linjc16/ctgov huggingface dataset:
Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.

Official Title
-----------------
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1005273 in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BI 1005273 s.c.
* Drug: BI 105273 i.v. Placebo
* Drug: BI 1005273 s.c. Placebo
* Drug: BI 1005273 i.v.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1. Healthy male subjects Exclusion criteria: 1. Any deviation from healthy conditions

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 1005273 i.v.<br>single dose i.v. infusion | Drug: BI 1005273 i.v.<br>* infusion<br>|
| Placebo Comparator: BI 1005273 i.v. Placebo<br>single dose i.v. infusion (Placebo) | Drug: BI 105273 i.v. Placebo<br>* infusion<br>|
| Experimental: BI 1005273 s.c.<br>single dose s.c. injection | Drug: BI 1005273 s.c.<br>* injection<br>|
| Placebo Comparator: BI 1005273 s.c. Placebo<br>single dose s.c. injection (Placebo) | Drug: BI 1005273 s.c. Placebo<br>* injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number (% subjects) with drug-related AEs. |  | day -21 to day 95 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | day 1 to day 90 | 
| AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | day 1 to day 90 | 
| AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose) |  | day 1 to day 90 |
The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the randomized blind research of the assessment of the different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during cardiac surgery, the investigators would like to know if the glycemia levels in clondine group will be lower than placebo group.

Official Title
-----------------
The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass.

Conditions
-----------------
Glycemia During Coronary Artery Bypass Graft, Sedation During Pre-anesthetic Medication

Intervention / Treatment
-----------------
* Drug: Clonidine
* Drug: Ringer lactato


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective CABG EF > 40% Sinus ritmy Exclusion Criteria: precordialgia emergency surgery combinated surgery not agreement

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clonidine<br>clonidine 2 mg/kg IV | Drug: Clonidine<br>* bolus, clonidine 2 mg/kg IV<br>|
| Placebo Comparator: ringer lactato 1 ml<br>Ringer lactato 1 ml IV as Placebo | Drug: Ringer lactato<br>* 1 ML ringer lactato IV, as placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation | Clonidine 2 mg/kg IV. assessment sedation with Ransay scale | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemia | clonide 2 mg/kg. assessment the glycemia during CPB. | 2 years |
South American Thoracic Stent-Graft Study

Study Overview
=================
Brief Summary
-----------------
A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).

Official Title
-----------------
A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System

Conditions
-----------------
Thoracic Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Implant Thoracic Stent Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The TriVascular Thoracic Stent Graft System is indicated in subjects diagnosed with an aneurysm in the descending thoracic aorta having vascular morphology suitable for endovascular repair, including: Adequate iliac/femoral access compatible with the required delivery systems, Non-aneurysmal aortic segments proximal and distal to the aneurysm.

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: Thoracic Stent Graft<br>Thoracic Stent Graft implanted device | Device: Implant Thoracic Stent Graft<br>* Endovascular implant of Thoracic Aortic Aneurysm Stent Graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of device-related serious adverse events within 30-days of endovascular procedure |  | 30-Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thoracic, aortic, aneurysm, TAA
Can Psychotherapy Reduce Sickness Absence?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine if psychotherapy can reduce sickness absence.

Detailed Description
-----------------
Sickness absence due to psychiatric problems is considered a growing problem in Norway. Little research is done to examine if psychotherapy can reduce sickness absence. Since 2007 there is a government sponsored program in Norway (Raskere tilbake) aimed at reducing sickness absence. This study examines if psychotherapy within this program, delivered at an out-patient clinic, actually reduces sickness absence. Levels of absenteeism is measured before, after and 6 months after treatment. This is a quasi-experimental study, where the treatment-group will be compared with a statistical group in the general population, that is socio-demographical similar and has similar history of sickness absence but haven't been to treatment. Changes in levels of symptoms and quality of life will also be measured. The participants will be asked to describe their working environment, and this will be related to outcome-measures.

