linjc16/ctgov huggingface dataset:
Multi-physics Modeling the Physiology of a Patient in Critical Condition

Study Overview
=================
Brief Summary
-----------------
The environment of the ICU and operating room allows the multi continuous monitoring of patients in critical situations. The physician anesthesiologist is working more and more in an environment where he receives a multitude of information from both the patient's medical history but also measured data in real time to its physiological situation. It is sometimes difficult for practitioners to consider all of the information by identifying a course of action. A decision support and a degree of automation can increase security along the lines of what has been observed in many processes and industries like aviation. The goal of this project is to establish initially a database of physiological parameters. We want to use patient data to model physiological processes in order to advance towards the creation of physios program,

Conditions
-----------------
Patient Care in ICU

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in intensive care unit ward Exclusion Criteria: Patient or familly refusing participating to the 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 |
| --- | --- | --- |
| Correlation between high blood pressure measurement during the first 24h in ICU and number of patient alive at 28 days post ICU |  | 28 days |
Change in Coronary Heart Disease Risk Factors in Young Adults

Study Overview
=================
Brief Summary
-----------------
To prospectively examine changes in lipids, lipoproteins, and blood pressure among 295 young adults who had been followed for sixteen years in the Beaver County Lipid Study. The Beaver County Lipid Study tracked the cholesterol values of 295 children, ages 11 to 14 at baseline.

Detailed Description
-----------------
BACKGROUND: Epidemiologic studies of coronary risk factors have been performed primarily in populations of middle-aged adults, children, and adolescents. Relatively little is known about these risk factors in men and women 20-29 years of age. This study provided important insights into the determinants of coronary heart disease risk factors in young adults and bolstered the argument of those who favor the early identification of and intervention in the young coronary candidate. DESIGN NARRATIVE: Three cross-sectional examinations had been carried out: 1) 1972-1973; 2) 1980-1981; and 3) 1988-1989. The study examined the predictors of change in total cholesterol (from examination 1 to examination 3, and change in LDL-C, HDL-C, and triglycerides between examinations 2 and 3. It also investigated the stability in several health habits and behaviors such as cigarette smoking, alcohol use, adherence to a low fat/low cholesterol diet, and physical activity. Weight gain and oral contraceptive use had been shown in previous analyses to be strong predictors of several lipids and lipoproteins. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.

Detailed Description
-----------------
This is a research feasibility study to evaluate various parameters of the multistage low-energy pulses and their effect on atrial fibrillation.

Official Title
-----------------
Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Multistage low-energy stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients indicated for an atrial fibrillation ablation procedure Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multistage low-energy stimulation<br>Multistage low-energy electrical pulses as described in Janardhan AH et al. JACC 2014 Jan7-14:63(1):40-8 will be delivered to a patient in atrial fibrillation. The responses to these stimuli will be recorded. | Device: Multistage low-energy stimulation<br>* The parameters of the Multistage waveform will be altered and the response of the atria will be recorded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy of Multistage low-energy pulses to organize, suppress, or terminate atrial fibrillation as determined by changes in atrial fibrillation cycle length, and atrial electrogram morphology. | Multistage low-energy pulses are delivered to the atria of patients while in atrial fibrillation. The atrial electrograms will be recorded and used to evaluate if there was a change in the atrial fibrillation cycle length, increased organization of the arrhythmia using frequency analysis or if the pulses were able to terminate the atrial fibrillation. | Patients will be followed during the acute procedure which is expected to average 60 minutes |
Induction of Transplant Tolerance in LDLT Via iTS

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to examine the immunotolerance-inducing ability (effectiveness) of induced inhibitory T cells JB-101 in patients with living-donor liver transplantation using whether or not operational tolerance is achieved as an index. And the safety of JB-101 will be evaluated.

