linjc16/ctgov huggingface dataset:
User Performance Evaluation of the INRatio® Prothrombin Time (PT) Monitoring System With a New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity

Study Overview
=================
Brief Summary
-----------------
This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.

Conditions
-----------------
Oral Anticoagulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years of age or older); Ability to read and speak English; Subjects on stable oral anticoagulation therapy with warfarin (at least 3 months); Target INR interval between 2.0 and 4.5 Willing and able to provide written informed consent and comply with study procedures; Exclusion Criteria: Hematocrit less than 25 or greater than 55% Lupus or antiphospholipid syndrome (APS) Already participated in this study A current INRatio PT Monitoring System User / Patient Self Tester

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 |
| --- | --- |
| BSTE-0125-Original Protocol<br> | |
| BSTE-0125.a-Amended Protocol<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients on stable OAT therapy for at least 3 months.
The Effect of Tracheal Intubation on AC and DC Components of a Photoplethysmograph

Study Overview
=================
Brief Summary
-----------------
Intraoperative stress responses (vasoconstriction and changes in heart rate) and postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component of PPG. The aim of this study was to investigate the effect of a known noxious stimulus (endotracheal intubation) on both the AC and DC components of PPG.

Official Title
-----------------
The Effect of Tracheal Intubation Induced Autonomic Response on Photoplethysmography

Conditions
-----------------
Anesthesia Intubation Complication

Intervention / Treatment
-----------------
* Procedure: endotracheal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery General endotracheal anesthesia Over 18 years of age Healthy Exclusion Criteria: Vascular disease Liver or kidney disease Overweight

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

| Intervention/Treatment |
| --- |
|Procedure: endotracheal intubation|standard endotracheal intubation of surgical patients after induction of anesthesia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photoplethysmography | changes in AC and DC components of photoplethysmography | within 60 seconds of intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse rate | Pulse rate from photoplethysmograph | within 60 seconds of intubation |
Effects Of Antidepressants On Sexual Functioning In Adults

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effects of two antidepression medications on sexual functioning.

Official Title
-----------------
A Multicenter, Double-blind Randomized Placebo-controlled Comparison of the Effects on Sexual Functioning of Extended-release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period

Conditions
-----------------
Major Depressive Disorder (MDD)

Intervention / Treatment
-----------------
* Drug: Extended-release Bupropion Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years. Subjects must engage in sexual activity that leads to orgasm at least once every two weeks. Subject must have normal orgasmic function and be willing to discuss with investigator. Exclusion Criteria: Subjects that have arousal or orgasm dysfunction. Has previously failed to respond to two adequate trials of antidepressants in past 2 years. Subject has other unstable medical disorders. Subject has a positive urine test for illicit drug use at screening.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extended-release Bupropion Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects in remission, HAMD-17. Changes in Sexual functioning Questionnaire. CGI-I and CGI-S. Percent of responders, HAMD-17. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, sexual dysfunction, orgasm disorder, MDD
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

Study Overview
=================
Brief Summary
-----------------
To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package insert to Japanese.

Detailed Description
-----------------
The study was terminated on September 30, 2008 at the current study site due to reported adverse events in the study subjects (n=8). While the adverse events reported were generally consistent with the known profile of gabapentin, it was decided that the study should continue at a different study site. The pharmacokinetics of gabapentin in the subjects with renal impairment will be evaluated in a separate study with a different study number at a different site. The study will be entitled: The Pharmacokinetic Study of Gabapentin in Japanese Epileptic Subjects with Renal Impairment.