Official Title
-----------------
Can Psychotherapy Reduce Sickness Absence?

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving psychotherapy at Lovisenberg DPS/Raskere Tilbake 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: Psychotherapy<br>Short-term pychotherapy and/or psychoeduchative courses. | Behavioral: Psychotherapy<br>* Standard psychotherapy for psychiatric disorders.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sickness absence | Present status (working or sick). | Before, after and 6 months after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric symptoms | CORE-OM. | Before, after and 6 months after treatment. | 
| Quality of life (QALY) | 15 D | Before, after and 6 months after treatment. |
Noninvasive Cochlear Stimulation System

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to develop a portable wearable hardware headset using a computer-based software that can establish the optimal stimulation parameters appropriate for medical and consumer environments for individuals with hearing impaired and normal hearing individuals.

Official Title
-----------------
Noninvasive Cochlear Stimulation System

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Cochlear Stimulation System (CSS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Employee of Mayo Clinic. Exclusion Criteria: Pregnant. Cochlear implants. History of fluctuating sensorineural hearing loss. Skin diseases of the head. History of acute paroxysmal tachycardia. History of trigeminal neuralgia. Recent of paralysis of the facial nerve. Recent cerebrovascular stroke.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal hearing subjects<br>Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system. | Device: Cochlear Stimulation System (CSS)<br>* Cochlear stimulation with surround sound and noise cancellation<br>|
| Experimental: Bilateral hearing impaired<br>Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system. | Device: Cochlear Stimulation System (CSS)<br>* Cochlear stimulation with surround sound and noise cancellation<br>|
| Experimental: Asymmetrical hearing-impaired<br>Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system. | Device: Cochlear Stimulation System (CSS)<br>* Cochlear stimulation with surround sound and noise cancellation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception threshold | Evaluated by increasing the amplitude of the current input until the subject can hear a tone. The threshold will be recorded as the perception threshold at that electrode pair and frequency. Reported in hertz (Hz). | Baseline, approximately 2 hours | 
| Speech Intelligibility | Measured using the modified rhyme test (MRT) consisting of a set of 50 six-item wordlist. Each word list contains single syllable words with a consonant-vowel-consonant sound sequence. | Baseline, approximately 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal hearing
MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS). Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.

Official Title
-----------------
A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test

Conditions
-----------------
Pregnant Women, Prenatal Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Clinically confirmed viable pregnancy at the time of enrollment Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators Able to provide consent for participation using language appropriate forms and consent process Exclusion Criteria: - Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chromosomal Abnormality<br>Fetus affected by chromosomal abnormality | |
| No Chromosomal Abnormality<br>Fetus not affected by chromosomal abnormality | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. |  | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trisomy 21
The Effect of a Single Bout of Balance and Coordination Exercise on Cognitive Function in Elderly People

Study Overview
=================
Brief Summary
-----------------
Individuals of advanced age are at higher risk of cognitive deterioration.A single bout of aerobic exercise was found to improve cognitive functions. The aim of this study is to explore the effect of a single bout of balance and coordination exercise versus aerobic exercise on cognitive functions among elderly people.

Official Title
-----------------
The Effect of a Single Bout of Aerobic Exercise Versus a Single Bout of Balance and Coordination Exercise on Cognitive Function in Elderly People

Conditions
-----------------
Aging, Cognitive Decline

Intervention / Treatment
-----------------
* Behavioral: Aerobic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to undergo physical activity for 60 minutes Participates in a physical activity center at least twice a week Exclusion Criteria: Scores beneath 24 on MMSE Unable to sign a consent form