Detailed Description
-----------------
This trial is a phase I / II, open-label, single-arm, multicenter clinical trial of JB-101, an inducible inhibitory T cell, in patients with end-stage liver failure who undergo living-donor liver transplantation. The primary endpoint of efficacy is withdrawal from immunosuppressant by 78 weeks (up to 91 weeks) after liver transplantation, and then whether or not operational tolerance is achieved.

Official Title
-----------------
Phase I/II Study to Evaluate the Safety and Efficacy of JB-101(Induced T Cell With Suppressing Functions), to Induce Operational Tolerance in Living Donor Liver Transplantation.

Conditions
-----------------
Living-donor Liver Transplantation

Intervention / Treatment
-----------------
* Biological: JB-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria： Patients with end-stage liver failure undergoing living-donor liver transplantation. Subjects who are healthy physically and psychologically and willing to donate organs voluntarily. Relative within the second degree of relationship or partner. (Acceptable degree conforms eligibility criteria of the institution.) Exclusion Criteria： Patients who have clinical findings of active infection. Patients with advanced heart disease, fulminant hepatitis in liver failure, renal disease, malignant tumors and complications of immunodeficiency.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JB-101<br>induced T cell with suppressive function | Biological: JB-101<br>* induced T cell with suppressive function<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of operational tolerance | Achievement of Operational Tolerance defined as no biopsy proven rejection diagnosed by Banff criteria for more than 52 weeks after withdrawal of immunosuppressive drugs post transplant | immunosuppressive drug cessation was maintained for at least 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
living-donor liver transplantation, immunotolerance, operational tolerance, cell therapy
Comparison of an Inexpensive Tablet-based Laparoscopic Box Trainer With a Standard Box Trainer

Study Overview
=================
Brief Summary
-----------------
Training is of great importance in laparoscopy. There are different commercially available trainers which are quite expensive and are used by trainees only inside the hospital. The aim of this study is to find out whether basic laparoscopic skills training using an inexpensive tablet-based laparoscopic box trainer leads to equal training results (= improvement of skills) compared to practicing with a conventional commercial box trainer. Furthermore, trainee satisfaction with this home-made alternative compared to the standard trainer will be assessed.

Conditions
-----------------
Basic Laparoscopic Skills Training

Intervention / Treatment
-----------------
* Device: Training on low-cost box trainer
* Device: Training on standard box trainer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical students of the Medical University of Vienna Exclusion Criteria: Extensive experience with laparoscopic box trainers or laparoscopic surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-cost box trainer<br>Trainees in this arm will perform their basic laparoscopic skills training on a low-cost tablet-based box trainer. | Device: Training on low-cost box trainer<br> <br> |
| Active Comparator: Standard box trainer<br>Trainees in this arm will perform their basic laparoscopic skills training on a standard box trainer | Device: Training on standard box trainer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fundamentals of Laparoscopy (FLS) manual Skills Score |  | After completion of training (4-6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trainee satisfaction with the two different training devices | Satisfaction will be measured using a visual analogue scale (VAS) | After completion of training (4-6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical education, Laparoscopy, Laparoscopic suturing
Methylene Blue Intra-vital Nerve Staining

Study Overview
=================
Brief Summary
-----------------
In previous studies, we know methylene blue (MB) stains nerves, and oxidized MB has near-infrared (NIR) fluorescence for fluorescent observation. In this trial we using MB on human skin and combining MB and third-harmonic generation imaging (THG) to label cutaneous nerve fibers.

Detailed Description
-----------------
Intravital images were obtained before injection and then taken at 0.5, 1, 1.5, 2, 2.5, and 3 h after intradermal 0.03% (0.3 mg/mL, 1500μM) MB (10mg/mL Astar) injection using a 0.5-mL 29-gauge insulin syringe needle (Becton, Dickinson and Company, USA). The participant lay down and the skin was imaged 10 cm above the ankle in the lower leg and above the wrist in the middle forearm; three sites in each limb were randomly selected for each time point. SHG or THG captured MB signals with two-photon excitation microscope at the Molecular Biomedical Imaging Research Center of National Taiwan University.

