protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Measurement Pain Threshold"
},
{
"name": "Measurement of Serum Asprosin"
}
]
},
"conditionsModule": {
"conditions": [
"Obstetric Pain",
"Cesarean Section",
"Postoperative Pain"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Adipokines are bioactive substances secreted from adipose tissue and have various functions on appetite, energy, lipid, carbohydrate metabolism, regulation of blood pressure, and inflammation. One of these is asprosin, discovered in 2016, which is secreted from white adipose tissue. It has been shown that the level of asprosin encoded by the Fibrillin 1 gene can vary in metabolic syndrome associated with obesity, diabetes, and insulin resistance . Some adipokines such as leptin, adiponectin, or resistin are found in increasing levels in the blood and placenta as pregnancy progresses. The detection of high concentrations of adipokines in cord blood has shown that they play an important role in fetal development and metabolism, can interfere with placental development, and affect pregnancy outcomes and fetal growth. Adipokines associated with appetite, energy, lipid, and carbohydrate metabolism have been shown to be effective in modulating pain in recent years. High levels of leptin have been shown to be associated with decreased preoperative pain threshold and increased postoperative analgesic consumption. Recent studies have indicated that asprosin also exhibits analgesic effects in neuropathic pain models and may have clinical benefits in alleviating chronic pain associated with diseases and injuries originating from peripheral structures.It is known that one of the most important factors affecting mothers\\' approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain. Almost one in five patients experiences severe acute pain after Cesarean section. Pain can be perceived differently by patients, and even with the same anesthesia technique, some patients may experience more severe pain. Patients\\' perception of pain is influenced by many factors such as pain threshold, mood, hormonal balance, central sensitization, and genetic factors.We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period. Additionally, we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels.In this study, we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 25,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section",
"nctId": "NCT06304246",
"orgStudyIdInfo": {
"id": "FU-S.OZCAN 001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Preoperative Asprosin Level"
},
{
"measure": "Postoperative Pain"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative analgesic consumption"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Firat University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Echocardiography"
},
{
"name": "Cardiac Magnetic Resonance Imaging"
},
{
"name": "Electrocardiography"
},
{
"name": "Blood sampling"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Diseases",
"Heart; Functional Disturbance",
"Schizophrenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Trondheim",
"contacts": [
{
"email": "[email protected]",
"name": "Morten A Høydal, PhD",
"phone": "+47 48134843",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Rita Brekke, MD, MSc",
"phone": "+47 45111574",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Norway",
"facility": "Norwegian University of Science and Technology",
"geoPoint": {
"lat": 63.43049,
"lon": 10.39506
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Trondheim",
"contacts": [
{
"email": "[email protected]",
"name": "Mette E Tunset, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Morten B Schou, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Norway",
"facility": "St Olavs Hospital, Trondheim University Hospital",
"geoPoint": {
"lat": 63.43049,
"lon": 10.39506
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease",
"nctId": "NCT06304233",
"orgStudyIdInfo": {
"id": "606103",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Alcohol intake at baseline using The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) questionnaire"
},
{
"measure": "Average length of inpatient stay for schizophrenia related admissions"
},
{
"measure": "Need of Care based on number of total hospital admission for schizophrenia"
},
{
"measure": "Severity scoring of psychiatric symptoms using Clinical Global Impressions (CGI) Scale - Severity"
},
{
"measure": "Schizophrenia symptom severity as scored on the Positive and Negative Syndrome Scale (PANSS)"
},
{
"measure": "Duration of schizophrenia"
},
{
"measure": "Length of treatment with an antipsychotic medication"
},
{
"measure": "Antipsychotic dosage in daily equivalent dosage of chlorpromazine"
},
{
"measure": "Smoking status"
},
{
"measure": "Waist Hip Ratio"
},
{
"measure": "Body Mass Index"
},
{
"measure": "Body fat percent"
},
{
"measure": "Physical Activity"
},
{
"measure": "Body muscle composition"
},
{
"measure": "Smoking history"
},
{
"measure": "Age of participant"
},
{
"measure": "Gender of participant"
}
],
"primaryOutcomes": [
{
"measure": "Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography"
},
{
"measure": "Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography"
},
{
"measure": "DISC1 mRNA quantification"
},
{
"measure": "Levels of high sensitive-CRP"
},
{
"measure": "Levels of CK-MB"
},
{
"measure": "Levels of Troponin T"
},
{
"measure": "Levels of Troponin I"
},
{
"measure": "Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter"
},
{
"measure": "Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter"
},
{
"measure": "Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter"
},
{
"measure": "Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter"
},
{
"measure": "Left ventricular mass measured by echocardiography"
},
{
"measure": "Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography"
},
{
"measure": "Fractional shortening measured by echocardiography"
},
{
"measure": "Global longitudinal strain (GLS), echocardiographic parameter"
},
{
"measure": "TAPSE echocardiographic parameter of right ventricular longitudinal systolic function"
},
{
"measure": "Echocardiographic parameter MPI, Myocardial performance index"
},
{
"measure": "Echocardiographic parameter Mitral E/A ratio"
},
{
"measure": "Echocardiography parameter of peak E velocity"
},
{
"measure": "Echocardiography parameter of E wave deceleration time"
},
{
"measure": "Echocardiography parameter of ratio of E/e'"
},
{
"measure": "Echocardiographic parameters septal e' and lateral e' velocities"
},
{
"measure": "Echocardiographic parameter LAVI, left atrial volume indexed"
},
{
"measure": "Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity"
},
{
"measure": "Echocardiographic parameter, S wave velocity"
},
{
"measure": "Echocardiographic parameter, Indexed LV and RV stroke volumes"
},
{
"measure": "Levels of NT-proBNP"
},
{
"measure": "Levels of IGF1"
},
{
"measure": "Levels of ANP"
},
{
"measure": "Levels of BDNF, brain derived neurotrophic factor"
},
{
"measure": "Levels of Tumor Necrosis Factor alpha"
},
{
"measure": "Levels of Transforming Growth Factor Beta"
},
{
"measure": "Levels of cardiac Myosin-Binding Protein C"
},
{
"measure": "Interleukin levels"
}
],
"secondaryOutcomes": [
{
"measure": "native T1 time, cardiac MRI"
},
{
"measure": "Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI"
},
{
"measure": "Indexed LV mass, cardiac MRI"
},
{
"measure": "LV Ejection Fraction, cardiac MRI"
},
{
"measure": "ECG corrected QT interval"
},
{
"measure": "Number of participants with and abnormal ECG"
},
{
"measure": "Number of participants with abnormal liver function"
},
{
"measure": "Number of participants with abnormal kidney function"
},
{
"measure": "Number of participants with abnormal thyroid function"
},
{
"measure": "Number of participants with low Vitamin D levels"
},
{
"measure": "Incidence of cardiovascular disease or mortality as registered in a health registry on follow up"
},
{
"measure": "Triglyceride levels"
},
{
"measure": "High-density lipoprotein, HDL-cholesterol levels"
},
{
"measure": "Low-density lipoprotein, LDL-cholesterol levels"
},
{
"measure": "Fasting glucose levels"
},
{
"measure": "Glycated Hemoglobin (HbA1c) levels"
},
{
"measure": "Heart rate measured on ECG"
},
{
"measure": "Systolic Blood Pressure"
},
{
"measure": "Diastolic Blood Pressure"
},
{
"measure": "Lipoprotein a"
},
{
"measure": "Magnesium levels"
},
{
"measure": "Calcium levels"
},
{
"measure": "Sodium levels"
},
{
"measure": "Potassium levels"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "St. Olavs Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Norwegian University of Science and Technology"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2038-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cerazet"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility, Female",
"Fertility Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Valencia",
"contacts": [
{
"email": "[email protected]",
"name": "Luis Quintero",
"phone": "+34 963160240",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "NextFertility",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": "Comunidad Valenciana",
"status": null,
"zip": "46009"
}
]
},
"descriptionModule": {
"briefSummary": "The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective, randomized, and controlled clinical study with two different progestogens: desogestrel 75 mg and medroxyprogesterone acetate 10 mg.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 210,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "34 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Two PPOS Models for Pituitary Suppression",
"nctId": "NCT06304220",
"orgStudyIdInfo": {
"id": "MedroGestrel",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total number of oocytes retrieved from follicular puncture"
},
{
"measure": "Number of mature oocytes (MII) retrieved from follicular puncture"
}
],
"secondaryOutcomes": [
{
"measure": "Oocyte quality variables"
},
{
"measure": "Ovarian sensitivity index (OSI"
},
{
"measure": "Follicles"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "SINAE SL"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "NextFertility"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Onsite Maintenance Exercise Training"
},
{
"name": "Telehealth Maintenance Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Copd",
"COPD Exacerbation",
"COPD Bronchitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Charlestown",
"contacts": [
{
"email": "[email protected]",
"name": "Shweta Gore, PhD",
"phone": "617-643-6326",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jane Bladwin, DPT",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "MGH Institute of Health Professions",
"geoPoint": {
"lat": 42.37787,
"lon": -71.062
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02129"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with COPD.The specific aims of the study are:* To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with COPD following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.* To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with COPD following discharge from traditional onsite outpatient rehabilitation.Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study design will be a pilot randomized controlled, assessor-blinded trial with three groups: 1) Tele-rehab where patient will be at home but will receive supervised intervention remotely, 2) Onsite outpatient physical therapy, 3) Control group.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "All baseline and follow up outcomes assessment will be conducted by a study team member blinded to the subject group allocation.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "COPD",
"briefTitle": "Telehealth and Onsite Maintenance Exercise in COPD",
"nctId": "NCT06304207",
"orgStudyIdInfo": {
"id": "300423",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Exercise Capacity"
},
{
"measure": "Exercise Capacity"
},
{
"measure": "Exercise Capacity"
},
{
"measure": "Dyspnea"
},
{
"measure": "Dyspnea"
},
{
"measure": "Dyspnea"
},
{
"measure": "Physical Function"
},
{
"measure": "Physical Function"
},
{
"measure": "Physical Function"
},
{
"measure": "Quality of life measure"
},
{
"measure": "Quality of life measure"
},
{
"measure": "Quality of life measure"
}
],
"secondaryOutcomes": [
{
"measure": "Inspiratory muscle strength"
},
{
"measure": "Inspiratory muscle strength"
},
{
"measure": "Inspiratory muscle strength"
},
{
"measure": "Physical activity"
},
{
"measure": "Physical activity"
},
{
"measure": "Physical activity"
},
{
"measure": "Participants adherence to the program"
},
{
"measure": "Healthcare utilization"
},
{
"measure": "Adverse events"
},
{
"measure": "PROMIS Global 10 score"
},
{
"measure": "PROMIS Global 10 score"
},
{
"measure": "PROMIS Global 10 score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "MGH Institute of Health Professions"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Analysis of biological samples"
}
]
},
"conditionsModule": {
"conditions": [
"Oncologic Disease",
"Hematologic Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Florence",
"contacts": [
{
"email": "[email protected]",
"name": "Marinella Veltroni",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Meyer Children's Hospital IRCCS",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Pisa",
"contacts": [
{
"email": null,
"name": "Gabriella Casazza",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero-Universitaria Pisana",
"geoPoint": {
"lat": 43.70853,
"lon": 10.4036
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Siena",
"contacts": [
{
"email": null,
"name": "Salvatore Grosso",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliero-Universitaria Senese",
"geoPoint": {
"lat": 43.31822,
"lon": 11.33064
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 340,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "0 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology",
"nctId": "NCT06304194",
"orgStudyIdInfo": {
"id": "BIOMARC_ONCO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Average sample delivery time and % of accepted sample"
},
{
"measure": "Appropriateness sample labelling"
},
{
"measure": "Percentage of sample suitable for RNA extraction"
},
{
"measure": "Quantity and quality of extracted material."
},
{
"measure": "Research report production time"
}
],
"secondaryOutcomes": [
{
"measure": "Genetic variants"
},
{
"measure": "Completed patient cards"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Meyer Children's Hospital IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-07-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
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"date": "2027-07-05"
},
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"startDateStruct": {
"date": "2023-07-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Paracetamol and Mannitol Injection"
},
{
"name": "Parecoxib"
}
]
},
"conditionsModule": {
"conditions": [
"Postoperative Analgesia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"masking": "DOUBLE",
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"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
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"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": "Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy",
"nctId": "NCT06304181",
"orgStudyIdInfo": {
"id": "KY-2023-195",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "NRS scores"
},
{
"measure": "RASS score"
}
],
"secondaryOutcomes": [
{
"measure": "Time of first use of remedial analgesics or analgesic pump"
},
{
"measure": "Total analgesic pump drug use"
},
{
"measure": "Postoperative liver enzyme level"
},
{
"measure": "Postoperative bilirubin level"
},
{
"measure": "Postoperative creatinine level"
},
{
"measure": "Postoperative cortisol level"
},
{
"measure": "Postoperative IL-6 level"
},
{
"measure": "Postoperative IL-8 level"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Fourth Affiliated Hospital of Zhejiang University School of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
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"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Interventional Study"
}
]
},
"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": "John B. Kisiel, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota",
"status": "RECRUITING",
"zip": "55905"
}
]
},
"descriptionModule": {
"briefSummary": "This study explores the potential value of a new blood test approach for early detection of cancer."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
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},
"enrollmentInfo": {
"count": 5850,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study",
"nctId": "NCT06304168",
"orgStudyIdInfo": {
"id": "19-000890",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-00954",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic Institutional Review Board",
"id": "19-000890",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall cancer (Y/N) - blood test"
},
{
"measure": "Overall cancer (Y/N) - urine test"
},
{
"measure": "Cancer specific site prediction - blood samples/MDM"
},
{
"measure": "Cancer specific site prediction - urine samples/MDM"
},
{
"measure": "Cancer specific site prediction - blood samples/RNA"
},
{
"measure": "Cancer specific site prediction - urine samples/RNA"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-05-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-05-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Diagnostic efficacy,SUV"
}
]
},
"conditionsModule": {
"conditions": [
"Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": [
{
"email": "[email protected]",
"name": "Xiao Chen, Ph.D",
"phone": "15922970174",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Department of Nuclear Medicine, Daping Hospital of Army Medical University",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": "Chongqing",
"status": "RECRUITING",
"zip": "400010"
}
]
},
"descriptionModule": {
"briefSummary": "According to statistics, in 2020, new head and neck malignancies in the world accounted for 4.9% (931931 cases) of malignant tumors in the whole body, and the new death cases were 467125, accounting for 4.7% of malignant tumors in the whole body. The high incidence rate and mortality brought great burden to the medical system. In addition, due to various types of head and neck cancer, hidden location, impact on function and quality of life, and low overall survival rate, this type of disease has seriously threatened human health and social development. The incidence of oropharyngeal cancer and laryngeal cancer is more subtle. Traditional examination methods include CT(computer tomography), MR(magnetic resonance), and laryngoscopy, but they cannot make accurate judgments on the systemic TNM(primary tumor, regional nodes, metastasis) staging of oropharyngeal cancer and laryngeal cancer. 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/CT examination can better diagnose and stage compared to traditional examination methods. However, due to the interference of more inflammatory lesions or physiological uptake in the pharynx, the false positive rate of 18F-FDG PET/CT examination is significantly increased, 18F-FAPI(18F-fibroblast activation protein inhibitors) is a novel broad-spectrum tumor imaging agent that can be specifically uptake by fibroblasts in the tumor microenvironment, and has lower physiological uptake and acute inflammatory lesion uptake in the larynx. 18F-FAPI PET/CT examination can more accurately stage tumors throughout the body than 18F-FDG PET/CT examination. Combined with PET/MR local scanning, it will further improve the accuracy of T and N staging of local tumors. Therefore, It is of great significance for clinical diagnosis and treatment to effectively and reliably determine the systemic TNM staging of oropharyngeal and laryngeal cancer through non-invasive methods."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
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"primaryPurpose": null,
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},
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"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Application of FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal Cancer",
"nctId": "NCT06304155",
"orgStudyIdInfo": {
"id": "202437",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic efficacy"
}
],
"secondaryOutcomes": [
{
"measure": "SUV"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Daping Hospital and the Research Institute of Surgery of the Third Military Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rehabilitation therapy"
},
{
"name": "Injection"
},
{
"name": "Lidocaine hydrochloride"
}
]
},
"conditionsModule": {
"conditions": [
"Gastroesophageal Reflux Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 10 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Lidocaine Block on Gastroesophageal Reflux Disease",
"nctId": "NCT06304142",
"orgStudyIdInfo": {
"id": "SGB-reflux",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gastroesophageal Reflux Disease Questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "Pressure pain threshold"
},
{
"measure": "Modified Mayo Clinic Dysphagia-30 questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Blood ponction"
}
]
},
"conditionsModule": {
"conditions": [
"Alzheimer Blood Biomarkers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nancy",
"contacts": null,
"country": "France",
"facility": "CHRU De Nancy",
"geoPoint": {
"lat": 48.68439,
"lon": 6.18496
},
"state": "Grand Est",
"status": null,
"zip": "54500"
}
]
},
"descriptionModule": {
"briefSummary": ".The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:* to define a threshold value for each of the plasma,* to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,* to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes* to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 189,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PLASM-ALZ",
"briefTitle": "Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers",