Official Title
-----------------
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

Conditions
-----------------
PK Properties Of Gabapentin In Subjects With Impaired Renal Function

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Gabapentin
* Drug: Gabapentin
* Drug: Gabapentin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subjects whose creatinine clearance is 5-59 mL/min, or hemodialysis patients. The hemodialysis patients who enter this study is required hemodialysis for at least six weeks (the frequency is three times per week) Exclusion Criteria: Renal allograft recipients

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Gabapentin<br>* CLcr: 29-30 mL/min<br>|
| Experimental: 2<br> | Drug: Gabapentin<br>* CLcr: 29-15 mL/min<br>|
| Experimental: 3<br> | Drug: Gabapentin<br>* CLcr:14-5 mL/min<br>|
| Experimental: 4<br> | Drug: Gabapentin<br>* Hemodialysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | dec 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There were no secondary outcomes measures for this study |  | dec 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gabapentin Pharmacokinetics, renal impairment
A Longitudinal Study of Multimodal Resonance Imaging in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Imaging of the ischaemic penumbra with a particular diffusion-weighted imaging (DWI)/ perfusion-weighted imaging (PWI) mismatch is a promising approach to the selection of patients with acute ischaemic stroke for trials of intervention. The investigators want to apply multimodal resonance imaging methods such as functional magnetic resonance imaging ( fMRI), diffusion tensor imaging (DTI), arterial spin labeling (ASL) to guide treatment and predict the prognosis of stroke.

Official Title
-----------------
A Longitudinal Study of Multimodal Resonance Imaging in Stroke Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Time from the onset of stroke till hospital within 24 hours. With clinical characteristics such as hemiplegia, headache. Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Patients must understand the nature of the study and give informed consent. Exclusion Criteria: The onset of stroke out of 24 hours. Pregnant women. Patients with intracranial metallic bodies from prior neurosurgical procedure, implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt. Past history of seizures within one year or unexplained loss of consciousness. Family history of epilepsy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental group<br>Hospitalized patients with acute stroke. | |
| Control group<br>Healthy Volunteers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional recovery |  | Participants will be followed till die or lost to follow-up,an expected average of three year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over survival | Time from stenting to the day when the patients died or lost to the follow-up | Participants will be followed till die or lost to follow-up,an expected average of three year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, fMRI, DTI
Hormonal and Metabolic Consequences of Sleep Disorders in Young Obese Patients

Study Overview
=================
Brief Summary
-----------------
There is a well-documented relationship between short sleep duration and high body mass index (BMI). The mechanism linking short sleep duration and weight gain is unknown. Current studies in healthy young volunteers have shown that experimental sleep restriction is associated with dysregulation of the neuroendocrine control of appetite and with alterations in glucose metabolism. The goal of our study is to determine the metabolic and hormonal modifications induced by chronic sleep curtailment in obese adolescents and young adults and to observe if short sleep is a negative prognostic factor in their weight evolution.

Detailed Description
-----------------
The main purpose of the study is investigate whether the concentrations of 2 hormones that regulate appetite (leptin, ghrelin), cytokines (TNF-a, IL-6) and CRP are modified in obese adolescents and young adults who had sleep disorders in comparison to obese adolescents and young adults who sleep longer.

Official Title
-----------------
Hormonal and Metabolic Consequences of Sleep Disorders in Young Obese Patients

Conditions
-----------------
Obesity, Sleep Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13-25 years old BMI > 30 kg/m2 (If adolescents aged under 18 years: BMI equivalent to a BMI for age and sex to a BMI of 30, according to the Cole et al. obesity criteria). Exclusion Criteria: Infection Liver disease Chronic inflammatory disease Endocrine disease Use of drugs that alter the sensitivity of insulin

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 25 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>Obese adolescent and young adult with sleep disorder | |
| 2<br>Obese adolescent and young adult without sleep disorder | |
| 3<br>Lean adolescent and young adult with sleep disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Study of the Effectiveness of Tissue Equivalent on the Basis of Cultured Cells to Heal Skin Blemishes

Study Overview
=================
Brief Summary
-----------------
In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells. During pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.

