
},
{
"name": "Medical Device Usage and Evaluation"
},
{
"name": "Survey Administration"
}
]
},
"conditionsModule": {
"conditions": [
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]
},
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"locations": [
{
"city": "Buffalo",
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{
"email": "[email protected]",
"name": "Kara M. Kelly",
"phone": "716-845-2333",
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"role": "CONTACT"
},
{
"email": null,
"name": "Kara M. Kelly",
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],
"country": "United States",
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"state": "New York",
"status": null,
"zip": "14263"
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},
"descriptionModule": {
"briefSummary": "This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication."
},
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},
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},
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"OLDER_ADULT"
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},
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"id": "I-3920723",
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},
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{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01734",
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{
"domain": "Roswell Park Cancer Institute",
"id": "I-3920723",
"link": null,
"type": "OTHER"
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{
"domain": null,
"id": "R01CA283501",
"link": "https://reporter.nih.gov/quickSearch/R01CA283501",
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]
},
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{
"measure": "Medication adherence"
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"class": "OTHER",
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},
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"date": "2029-06-15"
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"date": "2024-06-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
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}
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},
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{
"email": "[email protected]",
"name": "Olivia Gosseries, PhD",
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{
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"name": "Olivia Gosseries, PhD",
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"name": "Aurore Thibaut, PhD",
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},
{
"email": null,
"name": "Youssra Mezoudi, M.Sc.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
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{
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{
"email": "[email protected]",
"name": "Andreas Bender, MD",
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"phoneExt": null,
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{
"email": null,
"name": "Andreas Bender, MD",
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{
"email": null,
"name": "Martin Rosenfelder, PhD",
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"role": "SUB_INVESTIGATOR"
}
],
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{
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{
"email": "[email protected]",
"name": "Konstantinos Dimitriadis",
"phone": null,
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"role": "CONTACT"
},
{
"email": null,
"name": "Konstantinos Dimitriadis",
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{
"email": null,
"name": "Moritz Schmidbauer",
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},
{
"email": null,
"name": "Julia Zibold",
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}
],
"country": "Germany",
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{
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{
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"name": "Anna Estraneo, PhD",
"phone": "3396418648",
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{
"email": "[email protected]",
"name": "Alfonso Magliacano, PhD",
"phone": "3387389414",
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{
"email": null,
"name": "Anna Estraneo, MD",
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{
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"name": "Alfonso Magliacano, PhD",
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{
"email": null,
"name": "Giovanni Scarano, BS",
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}
],
"country": "Italy",
"facility": "Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS",
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{
"city": "Ferrara",
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{
"email": "[email protected]",
"name": "Susanna Lavezzi",
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"phoneExt": null,
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{
"email": null,
"name": "Susanna Lavezzi",
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{
"email": null,
"name": "Valentina Bonsangue",
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{
"email": null,
"name": "Sofia Straudi",
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"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara",
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{
"city": "Florence",
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{
"email": "[email protected]",
"name": "Bahia Hakiki, PhD",
"phone": null,
"phoneExt": null,
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},
{
"email": null,
"name": "Bahia Hakiki, PhD",
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{
"email": null,
"name": "Piergiuseppe Liuzzi, PhD",
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}
],
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{
"email": "[email protected]",
"name": "Angela Comanducci, PhD",
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"role": "CONTACT"
},
{
"email": null,
"name": "Angela Comanducci, PhD",
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{
"email": null,
"name": "Tiziana Atzori",
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{
"email": null,
"name": "Chiara-Camilla Derchi",
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}
],
"country": "Italy",
"facility": "IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS",
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"email": "[email protected]",
"name": "Enrique Noé, MD",
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{
"email": null,
"name": "Enrique Noé, MD",
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{
"email": null,
"name": "Alejandro Galvao, PhD",
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],
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"facility": "Instituto de Rehabilitación Neurológica IRENEA",
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},
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"briefSummary": "Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and/or sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC).This is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months."
},
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
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"acronym": "Blink-DoC",
"briefTitle": "Spontaneous Eye Blinking in Disorders of Consciousness",
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"id": "Blink-DoC",
"link": null,
"type": null
},
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},
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{
"measure": "Clinical Diagnosis"
}
],
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"name": "Therapiezentrum Burgau"
},
{
"name": "University of Liege"
},
{
"name": "University Hospital Munich"
},
{
"name": "VITHAS Valencia (Spain)"
},
{
"name": "Azienda Ospedaliera Universitaria Ferrara"
},
{
"name": "Ludwig-Maximilians - University of Munich"
}
],
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}
},
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},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Remote Ischemic Preconditioning"
},
{
"name": "SHAM"
}
]
},
"conditionsModule": {
"conditions": [
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"Cardiovascular Diseases",
"Bone Cement Implantation Syndrome",
"Kidney Diseases"
]
},
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{
"city": "Tartu",
"contacts": [
{
"email": "[email protected]",
"name": "Kaspar Tootsi, MD, PhD",
"phone": "+3727318282",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Estonia",
"facility": "University of Tartu",
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"lon": 26.72509
},
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"status": "RECRUITING",
"zip": "50406"
}
]
},
"descriptionModule": {
"briefSummary": "Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients."
},
"designModule": {
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"maskingDescription": "Randomization and intervention is done by a dedicated study nurse. Patient, orthopedic surgeon, investigator and outcomes assessor and statistician are all blinded to the study intervention.",
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
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},
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"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "90 Years",
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PRINCIPAL",
"briefTitle": "Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.",
"nctId": "NCT06323018",
"orgStudyIdInfo": {
"id": "384T-26",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"primaryOutcomes": [
{
"measure": "Myocardial injury"
}
],
"secondaryOutcomes": [
{
"measure": "Cardiovascular injury"
},
{
"measure": "Clinical serious complications"
},
{
"measure": "Carotid-femoral pulse velocity"
},
{
"measure": "Augmentation index"
},
{
"measure": "Brain injury"
},
{
"measure": "Kidney Injury"
},
{
"measure": "Total antioxidative capacity (TAC)"
},
{
"measure": "Oxidative stress level (total peroxide levels)"
},
{
"measure": "Inflammation level"
},
{
"measure": "Low molecular weight metabolites (uM)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "University of Tartu"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-04"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03"
},
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"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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"briefTitle": "[Trial of device that is not approved or cleared by the U.S. FDA]",
"nctId": "NCT06323005",
"orgStudyIdInfo": {
"id": "2024-0024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"collaborators": null,
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"class": null,
"name": "[Redacted]"
}
},
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"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
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"startDateStruct": null,
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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"interventions": null
},
"conditionsModule": {
"conditions": [
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]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features. The outcome of this project will be a final prototype app with 70% of patients indicating an overall MARS score of 4.0 or more and satisfaction with the three features."
},
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},
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},
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"minimumAge": null,
"sex": "ALL",
"stdAges": [
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"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
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"briefTitle": "App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients - Aim 3",
"nctId": "NCT06322992",
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"id": "R41CA271962",
"link": "https://reporter.nih.gov/quickSearch/R41CA271962",
"type": "NIH"
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"primaryOutcomes": [
{
"measure": "APP satisfaction"
},
{
"measure": "APP rating"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Masonic Cancer Center, University of Minnesota"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Daynamica, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mineral trioxide aggregate"
},
{
"name": "Premixed Bioceramic Putty"
}
]
},
"conditionsModule": {
"conditions": [
"Periapical Periodontitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tanta",
"contacts": [
{
"email": "[email protected]",
"name": "Shaimaa eldesouky, PhD",
"phone": "01008994242",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "mohamed ghaly, PhD",
"phone": "01098472899",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Tanta University",
"geoPoint": {
"lat": 30.78847,
"lon": 31.00192
},
"state": "Gharbia",
"status": "RECRUITING",
"zip": "6624033"
}
]
},
"descriptionModule": {
"briefSummary": "Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth",
"nctId": "NCT06322979",
"orgStudyIdInfo": {
"id": "# R-PED-11-23-3074",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)"
},
{
"measure": "the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)"
}
],
"secondaryOutcomes": [
{
"measure": "Change in the periapical index (PAI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tanta University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Air Action Curriculum"
}
]
},
"conditionsModule": {
"conditions": [
"Behavior and Behavior Mechanisms",
"Health Knowledge, Attitudes, Practice"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "Savannah M D'Evelyn, PhD",
"phone": "303-501-6656",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Washington",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": "RECRUITING",
"zip": "98195"
}
]
},
"descriptionModule": {
"briefSummary": "The proposed intervention in this Youth Participatory Action Research (YPAR) proposal will improve knowledge and awareness of the health impacts of air pollution exposure, will elevate the youth voice, improve youth self-efficacy and lead to behavior changes that would reduce exposure to air pollution in a high school setting. These outcomes will be accomplished through the introduction of a new air quality curriculum, called AirActions, into freshman science classes, and the establishment of an after-school air quality monitoring program.All students enrolled in freshman Honors Biology (Pueblo East and Montrose High Schools), Intro to Agriculture (The STEAD School) and Environmental Science (Grand Junction High School) will participate in the new air quality curriculum, as it will be built into the existing lesson plans. For the after-school monitoring program, the PI and participating teachers (Letters A and B) will recruit 10 to 15 students at each school to be involved in the Student Research Cohort (SRC). Information on this program and how to apply will be shared with students through their health and science classes, included in the school newsletter, and posted on billboards around the school. Students will be identified within the following inclusion criteria: 1) freshman or sophomores in high school and 2) participation in the AirActions curriculum. New students will be recruited each year to keep a consistent group as students leave and/or graduate. New students will be brought up to speed by carry-over students, and each new year will represent a separate SRC dedicated to a specific goal."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 400,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "14 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Learning and Living With Wildfire Smoke",
"nctId": "NCT06322966",
"orgStudyIdInfo": {
"id": "STUDY00017745",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "K99ES034442",
"link": "https://reporter.nih.gov/quickSearch/K99ES034442",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of students, staff, teacher and administrators with higher scores on a Likert-style questionnaire for content knowledge learning objectives."
