linjc16/ctgov huggingface dataset:
Eisenmenger's Syndrome in Adults With CHD

Study Overview
=================
Brief Summary
-----------------
Review the outcome of treatment with endothelin receptor antagonists (bosentan or sitaxsetan) alone or in combination with Sildenafil (a PDE-5 inhibitor) in adult patients with pulmonary hypertension due to congenital heart disease.

Detailed Description
-----------------
The primary objective of this study is to examine medical records of patients with Eisenmenger's Syndrome in order to determine the effect of endothelin receptor antagonists, alone or in combination, with Sildenafil, on symptoms of pulmonary hypertension. This review will be conducted on Standard of Care procedures such as New York Heart Association (NYHA) classification, six-minute walk exercise capacity, pulmonary pressures and oxygens saturations. Pulmonary pressures determined by echo or cardiac catheterization will be analyzed where available. We hypothesize that patients with congenital heart defects who develop ES will have an improved six-minute walk distance, improved pulmonary arterial pressures and improved oxygenation after treatment with endothelin receptor antagonists and other pulmonary vasodilators.

Official Title
-----------------
Treatment of Eisenmenger's Syndrome in Adults With Congenital Heart Disease With Pulmonary Arterial Vasodilators

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital heart disease (unoperated, palliated or repaired) Eisenmenger's syndrome Age 18 to 80 Exclusion Criteria: Those who do not meet inclusion criteria

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 |
| --- | --- | --- |
| Review the outcome of treatment with endothelin receptor antagonists (bosentan or sitaxsetan) alone or in combination with Sildenafil (a PDE-5 inhibitor) in adult patients with pulmonary hypertension due to congenital heart disease | Our study demonstrates that endothelin receptor blockers can be used to improve exercise tolerance, oxygenation, and functional status in adults with Eisenmenger syndrome without adverse effects. The role of newer treatment modalities such as prostacyclins, PDE inhibitors, and nitric oxide remain promising and their role needs to be investigated to help improve quality of life and life expectancy in these patients. | 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult, congenital heart disease, Eisenmenger's Syndrome, Bosentan, Sitaxsetan, Sildenafil
Association of Macular Pigment Optical Density (MPOD) and Genetic Variants in Complement Factor H in Subjects With Choroidal Neovascular (CNV)

Study Overview
=================
Brief Summary
-----------------
Subjects with wet AMD, dry AMD, and age-matched controls will undergo routine occular measurements, will provide a blood and cheek cell sample, and will have macular pigment optical density (MPOD) measured to determine if there is an association between genetics, MPOD and the risk of progression to wet AMD.

Official Title
-----------------
Collection of Whole Blood Specimens and Buccal Swabs From Subjects Diagnosed With CNV AMD, Dry AMD, and Age-Matched Controls to Assess the Association of Genetic Variants in Complement Factor H With Risk of Progression to CNV.

Conditions
-----------------
Age-related Macular Degeneration, Choroidal Neovascular Age-related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject is diagnosed with either CNV, dry AMD or is an age-matched control self reported as non-Hispanic Caucasian 60 years of age or older provides signed and dated informed consent agrees to provide 10 mL of whole blood and two buccal swabs Exclusion Criteria: previous donation under this protocol

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| choroidal neovascular (CNV) AMD subjects<br>Subjects diagnosed with CNV (AREDS Grade 4b) | |
| dry AMD subjects<br>Subjects diagnosed with dry AMD (AREDS Grade 3) | |
| age-matched controls<br>Subjects without AMD (AREDS Grade 1) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between a genetic variant in the CFH gene and risk of progression to CNV | DNA extracted from blood and buccal cells collected from subjects with either CNV, dry AMD, and age-matched controls will be analyzed to investigate a genetic variant in the CFH gene and its association with risk of progression to CNV | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic correlation between MPOD and risk of progression to CNV | DNA extracted from blood and buccal cells collected from subjects with either CNV, dry AMD, and age-matched controls will be analyzed to investigate the correlation between genetics, MPOD, and risk of progression to CNV | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age-related macular degeneration, choroidal neovascular age-related macular degeneration, genetics, macular pigment optical density (MPOD)
Effects of Meditation on Mechanism of Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
To study the effects of Transcendental Meditation on Coronary Heart Disease

