linjc16/ctgov huggingface dataset:
Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome

Study Overview
=================
Brief Summary
-----------------
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X Syndrome

Conditions
-----------------
Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: arbaclofen
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Molecular documentation of the full FMR1 mutation Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening. Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics. If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening Exclusion Criteria: Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. Subjects who have taken another investigational drug within the last 30 days. Subjects who are not able to take oral medications.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arbaclofen<br> | Drug: arbaclofen<br>* orally disintegrating tablet<br>* Other names: STX209;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* orally disintegrating tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist - FXS Social Avoidance Subscale |  | At 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fragile X syndrome, autism spectrum disorder
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacodynamic Response of FIAsp in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Faster-acting insulin aspart
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-64 years (both inclusive) at the time of signing informed consent Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.5-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIAsp<br>Each subject will be randomised to a treatment sequence consisting of 8 treatment periods | Drug: Faster-acting insulin aspart<br>* Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).<br>|
| Active Comparator: NovoRapid®<br>Each subject will be randomised to a treatment sequence consisting of 8 treatment periods | Drug: insulin aspart<br>* Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve |  | From 0 to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | From 0 to 12 hours | 
| Maximum glucose infusion rate |  | Within 0 to 12 hours after dosing | 
| Maximum observed serum insulin aspart concentration |  | Within 0 to 12 hours after dosing |
Comparison of Effects Between Amlodipine and Hydrochlorothiazide in Combination With Losartan on 24-hr Central Blood Pressure in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics

Official Title
-----------------
Comparison of Effects Between Calcium Channel Blocker and Diuretics in Combination With Angiotensin II Receptor Blocker on 24-hr Central Blood Pressure and Vascular Hemodynamic Parameters in Hypertensive Patients Multicenter, Double-blind, Active-controlled, Phase 4 Randomized Trial

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Losartan 50mg/amlodipine 5mg
* Drug: Losartan 100mg/amlodipine 5mg
* Drug: Losartan 50mg/Hydrochlorothiazide 12.5mg
* Drug: Losartan 100mg/Hydrochlorothiazide 25mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension patients not included exclusion criteria Mean seated SBP ≥140mmHg in patients with newly Diagnosed Exclusion Criteria: - msDBP≥110mmHg or ms SBP ≥ 180mmHg at the screening and randomization visit

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan 50mg/amlodipine 5mg<br>Once daily, 1T, PO medication | Drug: Losartan 50mg/Hydrochlorothiazide 12.5mg<br>* once daily, 1T, PO medication<br>* Other names: Cozaar Plus;|
| Experimental: Losartan 100mg/amlodipine 5mg<br>Once daily, 1T, PO medication | Drug: Losartan 100mg/Hydrochlorothiazide 25mg<br>* once daily, 1T, PO medication<br>* Other names: Cozaar Plus F;|
| Active Comparator: Losartan50 mg/Hydrochlorothiazide12.5 mg<br>Once daily, 1T, PO medication | Drug: Losartan 50mg/amlodipine 5mg<br>* once daily, 1T, PO medication<br>* Other names: amosartan 5/50mg;|
| Active Comparator: Losartan100 mg/Hydrochlorothiazide25 mg<br>Once daily, 1T, PO medication | Drug: Losartan 100mg/amlodipine 5mg<br>* once daily, 1T, PO medication<br>* Other names: amosartan 5/100mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in msSBP |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in AMcSBP |  | 20 weeks |
The Impact of Sinopharm COVID-19 Vaccination on Male Fertility

Study Overview
=================
Brief Summary
-----------------
The investigators shall study the effect of Sinopharm vaccination on semen parameters and serum testosterone

Detailed Description
-----------------
The investigators shall compare semen parameter (sperm density, sperm motility, and percentage of abnormal sperm form) as well as morning serum testosterone before vaccination, and 3 months after the second dose of the vaccine.

Official Title
-----------------
The Impact of Sinopharm COVID-19 Vaccination on Male Fertility of the Egyptian Population

Conditions
-----------------
Male Infertility, Hypogonadism, Male

Intervention / Treatment
-----------------
* Diagnostic Test: Semen analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving Sinopharm COVID-19 vaccines Male age 18-50 years old Exclusion Criteria: Adults unable to consent Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year Men with a history of male infertility Men with a genetic or other medical condition known to be associated with decreased semen parameters Positive COVID-19 PCR test within the 3 months

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sinopharm vaccine group<br>Participants scheduled to receive the Sinopharm vaccine will be evaluated on its effect on semen parameters for up to 6 months post vaccination. | Diagnostic Test: Semen analysis<br>* Semen analysis according to WHO laboratory manual for the examination and processing of human semen, Fifth edition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm density count/ml | As measured from semen samples | up to 6 months | 
| Total sperm count per ejaculate | As measured from semen samples | up to 6 months | 
| Percentage of motile sperm | As measured from semen samples | up to 6 months | 
| Percentage of abnormal sperm forms | As measured from semen samples | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning serum testosterone | Total serum testosterone measured using immunoassay | up to 6 months |
Restorative Yoga for Stress Management

Study Overview
=================
Brief Summary
-----------------
The study examined Restorative Yoga as a method of stress reduction for the HFA Addiction Medicine Clinic staff volunteers.