},
{
"measure": "Scores on Likert-style questionnaire to evaluate behavior change around air quality."
},
{
"measure": "Change in student exposure to air pollution calculated through measurements of indoor particulate matter and indoor carbon dioxide."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute of Environmental Health Sciences (NIEHS)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Washington"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Direct-Acting Oral Anticoagulants (used as per local standard practice)"
}
]
},
"conditionsModule": {
"conditions": [
"Traumatic Intracranial Haemorrhage"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Older people falling from a standing height is the most common cause of hospital admission for head injury. Up to 1 in 3 patients admitted are taking a tablet medication which thins the blood, known as an oral anticoagulant. This type of medication can increase the likelihood of bleeding in the brain. Many patients are taking oral anticoagulation due to having an irregular heartbeat (called atrial fibrillation) or because of having a previous stroke or blood clots. When a scan shows blood in the brain, oral anticoagulation is nearly always stopped. However, this leaves the question of when it is safe to restart them. The risk of making the bleeding in the brain worse must be balanced against the risk of having a stroke or blood clots. There is no clear evidence on the safest time to restart oral anticoagulation, but most neurosurgeons advise restarting them 1-4 weeks after head injury. The number of people who have a bleed on their brain after a head injury is increasing and further brain bleeding or a stroke can have a serious effect on patients' lives and their on-going healthcare needs. Public and patient groups have highlighted that many patients want to stop taking oral anticoagulation after a bleed but they may be unaware of the vital importance of restarting this medication to prevent strokes and blood clots. The most popular oral anticoagulation prescribed has changed in recent years from warfarin to newer medications called Direct Oral Anti-Coagulants (DOACs).This trial will recruit 1084 people who are admitted to hospital with a bleed on the brain caused by a head injury who were taking oral anticoagulation before their head injury and have been prescribed a Direct Oral Anti-Coagulant (DOAC) for previously diagnosed medical condition. Patients on other Oral Anti-Coagulants, such as Warfarin may also be able to take part. The main purpose of the trial is to determine when is most beneficial time for people to start or restart a DOAC after their head injury. People will be asked to start the medication either 1 week or 4 weeks after their head injury. They will be then followed closely for 12 weeks and any major bleeding events or a blood clots (thrombotic events) such as a stroke or heart attack will be recorded. The study will also look at the person's overall quality of life, how they recover physically, the number of people who die, the costs of the treatment, and the attitudes of people and their caregivers to starting or restarting a DOAC."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomised Controlled Trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1084,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RESTARTtlCrH",
"briefTitle": "Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage",
"nctId": "NCT06322953",
"orgStudyIdInfo": {
"id": "RG442-21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of patients with haemorrhagic or thrombotic event within 12 weeks following tICrH."
}
],
"secondaryOutcomes": [
{
"measure": "Time to first haemorrhagic or thrombotic event."
},
{
"measure": "Time to first haemorrhagic event"
},
{
"measure": "Time to first thrombotic event"
},
{
"measure": "Time to death"
},
{
"measure": "Functional outcome measured using modified Rankin Scale (mRS)"
},
{
"measure": "Functional outcome measured using Barthel Index"
},
{
"measure": "Functional outcome measured using extended Glasgow Outcome Scale (GOS-E)"
},
{
"measure": "Overall Quality of Life measured by EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire"
},
{
"measure": "Patient/caregiver attitudes to (re)starting OAC"
},
{
"measure": "Healthcare resource use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Liverpool"
},
{
"name": "National Institute for Health Research, United Kingdom"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Walton Centre NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "250 mL serving size, 3.25% fat content"
},
{
"name": "175 g serving size, ≥2% fat content"
},
{
"name": "50 g serving size, ≥28% fat content"
}
]
},
"conditionsModule": {
"conditions": [
"PreDiabetes",
"Overweight and Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": null,
"country": "Canada",
"facility": "RI-MUHC",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H4A 3J1"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of the study is to determine the effect of dairy product matrices on insulin sensitivity in overweight and obese adults with prediabetes. Females and males (30-65 y) will be recruited from the greater Montreal area. Upon screening, those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 serving/d of regular-fat dairy products (milk, yogurt, or cheese). Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d of reduced-fat or regular-fat dairy for 12 weeks. Participants will be instructed on how to incorporate foods into their diet to prevent changes in their body weight. The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome. In addition, glycemic variables, body composition, and cardiometabolic risk factors will be assessed as secondary outcomes. Adherence to intervention will be assessed at each visit by food diaries and a record of consumed dairy products."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Three treatment groups",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Participant's study group will be coded.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Dairy Product Matrices on Insulin Resistance in People With Overweight and Obesity and Prediabetes",
"nctId": "NCT06322940",
"orgStudyIdInfo": {
"id": "2024-10463",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Change in resting energy expenditure"
},
{
"measure": "Change in total energy expenditure"
},
{
"measure": "Change in metabolic equivalent of task"
},
{
"measure": "Change in total energy intake"
}
],
"primaryOutcomes": [
{
"measure": "Change in whole-body insulin sensitivity"
}
],
"secondaryOutcomes": [
{
"measure": "Change in glucose tolerance"
},
{
"measure": "Change in Matsuda index"
},
{
"measure": "Change in Insulinogenic index"
},
{
"measure": "Change in oral disposition index"
},
{
"measure": "Change in Homeostatic Model Assessment for Insulin Resistance"
},
{
"measure": "Change in glycated hemoglobin"
},
{
"measure": "Change in total lean body mass"
},
{
"measure": "Change in total fat mass"
},
{
"measure": "Change in visceral fat mass"
},
{
"measure": "Change in systolic blood pressure"
},
{
"measure": "Change in diastolic blood pressure"
},
{
"measure": "Change in lipid profile"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Dairy Farmers of Canada"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "McGill University Health Centre/Research Institute of the McGill University Health Centre"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patient Interview"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Manchester",
"contacts": null,
"country": "United Kingdom",
"facility": "The Christie NHS Foundation Trust",
"geoPoint": {
"lat": 53.48095,
"lon": -2.23743
},
"state": "Greater Manchester",
"status": null,
"zip": "M20 4BX"
}
]
},
"descriptionModule": {
"briefSummary": "This is a qualitative (interview) study to explore the experiences of people receiving treatment for MM and to understand what matters most to them when making treatment decisions."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "iPREFER",
"briefTitle": "PatIent exPeRiences and prEFerence of trEatment foR Multiple Myeloma",
"nctId": "NCT06322927",
"orgStudyIdInfo": {
"id": "CFTsp231",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "ChristieNHS",
"id": "24_CPCR_38",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient Experience and Preference"
}
],
"secondaryOutcomes": [
{
"measure": "Treatment and Preference Differences"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "CellCentric Ltd."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The Christie NHS Foundation Trust"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Chronic Total Occlusion (CTO)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": null,
"country": "China",
"facility": "First Affiliated Hospital of Nanjing Medical University",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": null,
"zip": "210029"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. The investigators reviewed the clinical and angiographic records of 432 patients with 459 CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 493,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Novel Scoring System for Predicting the Success of PCI in Patients With CTO",
"nctId": "NCT06322914",
"orgStudyIdInfo": {
"id": "029",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PCI technical success"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital with Nanjing Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2012-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Flap"
}
]
},
"conditionsModule": {
"conditions": [
"Bone Loss",
"Flap Design"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Melikgazi",
"contacts": null,
"country": "Turkey",
"facility": "Erciyes University Faculty of Dentistry",
"geoPoint": null,
"state": "Kayseri",
"status": null,
"zip": "38039"
}
]
},
"descriptionModule": {
"briefSummary": "This study evaluated the clinical and biochemical aspects of flap design in dental implant applications regarding implantation success and patient comfort. In this split-mouth randomized controlled clinical trial, a vertical releasing incision was made at the distal end of the crestal incision on the test side, and the control side received a crestal incision alone. Sixty-eight implants were placed in 17 patients. Peri-implant groove fluid was collected on postsurgical days 3, 7, 30, and 90; OPG and RANKL levels were assessed to determine bone formation and resorption around the implants. Cortisol levels were assessed in peri-implant groove fluid at postsurgical days 3, 7, and 14. Visual analog scale (VAS), and swelling measurements were taken postoperatively. Panoramic and periapical X-rays were obtained immediately post-surgery and at 3 months. No significant marginal bone loss difference was observed between the test and control sides at 3 months. The RANKL/OPG ratio, cortisol levels, VAS scores, and swelling scores were higher in the test vs. control sides. Overall, while the use of a vertical incision has advantages, such as increasing the visual field of the surgeon and improving the ease of the operation, this approach should be used only when necessary, given the disadvantages of increased bone resorption mediators in the peri-implant tissue and reduced postoperative patient comfort."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 17,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Vertikal",
"briefTitle": "The Effect Of Vertical Releasing Incision On Implant Procedures",
"nctId": "NCT06322901",
"orgStudyIdInfo": {
"id": "TDH-2018-7883",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "OPG/RANKL"
},
{
"measure": "visual analog scale (VAS)"
},
{
"measure": "cortisol levels"
}
],
"primaryOutcomes": [
{
"measure": "Bone loss"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "TC Erciyes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2020-10-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-10-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-08-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise Training Program"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer",