"nctId": "NCT06304129",
"orgStudyIdInfo": {
"id": "2023-A00709-36",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Aβ40 and Aβ42, P-Tau, Tau and NFL"
}
],
"secondaryOutcomes": [
{
"measure": "Sensitivity/specificity"
},
{
"measure": "Co-mobidity"
},
{
"measure": "Final diagnosis"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Thérèse Jonveaux"
},
{
"name": "Laure Joly"
},
{
"name": "Lucie Hopes"
},
{
"name": "Maia Simon"
},
{
"name": "Franck Schreiner"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Central Hospital, Nancy, France"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-01-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Rehabilitation therapy"
},
{
"name": "Stellate ganglion block"
},
{
"name": "Lidocaine Hydrochloride"
}
]
},
"conditionsModule": {
"conditions": [
"Traumatic Brain Injury"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Lidocaine Block in Traumatic Brain Injury",
"nctId": "NCT06304116",
"orgStudyIdInfo": {
"id": "SGB-TBI",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Penetration-Aspiration Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Modified Barthel Index"
},
{
"measure": "Swallowing duration"
},
{
"measure": "Functional Oral Intake Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AND017"
}
]
},
"conditionsModule": {
"conditions": [
"Myelodysplastic Syndromes"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a Phase 2, multicenter, randomized, open-lable study to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS)in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 63,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome",
"nctId": "NCT06304103",
"orgStudyIdInfo": {
"id": "AND017-MDS-206",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of HI-E/RBC-TI responding subjects"
}
],
"secondaryOutcomes": [
{
"measure": "Mean level and change from baseline in untransfused Hb throughout the first 8 weeks of treatment"
},
{
"measure": "Mean level and change from baseline in untransfused Hb at each visit throughout the treatment period and"
},
{
"measure": "Percentage of visits in which untransfused Hb was maintained in this range after reaching two consecutive increases of ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period"
},
{
"measure": "Mean time required after two consecutive increases in untransfused Hb ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period"
},
{
"measure": "For changes in mean transfusion units throughout the treatment period compared to baseline (mean transfusion units 16 weeks prior to first dose)"
},
{
"measure": "For LTB cohorts, the average time required to reach first transfusion independence throughout the treatment period"
},
{
"measure": "Levels of reticulocyte count at each visit and change from baseline"
},
{
"measure": "Levels of hematocrit at each visit and change from baseline"
},
{
"measure": "Levels of mean corpuscular volume at each visit and change from baseline"
},
{
"measure": "Levels of mean corpuscular hemoglobin at each visit and change from baseline"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Kind Pharmaceuticals LLC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-12"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "routine rehabilitation treatment"
},
{
"name": "Stellate ganglion block"
},
{
"name": "Lidocaine Hydrochloride"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "7 Years",
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of Lidocaine Block in Children With Cerebral Palsy and Dysphagia",
"nctId": "NCT06304090",
"orgStudyIdInfo": {
"id": "SGB-NT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Penetration-Aspiration Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Functional Oral Intake Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Forest"
},
{
"name": "Urban"
},
{
"name": "Rural"
}
]
},
"conditionsModule": {
"conditions": [
"Gait Analysis",
"Virtual Reality",
"Attention",
"Stress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "St. Gallen",
"contacts": [
{
"email": "[email protected]",
"name": "Dzuza Papik",
"phone": "+41 (0)71 243 88 30",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "Geriatrische Klinik St. Gallen",
"geoPoint": {
"lat": 47.42391,
"lon": 9.37477
},
"state": "Saint Gallen",
"status": "NOT_YET_RECRUITING",
"zip": "9000"
},
{
"city": "Zollikerberg",
"contacts": [
{
"email": "[email protected]",
"name": "Cor Dekker",
"phone": "+41 (0)44 397 27 11",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "Spital Zollikerberg",
"geoPoint": {
"lat": 47.3451,
"lon": 8.60088
},
"state": "Zürich",
"status": "RECRUITING",
"zip": "8125"
},
{
"city": "Schaffhausen",
"contacts": [
{
"email": "[email protected]",
"name": "Eliane Hepfer",
"phone": "+41 (0)52 634 83 50",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "Spitäler Schaffhausen",
"geoPoint": {
"lat": 47.69732,
"lon": 8.63493
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": "8208"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of our study is to investigate the effects of landscapes during gait therapy. The investigators will evaluate the impacts of restorative landscapes as they occur in urban, rural and forest environments. Older people will experience those landscapes using virtual reality (VR) goggles during their gait training. The investigators expect the landscapes to have an effect on the following three aspects: (1) stress reduction, (2) restoration of attention and (3) change in gait parameters. For this purpose, volunteers who are currently inpatient in one of our study centers and already participating in gait therapy will be assigned to a group. The control group will receive the standard therapy. The participants of the intervention groups will receive five additional VR training sessions to the standard therapy. In these sessions, the participants will walk through urban, rural and forest landscapes and perform balance improvement exercises. The five training sessions will take place within ten days. Allocation to the control or intervention groups and their landscapes is random. At the start and end of participation, tests defining stress levels and gait parameters are carried out so that comparisons can be made between before and after treatment. The goal of the study is to find out which type of landscape supports restoration and can therefore contribute to greater gait stability. The investigators expect that improved gait stability will be promoted by stress reduction and increased attention induced by the virtual environments. The investigators are investigating the consequences of repeated application of virtual landscapes and the relationship between the effect of the landscape and the preferences and habits of the study participants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a randomized, multi-arm (4-arm), open-label pilot controlled trial with an allocation ratio of 1:1:1:1 (per intervention group (urban, rural, forest) : control). The study setup is multicentric (Geriatrische Klinik St. Gallen, Spitäler Schaffhausen, Spital Zollikerberg).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 84,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "REGaitVR",
"briefTitle": "Restorative Environments for Gait Therapy With VR",
"nctId": "NCT06304077",
"orgStudyIdInfo": {
"id": "2023-01894",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Swiss National Clinical Trial Portal (SNCTP)",
"id": "000005739",
"link": null,
"type": "REGISTRY"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Age (Demographic data)"
},
{
"measure": "Height (Demographic data)"
},
{
"measure": "Weight (Demographic data)"
},
{
"measure": "Gender (Demographic data)"
},
{
"measure": "Education (Demographic data)"
},
{
"measure": "Diagnosis and reason for gait stability training"
},
{
"measure": "Time since last fall"
}
],
"primaryOutcomes": [
{
"measure": "Gait Stability"
}
],
"secondaryOutcomes": [
{
"measure": "Variability (Gait Parameter)"
},
{
"measure": "Speed (Gait Parameter)"
},
{
"measure": "Asymmetry (Gait Parameter)"
},
{
"measure": "Stance (Gait Parameter)"
},
{
"measure": "Max. Heel Clearance (Gait Parameter)"
},
{
"measure": "1-Minute-Sit-to-Stand Test (1-Min-STST)"
},
{
"measure": "Perceived Restorativeness Scale (PRS) (Attention Restoration)"
},
{
"measure": "Perceived Stress Scale (PSS) (Stress Reduction)"
},
{
"measure": "Skin Conductance Levels (SCL) (Stress Reduction)"
},
{
"measure": "Non-Specific Skin Conductance Responses (NS-SCRs) (Stress Reduction)"
},
{
"measure": "Event-related Skin Conductance Responses (ER-SCRs) (Stress Reduction)"
},
{
"measure": "Standard deviation of all NN (normal-to-normal) intervals (SDNN) (Heart Rate Variability (HRV), Stress Reduction)"
},
{
"measure": "Root Mean Square of Successive Differences (RMSSD) (Heart Rate Variability (HRV), Stress Reduction)"
},
{
"measure": "LF/HF-ratio (Heart Rate Variability (HRV), Stress Reduction)"
},
{
"measure": "Heart Rate change (ΔHR) (Meaning / Valence of Landscapes)"
},
{
"measure": "Questionnaire / structured interview on landscape preferences and meanings ascribed to landscapes (Meaning / Valence of Landscapes)"
},
{
"measure": "Gaze patterns"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "ETH Zurich"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Allogeneic Cardiosphere-Derived Cells (CAP-1002)"
}
]
},
"conditionsModule": {
"conditions": [
"Duchenne Muscular Dystrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gainesville",
"contacts": null,
"country": "United States",
"facility": "University of Florida",
"geoPoint": {
"lat": 29.65163,
"lon": -82.32483
},
"state": "Florida",
"status": null,
"zip": "32610"
},
{
"city": "Cincinnati",
"contacts": null,
"country": "United States",
"facility": "Cincinnati Children's Medical Center",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio",
"status": null,
"zip": "45229"
}
]
},
"descriptionModule": {
"briefSummary": "This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up.The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
"type": "ACTUAL"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "12 Years",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "HOPE-OLE",
"briefTitle": "Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE)",
"nctId": "NCT06304064",
"orgStudyIdInfo": {
"id": "CAP-1002-DMD-03",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants Experiencing Acute Respiratory Decompensation"
},
{
"measure": "Number of Participants With Hypersensitivity Reactions"
},
{
"measure": "All-cause Mortality"
},
{
"measure": "Number of Treatment-emergent Adverse Events (TEAEs) Related to Investigational Product or Administration and Serious Adverse Events (SAEs)"
},
{
"measure": "Number of Participants With Immune Sensitization Syndrome"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Capricor Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2019-03-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2019-03-06"
},
"resultsFirstPostDateStruct": {
"date": "2024-04-24"
},
"startDateStruct": {
"date": "2018-06-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | true | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2018-02-12",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 2102667,
"typeAbbrev": "Prot",
"uploadDate": "2024-03-29T13:28"
},
{
"date": "2019-03-26",
"filename": "SAP_001.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 741616,
"typeAbbrev": "SAP",
"uploadDate": "2024-03-29T13:25"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intermittent Oro-esophageal Tube Feeding"
},
{
"name": "Nasogastric Tube Feeding"
}
]
},
"conditionsModule": {
"conditions": [
"Intracerebral Hemorrhage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": null,
"country": "Hong Kong",
"facility": "Hongkong central Hospital",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.Participants will be divided into two groups randomly, with different nutritional support respectively."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 118,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage",
"nctId": "NCT06304051",
"orgStudyIdInfo": {
"id": "Naochuxue-IOE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of cases of successful extubation"
}
],
"secondaryOutcomes": [
{
"measure": "Body mass index"
},
{
"measure": "Serum albumin level"
},
{
"measure": "Hemoglobin level"
},
{
"measure": "Clinical Pulmonary Infection Score"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Flu Vaccine"
}
]
},
"conditionsModule": {
"conditions": [
"Influenza Vaccine",
"Cost-Benefit Analysis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": null,
"country": "Italy",
"facility": "Fondazione Policlinico Universitario \"A.Gemelli\" IRCCS",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": null,
"zip": "00168"
}
]
},
"descriptionModule": {
"briefSummary": "Flu vaccination, as well as being effective to prevent seasonal influenza, decreases staff illness and absenteeism and reduces costs resulting from loss of productivity. Despite the effectiveness of flu vaccination, the seasonal coverage among healthcare workers is usually low. The aim of this retrospective observational study is to analyze the vaccination coverage rate among all employees (healthcare workers and administrative staff) of a large teaching hospital in Rome during the 2017-2018 influenza season, to perform a cost-consequence analysis of influenza vaccination (by evaluating the absenteeism due to illness in the epidemic period), and to assess the impact of vaccination in terms of both costs and sick days."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 5483,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome",
"nctId": "NCT06304038",
"orgStudyIdInfo": {
"id": "2018",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effectiveness of the quadrivalent vaccine"
},
{
"measure": "Economic impact of the quadrivalent vaccine"
}
],
"secondaryOutcomes": [
{
"measure": "Expected economic savings for each one percentage point increase in vaccination coverage"
},
{
"measure": "Non-economic incentives for healthcare personnel who decide to vaccinate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2019-11-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2018-04-29"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2017-10-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Wharton's jelly mesenchymal stem cells (WJ-MSCs)"
}
]
},
"conditionsModule": {
"conditions": [
"Graft Versus Host Disease"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs).The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Experimental (pilot clinical study), randomized, blind, and parallel.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "GvHD",
"briefTitle": "Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment",
"nctId": "NCT06304025",
"orgStudyIdInfo": {
"id": "GvHD 01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of treatment-emergent adverse events: safety and tolerability"
},
{
"measure": "Efficacy clinic profile: response of acute GVDH"
},
{
"measure": "Efficacy clinic profile : duration of response"
},
{
"measure": "Efficacy clinic profile: decrease in treatments"
},
{
"measure": "Efficacy biological profile: secretion pattern of soluble factors"
},
{
"measure": "Efficacy biological profile: cell populations"
},
{
"measure": "Efficacy biological profile: ocrrelation of the biological markers with the clinical response"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nasogastric tube feeding"
},
{
"name": "Intermittent Oro-esophageal Tube Feeding"
},
{
"name": "Rehabilitation therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Traumatic Brain Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Yilan",
"contacts": null,
"country": "Taiwan",
"facility": "Jiansheng Hos.",
"geoPoint": {
"lat": 24.757,
"lon": 121.753
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 104,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury",
"nctId": "NCT06304012",
"orgStudyIdInfo": {
"id": "IOE-TBI lao",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Concentration of hemoglobin"
},
{
"measure": "Concentration of albumin"
},
{
"measure": "Concentration of prealbumin"
},
{
"measure": "Nutritional status-body mass index"
}
],
"secondaryOutcomes": [
{
"measure": "Complications-Pulmonary Infections"
},
{
"measure": "Complications-Gastroesophageal Reflux"
},
{
"measure": "Complications- Gastrointestinal Bleeding"
},
{
"measure": "Complications-Gastric Retention"
},
{
"measure": "Complications-Diarrhea"
},
{
"measure": "Complications-Constipation"
},
{
"measure": "Decannulation of tracheostomy tube-placement duration"
},
{
"measure": "Level of consciousness"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-01"
},
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"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-05-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intermittent Oro-esophageal Tube"
},
{
"name": "Nasogastric tube"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Small Vessel Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pengfu",
"contacts": null,
"country": "Taiwan",
"facility": "Huimin Hos.",
"geoPoint": {
"lat": 24.98333,
"lon": 121.41667
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
"masking": "SINGLE",
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Oral Enteral Nutrition on Cerebral Small Vessel Disease",
"nctId": "NCT06303999",
"orgStudyIdInfo": {
"id": "IOE-Small lao",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Functional Oral Intake Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Body mass index"
},
{
"measure": "Serum albumin"
},
{
"measure": "Hemoglobin"
},
{
"measure": "Pneumonia"
},
{
"measure": "Activities of daily living"
},
{
"measure": "World Health Organization Quality of Life Assessment Instrument Brief Version"
}
]
},
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"collaborators": null,
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"class": "OTHER",
"name": "Muhammad"
}
},
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"completionDateStruct": {
"date": "2023-06-15"
},
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"date": "2024-03-12"
},
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"date": "2023-06-02"
},
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"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Neomonki"
}
]
},
"conditionsModule": {
"conditions": [
"Neonatal Abstinence Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Krystle McConnell, MPH",
"phone": "410-550-8779",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Lauren Jansson, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "John Hopkins University",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "21224"
},
{
"city": "Albuquerque",
"contacts": [
{
"email": "[email protected]",
"name": "Sandra S Beauman, MSN, RNC-NIC",
"phone": "505-272-0363",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jessie R Maxwell, MD, MBA",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of New Mexico",
"geoPoint": {
"lat": 35.08449,
"lon": -106.65114
},
"state": "New Mexico",
"status": "RECRUITING",
"zip": "87106"
}
]
},
"descriptionModule": {
"briefSummary": "Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS). The prevalence of opioid use during pregnancy has increased by 333% from 2013 to 2014 and continues to rise. Approximately 1 in 3 women were prescribed opioids during pregnancy from 2008 to 2012. In the US, NAS was diagnosed every 25 minutes in 2014. By 2019, it became every 15 minutes. Although there are medication-based interventions for the treatment of NAS, used in up to 80% of opioid-exposed infants, these treatments carry risks of toxicity and drug interactions. Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias, resulting in poorer clinical outcomes, such as longer lengths of stay in the Neonatal Intensive Care Unit (NICU), for these babies. Studies have shown that continuous vital sign monitoring improves outcomes and decreases the length of stay in general practice. Preliminary machine learning models have been able to predict pharmacological treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). This project will collect physiological and behavioral data of NAS patients to develop an AI algorithm and establish the advantages of continuous monitoring in NAS. The AI algorithm, processed by machine learning, will help predict NAS symptoms, automate scoring, and provide healthcare personnel with predictive analytics to guide suggested treatments."
},
"designModule": {
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"timePerspective": "PROSPECTIVE"
},
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"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "4 Weeks",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process",
"nctId": "NCT06303986",
"orgStudyIdInfo": {
"id": "NAS-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Training/validation data collection"
}
],
"secondaryOutcomes": [
{
"measure": "Continuous Monitoring"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Johns Hopkins University"
},
{
"name": "Children's Hospital of Orange County"
},
{
"name": "Children's Hospital Los Angeles"
},
{
"name": "University of New Mexico"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Rekovar Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-18"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-03-23",
"filename": "ICF_000.pdf",
"hasIcf": true,
"hasProtocol": false,
"hasSap": false,
"label": "Informed Consent Form",
"size": 230657,
"typeAbbrev": "ICF",
"uploadDate": "2024-02-26T15:29"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IOE"
},
{
"name": "PNG"
}
]
},
"conditionsModule": {
"conditions": [
"Pierre Robin Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Yilan",
"contacts": null,
"country": "Taiwan",
"facility": "Renai Hospital",
"geoPoint": {
"lat": 24.757,
"lon": 121.753
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Months",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Oral Enteral Nutrition in Pierre Robin Syndrome",
"nctId": "NCT06303973",
"orgStudyIdInfo": {
"id": "IOE-PRS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of patients diagnosed as the pulmonary infection \"Positive\"."
