linjc16/ctgov huggingface dataset:
Validation of the Hebrew Version of the Montreal Affective Voices.

Study Overview
=================
Brief Summary
-----------------
Today, no non-verbal auditory stimuli that assess mental processing are available in Israel. The goal of this study is to make available a validated set of auditory stimuli in Israel. We created a computerized Hebrew version of the Montreal Affective Voices (MAV). The MAV is a novel tool for assessing mental processing. The MAV consists of 90 nonverbal affect bursts corresponding to nine different emotions (such as anger, fear, happiness etc.) recorded by ten different actors. The uniqueness of these affective bursts is that they do not contain verbal context, but rather express affective moods using the vowel /a/ (as in apple). In this study, the investigators will verify the new Hebrew version of MAV in healthy control groups. Next, the investigators will compare the mental processing ability in young vs. old population, using the MAV test. In addition, the investigators will assess mental processing in two pathologic study groups (Parkinson's disease, major depressive disorder) using the MAV test. The investigators intend to use the MAV tool in future research in Parkinson's disease and depression.

Conditions
-----------------
Parkinson's Disease, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy group Parkinson's disease Major depressive disorder All participants will be competent and willing to give written informed consent. Patients over 65 and/or suspected to have a cognitive decline will be tested by the Mini-mental test and will be included in the study only if the score is above 26. Exclusion Criteria: Non-competent or unable to give written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| healthy control group<br>Young (20-49) and Older (50-70) healthy group (n=60) | |
| Parkinson's disease patients<br>(n=30). | |
| Major depressive disorder patients<br>(n=30). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verifying the results achieved by Belin et al (2008) when using the Hebrew version of the MAV bursts in healthy control groups. |  | 12 months |
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge

Study Overview
=================
Brief Summary
-----------------
A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.

Official Title
-----------------
A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Technosphere® Insulin 10U + 20U
* Drug: Technosphere® Insulin 30U


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis No smoking in the past 6 months (including cigarettes, cigars, and pipes) Urine cotinine testing < 100 ng/mL Body mass index < 32 kg/m2 Completion of informed consent form Exclusion Criteria: FBG > 100 mg/dL Clinically significant active or chronic illness History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TI 30 units (10 unit + 20 unit<br>Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge | Drug: Technosphere® Insulin 10U + 20U<br>* Inhaled Insulin<br>|
| Experimental: TI 30 units (30 unit cartridge<br>Technosphere® Insulin 30 units given as one 30 unit cartridge | Drug: Technosphere® Insulin 30U<br>* Inhaled Insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area-under-the-serum insulin concentration versus time curve (AUC0-240min |  | 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing |
Post-exercise Insulin Reductions in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesise that reducing rapid-acting insulin dose after exercise will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.

Official Title
-----------------
The Metabolic and Glycaemic Responses to Reductions in Rapid-acting Insulin Dose After Running Exercise in People With Type 1 Diabetes Mellitus.

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1DM, Male, basal-bolus regimen (insulin glargine / detemir with insulin lispro / aspart), HbA1c < 9.9%, aged 18-50. Exclusion Criteria: HbA1c > 10%, not treated with basal-bolus (insulin glargine / detemir with insulin lispro / aspart), aged <18 > 50.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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 |
| --- | --- |
| Other: Insulin dose<br>Reducing rapid-acting insulin dose (insulin aspart or lispro) after exercise. | Other: Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose<br>* Dosage after exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour blood glucose area under the curve | 24 hour, post-exercise, glucose area under the curve. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ketogenesis | Blood beta-hydroxybutyrate concentrations | 60 minutes before and 24 hours post-exercise | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T1DM, Exercise
Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease

Study Overview
=================
Brief Summary
-----------------
Salivary gland ultrasonography is identified as a valuable diagnostic tool and potential criteria item for disease classification of sjögren's syndrome and evaluate evolution of parenchyma. The investigators have to include 242 patients. The objective is to evaluate the modification of ultrasonographic abnormalities according to disease in primary Sjögren syndrome.