"Breast Cancer Female"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Tari King, MD",
"phone": "617-632-3891",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Tari King, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Brigham and Women's Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02115"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Jennifer Ligibel, MD",
"phone": "617-632-3800",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jennifer Ligibel, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Dana Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program.The names of the study groups in this study are:* Exercise Training Group* Waitlist Control Group"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "59 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)",
"nctId": "NCT06322888",
"orgStudyIdInfo": {
"id": "23-676",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Irisin in Exercise Group"
},
{
"measure": "Change in Irisin in Control Group"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Tissue Markers in Exercise Group"
},
{
"measure": "Change in Tissue Markers in Control Group"
},
{
"measure": "Change in Biomarkers in Exercise Group - Meso scale"
},
{
"measure": "Change in Biomarkers in Exercise Group - Mass cytometry"
},
{
"measure": "Change in Biomarkers in Control Group - Meso Scale"
},
{
"measure": "Change in Biomarkers in Control Group - Mass cytometry"
},
{
"measure": "Change in Participant Weight in Exercise Group"
},
{
"measure": "Change in Participant Weight in Control Group"
},
{
"measure": "Change in Cardiorespiratory Fitness in Exercise Group"
},
{
"measure": "Change in Cardiorespiratory Fitness in Control Group"
},
{
"measure": "10-Repetition Max Test in Exercise Group"
},
{
"measure": "10-Repetition Max Test in Control Group"
},
{
"measure": "Change in Minutes of Total Exercise for Exercise Group"
},
{
"measure": "Change in Minutes of Total Exercise for Control Group"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Breast Cancer Research Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Dana-Farber Cancer Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Recombinant type III humanized collagen solution for injection"
},
{
"name": "SkinCeuticals recombinant humanized collagen (RHC) serum"
},
{
"name": "Regular face cream smear"
}
]
},
"conditionsModule": {
"conditions": [
"Facial Wrinkles"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "To evaluate the efficacy and safety of recombinant humanized collagen (type III) solution for injection combined with SkinCeuticals recombinant humanized collagen (RHC) serum Participants will be assessed by subjective questionnaire (FACE-Q Satisfaction with skin,Global Aesthetic Improvement Scale, et al) and some medical instruments (VISIA,Ultrascan UC22 et al)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 54,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "30 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Study to Evaluate the Efficacy and Satisfaction of RHC Serum Combined With RHC(III) Injection",
"nctId": "NCT06322875",
"orgStudyIdInfo": {
"id": "SKCCOL002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Changes from baseline in skin uniformity and spot area ratio measurements collected by VISIA's face image acquisition instrument."
}
],
"primaryOutcomes": [
{
"measure": "FACE-Q Satisfaction with skin"
}
],
"secondaryOutcomes": [
{
"measure": "Investigator Global Aesthetic Improvement Scale (I-GAIS) Rates"
},
{
"measure": "Subject Global Aesthetic Improvement Scale (S-GAIS) Rates"
},
{
"measure": "Improvement rate assessed by Atlas"
},
{
"measure": "Change in Cutometer® dual Analysis Score"
},
{
"measure": "Change in VISIA® Skin Analysis Score"
},
{
"measure": "FACE-Q Satisfaction with Outcome"
},
{
"measure": "FACE-Q Satisfaction with skin"
},
{
"measure": "Change of the thickness and density of subjects' facial dermis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "DeYi Aesthetic Medical Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Indocyanine green"
}
]
},
"conditionsModule": {
"conditions": [
"Bowel; Ischemic, Acute"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": [
{
"email": "[email protected]",
"name": "Sermed Ellebæk Nicolae, MD",
"phone": "+4535459666",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Michael P Achiam, MD, DMSc",
"phone": "+45 3545 0441",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Department of Organ Surgery and Transplantation",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": "Hovedstaden",
"status": "RECRUITING",
"zip": "2100"
},
{
"city": "Bispebjerg",
"contacts": [
{
"email": null,
"name": "Peter Bonde, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Department of Surgery, Bispebjerg Hospital",
"geoPoint": {
"lat": 55.71017,
"lon": 12.53147
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Herlev",
"contacts": [
{
"email": null,
"name": "Jakob Burcharth, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Department of Surgery, Herlev Hospital",
"geoPoint": {
"lat": 55.72366,
"lon": 12.43998
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Hillerød",
"contacts": [
{
"email": null,
"name": "Mai-Britt Tolstrup, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Department of Surgery, Nordsjællands Hospital",
"geoPoint": {
"lat": 55.92791,
"lon": 12.30081
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Hvidovre",
"contacts": [
{
"email": null,
"name": "Morten Laksafoss Lauritsen, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Department of Surgery, Hvidovre Hospital",
"geoPoint": {
"lat": 55.65719,
"lon": 12.47364
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, multicentre, non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green (ICG) in all-cause bowel ischemia.At intraoperative finding of bowel ischemia, the initial intraoperative plan is noted and resection margins marked with a steril pen. A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused, whether there is a change in the resection margins in centimeters, and if the intraoperative plan has changed. If resection is indicated and the strategy of choice is an anastomosis, a renewed fluorescence angiography will be performed to assess anastomotic perfusion."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery",
"nctId": "NCT06322862",
"orgStudyIdInfo": {
"id": "H-23042430",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change of strategy"
}
],
"secondaryOutcomes": [
{
"measure": "Anastomosis"
},
{
"measure": "Quantification using q-ICG"
},
{
"measure": "Stomas"
},
{
"measure": "Second-look"
},
{
"measure": "Anastomotic leaks"
},
{
"measure": "Postoperative medical complications"
},
{
"measure": "Postoperative surgical complications"
},
{
"measure": "Mortality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Rigshospitalet, Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Psychoeducation"
},
{
"name": "Testimonials and Saying is believing exercises"
},
{
"name": "Action planning"
},
{
"name": "Breathing exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Depression"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Depression is a leading cause of disability in young adults. However, access to care is limited due to structural and psychological barriers. Single-session interventions (SSIs) are structured programs designed to maximize the therapeutic output in one interaction between the patient and the provider or a program. Project ABC, a single-session intervention (SSI), has been shown to be effective in reducing depressive symptoms. Project ABC is based on four components-psychoeducation, testimonials, saying is believing exercises, and action planning. However, it is unclear what are the effects of the individual components.The primary aim of this study is to calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.The secondary aims of this study are to:1. calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on PHQ-8 scores at immediate post-treatment and 2-week follow-up.2. calculate the interaction effects, if any, among the candidate components on PHQ-8 scores at immediate post-treatment, 2-week, and 8-week follow-up.3. calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.4. determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence.Additionally, the exploratory aim of this study is to determine if common factors, like credibility of the intervention and expectations to improve, can lead to symptom change."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "Participants will be randomized to one of 8 different conditions (factorial trial), following the Multiphase optimization Strategy (MOST)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. Participants will be aware that there are other arms of the study to which other participants are randomized, but they will not be aware of what these other arms entail. Additionally, the measures will be self-administered, so there is no scope for evaluator bias.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 880,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Active Elements of Digital Single-session Interventions",
"nctId": "NCT06322849",
"orgStudyIdInfo": {
"id": "STU00220591",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Credibility/Expectancy questionnaire"
},
{
"measure": "Intervention satisfaction star rating at post-intervention"
}
],
"primaryOutcomes": [
{
"measure": "Patient Health Questionnaire-8"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Health Questionnaire-8"
},
{
"measure": "Beck Hopelessness Scale-4"
},
{
"measure": "Balanced measure of Psychological Needs scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Northwestern University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-11"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Duble current electro cardioversion"
}
]
},
"conditionsModule": {
"conditions": [
"Emergency Medical Services",
"Electric Countershock"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "'s-Hertogenbosch",
"contacts": null,
"country": "Netherlands",
"facility": "RAV Brabant MWN",
"geoPoint": {
"lat": 51.69917,
"lon": 5.30417
},
"state": "Noord Brabant",
"status": null,
"zip": "5212VM"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.The main question\\[s\\] it aims to answer are:Primary objective:In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation).Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention.Secondary objectives:Safety endpoint:Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Electra-1",
"briefTitle": "A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home",
"nctId": "NCT06322836",
"orgStudyIdInfo": {
"id": "Protocol ID ABR number 83536",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "completion of cardioversion to sinus rhythm"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of treatment-emergent adverse events (Safety endpoint a)"
},
{
"measure": "Incidence of treatment-emergent adverse events (Safety endpoint b)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Jeroen Bosch Ziekenhuis"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "RAV Brabant MWN"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "direct thawing"
},
{
"name": "Vitrification"
}
]
},
"conditionsModule": {
"conditions": [
"IVF"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": null,
"country": "Hong Kong",
"facility": "David Yiu Leung Chan",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": "000000"
}
]
},
"descriptionModule": {
"briefSummary": "There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 116,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Direct Thawing of Vitrified Human Blastocyst",
"nctId": "NCT06322823",
"orgStudyIdInfo": {
"id": "2010.432",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "blastocysts survival rate"
}
],
"secondaryOutcomes": [
{
"measure": "ferilization rate"
},
{
"measure": "pregnancy rate"
},
{
"measure": "live birth rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chinese University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Erector spinae plane block (ESPB)"