}
],
"secondaryOutcomes": [
{
"measure": "Nutritional status-total protein"
},
{
"measure": "Nutritional status-hemoglobin"
},
{
"measure": "Nutritional status-albumin"
},
{
"measure": "Nutritional status-prealbumin"
},
{
"measure": "Body weight"
},
{
"measure": "Swallowing function"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bilateral Cerebellar deep brain stimulation"
},
{
"name": "Unilateral Cerebellar deep brain stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jinan",
"contacts": [
{
"email": "[email protected]",
"name": "chao zhang",
"phone": "+8613969007232",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Chao Zhang",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Sichuan",
"status": "RECRUITING",
"zip": "250100"
}
]
},
"descriptionModule": {
"briefSummary": "Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. We hypothesized that bilateral stimulation was superior to unilateral stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bilateral or Unilateral Cerebellar Deep Brain Stimulation for Chronic Post-stroke Motor Rehabilitation",
"nctId": "NCT06303960",
"orgStudyIdInfo": {
"id": "Cerebellar DBS for stroke",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "safety and feasibility of bilateral cerebellar DBS"
}
],
"secondaryOutcomes": [
{
"measure": "FM-UE scores between bilateral and unilateral cerebellar DBS"
},
{
"measure": "Arm Motor Ability Test (AMAT) bilateral and unilateral cerebellar DBS"
},
{
"measure": "the Nine-Hole Peg Test between bilateral and unilateral cerebellar DBS"
},
{
"measure": "the Bilateral Box and Block Test between bilateral and unilateral cerebellar DBS"
},
{
"measure": "Short Form Health Survey (SF-12) between bilateral and unilateral cerebellar DBS"
},
{
"measure": "the EuroQol Five Dimensions Questionnaire (EQ-5D) between bilateral and unilateral cerebellar DBS"
},
{
"measure": "the Beck Depression Inventory or the Beck Anxiety Inventory between bilateral and unilateral cerebellar DBS"
},
{
"measure": "nerve conduction velocity between bilateral and unilateral cerebellar DBS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Qilu Hospital of Shandong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-27"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Intermittent Oro-esophageal Tube"
},
{
"name": "Nasogastric tube"
},
{
"name": "Comprehensive rehabilitation training"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Oral Enteral Nutrition Feeding in Parkinson Disease",
"nctId": "NCT06303947",
"orgStudyIdInfo": {
"id": "IOE-PKS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Serum albumin level"
},
{
"measure": "Hemoglobin"
}
],
"secondaryOutcomes": [
{
"measure": "Modified Barthel Index"
},
{
"measure": "Functional Oral Intake Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "systemic therapy"
},
{
"name": "Intermittent Oro-Esophageal Tube Feeding"
},
{
"name": "Persistent Nasogastric Tube Feeding"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pingdong",
"contacts": null,
"country": "Taiwan",
"facility": "River First Hos.",
"geoPoint": {
"lat": 24.46667,
"lon": 118.41667
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Months",
"minimumAge": "6 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia",
"nctId": "NCT06303934",
"orgStudyIdInfo": {
"id": "IOE-NT",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Oral Motor Assessment Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Pneumonia"
},
{
"measure": "Hemoglobin"
},
{
"measure": "Total Protein"
},
{
"measure": "Albumin"
},
{
"measure": "Prealbumin"
},
{
"measure": "body weight"
},
{
"measure": "Penetration-Aspiration Scale"
},
{
"measure": "Functional Oral Intake Scale for Infants"
},
{
"measure": "Feeding amount"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "11C-M503 PET"
},
{
"name": "Brain MRI"
},
{
"name": "Amyloid PET"
},
{
"name": "Neurological assessments"
}
]
},
"conditionsModule": {
"conditions": [
"Tauopathies"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": [
{
"email": "[email protected]",
"name": "Erin Schubert",
"phone": "215-662-3041",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "IIya Nasrallah, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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"whoMasked": null
},
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"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503",
"nctId": "NCT06303921",
"orgStudyIdInfo": {
"id": "854681",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Organ Biodistribution or Dosimetry"
},
{
"measure": "PET Uptake of Tracer"
}
],
"secondaryOutcomes": [
{
"measure": "Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Pennsylvania"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
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"primaryCompletionDateStruct": {
"date": "2029-02"
},
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"startDateStruct": {
"date": "2024-02-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Simple Gymnastics Training"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "How Traditional Chinese Medicine Exercise Improves Parkinson Disease",
"nctId": "NCT06303908",
"orgStudyIdInfo": {
"id": "Commu-PKS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Unified Parkinson's Disease Rating Scale"
}
],
"secondaryOutcomes": [
{
"measure": "The Berg Balance Scale"
},
{
"measure": "Patient Health Questionnaire-9"
},
{
"measure": "Generalized Anxiety Disorder-7"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-11"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Routine rehabilitation training"
},
{
"name": "Swallowing rehabilitation training"
},
{
"name": "Acupuncture therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Dysphagia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This study is focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"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": "How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients",
"nctId": "NCT06303895",
"orgStudyIdInfo": {
"id": "Acu-PKS-new",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Penetration-Aspiration Scale-liquid"
},
{
"measure": "Penetration-Aspiration Scale-paste"
}
],
"secondaryOutcomes": [
{
"measure": "Swallowing time"
},
{
"measure": "body mass index"
},
{
"measure": "Serum Albumin"
},
{
"measure": "Prealbumin"
},
{
"measure": "Hemoglobin"
},
{
"measure": "Swallowing Quality of Life"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "routine rehabilitation treatment"
},
{
"name": "Computer-assisted Cognitive Function Training"
},
{
"name": "conventional cognitive training"
}
]
},
"conditionsModule": {
"conditions": [
"Dysphagia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"OUTCOMES_ASSESSOR"
]
},
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},
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"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Computer-based Cognitive Function Training on Cognitive Dysphagia After Stroke",
"nctId": "NCT06303882",
"orgStudyIdInfo": {
"id": "AI-Dysphagia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Montreal Cognitive Assessment"
}
],
"secondaryOutcomes": [
{
"measure": "The coordination of swallowing"
},
{
"measure": "Penetration-Aspiration Scale"
},
{
"measure": "Swallowing duration"
},
{
"measure": "Swallowing reflex"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Deep Brain Stimulation (DBS) of the Motor Thalamus"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Brain Disease",
"Central Nervous System Diseases",
"Nervous System Diseases",
"Cardiovascular Diseases"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pittsburgh",
"contacts": [
{
"email": "[email protected]",
"name": "Cierra Clark, MS",
"phone": "240-441-4216",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Pittsburgh",
"geoPoint": {
"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania",
"status": null,
"zip": "15213"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective, non-randomized, open-label, descriptive, experimental.",
"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": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke",
"nctId": "NCT06303869",
"orgStudyIdInfo": {
"id": "STUDY22070043",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adverse Events"
},
{
"measure": "Discomfort and Pain"
}
],
"secondaryOutcomes": [
{
"measure": "Dysphagia"
},
{
"measure": "Hand dexterity"
},
{
"measure": "Muscle weakness"
},
{
"measure": "Dexterity of Articulation AMRs"
},
{
"measure": "Dexterity of Articulation SMRs"
},
{
"measure": "Intelligibility of Speech"
},
{
"measure": "Spasticity"
},
{
"measure": "Range of Motion (ROM)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Jorge Gonzalez-Martinez"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Active Breathing Exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Dysphagia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "How Active Breathing Training Improves Dysphagia in Elderly People",
"nctId": "NCT06303856",
"orgStudyIdInfo": {
"id": "ABE-OLDer",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Eating Assessment Tool-10"
}
],
"secondaryOutcomes": [
{
"measure": "Time consumed in eating"
},
{
"measure": "Swallowing-Related Quality of Life Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Muhammad"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transfer with an electric ride-on car"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety",
"Preoperative Anxiety",
"Pediatric Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Usak",
"contacts": null,
"country": "Turkey",
"facility": "Usak University Training and Research Hospital",
"geoPoint": {
"lat": 38.67351,
"lon": 29.4058
},
"state": null,
"status": null,
"zip": "64100"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group.Translated with DeepL.com (free version)"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 118,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre",
"nctId": "NCT06303843",
"orgStudyIdInfo": {
"id": "13.04.2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Perioperative anxiety"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Uşak University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-02-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sodium nitrate"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ribeirão Preto",
"contacts": null,
"country": "Brazil",
"facility": "Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão",
"geoPoint": {
"lat": -21.1775,
"lon": -47.81028
},
"state": "São Paulo",
"status": null,
"zip": "14.048-900"
}
]
},
"descriptionModule": {
"briefSummary": "Inorganic nitrite and nitrate can be reduced to NO and NO-related species such as S-nitrosothiols via the nitrate-nitrite-NO pathway. This is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to NO depending on the acidic pH on the stomach or by enzymes with nitrite-reductase activity. The acidic environment of the stomach is very important to the formation of NO and S-nitrosothiols and several studies suggest that changes in gastric pH can affect this conversion. In this context, bariatric surgery, by altering the anatomy of the stomach and increasing gastric pH, can affect the nitrate-nitrite-NO pathway and change the antihypertensive and antioxidant effect of sodium nitrate."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate",
"nctId": "NCT06303830",
"orgStudyIdInfo": {
"id": "BACA2019",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess changes in s-nitrosothiols"
}
],
"secondaryOutcomes": [
{
"measure": "Assess changes in blood pressure"
},
{
"measure": "Assess changes in endotelial function"
},
{
"measure": "Assess changes in Vascular stiffness"
},
{
"measure": "Assess changes in nitrate concentration"
},
{
"measure": "Assess changes in nitrite concentration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Sao Paulo"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-12-17"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2019-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Double knots facia closure method during cesarean section"
},
{
"name": "Triple knots facia closure method during cesarean section"
}
]
},
"conditionsModule": {
"conditions": [
"Cesarean Section",
"Pain",
"Cosmetics Sensitivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Adana",
"contacts": null,
"country": "Turkey",
"facility": "Adana Şehir Eğitim ve Araştırma Hastanesi",
"geoPoint": {
"lat": 37.00167,
"lon": 35.32889
},
"state": "Yüreğir",
"status": null,
"zip": "01120"
}
]
},
"descriptionModule": {
"briefSummary": "The study included women who were scheduled for an elective or had an emergency cesarean section. Age, body mass index (BMI), obstetric history, education status, smoking status and C-section indications of the patients were recorded. Patients with a previous suprapubic scar, medical conditions affecting wound healing (such as diabetes or chronic corticosteroid use), those needing a vertical incision (e.g., placenta previa), individuals with postoperative wound infection or under 18 years old were excluded. Data were collected in standardized data form by a research assistant. Pre- and post-surgery treatments and/or interventions were standardized. All patients received antimicrobial prophylaxis with cefazolin before the operation. The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion. Technical differences such as blunt and sharp dissection, uterus exteriorization vs in situ, or parietal peritoneum closure were left to the surgeon's discretion. The procedures for facia closure are as follows; in Group I (Double knots group), the edge of the fascia was determined with a Kocher clamp. The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture (Figure 2; a-b). In Group II (Triple knots group), the edge of the fascia was fixed with the same suture material instead of the Kocher clamp, and the fascia was closed similarly, starting from the opposite corner via the second loop. Then the loops from the first suture were tied to the second suture (Figure 2; c-d). After the incision was irrigated with sterile saline solution, the subcutaneous space was closed if the thickness was 2 cm or more. Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture, which was removed on the 10th day postoperatively. A closed subcutaneous suction drain was not used in any of the patients. Postoperative pain at and around the incision line was measured on the 1st, and 10th days postoperatively on the NRS (Numeric Rating Scale), with \"0\" being \"no pain\" and \"10\" being \"the worst pain imaginable.\" The 1st measurements were made face-to-face, and the 10th-day evaluation was made via telephone interviews by the same research assistant."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 203,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Double Knots Versus Triple Knots Facia Closure Method; is There a Difference in Pain Sensation or Cosmetic Satisfaction?",
"nctId": "NCT06303817",
"orgStudyIdInfo": {
"id": "1812",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline in pain on NRS (Numeric Rating Scale) at 10 days"
},
{
"measure": "Change from baseline in aesthetic results at 3 months"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Adana City Training and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Educational videos"
}
]
},
"conditionsModule": {
"conditions": [
"Opioid Misuse"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Alejandra Fernandez, PhD",
"phone": "972-546-2920",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of Texas Health Science Center at Houston",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"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": null,
"briefTitle": "Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective",
"nctId": "NCT06303804",
"orgStudyIdInfo": {
"id": "HSC-SPH-23-0837",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Acceptability of the educational materials presented via the educational videos, including cultural congruence as assessed by a questionnaire"
},
{
"measure": "Changes in opioid related knowledge as assessed by a questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The University of Texas Health Science Center, Houston"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Digital Psychosocial intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Autism Spectrum Disorder",
"Attention Deficit Hyper Activity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Valencia",
"contacts": null,
"country": "Spain",
"facility": "University of Valencia",
"geoPoint": {
"lat": 39.46975,
"lon": -0.37739
},
"state": null,
"status": null,
"zip": "46010"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support (randomized and with a control group) that will be conducted virtually and synchronously to families of children with autism spectrum disorder (ASD) and families of children with Attention Deficit with hyperactivity Disorder (ADHD). The main questions it aims to answer are:1. Will the program impact on different variables in the parents' domain (parental stress variables, quality of life/social support and coping skills),2. Will the program impact on different variables in the children's domain (daily life functioning, social behavioral variables, and executive functioning).3. Treatment outcomes will be assessed at pre-test, post-test, and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress, coping skills, social support, and children's dysfunctional outcomesParents and teachers will complete different questionnaires to see if there are improvements on parent's and children outcomes.Researchers will compare intervention group and control group to see if there are improvements on parent's domains (parenting stress, coping skills, social support) and children's dysfunctional outcomes (daily life functioning, social behavioral variables, and executive functioning)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "To test the proposed objectives, a design will be used with a between-groups factor (type of therapy) and a intra-groups with pre-treatment (T0), post-treatment (T1) and follow-up measurements at 6 months (T2). Participants will be randomly assigned (1:1) to the two conditions; a group that will receive the intervention of the structured psychosocial program with digital support (experimental group) and an active control group. The experimental group will undergo an evaluation prior to the intervention, one immediately after it, and a third follow-up evaluation. In the case of the control group, it will be evaluated through the pretest phases, posttest and follow-up.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Families/children who meet the inclusion criteria will be randomly assigned to one of the two conditions (intervention group or control group) using a controlled design. Block randomization will be applied to each of the diagnostic groups (ASD, ADHD) to ensure that participants were of approximately similar size (1:1 ratio) in the treatment and control conditions. After determining the size of each block in the sample (#ASD and #ADHD) the treatment allocation of each individual participant will be done randomly.A blind procedure will be used: participating families will not know the group to which participants will be assigned, and the researchers who will collect and enter the data will also have no knowledge of the condition to which the families will be assigned.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 90,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "INPSYD",
"briefTitle": "Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders",
"nctId": "NCT06303791",
"orgStudyIdInfo": {
"id": "1905517",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Parental stress in The Parenting Stress Index - Short Form (PSI-SF) Spanish adaptation"
},
{
"measure": "Social support: The Social Functional Support Questionnaire Duke-UNC"
},
{
"measure": "Coping Skills using The Brief COPE"
},
{
"measure": "Children's social problems using Strengths and Difficulties Questionnaire (SDQ)"
},
{
"measure": "Daily life executive functioning using the BRIEF"
}
],
"secondaryOutcomes": [
{
"measure": "Children Sleep problems: using The Sleep Disturbance Scale for Children (SDSC)"
},
{
"measure": "Behavioral problems using The Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P)"
},
{
"measure": "Children Learning Behavior using Learning behavior scale (LBS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Valencia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Stand Down mobile app"
},
{
"name": "Standard Care"
}
]
},
"conditionsModule": {
"conditions": [
"Alcohol Use Disorder (AUD)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montgomery",
"contacts": [
{
"email": "[email protected]",
"name": "Sebastian Skordallos, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Central Alabama Veterans Health Care System West Campus, Montgomery, AL",
"geoPoint": {
"lat": 32.36681,
"lon": -86.29997
},
"state": "Alabama",
"status": null,
"zip": "36109"
},
{
"city": "Phoenix",
"contacts": [
{
"email": "[email protected]",
"name": "Courtney Speaks, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Phoenix VA Health Care System, Phoenix, AZ",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona",
"status": null,
"zip": "85012"
},
{
"city": "Sacramento",
"contacts": [
{
"email": "[email protected]",
"name": "Christine Johnston, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "VA Northern California Health Care System, Mather, CA",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
},
"state": "California",
"status": null,
"zip": "95655-4200"
},
{
"city": "Dublin",
"contacts": [
{
"email": "[email protected]",
"name": "Deborah Hobbs, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Carl Vinson VA Medical Center, Dublin, GA",
"geoPoint": {
"lat": 32.54044,
"lon": -82.90375
},
"state": "Georgia",
"status": null,
"zip": "31021"
},
{
"city": "Battle Creek",
"contacts": [
{
"email": "[email protected]",
"name": "Elizabeth Ratti, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Battle Creek VA Medical Center, Battle Creek, MI",
"geoPoint": {
"lat": 42.3173,
"lon": -85.17816
},
"state": "Michigan",
"status": null,
"zip": "49037"
},
{
"city": "Minneapolis",
"contacts": [
{
"email": "[email protected]",
"name": "Elizabeth Welch, PharmD",
"phone": "612-618-8725",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Minneapolis VA Health Care System, Minneapolis, MN",
"geoPoint": {
"lat": 44.97997,
"lon": -93.26384
},
"state": "Minnesota",
"status": null,
"zip": "55417-2309"
},
{
"city": "Kansas City",
"contacts": [
