linjc16/ctgov huggingface dataset:
Colonic Motility in Constipation and Aging: A Study With a New 3D Transit System

Study Overview
=================
Brief Summary
-----------------
To study the motility of the bowel in constipated patients. Looking at the difference between young and elderly patients with constipation.

Official Title
-----------------
Colonic Motility in Constipation and Aging: A Pilot Study With a New 3D Transit System

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Device: MTS2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Constipation Exclusion Criteria: Constipation caused by other disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Constipated, Elderly<br>Investigation with MTS for motility | Device: MTS2<br> <br> |
| Constipation, Young<br>Investigation with MTS for motility | Device: MTS2<br> <br> |
| Normal Bowel, Elderly<br>Investigation with MTS for motility | Device: MTS2<br> <br> |
| Normal Bowel, Young<br>Investigation with MTS for motility | Device: MTS2<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transit time through the small intestine and the colon. Both the total transit time, the regional transit times and the antegrade and retrograde movements are measured by the MTS system | The measurements will all be at least three days long, but can be up to 5 days depending on the rate of bowel movements. | The total transit time will differ between healthy and constipated but probably between 3-5 days. |
Pharmacokinetics of Cyclosporin in Nephrotic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether there are differences in the pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease in children.

Detailed Description
-----------------
This is a prospective study on ten children using Cyclosporin-A (CSA) microemulsion to treat idiopathic nephrotic syndrome (INS), with normal renal function, who achieved complete remission with CSA. The objective is to compare the pharmacokinetic (PK) parameters of CSA in INS during remission and relapse of the disease. The PK profile of CSA was evaluated with the 12-hour area under the time-concentration curve (AUC0-12) using seven time-point samples. This procedure was done on each patient during remission and relapse with the same CSA dose in mg/kg/day. The AUC0-12 was calculated by trapezoidal rule. All PK parameters and the resumed 4-hour area under the time-concentration curve (AUC0-4) were correlated with AUC0-12. This study is very important because the cyclosporin is a nephrotoxic drug with narrow therapeutic window.

Official Title
-----------------
PHARMACOKINETICS OF CYCLOSPORIN - A MICROEMULSION IN CHILDREN WITH IDIOPATHIC NEPHROTIC SYNDROME

Conditions
-----------------
Nephrotic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with steroid-resistant nephrotic syndrome and steroid-dependent nephrotic syndrome in use of cyclosporine renal function evaluated by creatinine clearance estimated by stature ≥ 90 ml/min/1.73m2 cyclosporine trough level (C0) between 50 and 150 ng/ml complete remission with cyclosporine according to the guidelines of International Society of Kidney Diseases in Children Exclusion Criteria: renal and hepatic function abnormalities presence of infectious disease clinical or histological signs of CSA nephrotoxicity and suspicious of non-compliance

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| remission<br>Nephrotic patients in remission | |
| relapse<br>Nephrotic patients in recidive | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cyclosporin, nephrotic syndrome, pharmacokinetics, children
Myeloid-Related Protein in Evaluation of Acute Chest Pain in the Emergency Departement

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is the evaluation of multiple biomarkers related to acute coronary syndromes, including myeloid-related protein 8/14 (MRP 8/14), along with established clinical markers, for early diagnosis and risk stratification in patients presenting with acute chest pain at the emergency department. Study hypothesis: MRP 8/14, alone or together with other established or new biomarkers, increases the earliness, sensitivity, and specificity of diagnosing acute coronary syndromes.

Official Title
-----------------
Study of Myeloid-related Protein 8/14 and Additional Biomarkers (Multi Marker Approach) for Early Diagnosis and Risk Stratification in Patients Presenting With Acute Chest Pain at the Emergency Department

Conditions
-----------------
Myocardial Ischemia, Acute Coronary Syndrome, Myocardial Infarction, Coronary Occlusion, Coronary Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in the emergency department of the University Hospital Zurich with measurement of troponin during the routine diagnostic evaluation. Exclusion Criteria: Refusal or inability to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of acute coronary syndrome |  | Emergency room and/or hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any acute coronary event |  | 1 year | 
| Morbidity from coronary artery disease |  | 1 year | 
| Mortality |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease
Try Walking a Mile in These Shoes: Activity Level of Lower Extremity Amputees

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the accuracies of the Patient Activity Monitor to that of a standard pedometer during a walking task and some day-to-day activities in a simulated apartment setting.