},
{
"name": "Pecto-intercostal fascial plane blok (PIFB)"
}
]
},
"conditionsModule": {
"conditions": [
"Analgesia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Taichung",
"contacts": [
{
"email": "[email protected]",
"name": "Yi-Ting Chang, MD",
"phone": "(+886)4-23592525",
"phoneExt": "4101",
"role": "CONTACT"
},
{
"email": null,
"name": "Yi-Ting Chang, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Taiwan",
"facility": "Taichung Veterans General Hospital",
"geoPoint": {
"lat": 24.1469,
"lon": 120.6839
},
"state": null,
"status": null,
"zip": "407"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions\\].The main questions it aims to answer are:* Does ESPB provide superior analgesia than PIFB* Do patients who receive ESPB have better recovery outcomes"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial",
"nctId": "NCT06322810",
"orgStudyIdInfo": {
"id": "ESP vs. PIFB",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "48hr opioid consumption"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative static pain scores-Day 1"
},
{
"measure": "Postoperative static pain scores-Day 2"
},
{
"measure": "Postoperative dynamic pain scores-Day 1"
},
{
"measure": "Postoperative dynamic pain scores-Day 2"
},
{
"measure": "postoperative incentive spirometry volume (ml)-Day 1"
},
{
"measure": "postoperative incentive spirometry volume (ml)-Day 2"
},
{
"measure": "postoperative incentive spirometry volume (ml)-Day 3"
},
{
"measure": "QoL15 (pre-op)"
},
{
"measure": "QoL15 (POD3)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Taichung Veterans General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "rTMS"
},
{
"name": "rTMS"
},
{
"name": "Sham"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seongnam",
"contacts": [
{
"email": "[email protected]",
"name": "MinYoung Kim, MD,PhD",
"phone": "82-31-780-2954",
"phoneExt": "2954",
"role": "CONTACT"
}
],
"country": "Korea, Republic of",
"facility": "Department of Rehabilitation Medicine, CHA Bundang Medical Center",
"geoPoint": {
"lat": 37.43861,
"lon": 127.13778
},
"state": null,
"status": "RECRUITING",
"zip": "13496"
}
]
},
"descriptionModule": {
"briefSummary": "A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement",
"nctId": "NCT06322797",
"orgStudyIdInfo": {
"id": "rTMSinStroke",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change of Fugl-Meyer Assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Change of Range of motion"
},
{
"measure": "Change of Berg Balance Scale"
},
{
"measure": "Change of Motor Assessment Scale"
},
{
"measure": "Change of Trunk Imbalance Scale"
},
{
"measure": "Change of Functional Ambulation Category"
},
{
"measure": "Change of Time up and go"
},
{
"measure": "Change of Manual muscle Test"
},
{
"measure": "Change of Action reach arm test"
},
{
"measure": "Change of Jebsen taylor hand function test"
},
{
"measure": "Change of Functional Independence Measure"
},
{
"measure": "Change of Modified Barthel index"
},
{
"measure": "Change of National Institutes of Health Stroke Scale"
},
{
"measure": "Change of Korean Mini Mental State Exam"
},
{
"measure": "Change of Clinical Dementia Rating"
},
{
"measure": "Change of Global Deterioration Scale"
},
{
"measure": "Change of Geriatric Depression Scale"
},
{
"measure": "Change of Brain imaging"
},
{
"measure": "Change of Electroencephalography"
},
{
"measure": "Change of Evoked Potential"
},
{
"measure": "Changes in test results of WBC(/uL), RBC(/uL), , Hct(%), PLT(/uL), Hgb(g/dL)"
},
{
"measure": "Changes in test results of CRP (mg/dL), glucose (mg/dL), BUN (mg/dL), creatinine (mg/dL), total cholesterol (mg/dL)"
},
{
"measure": "Changes in test results of AST(IU/L), ALT(IU/L)"
},
{
"measure": "Change of Motricity index"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "MinYoung Kim, MD, PhD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-07-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Oat bran (dietary fiber)"
}
]
},
"conditionsModule": {
"conditions": [
"Rheumatoid Arthritis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shenzhen",
"contacts": null,
"country": "China",
"facility": "Jingjing Li",
"geoPoint": {
"lat": 22.54554,
"lon": 114.0683
},
"state": "Guangdong",
"status": null,
"zip": "518000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test in Rheumatoid arthritis. The main question it aims to answer are:* To verify the effect of dietary fiber supplementation on reducing the level of inflammation;* To verify the effect of dietary fiber supplementation on improving disease activity and quality of life in patients with rheumatoid arthritis .To verify the effect of dietary fiber supplementation on regulating the production of anti-inflammatory short-chain fatty acid in the gut of patients with rheumatoid arthritis.The experimental group was supplemented with dietary fiber for 12 weeks, and the control group was fed with the Mediterranean diet. Before and after the intervention, 1 tube of 3ml blood and 1 soybean-sized stool were taken and a questionnaire was made"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Experimental group=1,Control Group=2,",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Researchers set blinding to reduce implementation bias",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
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"timePerspective": null
},
"enrollmentInfo": {
"count": 25,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "DF(Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With RA",
"nctId": "NCT06322784",
"orgStudyIdInfo": {
"id": "LiJingjing",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease activity score"
},
{
"measure": "Quality of life score"
}
],
"secondaryOutcomes": [
{
"measure": "Compliance of oat bran"
},
{
"measure": "Inflammatory indicators :TNF- α"
},
{
"measure": "Inflammatory indicators:IL-6"
},
{
"measure": "Inflammatory indicators :IL-10"
},
{
"measure": "Inflammatory indicators: ESR"
},
{
"measure": "Inflammatory indicators :CRP"
},
{
"measure": "gut flora"
},
{
"measure": "Adjustment of anti rheumatic drugs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shenzhen People's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questionnaire"
},
{
"name": "Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Pregnancy Related"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Yoann Athiel, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Port-Royal Maternity",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "IDF",
"status": "RECRUITING",
"zip": "75014"
}
]
},
"descriptionModule": {
"briefSummary": "The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 830,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RANSPRE-refus",
"briefTitle": "Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal",
"nctId": "NCT06322771",
"orgStudyIdInfo": {
"id": "APHP240376",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Factors associated with women's refusal"
}
],
"secondaryOutcomes": [
{
"measure": "Number of acceptations"
},
{
"measure": "Number of refusals"
},
{
"measure": "Demographic characteristics"
},
{
"measure": "Questionnaire \"acceptance\""
},
{
"measure": "Questionnaire \"refusal\""
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tidal volume customization in the acute respiratory distress syndrome"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Respiratory Distress Syndrome ARDS"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Acute respiratory distress syndrome (ARDS) is associated with high mortality, some of which can be attributed to ventilator-induced lung injury (VILI) when artificial ventilation is not customized to the severity of lung injury. As ARDS is characterized by a decrease in aerated lung volume, reducing tidal volume (VT) from 12 to 6 mL/kg of predicted body weight (PBW) was shown to improve survival more than 20 years ago. Since then, the VT has been normalized to the PBW, meaning to the theoretical lung size (before the disease), rather than tailored to the severity of lung injury, i.e., to the size of aerated lung volume. During ARDS, the aerated lung volume is correlated to the respiratory system compliance (Crs). The driving pressure (ΔP), defined as the difference between the plateau pressure and the positive end expiratory pressure, represents the ratio between the VT and the Crs. Therefore, the ΔP normalizes the VT to a surrogate of the aerated lung available for ventilation of the diseased lung, rather than to the theoretical lung size of the healthy lung, and thus represents more accurately the actual strain applied to the lungs. In a post hoc analysis of 9 randomized controlled trials, Amato et al. found that higher ΔP was a better predictor of mortality than higher VT, with an increased risk of death when the ΔP \\> 14 cm H2O. These findings have been confirmed in subsequent meta-analysis and large-scale observational data. In a prospective study including 50 patients, the investigators showed that a ΔPguided ventilation strategy targeting a ΔP between 12 and 14 cm H2O significantly reduced the mechanical power, a surrogate for the risk of VILI, compared to a conventional PBW-guided ventilation. In the present study, the investigators hypothesize that the physiological individualization of ventilation (ΔP-guided VT) may improve the outcome of patients with ARDS compared to traditional anthropometrical adjustment (PBW-guided VT)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "comparing ΔP-guided VT to traditional PBW-guided VT during mechanical ventilation of patients with ARDS.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 750,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DRIVENT",
"briefTitle": "Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome",
"nctId": "NCT06322758",
"orgStudyIdInfo": {
"id": "APHP230851",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mortality"
},
{
"measure": "Number of days free from mechanical ventilation"
}
],
"secondaryOutcomes": [
{
"measure": "Ventilator parameters"
},
{
"measure": "Arterial blood gases"
},
{
"measure": "Mortality"
},
{
"measure": "Number of days alive without ventilation"
},
{
"measure": "Sequential Organ Failure Assessment score (SOFA)"
},
{
"measure": "Number of days alive without catecholamine"
},
{
"measure": "Number of days alive without continuous sedation"
},
{
"measure": "Number of days alive without neuromuscular blockers"
},
{
"measure": "Number of prone position sessions"
},
{
"measure": "Use of rescue procedures: inhaled nitric oxide, almitrine, ECMO, ECCO2R"
},
{
"measure": "Occurrence of ventilator-associated pneumothorax"
},
{
"measure": "Time to pressure support ventilation;"
},
{
"measure": "Duration of weaning unreadiness"
},
{
"measure": "Duration of weaning"
},
{
"measure": "The rate of tracheostomy"
},
{
"measure": "Total duration of mechanical ventilation"
},
{
"measure": "Length of stay"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy"
},
{
"name": "Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Renal Tumor",
"Renal Malignant Tumor"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Malakah Mohammed, Secretary",
"phone": "+20225107222",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Urology Department, Al-Azhar University Hospitals",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": "11511"
}
]
},
"descriptionModule": {
"briefSummary": "To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A randomized prospective comparative study. Two-arm parallel assignment:First Arm: involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.Second Arm: involves cases of laparoscopic partial nephrectomy using thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"ADULT",
"OLDER_ADULT"
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},
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"id": "1986",
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"type": null
},
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},
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{
"measure": "Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping)."