{
"email": "[email protected]",
"name": "Kyleigh Gould, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Kansas City VA Medical Center, Kansas City, MO",
"geoPoint": {
"lat": 39.09973,
"lon": -94.57857
},
"state": "Missouri",
"status": null,
"zip": "64128-2226"
},
{
"city": "Nashville",
"contacts": [
{
"email": "[email protected]",
"name": "Matthew Phillips, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Tennessee Valley Healthcare System Nashville Campus, Nashville, TN",
"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee",
"status": null,
"zip": "37212-2637"
},
{
"city": "San Antonio",
"contacts": [
{
"email": "[email protected]",
"name": "Cynthia Mascarenas, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "South Texas Health Care System, San Antonio, TX",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas",
"status": null,
"zip": "78229-4404"
},
{
"city": "Salt Lake City",
"contacts": [
{
"email": "[email protected]",
"name": "Chad Nelson, PharmD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "VA Salt Lake City Health Care System, Salt Lake City, UT",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": null,
"zip": "84148-0001"
},
{
"city": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "Thomas S Bundt, FACHE",
"phone": "253-583-3500",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Susan Perez, BA",
"phone": "(202) 461-6910",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Eric J. Hawkins, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "VA Puget Sound Health Care System Seattle Division, Seattle, WA",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington",
"status": null,
"zip": "98108-1532"
}
]
},
"descriptionModule": {
"briefSummary": "One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Following completion of informed consent and baseline assessments, participants will be randomized in a 1:1 ratio to MAUD+SD-App or MAUD only conditions.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 330,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Combining a Smartphone App With Medications to Manage Heavy Drinking",
"nctId": "NCT06303778",
"orgStudyIdInfo": {
"id": "IIR 22-141",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "VA HSR&D",
"id": "HX003742-01A1",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Percent Heavy Drinking Days"
},
{
"measure": "Semi-structured qualitative interview data from patients, providers, clinical leaders"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Short Inventory of Problems - Revised version (SIP-R)"
},
{
"measure": "Change in World Health Organization (WHO) Risk Levels"
},
{
"measure": "Change in Client Satisfaction Questionnaire (CSQ) Scores"
},
{
"measure": "Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores"
},
{
"measure": "Change in PTSD Checklist for DSM-5 (PCL-5) Scores"
},
{
"measure": "Change in Veterans RAND 12 Item Health Survey Scores"
},
{
"measure": "Change in Percent Heavy Drinking Days"
},
{
"measure": "Change in Short Inventory of Problems - Revised version (SIP-R)"
},
{
"measure": "Change in World Health Organization (WHO) Risk Levels"
},
{
"measure": "Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores"
},
{
"measure": "Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment"
},
{
"measure": "Number of Participants Receiving VA Emergency Department Services"
},
{
"measure": "Change in PTSD Checklist for DSM-5 (PCL-5) Scores"
},
{
"measure": "Change in Veterans RAND 12 Item Health Survey Scores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "VA Office of Research and Development"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Practice Resource for Driving After Stroke (PReDAS)"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke, Acute",
"Driving",
"Occupational Therapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "April K Vander Veen, PhD (c)",
"phone": "519-661-2111",
"phoneExt": "89153",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Liliana Alvarez, PhD",
"phone": "519-661-2111",
"phoneExt": "88957",
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Western University",
"geoPoint": {
"lat": 42.98339,
"lon": -81.23304
},
"state": "Ontario",
"status": "RECRUITING",
"zip": "N6G 1H1"
}
]
},
"descriptionModule": {
"briefSummary": "After stroke, individuals must be assessed to determine if they can resume driving. Return to driving is very important to people who have experienced a stroke. Unfortunately, health care providers face challenges in addressing driving after stroke. Common issues include being unsure of the best screening practices, difficulty discussing driving with patients, and challenges making informed recommendations about driving that balance the risk of public safety along with supporting patient goals. Occupational Therapists (OTs) are health care providers that provide screening, assessment, and intervention for driving to individuals who have had a stroke. OTs working in stroke care have highlighted the urgency for evidence-based resources to support practice to address driving with patients. The Practice Resource for Driving After Stroke (PReDAS), is an evidenced-based resource to support the clinical practice of OTs in addressing driving in acute stroke settings. A previous pilot study has demonstrated that the PReDAS is considered useful by both health care providers and patients. Further study is needed to evaluate how the PReDAS can support OTs in addressing driving with patients. The current study proposes to provide the PReDAS as an intervention to OTs working in acute stroke settings to see if the intervention increases OT's self efficacy and clinical reasoning for addressing driving. The study will take repeated measures of self-efficacy and clinical reasoning among participating OTs to determine if the PReDAS intervention supports improved self-efficacy and clinical reasoning."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "multiple baseline study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 8,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluating the Practice Resource for Driving After Stroke",
"nctId": "NCT06303765",
"orgStudyIdInfo": {
"id": "13Nov2023PReDAS Study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "clinical reasoning"
},
{
"measure": "self-efficacy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Western University, Canada"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-09"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ADRC injection"
},
{
"name": "ADRC001 injection"
}
]
},
"conditionsModule": {
"conditions": [
"Anal Fistula"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Odense",
"contacts": [
{
"email": "[email protected]",
"name": "Karam M Sørensen, Ph.D",
"phone": "+4565415190",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Tina D Hansen",
"phone": "+4565415190",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Odense University Hospital",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
},
"state": null,
"status": null,
"zip": "5000"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "REP-PAF",
"briefTitle": "Tissue Therapy of Transsphincteric Anal Fistula",
"nctId": "NCT06303752",
"orgStudyIdInfo": {
"id": "260-2021-NQ",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2022-502659-73",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Healing rate (percentage)"
}
],
"secondaryOutcomes": [
{
"measure": "QoL"
},
{
"measure": "Fecal Incontinence"
},
{
"measure": "Risk factors for recurrence of fistula."
},
{
"measure": "Radiological healing."
},
{
"measure": "Treatment efficacy."
},
{
"measure": "Cellular composition"
},
{
"measure": "Transplantation-related alloantibodies"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Southern Denmark"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "psilocybin"
}
]
},
"conditionsModule": {
"conditions": [
"Refractory Depression",
"Treatment Resistant Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chapel Hill",
"contacts": [
{
"email": null,
"name": "Mary Pruden, BA",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Robert K McClure, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Amanda Tow, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Lindley Reynolds, MSW",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UNC Chapel Hill Medical Center",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27514"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are:* Does psilocybin with assisted therapy help improve symptoms for people with depression?* How long do the effects of this treatment last?Participants will:* Take part in a couple of screening and preparation visits.* Be given psilocybin in one or two treatment sessions.* Attend a series of follow-up sessions over the following year.* Complete forms and surveys to test how their symptoms have changed and what they thought of their experience.Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants are randomized into one of two groups and will receive either one single treatment of psilocybin-assisted therapy with follow-up therapy and assessments or two treatments spaced two weeks apart with follow-up therapy and assessments.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Due to the nature of the study and limitations of study staffing, only those conducting assessments and ratings throughout the study will be masked to the treatments. All others, including participants, therapists, investigators, and study coordinator, will not be masked to the number of treatments a participant receives.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Psilocybin-Assisted Therapy in Treatment-Resistant Depression",
"nctId": "NCT06303739",
"orgStudyIdInfo": {
"id": "22-1421",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in HAM-D-17 Scores between Baseline and 2 Weeks after Treatment"
},
{
"measure": "Change in QIDS SR-16 Scores between Baseline and 2 Weeks after Treatment"
},
{
"measure": "Number of Participants Achieving Remission 2 Weeks after Treatment"
},
{
"measure": "Number of Participants Achieving Response 2 weeks after treatment"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants Achieving Remission at 6 Weeks"
},
{
"measure": "Number of Participants Achieving Response at 6 Weeks"
},
{
"measure": "Number of Participants Achieving Remission at 3 Months"
},
{
"measure": "Number of Participants Achieving Response at 3 Months"
},
{
"measure": "Number of Participants Achieving Remission at 6 Months"
},
{
"measure": "Number of Participants Achieving Response at 6 Months"
},
{
"measure": "Number of Participants Achieving Remission at 9 Months"
},
{
"measure": "Number of Participants Achieving Response at 9 Months"
},
{
"measure": "Number of Participants Achieving Remission at 12 Months"
},
{
"measure": "Number of Participants Achieving Response at 12 Months"
},
{
"measure": "Time to Relapse in Participants Who Showed Remission at 2 weeks"
},
{
"measure": "Time to Relapse in Participants Who Showed Response at 2 Weeks"
},
{
"measure": "Change in HAM-D-17 Scores between Baseline and 6 Weeks after Treatment"
},
{
"measure": "Change in HAM-D-17 Scores between Baseline and 3 Months after Treatment"
},
{
"measure": "Change in HAM-D-17 Scores between Baseline and 6 Months after Treatment"
},
{
"measure": "Change in HAM-D-17 Scores between Baseline and 9 Months after Treatment"
},
{
"measure": "Change in HAM-D-17 Scores between Baseline and 12 Months after Treatment"
},
{
"measure": "Change in QIDS SR-16 Scores between Baseline and 6 Weeks after Treatment"
},
{
"measure": "Change in QIDS SR-16 Scores between Baseline and 3 Months after Treatment"
},
{
"measure": "Change in QIDS SR-16 Scores between Baseline and 6 Months after Treatment"
},
{
"measure": "Change in QIDS SR-16 Scores between Baseline and 9 Months after Treatment"
},
{
"measure": "Change in QIDS SR-16 Scores between Baseline and 12 Months after Treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Foundation of Hope, North Carolina"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of North Carolina, Chapel Hill"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-19"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ACL reconstruction single bundle"
},
{
"name": "ACL reconstruction double bundle"
}
]
},
"conditionsModule": {
"conditions": [
"Anterior Cruciate Ligament Reconstruction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Maribor",
"contacts": null,
"country": "Slovenia",
"facility": "University Clinical Center Maribor",
"geoPoint": {
"lat": 46.55472,
"lon": 15.64667
},
"state": null,
"status": null,
"zip": "2000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined).The main question it aims to answer are:* which surgery gives better outcome in patients (short- and long-term results)?* are there any sings of osteoarthritis in an injured knee compared to a healthy knee?Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging (MRI) of both knees. Subjective exams with different scores (Tegner score, Lysholm score..) were also done. The same exam protocol for participant was used again after two years and fifteen years since surgery."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction",
"nctId": "NCT06303726",
"orgStudyIdInfo": {
"id": "IRP-2021/02-19",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "IKDC SUBJECTIVE SCORE"
},
{
"measure": "TEGNER SCORE"
},
{
"measure": "LYSHOLM SCORE"
},
{
"measure": "OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS"
},
{
"measure": "OBJECTIVE PARAMETER: AP TRANSLATION (anterior-posterior)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Medical Centre Maribor"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Carboplatin"
},
{
"name": "177Lu-PSMA-617"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer",
"Metastatic Prostate Cancer",
"Metastatic Castration-resistant Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Daniel Fein, MD",
"phone": "617-667-2100",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Daniel Fein, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Beth Israel Deaconess Medical Center",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": null,
"zip": "02215"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Praful Ravi, MB BCHir, MRCP",
"phone": "617-632-3466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Praful Ravi, MB BCHir, MRCP",
"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": "02215"
},
{
"city": "Boston",
"contacts": [
{
"email": "[email protected]",
"name": "Praful Ravi, MB BChir, MRCP",
"phone": "617-632-3466",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Praful Ravi, MB BCHir, MRCP",
"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 purpose of this study is to see whether the combination of a chemotherapy drug, carboplatin, along with the radioligand treatment, 177Lu-PSMA-617, is safe in treating prostate cancer and whether the combination is effective in shrinking or preventing growth of prostate cancer.The names of the study drugs used in this research study are:* Carboplatin (A type of chemotherapy)* 177Lu-PSMA-617 (A type of radioligand therapy)"
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 37,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer",
"nctId": "NCT06303713",
"orgStudyIdInfo": {
"id": "23-693",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Maximum tolerated dose (MTD) or the Recommended Phase 2 dose (RP2D) of carboplatin administered in combination with 177Lu-PSMA-617"
}
],
"secondaryOutcomes": [
{
"measure": "PSA response rate (PSA reduction by ≥50% from baseline)."
},
{
"measure": "Overall Response Rate (ORR)"
},
{
"measure": "Radiographic Progression-Free Survival (rPFS)"
},
{
"measure": "Overall Survival (OS)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Novartis"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Dana-Farber Cancer Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-07-19"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Public Health"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gamasa",
"contacts": null,
"country": "Egypt",
"facility": "Amira Hussin Mohammed",
"geoPoint": {
"lat": 31.44112,
"lon": 31.53675
},
"state": null,
"status": null,
"zip": "35712"
}
]
},
"descriptionModule": {
"briefSummary": "To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 604,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups",
"nctId": "NCT06303700",
"orgStudyIdInfo": {
"id": "Quality of life",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "the severity of dyspnea"
},
{
"measure": "the level of fear of falling through daily life activities"
},
{
"measure": "quality of life and public health"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Amira Hussin Hussin Mohammed"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-10"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "VR-PAT"
}
]
},
"conditionsModule": {
"conditions": [
"Acute Pain",
"Pediatric ALL",
"Procedural Pain",
"Burns"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Columbus",
"contacts": null,
"country": "United States",
"facility": "Nationwide Children's Hospital",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": null,
"zip": "43205"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Participants will be randomly assigned to either the intervention (fNIRS and VR-PAT) or the control (fNIRS and standard of care) at the first research dressing change and will then crossover to the alternative group for the second laser procedure.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 4,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "VR-PAT and fNIRS to Identify CNS Biomarkers of Pain",
"nctId": "NCT06303687",
"orgStudyIdInfo": {
"id": "STUDY00003496",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in brain activity"
}
],
"secondaryOutcomes": [
{
"measure": "Procedural pain during burn dressing changes"
},
{
"measure": "Change in procedural anxiety"
},
{
"measure": "Self-reported VR experience"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Nationwide Children's Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Physical activity with engaging cognitively"
},
{
"name": "Physical activity without engaging cognitively"
}
]
},
"conditionsModule": {
"conditions": [
"ADHD"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palma",
"contacts": null,
"country": "Spain",
"facility": "University of the Balearic Islands",
"geoPoint": {
"lat": 39.56939,
"lon": 2.65024
},
"state": "Balearic Islands",
"status": null,
"zip": "07122"
}
]
},
"descriptionModule": {
"briefSummary": "Advancement in teaching methods, together with the frenetic change in the lifestyles of the school population, provides a unique opportunity to advance scientific knowledge. The current project, called \"The Break4Brain Project\", aims to examine the acute (transient) effects of physical activity on brain function, cognition, and academic performance in children with and without Attention Deficit Hyperactivity Disorder (ADHD). Specifically, a total of 60 children between 10 and 12 years old will be included with (n=30) and without (n=30) ADHD. The study will use an intra-subject design of isolated conditions with four measurement moments where the children will perform three different experimental conditions lasting 10 minutes, which will be randomized in a counterbalanced manner. These experimental conditions will be based on physical activity engaging cognitively, physical activity without engaging cognitively, and cognitively engaging control condition. This project could have a significant impact in the educational field, since, if brain function, cognition, and academic performance prove to be favorably stimulated, acutely, by physical activity through active breaks, these could be prescribed as an effective teaching strategy for children with and without ADHD in the school setting."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The design of the study is a within-participants crossover pretest-posttest comparison design under laboratory settings will be used. In this design, all participants will engage in all experimental conditions (on separate days), with the order of the experimental conditions being counterbalanced across participants and outcomes assessed following each experimental condition.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "10 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project",
"nctId": "NCT06303674",
"orgStudyIdInfo": {
"id": "301CER22",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Ministry of Science and Innovation - Spanish State Research Agency - European Regional Development Fund",
"id": "PID2021-123357OA-I00",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Academic achievement"
},
{
"measure": "Inhibition"
},
{
"measure": "Working memory"
},
{
"measure": "Sustained attention"
},
{
"measure": "Brain function"
}
],
"secondaryOutcomes": [
{
"measure": "Physical fitness and body composition"
},
{
"measure": "Physical activity levels and sleep"
},
{
"measure": "Self-reported sedentary patterns"
},
{
"measure": "Motor proficiency"
},
{
"measure": "Biological maturation"
},
{
"measure": "ADHD symptoms"
},
{
"measure": "IQ"
},
{
"measure": "Socioeconomic levels"
},
{
"measure": "Educational levels"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Ministry of Science and Innovation"
},
{
"name": "European Regional Development Fund"
},
{
"name": "Spanish State Research Agency"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of the Balearic Islands"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-ablative Radiofrequency"
},
{
"name": "Low-intensity Shock Wave Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Peyronie Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salvador",
"contacts": [
{
"email": "[email protected]",
"name": "Patricia V Lordelo, Phd",
"phone": "+5571988592400",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Carlos Mamede, Phd",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Patricia V Lordelo, Phd",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Brazil",
"facility": "Centro de Atenção ao Assoalho Pelvico",
"geoPoint": {
"lat": -12.97111,
"lon": -38.51083
},
"state": "Ba",
"status": "RECRUITING",
"zip": "40.290-000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question\\[s\\] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Combination of two therapies with conservative devices is proposed.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 10,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease",
"nctId": "NCT06303661",
"orgStudyIdInfo": {
"id": "74001323.3.0000.5544",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function."
