linjc16/ctgov huggingface dataset:
Effects of Fiber on Satiety

Study Overview
=================
Brief Summary
-----------------
The effects of a dietary fiber on hunger and food intake will be tested in men and women. Participants will receive fiber as part of a breakfast meal on two occasions. On another occasion, participants will receive the same breakfast, without added fiber. Their feelings of hunger and fullness will be measured over the day. They will be offered lunch, dinner and an evening snack and how much they eat will be recorded. It is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.

Official Title
-----------------
Effects of Fiber on Satiety and Food Intake in Men and Women

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Dietary Fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal-weight adults Exclusion Criteria: eating disorders, on medications that affect food intake, pregnant or lactating, non-breakfast eaters

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Breakfast without fiber | Other: Dietary Fiber<br>* Fiber added to breakfast<br>|
| Experimental: Low-dose<br>Low-dose of fiber in breakfast | Other: Dietary Fiber<br>* Fiber added to breakfast<br>|
| Experimental: High-dose<br>high dose of fiber added to breakfast | Other: Dietary Fiber<br>* Fiber added to breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake | 24-hour Food intake will be measured 3 times | 24-hr food intake, on three occasions within 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite ratings | Ratings of hunger and fullness will be assessed 18 times | Hourly, over 8 hrs, on 3 days within a 3-week period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food intake, satiety, fiber
Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test

Study Overview
=================
Brief Summary
-----------------
CT scans of the spine include vertebrae, intervertebral discs and the spinal cord. These tests are performed in an orderly protocol and allow for three-dimensional reconstruction of the vertebra in sagittal and coronal guides.

Detailed Description
-----------------
In spinal surgery, there are a number of navigation technologies based on CT scans performed before surgery (or during surgery) and identify the vertebrae (using special photographs or markers on the spine), such as Mazor with the Renaissance Robotic Surgical System used in hospitals, or BrianLab Which uses non-robotic navigation and is based on a marker located on the patient's back. These technologies are not optimal, and have a number of significant drawbacks: Because during spinal surgery, there is a displacement, the level of accuracy decreases as the surgery progresses. In addition, there is extensive use of radiation in these means since in many cases CT is performed before and during surgery. Today, in the age of optical detection, it is possible to detect three-dimensional structures in photography and allow high levels of accuracy (less than 0.5 mm). Optical scanning does not include radiation and lasts the entire length of the operation. Of the patient and of the treating staff.

Official Title
-----------------
Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test

Conditions
-----------------
Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal Cord, CT Scans

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women 18 and above years old Patients who have available spinal CT tests will be included in the study Patients who are about to undergo spinal surgery Exclusion Criteria: NA

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 |
| --- | --- | --- |
| DEEP HEALTH's detection algorithm for optical detection of vertebrae in the spine in patients undergoing spinal surgery. | Verify an algorithm for automatic detection of vertebrae in the spine, while building an optical model for optical identification in the operating room, and reducing the need for radiation use during spinal surgery. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal surgery, CT scans, surgical navigation, optical tracking
Heart TIMING - Heart Transplantation IMagING

Study Overview
=================
Brief Summary
-----------------
The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.

Detailed Description
-----------------
12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed. Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers. Endomyocardial biopsy Detailed transthoracic echocardiography including strain analysis and 3D measurement Detailed cardiac magnetic resonance (CMR) examination Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT) Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)

Official Title
-----------------
Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy

Conditions
-----------------
Heart Transplant Failure and Rejection, Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Diagnostic Test: cardiac magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First heart transplantation Exclusion Criteria: Cardiogenic shock on/after day 28 after heart transplantation Lack of consent Lack of cooperation

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: cardiac magnetic resonance imaging|Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary allograft vasculopathy | Coronary allograft vasculopathy confirmed based on IVUS/OCT | 5 years | 
| Coronary allograft rejection | Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters | 5 years |
Continuation of Aspirin Before Isolated Heart Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Whether or not continuing aspirin up to de day before surgery increases the risk of bleeding and/or prevents thrombo-embolic complications remains debated. The investigators retrospectively investigated the whether continuing aspirine within 5 days of isolated heart valve surgery increased the risk of bleeding.

Official Title
-----------------
Effect of Continuation of Aspirin Before Isolated Heart Valve Surgery on Postoperative Bleeding and Transfusion: a Single-center Retrospective Study

Conditions
-----------------
Isolated Heart Valve Surgery

Intervention / Treatment
-----------------
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Isolated heart valve surgery Exclusion Criteria: Antiplatelet agent other than aspirin or anticoagulant not discontinued preoperatively Emergent or salvage surgery Surgery for endocarditis Use of NSAIDs within 48 hours before surgery

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aspirin continued within 5 days before surgery<br> | Drug: Aspirin<br>* Daily aspirin intake for cardiovascular prevention<br>|
| Aspirin discontinued more than 5 days before surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of units of packed red blood cells transfused anytime during the hospital stay |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest tube drainage | volume of chest tube drainage | 24 hours | 
| Surgical revision for bleeding |  | 24 hours | 
| Any thrombo-embolic complication |  | 30 days | 
| Transfusion of any type of blood product |  | 30 days |
Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement

Study Overview
=================
Brief Summary
-----------------
Retrospective data analysis of mortalities and the evaluation of the quality of care offered, using the Fishbone method.