},
{
"measure": "Suture time and operative time in minutes"
},
{
"measure": "Intraoperative number of sutures for renorraphy"
},
{
"measure": "Intraoperative Blood loss"
},
{
"measure": "Blood transfusion rate"
},
{
"measure": "Renal function: serum creatinine"
},
{
"measure": "Renal function: estimated GFR (eGFR)"
},
{
"measure": "Transforming growth factor beta (TGF-β) urine level"
},
{
"measure": "Monocyte chemoattractant protein (MCP-1) urine level"
}
],
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"measure": "Hospital stay"
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"measure": "Post operative pain"
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},
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}
} | false | null |
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{
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{
"measure": "Outcome"
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{
"measure": "Characteristics of suboptimal care"
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{
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{
"measure": "Ad-hoc survey"
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},
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"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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{
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]
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"Intubation",
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"Videolaryngoscopy",
"Intubation Complication"
]
},
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{
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},
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{
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],
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],
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],
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],
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],
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},
"descriptionModule": {
"briefSummary": "Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the \"Macintosh\" blade with a slight curvature, and hyperangulated blades. The \"Macintosh\" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients."
},
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"whoMasked": [
"PARTICIPANT"
]
},
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"primaryPurpose": "SUPPORTIVE_CARE",
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},
"enrollmentInfo": {
"count": 1036,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "INVIBLADE",
"briefTitle": "Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU",
"nctId": "NCT06322719",
"orgStudyIdInfo": {
"id": "INVIBLADE",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Difference in the first attempt intubation success rate (percentage)"
}
],
"secondaryOutcomes": [
{
"measure": "Difference in the overall success rate"
},
{
"measure": "Number of intubation attempts"
},
{
"measure": "Modified Cormack-Lehane grade of glottic view"
},
{
"measure": "Diference in the incidence of \"easy intubation\""
},
{
"measure": "Duration of tracheal intubation"
},
{
"measure": "Reason for unsuccessful intubation on the first attempt"
},
{
"measure": "Number of videolaryngoscopy attempts"
},
{
"measure": "Number of attempts to cannulate the trachea with a bougie or an endotracheal tube"
},
{
"measure": "Operator-assessed difficulty of intubation"
},
{
"measure": "Need for additional airway equipment"
},
{
"measure": "Need to change the device for intubation"
},
{
"measure": "Complications of tracheal intubation"
}
]
},
"sponsorCollaboratorsModule": {
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"leadSponsor": {
"class": "OTHER",
"name": "Hospital Clinico Universitario de Santiago"
}
},
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"completionDateStruct": {
"date": "2024-05-30"
},
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"date": "2024-03-21"
},
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"date": "2024-05-01"
},
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"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ABSK021"
},
{
"name": "Omeprazole"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy Subjects"
]
},
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},
"descriptionModule": {
"briefSummary": "Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to evaluate the effect of multiple oral doses of Omeprazole Enteric-coated Tablets on the PK profile of ABSK021 Capsules in healthy subjects"
},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021",
"nctId": "NCT06322706",
"orgStudyIdInfo": {
"id": "ABSK021-105",
"link": null,
"type": null
},
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"briefSummary": "This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy."
},
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
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"acronym": null,
"briefTitle": "A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)",
"nctId": "NCT06322693",
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"id": "213348",
"link": null,
"type": null
},
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"domain": null,
"id": "2023-507564-39",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs)"
},
{
"measure": "Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs)"
},
{
"measure": "Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs)"
},
{
"measure": "Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs)"
},
{
"measure": "Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications"
},
{
"measure": "Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1"
}
],
"secondaryOutcomes": [
{
"measure": "Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1"
},
{
"measure": "Part 2 (A, B, C, D) : ORR by Immune related RECIST (irRECIST)"
},
{
"measure": "Part 2: Duration of response (DOR) by RECIST v 1.1"
},
{
"measure": "Part 2 (A, B, C, D) : DOR by irRECIST"
},
{
"measure": "Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1"
},
{
"measure": "Part 2 (A, B, C, D) : DCR by irRECIST"
},
{
"measure": "Part 2: Progression-free survival (PFS) by RECIST v 1.1"
},
{
"measure": "Part 2 (A, B, C, D) : PFS by irRECIST"
},
{
"measure": "Parts 1 and 2 (A, B, C, D, E, F) : Serum concentration of TSR-022"
},
{
"measure": "Part 1d: Serum concentration of TSR-033"
},
{
"measure": "Part 1 (c, d, e, f, g ,h): Serum concentration of TSR-042"
},
{
"measure": "Part 2 (A, B, C, D, F): Serum concentration of TSR-042"
},
{
"measure": "Part 2: Overall survival (OS)"
},
{
"measure": "Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy"
},
{
"measure": "Part 1b: Cmin of TSR-022 in combination with nivolumab"
},
{
"measure": "Part 1c: Cmin of TSR-022 in combination with TSR-042"
},
{
"measure": "Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033"
},
{
"measure": "Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy"
},
{
"measure": "Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab"
},
{
"measure": "Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042"
},
{
"measure": "Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033"
},
{
"measure": "Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy"
},
{
"measure": "Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab"
},
{
"measure": "Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042"
},
{
"measure": "Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033"
},
{
"measure": "Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy"
},
{
"measure": "Part 1b: t1/2 of TSR-022 and in combination with nivolumab"
},
{
"measure": "Part 1c: t1/2 of TSR-022 in combination with TSR-042"
},
{
"measure": "Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033"
},
{
"measure": "Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy"
},
{
"measure": "Part 1b: AUCtau of TSR-022 and in combination with nivolumab"
},
{
"measure": "Part 1c: AUCtau of TSR-022 in combination with TSR-042"
},
{
"measure": "Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033"
},
{
"measure": "Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022"
},
{
"measure": "Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022"
},
{
"measure": "Part 1 (c, d, e, f, g ,h): Number of participants with ADA to TSR-042"
},
{
"measure": "Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042"
},
{
"measure": "Part 1d: Number of participants with ADA to TSR-033"
},
{
"measure": "Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to death"
},
{
"measure": "Part 2F: Percent change from Baseline in Alpha-fetoprotein (AFP)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "GlaxoSmithKline"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-07-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Main pancreatic duct and biliary duct external drainage"
},
{
"name": "Main pancreatic duct and biliary duct internal drainage"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreaticoduodenectomy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": null,
"country": "China",
"facility": "Zhongshan Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200000"
}
]
},
"descriptionModule": {
"briefSummary": "Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage.To date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients.Thus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective, Multicenter, Controlled, Superiority Trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 322,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy",
"nctId": "NCT06322680",
"orgStudyIdInfo": {
"id": "ZSPAC-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery"
}
],
"secondaryOutcomes": [
{
"measure": "Surgical Complications: Incidence and grading of complications within 90 days after surgery"
},
{
"measure": "Surgical Complications: Clavien-Dindo classification"
},
{
"measure": "Surgical Complications: Mortality rate"
},
{
"measure": "Surgical Complications: reoperation rate"
},
{
"measure": "Surgical Complications: readmission rate"
},
{
"measure": "Surgical Complications: rate of digital subtraction angiography for postoperative pancreatic hemorrhage"
},
{
"measure": "Surgical Complications: Total cost of perioperative treatment"
},
{
"measure": "Surgical Complications: Length of hospital stay"
},
{
"measure": "Adjuvant treatment: Proportion of patients with delayed adjuvant treatment (≥12 weeks) due to complications such as pancreatic fistula after surgery"
},
{
"measure": "Adjuvant treatment: Interval between the start of adjuvant treatment and surgery"
},
{
"measure": "Long-term survival related to malignant tumors: Overall survival (OS)"
},
{
"measure": "Long-term survival related to malignant tumors: Disease-free survival (DFS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Huadong Hospital"
},
{
"name": "RenJi Hospital"
},
{
"name": "The First People's Hospital of Yunnan"
},
{
"name": "First Affiliated Hospital Xi'an Jiaotong University"
},
{
"name": "The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Zhongshan Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Alzheimer's Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hiroshima",
"contacts": null,
"country": "Japan",
"facility": "Eisai trial site 2",
"geoPoint": {
"lat": 34.4,
"lon": 132.45
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Kyoto",
"contacts": null,
"country": "Japan",
"facility": "Eisai trial site 3",
"geoPoint": {
"lat": 35.02107,
"lon": 135.75385
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Tokyo",
"contacts": null,
"country": "Japan",
"facility": "Eisai trial site 1",
"geoPoint": {
"lat": 35.6895,
"lon": 139.69171
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 5000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab",
"nctId": "NCT06322667",
"orgStudyIdInfo": {
"id": "BAN2401-J081-401",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H)"
},
{
"measure": "Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants With Infusion Related Reaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Eisai Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-22"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Robotically Assisted Locomotion"
},
{
"name": "Robotically Assisted Verticalization"
}
]
},
"conditionsModule": {
"conditions": [
"SMA"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Poznań",
"contacts": [
{
"email": "[email protected]",
"name": "Marek Jóźwiak",
"phone": "696052475",
"phoneExt": "+48",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Radosław Rutkowski",
"phone": "696052475",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "Wiktor Dega University Orthopedic and Rehabilitation Hospital",
"geoPoint": {