},
{
"measure": "It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to pain."
},
{
"measure": "It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to penile erection."
}
],
"secondaryOutcomes": [
{
"measure": "It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on quality of life and psycho-emotional aspects of anxiety and depression."
},
{
"measure": "It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on psycho-emotional aspects of anxiety and depression."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centro de Atenção ao Assoalho Pélvico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-08"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Methylone"
}
]
},
"conditionsModule": {
"conditions": [
"Post Traumatic Stress Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Adelaide",
"contacts": [
{
"email": null,
"name": "Research Team",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "CMAX Clinical Research",
"geoPoint": {
"lat": -34.92866,
"lon": 138.59863
},
"state": "South Australia",
"status": "RECRUITING",
"zip": "5000"
}
]
},
"descriptionModule": {
"briefSummary": "This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects",
"nctId": "NCT06303648",
"orgStudyIdInfo": {
"id": "TSND201-PK-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cmax: Maximum Observed Plasma Concentration for methylone"
},
{
"measure": "AUC: Area under the plasma concentration-time curve for methylone"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence and frequency of adverse events"
},
{
"measure": "Change overtime in Visual Analog Scales"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Transcend Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Healthy People"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 156,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "UFRJvac-1",
"briefTitle": "Safety of UFRJvac, Trivalent COVID-19 Vaccine",
"nctId": "NCT06303635",
"orgStudyIdInfo": {
"id": "UFRJvac-1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluate the safety and reactogenicity of the vaccine booster with the trivalent UFRJvac COVID-19"
},
{
"measure": "Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19"
},
{
"measure": "Evaluate the humoral immunogenicity of the vaccine booster the trivalent UFRJvac COVID-19"
},
{
"measure": "Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac"
},
{
"measure": "Evaluate the humoral immunogenicity of the vaccine booster trivalent UFRJvac"
},
{
"measure": "Evaluate the cellular immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universidade Federal do Rio de Janeiro"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Azidus Brasil"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-11-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-24"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MRI-USG fusion approach"
},
{
"name": "Cognitive-guided approach"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hong Kong",
"contacts": null,
"country": "Hong Kong",
"facility": "Prince of Wales Hospital",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial",
"nctId": "NCT06303622",
"orgStudyIdInfo": {
"id": "CRE-2023.610",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of men with clinically significant Prostate cancer(csPCa)"
}
],
"secondaryOutcomes": [
{
"measure": "Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm"
},
{
"measure": "Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m"
},
{
"measure": "The proportion of men with a diagnosis of csPCa only in targeted biopsy"
},
{
"measure": "Proportion of men with a diagnosis of csPCa only in systemic biopsy"
},
{
"measure": "Proportion of men with a diagnosis of clinically insignificant PCa,"
},
{
"measure": "Procedure time"
},
{
"measure": "Pain score on a scale of 0-10 taken after biopsy"
},
{
"measure": "Proportion of men with post-biopsy adverse events within 30 days after biopsy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Chinese University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-10"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "nonablative radiofrequency"
},
{
"name": "Vaginal dilator"
},
{
"name": "Sham nonablative radiofrequency"
}
]
},
"conditionsModule": {
"conditions": [
"Pelvic Pain"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 56,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Pelvic Pain",
"briefTitle": "Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder",
"nctId": "NCT06303609",
"orgStudyIdInfo": {
"id": "61102222.5.0000.5544",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Penetration capacity with reduced vaginal pain"
}
],
"secondaryOutcomes": [
{
"measure": "Sexual function"
},
{
"measure": "Quality of sexual life"
},
{
"measure": "Stress perception"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Centro de Atenção ao Assoalho Pélvico"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-07-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-06-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Hippotherapy"
},
{
"name": "Standard psychiatric treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Equine-Assisted Therapy",
"Schizophrenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erzurum",
"contacts": [
{
"email": "[email protected]",
"name": "Musa Eymir, Ph.D., PT, Assist. Prof.",
"phone": "+904424445388-2733",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Erzurum Technical University, Erzurum Community Mental Health Center",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": null,
"status": null,
"zip": "25010"
}
]
},
"descriptionModule": {
"briefSummary": "This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The evaluator who collects the data is blinded to the allocation of groups.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 88,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Hippotherapy in Patients With Schizophrenia",
"nctId": "NCT06303596",
"orgStudyIdInfo": {
"id": "Hippotherapy in Schizophrenia",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Positive and Negative Syndrome Scale (PANSS)"
},
{
"measure": "State-Trait Anxiety Inventory (STAI)"
},
{
"measure": "The Quality of Life Scale (QLS)"
},
{
"measure": "UCLA Loneliness Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Erzurum Technical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "paclitaxel"
},
{
"name": "carboplatin"
},
{
"name": "tislelizumab"
},
{
"name": "radiotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Esophageal Squamous Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hangzhou",
"contacts": null,
"country": "China",
"facility": "Zhejiang Cancer Hospital",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang",
"status": null,
"zip": "310000"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CRIS",
"briefTitle": "Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma",
"nctId": "NCT06303583",
"orgStudyIdInfo": {
"id": "IRB- 2022-213",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Complete pathological response rate"
}
],
"secondaryOutcomes": [
{
"measure": "R0 resection rate"
},
{
"measure": "2-year Disease-free survival rate"
},
{
"measure": "2-year overall survival rate"
},
{
"measure": "Safety will be analyzed through the incidence of adverse events, serious adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Qiu Guoqin"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CBL-514 injection"
},
{
"name": "0.9% Sodium chloride"
}
]
},
"conditionsModule": {
"conditions": [
"Dercum's Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas",
"nctId": "NCT06303570",
"orgStudyIdInfo": {
"id": "CBL-0202DD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To estimate the treatment effect, as measured by Complete Response (CR), between CBL-514 and placebo at Week 12 in participants with Dercum's disease (DD)."
}
],
"secondaryOutcomes": [
{
"measure": "To estimate the treatment effect, as measured by pain, between CBL-514 and placebo at Week 12 in participants with DD."
},
{
"measure": "To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24."
},
{
"measure": "To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24."
},
{
"measure": "To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24."
},
{
"measure": "To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24."
},
{
"measure": "To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24."
},
{
"measure": "To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24."
},
{
"measure": "To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24."
},
{
"measure": "To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24."
},
{
"measure": "To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24."
},
{
"measure": "To evaluate the treatment effect, as measured by change in volume, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24."
},
{
"measure": "To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24."
},
{
"measure": "To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24."
},
{
"measure": "To evaluate the incidence of adverse events of special interests (AESI) as defined in the protocol."
},
{
"measure": "To evaluate the incidence of clinically significant abnormal findings as defined in the protocol as defined in the protocol."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Caliway Biopharmaceuticals Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-28"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Preoperative Erector Spinae Plane Block"
},
{
"name": "Postperative Erector Spinae Plane Block"
}
]
},
"conditionsModule": {
"conditions": [
"Lumbar Spine Surgery",
"Erector Spinae Plane Block",
"Remifentanil Consumption"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Yenimahalle",
"contacts": [
{
"email": "[email protected]",
"name": "Musa Zengin, Associate Professor",
"phone": "00905307716235",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Deniz Çolak, MD",
"phone": "00905386519710",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ankara Etlik City Hospital",
"geoPoint": null,
"state": "Ankara",
"status": "RECRUITING",
"zip": "06170"
}
]
},
"descriptionModule": {
"briefSummary": "In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifantanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.As a result of all these; it was aimed to compare the intraoperative remifantanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of ESPB on Intraoperative Remifentanil Consumption",
"nctId": "NCT06303557",
"orgStudyIdInfo": {
"id": "AEŞH-EK1-2023-797",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Intraoperative remifentanil consumption"
}
],
"secondaryOutcomes": [
{
"measure": "Mean arterial pressure"
},
{
"measure": "Heart rate"
},
{
"measure": "Pain scores"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Atatürk Chest Diseases and Chest Surgery Training and Research Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-31"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Wedge 1"
}
]
},
"conditionsModule": {
"conditions": [
"Child Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Anchorage",
"contacts": null,
"country": "United States",
"facility": "Alaska Native Tribal Health Consortium",
"geoPoint": {
"lat": 61.21806,
"lon": -149.90028
},
"state": "Alaska",
"status": null,
"zip": "99508"
}
]
},
"descriptionModule": {
"briefSummary": "The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Wedge design using repeated cross sectional samples of Head Start preschool students",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 450,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "MOYD",
"briefTitle": "More Outside Your Door: A Diet/Physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers",
"nctId": "NCT06303544",
"orgStudyIdInfo": {
"id": "R01HL168853",
"link": "https://reporter.nih.gov/quickSearch/R01HL168853",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "BMI"
},
{
"measure": "Physical activity"
},
{
"measure": "Outdoor time"
},
{
"measure": "Sleep quality"
},
{
"measure": "Fingernail nitrogen & carbon stable isotope ratios"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Washington State University"
},
{
"name": "University of Alaska Anchorage"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Alaska Native Tribal Health Consortium"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Ferrous Fumarate"
},
{
"name": "Polysaccharide Iron"
},
{
"name": "Ferrous Ascorbate"
}
]
},
"conditionsModule": {
"conditions": [
"Iron Deficiency Anemia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Etobicoke",
"contacts": null,
"country": "Canada",
"facility": "Albion Finch Medical Centre",
"geoPoint": {
"lat": 43.65421,
"lon": -79.56711
},
"state": "Ontario",
"status": null,
"zip": "M9V 4B4"
}
]
},
"descriptionModule": {
"briefSummary": "Iron deficiency anemia (IDA) is a widespread condition affecting many people globally. Despite the many cases of IDA, there are few studies that compare the effectiveness of different types of iron supplements with a greater emphasis on the cost of supplements and their tolerability. This study aims to conduct a comparison between different iron supplements to determine the superiority of the iron supplements Ferrous Ascorbate (EBMfer) and Ferrous Fumarate (Eurofer) over polysaccharide iron (FeraMax). This comparison will be conducted by determining the change in hemoglobin levels for participants in this trial over a 3-month period."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 111,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacious Iron for Iron Deficiency Anemia in Adults Aged ≥18 Years",
"nctId": "NCT06303531",
"orgStudyIdInfo": {
"id": "Efficacious Iron",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Hemoglobin Levels"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Serum Ferritin"
},
{
"measure": "Tolerability of Study Medication - Discontinuation Rate"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NETWORK",
"name": "Dr. Anil K. Gupta Medicine Professional Corporation"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-24"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg)"
},
{
"name": "Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg)"
},
{
"name": "Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg)"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia",
"Hypercapnia",
"Hypocapnia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children.During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are.The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The investigators plan to conduct a randomized, prospective, crossover trial. The six arms will be as below:1. Normal ETCO2 -\\> High Normal ETCO2 -\\> Low Normal ETCO22. Normal ETCO2 -\\> Low Normal ETCO2 -\\> High Normal ETCO23. High Normal ETCO2 -\\> Low Normal ETCO2 -\\> Normal ETCO24. High Normal ETCO2 -\\> Normal ETCO2 -\\> Low Normal ETCO25. Low Normal ETCO2 -\\> High Normal ETCO2 -\\> Normal ETCO26. Low Normal ETCO2 -\\> Normal ETCO2 -\\> High Normal ETCO2",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The anesthesiologist will be blinded to the BIS reading and will continue to provide anesthesia according to the protocol. The BIS numerical value in the OR will be covered, but the waveform will be visible to assess signal quality. The anesthesiologist providing care to the patient will not be involved in data collection or analysis",
"whoMasked": [
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children",
"nctId": "NCT06303518",
"orgStudyIdInfo": {
"id": "H23-03546",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS."
}
],
"secondaryOutcomes": [
{
"measure": "Patient movement as detected clinically by the surgical or anesthetic team."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of British Columbia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
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"date": "2024-12-31"
},
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"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TUB-040"
}
]
},
"conditionsModule": {
"conditions": [
"Ovarian Cancer",
"Non-small Cell Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cincinnati",
"contacts": [
{
"email": null,
"name": "Alexander Starodub",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Alexander Starodub, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Christ Hospital",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio",
"status": null,
"zip": "45219"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients.TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
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"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
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},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NAPISTAR1-01",
"briefTitle": "FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC",
"nctId": "NCT06303505",
"orgStudyIdInfo": {
"id": "NAPISTAR 1-01",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2024-511074-80",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Determination of MTD"
}
],
"secondaryOutcomes": [
{
"measure": "Maximum plasma/serum concentration (Cmax)"
},
{
"measure": "Through plasma/serum concentration (Cmin)"
},
{
"measure": "The time taken to reach the maximum concentration (Tmax)"
},
{
"measure": "Area Under Curve (AUC)"
},
{
"measure": "Half life (T1/2)"
},
{
"measure": "Determination of immunogenicity"
},
{
"measure": "Determination of efficacy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Tubulis GmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "GUS"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Aspiration",
"Emergency Surgery"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 142,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study",
"nctId": "NCT06303492",
"orgStudyIdInfo": {
"id": "CTO 4096",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of change in Anesthetic Plan"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage change in the three-category risk assessment before and after GUS"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Samuel Lunenfeld Research Institute, Mount Sinai Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Non-Instrumental breathing exercise group"
},
{
"name": "Instrumental breathing exercise group"
}
]
},
"conditionsModule": {
"conditions": [
"Breathing Exercises",
"Telerehabilitation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "[email protected]",
"name": "Esra PEHLİVAN, Assoc. Dr.",
"phone": "+90 212 409 02 00",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Esra PEHLİVAN, Assoc. Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Fatma Nur AYYILDIZ, Student",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Beyzanur YEŞİLYURT, Student",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Mustafa ÇÖRTÜK, Prof. Dr.",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Fulya KARAAHMETOĞLU, PhD (c)",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "University of Health Sciences",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason;* Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities,* It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment.In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly.Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants.Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated."
},
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"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
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"count": 26,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Telerehabilitation-Based Respiratory Exercise Programs on Lung Capacity",
"nctId": "NCT06303479",
"orgStudyIdInfo": {
"id": "Voldyne_Tele",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pulmonary Function Test for FEV1"
},
{
"measure": "Pulmonary Function Test for PEF"
},
{
"measure": "Pulmonary Function Test for FEV1/FVC"
},
{
"measure": "Pulmonary Function Test for FVC"
}
],
"secondaryOutcomes": [
{
"measure": "International Physical Activity Questionnaire-Short Form (IPAQ-SF)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Saglik Bilimleri Universitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-29"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Fabry Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": null,
"country": "Denmark",
"facility": "Rigshospitalet",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": null,
"zip": "2100"
}
]
},
"descriptionModule": {
"briefSummary": "Fabry is a rare X-linked metabolic lysosomal disorder caused by deficiency in the enzyme α-galactosidase A (alpha-Gal A) by mutations in the GLA gene, encoding the alpha-Gal A enzyme, which catalyses glycosphingolipids, namely globotriaosylceramide (Gb3). Reduced or absent alpha-Gal A activity leads to accumulation of Gb3 in various organs as well as cellular dysfunction and inflammation causing phsyical symptoms and eventual organ failure. Treatment has been available since 2001 for Fabry patients - first enzyme replacement therapy and since 2016, an oral chaperone therapy, Migalastat. Although the initial trials of Migalastat had some both short and extended outcome treatment comparisons, the overall evidence of clinical efficacy is based on too small numbers considering the heterogeneity of the Fabry patient population as well as the very slow progression of the disease. Though the body of real-world evidence is growing, there is a need for more publications of real-world long-term data on clinical outcomes with a focus on treatment with Migalastat.Research Question:Is the incidence and prevalence of Fabry associated clinical events (FACEs) (cardiac, renal, and cerebrovascular) associated with sex, genotype, phenotype at time of diagnosis, biomarkers, and Fabry specific therapy?Objectives:* To investigate time to first Fabry associated clinical events (FACE) (cardiac, renal, and cerebrovascular) with particular focus on Migalastat clinical outcomes and treatment outcomes preceding Migalastat therapy.* To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment.* To describe FACEs in accordance with different geno- and phenotypic groups.* To investigate the incidence and time to a first fatal or non-fatal cardiac, renal, and cerebrovascular clinical event, separated by each category.Primary outcomes - Time to first FACE (cardiac, renal, and cerebrovascular) with particular focus on Migalastat on clinical outcomes and treatment outcomes preceding Migalastat therapy.Secondary outcomes* To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment.* To describe FACEs in accordance with different geno- and phenotypic groups To investigate the incidence and time to a first fatal or non-fatal cardiac, renal and cerebrovascular clinical event, separated by each category.Exploratory outcomes- To describe disease progression with focus on organ involvement.The study design is a retrospective clinical and paraclinical follow-up of the Danish National Fabry cohort in the period 01.01.2001-31.12.2022. Patient followed a structured yearly monitoring program as part of routine clincal care."
