linjc16/ctgov huggingface dataset:
Spironolactone for Paroxysmal Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.

Detailed Description
-----------------
To determine whether or not adding spironolactone can prevent or delay the occurrence of paroxysmal atrial fibrillation in patients who have received propafenone treatment.

Official Title
-----------------
Use of Spironolactone to Treat Patients With Paroxysmal Atrial Fibrillation- A Multi-Center, Prospective, Randomized, Placebo-Controlled, Double Blind Study

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

Intervention / Treatment
-----------------
* Drug: Spironolactone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 18 to 80 Y/O, Paroxysmal AF. Exclusion criteria: GPT>100 IU/L or tota bilirubin >2 mg/dl; Creatinine > 2 mg/dl; Serum potassium >= 5 mM; Serum sodium <=130 mM; Uric acid > 10 mg/dl。

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: III<br>Placebo | Drug: Spironolactone<br>* 25 mg po qd 25 mg po bid<br>* Other names: Aldactone;|
| Experimental: Experimental<br>Drug intervention | Drug: Spironolactone<br>* 25 mg po qd 25 mg po bid<br>* Other names: Aldactone;Drug: Placebo<br>* Spironolactone 25 mg po qd<br>* Other names: Aldactone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to a first electrocardiographically confirmed AF |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Response rate: Improvement of any symptom scores and/or SF36 scores more than 50 % (compared with re-randomization scores) 2. Difference of mean episodes of documented AF between the spironolactone and placebo groups. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, spironolactone
Oxygen Extraction-guided Transfusion in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. In the TRICC Trial, patients assigned to a restrictive transfusion strategy (transfusion if Hb<7 g/dL) had similar mortality to patients transfused if Hb<10 g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. We therefore hypothesized that patients with high extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin levels.

Official Title
-----------------
Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients

Conditions
-----------------
Anemia, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemoglobin level <10 g/dL during the first 72 hours of ICU Exclusion Criteria: Acute bleeding Hemoglobin level less than 7 g/dL

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 |
| --- | --- |
| Appropriate transfusion policy<br>Patients transfused with high arterial-venous oxygen difference (≥3.7 ml/dl) or non-transfused with low arterial-venous oxygen difference (<3.7 ml/dl) | |
| Non-Appropriate transfusion policy<br>Patients transfused despite low arterial-venous oxygen difference or non-transfused with high arterial-venous oxygen difference | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day mortality | mortality | after 90 days from study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Occurence of acute kidney injury according to KDIGO 2012 guidelines | 7 days after study inclusion | 
| Length of ICU stay |  | from ICU admission to discharge, up to 8 weeks | 
| Variation in Sequential Organ Failure Assessment (SOFA) score | daily variation in SOFA score (0-24 points scale with higher values indicating worst conditions) | 5 days | 
| Days of vasopressor | Need for vasopressor | 28 days after study inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transfusion, intensive care medicine, 90-day mortality
Asian Youth and Tobacco Control Survey

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to identify and understand the environmental characteristics associated with tobacco use and tobacco initiation among Asian American youth from primarily two communities: Chinese and Vietnamese. The specific aims of this study are twofold: To estimate the prevalence of smoking among Chinese and Vietnamese youth in the Houston area compared with non-Asian American communities. To study the relationship between environmental characteristics (both pro- and anti-tobacco) and tobacco initiation and use among Chinese and Vietnamese youth. To explore if degree of acculturation is related to tobacco initiation and use among Chinese and Vietnamese youth.

Detailed Description
-----------------
This is a survey about health-related behaviors, risks, attitudes and acculturation. It includes questions about use of alcohol, tobacco, and other drugs; safety and violence; diet and physical activity; and youth programs and resources in your community. Your answers are completely anonymous, and your name will not appear anywhere on this survey or as part of this survey. Your parents will not see your responses.