Official Title
-----------------
Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome

Conditions
-----------------
Primary sjögren's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient ≥ 18 years Primary sjögren syndrome according of age to 2002 or 2016 classification criteria Exclusion Criteria: Secondary sjögren syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Presence or absence of parenchymal abdnormalities. | Presence or absence of parenchymal abdnormalities. Scored following a standardized fill and according to disease duration | inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenchymal abnormalities according to disease activity | Ultrasonography parenchymal abnormalities of salivary gland | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary sjögren's syndrome, ultrasonography, salivary glands, auto-immune disease
Pompe Lactation Sub-Registry

Study Overview
=================
Brief Summary
-----------------
The objective is to determine if alglucosidase alfa is present in breast milk from mothers with Pompe Disease being treated with alglucosidase alfa and to measure breast milk production and composition in women with Pompe Disease who receive alglucosidase alfa.

Official Title
-----------------
A Sub-Registry to Determine the Presence of Alglucosidase Alfa in Breast Milk From Women With Pompe Disease Treated With Alglucosidase Alfa.

Conditions
-----------------
Glycogen Storage Disease, Pompe Disease

Intervention / Treatment
-----------------
* Biological: alglucosidase alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be enrolled in Pompe Registry (NCT00231400) Must be pregnant and intend to breast-feed or be currently lactating and receive at least one infusion of alglucosidase alfa while lactating Provide a signed Patient Information and Authorization form to participate in the sub-registry prior to any sub-registry-related assessments are performed Agree to adhere to the sub-registry guidelines for antibody testing and recommended schedule of assessments. Exclusion Criteria: Patients will be excluded from this sub-registry if they have received an investigational drug (excluding alglucosidase alfa in regions where alglucosidase alfa is not commercially available) within 30 days prior to Visit 1 breast milk collection
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: alglucosidase alfa|At least one infusion of alglucosidase alfa post partum|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alglucosidase alfa accumulation in immature (1-3 months post partum) or mature (4-6 months post partum) breast milk sample from mothers with Pompe disease who are being treated with alglucosidase alfa. |  | 6 Months | 
| breast milk production and composition in women with Pompe disease who receive alglucosidase alfa |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycogen Storage Disease, GSD-II, Pompe Disease, Pompe Disease (Late-Onset), Acid Maltase Deficiency Disease, Glycogenosis II
Fatty Liver Disease Collaborative Research in China

Study Overview
=================
Brief Summary
-----------------
A multi-center, prospective cohort study on the natural history of fatty liver disease in China

Detailed Description
-----------------
This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with liver biopsy-proven macrovesicular steatosis (>5%) will be enrolled in the baseline cross-sectional analysis. Those who are either diagnosed as NAFLD or ALD, if meeting all the inclusion and exclusion criteria, will be enrolled in the following cohort study, will be followed up after 1 year, 3 years and 5 years with a visit window of +1 month.

Official Title
-----------------
A Multi-center, Prospective Cohort Study on the Natural History of Fatty Liver Disease in China

Conditions
-----------------
Fatty Liver, Fatty Liver, Alcoholic, Non-alcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed fatty liver disease, confirmed by liver biopsy. Specific biopsy requirements: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope. Only patients with NAFLD or ALD are eligible for the 5-year follow-up cohort study. Willing to participate in the long-term follow-up and cooperative. Able to provide informed consent file. Exclusion Criteria: Unable to provide informed consent. Patients are eligible for baseline cross-sectional analysis but not eligible for the cohort section, if having any of the following condition: Any end-stage liver disease. Any malignant tumor. Any infection of hepatitis virus or HIV. Any congenital liver disease such as Wilson disease. Any other serious disease of projected survival < 5 years. Combined NAFLD and ALD.
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 |
| --- | --- | --- |
| liver cirrhosis |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver cancer |  | 5 years | 
| liver failure |  | 5 years | 
| type 2 diabetes |  | 5 years | 
| cardiovascular and cerebrovascular events |  | 5 years | 
| death |  | 5 years |
Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis

Study Overview
=================
Brief Summary
-----------------
Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system

Detailed Description
-----------------
After inclusion, patients will be dialysed with low-flux artificial kidneys. 1 week of dialysis exists of 3 days of dialysis. In week 4, day 2, patients will be treated once with the Prometheus artificial hepatic system or with high-flux dialysis. The other days low-flux kidneys will be used. Week 5 and 6 are a wash-out period. Week 7 is identical to week 4 but the other system than in week 4 is used. Blood samples are taken at regular moments in week 3, week 4 (day 2) and week 7 (day 2).

Official Title
-----------------
Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis

Conditions
-----------------
Renal Failure, Chronic

Intervention / Treatment
-----------------
* Device: Dialysis with different artificial devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable patients At least 3 months on dialysis Arterio-venous fistula Exclusion Criteria: Diabetic patients Malignancies Acute illnesses

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dialysis with different artificial devices|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the concentration of protein-bound toxins after treatment with different artificial devices |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the kinetics of protein-bound toxins after treatment with different artificial devices |  |  |
Tissue Acquisition for Molecular Diagnostics

Study Overview
=================
Brief Summary
-----------------
Acquisition of fresh tumor and normal tissue samples are necessary for the preparation of cDNA libraries, microarray chips, and tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of samples at the time of tissue sampling for surgery, diagnostic tests, or therapeutic phereses. These samples will be forwarded without patient identifiers, pathology reports, or other labels. Tissue pathology will be verified within the Laboratory of Pathology and samples used strictly for CGAP and Proteomic Initiative indications.

Detailed Description
-----------------
Acquisition of fresh tumor and normal tissue samples is necessary for the preparation of cDNA libraries, microarray chips, tissue specific probes, and proteomics development and validation. This protocol will allow acquisition of patient samples at the time of tissue sampling for surgery, diagnostic tests, or therapeutic phereses. These samples will be forwarded without patient identifiers, pathology reports, or other labels. Tissue pathology will be verified within the Laboratory of Pathology and samples used strictly for CGAP and Proteomic Initiative indications.

Official Title
-----------------
Tissue Acquisition for Molecular Diagnostics

Conditions
-----------------
Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: All patients willing to sign the informed consent for whom tissue, blood or body fluids will be available are eligible. Histopathologic diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute and is not a criteria for inclusion.
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
-----------------
Molecular Diagnostics, Ovary, Tissue Acquisition, cDNA Library, CGAP
Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

Study Overview
=================
Brief Summary
-----------------
To determine whether the administration of test article will decrease the occurrence of ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, ST segment elevated myocardial infarction or myocardial infarction without ST elevation).

Official Title
-----------------
Study Evaluating Subjects With Non-sustained Ventricular Tachycardia

Conditions
-----------------
Arrhythmias

Intervention / Treatment
-----------------
* Drug: Double-blind investigational anti-arrhythmic
* Drug: GAP-486


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Male and female patients, 18 years of age or older, that have experienced an acute ischemic event within 24 hours prior to study entry. Patients with a documented history of coronary artery disease or left ventricular dysfunction Patients who have experienced an episode of non-sustained ventricular tachycardia within 24 hours of the index ischemic event EXCLUSION CRITERIA: Patients who have had percutaneous coronary intervention (PCI), thrombolytics, or open-heart surgery within 48 hours prior to study entry, or who require it during test article administration Patients who have taken another antiarrhythmic medication (other than a beta blocker) within 5 half-lives of the start of test article Patients who have a history of torsades de pointes, long QT syndrome, QTc > 0.50

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Double-blind investigational anti-arrhythmic|nan|
|Drug: GAP-486|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of NSVT beats, PVCs/couplets, NSVT episodes during the 24 hr. on-therapy phase and incidence of new-onset atrial fibrillation during the 24hr. on-therapy phase. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmias