linjc16/ctgov huggingface dataset:
CI532 - Early Experience Study

Study Overview
=================
Brief Summary
-----------------
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.

Detailed Description
-----------------
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.

Official Title
-----------------
Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study

Conditions
-----------------
Sensorineural Hearing Loss, Bilateral

Intervention / Treatment
-----------------
* Device: Cochlear Nucleus CI532


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications Post-linguistically deafened Ability to complete age appropriate testing Exclusion Criteria: Previous cochlear implantation in the ear to be implanted Pre-linguistically deafened (onset of hearing loss at less than two years of age) Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array Diagnosis of retro-cochlear pathology Diagnosis of auditory neuropathy Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device Unwillingness or inability to comply with all investigational requirements Additional cognitive handicaps that would prevent participation on all study requirements

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implanted<br>Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant | Device: Cochlear Nucleus CI532<br>* cochlear implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear | Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet. | 3 months postactivation of the sound processor | 
| Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear | unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise | 3 months post-activation |
Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry

Study Overview
=================
Brief Summary
-----------------
This is a new vessel wall imaging-based stroke registry which will investigate the clinical utility of the whole-brain intracranial vessel wall Magnetic Resonance Imaging (MRI) technique in assessing the etiologies in patients with ischemic stroke.

Detailed Description
-----------------
The registry will focus on investigating the utility of whole-brain vessel wall MRI techniques in assessing the etiologies in patients with recent ischemic stroke. Patients who have had ischemic stroke (as confirmed by diffusion weighted MRI) and have had or will undergo 3D whole-brain vessel wall MRI within 8 weeks of symptom onset will be recruited into this study. It is anticipated that a total of 1000 subjects will be recruited from Feb 2017 to Feb 2019. Approximately 12 centers in the US and China will participate in the registry. MRI whole-brain vessel wall images will be analyzed for detection and characteristics of various vessel wall pathologies and association between vessel wall imaging findings and patient's clinical information.

Official Title
-----------------
Whole Brain Vessel Wall Imaging in Stroke Patients (WISP): An International Multi-Center Registry

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 18 years of age Ischemic stroke onset within 8 weeks and confirmed by diffusion weighted MRI Ability to read and understand informed consent Exclusion Criteria: The cause of stroke has been confirmed to be related to cardiac or extracranial carotid or aorta pathologies. Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy. Inability to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia. Non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions

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 |
| --- |
|Device: MRI|Contrast-enhanced MRI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel wall pathology findings by MRI | To identify vessel wall pathologies such as atherosclerosis, dissection, vasculitis | baseline |
Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).

Official Title
-----------------
Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)

Conditions
-----------------
Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver biopsy proved CHB and/or NAFLD at baseline; Chinese Follow-up duration>12 months Exclusion Criteria: Other liver diseases; Secondary causes of hepatic steatosis; Alcohol abuse; Liver cirrhosis, cirrhosis related complications or HCC at baseline; Malignancy; History of liver transplantation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHB Group<br>Patients with chronic hepatitis B | |
| CHB/NAFLD Group<br>Patients with chronic hepatitis B and comorbid nonalcoholic fatty liver disease | |
| NAFLD Group<br>Patients with nonalcoholic fatty liver disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma |  | Up to 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia |  | Up to 20 years | 
| Number of patients with liver transplantation and liver-related death |  | Up to 20 years | 
| Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline |  | Up to 20 years | 
| Occurrence time of liver transplantation and liver-related death from baseline |  | Up to 20 years |
Methylphenidate in Myotonic Dystrophy Type 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether methylphenidate is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).

Detailed Description
-----------------
Myotonic dystrophy type 1 (DM1) is a multisystemic disorder characterized by muscle weakness, myotonia, and the involvement of several systems. Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities.The current investigation represents a prospective, double-blind, randomized, crossover, placebo-controlled study designed to evaluate the efficacy of methylphenidate for the treatment of excessive daytime sleepiness (EDS) in adults with DM1.

Official Title
-----------------
Phase 2/3 Study of Efficacy and Tolerability of Methylphenidate in the Treatment of Excessive Daytime Sleepiness in Myotonic Dystrophy Type 1

Conditions
-----------------
Dystrophia Myotonica 1

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults Epworth score ≥ 10 Diagnosis of myotonic dystrophy type 1 Exclusion Criteria: hypersensibility to methylphenidate Pregnancy Patients who receive drugs that interfere with methylphenidate Cognitive impairment Sleep apnea

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1: Methylphenidate versus baseline<br> | Drug: Methylphenidate<br>* One Tablet of methylphenidate, 20 mg per day during 3 weeks<br>* Other names: Ritalin;|
| Placebo Comparator: Arm 2: Placebo versus baseline<br>One table placebo per day during 3 week | Drug: Placebo<br>* one tablet placebo per day during 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of excessive daytime sleepiness |  | 3 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of POMS, Rand36-Item Health survey and mean sleep latency | Mean sleep latency was measured using the behavioural Osler's test | 3 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized, double-blind, crossover, methylphenidate, excessive daytime sleepiness
Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery

Study Overview
=================
Brief Summary
-----------------
We have herein analysed the patients admitted to our Department that underwent serologic tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to evaluate if security measures are necessary for this context.