"lat": 52.40692,
"lon": 16.92993
},
"state": null,
"status": "RECRUITING",
"zip": "61-545"
}
]
},
"descriptionModule": {
"briefSummary": "A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion.The objective of research:The main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models.1. Research period: 4 years2. Patients age: 0-21 y.o.3. Group size: 200 patients (100 patients in each group)4. Assignment of patients to study groups in a randomised manner"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "There are two research groups with 100 patients in each group.1. Experimental: Robotically Assisted Locomotion2. Comparison: Robotically Assisted Verticalization",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Patients and their parents will not be blinded by the nature of the therapeutic procedure used after random allocation to the treatment group. Study personnel will be divided into Blinded Team and Unblinded Team to ensure objectivity of the assessment of safety and effectiveness of both strategies.",
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "21 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "SMArt",
"briefTitle": "A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients",
"nctId": "NCT06322654",
"orgStudyIdInfo": {
"id": "2023/ABM/01/00004/P/02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale"
},
{
"measure": "Clinical assessment of patients using Balance test minimum 1 min., Self-walk test of at least 2 meters, 6-minute gait test, Up&Go test, 10 meters gait test, hip range of motion and muscle strength evaluation."
},
{
"measure": "Functional assessment of patients using GMFM (Gross Motor Function Measure) scale"
},
{
"measure": "X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density"
},
{
"measure": "Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0"
}
],
"secondaryOutcomes": [
{
"measure": "Hospitalization during or between rehabilitations that take place each 6 months"
},
{
"measure": "Occurence of discomfort during therapy requiring abrupt interruption or significant modification"
},
{
"measure": "Number of fractures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Wiktor Dega University Orthopedic and Rehabilitation Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "No treatment given"
}
]
},
"conditionsModule": {
"conditions": [
"Atherosclerotic Cardiovascular Disease (ASCVD)",
"Chronic Kidney Disease (CKD)",
"Systemic Inflammation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": null,
"country": "United States",
"facility": "KJT Group, Inc.",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York",
"status": null,
"zip": "14623"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD)"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 336,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Nephrologists",
"nctId": "NCT06322641",
"orgStudyIdInfo": {
"id": "DAS-8092",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "World Health Organization (WHO)",
"id": "U1111-1303-3089",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Nephrologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novo Nordisk A/S"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-04-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VSA006"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Nash"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Human genetic studies have shown that loss of function (LOF) mutations in HSD17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as NASH, without significant adverse phenotypes.VSA006 is a siRNA drug targeting HSD17β13 mRNA in the liver and reduce the protein level of HSD17β13. Based on phase 1 study results in healthy volunteers and NASH/suspected NASH patients, this phase 2 study is designed to evaluate the efficacy, safety, PK profiles and immunogenicity of VSA006 in Chinese NASH patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 45,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients",
"nctId": "NCT06322628",
"orgStudyIdInfo": {
"id": "VSA006-2001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH"
},
{
"measure": "Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis"
}
],
"secondaryOutcomes": [
{
"measure": "Compared with placebo, the percentage change in serum alanine aminotransferase (ALT)"
},
{
"measure": "Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline"
},
{
"measure": "Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline"
},
{
"measure": "Compared with placebo, the change and percentage change in noninvasive markers of fibrosis from baseline: FIB-4, NAFLD fibrosis score, and AST/PLT ratio index (APRI)"
},
{
"measure": "Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis"
},
{
"measure": "Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006"
},
{
"measure": "Maximum observed concentration (Cmax) of VSA006"
},
{
"measure": "Time of maximum concentration of VSA006 (Tmax)"
},
{
"measure": "Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006"
},
{
"measure": "anti-drug antibodies (ADAs) of VSA006"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Visirna Therapeutics HK Limited"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acupressure Therapy"
},
{
"name": "Educational Intervention"
},
{
"name": "Electronic Health Record Review"
},
{
"name": "Questionnaire Administration"
}
]
},
"conditionsModule": {
"conditions": [
"Hematopoietic and Lymphatic System Neoplasm",
"Malignant Solid Neoplasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Laura S. Rhee, D.O.",
"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": "RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial evaluates whether acupressure is helpful to reduce anxiety related to chemotherapy. Anxiety is experienced by many patients with cancer. Anxiety can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicinal ways to manage symptoms. Acupressure is a noninvasive intervention that can be used for many different symptoms. Acupressure is well tolerated with minimal reports of adverse reactions, making it a good choice for patients with cancer. This study may help researchers learn whether acupressure is useful for managing anxiety in patients undergoing chemotherapy."
},
"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": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Acupressure for Reducing Anxiety in Patients Undergoing Chemotherapy",
"nctId": "NCT06322615",
"orgStudyIdInfo": {
"id": "MC221001",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-00538",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic Institutional Review Board",
"id": "23-004067",
"link": null,
"type": "OTHER"
},
{
"domain": "Mayo Clinic in Rochester",
"id": "MC221001",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of patients approached about undergoing acupressure intervention (Feasibility)"
},
{
"measure": "Number of patients interested in the initial acupressure intervention in the chemotherapy unit (Feasibility)"
},
{
"measure": "Number of patients interested in the home acupressure intervention (Feasibility)"
},
{
"measure": "Time taken for each nurse-led acupressure intervention in the chemotherapy unit (Feasibility)"
},
{
"measure": "Patient-reported changes in acute anxiety"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intracranial Catheter Placement"
},
{
"name": "Lumbar Puncture"
},
{
"name": "Biopsy"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Computed Tomography"
}
]
},
"conditionsModule": {
"conditions": [
"Brain Neoplasms"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rochester",
"contacts": [
{
"email": "[email protected]",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Terry C. Burns, M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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]
},
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"briefTitle": "Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors",
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},
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}
]
},
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"primaryOutcomes": [
{
"measure": "Feasibility of Ommaya reservoir placement"
}
],
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{
"measure": "Utility of Ommaya reservoir"
}
]
},
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},
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},
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"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
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}
}
} | false | null |
{
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"interventions": [
{
"name": "SOD like Super Drink"
},
{
"name": "placebo drink"
}
]
},
"conditionsModule": {
"conditions": [
"Dermatology"
]
},
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"locations": [
{
"city": "Taichung City",
"contacts": [
{
"email": "[email protected]",
"name": "Hsiu-Mei Chiang, Ph.D.",
"phone": "+886-04-22053366",
"phoneExt": "5302",
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},
{
"email": "[email protected]",
"name": "Ping Lin",
"phone": "+886-02-879778111",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Taiwan",
"facility": "China Medical University of department of cosmeceutics",
"geoPoint": {
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"lon": 120.6839
},
"state": null,
"status": "RECRUITING",
"zip": "406040"
}
]
},
"descriptionModule": {
"briefSummary": "To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human"
},
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],
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},
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]
},
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"briefTitle": "Evaluation of Human Efficacy of SOD Like Super Drink",
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"link": null,
"type": null
},
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},
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"otherOutcomes": [
{
"measure": "The change of liver function biomarkers (AST, ALT) of blood"
},
{
"measure": "The change of renal function biomarkers (creatinine, BUN) of blood"
},
{
"measure": "The change of self-assessment skin condition and immuno condition"
}
],
"primaryOutcomes": [
{
"measure": "the volume of skin wrinkles"
},
{
"measure": "the roughness of skin texture"
},
{
"measure": "the change of skin elasticity"
},
{
"measure": "the change of Total Anti-oxidative Capacity (TAC) of blood"
},
{
"measure": "the change of Superoxide Dismutase (SOD) of blood"
},
{
"measure": "the change of Glutathione S-transferase (GST) of blood"
},
{
"measure": "the change of Glutathione (GSH) of blood"
},
{
"measure": "the change of Malondialdehyde (MDA) of blood"
},
{
"measure": "the change of immune-related cytokines of blood"
}
],
"secondaryOutcomes": [
{
"measure": "the change of skin surface hydration"
},
{
"measure": "the change of skin Transepidermal Water Loss (TEWL)"
},
{
"measure": "the change of Skin Melanin Index"
},
{
"measure": "the change of Skin Erythema Index"
}
]
},
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}
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"date": "2024-12-31"
},
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"date": "2024-10-31"
},
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"date": "2024-03-01"
},
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"date": "2024-03-21"
}
}
} | false | null |
{
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"interventions": [
{
"name": "177Lu-PNT2002"
}
]
},
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"conditions": [
"Adenoid Cystic Carcinoma"
]
},
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"locations": [
{
"city": "Baltimore",
"contacts": null,
"country": "United States",
"facility": "Johns Hopkins Hospital",
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},
"state": "Maryland",
"status": null,
"zip": "21287"
}
]
},
"descriptionModule": {
"briefSummary": "This is a single arm trial with one Cohort for people with recurrent or metastatic adenoid cystic carcinoma that cannot be treated with surgery. 10 participants will be enrolled in Cohort 1 at Johns Hopkins and will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single tracer dose). A feasibility analysis of dosimetry will be performed after meeting the accrual goal of Cohort 1 to determine if the study will proceed into Cohort 2.If Cohort 2 proceeds, based on the dosimetry analysis, the major requirements of the study are to undergo treatment with 177Lu-PNT2002, have bloodwork, physical exams, and imaging done at study-specific time points, and to answer questionnaires. Patients will be in the study for about two years after enrolling."