},
"designModule": {
"designInfo": {
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"observationalModel": "COHORT",
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"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 115,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RWE-FABRY",
"briefTitle": "Real World Evidence Study of Danish Fabry Patients",
"nctId": "NCT06303466",
"orgStudyIdInfo": {
"id": "R-23053109",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Organ-specific decline"
}
],
"primaryOutcomes": [
{
"measure": "Time to first individual FACE since confirmed diagnosis (Composite endpoint)"
},
{
"measure": "Time to first FACE after initiation of Migalastat treatment (Composite endpoint)"
}
],
"secondaryOutcomes": [
{
"measure": "Time to first individual FACE since confirmed diagnosis (cardiac)"
},
{
"measure": "Time to first individual FACE after initiation of Migalastat treatment (cardiac)"
},
{
"measure": "Time to first individual FACE since confirmed diagnosis (renal)"
},
{
"measure": "Time to first individual FACE after initiation of Migalastat treatment (renal)"
},
{
"measure": "Time to first individual FACE after initiation of Migalastat treatment (cerebrovascular)"
},
{
"measure": "Time to first individual FACE since confirmed diagnosis (cerebrovascular)"
},
{
"measure": "Prevalence of FACE since confirmed diagnosis"
},
{
"measure": "Prevalence of FACE after initiation of Fabry-specific treatment"
},
{
"measure": "Incidence of FACE since confirmed diagnosis"
},
{
"measure": "Incidence of FACE after initiation of Fabry-specific treatment"
},
{
"measure": "Incidence of cardiac events since confirmed diagnosis"
},
{
"measure": "Incidence of renal events since confirmed diagnosis"
},
{
"measure": "Incidence of cerebrovascular events since confirmed diagnosis"
},
{
"measure": "Incidence of cardiac events after initiation of Fabry-specific treatment"
},
{
"measure": "Incidence of renal events after initiation of Fabry-specific treatment"
},
{
"measure": "Incidence of cerebrovascular events after initiation of Fabry-specific treatment"
},
{
"measure": "Annualized rate of change in eGFR by CKDEPI-formula since initiation of treatment"
},
{
"measure": "Annualized rate of change in eGFR by CKDEPI-formula after initiation of Fabry-specific treatment"
},
{
"measure": "Rapid renal progression of disease since confirmed diagnosis"
},
{
"measure": "Rapid renal progression of disease after initiation of Fabry-specific treatment"
},
{
"measure": "Incidence of albuminuria since confirmed diagnosis"
},
{
"measure": "Incidence of albuminuria after initiation of Fabry-specific treatment"
},
{
"measure": "Prevalence of albuminuria since confirmed diagnosis"
},
{
"measure": "Prevalence of albuminuria after initiation of Fabry-specific treatment"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Amicus Therapeutics"
},
{
"name": "Rigshospitalet, Denmark"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Caroline Michaela Kistorp"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-06-30",
"filename": "Prot_000.pdf",
"hasIcf": false,
"hasProtocol": true,
"hasSap": false,
"label": "Study Protocol",
"size": 1310571,
"typeAbbrev": "Prot",
"uploadDate": "2024-02-21T07:57"
},
{
"date": "2023-12-13",
"filename": "SAP_001.pdf",
"hasIcf": false,
"hasProtocol": false,
"hasSap": true,
"label": "Statistical Analysis Plan",
"size": 519985,
"typeAbbrev": "SAP",
"uploadDate": "2024-01-12T12:10"
}
]
}
} |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Balance exercises"
},
{
"name": "Resisted exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Diabetic Peripheral Neuropathy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "Muhammad Kashif, PhD-PT",
"phone": "03333125303",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Muhammad Kashif, PhD-PT",
"phone": "03333125303",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Riphah International University",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "54660"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 58,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Effects of Balance and Resisted Training in Diabetic Peripheral Neuropathy.",
"nctId": "NCT06303453",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0291",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Michigan neuropathy screening instrument"
},
{
"measure": "De Morton mobility index test"
},
{
"measure": "PainDETECT Tool"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Routine Physical Therapy+ Balance Training"
},
{
"name": "Virtual Reality+ Routine Physical Therapy"
},
{
"name": "Motor Imagery+ Routine Physical Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "Muhammad Kashif, PhD-PT",
"phone": "03333125303",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Riphah International University",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "54660"
}
]
},
"descriptionModule": {
"briefSummary": "Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Virtual Reality Training Versus Motor Imagery in Children With Cerebral Palsy",
"nctId": "NCT06303440",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0288",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Gross Motor Function Classification System(GMFCS)"
},
{
"measure": "Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 )"
},
{
"measure": "WeeFIM scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-25"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Modified constraint-induced movement therapy"
},
{
"name": "Electrical stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Erb's Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "Muhammad Kashif, PhD-PT",
"phone": "03333125303",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Riphah International University",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": "54660"
}
]
},
"descriptionModule": {
"briefSummary": "ERB's palsy is an injury of upper section of the brachial plexus (C5-6) leading to an internally rotated and adducted shoulder and a pronated forearm. Modified constraint-induced movement therapy improves the functionality of the affected limb, while electrical stimulation helps in the improvement of active range of motion and muscle strength in ERB's palsy patients. This study aims to investigate the effects of modified constraint-induced movement therapy with and without electrical stimulation on range of motion, muscle strength, and motor functions in patients with ERB's Palsy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The study would be single-blinded as the assessor of the study would be kept blind to the treatment groups to which patients will be allocated.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "6 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy",
"nctId": "NCT06303427",
"orgStudyIdInfo": {
"id": "REC/RCR & AHS/23/0292",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Standard universal goniometer"
},
{
"measure": "Medical Research Council (MRC) Scale"
},
{
"measure": "Active Movement Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Carotid Endarterectomy (CEA)"
},
{
"name": "Carotid Artery Stenting (CAS)"
},
{
"name": "Hybrid Surgery"
}
]
},
"conditionsModule": {
"conditions": [
"Non-acute Carotid Artery Occlusion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Tao Wang, MD",
"phone": "18810302298",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xuanwu Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100005"
},
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Liqun Jiao, Dr.",
"phone": "13911224991",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Xuanwu Hospital, Capital Medical University.",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": "RECRUITING",
"zip": "100053"
}
]
},
"descriptionModule": {
"briefSummary": "The short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. The purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RESCO",
"briefTitle": "Revascularization for Symptomatic Non-acute Carotid Artery Occlusion",
"nctId": "NCT06303414",
"orgStudyIdInfo": {
"id": "RESCO",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Stroke or death whthin 30 days or recurrent ischemic stroke related of qualifying artery beyond 30 days through 12 months"
},
{
"measure": "MMSE within 30 and 90 days after procedure"
},
{
"measure": "MoCA scale within 30 and 90 days after procedure"
}
],
"secondaryOutcomes": [
{
"measure": "Technical success rate"
},
{
"measure": "Procedural success rate"
},
{
"measure": "Any stroke within 30 days, 90 days and 12 months after procedure"
},
{
"measure": "Death within 30 days, 90 days and 12 months after procedure"
},
{
"measure": "Cranial nerve injury"
},
{
"measure": "Carotid artery or internal carotid artery reocclusion"
},
{
"measure": "Functional outcome"
},
{
"measure": "Other major complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Xuanwu Hospital, Beijing"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2016-06-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SI joint thrust manipulation"
},
{
"name": "pelvic stabilization exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain, Post Partum"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Peshawar",
"contacts": [
{
"email": "[email protected]",
"name": "Asmar Fatima, MS OMPT",
"phone": "03336195644",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gull alay, MS OMPT*",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Asmar Fatima, MS OMPT",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Lady Reading Hospital and Shahab Orthopedic & General Hospital",
"geoPoint": {
"lat": 34.008,
"lon": 71.57849
},
"state": "KPK",
"status": "RECRUITING",
"zip": "25000"
}
]
},
"descriptionModule": {
"briefSummary": "compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises in Post Partum Low Back Pain",
"nctId": "NCT06303401",
"orgStudyIdInfo": {
"id": "REC/MS-PT/01787 Gullalay",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numeric pain rating scale (NPRS)"
},
{
"measure": "Modified Oswestry Disability Index (ODI)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-27"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bruegger,s Exercise"
},
{
"name": "Egoscue Exercise"
}
]
},
"conditionsModule": {
"conditions": [
"Lower Cross Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": null,
"name": "Abdul Wasay, MS(SPT)",
"phone": "03345056564",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Azka Batool, MS(OMPT)",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Nadia Ishtiaq, MS-OMPT",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Pakistan Railway General Hospital",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Federal",
"status": "RECRUITING",
"zip": "44000"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to find effects of Bruegger's Exercise versus Egoscue exercise on pain and hyperlordosis on patient with lower cross syndrome. This is interventional study which recruits 34 participants ,14 in each group."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 34,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Bruegger's Exercises Versus Egoscue Exercise on Lower Cross Syndrome",
"nctId": "NCT06303388",
"orgStudyIdInfo": {
"id": "REC/MS-PT/01721",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Flexicurve Ruler"
},
{
"measure": "Pelvic Inclinometer"
},
{
"measure": "NPRS"
}
],
"secondaryOutcomes": [
{
"measure": "Modified Thomas Test"
},
{
"measure": "Visual Assessment through toe touching"
},
{
"measure": "Prone Hip Extension Co-ordination Test"
},
{
"measure": "Trunk Flexion Co-ordination and Strength Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-26"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Kinesio taping"
},
{
"name": "Conventional physical therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Lower Cross Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "[email protected]",
"name": "Asmar Fatima, MS OMPT",
"phone": "03336195644",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nida Kausar, MS OMPT*",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Asmar Fatima, MS OMPT",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Railway hospital Rawalpindi",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "46060"
}
]
},
"descriptionModule": {
"briefSummary": "Determine the impact of Kinesio taping on pain, postural alignment and functional outcomes in individuals with lower cross syndrome."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "30 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Kinesio Taping on Pain, Posture and Function in Lower Cross Syndrome",
"nctId": "NCT06303375",
"orgStudyIdInfo": {
"id": "REC/MS-PT/01718 Nida Kausar",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual analog scale (VAS)"
},
{
"measure": "Anterior pelvic tilting"
},
{
"measure": "Oswestry Disability Index (ODI)"
},
{
"measure": "Muscle Length"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-13"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Elastic band excercise"
},
{
"name": "strengthening with conventional physical therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Forward Head Posture"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": null,
"country": "Pakistan",
"facility": "Railway hospital Rawalpindi",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": null,
"zip": "46060"
}
]
},
"descriptionModule": {
"briefSummary": "• To determine the effects of Elastic Band Exercises on Chest Expansion, Forward Head Posture and disability"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Elastic Band Excercises on Chest Expansion",
"nctId": "NCT06303362",
"orgStudyIdInfo": {
"id": "REC/MS-PT/014258 Sumbal Nawaz",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cloth tape measurement"
},
{
"measure": "Neck Disability Index"
},
{
"measure": "Craniovertebral angle"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Samples collection"
}
]
},
"conditionsModule": {
"conditions": [
"Cerebral Vasospasm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bordeaux",
"contacts": [
{
"email": "[email protected]",
"name": "Grégoire CANE, Dr",
"phone": "0557821019",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Laure ESTEVE",
"phone": "0557821913",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "CHU de Bordeaux",
"geoPoint": {
"lat": 44.84044,
"lon": -0.5805
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective is to create a dynamic clinical prediction model that includes routinely measured care and biological biomarkers to predict cerebral vasospasm within 14 days of bleeding in patients treated in the neurosurgical intensive care unit for subarachnoid hemorrhage.Patients admitted to intensive care will be followed for up to 14 days (D14 time horizon of interest), or until discharge from intensive care if earlier.Blood samples will be taken from D1 to D10 to isolate the blood biomarkers of interest for each patient.The measurement of biomarkers and cerebral vasospasm will be blinded to each other."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective single-centre cohort study with prognostic aim, carried out in the neuro-resuscitation unit of the Bordeaux University Hospital.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CVSBIODIAG",
"briefTitle": "Predictive Model for the Occurrence of Cerebral Vasospasm Complicating Subarachnoid Haemorrhage by Combined Analysis of the Kinetics of a Panel of Biomarkers.",
"nctId": "NCT06303349",
"orgStudyIdInfo": {
"id": "CHUBX 2023/45",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Occurrence of cerebral vasospasm"
}
],
"secondaryOutcomes": [
{
"measure": "Biomarkers measurements"
},
{
"measure": "WFNS (World Federation of Neurologic Surgeons) score"
},
{
"measure": "Glasgow score"
},
{
"measure": "Medical Research Council (MRC) score"
},
{
"measure": "PtiO2 (oxygen pressure in the cerebral tissue)"
},
{
"measure": "Transcranial Doppler"
},
{
"measure": "Modified Fisher score"
},
{
"measure": "Non-significant angiographic vasospasm"
},
{
"measure": "Non-significant perfusion anomaly"
},
{
"measure": "Glasgow Outcome Scale -Extended (GOS-E)"
},
{
"measure": "Cerebral ischemic lesions"
},
{
"measure": "Occurrence of symptomatic vasospasm"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Bordeaux University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Bordeaux"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "NMES with Dynamic Bracing"
},
{
"name": "NMES without Dynamic Bracing"
},
{
"name": "Dynamic Bracing Only"
}
]
},
"conditionsModule": {
"conditions": [
"Diplegic Spastic Cerebral Palsy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Faisalābad",
"contacts": [
{
"email": "[email protected]",
"name": "Ammara Abbas, tDPT",
"phone": "03214932464",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ayesha Ashraf, MS NMPT*",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Children Hospital",
"geoPoint": {
"lat": 31.41554,
"lon": 73.08969
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "54000"
}
]
},
"descriptionModule": {
"briefSummary": "The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "participants and outcome assessors will be kept blind about the intervention which the patients will be receiving",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP",
"nctId": "NCT06303336",
"orgStudyIdInfo": {
"id": "REC/0258 Ayesha Ashraf",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Modified Ashworth Scale"
},
{
"measure": "Observable Movement Quality Scale"
},
{
"measure": "Physicians Rating Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-14"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Qigong Exercise"
},
{
"name": "Wu Dang Tai Chi"
}
]
},
"conditionsModule": {
"conditions": [
"Cardiovascular Diseases",
"Risk Behavior, Health"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": "[email protected]",
"name": "Mehwish Waseem, MSPT-CPPT",
"phone": "0331-5309015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Nawal Fatima, MSPT-CPPT*",
"phone": "0307 6500954",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Pakistan Railway General Hospital",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "4600"
}
]
},
"descriptionModule": {
"briefSummary": "To compare whether the Qigong exercise or Wu Dang Tai Chi Chuan will be effective in improving exercise capacity and reducing stress in CVD-risk individuals. Based on preliminary data, Qigong and Tai-Chi may help treat anxiety and depression symptoms in patients with chronic illnesses as well as in healthy adults. Without the need for specialized equipment, Qigong and Tai-Chi are both readily adjustable mind-body exercises that may be done whenever and wherever. For this reason, Qigong and TaiChi should be extensively encouraged as ways to enhance emotional wellbeing"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Effectiveness of Qigong Exercise Versus Wu Dang Tai Chi Chuan in CVD Risk Individuals",
"nctId": "NCT06303323",
"orgStudyIdInfo": {
"id": "Nawal Fatima",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Exercise Capacity"
},
{
"measure": "Stress"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-03"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Gaze Stability Exercises"
},
{
"name": "Optokinetic Exercises"
},
{
"name": "Routine Physical Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Vestibular Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bahāwalpur",
"contacts": [
{
"email": "[email protected]",
"name": "Farrukh Rashid, MBBS, MCPS",
"phone": "03336390907",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Tassaduq, MBBS, MCPS",
"phone": "03068200034",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Bahawal Victoria Hospital",
"geoPoint": {
"lat": 29.4,
"lon": 71.68333
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "63100"
}
]
},
"descriptionModule": {
"briefSummary": "This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Participants fulfilling the inclusion criteria will be recruited by using the convenience sampling randomly allocated into two groups by computer generator method. 20 participants will be assigned to Group A receiving gaze stability exercises and 20 to the Group B receiving optokinetic exercises, both alongside routine physical therapy. Each group will undergo 5 weekly sessions of treatment for 4 weeks.The assessment tools include Dizziness Handicap Inventory for dizziness; Mini-BESTest and modified-Clinical Test of Sensory Interaction of Balance for balance assessment while Vestibular Disorders Activities of Daily Living Scale for daily activities."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Group A (Gaze Stability Exercises + Balance Exercises) Group B (Optokinetic Exercises + Balance Exercises)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Assessor will be blinded. Assessor will be the person having 10 years experience in neuromuscular rehabilitation.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Effects Of Gaze Stability Exercises And Optokinetic Exercises In Patients With Vestibular Hypofunction",
"nctId": "NCT06303310",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0296",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Dizziness Handicap Inventory"
},
{
"measure": "Mini-Bestest"
},
{
"measure": "Modified-Clinical Test of Sensory Interaction on Balance"
},
{
"measure": "Vestibular Disorders Activities of Daily Living Scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "REFLEXOLOGY"
},
{
"name": "GENERALIZED STRETCHING"
}
]
},
"conditionsModule": {
"conditions": [
"Postmenopausal Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "imran amjad",
"phone": "03324390125",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Aneela Shahid, MSPT(WH)",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Akhtar Saeed trust hospital,",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "05499"
}
]
},
"descriptionModule": {
"briefSummary": "To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 32,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "50 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Reflexology and Generalized Stretching in Postmenopausal Females.",
"nctId": "NCT06303297",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0576",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Insomnia severity index score"
},
{
"measure": "Menopause Rating Scale"
},
{
"measure": "Menopause Specific Quality of Life"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "subcutaneous Teriparatide injection"
},
{
"name": "placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Ankle Fractures"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs.There is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications.The proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed.This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT",
"nctId": "NCT06303284",
"orgStudyIdInfo": {
"id": "Pending",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Participant recruitment rate"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of composite measure of complications"
},
{
"measure": "Adverse events"
},
{
"measure": "modified Radiological Union Scale for Tibia [RUST] score),"
},
{
"measure": "Olerud Molander Score"
},
{
"measure": "EuroQol five dimensions [EQ-5D]"
},
{
"measure": "short form-12 [SF-12]"
},
{
"measure": "pain visual analogue score [VAS]"
},
{
"measure": "time-to-fracture union"
},
{
"measure": "90 day mortality"
},
{
"measure": "Bone mineral density"
},
{
"measure": "Total cost and QALYs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Calgary"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey"
},
{
"name": "Caw Thorne Cooksey"
}
]
},
"conditionsModule": {
"conditions": [
"Vestibular Hypofunction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kashmir",
"contacts": [
{
"email": "[email protected]",
"name": "Nadia Azhar, NMPT",
"phone": "03335281431",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "ENT dept. of DHQ Mirpur AJK",
"geoPoint": null,
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of the study is to determine the effects of transcutaneous auricular vagus nerve stimulation on dizziness and balance on elderly population with unilateral vestibular hypofunction. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. Intervention Group A received Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey exercise while Group group B received Caw Thorne Cooksey exercise only. Both groups received intervention of 30 minutes daily for 4 weeks (16 sessions). Assessment was done at the baseline, after 2 weeks and after 4 weeks"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population",
"nctId": "NCT06303271",
"orgStudyIdInfo": {
"id": "MUHAMMAD NISAR",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Dix-Hall pike test"
},
{
"measure": "Berg Balance Scale"
},
{
"measure": "The Dizziness Handicap Inventory (DHI)"
},
{
"measure": "Dynamic Gait Index (DGI)"
},
{
"measure": "Modified Clinical Test of sensory interaction & Balance (MCTSIB)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Core Stabalization Exercises"
},
{
"name": "Generalized Antenatal Exercises"
}
]
},
"conditionsModule": {
"conditions": [