Official Title
-----------------
Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery

Conditions
-----------------
Surgery, Covid19, SARS (Severe Acute Respiratory Syndrome)

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2 Ab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized during pandemic spread Exclusion Criteria: Incomplete data
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized patients<br> | Diagnostic Test: SARS-CoV-2 Ab<br>* Patient test for specific antibodies for SARS-CoV-2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprevalence of SARS-CoV-2 | Positivity of specific IgM or IgG | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, surgery
Virtual Reality Helmet to Test for Problems With Memory

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare a virtual reality display device with the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Detailed Description
-----------------
Since many individuals with mild cognitive impairment (MCI) appear to function normally, MCI may often be recognizable through testing in advance of any changes noticed by family members or caregivers. Early and frequent testing can therefore trigger an earlier diagnosis, which may increase the effectiveness of currently available medications used to delay onset of Alzheimer's symptoms. Primary care and geriatric physicians currently lack the necessary tools required for quick and accurate MCI screening in the doctor's office environment. The current industry-standard is a battery of pen & paper neuropsychological tests that require 1.5 hours in a quiet room with a neuropsychologist. Comparison: virtual reality display device compared to the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Official Title
-----------------
Display Enhanced TEsting for Cognitive Impairment and Traumatic Brain Injury

Conditions
-----------------
Memory

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 yrs of age and older MMSE of 18 or greater or mini-cog of 4 or greater Ability to read Informed consent given Exclusion Criteria: Visual, hearing or physical impairment that would limit ability to use the virtual reality helmet or control device Non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| No treatment<br> | |

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
-----------------
memory, display enhanced testing
Aortic-Stent-Register

Study Overview
=================
Brief Summary
-----------------
The aims of the aorta-stent-Registry are: • participating hospitals (with audit) document all consecutive patients diagnosed with a disease of the distal thoracal aorta that receive one of the following therapies:

Detailed Description
-----------------
Endovascular Aorta-Stent-Graft Surgical operation of the distal thoracal aorta Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine. Documentation of the operational risk (Euroscore) Documentation of the technical enforcement of the procedure as well as the result of the intervention Documentation of the hospital lethality and the non-fatal serious complications (Spinal Cord Ischemia, SCI, Stroke, TIA, high blood loss etc.) Documentation of medication at hospital discharge Documentation of long-term lethality and non-fatal serious complications (SCI, Stroke, TIA, major bleeding etc.) as well as hospitalization, re-intervention rates and medicinal drug therapy after 30 days, 1, 3 & 5 years.

Official Title
-----------------
Aortenstent-Register Thorakale Aorta

Conditions
-----------------
Aortic Dissection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with significant illness of the distal thoracal aorta (distal Aortic-dissection; TAA; penetrated ulcer; covered perforation; traumatically transection of the distal thoracal aorta) including those that receive an endovascular stent or an open surgical operation. Exclusion Criteria: Missing signed informed consent
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ◦Documentation of the indications, the procedural results and the clinical short- and long-term results of the endovascular and chirurgical treatment in day to day hospital routine |  | Hospital-stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aorta, Aorta-Stent-Graft, Surgical operation, Aortic dissection
Quality of Life Validation in Laryngitis

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the questionnaire that were evaluated were: validity, reliability, and responsiveness to change (as a measure of treatment effect).

Official Title
-----------------
Laryngopharyngeal Reflux Health Related Quality of Life (LPR-HRQL) Questionnaire Development and Psychometric Testing in Patients Receiving Omeprazole 20 mg Bid as Treatment for Laryngopharyngeal Reflux.

Conditions
-----------------
Laryngopharyngeal Reflux (LPR)

Intervention / Treatment
-----------------
* Drug: Omeprazole
* Behavioral: Quality of Life questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New Laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment Exclusion Criteria: Unable to comply with study requirements.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Omeprazole|nan|
|Behavioral: Quality of Life questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LPR-HRQL questionnaire, which measured symptom distress and the effects of LPR on voice, cough, throat clearing, swallow , and overall impact of acid reflux |  | 2 monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments via adverse event recording and physical examinations |  | 2 monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laryngopharyngeal reflux (LPR), Omeprazole, Losec, Quality of Life, Laryngitis
Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to analyze the sensitivity of blood pressure to oral salt intake. Matched male and female participants will be selected as normal weight, overweight, and obese. Participating subjects will have a first visit with blood pressure measurement and a blood sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6 grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.

Official Title
-----------------
Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: sodium chloride
* Other: Methylcellulose crystalline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Age 18-45 for adults and 6-8 for children Exclusion Criteria: African ethnicity (known to affect blood pressure sensitivity to salt) Chronic condition affecting blood pressure Diabetes (known to affect blood pressure sensitivity to salt) Hypertension

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 45 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 |
| --- | --- |
| Experimental: chlorure de sodium<br> | Other: sodium chloride<br>* sodium chloride 500mg<br>|
| Placebo Comparator: Methylcellulose<br> | Other: Methylcellulose crystalline<br>* Methylcellulose 37 ml<br>|

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
-----------------
Blood pressure