},
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"interventionModelDescription": "Cohort 1of this study involves only Dosimetry for (10 patients).(Cohort 2 may be added based on dosimetry analysis of Cohort 1. Planned Treatment for would be for 20 patients, single arm).",
"maskingInfo": {
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},
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]
},
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"id": "IRB00347750",
"link": null,
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},
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},
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{
"measure": "Absorbed dose in tumor and normal organs"
},
{
"measure": "Objective response rate (ORR) by RECIST 1.1 measured in patients treated with 177Lu-PSMA for recurrent and metastatic ACC."
}
],
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{
"measure": "Stability of Disease: Proportion of patients with Stable Disease"
},
{
"measure": "Progression Free Survival"
},
{
"measure": "Overall Survival"
},
{
"measure": "Duration of Response"
},
{
"measure": "Xerostomia questionnaire (XQ) score"
},
{
"measure": "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43)"
}
]
},
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"name": "Adenoid Cystic Carcinoma Research Foundation"
},
{
"name": "Progenics Pharmaceuticals, Inc."
}
],
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"name": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins"
}
},
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"date": "2035-12"
},
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"date": "2024-03-22"
},
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"date": "2030-12"
},
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"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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"interventions": [
{
"name": "LTC004+regorafenib"
}
]
},
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"conditions": [
"Advanced/Metastatic Colorectal Cancer"
]
},
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{
"city": "Tianjin",
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"facility": "Tianjin Medical University Cancer Institute and Hospital",
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}
]
},
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},
"designModule": {
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},
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},
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"eligibilityModule": {
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},
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"id": "LTC004-202",
"link": null,
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},
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},
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"measure": "Treatment-Emergent Adverse Events-Safety and Tolerability"
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{
"measure": "SAE-Safety and Tolerability"
}
],
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"measure": "ORR"
},
{
"measure": "DCR"
},
{
"measure": "PFS"
},
{
"measure": "OS"
}
]
},
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}
},
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},
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},
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},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "cover story"
}
]
},
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]
},
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"locations": [
{
"city": "Hamburg",
"contacts": null,
"country": "Germany",
"facility": "UKE",
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},
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}
]
},
"descriptionModule": {
"briefSummary": "This study was preregistered 2019 under https://osf.io/nczhj. Since JAMA requires a registration with ClinicalTrials.gov, we post-register the study here with the identical informations from OSF (see there)Migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual processing. Clinical symptoms and underlying brain mechanisms during self-motion visual stimulation were not yet investigated in this population. Therefore the aim is to investigate the behavioral responses from a visually simulated roller coaster ride of patients with migraine and headache-free controls. In order to verify the effect of response bias, part of the patients with migraine will be informed that the study aims to investigate vestibular disorders instead of headache disorders and that they are invited as healthy controls."
},
"designModule": {
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},
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},
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"count": 366,
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},
"phases": [
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],
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},
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"id": "beingapatient",
"link": null,
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},
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},
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"primaryOutcomes": [
{
"measure": "self-reported vestibular symptoms"
}
],
"secondaryOutcomes": [
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"measure": "differences in motion sickness susceptibility using a standardized motion sickness questionnaire"
},
{
"measure": "differences in disability level using a standardized motion sickness questionnaire"
},
{
"measure": "differences in headache days per month"
},
{
"measure": "differences in headache burden and migraine disability questionnaires"
}
]
},
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}
},
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"date": "2023-02-01"
},
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"date": "2023-02-01"
},
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"startDateStruct": {
"date": "2019-10-29"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
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},
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"conditions": [
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"Albumin"
]
},
"contactsLocationsModule": {
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{
"city": "New Westminster",
"contacts": [
{
"email": null,
"name": "Michael Law, MD FRCPC",
"phone": null,
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"role": "CONTACT"
},
{
"email": null,
"name": "Ramanjot Kaur, MSc",
"phone": null,
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"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Royal Columbian Hospital",
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},
"state": "British Columbia",
"status": null,
"zip": "V3L 3W7"
},
{
"city": "Vancouver,",
"contacts": [
{
"email": null,
"name": "Darren Mullane, MB BCh BAO FRCPC FCAI FJFICM",
"phone": null,
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"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Vancouver General Hospital",
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},
"state": "British Columbia",
"status": null,
"zip": "V5Z 1M9"
},
{
"city": "Halifax",
"contacts": [
{
"email": null,
"name": "Pieter de Jager",
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}
],
"country": "Canada",
"facility": "Nova Scotia Health Authority",
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},
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"status": null,
"zip": "B3H 3A6"
},
{
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"email": null,
"name": "Michelle Zeller, MD FRCPC",
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}
],
"country": "Canada",
"facility": "McMaster University Medical Centre",
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},
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},
{
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"email": null,
"name": "Jeannie Callum, MD BA FRCPC",
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}
],
"country": "Canada",
"facility": "Kingston Health Sciences Centre",
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"lat": 44.22976,
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},
"state": "Ontario",
"status": null,
"zip": "K7L 3N6"
},
{
"city": "London",
"contacts": [
{
"email": null,
"name": "Christopher Harle, MD",
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"role": "CONTACT"
},
{
"email": null,
"name": "Ziad Solh, MD MSc FRCPC",
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}
],
"country": "Canada",
"facility": "London Health Science Centre",
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"lat": 42.98339,
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},
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"zip": "N6A 5A5"
},
{
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"contacts": [
{
"email": null,
"name": "Diem Tran",
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},
{
"email": null,
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}
],
"country": "Canada",
"facility": "University of Ottawa Heart Institute",
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},
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"status": null,
"zip": "K1Y 4W7"
},
{
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}
],
"country": "Canada",
"facility": "Sunnybrook Health Sciences Centre",
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},
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"zip": "M4N 3M5"
},
{
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"email": null,
"name": "Katerina Pavenski, MD",
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}
],
"country": "Canada",
"facility": "St. Michael's Hospital",
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},
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"zip": "M5B 1W8"
},
{
"city": "Toronto",
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"facility": "Toronto General Hospital - University Health Network",
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},
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"zip": "M5G 2C4"
}
]
},
"descriptionModule": {
"briefSummary": "All heart surgery patients universally require hydration, which is given through a vein in the arm, but practices for treating patients are not universal. There are disagreements about whether crystalloids should be used alone or in combination with albumin. This question has important implications because albumin is an expensive blood product in relatively limited supply, and 20% of its use is by heart surgery patients. The goal of this study is to learn more about how crystalloids and albumin are used during heart surgery, as well as, key patient outcomes."
