linjc16/ctgov huggingface dataset:
Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)

Study Overview
=================
Brief Summary
-----------------
It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP). All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP. The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.

Official Title
-----------------
Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep

Conditions
-----------------
Vigilance Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: tests of attentional performance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 20-70 years Memory disorders without memory problems in episodic memory Presence of polysomnography of a obstructive sleep apnea/hypopnea syndrome (OSAHS) requiring Continuous positive airways pressure Moderate OSAHS (Apnea Hypopnea Index ≥ 15 / hour with arousals ≥ 10) Severe OSAHS (Apnea Hypopnea Index ≥ 30 / h) Exclusion Criteria: Age <20 years or ≥ 70 years Neurodegenerative disease (Alzheimer's disease, Parkinson's disease) Dysthyroidism Severe depression, schizophrenia, bipolar disorder Treatment with an effect on cognition: hypnotics, sedative Chronic Obstructive Pulmonary Disease Chronic alcoholism, other addictions Contraindications to Magnetic Resonance Imaging Refusal of equipment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tests of attentional performance<br> | Diagnostic Test: tests of attentional performance<br>* tests of attentional performance before and after 6 months of continuous positive airways pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP | Reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP | After 6 months of continuous positive airways pressure in the OSAHS patient |
The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver.

Study Overview
=================
Brief Summary
-----------------
To address the existing deficiencies in the knowledge regarding liver involvement and spectrum of clinical presentation and the impact of COVID-19 infection in patients of liver disease was planned. The present study will be a hospital based and the cases of confirmed COVID-19 infection will be evaluated in relation to liver involvement irrespective of pre-existing liver disease. The primary objective was to address the clinical presentation, biochemical alteration and outcomes of COVID-19 infection in subjects with chronic hepatitis, cirrhosis in comparison to those having infection in the absence of pre-existing liver disease

Official Title
-----------------
The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver - The Pan Asia-Pacific Prospective Multi-centre Observational Study (APCOLIS STUDY)

Conditions
-----------------
Liver Cirrhoses

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients of COVID-19 positive Age 18-70 years Exclusion Criteria: No Valid consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid-19 with liver disease<br>Covid-19 with liver disease | Other: no intervention<br>* no intervention<br>|
| Covid-19 without liver disease<br>Covid-19 without liver disease | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous recovery or death in both groups |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of prior as well as present decompensation in both groups |  | 90 days | 
| Duration of prior as well as present decompensation in both groups |  | 90 days | 
| Improvement in severity assessment Indices Model for End Stage Liver Disease (MELD) scores in both groups |  | 90 days | 
| Improvement in severity assessment Indices Child-Turcotte-Pugh (CTP) scores in both groups |  | 90 days | 
| Improvement in severity assessment Indices Sequential Organ Failure Assessment (SOFA) scores in both groups |  | 90 days | 
| Improvement in severity assessment Indices Acute Physiology And Chronic Health Evaluation (APACHE) scores II in both groups |  | 90 days | 
| Improvement in severity assessment Indices Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF SOFA) scores in both groups. |  | 90 days |
Swiss National Iodine Survey 2015

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to monitor iodine nutrition in Switzerland in order to inform the authorities regarding iodine content in iodized salt. As a proxy for the entire population the investigators will study school aged children, pregnant women and women of reproduction age.

Detailed Description
-----------------
In a national sample of school aged children (n=990), pregnant women (n=700) and women of reproductive age (n=700) urinary iodine will be determined in order to assess iodine nutrition in Switzerland. In addition, in both groups of women a blood sample will be taken for the determination of thyroid hormones, iron- and folate status. Questionnaires will be used for the determination of dietary iodine and salt intake as well as sociodemographic parameters.

