linjc16/ctgov huggingface dataset:
Acetaminophen-Induced Hepatotoxicity in Chronic Alcohol Abusers

Study Overview
=================
Brief Summary
-----------------
It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will undergo baseline tests to ensure that they do not have liver damage at the time of enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of acetaminophen or a placebo three times a day for four days. Subjects will have blood work drawn on a daily basis to monitor the status of the liver. These tests will include conventional markers of liver injury in addition to a novel biomarker of liver function, a-GST. Previous work in the investigators' group has shown that a-GST is a more sensitive indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x 2). However, it has never been used to study the alcoholic population. The investigators believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population.

Conditions
-----------------
Hepatotoxicity

Intervention / Treatment
-----------------
* Drug: acetaminophen sustained-release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who self-report consuming at least 6 drinks per day, daily, for at least 6 weeks and who are currently enrolled at the Detoxification Center, Hotel Dieu Hospital. Last alcohol consumption occurring between 12 and 72 hours prior to screening for study. Exclusion Criteria: Individuals with a self-reported or previously documented history of hepatitis A, B, C or HIV. Individuals who have ingested any acetaminophen regardless of dose in the previous 48 hours. Individuals who have ingested > 4 grams of acetaminophen/day in any of the previous 7 days. Individuals < 18 years of age. Individuals with abnormal liver function at baseline (defined as AST or ALT > 120 IU/L, International Normalized Ratio [INR] > 1.5, and a-GST > 7.5 7 :g/L). Individuals who have an allergy or sensitivity to acetaminophen.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: acetaminophen sustained-release|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum a-GST relative to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conventional liver function tests (LFTs) |  |  |
A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

Study Overview
=================
Brief Summary
-----------------
This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: MK0217, alendronate sodium/Duration of Treatment: 6 months
* Drug: Comparator: placebo / Duration of Treatment: 6 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with postmenopausal osteoporosis Exclusion Criteria: High risk for fractures Esophageal abnormalities Upper gastrointestinal symptoms that are not relieved with medication Metabolic bone disease (example - vitamin D deficiency) Medications that would affect the breakdown or build-up of bone

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

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

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

| Intervention/Treatment |
| --- |
|Drug: MK0217, alendronate sodium/Duration of Treatment: 6 months|nan|
|Drug: Comparator: placebo / Duration of Treatment: 6 months|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo |  |  | 
| To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months |  |  |
Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine wether the combined measurement of the soluble form of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in critically ill patients.

Official Title
-----------------
Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis: a Prospective, Bicentric Study

Conditions
-----------------
Critically Ill Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive patients admitted into the ICU Exclusion Criteria: absence of social protection

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 |
| --- | --- |
| ICU patients<br>all patients admitted into the ICU | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of sTREM-1, PCT, and CD64, taken alone or in combination in diagnosing sepsis in ICU patients as defined by the expert panel | A prospective study will be conducted in 300 patients admitted to a medical Intensive Care Unit, assaying serum concentrations of soluble Triggering Receptor Expressed on Myeloid cells-1 (sTREM-1) and procalcitonin (PCT), and measuring the expression of the high affinity immunoglobulin-Fc fragment receptor I (FcγRI) CD64 on neutrophils (PMN CD64 index) in flow cytometry. These biomarkers will be tested for their association with the diagnosis of infection. The final diagnosis of infection will be done by independent experts blinded for the results of CD64, sTREM-1, and PCT results. A Bioscore combining these biomarkers will be constructed and validated in an independent prospective cohort from another center. | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, diagnosis, biomarker
The Presence of Friends Increases Food Intake in Youth

Study Overview
=================
Brief Summary
-----------------
Participants will be matched with either their friend or an unfamiliar peer who is the same gender and about the same age. Participants will have 45 minutes of free-play in an experimental room where they will have free access to energy-dense and nutrient-dense foods and an assortment of games and puzzles. The investigators predict that participants eating with a friend will eat significantly more than participants eating with an unfamiliar peer. The investigators also predict that overweight participants eating with an overweight partner will eat significantly more than participants eating with a non overweight participant.

Official Title
-----------------
The Presence of Friends Increases Food Intake in Youth

Conditions
-----------------
Total Caloric Intake, Nutrient Dense Caloric Intake, Energy Dense Caloric Intake

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls ages 9-15 Between 15th and 95th BMI percentile for their age Exclusion Criteria: Sickness, psychopathology or developmental disabilities Participant has a cold or upper respiratory distress Food allergies to the study food Participant is on medication or has a medical condition that could influence taste, appetite or olfactory sensory responsiveness.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 15 Years

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

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

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
-----------------
social influence, friends, eating behavior, childhood overweight
A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to see if Glucovance, a medication currently approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and effectively in children 9 to 16 years of age.