},
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},
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},
"eligibilityModule": {
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"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "AlbACS-1R",
"briefTitle": "Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective",
"nctId": "NCT06322537",
"orgStudyIdInfo": {
"id": "23-5339",
"link": null,
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},
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},
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"primaryOutcomes": [
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"measure": "Albumin"
},
{
"measure": "Crystalloid, volume dose and type administered"
}
],
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},
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"collaborators": [
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"name": "Queen's University"
},
{
"name": "Unity Health Toronto"
},
{
"name": "McMaster University"
},
{
"name": "Sunnybrook Health Sciences Centre"
},
{
"name": "London Health Sciences Centre"
},
{
"name": "The Ottawa Hospital"
},
{
"name": "Vancouver General Hospital"
},
{
"name": "Royal Columbian Hospital"
},
{
"name": "Nova Scotia Health Authority"
}
],
"leadSponsor": {
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"name": "University Health Network, Toronto"
}
},
"statusModule": {
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"date": "2025-11-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
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"date": "2025-11-01"
},
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"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gamma sensory flicker"
}
]
},
"conditionsModule": {
"conditions": [
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"Sleep Duration",
"Sleep Onset Latency"
]
},
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"locations": [
{
"city": "Taiyuan",
"contacts": null,
"country": "China",
"facility": "Yong Xu",
"geoPoint": {
"lat": 37.86944,
"lon": 112.56028
},
"state": "Shanxi",
"status": null,
"zip": "030000"
}
]
},
"descriptionModule": {
"briefSummary": "This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 37,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study on Gamma Sensory Flicker for Insomnia",
"nctId": "NCT06322524",
"orgStudyIdInfo": {
"id": "FirstShanxiMU_jsk",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment adherence rate"
},
{
"measure": "Patient treatment adherence rate"
},
{
"measure": "Incidence rate of adverse reaction"
},
{
"measure": "Differences in sleep duration between the first and eighth weeks"
},
{
"measure": "Differences in sleep onset latencies between the first and eighth weeks"
},
{
"measure": "Differences in awakening times between the first and eighth weeks"
}
],
"secondaryOutcomes": [
{
"measure": "pre-sleep efficiency."
},
{
"measure": "post-sleep efficiency."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Shanxi Medical University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The First Affiliated Hospital of Shanxi Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dialogical Family Guidance (DFG)"
}
]
},
"conditionsModule": {
"conditions": [
"Family Dynamics",
"Family Relations",
"Family Support"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Helsinki",
"contacts": null,
"country": "Finland",
"facility": "Helsinki university hospital",
"geoPoint": {
"lat": 60.16952,
"lon": 24.93545
},
"state": null,
"status": "RECRUITING",
"zip": "00029"
}
]
},
"descriptionModule": {
"briefSummary": "This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Participants (families) experienced that they got information, guidance to ordinary life and that the DFG-therapists were listening to them and above all, helping with individual problems and questions. DFG include six meetings and professionals need to attend on a 3-day long education before using this intervention."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Families attending the study Group I: receives Dialogical Family Guidance intervention and they fill questionnaires before and after the intervention.Group II: Families do not receive Dialogical Family Guidance (but belong to the same focus group)",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Families include both parents and children. Parents fill the questionnaires, but all family members attend on the meetings during the intervention (six meetings).",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "13 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "DFG II",
"briefTitle": "Dialogical Family Guidance PostDoc Study",
"nctId": "NCT06322511",
"orgStudyIdInfo": {
"id": "HUS/7626/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "FAFHES"
}
],
"secondaryOutcomes": [
{
"measure": "DFG-questionnaire"
},
{
"measure": "SDQ-p questionnaire (Strengths and difficulties regarding the child)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tampere University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Uterine lavage"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility Due to Nonimplantation",
"Infertility Secondary",
"Cesarean Section Complications"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jerusalem",
"contacts": [
{
"email": "[email protected]",
"name": "Hadas Lemberg, PhD",
"phone": "00 972 2 6777572",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Chana Adler Lazarovits, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Israel",
"facility": "Hadassah Medical Organization",
"geoPoint": {
"lat": 31.76904,
"lon": 35.21633
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section. Eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche. After fixation of the transcervical catheter, we will flush 2 ml sterile NaCl 0.9% into the uterine cavity and aspirate the fluid. After collecting all samples, the samples will be snap frozen and stored at -80o C, until they undergo an immunological analysis."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity",
"nctId": "NCT06322498",
"orgStudyIdInfo": {
"id": "INFLAM.UTERUS-HMO-CTIL",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Inflammatory cell population"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hadassah Medical Organization"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Internet-based self-management intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Fibromyalgia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Leiden",
"contacts": null,
"country": "Netherlands",
"facility": "Fibrocentrum",
"geoPoint": {
"lat": 52.15833,
"lon": 4.49306
},
"state": "Zuid-Holland",
"status": null,
"zip": "2321 GL"
}
]
},
"descriptionModule": {
"briefSummary": "This study has been previously registered with the National Trial Registry (NTR6267) that has been cancelled. The registered trial has been automatically transferred to a new \"Landelijk Trial Register\", which does not contain all correct information on the current study and where no corrections can be made. Hence, the current study has been registered again with ClinicalTrials.gov.The goal of this clinical trial is to study the effectiveness of an internet-based self-management intervention in adult patients with fibromyalgia. A randomized controlled trial (RCT) will be performed, in which 70 participants will be randomized to either the self-management intervention or a waitlist control condition (patients in the waitlist condition will receive the intervention after the intervention ends in the intervention group, i.e., after 6 months). The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention and the quality of the therapeutic relationship will be measured."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "Blinding of participants and practitioners is not possible due to the nature of the study. However, the statistician who creates the randomization schedule and performs statistical analyses is blinded to group allocation.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Online Self-management in Fibromyalgia",
"nctId": "NCT06322485",
"orgStudyIdInfo": {
"id": "P16.230",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Economic evaluation: Five-Level Version of the EQ-5D (EQ-5D-5L)"
},
{
"measure": "Economic evaluation: iMTA Medical Consumption Questionnaire (iMCQ)"
},
{
"measure": "Economic evaluation: iMTA Productivity Cost Questionnaire (iPCQ)"
},
{
"measure": "Patient satisfaction"
},
{
"measure": "Expected/perceived patient-provider interaction"
}
],
"primaryOutcomes": [
{
"measure": "Change in pain coping"
}
],
"secondaryOutcomes": [
{
"measure": "Change in well-being"
},
{
"measure": "Change in illness cognitions"
},
{
"measure": "Change in pain coping strategies"
},
{
"measure": "Change in Illness Perceptions"
},
{
"measure": "Change in pain"
},
{
"measure": "Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress"
},
{
"measure": "Change in health-related quality of life"
},
{
"measure": "Change in fibromyalgia impact"
},
{
"measure": "Change in health-related quality of life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Fibrocentrum"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Leiden University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-01-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-01-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-01-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2022-07-25",
"filename": "SAP_000.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 109827,
"typeAbbrev": "SAP",
"uploadDate": "2023-11-27T05:27"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The Turkish Early Language Development Test (TEDIL)"
},
{
"name": "The Family Literacy Scale"
},
{
"name": "The Early Childhood Phonological Sensitivity Scale (PASECP)"
},
{
"name": "The Early Literacy Home Environment Scale (ELHES)"
},
{
"name": "Demographic Questionaries"
}
]
},
"conditionsModule": {
"conditions": [
"Cochlear Implants",
"Child Language",
"Literacy",
"Phonological (Speech) Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": null,
"country": "Turkey",
"facility": "Uskudar University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim was to examine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Descriptive research",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 46,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Relationship Between Phonological Awareness Skills And Home Environment Literacy in Cochlear Implant Users",
"nctId": "NCT06322472",
"orgStudyIdInfo": {
"id": "138956",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The data the Early Childhood Phonological Sensitivity Scale (PASECP) from children with cochlear implants"
},
{
"measure": "The data Family Literacy Scale from parents"
},
{
"measure": "The data Early Literacy Home Environment Scale (ELVES) from parents"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Uskudar University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-02-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2021-05-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-01-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sport Education Curriculum"
},
{
"name": "Normal teaching"
}
]
},
"conditionsModule": {
"conditions": [
"Physical Fitness"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Qinhuangdao",
"contacts": [
{
"email": "[email protected]",
"name": "Junlong Zhang, PHD",
"phone": "0397698153",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gege Yao, Master",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Junlong Zhang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The 19th Middle School",
"geoPoint": {
"lat": 39.93167,
"lon": 119.58833
},
"state": "Hebei",
"status": "RECRUITING",
"zip": "066000"
}
]
},
"descriptionModule": {
"briefSummary": "Since the outbreak of COVID-19, students; sports environment and time have been severely compressed, which has had an unprecedented impact on their physical fitness and sports learning attitude. Therefore, it is urgent to adopt an effective teaching mode that aligns with curriculum reform to improve students; physical quality and learning attitude. The Sports Education Model is one of the most popular teaching models in Western developed countries, but the application in China and the related evidence of improving students; physical quality and learning attitude towards sports are relatively scarce. This study compares and analyzes the influence of the Sports Education Model and Traditional Teaching on junior middle school students; physical fitness and learning attitude, aiming to provide theoretical support for improving students; physical fitness and learning attitude and promoting the Sports Education Model in China. Promote the healthy development of junior middle school students."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Employing a Cluster randomized controlled experiment design, the experimental and control groups were randomly assigned to two different schools. Students participated in the Sport Education Model (experimental group) and traditional teaching (control group).",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "15 Years",
"minimumAge": "13 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Sport Education on Physical Fitness and Learning Attitude Among Junior High School Students",
"nctId": "NCT06322459",
"orgStudyIdInfo": {
"id": "Junlong Zhang",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cardiovascular fitness test"
},
{
"measure": "Flexibility test"
},
{
"measure": "Speed test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universiti Putra Malaysia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-21"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-21"
}
}
} | false | null |
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