linjc16/ctgov huggingface dataset:
EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how the commonly used anesthetic drug propofol works in the brain to produce loss of consciousness. While under general anesthesia your brain waves will be measured using electroencephalogram (EEG). On a separate day, the patient's brain will be imaged using magnetic resonance imaging (MRI).

Official Title
-----------------
Electroencephalogram Studies of Induction and Recovery From Propofol Induced General Anesthesia

Conditions
-----------------
Brain Activity Under Sedation

Intervention / Treatment
-----------------
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, non-smoking male and female volunteers, ages 18-36 with normal body weight. American Society of Anesthesiologists (ASA) physical status I Exclusion Criteria: History of head trauma Surgical aneurysm clips Cardiac pacemaker Prosthetic heart valve Neurostimulator Implanted pumps Cochlear implants Metal rods, plates Screws Intrauterine device Hearing aid Dentures (which might create NMR artifacts) Metal injury to eyes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Study Arm<br>Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli. | Drug: Propofol<br>* Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG Power in Alpha, Slow, and Delta Bands | We used EEG measurements to study the dynamics of loss of consciousness, auditory processing, sensation, and memory under general anesthesia induced with propofol. The EEG data in each of the three specific aims will be analyzed using spectral methods, source localization, and event-related potentials. Through spectral analysis, EEG power (in decibels) in alpha, slow, and delta bands are measured. | 11 hours |
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iloperidone for 4 Weeks in the Treatment of Patients With Acute Manic Episodes Associated With Bipolar I Disorder

Conditions
-----------------
Bipolar I Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients 18 to 65 years of age (inclusive) Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria Voluntary hospitalization for current manic episode Exclusion Criteria: Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months Patients who are experiencing a first manic episode or meeting criteria for rapid cycling

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iloperidone<br> | Drug: Iloperidone<br>* Oral iloperidone<br>* Other names: VYV-683;|
| Placebo Comparator: Placebo<br> | Drug: Iloperidone Placebo<br>* Oral placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Young Mania Rating Scale (YMRS) total score | The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst). | Week 4 |
Increasing Smoking Cessation Counselling in Primary Care Using a Chronic Disease Management System

Study Overview
=================
Brief Summary
-----------------
This pilot study will determine the feasibility of studying a new smoking cessation management module in an existing chronic disease management system. The new module is intended to help healthcare providers deliver more smoking cessation counselling to their patients.

Official Title
-----------------
A Cluster Randomized Controlled Pilot Trial of the Effect of a New, Improved Smoking Cessation Management Module, Compared With Use of the Standard Version of Such a Management Module, on Smoking Counselling Initiation and Continuation Rates in Primary Care Practices Currently Using P-PROMPT Chronic Disease Management System in Ontario

Conditions
-----------------
Delivery of Health Care, Smoking Cessation

Intervention / Treatment
-----------------
* Other: New, improved smoking cessation management module


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician subscribers to P-PROMPT CDMS Exclusion Criteria: Paper users Physicians expected to retire during the course of the study Physicians whose billing files are not set-up with DataSynch
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Improved module<br> | Other: New, improved smoking cessation management module<br>* The intervention that will be tested is an improved smoking cessation management module in an existing chronic disease management system, P-PROMPT CDMS. This module includes the following components: a) the Patient Care Status and Update Form, b) the smoking registry and c) patient prompts.<br>|
| No Intervention: Standard module<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoker Identifying Cards |  | 3 months post-intervention | 
| Chronic disease management system's activity log |  | monthly post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation counselling billing codes from physician's remittance advice files |  | monthly post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary health care, delivery of health care, smoking cessation, chronic disease, disease management, pilot projects
Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.

Detailed Description
-----------------
In this open-label study, volunteers are given an intramuscular injection of GENEVAX-HIV vaccine using the Biojector 2000. Safety measures and immune response are assessed accordingly.

Official Title
-----------------
GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Dose Escalation Study of GENEVAX-HIV Delivered Intramuscularly Using the Biojector 2000 in HIV Seronegative Volunteers

Conditions
-----------------
HIV Infections, HIV Seronegativity

Intervention / Treatment
-----------------
* Biological: APL 400-003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are 18 - 60 years old. Are HIV-negative and in good health. Are able to understand how infections such as HIV are spread. Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have hepatitis B or C. Have any condition that may prevent you from completing the study. Are allergic to bupivacaine, vaccines, or certain local anesthetics. Have taken certain medications or have received certain therapies that may affect your immune system. Have an immune system disorder or have received therapy for an immune system disorder. Have been exposed to HIV within 6 months prior to study entry. Have received an experimental HIV vaccine or any other experimental treatment within 30 days prior to study entry. Have received blood transfusions within 6 months prior to study entry. Abuse alcohol or drugs or have an uncontrolled psychiatric disorder. Are pregnant or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: APL 400-003|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS Vaccines, Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA
Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome

Study Overview
=================
Brief Summary
-----------------
Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. In this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's syndrome and compare the results with those of healthy control subjects.