Official Title
-----------------
Asian Youth and Tobacco Control Survey

Conditions
-----------------
Tobacco Use, Smoking

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identified male or female of Chinese or Vietnamese descent Age 12-17 years Living in the Greater Houston area Intellectual age of 7 or higher Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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 |
| --- | --- |
| Asian Youth and Tobacco Control<br>Smoking Questionnaire for self-identified Chinese or Vietnamese participants. | Behavioral: Questionnaire<br>* Questionnaire about tobacco and alcohol use, acculturation, and other related topics.<br>* Other names: Survey;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence Rates of smoking among Chinese and Vietnamese youth in the Houston area. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Control, Tobacco Use, Tobacco Initiation, Smoking, Questionnaire, Survey
Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient

Study Overview
=================
Brief Summary
-----------------
Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). However, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment. Recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life. This retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program. These patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program. Furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation. In this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of Quebec, muscle Tests Shirado and Sorensen).

Official Title
-----------------
Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient

Conditions
-----------------
Non-specific Low Back Pain, Functional Capacities

Intervention / Treatment
-----------------
* Other: Physical Rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male age between 18 and 70 Non-specific low back pain - achieved rehabilitation program Exclusion Criteria: inflammatory diseases cancer infectious diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients included for rehabilitation program | Other: Physical Rehabilitation program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMFORTABLE WALKING SPEED (TEST OF 400M) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 200m fast walk test walking velocity |  | 4 weeks | 
| Quebec score |  | 4 weeks | 
| Shirado test |  | 4 weeks | 
| Sorensen test |  | 4 weeks |
Objective Assessment of Sensory Nerve Fiber Sensitivity

Study Overview
=================
Brief Summary
-----------------
This pilot study utilizes a unique technology to determine nerve fiber sensitivity. This will allow us to determine whether this method and device can discern changes in pain intensity and type, which is predicated on differing nerve fiber sensitivities.

Official Title
-----------------
Developing a Method to Objectively Assess Sensory Nerve Fiber Sensitivity: A Pilot Study

Conditions
-----------------
Nerve Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is 18 to 65 years of age The subject is willing to have a tourniquet applied as part of the study The subject is willing and able to provide written informed consent to the study participation The subject is willing and able to comply with all study procedures Exclusion Criteria: Eye pathology precluding pupillometry Subjects who have ongoing pain requiring medical attention Subjects who are not normotensive Subjects with peripheral vascular disease Subjects who are morbidly obese (BMI >40) Subjects with diabetes or diabetic retinopathy Subjects who are or may be pregnant Subjects with cardiac disease Subjects with neuropathic disease states

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupillary Reflex Parameters | The primary measurable endpoint is the change in the Area Under the Curve (AUC) of the three sensory nerve fiber types that occurs as a response to tourniquet ischemia and reperfusion. The change is calculated by the difference between measurements at various time points: baseline, tourniquet application, and tourniquet release. | 0,5,10,15,20,25,30,35 minutes |
Evaluation of Atuna Racemosa Toxicity

Study Overview
=================
Brief Summary
-----------------
For thousands of years people in the South Pacific have used Atuna racemosa extract as a topical anti-inflammatory. We, the researchers at the Mayo Clinic, have shown this extract to also have antibacterial properties. While this extract has been used for decades in the South Pacific, a controlled clinical trial to evaluate toxicity has never been performed.

Official Title
-----------------
Evaluation of Atuna Racemosa Toxicity

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Atuna Racemosa


Participation Criteria
=================
Eligibility Criteria
-----------------
The subjects will be 20 healthy male and non-pregnant, non-lactating, female volunteers of ages 18 - 65. No subject will be excluded based on minority status.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atuna Racemosa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Carotid Intima-media Thickness as Cardiovascular Mortality Predictor in Peritoneal Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of this study is the long-term prognostic values of carotid intima-media thickness and coronary flow reserve in cardiovascular mortality of peritoneal dialysis patients.

Detailed Description
-----------------
Endothelial dysfunction (ED) is a precursor and cause of cardiovascular diseases. Defining of endothelial thickness and coronary microvascular function could be useful for detecting ED. Endothelial dysfunction could be assessed by coronary flow reserve (CFR), carotid intima media thickness (IMT). Repeating measurement of IMT and CFR could be predictor of cardiovascular events and mortality in peritoneal dialysis patients.

Official Title
-----------------
Carotid Intima-media Thickness and Coronary Flow Reserve as Cardiovascular Event and Mortality Predictors in Peritoneal Dialysis Patients: Results of Seven-year Follow-up From a Single Center

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peritoneal dialysis patients whose followed up at least six months from October 1994 to October 2011 (for study group) Kidney transplant recipients whose followed up at least six months from October 1994 to October 2011 (for control group) Exclusion Criteria: diabetes mellitus valvular heart disease, any prior coronary intervention and congestive heart failure Patients whose left anterior descending coronary artery (LAD) could not be visualized adequately by Doppler echocardiography were also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| peritoneal dialysis patients<br>37 peritoneal dialysis patients followed at the Istanbul Medical Faculty from October 1994 to October 2011 | |
| renal transplant recipients<br>20 renal transplant recipients followed at the Istanbul Medical Faculty from October 1994 to October 2011 setted as the control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diseases morbidity |  | 10-15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival |  | 10-15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peritoneal dialysis, carotid intima-media thickness, coronary flow reserve, cardiovascular mortality
Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.

Detailed Description
-----------------
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: Topotecan Docetaxel For ever 2 patients treated, 1 will receive treatment A (Topotecan) and 1 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Official Title
-----------------
A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Topotecan
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Relapsed or Progressive Disease Stage IIIB (not candidate for combined modality) or IV No more than one prior chemotherapy regimen Able to perform activities of daily living without assistance Measurable disease outside of radiation port Adequate bone marrow, liver and kidney function Must understand study and sign informed consent prior to enrollment Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Prior treatment with Topotecan or Docetaxel Uncontrolled brain metastases Moderate peripheral neuropathy Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topotecan|nan|
|Drug: Docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression |  |  | 
| Overall survival |  |  | 
| Overall toxicity |  |  |
The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patient

Study Overview
=================
Brief Summary
-----------------
Background. Acute renal failure after liver transplantation (LT) requiring continuous renal replacement therapy (CRRT) adversely affects patient survival. However, there are few reports to assess the predictors for postoperative CRRT in liver transplant patients. The investigators undertook this study to identify perioperative factors that would predict patients at risk of CRRT. Patients and Methods. The investigators retrospectively reviewed the data of 148 liver transplant patients from January 2007 to November 2010 at Severance Hospital, Yonsei University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18 patients from living and 26 from deceased donors) and those without CRRT was 104. Univariate and stepwise logistic multivariate analyses were performed.

Conditions
-----------------
Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19-65 year Liver transplant patients from January 2008 to December 2011 Exclusion Criteria: Patients treated with CRRT before transplantation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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 |
| --- | --- |
| liver transplantation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| status before operation | laboratory data(ex : total bilirubin, albumin, coagulation factors, blood gas analysis(arterial CO2 pressure. Blood urea nitrate/Creatinine, Hemoglobin/Hematocrit.) | 1 day before operation | 
| the amount of ascites |  | intraoperative | 
| the duration of anesthesia and operation |  | intraoperative | 
| intraoperative hemodynamic instability |  | intraoperative | 
| intraoperative bleeding |  | intraoperative | 
| Intraoperative urine output |  | intraoperative | 
| the types of donation(living or deceased donor) |  | intraoperative | 
| survival rate |  | on the postoperative 28th days, 365 days | 
| postoperative bleeding amount |  | on the postoperative 28th days, 365 days. | 
| postoperative CRRT(continuous renal replacement therapy), |  | on the postoperative 28th days, 365days | 
| mortality |  | on the postoperative 28th days, 365 days. |