linjc16/ctgov huggingface dataset:
Pharmacogenomic Research in Korean Patients With Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV.

Official Title
-----------------
Pharmacogenomic Research for Prediction of Drug Response in Korean Patients With Hepatitis C

Conditions
-----------------
Chronic Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis C virus infected patients Exclusion Criteria: Patients who infected Hepatitis B virus or Human immunodeficiency virus HCV infected patients previously treated with antiviral drugs Patients had a history of autoimmune hemolytic anemia

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SVR group<br>A patients who achieved SVR (sustained virologic response) | |
| non-SVR group<br>A patients who not achieved SVR (sustained virologic response) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response (SVR) | Undetectable HCV RNA in serum ( <15 IU/ml ) 24 weeks after the end of treatment | 24 weeks after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia | a reduction in Hemoglobin of >3.0 g/dL a reduction in Hemoglobin levels to 10.0g/dL. | 4 weeks after start of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis C, Pharmacogenomics, IL28B, ITPA
Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

Study Overview
=================
Brief Summary
-----------------
Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).

Official Title
-----------------
Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)

Conditions
-----------------
Peripheral Nerve Injuries

Intervention / Treatment
-----------------
* Biological: Autologous Human Schwann Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year; Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings; Exclusion Criteria: Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety); Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve); Persons with severe peripheral nerve injury gap length > 10 cm in length; Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve; Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation; Presence of disease that might interfere with participant

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Autologous Human Schwann Cells|Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Vinayasa Yoga and Mood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the immediate and cumulative effects of yoga on stress and mood among young adult college students attending an 8-week program in Vinyasa yoga.

Detailed Description
-----------------
Traditional vigorous aerobic exercises (TAE), such as running and bicycling have been shown to improve mood and relieve stress. Yoga is an ancient physical and mental practice that as a form of exercise may share properties of TAE and in turn offer similar mood and stress effects. However, scientifically rigorous studies examining the psychological effects of yoga and published in peer-reviewed Western journals are rare. The aim of this research was to establish preliminary evidence for the acute effects of vinyasa yoga on mood and stress among young adults.

Official Title
-----------------
The Effects of Vinayasa Yoga on Mood and Stress

Conditions
-----------------
Affect, Stress, Psychological

Intervention / Treatment
-----------------
* Behavioral: Vinyasa yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ages 18 or older English-speaking Exclusion Criteria:

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vinyasa yoga<br>Group administered 60 minute vinyasa yoga classes delivered twice weekly for 8 weeks | Behavioral: Vinyasa yoga<br> <br> |

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
-----------------
yoga,, exercise, affect, mind/body therapies, stress, psychological
Near Death Experience (NDE) and Migraine

Study Overview
=================
Brief Summary
-----------------
Migraine is a common disabling primary headache disorder. Epidemiological studies have documented its high prevalence and high socio-economic and personal impacts. Migraine affects more than 20% of the French population. However, the physiopathology of migraine is always partially known. Cortical spreading depression (CSD) is the widely accepted as the electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep intrusion have been discussed. However, the role of DCE has never been discussed. The goals of this study are : to see if there is an epidemiological link between NDE and migraine/ to specify if NDE was followed by a migrainous headache.

Official Title
-----------------
Near Death Experience (NDE) and Migraine

Conditions
-----------------
Migraine, Near Death Experience

Intervention / Treatment
-----------------
* Other: questioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who experienced an NDE defined by the occurrence, when the subject is in a state of clinical death or a particular state of consciousness of a following event: body output experience, disembodiment, for a tunnel and / or light; Topic recorded in the EMI database (Dr. Postel, National Center for Education, Research and Information on the conscience; Topic agreeing to participate in the study. Exclusion Criteria: Patient mental condition or disorder or psychiatric history or any other factor limiting the ability to participate in an informed manner and compliant to the study; Other than obtained Participation Agreement.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questioning|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical death, state of consciousness
French Registry of Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The Fast-MI registry was designed to evaluate the real world management of patients with acute myocardial infarction (MI), and to assess their in-hospital, medium and long-term outcomes

Detailed Description
-----------------
Primary objectives : compare survival following the admission to a USIC according to the terms of care

Official Title
-----------------
French Registry of Acute Coronary Syndrome With or Without ST Elevation

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission within the 48 hours after the occurence of acute myocardial infarction (AMI) written informed consent for the DNA and serum databank Exclusion Criteria: AMI occured within the 48 hours after therapeutic intervention (bypass, coronary angioplasty or other chirurgical intervention) diagnostic of AMI not confirmed

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Adults (female and male) with a acute coronary syndrome | Other: Blood sample<br>* 60 ml of whole blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All causes mortality at each follow-up period |  | 6 months, each year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | 6 month, each year | 
| validation of guidelines across the country |  | 6 month, each year | 
| Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes |  | 6 month each year | 
| Serum databank for evaluation of biomarkers in MI |  | 6 month each year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary syndrome, Myocardial infarction, French registry
Star-Close Early Ambulation Trial

Study Overview
=================
Brief Summary
-----------------
To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.

Detailed Description
-----------------
To confirm that patients who receive the Star-Close vascular closure system (VCS) after diagnostic cardiac catheterization can safely ambulate within 30 minutes of catheterization.

