linjc16/ctgov huggingface dataset:
Comparing Adjustable Sutures Surgery

Study Overview
=================
Brief Summary
-----------------
Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment

Detailed Description
-----------------
Forty patients will be equally divided into two groups and time of adjustment of the suture will be compared as regards efficacy and pain tolerance

Official Title
-----------------
Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery

Conditions
-----------------
Strabismus, Comitant

Intervention / Treatment
-----------------
* Procedure: Adjustable strabismus surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients Exclusion Criteria: Patients with previous strabismus surgery Patients with oblique deviations

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Active Comparator: Early adjustable suture surgery<br>Suture adjustment after 2 hours of surgery | Procedure: Adjustable strabismus surgery<br>* Adjustable surgery will be done using sliding nose technique using fornix approach<br>|
| Active Comparator: Late adjustable suture surgery<br>Suture adjustment after 24 hours of surgery | Procedure: Adjustable strabismus surgery<br>* Adjustable surgery will be done using sliding nose technique using fornix approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alignment of the strabismus | Percentage of patients with successful postoperative alignment using prism cover test for measurement | 3 months |
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

Study Overview
=================
Brief Summary
-----------------
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.

Official Title
-----------------
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Pitavastatin
* Drug: Pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent. Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception Documented HIV infection. Exclusion Criteria: Homozygous familial hypercholesterolemia Any conditions that may cause secondary dyslipidemia History of coronary artery disease (CAD) or CAD equivalent

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin 4 mg QD<br> | Drug: Pitavastatin<br>* Pitavastatin 4 mg QD<br>* Other names: Livalo;|
| Active Comparator: Pravastatin 40 mg QD<br> | Drug: Pravastatin<br>* Pravastatin 40 mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks |  | 12 weeks minus baseline |
Evaluation of Immediate Postpartum LARC Implementation Programs

Study Overview
=================
Brief Summary
-----------------
This study will engage hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. All hospitals in New Mexico interested in implementing immediate postpartum LARC programs will be eligible to participate in the NPMC program evaluation. The study will evaluate the components of this implementation program at several New Mexico hospitals using a stepped wedge design,with components being introduced to each hospital one at a time

Official Title
-----------------
Evaluation of Immediate Postpartum LARC Implementation Programs

Conditions
-----------------
Post Partum Contraception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital staff: Important individuals at New Mexico hospitals planning to implement immediate postpartum LARC programs, with an emphasis on diversity of administrative perspectives. If more than 4 potential participants are identified at one institution, additional participants may be included if their participation in the study is likely to contribute additional information (e.g. job title or background is different from other study participants) Exclusion Criteria: - Inability to speak and read English proficiently
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 |
| --- | --- |
| NM Perinatal Collaborative<br>Hospitals working with the New Mexico Perinatal Collaborative (NMPC) on implementing immediate postpartum long-acting reversible contraception programs. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline immediate postpartum LARC Implementation | To determine baseline immediate postpartum LARC implementation in various rural New Mexico hospitals. | April 2017-December 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LARC, New Mexico, Contraception
Neutrophil Lymphocyte Ratio as a Predictor of Outcome in Critically Traumatic Patients

Study Overview
=================
Brief Summary
-----------------
Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status . It is a cost effective and readily available , and simply calculated , so that why investigators try to use it as a predictor of short term survival in the critically ill patients

Detailed Description
-----------------
NLR will be used as predictor for short term survival and patients stay in ICU in 2 groups of patients . Investigators will use it in a group of Medical Critically ill patients as respiratory failure , neuromuscular disorders , renal impairment . the other group is the critically ill surgical patients , as patients with multiple trauma , post major surgery

Official Title
-----------------
Neutrophil Lymphocyte and Platelet Lymphocyte Ratios as Predictors of Outcome in Traumatic Critically Ill Patients

Conditions
-----------------
Critical Care

Intervention / Treatment
-----------------
* Other: Neutrophil Lymphocyte Ratio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill trauma patients Exclusion Criteria: auto immune disease endocrine disease renal dysfunction hepatic dysfunction malignancy smoking

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cured (c)<br>Neutrophil Lymphocyte and platelet lymphocyte ratios as Predictors of Outcome in Traumatic Critically ill Patients | Other: Neutrophil Lymphocyte Ratio<br>* Neutrophil:lymphocyte ratio (NLR) is an emerging biomarker that is used to predict mortality and morbidity. The association of this biomarker with systemic illness and its usefulness in risk assessment of critically ill patients has not been fully elucidated.<br>|
| Died ( M)<br>Neutrophil Lymphocyte and platelet lymphocyte ratios as Predictors of Outcome in Traumatic Critically ill Patients | Other: Neutrophil Lymphocyte Ratio<br>* Neutrophil:lymphocyte ratio (NLR) is an emerging biomarker that is used to predict mortality and morbidity. The association of this biomarker with systemic illness and its usefulness in risk assessment of critically ill patients has not been fully elucidated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short term survival |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Care, Neutrophils, Lymphocytes
Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese Men

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the safety and tolerability of ascending multiple oral doses of HCV-796 in healthy Japanese male subjects.

