linjc16/ctgov huggingface dataset:
Evaluation of Physiological and Vocal Parameters in Volunteers of Both Genders Submitted to an Anxiogenic Task

Study Overview
=================
Brief Summary
-----------------
Objective: To assess whether the anxiety caused by a task considered anxiogenic, Simulated Public Speaking (SPS) test, would change the responses of healthy individuals regarding physiological and vocal parameters. Method: The sample comprised 30 participants of both genders, 19-42 years old, with no history of psychiatric disorders. The score in the STAI-Trait enabled investigators to assign participants to two groups: LOW ANXIETY (LA) and HIGH ANXIETY (HA). The investigators evaluated physiological parameters (heart rate, skin conductance, temperature in the extremities, electromyogram of the frontal muscle and salivary cortisol) and vocal parameters (vocal self-evaluation, quality of life in voice and vocal symptoms and signs) BEFORE, DURING and AFTER the SPS.

Official Title
-----------------
Psychophysiological and Vocal Affections in Subjects Submitted to a Public Speaking Mock Test

Conditions
-----------------
Anxiety, Communication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 45 years Volunteers with no psychiatric history and diagnosis of vocal problem Have a minimum of the average school Exclusion Criteria: Chronic smokers Subjects with paralysis or neurological diseases Compromised upper airway at the time of the experiment User stimulants, psychotropic drugs, herbal medicines, tranquilizers, antidepressants Have drunk coffee or alcohol on the day of the experiment

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Anxiety (HA) group<br>13 participants of both genders, 19-42 years old, with no history of psychiatric disorders and scores above 41 in STAI-Trait | |
| Low Anxiety (LA) group<br>11 participants of both genders, 19-42 years old, with no history of psychiatric disorders and scores below 41 in STAI-Trait | |

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
-----------------
Behavior, Anxiety, Communication, Voice
VENUS: Septic Gene Expression Using SeptiCyte

Study Overview
=================
Brief Summary
-----------------
The investigators seek to evaluate a new test for determining presence of infection/sepsis as compared to non-infection/systemic inflammatory response syndrome among critically ill patients within the first 24 hours of their being hospitalized in an intensive care unit (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2) existing clinical parameters. The investigators also hope to assess how well a related, new blood test, SeptID® identifies different types of infection, as compared to cultures and other lab tests.

Official Title
-----------------
VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®

Conditions
-----------------
Sepsis, Systemic Inflammatory Response Syndrome (SIRS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-89 years old on the day of ICU admission SIRS present as defined by the presence of two or more of the following: Temperature > 38°C or < 36°C Heart Rate > 90 beat/min Tachypnea > 20/min or PaCO2 < 32 mmHg White Blood Cell count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands) Exclusion Criteria: Consent not provided Age less than 18 or greater than 89 years old on the day of ICU admission Not admitted to ICU Clinical cultures or serologies not obtained Subject has been admitted to study hospital (or transferring facility) for ≥ 24 hours Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours. Patients on non-prophylactic antibiotics for more than 24 hours prior to ICU admission Delay of >24 hours between trial enrollment and sample draw time Ethnic/racial category has completed enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Critically ill patients sepsis suspected<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SeptiCyte® Lab score |  | Subjects will be followed for the duration of their hospital stay, an expected average of 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of SeptiCyte® Lab score to Leukocytosis, Bandemia, & procalcitonin |  | Subjects will be followed for the duration of their hospital stay, an expected average of 7 days. |
Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty

Study Overview
=================
Brief Summary
-----------------
This study evaluates a novel noninvasive method to dynamically monitor the effect of percutaneous transluminal angioplasty on arterial pulse wave

Detailed Description
-----------------
Patients with stenosis of superficial femoral artery referred for percutaneous transluminal angioplasty are monitored before, during and after the procedure and pulse wave analysis is conducted.

Official Title
-----------------
Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: Noninvasive pulse wave analysis sensor, ECG-sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has been clinically examined at policlinic of vascular surgery The patient has undergone measurement of ankle-brachial index (ABI) and toe-brachial index (TBI) at policlinic of vascular surgery and exhibits abnormal ABI<0.9 or ABI>1.3 The patient is considered to have an indication for vascular procedure (critical limb ischemia, intermittent claudication) The patient has been examined with magnetic resonance imaging (MRA) The patient has been considered a candidate for superficial femoral artery percutaneous transluminal balloon angioplasty (PTA) and/or stenting Exclusion Criteria: Pacemaker Measurement disturbs or risks the subject's treatment process Withdrawal: Emergency cases By subject's denial Inability to detect signals -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Noninvasive pulse wave analysis sensor, ECG-sensor|Noninvasive pulse wave sensors and ECG-sensors are attached|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave change from baseline during PTA |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave characteristics after PTA |  | 30 days |
Flicker App for Minimal Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients

Detailed Description
-----------------
SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in clinic supervised by a research assistant and calculate the level of agreement between the CFF determined by the Flicker-App, the CFF determined by the gold-standard FFS device, and the test scores on the EncephalApp Stroop test. SA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at home, including daily measurements over 1 week and weekly measurements over 6 weeks, and calculate the adherence to this protocol and the variability of these CFF measurements. SA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and simplify its self-administration by patients based on structured interview-questionnaires with the study participants and with clinical Gastroenterologists/Hepatologists

Official Title
-----------------
Evaluating a Novel, Self-administered Device (Flicker-App) That Measures Critical Flicker Frequency as a Test for Minimal Hepatic Encephalopathy in Cirrhosis

Conditions
-----------------
Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Diagnostic Test: Critical flicker frequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis (standard criteria) Chronic liver disease Exclusion Criteria: Grade III or IV hepatic encephalopathy Mini-mental state examination score ≤25 (suggestive of dementia) alcohol or illicit drug use within 3 months current use of benzodiazepines antiepileptics or psychotropic drugs color blindness severe vision impairment (blindness, macular degeneration).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Critical flicker frequency|Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CFF Agreement | Level of agreement between Flicker App CFF and gold-standard device | 1 day |
MRIPositive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence on a 1.5 Tesla

Study Overview
=================
Brief Summary
-----------------
Our objective is to allow positive MRI diagnosis of vestibular neuritis by highlighting contrast enhancement of the vestibular nerve on the pathological side of the FLAIR sequence acquired 1h after intravenous gadolinium injection in patients with typical vestibular neuritis. At present, the diagnosis is based on a combination clinical examination / video-head impulse test, and no imaging examination allows the diagnosis to be positive.

Official Title
-----------------
Positive Diagnosis of Vestibular Neuritis Using Fluid Attenuated Inversion Recuperation (FLAIR) Sequence, One Hour After Intravenous Gadolinium Injection, on a 1.5 Tesla

Conditions
-----------------
Vestibular Neuritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years Presence of a typical unilateral vestibular neuritis during the ENT examination with videonystagmography Subject having his agreement for the use of his medical data for research purposes. Exclusion Criteria: Special clinical forms of the disease: doubtful or atypical forms, especially the presence of deafness Treatments and related interfering diseases, antecedents: antecedents of neuritis for controls, presence of vertigo, bilateral involvement Impossibility to give the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...) Subject under the protection of justice Subject under guardianship or curatorship

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of vestibular neuritis |  | one hour after intravenous gadolinium injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vestibular neuritis, Magnetic resonance imaging (MRI), Vertigo, Fluid attenuated inversion recuperation (FLAIR)
Effect of Exercise Programs on 3-dimensional Scapular Kinematics, Disability and Pain

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effect of exercise program on 3-dimensional scapular kinematics, disability and pain on shoulder impingement with scapular dyskinesia.