Official Title
-----------------
Swiss National Iodine Survey 2015; A Cross-sectional Study to Assess Iodine Status in School Children, Women of Reproductive Age and Pregnant Women

Conditions
-----------------
Healthy Subjects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Living in Switzerland for at least 1 year For pregnant women: singleton pregnancy Exclusion Criteria: Major known medical illness: thyroid dysfunction, gastrointestinal or metabolic disorders and taking chronic medications For women of reproductive age: pregnancy, breastfeeding Use of X-ray or CT contrast agent or iodine containing medication within the past year

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 44 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 |
| --- | --- |
| School aged children<br> | |
| Pregnant women<br> | |
| Women of reproductive age<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median urinary iodine concentration in school aged children, pregnant women and women of reproductive age | analysis of urine samples | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population mean thyroglobulin | Analysis of venous blood samples. Assessed only in women | Baseline | 
| Population mean thyroid stimulating hormone | Analysis of venous blood samples. Assessed only in women | Baseline | 
| Population mean thyroxine | Analysis of venous blood samples. Assessed only in women | Baseline | 
| Median urinary sodium concentration |  | Baseline | 
| Median urinary creatinin concentration |  | Baseline |
Neuromodulation of Aspiration Secondary to Stroke

Study Overview
=================
Brief Summary
-----------------
Aspiration could induce major respiratory affection. They are often present after stroke. The aim of this study is to facilitate swallowing recuperation in stroke patients using peripheral laryngeal stimulation and to understand its mechanisms using motor evoked potential and cortical evoked potential.

Official Title
-----------------
Neuromodulation of Aspiration Secondary to Stroke

Conditions
-----------------
Deglutition Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke aspiration Exclusion Criteria: pace maker tracheostomy epilepsy pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspiration, stroke, motor evoked potential, cortical evoked potential, neuromodulation
Investigation of Ultrasound Elastographic Techniques in Soft Tissue Pathology

Study Overview
=================
Brief Summary
-----------------
Ultrasound (US)tissue elastography has recently been found to have a number of clinical applications in the assessment of soft tissue disease for example, in breast and thyroid pathology. There are few current studies exploring its use in musculoskeletal pathology, particularly a new technique called sheer wave ultrasound elastography (SWUE). Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics, sports medicine and rheumatology and SWUE may have the potential to also demonstrate clinical effectiveness in these areas. Our aim is to explore the effectiveness of this technique in the assessment of musculoskeletal pathology. Participants will be recruited through current referral protocols and would undergo an additional elastographic investigation in addition to their standard US examination. This investigation will be conducted within the musculoskeletal US department at Chapel Allerton Hospital by trained musculoskeletal specialists. The study will be conducted over a period of approximately 24 months with quarterly review during this time.

Conditions
-----------------
Tissue Pathology

Intervention / Treatment
-----------------
* Procedure: SWUE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have clinical symptoms and signs of soft tissue pathology Be able to give consent Be over 16 years of age Exclusion Criteria: Unable to give consent 16years of age or less Multifactorial soft tissue pathology

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| SWUE<br> | Procedure: SWUE<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness of Sheer wave ultrasound elastography (SWUE) in the assessment of soft tissue pathology | Ability of SWUE to accurately detect soft tissue pathology when compared with standard ultrasound techniques. | Baseline to 24 months |
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure with preserved and mid-range ejection fraction.

Detailed Description
-----------------
Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.

Official Title
-----------------
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure With Preserved Ejection Fraction (ANTHEM-HFpEF) Study

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: Vagus Nerve Stimulation (VNS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%). Exclusion 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy<br>Right Cervical Vagus Nerve Stimulation (VNS) | Device: Vagus Nerve Stimulation (VNS)<br>* Electrical Stimulation of the Vagus Nerve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of procedure and device-related complications | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Size (LAVI) | Left atrial volume index | 12 months | 
| Functional Status (6MWD) | 6-minute walk distance | 12 months | 
| Quality of Life Score | Minnesota Living with Heart Failure Questionnaire score | 12 months | 
| Functional Status (NYHA Class) | New York Heart Association classification | 12 months | 
| Cardiac Function (E/E') | Ratio of mitral velocity to early diastolic velocity of the mitral annulus | 12 months | 
| Cardiac Size (LV mass index) | Left ventricular mass index | 12 months | 
| Autonomic Function (HRV) | Heart rate variability | 12 months | 
| Blood Biomarkers | Blood Levels of Heart Failure Biomarkers (NT-proBNP, creatinine, C-reactive protein) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Preserved Ejection Fraction, VNS, Vagus Nerve, Autonomic Regulation Therapy
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.