Official Title
-----------------
An Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Study Drug Administred Orally to Healthy Japanese Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HCV-796


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HCV-796|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and pharmacokinetics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAD
Feasibility Study of a Hemodynamic Parameter Algorithm

Study Overview
=================
Brief Summary
-----------------
An algorithm to calculate hemodynamic parameters based on blood pressure waveform was developed by collecting arterial blood pressure of patients during surgery

Official Title
-----------------
Feasibility Study of a Hemodynamic Parameter Algorithm

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Other: anesthesia;Radial artery puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgery patients Exclusion Criteria: Weight ≤18kg arrhythmology cardiac disfunction
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: anesthesia;Radial artery puncture|we chose the patients who need to monitor invasive blood pressure to obtain high-fidelity arterial waveforms|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood pressure | a high-fidelity blood pressure waveforms | 30min 1 hour |
Pharmacology and Physiology of the Lower Urinary Tract

Study Overview
=================
Brief Summary
-----------------
The function of the lower urinary tract is simple - urine storage and voiding. However, despite this simplicity of function, the control of the lower urinary tract is a rather complex, multilevel process (urothelium, detrusor, peripheral nerves, spinal cord and higher cerebral centres) and the mechanisms involved remain poorly elucidated. This study is designed to gain a more in depth understanding of the lower urinary tract function. Using bladder biopsies, tissue staining for characteristic markers present on nerves and other cells will be performed. We hypothesize that certain markers are altered in disease and turn back towards the control level of healthy people or patients with successful medical treatment.

Official Title
-----------------
Pharmacology and Physiology of the Lower Urinary Tract

Conditions
-----------------
Urologic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lower urinary tract dysfunction Controls with normal lower urinary tract function Exclusion Criteria: Age < 18 years old Pregnancy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with lower urinary tract dysfunction | |
| 2<br>Controls with normal lower urinary tract function | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemistry + PCR of bladder tissue |  | not specified (storage of biopsies) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower urinary tract, Physiology, Pathology, Immunohistochemistry, Urinary bladder
Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

Study Overview
=================
Brief Summary
-----------------
To determine long-term safety and efficacy of pregabalin in patients with partial seizures.

Official Title
-----------------
Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

Conditions
-----------------
Seizure Disorder, Partial

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the inclusion criteria for preceding double-blind study Have received double-blind study medication and wish to receive open-label pregabalin. Exclusion Criteria: Cannot be pregnant or considering becoming pregnant during the course of the study. Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pregabalin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Efficacy |  |  |
Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation

Study Overview
=================
Brief Summary
-----------------
Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.

Official Title
-----------------
Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study

Conditions
-----------------
Vertebral Body Fracture

Intervention / Treatment
-----------------
* Procedure: Vertebroplasty
* Procedure: Cavuplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification Exclusion Criteria: More Than 2 Vertebral Body Fractures Fractures of Vertebral Body Based on Malignancy Previous Spinal Operation Spinal Infection Spinal Deformity (scoliosis)

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vertebroplasty<br>This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body) | Procedure: Vertebroplasty<br>* Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement<br>|
| Experimental: Cavuplasty<br>This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement) | Procedure: Cavuplasty<br>* Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT-Scan evaluation | Number of Cement Extravasation in each Vertebral Body | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Scores range from 0 (no pain) to 10 (worst possible pain) | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cement leakage, cement augmentation, vertebral body fracture, vertebral cavity, vertebroplasty
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

Study Overview
=================
Brief Summary
-----------------
Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.

Official Title
-----------------
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages(T2N0, T1 - 2N1, T3N0 AND T3N1) Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: gemcitabine
* Drug: Cisplatin
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: Must have pathologic documentation of non-small cell lung cancer, IB, II, IIIA. ECOG Performance Status of 0 - 1 Bidimensionally measurable disease or evaluable disease Adequate organ function Main exclusion Criteria: Have greater than Grade 1 neuropathy - motor/sensory Significant history of cardiac disease Pleural effusion

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br> | Procedure: surgery<br>* surgery<br>|
| Experimental: B<br> | Drug: gemcitabine<br>* 1250 mg/m2, IV, day 1 and 8, q 21 days x 3 cycles<br>* Other names: Gemzar;Drug: Cisplatin<br>* 75 mg/m2, IV, q 21 days x 3 cycles<br>Procedure: surgery<br>* surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | baseline to measure progressive disease | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the survival and sites of relapse in the two study arms. |  | baseline to progressive disease | 
| Pharmacology toxicity |  | every cycle | 
| Response rate |  | baseline to measured progressive disease | 
| Pathologic response rate of tissue samples |  | baseline, post chemotherapy, post surgery |
Sheba Medical Center Home Monitoring Clinic Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Official Title
-----------------
Sheba Medical Center Home Monitoring Clinic Registry

Conditions
-----------------
Clinical Workload Assessment Based Upon a Home Monitoring System

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved indication for ICD or CRTD Implanted with or replaced with a Biotronik Lumax device Patient willing and able to sign consent form Willing and able to attend clinic visits and follow up schedule Transmission of more than 80% at 3-month follow up Patient older than 18 years Exclusion Criteria: no indication for ICD or CRTD implant Life expectancy shorter than 12 months Pregnancy Participation in other clinical studies

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 |
| --- | --- |
| Patients post implantation of ICD or CRTD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |