linjc16/ctgov huggingface dataset:
Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the feasibility of the Multiple Sclerosis Performance Test (MSPT) in a clinical care setting when used by participants with Multiple Sclerosis (MS).

Official Title
-----------------
Feasibility of the Multiple Sclerosis Performance Test for Assessment of Functional Performance Measures in Patients With Multiple Sclerosis

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

Intervention / Treatment
-----------------
* Other: Multiple Sclerosis Performance Test (MSPT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations Diagnosis of MS, including Clinically Isolated Syndrome Ability to understand the audio and visual instructions for the test modules Visual function, based on the investigator's clinical judgement that does not preclude an ability to interact with the Multiple Sclerosis Performance Test (MSPT). Key Exclusion Criteria: Unable or unwilling to provide informed consent Participants younger than 18 years of age, unless their parent or legal guardian provides the required signed and dated informed consent and authorization to use confidential health information and the participant provides assent in accordance with national and local subject privacy regulations NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Participants<br>Participants with MS, including CIS will complete the MSPT at their standard of care visits. | Other: Multiple Sclerosis Performance Test (MSPT)<br>* Administered as specified in the treatment arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Completing All Modules |  | Baseline to Month 24 | 
| Percentage of Participants Completing Each Individual Module |  | Baseline to Month 24 | 
| Percentage of Participants Skipping Modules |  | Baseline to Month 24 | 
| Average Time to Complete the Multiple Sclerosis Performance Test (MSPT) |  | Baseline to Month 24 | 
| Average Time to Complete Individual MSPT Modules |  | Baseline to Month 24 | 
| Frequency of Reasons for Not Completing MSPT Modules |  | Baseline to Month 24 | 
| Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules |  | Baseline to Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinically Isolated Syndrome
The Value of Three Dimensional Echocardiography in Congenital Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
There are few studies evaluating the value of 3D echocardiography in children undergoing congenital cardiac surgery. The aim of this observational study is to describe common and uncommon congenital malformations with the help of 3D echo and compare the findings and the measurements with those obtained with conventional 2D echo.

Official Title
-----------------
Three Dimensional Echocardiography in Congenital Cardiac Surgery

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children requiring general anesthesia for congenital heart surgery and in whom informed parental consent has been obtained Exclusion Criteria: Children with congenital heart disease who do not require heart surgery

Ages Eligible for Study
-----------------
Minimum Age: 5 Hours
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational|This is an observational study. There is no intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlate three dimensional measurements with two dimensional measurements | correlation of two dimensional transthoracic echo with three dimensional transthoracic echo | 1 month |
Treatment of Whiplash Associated Disorders by APOS Kit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two techniques for treating patients with Whiplash Associated Disorders, in relation to: disability, balance, cervical pain and cervical range of motion. The hypothesis: The APOS kit treatment is more effective than the short wave therapy.

Official Title
-----------------
A Randomized Controlled Trial Which Compare the Effectiveness of an APOS Kit With Short Waves Therapy for Treating Whiplash Associated Disorders

Conditions
-----------------
Whiplash Associated Disorders, Cervical Pain

Intervention / Treatment
-----------------
* Device: APOS - exercise component


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Cervical pain, Motor vehicle accident a week prior to cervical pain, age above 16, ability to walk independently, signed inform consent, insured in Clalit health services Exclusion Criteria: Inability to walk independently, age 16 or less, not signed an inform consent, WAD grade 4, past treatment for WAD, pregnancy, pacemaker, cancer. -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: APOS - exercise component|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neck disability score |  |  | 
| neck pain score |  |  | 
| balance score |  |  | 
| cervical range of motion |  |  |
Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux

Study Overview
=================
Brief Summary
-----------------
Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.

Detailed Description
-----------------
Many patients with gastro-esophageal reflux disease (GERD) report that drinking coffee causes heartburn. The purpose of this study is to investigate the effects of coffee on gastro-esophageal acid reflux, and its relation to esophageal motility parameters in patients who are already scheduled to undergo 48 hour wireless pH testing as a result of having symptoms suggestive of GERD. The specific aims are to evaluate the effects of coffee on GERD during daily life and to elucidate the underlying pathogenic mechanism by which coffee induces reflux.

Official Title
-----------------
Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Other: Coffee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persons undergoing wireless pH testing for diagnosis and treatment of GERD Exclusion Criteria: those under the age of 18 pregnant and lactating women those who do not meet the inclusion criteria

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Coffee|3 cups of coffee over a 24 hour period|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coffee leads to reflux events |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Gastro-Esophageal Disease
The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture

Study Overview
=================
Brief Summary
-----------------
The use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (CRPS)

Detailed Description
-----------------
There are several studies similar in wrist fracture.

Official Title
-----------------
The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture, Prospective Double Blind Study

Conditions
-----------------
Ankle Fracture

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin c
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ankle fracture within 3 weeks after the fracture Exclusion Criteria: pregnant or lactating woman open fracture already treated with vitamin c chronic renal failure

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin c<br>administration of vitamin c for 45 days following ankle fracture operation | Dietary Supplement: vitamin c<br>* 1000 mg of vitamin c for 45 days<br>* Other names: ascorbic acid;|
| Placebo Comparator: placebo<br>placebo pills | Drug: placebo<br>* placebo pills<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRPS incidence | the incidence of CRPS (according to the IASP or Bruehl diagnostic cruteria) in both population following the fracture will be record and compared | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin c, ascorbic acid, ankle fracture, crps, rds, crps prevention
Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)

Study Overview
=================
Brief Summary
-----------------
Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.