Detailed Description
-----------------
The purpose of this study is to determine if there is a perceived benefit from adding a restorative yoga class as a method of stress reduction for the HFA Addiction Medicine Clinic staff. Working in a busy clinic can be very stressful. While it is not always possible to completely eliminate stress from our lives, it is known that stress reduction techniques help to diminish the negative consequences of stress. This study was designed to answer the following question How much change in perceived stress is obtained through weekly Restorative Yoga sessions? Study population were members of the HFA Addiction Medicine Clinic. All staff completed the Spielberger Job Stress Survey and the State-Trait Anxiety Inventory at baseline and at six months following intervention onset. Volunteers from the Addiction Medicine Clinic attended weekly restorative yoga sessions 45 minutes in length held over the noon hour. Serial State-Trait Anxiety Inventory and weekly questionnaire regarding the perceived effects of the restorative yoga on aspects fo patient care were completed by study volunteers.

Official Title
-----------------
Restorative Yoga for Stress Management

Conditions
-----------------
Stress, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Restorative Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: member of HFA Addiction Medicine Clinic staff willing to participate in the restorative yoga sessions and to complete study instruments Exclusion Criteria: unwilling to participate in the restorative ygoa sessions (assigned then to the control group)

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Restorative Yoga|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measurement were the Spielberger State-Trait Anxiety Inventory scores. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary measurements were : |  |  | 
| -number of sessions attended |  |  | 
| -results of restorative yoga questionnaire on patient care and stress levels |  |  | 
| -results of Job Stress Survey |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress, Yoga
Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study

Study Overview
=================
Brief Summary
-----------------
Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures.

Official Title
-----------------
A Pilot Study Examining the Efficacy of Keppra in Acute Alcohol Related Seizure Control in the Emergency Department Setting

Conditions
-----------------
Seizure, Alcohol Related

Intervention / Treatment
-----------------
* Drug: levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No trauma Not pregnant No other cause for seizure (hypoglycemia, CNS causes, trauma) Good family support Working telephone contact Exclusion Criteria: Pregnancy Renal failure (creatine > 2mg/dl Fever or illness Hypotension Any trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: 1<br> | Drug: levetiracetam<br>* 2 gram iv load, 500mg bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased seizures |  | 1, 2, 4, 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol seizure
INR Comparison Testing in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The investigator is testing blood samples to compare the results of two different techniques. Since blood loss and the need for blood transfusions continue to be major problems after heart surgery and other types of surgery, the blood clotting levels are constantly checked during heart surgery as part of clinical care.The purpose of this study is to compare the INR levels in blood before and after the heart bypass during surgery.

Official Title
-----------------
Comparison of INR Determined by Point-of-Care to Standard Laboratory Testing Before and After Reversal of Heparin in Cardiac Surgery

Conditions
-----------------
Coagulation Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: International Normal Ratio (INR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients greater than or equal to 18 years of age. Patients undergoing elective surgery. Patients undergoing cardiac surgery. Patients to undergo general anesthesia with endotracheal intubation. Patients with well-controlled health disorders. Exclusion Criteria: Patients currently on Coumadin or other anticoagulants; including, direct thrombin inhibitors and direct Xa inhibitors. Patients who are under 18 years of age or pregnant. Patients undergoing emergency surgery. Patients with known coagulation disorders. Patients who are unable to provide informed consent in the form of a signature

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 |
| --- | --- |
| Heart surgery<br>Patients undergoing heart surgery will have blood samples tested for INR values | Diagnostic Test: International Normal Ratio (INR)<br>* Blood test for INR using laboratory and point of care methods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in correlation between laboratory and point of care INR | Pearson's Coefficient | Baseline, Within ten minutes of completion of bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in agreement between laboratory and point of care INR | Bland-Altman plots | Baseline, Within ten minutes of completion of bypass | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bleeding, heart surgery, coagulation, coagulopathy, INR
Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography

Study Overview
=================
Brief Summary
-----------------
This study will look at the way activity within the brain changes over time while a person is trying to think about certain everyday concepts. To measure brain activity accurately, we will be using electrodes placed on people's brains during awake brain surgery.

Detailed Description
-----------------
This study will measure the dynamics of cortical activity among early modal cortex and multimodal cortical regions during conceptual retrieval using electrocorticography. Participants will be patients undergoing awake temporal lobe craniotomies. During the surgery patients will have multiple high-density grids placed to simultaneously record activity in multiple areas while the patient is performing language tasks. Activity in each of these regions will be tested for timing differences and informational directionality to determine the temporal dynamics.

Official Title
-----------------
Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography

Conditions
-----------------
Aphasia

Intervention / Treatment
-----------------
* Behavioral: Concepts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically determined to require an awake left temporal resection of a brain lesion with concurrent language testing. English as a first language. Exclusion Criteria: Significant preoperative neuropsychological deficits in memory or naming. Patients with inability to make decisions regarding their participation in this research project. Surgeon does not plan to expose the area of interest or determines that recording during the resection will interfere with his surgical plan.

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: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Present a behavioral intervention to a single group of participants and measure subsequent electrical activity in the brain.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concept Retrieval<br>Patients will be given behavioral intervention, and their brain activity recorded. | Behavioral: Concepts<br>* Images and sounds that are characteristic of various common objects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity | Electrocorticographic brain activity measured from brain surface | Recorded immediately during experiment |