Detailed Description
-----------------
Recent advances in our understanding of the pathophysiology of acute cardiac events - specifically, identification of the roles that arterial vasomotor dysfunction and autonomic nervous system imbalances play in the pathophysiologic cascade during such acute events - provides a platform for new mechanistic investigation of the interplay of psychosomatic stress and CHD (coronary heart disease). Preliminary evidence further suggests that Complementary and Alternative Medicine (CAM) practices, such as the Transcendental Meditation (TM) technique, can not only reduce stress but also reduce acute cardiac events in patients with CHD. Based on these and related data, we propose a randomized, blinded, controlled study of the effects of one CAM practice, the TM technique, compared to a control group, on the primary outcomes of (1) arterial vasomotor dysfunction (brachial artery reactivity); (2) autonomic nervous system imbalances (heart rate variability); (3) transient myocardial ischemia (ST-segment depression); and (4) the secondary outcomes of psychological stress and quality of life (anger, hostility, anxiety, depression, perceived health, disease-specific symptoms, and life stress/social resources).

Official Title
-----------------
Effects of Meditation on Mechanism of Coronary Heart Disease

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Procedure: Meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to attend training sessions and meetings Local residence Exclusion Criteria: Comorbid disease precluding survival in group MI, unstable angina, CABG or PTCA within last three months. Cognitive/psychological/substance abuse impairment Atrial fibrillation, predominant pacemaker rhythm or significant conduction system disease Significant valvular heart disease Class III or IV heart failure Renal failure Participating in a formal stress management program Participation in another trial

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Meditation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.

Detailed Description
-----------------
Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.

Official Title
-----------------
Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial

Conditions
-----------------
Trauma, Macular Hole

Intervention / Treatment
-----------------
* Procedure: vitrectomy surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: closed globe injury identification of full-thickness macular hole by optical coherence tomography within one month after trauma Exclusion Criteria: open globe injury coexistence of idiopathic macular hole severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage) combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis) coexistence of high myopia coexistence of choroidal rupture or subretinal hemorrhage within the diameter of 400μm from the center of the foveola coexistence of severe optic nerve injury (no light perception, positive afferent pupillary defect)
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: obervation<br>patients in this arm received 6-months observation alone after injury | |
| Active Comparator: Surgical intervention<br>patients in this arm received vitrectomy surgery as soon as possible after injury | Procedure: vitrectomy surgery<br>* pars plana vitrectomy +internal limiting membrane peeling done immediately after the identification of the macular hole<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular hole closure rate |  | 6 month after injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central foveal thickness |  | 6 month after hole closure | 
| length of inner-segment outer-segment junction defect |  | 6 month after hole closure | 
| final visual acuity |  | 6 month after hole closure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic macular hole, vitrectomy, observation
Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to continue follow up of conservatively treated CHI patients and to focus on their metabolic outcome, including frequency of hypoglycemia after discontinuing treatment and incidence of diabetes mellitus in the long term.

Official Title
-----------------
Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism

Conditions
-----------------
Conservatively Treated CHI Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: conservatively treated CHI patients who are in remission for at least one year Exclusion Criteria: none
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 below 15 years old<br> | |
| Patients above 15 years old<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence and frequency of hypoglycemia and hyperglycemia. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of diabetes mellitus |  | 5 years |
Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

Study Overview
=================
Brief Summary
-----------------
Upper gastrointestinal subepithelial tumors are frequently encountered during esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of subepithelial tumors. Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection technique and multiple endoscopic biopsies were performed. The investigators will perform deep biopsy in subepithelial tumor.