Ages Eligible for Study
-----------------
Minimum 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Type of intervention<br>A single bout of aerobic exercise, or a single bout of balance and coordination exercise, or reading a magazine | Behavioral: Aerobic exercise<br>* 30 minutes of either aerobic, or balance and coordination, or reading magazines<br>* Other names: Control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function - Attention | This cognitive domain will be based on scores of two tests: Go-NoGo test and the Stroop test, which will be performed by the use of NeuroTrax (NeuroTrax Corp., Israel) computerized battery that utilizes novel adaptations of traditional neuropsychological tests. In order to assess attention the mean reaction times (RTs) for the Go-NoGo test and the no-interference (meaning) phase of the Stroop test, and mean SD of RT for the Go-NoGo test will be calculated. | Each cognitive test will be performed immediately following the intervention | 
| Cognitive function - Executive functions | This cognitive domain will be based on scores of three tests: Go-NoGo test, Catch game and the Stroop test, which will be performed by the use of NeuroTrax (NeuroTrax Corp., Israel) computerized battery that utilizes novel adaptations of traditional neuropsychological tests. In order to assess executive function Performance indices for the Stroop test and the Go-NoGo test, and mean accuracy for the Catch Game will be calculated. | Each cognitive test will be performed immediately following the intervention |
Colloid Osmotic Pressure in Patients With Fontan Circulation

Study Overview
=================
Brief Summary
-----------------
Children born with univentricular heart will go through step surgery and end up with a Fontan circulation. A circulation with cause problems with body fluid balance.This project will evaluate changes in interstitial colloid osmotic pressure in patients 10 year after completion of a three step Fontan surgery. This project will evaluate whether increased micro vascular leakage and change in interstitial colloid osmotic pressure are present in patients after ten years with a Fontan circulation.

Official Title
-----------------
Interstitial Colloid Osmotic Pressure in Children With Fontan Circulation After Fontan Surgery

Conditions
-----------------
Heart Defects, Congenital

Intervention / Treatment
-----------------
* Other: Catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fontan circulation after completed Fontan surgery. Anesthesia during catheterization. Exclusion Criteria: No consent

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Catheterization|Routine catheterization during follow up.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial colloid osmotic pressure |  | Ten years after completed Fontan surgery |
Effects the Glycemic Index on Metabolic Risk Markers

Study Overview
=================
Brief Summary
-----------------
Recent population studies have shown that the glycemic index (GI) of food products is positively associated with the risk of developing type 2 diabetes and cardiovascular disease (CVD). In the pathogenesis of type 2 diabetes and CVD, inflammatory processes play a pivotal role. In a previous intervention study (11 weeks), however, we found no effects of lower-GI vs. higher-GI diets on fasting inflammatory markers in subjects with increased risk of developing the metabolic syndrome. People, however, spent most of their time in the postprandial period. Therefore, there is a need to study the postprandial effects of low-GI vs. high-GI diets. In addition, it needs to be emphasized the GI is derived from studies in lean subjects, while especially overweight and obese people suffer from metabolic aberrations related to the development of type 2 diabetes and CVD. AIM: To investigate in obese subjects the postprandial effects of a low-GI vs. high-GI food product on metabolic risk markers. A second research objective is to compare these effects with those in lean subjects.

Official Title
-----------------
Postprandial Effects of a Low vs. a High Glycemic Index Food Product on Metabolic Risk Markers in Lean and Obese Subjects

Conditions
-----------------
Metabolic Syndrome X

Intervention / Treatment
-----------------
* Dietary Supplement: Low GI+high GI
* Dietary Supplement: High GI+low GI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy and obese men Exclusion Criteria: smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br>Consumption of low GI food product on day 1 Consumption of high GI food product on day 2 | Dietary Supplement: Low GI+high GI<br>* Consumption of low GI food product on day 1 Consumption of high GI food product on day 2<br>|
| Experimental: A2<br>Consumption of high GI food product on day 1 Consumption of low GI food product on day 2 | Dietary Supplement: High GI+low GI<br>* Consumption of high GI food product on day 1 Consumption of low GI food product on day 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation markers |  | postprandial effect | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose response |  | postprandial |