Official Title
-----------------
Star-Close Early Ambulation Trial

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: Walking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to for an outpatient left heart catheterization Catheterization through the femoral artery Able to ambulate at least 20 feet Able to receive the Star-Close Vascular Closure System Be a candidate for hospital discharge following catheterization Exclusion Criteria: Known peripheral arterial disease Blood pressure greater than 180/110 Pregnant or lactating Anemic or low blood count Blood thinning medication within 5 days before catheterization Unable to walk 20 feet with out rest Complications during catheterization procedure

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system. | Behavioral: Walking<br>* Patient will walk within 30 minutes of vascular closure system procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence or absence of adverse outcomes after ambulation within 30 minutes of cardiac catheterization |  | 7 days post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Catheterization, Walk, Heart Catheterization, Coronary Disease, Heart Disease, Coronary Artery Disease
Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Previous studies have reported that about 3 % of patients who have had open inguinal herniorrhaphy had a visceral, ejaculatory-related pain. The investigators want to assess this problem among patients after laparoscopic inguinal hernia repair with(self-administered questionnaire study).

Official Title
-----------------
Pain Related Sexual Dysfunction After Laparoscopic Inguinal Hernia Repair

Conditions
-----------------
Sexual Dysfunction, Hernia, Inguinal, Other Chronic Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients >18 yrs Exclusion Criteria: Research protection

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pain patients<br>Patients with pain related sexual dysfunction after laparoscopic inguinal hernia repair | |
| Non-pain patients<br>Patients with no pain related sexual dysfunction after laparoscopic inguinal hernia repair | |

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
-----------------
Groin hernia, chronic pain, Persistent postoperative pain, Laparoscopic inguinal herniotomy, Sexual dysfunction
Different Doses of Vitamin D and T Regulatory Cells in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives 800 IU vitamin D.

Detailed Description
-----------------
Vitamin D, in addition to its bone mineralization effect, is an immune- modulatory agent. Fetal and premature cellular immunity are generally delayed. Whether vitamin D can enhance cellular immunity by increasing T regulatory cells is unknown. The effect of two different doses of vitamin D; 400 IU and 800 IU will be studied.

Official Title
-----------------
A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on T Regulatory Cells in Preterm Infants

Conditions
-----------------
Prematurity, Immune Defect

Intervention / Treatment
-----------------
* Drug: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants with gestational age 28-33 weeks Exclusion Criteria: Necrotizing enterocolitis Bowel perforation Chromosomal anomalies Inborn errors of metabolism Major congenital anomalies

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>Subjects in this group receive 400 IU vitamin D daily for 4 weeks. | Drug: Vitamin D<br>* Oral vitamin D<br>* Other names: Oral vitamin D;|
| Experimental: High dose<br>Subjects in this group receive 800 IU vitamin D daily for 4 weeks. | Drug: Vitamin D<br>* Oral vitamin D<br>* Other names: Oral vitamin D;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in The Number of T Regulatory Cells | Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells | At 1 week (compared to baseline) | 
| Percent Change in The Number of T Regulatory Cells | Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells | At 4 weeks (compared to baseline) |
Pharmacokinetic Study of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multicenter pharmacokinetic study of HD od PD patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.

Detailed Description
-----------------
This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.

Official Title
-----------------
Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: iron sucrose injection USP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 12 and 18 History of Chronic Renal Failure requiring HD or PD Hgb </= 13 g/dL Ferritin < 800 ng/ml TSAT < 50% Receiving EPO Exclusion Criteria: Known Sensitivity to Iron Sucrose Severe Concomitant disease of the liver or cardiovascular system Serious bacterial Infection Pregnancy / Lactation Active Hepatitis Patients with Causes of iron deficiency other that Chronic Renal Failure Blood Transfusion Body Weight < 25 KG Currently being treated for Asthma Received investigational drug within last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: iron sucrose injection USP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Parameters |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of safety events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Pharmacokinetics
Electronic Triggers: Messaging After A1C EHR Alert

Study Overview
=================
Brief Summary
-----------------
Studying subjects with HbA1C tests >10 and no follow-up test within 6 months and appointments scheduled in the next 60 days from data run date. Subjects who receive intervention message may be more likely to follow up with their provider to schedule a follow up HbA1C test.

Official Title
-----------------
Electronic Triggers: Messaging After A1C EHR Alert

Conditions
-----------------
Hemoglobins, Diagnostic Tests

Intervention / Treatment
-----------------
* Behavioral: MyChart message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MyChart active patients with HbA1C tests >10 and no follow-up test within 6 months and no appointments scheduled in the next 60 days from data run date Exclusion Criteria: Patients with a scheduled appointment within 60 days from time algorithm is run; hospital encounters; non English or Spanish patients as indicated by primary language in Epic

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 |
| --- | --- |
| MyChart message<br>MyChart message subjects with high A1C blood tests to help manage their diabetes and prevent some of the complications caused by high sugars. The message recommends that they schedule a visit with their doctor who can recheck the blood test and help get their diabetes under control. | Behavioral: MyChart message<br>* Message subjects through MyChart to follow-up with their provider to schedule a follow up HbA1C test.<br>|
| No MyChart message<br>No message | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of follow up A1C within 9 months after original A1C (allowing 3 months after email is sent) | This outcome measures the rate at which participants complete an A1C test within 3 months of the message intervention being sent and 9 months of their original test. | 2 years |