Detailed Description
-----------------
The ability to accurately measure daily activity levels in lower extremity amputee patients is important for a better understanding of their use of prosthetic limbs. Most studies have shown that patients often report their activity level inaccurately. More objective data on activity levels will not only provide information helpful for determining the appropriate prosthetic components for an individual, it will also be helpful when assessing the effects that medical illness have on activity levels and in objectively determining the benefits of rehabilitation. In addition, being able to measure activity accurately will allow further verification of currently developed clinical surveys designed to determine amputee activity in a practical form. Until more recently a practical, accurate and affordable means of monitoring lower extremity amputee activity has not been available for use. Currently a monitoring device designed specifically for this task is available for research use. It is called the Patient Activity Monitor (PAM). Many different models of more generic activity monitoring devices, called pedometers, also exist and need to be further tested in the amputee population. The objective of our study was to measure and compare the step count and ambulation distance accuracies of a Yamax Digi-Walker pedometer and the PAM in transtibial amputees at the K3 Level within a simulated apartment setting and during relatively continuous gymnasium walking.

Official Title
-----------------
Comparison of the Patient Activity Monitor to a Pedometer During Ambulation Monitoring of Transtibial Amputees

Conditions
-----------------
Amputee

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral transtibial amputees who were identified as community level ambulators (K-Level 3) Exclusion Criteria: Malfunction of prosthesis; or New medical co-morbidities that impacted on ambulation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ambulation, Ambulatory Monitoring, Activities of Daily Living, Pedometer, Validation Studies [PT]
Chronology of Occult and Gross Coagulopathy in Burn Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to identify the inflammatory and coagulation pathways and mechanisms that are activated immediately following burn injury, and how they affect outcomes in terms of organ failure and death. This study also addresses the limitation of current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in severely injured patients both in a comprehensive and rapid manner.

Official Title
-----------------
Determining the Chronology of Occult and Gross Coagulopathy in Thermally Injured Patients: A Systems Biology Approach

Conditions
-----------------
Thermal Burns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, male or female, > or = 18 years of age, who arrive at Burn/Trauma Center with anticipated admission to The Burn Center within 4 hours of injury, with a thermal burn injury due to flash, flame, contact with hot object or liquid. Exclusion Criteria: Patients suffering concomitant trauma that are in hemorrhagic shock. Patients with a preexisting history of coagulopathy, or currently taking anti-coagulants. Children and pregnant women. Patients with chemical or electrical injury. Patients who do not fluently speak either English or Spanish.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group #1 - Burns affecting less than 10% BSA<br> | |
| Group #2 - Burns affecting 10%-30% TBSA<br> | |
| Group #3 - Burns affecting 31%-50% TBSA<br> | |
| Group #4 - Burns affecting 51%-70% TBSA<br> | |
| Group #5 - Burns affecting >70% TBSA<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Monitoring Arrhythmia Patients in in Hospital Monitoring

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single center, non-randomized study to evaluate the arrhythmia monitoring performance of the AVIVO™ System in a hospital setting.

Detailed Description
-----------------
The AVIVO™ System will continuously monitor the patient's cardiac activity which will be compared to the performance of standard telemetry system.

Official Title
-----------------
Arrhythmia Detection With Adherent Patient Monitoring Study

Conditions
-----------------
Arrhythmias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is female or male, 18 years of age or older Undergoing in-hospital electrocardiographic monitoring for primarily cardiac reasons Exclusion Criteria: Is participating in another clinical study that may confound the results of this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Complications in Lower Body Lifts

Study Overview
=================
Brief Summary
-----------------
A prospective study on 50 consecutive patients who are going to have a lower body lift procedure is performed. Measures include comorbidities and complications. Risk factors assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max), current BMI, excess weight loss (EWL), type of weight loss and nicotine consumption.

Official Title
-----------------
Prospective Study on Complications Following a Lower Body Lift After Massive Weight Loss

Conditions
-----------------
Surplus Skin After Massive Weight Loss

Intervention / Treatment
-----------------
* Procedure: body contouring surgery of back, abdomen and thighs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: after massive weight loss age > 18 years and < 65 years excess weight loss > 66% current body mass index < 35 stable weight after weight loss for at least 12 months Exclusion Criteria: insulin dependent diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: body contouring surgery of back, abdomen and thighs|simultaneous body contouring surgery of back, abdomen and thighs|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lower body lift, body contouring surgery, massive weight loss
Postoperative Cognitive Dysfunction in Geriatric Patients

Study Overview
=================
Brief Summary
-----------------
Geriatric patients have a high risk of developing postoperative cognitive deficits. Hypothetical causes are insufficient intraoperative cerebral perfusion or drugs that are administered in the perioperative setting. This study will investigate the role of these two factors in patients aged 65 or older undergoing elective surgical procedures under general aesthesia. Non-invasive techniques will be used to monitor intraoperative cerebral perfusion and anticholinergic activity in the patient's blood is determined. Data will be compared to those of a young (20-40 year old) group of patients undergoing elective surgical procedures using an identical anesthetic technique. A second control group of healthy volunteers older than 65 will be investigated to quantify practice effects with repeated testing of cognitive functions.

