linjc16/ctgov huggingface dataset:
Epigenetic Mechanisms and Severe Obesity (Biological Tissue Collection)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.

Official Title
-----------------
Influence of Vitamins Status on Severe Obesity Related Complications

Conditions
-----------------
Obesity, Diabetes, Metabolic Diseases, Non-alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Procedure: gastric bypass, sleeve, gastric banding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for bariatric surgery with BMI > 35 kg/m2 Exclusion Criteria: unable to receive clear information refusal to sign the consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: gastric bypass, sleeve, gastric banding|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of folate mediated one-carbon metabolic pathway parameters (Folates, Vitamin B12, Methionine, Homocysteine) on severe obesity-related complications before and after bariatric surgery |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of DNA Methylation on severe obesity-related complications before and after bariatric surgery |  | 10 years |
irAE Prediction of Anti-PD-1/L1 in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer

Detailed Description
-----------------
After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.

Official Title
-----------------
Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model

Conditions
-----------------
Immune Checkpoint Inhibitors, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years of age Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication) Exclusion Criteria: Other cancer treatment Other malignancies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| occurrence of immune-related adverse event (irAE) | Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented | 12 months since immunotherapy initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Patients will be followed up for 2 years to investigate Overall Survival | 24 months since immunotherapy initiation | 
| Progression Free Survival. | Patients will be followed up for 2 years to investigate Progression Free Survival. | 24 months since immunotherapy initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunology, biomarkers, prediction, multidimensional
Metabolic Syndrome and Long-term Survival Following Liver Resection

Study Overview
=================
Brief Summary
-----------------
Although hepatitis C virus (HCV) infection remains one of the main causes of hepatocellular carcinoma (HCC) worldwide, metabolic syndrome, with its increase in prevalence, has become an important and significant risk factor for HCC

Detailed Description
-----------------
Hepatocellular carcinoma (HCC) represents the sixth most common cancer worldwide. In Egypt, it represents the fourth common cancer. Many hospital-based studies reported increasing the incidence of HCC. The reason for increased incidence could be attributed to (1) improvement in screening programs and diagnostic tools, (2) increasing the survival rate of cirrhotic patients that increases the chance of developing HCC, and (3) increasing the incidence and complications of hepatitis C virus (HCV) which is the most important risk factor in developing liver cancer including HCC in Egypt Precise staging of HCC initially is very useful for determination of the therapeutic options and the overall prognosis of the disease. There are certain clinical features upon which most staging systems use for HCC assessment. These clinical features are size and local extent of the tumor, metastasis of the tumor, severity of the liver disease, and the overall patient performance status Several studies in the United States, Europe, Taiwan, Hong Kong , and New Zealand have examined the potential relationships between various metabolic factors and HCC risks, mostly focusing on type 2 DM and obesity. Diabetes , or even prediabetes, has been observed to be a major metabolic factor related to an increased risk of HCC in individuals with HBV infections. There is paucity in literature about effect of metabolic syndrome on Long-term Survival Following Liver Resection for Hepatocellular Carcinoma Among Patients With Chronic Hepatitis C Virus Infection

Official Title
-----------------
Metabolic Syndrome and Long-term Survival Following Liver Resection for Hepatocellular Carcinoma Among Patients With Chronic Hepatitis C Virus Infection

Conditions
-----------------
Survival

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients with HCC secondary to HCV infection underwent hepatic resection Exclusion Criteria: HBV patients other modalities of therapy
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 with HCC underwent resection<br>patients with HCC underwent resection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | assess frequency long term survival after resection | between two and five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic syndrome, survival, hepatocellular carcinom
Impact of Left Atrial Appendage Closure on Physical Capacity.

Study Overview
=================
Brief Summary
-----------------
Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke is a increasing technology leading to exclusion of the left atrial appendage volume from the blood circulation and therefore protects from cardioembolic strokes- It is unclear if the volume reduction of the left atrium leads to a change in exercise capacity or Quality of life.

Detailed Description
-----------------
The monocentric trial deals with the endocrinological changes as a result of closure of the left atrial appendage with a internal closure device. Specially, the changes in atrial natriuretic peptide, brain natriuretic peptide and their impact on exercise capacity is on focus of the trial. The trial is planned as a all comers trial.

Official Title
-----------------
Impact of Left Atrial Appendage Closure With a Closure Device on Quality of Life, Physical Capacity and Expression of Atrial Natriuretic Peptide and Brain Natriuretic

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a indication for LAA closure device Implantation Exclusion Criteria: Inability to perform exercise testing

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 |
| --- | --- | --- |
| exercise capacity measured by maximal oxygen consumption | Change from baseline spiroergometry to 45 days to 6 months | Baselina, 45 days, 6 months |
Tooth Extraction With Deep Sedation in Children: A Retrospective Study

Study Overview
=================
Brief Summary
-----------------
In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.

Detailed Description
-----------------
Majority of dental treatments can be performed under local anesthesia. However, this is not always possible for pediatric non-cooperated patients with severe anxiety. In these patients, unpleasant dental experiences may lead to development of dental phobia when they become adults . Therefore, it is important to eradicate anxiety, and to prevent a possible psychological trauma in pediatric patients. For this purpose, psychological and medical methods have been applied to increase patient compliance. It has been proven that general anesthesia especially prevents dental phobia in elderly, and increases the quality of life related to oral health. In this study we aimed to evaluated the patients in whom dental local anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep sedation. All patients dates will evaluate from their patient file retrospectively from 2011 to 2014.