Official Title
-----------------
Effect of Exercise Programs on 3-dimensional Scapular Kinematics, Disability and Pain in Subjects With Shoulder Impingement

Conditions
-----------------
Shoulder Impingement Syndrome

Intervention / Treatment
-----------------
* Other: Kinetic Chain Exercises
* Other: Traditional Exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subacromial impingement with scapular dyskinesia Exclusion Criteria: Additional muscular and skeletal or systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Kinetic Chain Exercises | Other: Kinetic Chain Exercises<br>* Exercises include kinetic chain segments.<br>|
| Active Comparator: Group B<br>Traditional Exercises | Other: Traditional Exercises<br>* Stretching, strengthening exercises.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-Dimensional Scapular Kinematics measured by electromagnetic tracking system | Scapular rotations and orientations in degrees | Change from Baseline in Angular Data at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Disability Status measured by Shoulder Pain and Disability Index (SPADI) | Scoring with patient-reported outcome measure | Change from Baseline in Scor at 1 year | 
| Pain Severity measured by Visual Analogue Scale (in millimeters) | Scale is in millimeters | Change from Baseline in Pain Severity at 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Kinematics
The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years

Study Overview
=================
Brief Summary
-----------------
It is well-known that preterm delivery can be accompanied by complications. One of these complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes, including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim of this study is to determine whether they do have any neurodevelopmental outcomes.

Conditions
-----------------
Premature Infants

Intervention / Treatment
-----------------
* Other: Telephone interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All preterm infants born at 35 weeks or less Underwent at least 1 brain ultrasound Diagnosed with IVH Grades 1-2 Had no other severe illness in NICU Had neurodevelopmental follow-up Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 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 |
| --- | --- |
| Preterm infants with IVH Grades I-II<br>Preterm infants (post-menstrual age 24-35 weeks) who were diagnosed with IVH Grades 1-2 in the neonatal intensive care unit (NICU). | Other: Telephone interview<br>* Subjects with incomplete data will be asked to complete a telephone interview<br>|
| Control Group<br>Preterm infants (post-menstrual age 24-35 weeks) who had no imaging evidence of IVH in the neonatal intensive care unit (NICU). | Other: Telephone interview<br>* Subjects with incomplete data will be asked to complete a telephone interview<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Neurodevelopmental Assessment | Retrospective study of preterm infants born in the years 2007-2011 and suffered IVH Grades 1-2 who have undergone a general neurodevelopmental assessment in the Institute for Child Development in Hillel Yaffe Medical Center at ages 1-7. This assessment will indicate whether IVH Grades 1-2 has any neurodevelopmental effect on these children. | Seven years |
Bimatoprost Monotherapy vs. Dual Therapy With Travoprost and Timolol in Patients With Glaucoma and Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03% monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of glaucoma or ocular hypertension.

Official Title
-----------------
Comparison of Bimatoprost 0.03% Monotherapy vs. Dual Therapy With Travoprost 0.004% and Timolol 0.5% in Patients With Glaucoma and Ocular Hypertension

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Bimatoprost 0.03%, Travoprost 0.004%, Timolol 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Male or female > 18 years of age Diagnosis of primary open-angle glaucoma or ocular hypertension Untreated IOP > 18 mm Hg in each eye at the baseline evaluation Ability to provide informed consent and likely to complete all study visits Exclusion Criteria: · Known contraindication to bimatoprost, travoprost, timolol, or any component of any study medication Uncontrolled systemic disease Active ocular disease other than POAG or ocular hypertension Required use of ocular medications other than the study medications during the study (intermittent use of OTC artificial tear products will be permitted) History of intraocular surgery within the last 3 months Patient must not have discontinued use of any medication included in this study in the past for reasons of efficacy or intolerance

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bimatoprost 0.03%, Travoprost 0.004%, Timolol 0.5%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Evaluating ERB-041 in Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: ERB-041


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months, Eligible subjects must have adequate hematologic, renal, and hepatic function. Other inclusions apply Exclusion Criteria: Use of the following medications within the specified time period before randomization is prohibited: Within 48 hours before randomization Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization Herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components). Other exclusions applies

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ERB-041|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory serum markers |  |  | 
| Pharmacogenomics |  |  | 
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crohn's Disease Activity Index (CDAI) scores. |  |  | 
| Cell surface markers |  |  | 
| Fecal markers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, Inflammation