Official Title
-----------------
Harmonic Generation Microscopy Observation of Intradermal Injection Nerve Fibers by Methylene Blue Intra-vital Staining

Conditions
-----------------
Neurologic Findings

Intervention / Treatment
-----------------
* Diagnostic Test: Methylene blue intradermal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers Exclusion Criteria: used serotonin agonist medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Methylene blue intradermal injection<br>Methylene blue intradermal injection | Diagnostic Test: Methylene blue intradermal injection<br>* Methylene blue intradermal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intravital staining | injected 10 μL of 0.03% methylene blue intradermally then calculate nerve fiber image | 12 months |
Effect of Antidepressants on White Matter Structure

Study Overview
=================
Brief Summary
-----------------
Subjects with major depression will be evaluated and intensively characterized through questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic resonance imaging will be used to document baseline white matter structure. subjects will then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks the evaluations will be repeated.

Detailed Description
-----------------
40 subjects will be included in the study. Diagnosis will be confirmed by MINI. Participants will be characterised using questionnaires, pain threshold, cognition, facial expression recording and MRI. Desvenlafaxine will be initiated at 50mg AM. At week 8 Desvenlafaxine may be increased to 100mg as clinically indicated. Measures will be repeated at the end of the study.

Official Title
-----------------
White Matter Structure and Response to Treatment With Antidepressants: a Study of Desvenlafaxine in Major Depression. A Pilot Study

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: Desvenlafaxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major depression Age 18 to 55 Hamilton grater or equal to 20 Exclusion Criteria: Major neurologic disorder Major cardiovascular disorder Unstable medical condition Significant psychiatric co-morbidity Current substance dependance Pregnancy or lactation -Treatment resistance as defined by nonresponse to 2 or more antidepressant treatments (adequate dose and duration) -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Desvenlafaxine|Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anisotropy | Degree of anisotropy will be measured at baseline and 16 weeks and correlated to remission status | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive measures | cognitive deficits will be measured at baseline and 16 weeks and correlated to anisotropy using computerized neuropsychological testing of memory, speed and executive function. | 16 weeks | 
| Pain threshold | Pain threshold will be measured at basline and 16 weeks and correlated to inflammatory markers and anisotropy | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
major depression, DTI, inflammatory markers, cognition
PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and validate a work-model in Primary Health Care for identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory monitoring study.

Official Title
-----------------
PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment. A Multi-Centre Study to Validate a Sleep Apnea Screening Model in Primary Health Care

Conditions
-----------------
Sleep Apnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 to 75 years. Exclusion Criteria: Cognitive impairment or psycho-physical deterioration that impede to perform ambulatory monitoring study. Worsened or unstable cardiovascular or cerebrovascular disease. Chronic insomnia (<5h sleep / day). Relevant respiratory comorbidity that could interfere with arterial saturation measurements, as moderate to severe chronic obstructive pulmonary disease. Neuromuscular disease. Refusal to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Apnea/Hypopnea Index | At primary healthcare | At baseline | 
| Apnea/Hypopnea Index | At Sleep Lab Unit | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk factors |  | At baseline | 
| History of cardiovascular or cerebrovascular disease |  | At baseline | 
| Lung function tests |  | At baseline | 
| Self-perceived sleepiness. Epworth Test | At primary healthcare | At baseline | 
| Self-perceived sleepiness. Epworth Test | At Sleep lab unit | At 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea Syndrome, Primary Health Care
SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma.

Official Title
-----------------
A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open, Parallel Group Multicentre Study

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol Turbuhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of ³400 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1. Exclusion Criteria: Use of any b-blocking agent, including eye-drops, Use of oral GCS as maintenance treatment, A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol Turbuhaler|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe asthma exacerbation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of asthma exacerbations, Mean use of as-needed medication, Prescribed asthma medication, Asthma Control Questionnaire, Satisfaction with Asthma Treatment Questionnaire, Safety: Serious Adverse Events and discontinuations due to adverse events |  |  |