Official Title
-----------------
Phase 2 The Use of Tissue-equivalent Based on Cultured Cells for Healing Skin Blemishes

Conditions
-----------------
Neurotrophic Ulcers, Burns

Intervention / Treatment
-----------------
* Biological: study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects; Availability of burns II or III level; Epidermolysis bullosa; Availability of post-burn scars Defects in the skin after surgery Exclusion Criteria: Acute and chronic diseases in the acute stage; Autoimmune diseases of connective tissue (collagen); Immunodeficiency states; System of inflammatory diseases of the skin; Conduct an aggressive corticosteroid therapy; Acute coronary syndrome; Acute disorders of cerebral circulation; Availability of local inflammation in the acute stage; Pregnancy; Breast-feeding. Positive results of the following tests: Anti-HIV-1 and -2, HIV-1Ag, anti-HTL VI and-II, anti-HbcorAg, HBs-Ag, anti-HCV, anti-CMV, anti-Toxoplasma gondii, RW, Neisseria gonorrheae, Chlamydia.

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
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cell therapy<br>study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions | Biological: study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficiency |  | six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
damage to the skin, the skin equivalent, cell therapy
Acute and Long-term Outcomes of Patients With Acute Myocardial Infarction Treated With PCI

Study Overview
=================
Brief Summary
-----------------
Randomized studies may often be burdened by the selective nature of patient inclusion thus not reflecting real-world outcomes. This is evident from the discrepancy in the mortality rates reported in major randomized trials enrolling patients with acute myocardial infarction (AMI), as compared with registry data. The primary objective of this observational study is to assess short- and long-term outcomes of unselected, real-world patients presenting with AMI and treated with contemporary percutaneous coronary intervention (PCI).

Official Title
-----------------
Acute and Long-term Outcomes of Patients Presenting With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

Conditions
-----------------
Acute Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Percutaneous Coronary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute myocardial infarction referred to catheterization laboratory for percutaneous coronary intervention Exclusion Criteria: Initial acute myocardial infarction diagnosis not confirmed Patients with acute myocardial infarction not undergoing invasive coronary angiography

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 |
| --- | --- |
| Acute Myocardial Infarction<br>Consecutive patients with acute myocardial infarction | Procedure: Percutaneous Coronary Intervention<br>* Percutaneous Coronary Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality | Rate of all-cause mortality at 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality | Rate of all-cause mortality at 5 years | 5 years | 
| Rate of cardiovascular mortality | Rate of cardiovascular mortality at 5 years | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMI
Natural Antioxidants in the Treatment of Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (MS).

Detailed Description
-----------------
Multiple sclerosis (MS) is an immune mediated disease of the central nervous system that affects over 350,000 Americans. T lymphocytes, macrophages and soluble mediators of inflammation cause demyelination and axonal injury in MS. Activated macrophages release nitric oxide and oxygen free radicals that cause demyelination and axonal injury in MS and experimental autoimmune encephalomyelitis (EAE). Natural antioxidants may favorably influence the course of MS by decreasing oxidative injury. Chronic relapsing EAE in mouse models is clinically and pathologically useful for testing potential therapies for MS. This study will assess three natural antioxidant regimens for their potential as treatments for MS: Ginkgo biloba, alpha-lipoic acid/essential fatty acids, and vitamin E/selenium. The effects of each regimen will be compared to determine which regimen appears most effective at suppressing EAE and decreasing markers of oxidative injury in patients with MS. As part of this study, two smaller trials will be conducted. A Phase I/II trial in patients with MS will determine if the selected antioxidant regimen can decrease disease activity as detected with gadolinium-enhanced magnetic resonance imaging. The results of this study will serve as the basis for a Phase III trial to assess the long term effectiveness of natural antioxidant therapy in MS.

Official Title
-----------------
Natural Antioxidants in the Treatment of Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Ginkgo biloba
* Drug: Alpha-lipoic acid
* Drug: Vitamin E/Selenium
* Drug: Essential fatty acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Pregnant Other significant health problems

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ginkgo biloba|nan|
|Drug: Alpha-lipoic acid|nan|
|Drug: Vitamin E/Selenium|nan|
|Drug: Essential fatty acids|nan|

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

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