Conditions
-----------------
Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
-----------------
* Drug: Glucovance (metformin HCl/glyburide)
* Drug: metformin HCl
* Drug: glyburide


Participation Criteria
=================
Eligibility Criteria
-----------------
Children ages 9-16 years with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, with or without oral hypoglycemic therapy, and have an HbA1c greater than 6.4%

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glucovance (metformin HCl/glyburide)|nan|
|Drug: metformin HCl|nan|
|Drug: glyburide|nan|

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
-----------------
Diabetes Mellitus, Type II
Follow-up of Patients' Physical Activity in Post-hospitalization

Study Overview
=================
Brief Summary
-----------------
Physical exercise has been identified as a major item of many affecting many chronic diseases and stroke rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side-effects and mortality. Stroke in association with an inactive lifestyle lead to a decrease in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to vicious circle of less and less mobility. Therefore, physical activity for the health is a valid and relevant way to improve the quality of life and to recover functional capacity. The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke.

Official Title
-----------------
Follow-up of Patients' Physical Activity in Post-hospitalization by Implementation of Systems of Active Monitoring.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: incentive program for physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person having stroke (ischemic or hemorrhagic) Whatever the area of stroke Person supported by HEMIPASS (monitoring team and home support) Stroke less than 6 months Patient walking with or without technical or human assistance: FCC score Exclusion Criteria: Disability limiting the gait before the stroke Age < 18 years Cognitive impairment limiting participation to the program Non signature of the consent cardiopulmonary pathology which forbid/banned effort

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: effects of a incentive program for physical activity<br>The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke | Other: incentive program for physical activity<br> <br> |
| No Intervention: control group<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distance on the 6 minute walking test (6MWT) |  | 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | EQ-5D | at 0 month, 6 months and 12 months |
Perfluorocarbon Perfused Vitrectomy and 3D Vitrectomy System in Advanced Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
To investigate the feasibility and advantages of using perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting vitrectomy using a dual, dynamic drive (3D)technology. In complicated surgeries in advanced diabetic retinopathy and retinal detachment

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced diabetic retinopathy with retinal detachment Exclusion Criteria: Retinal detachments of more than 6 months

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time |  |  | 
| Facility of surgical maneuvers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitreoretinal surgery
Mindfulness Based Stress Reduction for Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Mindfulness based stress reduction offered to couples where one has metabolic syndrome to see if their stress is reduced as measured by bio markers and surveys

Detailed Description
-----------------
This is a pilot study being designed to pilot a MBSR program for the purposes of future research.The investigators will be using two cohorts. One who will get the intervention and the other who will be wait listed and receive the intervention at a later date. Eight week mindfulness class offered to couples, who also attend an orientation session and a half day retreat with other couples to learn how to control stress through mindfulness meditation practices. Participants will come for lab work before intervention, eight weeks after initial class and at the end of entire program. Bio- markers to be measured are waist circumference, FBS and cholesterol.

Official Title
-----------------
Mindfulness-Based Stress Reduction Study for Couples

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: MBSR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has 3 of the following: a Abdominal Obesity; b. Hypertriglyceridemia; c. Low High Density Lipoproteins (HDL); d. High Blood Pressure; e. High Fasting Blood Sugar (FBS) Participant must be married or co- habituating Both partners are over sixty Exclusion Criteria: Either partner is non- English speaking Either partner practices mind- body therapies more than once a week/ Either partner taking psychiatric medicine

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait List Control<br>Will receive voucher for MBSR after study is concluded | |
| Other: Intervention<br>These people will receive the MBSR | Behavioral: MBSR<br>* Eight week class on MBSR in addition to an orientation class and a half day retreat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self- reported physical health status | SF 12 | Up to three weeks after intervention ends | 
| Perceived stress | Perceived stress scale, | Up to three weeks after intervention ends | 
| Mindfulness Skills | Kentucky Inventory of Mindfulness Skills | Up to three weeks after intervention ends |
Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced esophageal cancer.

Detailed Description
-----------------
By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced esophageal cancer. The safety will be evaluated by statistics of adverse reactions.The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Conditions
-----------------
Metastatic Esophageal Cancer

Intervention / Treatment
-----------------
* Device: Cryosurgery
* Biological: NK immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence Body tumor 1-6, the maximum tumor length < 5 cm KPS ≥ 70, lifespan > 6 months Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Exclusion Criteria: Patients with cardiac pacemaker Patients with brain metastasis Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryosurgery and NK immunotherapy<br>We use comprehensive cryosurgery to destroy big tumors, and use multiple (more than 6 times) NK immunotherapy to destroy small tumors | Device: Cryosurgery<br>* Argon-helium cryosurgical system<br>Biological: NK immunotherapy<br>* Nutral killer cell immunotherapy for more than 6 times<br>|
| Active Comparator: Cryosurgery<br>We use comprehensive cryosurgery to destroy big tumors | Device: Cryosurgery<br>* Argon-helium cryosurgical system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival（PFS） |  | 1 year | 
| Overall survival（OS） |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Cancer, NK immunotherapy, Safety, Efficacy