Official Title
-----------------
Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study

Conditions
-----------------
Ulcerative Colitis, Dysplasia

Intervention / Treatment
-----------------
* Device: DiscoveryTM
* Device: iSCAN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulcerative Colitis confirmed by endoscopy and histology. Involvement 30% of the colonic surface (or any extent if concomitant with PSC). Duration of the disease >7 years (or any duration if concomitant with PSC). Exclusion Criteria: Personal history of colorectal cancer or high-grade dysplasia. Previous colectomy (partial or complete). Coagulopathy that prevents biopsies or polypectomy. Colonoscopy performed in the previous 6 months. Pregnant or nursing women. Inadequate bowel preparation. Presence of endoscopic Ulcerative Colitis activity. Colonic stenosis and incomplete colonoscopy.

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: Screening
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonoscopy assisted by DiscoveryTM<br> | Device: DiscoveryTM<br>* Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).<br>|
| Active Comparator: Virtual Colonoscopy with iSCAN<br> | Device: iSCAN<br>* Virtual colonoscopy assisted by iSCAN<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per lesion dysplasia detection rate (DDR) | Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy. | Immediately after the procedure. | 
| Per patient dysplasia detection rate (DDR) | Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN. | Immediately after the procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual chromoendoscopy, Artificial intelligence, iSCAN, Dysplasia
Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Non critical hospitalized patients were bathed daily with 4 substances: bleach at .005%, bleach at .0125%, clorhexidine 2% and soap and water. 76 patients were enrolled and divided 19 subjects per group. Each patient was cultured with swab technique in palm, antecubital fold and armpit at day 0, day 3 and day 7 of enrollment. Bacterial cultures were incubated and compared if decolonization occurred. Adverse events were evaluated in all patients. Only 1 patient had and adverse event and was dry skin. Before patient was enrolled, he had dry skin because of his baseline disease. Moisturizing lotion was applied and patient continue in the study.

Official Title
-----------------
Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients

Conditions
-----------------
Safety Issues

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non critical hospitalized patients in internal medicine 18 years old and older Exclusion Criteria: Burn patients Pregnant women Chloride hypersensitivity

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 |
| --- | --- |
| Bleach baths with .0125%<br> | |
| Clorhexidine 2%<br> | |
| Soap and water<br> | |
| Bleach baths with .005%<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Bleach baths as determined by the incidence of adverse or serious adverse events |  | November 26, 2019 - October 25, 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of bacterial colonization from pathogens belonging to the ESKAPE group | Identification of colonization by Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species | November 26, 2019 - October 25, 2020 | 
| Percentage of patients remaining colonized 3, 5 and 7 days after daily baths |  | November 26, 2019 - October 25, 2020 |
Evaluation of Nerve Regeneration After Nerve Transsection Using (Diffusion-tensor Magnetic Resonance Imaging) DTI MR Imaging

Study Overview
=================
Brief Summary
-----------------
To prospectively evaluate the nerve regeneration after traumatic nerve transsection using diffusion tensor magnetic resonance imaging (DTI MR imaging).

Conditions
-----------------
Nerve Degeneration

Intervention / Treatment
-----------------
* Other: MR Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with traumatic nerve transsection and nerve repair. Exclusion criteria: contraindication for MRI; pregnancy;

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 |
| --- |
|Other: MR Imaging|MRI is used to evaluate nerve regeneration after traumatic transsection and nerve repair.|

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
-----------------
Nerve transsection
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Study Overview
=================
Brief Summary
-----------------
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.

Detailed Description
-----------------
Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.

Official Title
-----------------
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: Nicotrol Inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 13-26 weeks pregnant Smoking at least 5 cigarettes per day the preceding 7 days Motivated to quit smoking (at least 7 on a 10 pt. scale) Able to speak English Intend to carry pregnancy to term Stable residence Exclusion Criteria: Current drug or alcohol abuse or dependence (other than methadone maintenance Twins or multiple gestation Unstable psychiatric disorder Unstable medical problems Known congenital abnormality High risk pregnancy

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotrol with Behavioral Counseling<br>Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern | Drug: Nicotrol Inhaler<br>* 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days of Inhaler Use |  | Baseline to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cartridge Use |  | Baseline to 4 weeks | 
| Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. |  | Baseline to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking Cessation during Pregnancy, Nicotrol Inhaler
Targeted Management Intervention for African-American Men With TIA or Stroke

Study Overview
=================
Brief Summary
-----------------
Stroke is the leading cause of disability, third leading cause of death, and one of the most resource-intensive diseases among Americans. African-Americans (AA) have a stroke rate nearly double that of Euro-Americans (EA), and AA who experience a first-ever stroke are younger, have greater stroke disability, more post-stroke complications, and slower recovery compared to EA.

Official Title
-----------------
Targeted Management Intervention for African-American Men With TIA or Stroke.

Conditions
-----------------
Stroke, Transient Ischemic Attack (TIA)

Intervention / Treatment
-----------------
* Behavioral: Psychoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identified AA male Between 22 and 64 years of age (> age 21 and < age 65). Within 6 months of discharge for Stroke /TIA Planned or recent home discharge Barthel Index (BI) score of > 60 Available care partner willing to participate Be able to speak and understand English Exclusion Criteria: Individuals who are unable or unwilling to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Psychoeducation<br>Psychoeducation will include attending individual and group sessions. | Behavioral: Psychoeducation<br> <br> |
| No Intervention: Care as usual<br>Receive care as usual | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | The primary outcome will be change in medication treatment adherence with stroke risk reduction pharmacotherapies as measured by the Tablets Routines Questionnaire (TRQ) | Screening/baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological and health behaviors parameters | Secondary outcomes are changes in biologic parameters of stroke risk (blood pressure, HbA1c, BMI, cholesterol and triglycerides) and in health behaviors (diet, exercise, smoking, substance use) using standardized instruments | Baseline, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, TIA, African American