linjc16/ctgov huggingface dataset:
Preoperative CHG Cloth on Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.

Detailed Description
-----------------
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.

Official Title
-----------------
Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Drug: Chlorhexidine Gluconate
* Other: Vehicle
* Drug: DynaHex-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or Females 16 years of age or older Signed informed consent Good Health Six inches of abdomen and groin areas without tattoos, or skin disorders Exclusion Criteria: Dermatological Conditions Sensitivity to latex Sensitivity to CHG

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine Gluconate Cloth<br>2% CHG, single application | Drug: Chlorhexidine Gluconate<br>* comparison with other CHG products<br>* Other names: CHG;|
| Placebo Comparator: Vehicle Cloth<br>Excipients on cloth | Other: Vehicle<br>* Excipients of CHG product only.<br>* Other names: Control;|
| Active Comparator: Active Chlorhexidine gluconate solution<br>Dynahex 2% CHG | Drug: DynaHex-2<br>* 2% CHG solution<br>* Other names: CHG 2% Solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline. Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline. | 10 minutes to 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preoperative surgical skin preparation
Predictive Value of Cognitive Tests Performed for the Diagnosis of Alzheimer's Disease and Related Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

Detailed Description
-----------------
The main objective of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

Official Title
-----------------
Valeur prédictive d'Une évaluation Cognitive standardisée en Centre d'Examens de Santé Pour le Diagnostic de la Maladie d'Alzheimer ou Des Maladies apparentées en Population générale Chez Les Plus de 65 Ans Avec Plainte mnésique

Conditions
-----------------
Alzheimer's Disease, Impaired Cognition, Memory Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 65 years Community-dwellers Volunteers receiving a free medical examination in Health examination centre Subjective memory complaint Exclusion Criteria: Known dementia Sensory deficit compromising the cognitive evaluation Poor workmanship of the written or oral French language

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Group 1<br>Healthy controls | |
| Group 2<br>Patients with an Alzheimer's disease or related disorders | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of episodic memory and executive psychometric tests |  | Baseline |
Digitalis Investigation Group (DIG)

Study Overview
=================
Brief Summary
-----------------
To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.

Detailed Description
-----------------
BACKGROUND: Despite widespread use of digitalis and its availability for nearly two centuries, uncertainty surrounded the appropriateness of its role and value in treating congestive heart failure patients in sinus rhythm. The study was a multicenter collaborative effort with the Department of Veteran Affairs Cooperative Studies Program which provided support for a data coordinating center and a pharmacy coordinating center. DESIGN NARRATIVE: Randomized, double-blind, simple, multicenter, international trial with 186 centers in the United States and 116 in Canada. In the main trial, patients with left ventricular ejection fractions of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and ACE inhibitors. In an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo. Patients were recruited over a three-year period at the 302 centers and followed for a minimum of two years. Patient enrollment began in February 1991 and ended in September 1993. Follow-up ended in December 1995. The main results paper was published in 1997. Three substudies were conducted. The quality of life/6-minute walk test substudy determined the effect of treatment on a patient's well-being, daily activities, and functional status. The Holter/signal averaging electrocardiogram substudy examined the pathophysiology of sudden cardiac death. The neurohormonal substudy determined whether long-term administration of digoxin attenuated the neuroendocrine response in patients with heart failure. The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System (QVR).

Conditions
-----------------
Arrhythmia, Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive, Sinus Arrhythmia, Heart Failure

Intervention / Treatment
-----------------
* Drug: digitalis


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women with clinical heart failure, sinus rhythm, and an ejection fraction less than or equal to 45 percent.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome

Study Overview
=================
Brief Summary
-----------------
This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.

Detailed Description
-----------------
This retrospective chart review study seeks to collect data from pediatric patients treated with Korlym (mifepristone) to help provide clinicians with some insight on the potential role of mifepristone in the treatment of pediatric patients with Cushing syndrome. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate and contribute data on their patients Data to be collected from a retrospective chart review will include: Patient demographics Medical history Pre and post treatment clinical assessments and laboratory results Radiologic findings (if available) Adverse events Data will be collected for all follow-up visits, up until the most recent encounter prior to IRB approval.

Official Title
-----------------
Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome

Conditions
-----------------
Hypercortisolism, Cushing Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatrics (age≤21 years) at time Korlym initiation Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare provider Received at least one dose of Korlym Availability of pre-treatment (baseline) and follow-up data Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| Pediatric Cushing Syndrome Patients<br>Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug utilization patterns as assessed by chart review | The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym | Length of Korlym therapy, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight as assessed by chart review | The retrospective review would analyze changes in Weight (in kg) in pediatric patients treated with Korlym | Length of Korlym therapy, up to 5 years | 
| Blood Pressure as assessed by chart review | The retrospective review would analyze changes in Blood Pressure (in mmHg) in pediatric patients treated with Korlym | Length of Korlym therapy, up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cushing syndrome, hypercortisolism
Assessment of Socket Shapes Made by Central Fabrication Facilities

Study Overview
=================
Brief Summary
-----------------
Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. The aim of this research is to assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination of how and where manufacturing errors occur will contribute to better quality of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the manufactured products to their patients. Computer manufactured sockets are made for subjects, then their fits assessed by research practitioners.