Official Title
-----------------
The Application of In Vivo Confocal Scanning Laser Microscopy in the Evaluation of the Secretory Glands in Patients With Sjögren's Syndrome

Conditions
-----------------
Primary Sjogren's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Sjögren's syndrome diagnosis was made according to the revised American-European consensus criteria. Briefly, the patients had to have ocular and oral symptoms of dryness, clinically diagnosed dry eye and dry mouth disease, serum rheumatoid factor and antinuclear antibody levels ≥1:160, positive serology for anti SS-A or anti SS-B antibodies, labial salivary gland inflammatory infiltration focus score ≥2 and consents for lacrimal gland biopsy to be included into this study. Exclusion Criteria: Patients with any history of ocular surgery including punctal occlusion, other ocular or systemic disease or a history of topical/ systemic drug use or contact lens wear or other systemic disorders that would cause dry eyes or that would alter the ocular surface.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Dry eye group<br>Dry eye patients with Primary Sjogren's syndrome | |
| Controls<br>Healthy subjects without dry eyes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory cell density |  | 1.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland
Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy

Study Overview
=================
Brief Summary
-----------------
The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to evaluate ultrastructure with electron microscopy.

Official Title
-----------------
Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy

Conditions
-----------------
Myopic Traction Maculopathy

Intervention / Treatment
-----------------
* Procedure: Vitrectomy with internal limiting membrane peeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane peeling for myopic traction maculopathy and had a follow-up for more than 6 months. Exclusion Criteria: The patients with follow-up less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Myopic traction maculopathy<br> | Procedure: Vitrectomy with internal limiting membrane peeling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity before and after surgery | Comparison in logarithm of Minimum Angle of Resolution (logMAR) vision | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal reattachment | Resolution of macular retinoschisis and foveal detachment | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopic traction maculopathy
The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks.

Detailed Description
-----------------
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks. Hair count and thickness will be primary outcomes.

Official Title
-----------------
The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia

Conditions
-----------------
Androgenic Alopecia

Intervention / Treatment
-----------------
* Other: stem cell component extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: androgenic alopecia basic and specific(BASP) classification: M2, C2, U1, V1, or F1 or higher Exclusion Criteria: patient of scalp disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stem cell group<br>stem cell group who apply 1.2 g of allogeneic human adipose derived stem cell component extract on their scalp for 16 weeks | Other: stem cell component extract<br>* The Allogeneic Human adipose derived stem cell component extract<br>* Other names: Tiara hair toninc;|
| Placebo Comparator: placebo group<br>placebo group who apply a placebo on their scalp for 16 weeks | Other: stem cell component extract<br>* The Allogeneic Human adipose derived stem cell component extract<br>* Other names: Tiara hair toninc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of total hair counts by phototrichogram |  | 16 weeks |
The Glycemic Effect of Taking a Supplementation of Orange Juice With Fibers

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the glycemic effect of supplementation Fibers in orange juice. This will be a double-blind parallel controlled study. Each subject will serve as his own control. Study population will include 10 subjects. The subjects will be randomly assigned to receive one of two juices in occasion, in two visits. Each drink will be containing orange juice with\without fibers.

Conditions
-----------------
Healthy People

Intervention / Treatment
-----------------
* Other: Other: Dietary Fibers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers Age 60 >18 years Written informed consent Consumers of orange drinks: freshly squeezed juices, commercial pasteurized juices and / or orange soft drinks Regular eating pattern Exclusion Criteria: Patients with chronic disease sach as: diabetes, cancer, C.O.P.D., metabolic syndrome, overweight, kidney failure, heart disease, osteoporosis. Antibiotic treatment in the last 4 weeks Subjects on regular probiotic or prebiotic supplementation, unless they do 2 weeks of wash out. Subjects with intestinal disorders such as: IBD, IBS, celiac, colon cancer. Subjects after intestinal surgery. Use of medicines for lowering cholesterol (simvastatin), sugar control Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Other: Dietary Fibers|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the Glycemic Effect by drawing blood for glucose and insulin |  |  |
Dyspnea Threshold During 6 Minutes Walk Test

Study Overview
=================
Brief Summary
-----------------
In view of the multiple limitations and restrictions relative to CPET (technical, time, physical…), determination of individualized training threshold from this evaluation is today not possible for a lot of patients. The aim of this study was to propose a new clinical tool from 6MWT for individualized exercise training: the dyspnea threshold (DT6).

Official Title
-----------------
Self-perception of Dyspnea Threshold During the 6-minute Walk Test (DT6): A New Tool for Individualized Exercise Training With Chronic Obstructive Pulmonary Disease Patients (COPD)

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: Patient has to get up his hand when he defined his dyspnea threshold during 6MWT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD with or without rest and/or ambulation oxygen therapy Exclusion Criteria: exacerbation in the previous four weeks with a restrictive or mixed respiratory syndrome, angina , recent heart attack (< 1 month) or coronary progressive pathology under beta-blockers cognitive or motor problems which limit significantly comprehension or achievement of evaluations
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD patient<br> | Other: Patient has to get up his hand when he defined his dyspnea threshold during 6MWT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of heart rate between 1st and 2nd 6MWT |  | at baseline (2 days after entry in pulmonary rehabilitation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of heart rate between VT (CPET) and DT6 (6MWT) |  | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise training, Dyspnea threshold, 6MWT