Official Title
-----------------
Tooth Extraction With Deep Sedation in Children: A Retrospective Study

Conditions
-----------------
Tooth Extraction Status Nos

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients who dental treatment was performed with deep sedation Exclusion Criteria: the patients who dental treatment was performed local anesthesia or general anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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 |
| --- | --- | --- |
| anesthetic technics used for deep sedation |  | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects observed in patients |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation,, tooth extraction,
Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia

Official Title
-----------------
ONO-5046Na Phase II Study - A Pilot Study for Patients With Acute Respiratory Failure

Conditions
-----------------
Community-acquired Pneumonia

Intervention / Treatment
-----------------
* Drug: ONO-5046Na
* Drug: ONO-5046Na


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with community-acquired pneumonia Patients with acute respiratory failure Exclusion Criteria: Patients with nosocomial pneumonia Patients on mechanical ventilation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: ONO-5046Na<br>* twenty four hour infusion at 0 mg/kg/hr for 14 days<br>|
| Experimental: E<br> | Drug: ONO-5046Na<br>* twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 28 days | 
| ventilator status |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-5046Na, acute respiratory failure, community-acquired pneumonia
The Use of Repetitive Magnetic Stimulation for Strength Training of the Quadriceps Muscle

Study Overview
=================
Brief Summary
-----------------
We intend to use repetitive magnetic stimulation to the quadriceps muscle to try to improve strength and improve the metabolic function of the muscle.

Detailed Description
-----------------
Quadriceps strength is reduced in COPD. Increasing quadriceps strength is one of the goals of pulmonary rehabilitation yet some patients with severe COPD are unable to exercise with sufficient intensity, due to breathlessness, to achieve a true training benefit. Transcutaneous electrical stimulation of the femoral nerve has been shown to improve quadriceps muscle strength, muscle mass, and performance in patients with severe COPD. Magnetic stimulation may be preferred because it offers the opportunity to train the whole muscle and because it is painless. In this pilot study we are investigating whether repetitive magnetic stimulation camn increase the strength of the quadriceps muscle and whether it confers any change in structure or metabolism of the muscle itself.

Official Title
-----------------
The Use of Repetitive Magnetic Stimulation for Strength Training of the Quadriceps Muscle in Patients With Chronic Obstructive Pulmonary Disease

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

Intervention / Treatment
-----------------
* Device: Repetitive magnetic stimulation to the quadriceps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Obstructive Pulmonary Disease Exclusion Criteria: Aspirin therapy Cardiac Pacemaker -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- |
|Device: Repetitive magnetic stimulation to the quadriceps|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps Twitch force |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps maximal voluntary contraction, Oxidative enzyme profile, fibre type distribution and capillarity of the muscle, quality of life questionnaires |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromuscular electrical stimulation
Chinese Adolescent Registry for Diabetes (CARD) Study

Study Overview
=================
Brief Summary
-----------------
The CARD study is a observational study which includes Chinese adolescents with diabetes aged 18-30. The study aims to explore the status of disease treatment, self-management, the relationship between disease treatment and disease outcome in Chinese adolescents with diabetes.

Conditions
-----------------
Chinese Adolescents With Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed diabetes aged 14-30 signed the informed consent Exclusion Criteria: taking part in other drug research gestational diabetes diagnosed with tumor or cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 30 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 |
| --- | --- | --- |
| cardiovascular events |  | six year |
Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.

Study Overview
=================
Brief Summary
-----------------
Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially late second and third trimester. We aimed to investigate the role of apoptosis in etiopathogenesis of obstetric cholestasis.

Detailed Description
-----------------
M30 (caspases cleaved Cytokeratin-18 (CK-18) fragment) is a specific apoptosis marker. We aimed to use it to evaluate the apoptotic process.

Official Title
-----------------
Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Late second or third trimester of pregnancy. Exclusion Criteria: Foreknown systemic diseases, multiple pregnancy, smoking cigarettes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Group 1<br>Pregnant subjects diagnosed with obstetric cholestasis who didn't have any foreknown systemic disease. | |
| Group 2<br>entirely healthy pregnant subjects, the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M30 value as Unit per Liter. |  | Four months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of delivery with cesarean section. |  | Four months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Apoptosis, intrahepatic cholestasis, obstetric outcomes
Divalproex vs. Lamotrigine for Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.

Detailed Description
-----------------
The primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). The primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. The secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.

Official Title
-----------------
Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Bipolar I or Bipolar II disorder Prescription of divalproex (any formulation except for Depakene/valproic acid) or lamotrigine in the electronic pharmacy profile. Age 19 or older Demonstrated stability for at least 4 weeks on an adequate dose of each medication (at least 50mg/d lamotrigine or 15mg/kg/day divalproex). Treatment at the TVAMC for at least 6 months following the prescription of divalproex or lamotrigine. Exclusion Criteria: Primary diagnosis of schizoaffective or schizophrenia during the evaluation period. Prescription of divalproex and lamotrigine given concurrently during the observation period. History of Dementia or cognitive disorders

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Relapse, Retrospective