Official Title
-----------------
Prospective Study: Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

Conditions
-----------------
Benign Neoplasm, Pathology

Intervention / Treatment
-----------------
* Procedure: deep biopsy via ESD technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with upper GI SETs Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Active Comparator: deep biopsy<br> | Procedure: deep biopsy via ESD technique<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of pathologic diagnosis of deep biopsy |  | within the 7 day |
Development of an Artificial Intelligence Algorithm

Study Overview
=================
Brief Summary
-----------------
Mechanical obstruction of the small intestine is an interruption of intestinal transit due to an organic obstacle in the digestive tract that results in a shutdown of materials and gas. Without medical care, it can lead to perforation of the intestinal wall and acute peritonitis. It accounts for 4% of emergency department admissions and 20% of emergency surgeries

Detailed Description
-----------------
The abdominopelvic tomodensitometric examination is the gold standard for making a diagnosis and identifying the cause, the level of the lesion and looking for signs of severity related to the risk of ischemia of the intestinal tissue. Well characterized, these signs remain difficult to identify for a non-expert radiologist. The evaluation of the detection performance of these signs shows a sensitivity between 63 and 100% and a specificity between 61 and 96% with a great variation according to the signs studied. Our research project aims to develop a tool for the detection of the three main signs of severity of mechanical intestinal obstruction to raise and standardize the level of detection of the risk of ischemia on abdominal CT images.

Official Title
-----------------
Development of an Artificial Intelligence Algorithm to Identify the Main Risks of Ischemia of Mechanical Intestinal Obstruction

Conditions
-----------------
Mechanical Intestinal Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient whose age is ≥ 18 years Patients with an abdominal scan performed at Saint-Joseph Hospital Patients diagnosed with mechanical obstruction of the small intestine on a flange or adhesion Patients having abdominal surgery within 48 hours of diagnosis or medical follow-up at Saint Joseph Hospital French-speaking patient Exclusion Criteria: Patients with a history of abdominal surgery one month before diagnosis Patients objecting to the use of their data for this research Patient under guardianship or curatorship Patient under legal protection Patient deprived of liberty

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 |
| --- | --- | --- |
| Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction | The comparison score (Dice) between manual classifications and locations performed by clinical experts and those automatically predicted by the tool. | Day 1 | 
| Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction | The number of occlusions | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemia
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.

Detailed Description
-----------------
The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy. This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Official Title
-----------------
A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

Conditions
-----------------
Diabetic Neuropathies

Intervention / Treatment
-----------------
* Drug: Cesamet™ (nabilone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetic peripheral neuropathic pain Chronic daily pain present for at least 2 months On stable analgesic regimen for one month Baseline pain score greater than 40mm on a visual analog scale Exclusion Criteria: Hypersensitivity to compounds in study drug or similar drugs Pregnant or lactating females Drug or alcohol abuse Unstable medical condition

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cesamet™ (nabilone)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Average Pain Score at target site. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Worst Pain Score at target site. |  |  | 
| The Pain at Night Score at target site. |  |  | 
| Quality of Life measures |  |  | 
| Patient satisfaction with treatment |  |  | 
| Safety will be assessed through the collection of AEs and vital signs. |  |  |
Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students

Study Overview
=================
Brief Summary
-----------------
Depression is an important mental health concern in college students. This study will recruit students who test positive for moderate to severe depression on the Beck Depression Inventory (BDI). Subjects will be randomly assigned to either a treatment or a control condition. Those in the treatment group will receive four 90 minute group classes using EFT (Emotional Freedom Techniques) to address traumatic memories and other self-identified causes of depression. It will compare them to a no treatment control group.

Official Title
-----------------
Brief Group Intervention Using EFT (Emotional Freedom Techniques) for Depression in College Students: A Randomized Controlled Trial

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: EFT (Emotional Freedom Techniques)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A score of 19 or more on the Beck Depression Inventory Currently enrolled at the University of Santo Tomas Able to read, understand, and complete forms Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EFT<br>Four 90 minute group EFT classes | Behavioral: EFT (Emotional Freedom Techniques)<br>* Four 90 minute group therapy classes of this behavioral intervention<br>|
| No Intervention: No Treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Student scores on the Beck Depression Inventory (BDI) |  | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
students,, depression,, group therapy,, EFT (Emotional Freedom Techniques),, energy psychology