Official Title
-----------------
Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities

Conditions
-----------------
People With Lower Limb Amputation That Are Ambulatory

Intervention / Treatment
-----------------
* Other: Assessed for socket fit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: trans-tibial amputees who use a prosthesis and are ambulatory Exclusion Criteria: do not have a prosthesis, cannot ambulate

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lower-limb amputee<br>Subjects with at least one lower limb amputated at teh trans-tibial level | Other: Assessed for socket fit<br>* Subjects are clinically assessed during standing to see how well computer manufactured sockets fit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb volume |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb shape |  | 1 day |
Correlation of Hyperghrelinemia With Carotid Artery Intima-Media Thickness in Children With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity and endocrine dysfunction that leads to cardiovascular disability and early death within the first 3 decades of life.To assess the significance of risk factors for future disabilities, carotid artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted controls.

Detailed Description
-----------------
Main outcome measures: Correlation of IMT with age, standard deviation score of BMI (BMI-SDS), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), C-reactive protein, HOMA-IR and ghrelin.

Conditions
-----------------
Prader Willi Syndrome, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prader Willi syndrome Children with obesity Exclusion Criteria: Acute illness On regular medications except growth hormone

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 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 |
| --- | --- | --- |
T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy

Study Overview
=================
Brief Summary
-----------------
T-wave alternans is an electrocardiographic finding that has been shown to predict the occurrence of future cardiac arrhythmias in patients who have had a heart attack. What is unknown about T-wave alternans testing is when is the best time to perform the test. In most studies, T-wave alternans testing is conducted 4 weeks or more after a heart attack. It is unknown if T-wave alternans testing performed prior to hospital discharge in heart attack patients is reliable. The objective of this project is to determine the diagnostic accuracy of T-wave alternans testing performed prior to hospital discharge and again at 30 days after hospital discharge in patients who have suffered a heart attack.

Official Title
-----------------
T-Wave Alternans in Acute Myocardial Infarction: An Evaluation of the Time of Testing on Its Prognostic Accuracy

Conditions
-----------------
Myocardial Infarction, Arrhythmias

Intervention / Treatment
-----------------
* Procedure: T-wave Alternans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Myocardial Infarction (MI) confirmed by electrocardiographic and or/ enzymatic criteria Patients with a left ventricular ejection fraction of 45% or less Exclusion Criteria: Patients with (1) atrial fibrillation, (2) pacemaker rhythm, (3) left bundle branch block, (4) class III-IV heart failure, (5) inability to achieve a target heart rate with exercise or handgrip stress or (6) spontaneous sustained ventricular tachycardia/ventricular fibrillation will be excluded Patients with recurrent angina pectoris, MI, coronary revascularization, or any other adverse cardiovascular event in the 30 days following their initial MI will also be excluded

Ages Eligible for Study
-----------------
Minimum Age: 19 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> | Procedure: T-wave Alternans<br>* T-wave alternans is an electrocardiographic finding that is defined as the beat-to beat fluctuation in the amplitude or shape of T wave<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI |  | 30 days | 
| Event Free Survival at 1 Year | Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial Infarction, Arrhythmia, T-wave alternans
Comparison of Two Treatments for Low Back Pain: Re Spine vs. Physiotherapy

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the effectiveness of the Re Spine mattress, which was designed as an alternative to physiotherapy in the treatment of low back pain (LBP).

Official Title
-----------------
Comparison of Two Treatments for Low Back Pain: Re Spine vs. Physiotherapy

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Device: Re Spine
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Re Spine Mattress<br>Adults suffering low back pain will treat their low back pain using the Re Spine mattress | Device: Re Spine<br>* A new mattress design made of special materials and built in a specially shaped structure that allows the brain to relax the body and dissipate tension accumulated on the lumbar spine.<br>|
| Active Comparator: Physiotherapy<br>Adults suffering low back pain will treat their low back pain using conventional physiotherapy protocols | Other: Physiotherapy<br>* Usual protocol for treatment of low back pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in low back pain | Pain levels will be measured using the Visual Analogue Scale (VAS) on the first day of study and 6 weeks, and 3 months after treatment at end of study. | 1 day, 6 weeks, 3 months | 
| Effectiveness of treatment | Effectiveness of treatment will be assessed based on Oswestry Disability Index and Mini Sleep Questionnaire on the first day of study and 6 weeks, and 3 months after treatment at end of study. | 1 day, 6 weeks, 3 months |
The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees

Study Overview
=================
Brief Summary
-----------------
With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response.

Detailed Description
-----------------
This project will investigate two main hypotheses based on our previous studies on phantom limb sensation and phantom limb pain. The first hypothesis states that phantom limb sensation and phantom limb pain both correlate with the 'phantom limb', while the second one maintains that the phantom limb can interact with the patient's body by means of the meridian system. With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response. By analyzing the data collected from both groups, the investigators expect both hypotheses will be supported by the results of experiments in this project.

Official Title
-----------------
The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees

Conditions
-----------------
Exposure to Infrared Radiation

Intervention / Treatment
-----------------
* Other: Far infrared ray to the sole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amputees: at least one arm or one leg amputated Healthy subjects: healthy person under 30 years old Exclusion Criteria: with mental diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Amputees<br>Amputee with one arm or one leg amputated/ Far infrared ray to the phantom limb site | Other: Far infrared ray to the sole<br>* exposure 40-minute far infrared ray to the sole for each person/amputee.<br>|
| Healthy subjects<br>Healthy subjects under 30 years old/ Far infrared ray to the sole | Other: Far infrared ray to the sole<br>* exposure 40-minute far infrared ray to the sole for each person/amputee.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting functional MR images | The resting fMRI images will be obtained before and after the far infrared exposed to the phantom limb site. The default mode of the brain will be analyzed. If the default mode was changed, it was one of the evidence that the neural signal was transmitted from the phantom limb site into the brain and caused the change. | one year |