"Low Back Pain",
"Pelvic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "Sharmeen Kanwar, MS-WHPT*",
"phone": "0307-8778164",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Tehsil Headquarter Hospital Raiwind",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": "RECRUITING",
"zip": "55150"
}
]
},
"descriptionModule": {
"briefSummary": "Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Single (Outcomes Assessor)",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain",
"nctId": "NCT06303258",
"orgStudyIdInfo": {
"id": "RiphahIU Sharmeen Kanwar",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analogue Scale (VAS)"
},
{
"measure": "Visual Analogue Scale (VAS)"
},
{
"measure": "Pregnant women's quality of life questionnaire (QOL-GRAV)"
},
{
"measure": "Pregnant women's quality of life questionnaire (QOL-GRAV)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ABDOMINAL BINDERS"
},
{
"name": "TENS"
}
]
},
"conditionsModule": {
"conditions": [
"Cesarean Section; Complications, Wound, Dehiscence"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "imran amjad",
"phone": "03324390125",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Mishal Jamal, MSPT(WH)",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "PAF hospital",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": null,
"status": "RECRUITING",
"zip": "05499"
}
]
},
"descriptionModule": {
"briefSummary": "To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 28,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section",
"nctId": "NCT06303245",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0579",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "o Numeric Pain rating Scale"
},
{
"measure": "o Symptom Distress scale"
},
{
"measure": "o PAC-SYM Questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "MANUAL LYMPHATIC DRAINAGE"
},
{
"name": "THERAPEUTIC ULTRASOUND"
}
]
},
"conditionsModule": {
"conditions": [
"Postpartum Complication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "hina gul gul",
"phone": "03214979172",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Irsa Zahid, MSPT(WH)",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Innovative Health Concepts Clinic",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": null,
"status": "RECRUITING",
"zip": "05499"
}
]
},
"descriptionModule": {
"briefSummary": "To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 42,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement",
"nctId": "NCT06303232",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0578",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual Analogue Scale - VAS"
},
{
"measure": "Six Point Engorgement Scale - SPE"
},
{
"measure": "Breastfeeding Self-Efficacy Scale - BSES"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-02-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "RADITIONAL MODERATE INTENSITY TRAINING"
},
{
"name": "HIGH INTENSITY INTERVAL TRAINING"
}
]
},
"conditionsModule": {
"conditions": [
"Polycystic Ovarian Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": [
{
"email": "[email protected]",
"name": "hina gul gul",
"phone": "03214979172",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Fatima Kashif, MSPT(WH)",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Pakistan",
"facility": "Gynecological Department of Fatima Memorial Hospital",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": null,
"status": "RECRUITING",
"zip": "05499"
}
]
},
"descriptionModule": {
"briefSummary": "To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome",
"nctId": "NCT06303219",
"orgStudyIdInfo": {
"id": "REC/RCR&AHS/23/0577",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Hamilton Anxiety Rating scale (HAM-A)"
},
{
"measure": "The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)"
},
{
"measure": "The Fatigue Impact Scale (FIS)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-11-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)"
}
]
},
"conditionsModule": {
"conditions": [
"Hypertension"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (HBPT) and case management (CM), relative to usual care, for improving blood pressure (BP) control among patients with high blood pressure discharged from the emergency department (ED).The main question it aims to answer is: Does telemonitoring with case management improve BP control, relative to usual care, for people with high blood pressure discharged from the ED?Secondary research questions will address:1. How do these interventions (telemonitoring and case management) improve medication adherence?2. Do these interventions reduce physician and ED visits?3. Are these interventions safe?4. How do these interventions influence patient experience?Participants in the intervention group will receive training and use of a home BP telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored BP data, and adjust medications. The control group will receive usual care from their primary care physician and will receive the same home BP monitor and hypertension education."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 408,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "TEC4Home Blood Pressure Randomized Controlled Trial",
"nctId": "NCT06303206",
"orgStudyIdInfo": {
"id": "H23-00623",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Systolic blood pressure controlled"
}
],
"secondaryOutcomes": [
{
"measure": "Impact of intervention on other blood pressure measures"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of British Columbia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "pacritinib"
}
]
},
"conditionsModule": {
"conditions": [
"Myelodysplastic Syndromes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bethesda",
"contacts": [
{
"email": "[email protected]",
"name": "National Cancer Institute Referral Office",
"phone": "888-624-1937",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "National Institutes of Health Clinical Center",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland",
"status": null,
"zip": "20892"
}
]
},
"descriptionModule": {
"briefSummary": "Background:Myelodysplastic syndrome (MDS) and myelodysplastic/myeloproliferative neoplasm (MDS/MPN) are blood disorders that can cause serious complications in children and adults. MDS and MDS/MPN can also progress to acute myeloid leukemia. Treatments for these disorders are risky and not always effective. Better treatments are needed.Objective:To test a study drug (pacritinib) in adults and children with MDS or MDS/MPN.Eligibility:Children (aged 12 to 17 years) and adults (aged 18 years and older) with MDS or MDS/MPN.Design:Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function. They may have a bone marrow biopsy: An area over the hip will be numbed; a needle will be inserted to remove a sample of soft tissue from inside the hipbone.Pacritinib is a capsule taken by mouth. All participants will take the study drug 2 times a day, every day, in 28-day cycles. They will write down the date and time they take each capsule. Doctors will assign varying dosages of the drug to different participants.Participants will have clinic visits each week during cycle 1; every 2 weeks during cycle 2; and gradually increasing to every 3 months after cycle 13. Treatment will continue for up to 8 years.Bone marrow biopsies, heart tests, and other tests will be repeated at intervals throughout the study. Participants will also fill out questionnaires about their quality of life, the symptoms of their disease, and other topics."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "120 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms",
"nctId": "NCT06303193",
"orgStudyIdInfo": {
"id": "10001554",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "001554-C",
"link": null,
"type": null
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recommended phase 2 dose of pacritinib in participants 12-17 years of age"
},
{
"measure": "Efficacy as measured by Objective Response Rate (ORR) per each risk-based cohort"
}
],
"secondaryOutcomes": [
{
"measure": "Pharmacokinetic (PK) properties of pacritinib"
},
{
"measure": "Extended safety of pacritinib"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2035-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-26"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Hearing Loss",
"Head and Neck Neoplasms",
"Hearing Disorders",
"Laryngeal Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bethesda",
"contacts": [
{
"email": "[email protected]",
"name": "Marcia Mulquin, RN, MSN",
"phone": "301-496-1601",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "NIH Clinical Center Office of Patient Recruitment (OPR)",
"phone": "(800) 411-1222",
"phoneExt": "TTY dial 711",
"role": "CONTACT"
}
],
"country": "United States",
"facility": "National Institutes of Health Clinical Center",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "20892"
}
]
},
"descriptionModule": {
"briefSummary": "Background:Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.Objective:To collect biological samples for a repository that will be used for research.Eligibility:People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.Design:Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.Samples may be used for genetic testing."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "NIDCD Otolaryngology Clinical Protocol Biospecimen Bank",
"nctId": "NCT06303180",
"orgStudyIdInfo": {
"id": "10001560",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "001560-DC",
"link": null,
"type": null
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To create a biorepository of diseased and normal tissue specimens for research purposes."
}
],
"secondaryOutcomes": [
{
"measure": "To share specimens with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Institute on Deafness and Other Communication Disorders (NIDCD)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2033-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2033-12-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biopsy"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Echocardiography"
},
{
"name": "Multigated Acquisition Scan"
},
{
"name": "Osimertinib"
},
{
"name": "Radiologic Examination"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Lymphoma",
"Advanced Malignant Solid Neoplasm",
"Hematopoietic and Lymphoid Cell Neoplasm",
"Refractory Lymphoma",
"Refractory Malignant Solid Neoplasm",
"Refractory Multiple Myeloma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This phase II MATCH treatment trial evaluates the effectiveness of osimertinib (AZD9291) in treating patients with cancer that has certain genetic changes called EGFR mutations. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of mutant forms of the EGFR protein, which play a key role in tumor cell growth. Osimertinib may cause tumor cell death and inhibit tumor growth in EGFR-overexpressing tumor cells, thereby stopping or slowing the spread of tumor cells."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E)",
"nctId": "NCT06303167",
"orgStudyIdInfo": {
"id": "NCI-2024-01150",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01150",
"link": null,
"type": "REGISTRY"
},
{
"domain": "ECOG-ACRIN Cancer Research Group",
"id": "EAY131-E",
"link": null,
"type": "OTHER"
},
{
"domain": "CTEP",
"id": "EAY131-E",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "U10CA180820",
"link": "https://reporter.nih.gov/quickSearch/U10CA180820",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Objective response rate"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Progression free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-26"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-26"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2015-08-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mobiderm Intimate Bra group"
}
]
},
"conditionsModule": {
"conditions": [
"Breast Cancer Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": null,
"name": "Séverine ALRAN, Dr",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "France",
"facility": "Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Paris 14",
"status": "RECRUITING",
"zip": "75014"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective, exploratory, monocentric, uncontrolled clinical study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MOBIBRA",
"briefTitle": "Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment",
"nctId": "NCT06303154",
"orgStudyIdInfo": {
"id": "EC45 MOBIBRA",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "2023-A01937-38",
"id": "ID-RCB",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evolution of breast edema severity"
}
],
"secondaryOutcomes": [
{
"measure": "Comparison of methods to follow changes in the severity of breast edema - TDC measurement"
},
{
"measure": "Comparison of methods to follow changes in the severity of breast edema - Clinical assessment"
},
{
"measure": "Comparison of methods to follow changes in the severity of breast edema - Ultrasound measurement"
},
{
"measure": "Time to edema onset"
},
{
"measure": "Time to edema disappearance"
},
{
"measure": "Symptoms and quality of life changes associated with breast edema"
},
{
"measure": "Breast edema hypersensitivity"
},
{
"measure": "Breast pain"
},
{
"measure": "Skin changes associated with breast edema"
},
{
"measure": "Physical activity"
},
{
"measure": "Healing time"
},
{
"measure": "Safety of the device"
},
{
"measure": "Compliance to the device"
},
{
"measure": "Patient's satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Thuasne"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-16"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-21"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Closed Chain exercises"
},
{
"name": "Neuromuscular Training"
},
{
"name": "Mobilization with Movement"
}
]
},
"conditionsModule": {
"conditions": [
"Ankle Injuries",
"Musculoskeletal Manipulations"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": null,
"country": "Pakistan",
"facility": "Pakistan Sports Board",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to compare the effects of neuromuscular training and mobilization with movement on pain, range of motion, function, and disability in professional athletes with ankle sprain. Neuromuscular training focuses on improving neuromuscular control and stability, while mobilization with movement aims to restore joint mobility and function. By investigating the outcomes of these two interventions, the study seeks to provide insights into their effectiveness for managing ankle sprains in professional athletes."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "the assessor who take the reading is blind",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparative Effects of Neuromuscular Training and Mobilization With Movement in Professional Athletes With Ankle Sprain",
"nctId": "NCT06303141",
"orgStudyIdInfo": {
"id": "LUC/CPGS/PGS/20230405/001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numerical Pain Rating Scale for Pain"
},
{
"measure": "Goniometer for Range of Motion"
},
{
"measure": "Star balance excursion test for Balance"
},
{
"measure": "Foot and ankle ability Measure for Functional Performance"
},
{
"measure": "Cumberland Ankle Instability"
}
],
"secondaryOutcomes": [
{
"measure": "Agility T-test"
},
{
"measure": "Speed (20m sprint test)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-09-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-05"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Amoxicillin 250 MG"
},
{
"name": "Placebo"
},
{
"name": "Amoxicillin 62.5mg"
},
{
"name": "Amoxicillin 187.5mg"
}
]
},
"conditionsModule": {
"conditions": [
"Penicillin Allergy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lubbock",
"contacts": [
{
"email": "[email protected]",
"name": "Study Coordinator",
"phone": "806-543-8994",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Joshua A Peterson, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Joshua A Peterson, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Nicole Welch, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "KaKa L Adams, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Barbara Mora Gonzalez, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sebastian Sanchez Lopez, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Sierra Sullivan, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jacob Nichols, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "James A Tarbox, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Texas Tech University Health Sciences Center",
"geoPoint": {
"lat": 33.57786,
"lon": -101.85517
},
"state": "Texas",
"status": "RECRUITING",
"zip": "79430"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as \"penicillin-allergic\" previously. The main question it aims to answer is:- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "- Low-risk penicillin allergic patients (\"low-risk\" determined by a PEN-FAST score of 2 or less) will be recruited. Clinically stable patients will be randomly assigned in a double-blinded manner to receive either a one-dose or graded two-dose direct oral challenge with amoxicillin in an outpatient setting. Those assigned to receive one dose of amoxicillin will receive a placebo in place of a second dose of amoxicillin. Both groups will receive the same cumulative dose of amoxicillin (250mg) by the end of the trial. Baseline vital signs will be obtained and tracked throughout the trial. Patients will also be monitored for development of signs of allergic reactions during the trial, with administration of appropriate treatment should the need arise.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 380,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "89 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge",
"nctId": "NCT06303128",
"orgStudyIdInfo": {
"id": "IRB-FY2024-61",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Proportion of successfully \"delabeled\" subjects in one-dose versus two-dose groups"
}
],
"secondaryOutcomes": [
{
"measure": "Analysis of adverse reactions"
},
{
"measure": "Analysis of medical and allergic history"
},
{
"measure": "Validation of penicillin allergy delabeling"
},
{
"measure": "Analysis of demographic data"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Texas Tech University Health Sciences Center"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "James Tarbox, MD"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-03"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Nicotine Pouch P1312914, 4 mg nicotine"
},
{
"name": "Nicotine Pouch P1312915, 8 mg nicotine"
},
{
"name": "Nicotine Pouch P1013215, 8 mg nicotine"
},
{
"name": "Nicotine Pouch P1013218, 10 mg nicotine"
},
{
"name": "Nicotine Pouch P1012919, 12 mg nicotine"
},
{
"name": "Smoking Abstinence"
},
{
"name": "Continued UB cigarette smoking"
}
]
},
"conditionsModule": {
"conditions": [
"Tobacco Use",
"Smoking"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bentonville",
"contacts": null,
"country": "United States",
"facility": "Pillar Bentonville",
"geoPoint": {
"lat": 36.37285,
"lon": -94.20882
},
"state": "Arkansas",
"status": null,
"zip": "72712"
},
{
"city": "Lexington",
"contacts": null,
"country": "United States",
"facility": "AMR Lexington",
"geoPoint": {
"lat": 37.98869,
"lon": -84.47772
},
"state": "Kentucky",
"status": null,
"zip": "40509"
},
{
"city": "Springfield",
"contacts": null,
"country": "United States",
"facility": "QPS Missouri",
"geoPoint": {
"lat": 37.21533,
"lon": -93.29824
},
"state": "Missouri",
"status": null,
"zip": "65802"
},
{
"city": "Knoxville",
"contacts": [
{
"email": null,
"name": "William Smith, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "AMR Knoxville",
"geoPoint": {
"lat": 35.96064,
"lon": -83.92074
},
"state": "Tennessee",
"status": null,
"zip": "37920"
},
{
"city": "Richardson",
"contacts": null,
"country": "United States",
"facility": "Pillar Richardson",
"geoPoint": {
"lat": 32.94818,
"lon": -96.72972
},
"state": "Texas",
"status": null,
"zip": "75080"
}
]
},
"descriptionModule": {
"briefSummary": "This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "CSD231005 Nicotine Pouch Biomarkers of Exposure",
"nctId": "NCT06303115",
"orgStudyIdInfo": {
"id": "CSD231005 BoE",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL]"
}
],
"secondaryOutcomes": [
{
"measure": "4Aminobiphenyl [4ABP]"
},
{
"measure": "1Aminonaphthalene [1AN]"
},
{
"measure": "2Aminonaphthalene [2AN]"
},
{
"measure": "2Cyanoethyl mercapturic acid [CEMA]"
},
{
"measure": "3Hydroxypropyl mercapturic acid [3HPMA]"
},
{
"measure": "3Hydroxy1methylpropylmercapturic acid [HMPMA]"
},
{
"measure": "3hydroxybenzo[a]pyrene [3-OH-B[a]P]"
},
{
"measure": "1hydroxypyrene [1OHP]"
},
{
"measure": "Monohydroxybutyl mercapturic acid [MHBMA]"
},
{
"measure": "Nnitrosonornicotine [NNN] + glucuronides [Total NNN]"
},
{
"measure": "SPhenyl mercapturic acid [SPMA]"
},
{
"measure": "Total nicotine equivalents (molar sum of nicotine, cotinine, 3hydroxycotinine and their glucuronides) [TNneq]"
},
{
"measure": "Carboxyhemoglobin [COHb]"
},
{
"measure": "Nnitrosonornicotine [NNN] + glucuronides [Total NNN]"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "RAI Services Company"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise"
},
{
"name": "Manual PT/Conventional PT Treatment"
}
]
},
"conditionsModule": {
"conditions": [
"UPPER CROSS SYNDROME"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jhang",
"contacts": null,
"country": "Pakistan",
"facility": "Ismail Medicare",
"geoPoint": null,
"state": "Punjab",
"status": null,
"zip": "35200"
}
]
},
"descriptionModule": {
"briefSummary": "Upper cross syndrome is relative prevalent 67% musculoskeletal disorder among general population due to increased usage of smart gadgets and poor postural habits. Upper cross syndrome is known for initiating malfunction of cervical and upper back muscles also associated with respiration. Individuals with upper cross syndrome may present with relaxed supine positioning, they may having normal respiratory mechanics but might be converted to accessory muscles activated pattern. Neck pain is the most common type of pain in non-traumatic conditions, affecting about 75.7% of people. The aim of this study is to compare the effects of segmental and pursed lip breathing exercises on pain, functional disability and quality of life in population with upper cross syndrome.Current study will be randomized controlled trial conducted at Ismail Medicare Jhang, 40 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A (control group) will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises) while Group B (experimental group) receive conventional physical therapy treatment with segmental and pursed lip breathing exercises. Outcome measures are Pain Numeric Scale, Quality of life (SF 36) and Functional disability (neck disability index). These tools will measure neck function and neck pain intensity. Treatment time will be 4 weeks, 3 sessions per week, each session will be 45 minutes long, and measurements will be taken after 4 weeks. Data will be analyzed by SPSS version 25. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups analysis.Key Words: Breathing Exercises, Cervical Pain, Disability, Upper Cross"
},
"designModule": {
"designInfo": {
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},
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},
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"type": "ACTUAL"
},
"phases": [
"NA"
],
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},
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"maximumAge": "40 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of Segmental and Pursed Lip Breathing Exercises on Upper Cross Syndrome",
"nctId": "NCT06303102",
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"id": "REC/RCR&AHS/23/0356",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "NPRS"
},
{
"measure": "Quality of Life (SF-36 questionnaire)"
},
{
"measure": "Neck Disability Index (NDI)"
}
],
"secondaryOutcomes": null
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
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"completionDateStruct": {
"date": "2024-02-15"
},
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"date": "2024-03-12"
},
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"date": "2024-01-30"
},
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"startDateStruct": {
"date": "2023-05-23"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questionnaires set"
}
]
},
"conditionsModule": {
"conditions": [
"Smoking Cessation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "[email protected]",
"name": "Wei Xia, PhD",
"phone": "18823359471",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "XIAW",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510080"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to describe the tobacco exposure and characteristics of patients with Chronic Kidney Disease (CKD) who quit smoking, to identify patients' tobacco-related knowledge, attitude, and practice (KAP) and explore the influencing factors of smoking cessation."