Official Title
-----------------
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan

Conditions
-----------------
Polycystic Kidney, Autosomal Dominant

Intervention / Treatment
-----------------
* Drug: tolvaptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed ADPKD total kidney volume of 750 or more Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADPKD<br> | Drug: tolvaptan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total kidney volume |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver function |  | 8 years |
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis

Study Overview
=================
Brief Summary
-----------------
-Rivaroxaban is factor Xa inhibitor

Detailed Description
-----------------
PVT is a common complication of liver cirrhosis

Official Title
-----------------
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis

Conditions
-----------------
Portal Vein Thrombosis

Intervention / Treatment
-----------------
* Drug: rivaroxaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute PVT Exclusion Criteria: Malignant PVT Bleeding disorders
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Portal Vein thrombosis<br>rivaroxaban | Drug: rivaroxaban<br>* rivaroxaban<br>* Other names: xarelto;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with recanalized portal vein | recanalization of portal vein | 6 months |
Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study intends to evaluate how safe and well tolerated the LY2405319 compound is when given to people for 7 days (in Part 1) and 28 days (in Part 2). This study intends to also determine if there is a positive effect on lowering the level of glucose in people with type 2 diabetes.

Detailed Description
-----------------
Subjects in Part 1 will be randomized to receive LY2405319 or placebo over 7 days in one of 4 dose level groups, in ascending order: 1 mg, 3 mg, 10 mg, or 20 mg. Subjects in Part 2 will be randomized to receive LY2405319 or placebo over 28 days, and will receive the dose level determined to be the most well tolerated in Part 1.

Official Title
-----------------
Safety, Tolerability, PK and PD of LY2405319 After Multiple Subcutaneous Injections in Subjects With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: LY2405319
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women without child bearing capability Ages 35 to 70 years Type 2 diabetic subjects, diagnosed for at least 3 months Average body weight (relative to height) Willing to be available for the duration of the study Exclusion Criteria: Significant medical illnesses (except Type 2 diabetes) Abnormal 12-lead electrocardiogram (ECG ) Current or previous use of insulin for greater than 7 days for control of diabetes Regular use of drugs of abuse Excessive alcohol use

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY2405319|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety labs, ECGs, vital signs, adverse events. |  | End of dosing period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (lab samples) and Pharmacokinetics (lab samples) |  | End of dosing period |
Optical Coherence Tomography Measurements in Eyes With Band Atrophy

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the ability of optical coherence tomography and VCC scanning laser polarimetry to measure and identify the pattern of band atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is that these new technologies are able to identify such pattern. The idea is that by using eyes with band atrophy one is able to investigate the ability of the new technologies in measuring the retinal nerve fiber layer particularly in the nasal and temporal portions of the optic nerve.

Official Title
-----------------
Evaluation of the Diagnostic Ability of Optical Coherence Tomography With a Normative Database to Detect Band Atrophy of the Optic Nerve

Conditions
-----------------
Vision Disorders

Intervention / Treatment
-----------------
* Device: Retinal nerve fiber layer and macular thickness measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with long standing chiasmal lesions and temporal visual field defect with the following criteria: Visual acuity better than 20/30 Refractive error less 5 spherical diopter and 3 cylinder diopter Temporal field defect Exclusion Criteria: Presence of glaucoma and optic nerve anomalies Anormal nasal field

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Retinal nerve fiber layer and macular thickness measurements|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retina nerve fiber layer measurements |  |  | 
| Macular thickness measurements |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Band Atrophy, Optical Coherence Tomography, Scanning Laser Polarimetry, Chiasmal Lesions