Official Title
-----------------
Postoperative Cognitive Dysfunction in Geriatric Patients: the Role of Intraoperative Cerebral Perfusion and Perioperative Anticholinergic Medication

Conditions
-----------------
Delirium, Dementia, Amnestic, Cognitive Disorders, Postoperative Complications, Memory Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgical procedure under general anaesthesia Exclusion Criteria: History of cerebrovascular disease Mini Mental status <23 Cardiac surgery Neurosurgery

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Patients aged 65 or older | |
| Control<br>Patients aged 20 to 40 | |
| Control 2<br>Healthy volunteers aged 65 or older | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function due to surgery under general aesthesia | cognitive function measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neurological test battery | cognitive function measured prior to and after surgery |
Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.

Official Title
-----------------
A Phase 2a, Open-label,Proof -Of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Clonazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of refractory epilepsy No Nasal conditions that would preclude the use of intranasal product Exclusion Criteria: Subject with a clinical significant unstable medical abnormality Subject currently or regularly taking Clonazepam

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Clonazepam 2 mg<br> | Drug: Clonazepam<br>* 1 Dose<br>|
| Experimental: Intranasal Clonazepam 3 mg<br> | Drug: Clonazepam<br>* 1 Dose<br>|
| Experimental: Intranasal Clonazepam both Dose Groups 2 mg & 3 mg<br> | Drug: Clonazepam<br>* 1 Dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). | Summary of video EEG number of spikes and sharp waves. Over a 24 hour period. | Change from baseline to treatment day |
Technical Accuracy and Userfriendliness of a Point-Of-Care C Reactive Protein Device in a Nursing Home Setting

Study Overview
=================
Brief Summary
-----------------
Study to test the technical accuracy and userfriendliness of a Point-of-care C Reactive Protein device (POC CRP device) in comparison with laboratory CRP testing in nursing home residents

Official Title
-----------------
Technical Accuracy and Userfriendliness of a Point-Of-Care C Reactive Protein (CRP) Device in Comparison With Laboratory CRP Testing in Nursing Home Residents.

Conditions
-----------------
Healthy Older Adults, Ill Older Adults

Intervention / Treatment
-----------------
* Device: Point-of-care test for CRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older (65 years or older) nursing home residents Exclusion Criteria: Residents not understanding Dutch

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Point-of-care test for CRP<br>Device: C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine the CRP level in the blood | Device: Point-of-care test for CRP<br>* Device: C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine the CRP level in the blood<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical accuracy | Correlation between the results of the Point-of-care C Reactive Protein device and the results of the laboratory | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User-friendliness | Evaluation of the user-friendliness on a five point Likert-scale. Following items are scored: device start-up, test duration, sample size, test characteristics, calibration, measuring range, handling of test tubes, filling of the capillary, placing the test cartridge, test recording and additional material usage. | 2 months |
Association Between CRSA and OSA

Study Overview
=================
Brief Summary
-----------------
This goal of this study is to know the association between the central serous chorioretinopathy and the obstructive sleep apnea. Many studies have been done in order to assess the association between the central serous chorioretinopathy and obstructive sleep apnea and the results are always controverses actually.

Official Title
-----------------
The Association Between Central Serous Chorioretinopathy and the Obstructive Sleep Apnea

Conditions
-----------------
Chorioretinopathy, Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Central serous chorioretinopathy since 6 months at least Patients beyond 18 years old Exclusion Criteria: - All retina pathology will be excluded : diabetes with affected retina, maculopathy, retina central veinous oclusion, epithéliopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between central serous chorioretinopathy and the obstructive sleep apnea. | Percentage of high risks of obstructive sleep apnea in patients affected by central serous chorioretinopathy in using the Berlin survey. The Berlin questions include 3 categories: The category 1 is positive if 2 answers are positive. The category 2 is positive if 2 answers are positive. The category 3 is positive if 1 answer is positive. Finally, if 2 categories are positive, the patient is considered as high risk of obstructive sleep apnea. | During 3 months we will collect the results of Berlin survey. |