Detailed Description
-----------------
Evaluation of mortalities seen between 01 January 2017 and 31 December 2018. Analysis of the mortality decision into preventable, non-preventable and potentially preventable categories. Identifying the associated risk factors and co-morbidities in a single centre study in Johannesburg. Further analysing was performed on the subset of preventable mortalities and further do the fishbone model of quality of care. RedCap data was utilized for all data points. A further comparison was done to the MNM classification based on the team and an independent senior surgeon.

Official Title
-----------------
Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement

Conditions
-----------------
Complication of Surgical and Medical Care, Unspecified

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All mortality of patients seen in the Department who were 18yrs or older - Exclusion Criteria: incomplete data death in the Emergency department

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


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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mortality outcomes<br>mortality classification into preventable, potentially preventable and non-prevenatable | Other: observation<br>* quality<br>* Other names: mortality outcomes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality outcomes | in-hospital mortality | study period (Jan 2017 to Dec 2018) |
Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very important therapy for those patients,but traditional ventilation modes have some defects, so investigators need to find new modes to solve these problems. In this study, the investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more appropriate ventilation mode for AECOPD patients.

Official Title
-----------------
Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: NAVA and PSV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AECOPD patients who need invasive mechanical ventilation Patients who can tolerate assist mechanical ventilation Patients who have signed ICF Exclusion Criteria: Patients who are younger than 18 years old or older than 75 years old Patients whose respiratory center is severely inhibited Patients who can not stand NAVA gastric tube Patients who have coagulation disorders Patients whose vital signs are unstable Patients who are in other clinical trails

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neurally adjusted ventilatory assist<br> | Device: NAVA and PSV<br>* change ventilation modes(NAVA and PSV) with different support levels<br>|
| Sham Comparator: pressure support ventilation<br> | Device: NAVA and PSV<br>* change ventilation modes(NAVA and PSV) with different support levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the ratio of physiologic dead space over tidal volume (VD/VT) |  | 1 year |
The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.

Official Title
-----------------
The Effect of Gemcabene (CI-1027) on Insulin Sensitivity in Nondiabetic Subjects

Conditions
-----------------
Insulin Sensitivity

Intervention / Treatment
-----------------
* Drug: Gemcabene 900 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments Males; and females of non-reproductive potential Obesity Non-diabetic Exclusion Criteria: Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day 1. Hormone Replacement Therapy is acceptable. Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening Use of any anti-diabetic medications Use of any steroid medications Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1 If female, pregnant, lactating or of childbearing potential; and History of significant reaction to any fibrate lipid-lowering agent

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcabene 900 mg<br>Gemcabene 900 mg | Drug: Gemcabene 900 mg<br>* Gemcabene 900 mg once daily (QD)<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 4 weeks | 
| ECG | Clinically Significant Changes | 4 weeks | 
| Clinical Laboratory - hematology, chemistry | Clinical Laboratory Abnormalities | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin Resistance, Lipid Regulator
Trancutaneous Monitoring to Avoid Hypercapnea During Complex Catheter Ablations

Study Overview
=================
Brief Summary
-----------------
Use of trancutaneous CO2 (TC02) monitoring to aide in titration of sedation of midazolam and fentanyl. Trancutaneous readings validated with invasively obtained specimens from existing arterial sheaths required during AF and VT ablations (trans-septal and retrograde aortic respectively)

Detailed Description
-----------------
Cardiac electrophysiology procedures are typically performed under moderate (conscious) sedation in most centers. Advantages over general anesthesia include facilitating arrhythmia induction, avoidance of intubation and ventilator related complications and shorter post-procedure recovery times for most patients. However, the cumulative respiratory depressant effects of fentanyl and midazolam during prolonged procedures can rarely cause hypoventilation resulting in hypercapnea and respiratory failure. Complex catheter ablations for atrial fibrillation and ventricular tachycardia can exceed 3-5 hours in duration requiring large cumulative doses of midazolam and fentanyl. End tidal CO2 monitors, particularly in non-ventilated patients, have limitations and obtaining frequent arterial blood gas samples are often impractical. It remains unknown if contemporary trancutaneous CO2 monitoring (TCO2)can provide a feasible alternative to avoid over-sedation and resultant respiratory complications during complex catheter ablations with sufficient agreement to invasively obtained PCO2 data.

Official Title
-----------------
Transcutaneous Monitoring to Avoid Hypercapnea During Complex Catheter Ablations: a Joint Quality Initiative Pilot From Cardiac Electrophysiology and Anesthesiology

Conditions
-----------------
Hypercapnia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing catheter ablation for atrial fibrillation (AF) or ventricular tachycardia (VT) under moderate sedation. Exclusion Criteria: Procedures scheduled for general anesthesia
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 |
| --- | --- | --- |
| Agreement with invasively obtained PCO2 data within 5 mm Hg |  | up to 24 months |
Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)

Study Overview
=================
Brief Summary
-----------------
Registry to follow patients with sarcoidosis associated pulmonary hypertension

Detailed Description
-----------------
This is a multi center registry of sarcoidosis associated pulmonary hypertension (SAPH). With this registry, the investigators will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension on the United States. The investigators will also compare these features to non-US sites.

Official Title
-----------------
Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)

Conditions
-----------------
Sarcoidosis, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sarcoidosis as defined by the ATS/WASOG statement Patients with pulmonary hypertension as confirmed by right heart catheterization Patients willing to provide written informed consent Exclusion Criteria: Unwillingness to provide assurance that they will complete the follow up visits for the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Patients<br>All patients with sarcoidosis associated pulmonary hypertension | Other: Observation<br>* Observe patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Mortality during time of study | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease management | Examine initial and follow up management | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ambrisentan, Bosentan, Iloprost