},
"designModule": {
"designInfo": {
"allocation": null,
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"timePerspective": "CROSS_SECTIONAL"
},
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"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients",
"nctId": "NCT06303089",
"orgStudyIdInfo": {
"id": "zzwee-quit (CKD) 23152",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Prevalence of current smokers"
},
{
"measure": "Abstinence rates"
}
],
"secondaryOutcomes": [
{
"measure": "Nicotine dependence"
},
{
"measure": "Perceptions of tobacco harm"
},
{
"measure": "knowledge of tobacco-related diseases"
},
{
"measure": "Smoking related attitudes"
},
{
"measure": "Self-efficacy level"
},
{
"measure": "Withdrawal symptoms"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sun Yat-sen University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-01"
},
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"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2025-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Tizanidine Hcl 4Mg Tab"
},
{
"name": "Zolpidem Tartrate 10 mg"
}
]
},
"conditionsModule": {
"conditions": [
"Depressive Disorder, Major"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg/Kg/HS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout/lost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia."
},
"designModule": {
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"OUTCOMES_ASSESSOR"
]
},
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},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial",
"nctId": "NCT06303076",
"orgStudyIdInfo": {
"id": "134",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pittsburgh Sleep Quality Index"
}
],
"secondaryOutcomes": [
{
"measure": "Frequency and Severity of Side Effects"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sultan Qaboos University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2026-09"
},
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"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SINOMED IAS Stent System"
},
{
"name": "Neuroform Atlas Stent System"
}
]
},
"conditionsModule": {
"conditions": [
"Intracranial Aneurysm"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Jianxin Yang",
"phone": "010-59978595",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Beijing Tiantan Hospital, Capital Medical University",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms."
},
"designModule": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms",
"nctId": "NCT06303063",
"orgStudyIdInfo": {
"id": "SNSC-IAS-202301",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Success aneurysm occlusion at 6 month post procedure"
}
],
"secondaryOutcomes": [
{
"measure": "Technical success"
},
{
"measure": "Success aneurysm occlusion immediately after the procedure"
},
{
"measure": "Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 6 months post procedure"
},
{
"measure": "Complete aneurysm occlusion at 6 months post procedure"
},
{
"measure": "Retreatment Rate at 6 months and 1 year post procedure"
},
{
"measure": "In-Stent Stenosis at 6 months post procedure"
},
{
"measure": "Modified Rankin Scale (mRS) at 30 days, 6 months and 1 year post procedure"
},
{
"measure": "Major ipsilateral stroke at 30 days, 6 months and 1 year post procedure"
},
{
"measure": "All-cause mortality at 30 days, 6 months and 1 year post procedure"
},
{
"measure": "Incidence of adverse events/serious adverse events during 30 days, 6 months and 1 year post procedure"
},
{
"measure": "In-stent thrombosis at 6 months post procedure"
},
{
"measure": "Rate of Device defect"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sinomed Neurovita Technology Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-17"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Mental Imagery with task Oriented training group"
},
{
"name": "Task Oriented training group"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke, Cardiovascular"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Peshawar",
"contacts": [
{
"email": "[email protected]",
"name": "Nadia Azhar, NMPT",
"phone": "03335281431",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "Khyber Medical University",
"geoPoint": {
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"lon": 71.57849
},
"state": "KPK",
"status": "RECRUITING",
"zip": "2500"
}
]
},
"descriptionModule": {
"briefSummary": "The objective of this study to determine the effect of mental imagery and task oriented training on Kinesiophobia in stroke patients. And to determine the association of Kinesiophobia with gait and balance in stroke patients. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. The experimental group will receive 20 minutes of MI training followed by 25 minutes of TOT for a total of 45 minutes, 5 days per week for 6 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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},
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},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Additional Effects of Mental Imagery Along With Task Oriented Training on Kinesiophobia in Patients With Stroke",
"nctId": "NCT06303050",
"orgStudyIdInfo": {
"id": "Urooj Amir",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Berg And Balance scale"
},
{
"measure": "Tempa scale for kinesiophobia"
},
{
"measure": "Ten-meter walk test"
},
{
"measure": "Dynamic gate index"
},
{
"measure": "Time Up and Go Test"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-07"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-07"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Remimazolam besylate and low-dose Esketamine"
},
{
"name": "Remimazolam besylate and Medium dose Esketamine"
}
]
},
"conditionsModule": {
"conditions": [
"Pediatric",
"Gastroscopy",
"ED95",
"Sedation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wenzhou",
"contacts": null,
"country": "China",
"facility": "The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University",
"geoPoint": {
"lat": 27.99942,
"lon": 120.66682
},
"state": "Zhejiang",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
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"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
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},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "EEIDR",
"briefTitle": "Effect of Esketamine on 95% Induction Dose of Remimazolam",
"nctId": "NCT06303037",
"orgStudyIdInfo": {
"id": "SAHoWMU-CR2024-03-105",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sedation induction time"
}
],
"secondaryOutcomes": [
{
"measure": "Modified observer's assessment of alertness#sedation#MOAA/S#scale"
},
{
"measure": "Recovery times"
},
{
"measure": "VAS(The difficulty of gastroscope insertion)"
},
{
"measure": "Number of children with adverse effects"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Second Affiliated Hospital of Wenzhou Medical University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "personalized combined physical and cognitive intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis, Relapsing-Remitting"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Firenze",
"contacts": [
{
"email": "[email protected]",
"name": "Maria Pia Amato, Prof",
"phone": "0557947836",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Fondazione Don Carlo Gnocchi ONLUS",
"geoPoint": {
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"lon": 11.24626
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"state": null,
"status": "RECRUITING",
"zip": "50143"
}
]
},
"descriptionModule": {
"briefSummary": "Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "This is a multicentric no-profit pilot study, composed by two phases. I phase: observational prospective study II phase: interventional study",
"maskingInfo": {
"masking": "NONE",
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"whoMasked": null
},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RELIABLE",
"briefTitle": "Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis",
"nctId": "NCT06303024",
"orgStudyIdInfo": {
"id": "RELIABLE Clinical Study",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Symbol Digit Modalities Test (SDMT)"
},
{
"measure": "California Verbal Learning Test second edition (CVLT-II)"
},
{
"measure": "Brief Visuo-Spatial Memory Test- Revised (BVMT-R)"
},
{
"measure": "Word list generation (WLG)"
},
{
"measure": "Stroop test"
},
{
"measure": "Test Intelligenza Breve (TIB)"
},
{
"measure": "9 hole peg test (9HPT)"
},
{
"measure": "The Hospital Anxiety and Depression Scale (HADS)"
},
{
"measure": "Beck Depression Inventory second edition"
},
{
"measure": "The Modified Fatigue Impact Scale (MFIS)"
},
{
"measure": "The Multiple Sclerosis Walking Scale (MSWS-12)"
},
{
"measure": "Multiple Sclerosis Impact Scale (MSIS-29-V2)"
},
{
"measure": "Multiple Sclerosis Quality of Life-54 (MSQOL-54)"
},
{
"measure": "six minutes walking test (6MWT)"
},
{
"measure": "Romberg test"
},
{
"measure": "handgrip test"
},
{
"measure": "cognitive-motor interference"
},
{
"measure": "Timed 25-foot walk"
},
{
"measure": "brain MRI scan"
},
{
"measure": "International Physical Activity Questionnaire (IPAQ)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Careggi Hospital"
},
{
"name": "Sheba Medical Center"
},
{
"name": "Uppsala University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Don Carlo Gnocchi Onlus"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-14"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcutaneous Electrical Nerve Stimulator"
},
{
"name": "TENS on para sacral area with Abdominal Massage"
}
]
},
"conditionsModule": {
"conditions": [
"Constipation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Lahore",
"contacts": null,
"country": "Pakistan",
"facility": "Jinnah Hospital",
"geoPoint": {
"lat": 31.558,
"lon": 74.35071
},
"state": "Punjab",
"status": null,
"zip": "44000"
}
]
},
"descriptionModule": {
"briefSummary": "Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 26,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "14 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females.",
"nctId": "NCT06303011",
"orgStudyIdInfo": {
"id": "S22C14G92003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PAC-SYM Questionnaire"
},
{
"measure": "PAC-QOL Questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "DEX-PRESSIN"
},
{
"name": "Standard of Care"
}
]
},
"conditionsModule": {
"conditions": [
"Sepsis",
"Septic Shock"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized controlled superiority trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The outcome assessor will be nurses - not invovled in the study - will be unware about the study drug.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 260,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DecatSepsis-2",
"briefTitle": "Dexmedetomidine and Vasopressin in Septic Shock",
"nctId": "NCT06302998",
"orgStudyIdInfo": {
"id": "MS.111",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "in-hospital mortality"
}
],
"secondaryOutcomes": [
{
"measure": "survival analysis"
},
{
"measure": "Norepinephrine Equivalent Dose (NED)"
},
{
"measure": "Duration of vasopressor infusion in survivors"
},
{
"measure": "Initiation of invasive mechanical ventilation (IMV)"
},
{
"measure": "Duration of IMV"
},
{
"measure": "Early acute kidney injury (AKI)"
},
{
"measure": "Late acute kidney injury (AKI)"
},
{
"measure": "Acute Physiology and Chronic Health Evaluation (APACHE-II)"
},
{
"measure": "Simplified Acute Physiology Score (SAPS) II score"
},
{
"measure": "ICU length of stay"
},
{
"measure": "Hospital length of stay"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mansoura University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "atomized inhalation ICG before thoracoscope pneumonectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Pulmonary Sequestration",
"Congenital Pulmonary Airway Malformation",
"Indocyanine Green",
"Thoracoscopic Surgery",
"Children"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuhan",
"contacts": null,
"country": "China",
"facility": "Tongji Hospital",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
},
"state": "Hubei",
"status": null,
"zip": "430030"
}
]
},
"descriptionModule": {
"briefSummary": "To investigate the safety and effectiveness of preoperative aerosol inhalation ICG solution for thoracoscopic accurate resection of congenital lung malformations in children."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "14 Years",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Atomized Inhalation ICG for Treatment of Congenital Lung Malformations",
"nctId": "NCT06302985",
"orgStudyIdInfo": {
"id": "ICG-CLMs",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "rate residual"
}
],
"secondaryOutcomes": [
{
"measure": "peak volume ratio"
},
{
"measure": "length of hospital stay"
},
{
"measure": "peak time ratio"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Jiexiong Feng"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2050-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-12"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2050-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Traditional treatment"
},
{
"name": "IASTM and CCEP"
}
]
},
"conditionsModule": {
"conditions": [
"Upper Cross Syndrome"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Islamabad",
"contacts": null,
"country": "Pakistan",
"facility": "Maroof international Hospital and Railway Hospital",
"geoPoint": {
"lat": 33.72148,
"lon": 73.04329
},
"state": "Federal",
"status": "RECRUITING",
"zip": "44000"
}
]
},
"descriptionModule": {
"briefSummary": "This study will see the effects of IASTM along with comprehensive corrective exercise program in upper cross syndrome through their effects on pain and cervical ranges as well as postural improvement. Our study targets both male and female population. In the reference study only male population was targeted which did not show effects of both techniques on the female population though females have high stress levels which may alter results."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants were randomly assigned to the experimental group or control group after a baseline assessment with sealed enveloped method. Each participant took a envelope that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Participants were informed that they would receive treatment either from group 1 or group 2 without indicating which group should undergo IASTM and comprehensive corrective exercise program and which group undergo only comprehensive corrective exercise program",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 44,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effects of IASTM Along With Comprehensive Corrective Exercise Program in Upper Cross Syndrome.",
"nctId": "NCT06302972",
"orgStudyIdInfo": {
"id": "RCRAHS-ISB/REC/MS-PT/01771",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Range of motion Cervical (Flexion)"
},
{
"measure": "ROM Cervical (Extension)"
},
{
"measure": "ROM Cervical (Left Lateral Flexion)"
},
{
"measure": "ROM Cervical( Right Lateral Flexion)"
},
{
"measure": "ROM Cervical ( Right Rotation)"
},
{
"measure": "ROM Cervical ( Left Rotation)"
}
],
"secondaryOutcomes": [
{
"measure": "Numeric Pain Rating Scale (NPRS)"
},
{
"measure": "Flexicurve Ruler and Photogrammetry for posture"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Riphah International University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-30"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Severe Eosinophilic Asthma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Asthma is a chronic inflammatory disease of the airways that follows a strong circadian rhythm: Signs of inflammation and symptoms worsen especially in the early morning hours. The molecular circadian clock, which is a complex machinery of transcriptional and translational feedback loops, seems to reflect the inflammatory environment of peripheral blood leukocytes. Therefore, in this observational study the investigators will monitor the molecular circadian clock in patients with severe eosinophilic asthma before and during mepolizumab treatment. Our major goal is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression, treatment response or remission in patients with severe eosinophilic asthma. The molecular circadian clock will be monitored in blood and sputum leukocytes from patients with severe eosinophilic asthma before mepolizumab treatment, after 4 month of mepolizumab therapy, and once they reach remission under mepolizumab treatment. Effects will be compared to healthy controls and patients with mild-moderate asthma without mepolizumab treatment."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CLOCK-PM",
"briefTitle": "Clock Proteins as Prognostic Markers",
"nctId": "NCT06302959",
"orgStudyIdInfo": {
"id": "36-232 ex 23/24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Correlation between clock expression, exacerbation rate and lung function."
}
],
"secondaryOutcomes": [
{
"measure": "Correlation between clock expression, symptoms and quality of life."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Graz"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-03-12"
}
}
} | false | null |
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