linjc16/ctgov huggingface dataset:
Patient Reported Outcome Instruments in Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.

Official Title
-----------------
Clinical Studies Network Research Trial: Development of an On-Line Sarcoidosis Assessment Platform (OSAP) to Validate Sarcoidosis Phenotypes and Monitor Disease Burden Longitudinally

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Diagnostic Test: Quality of Life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sarcoidosis by established criteria. Patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit. Ability to understand and read English at least at a 7th grade level. Have access to a computer, iPad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform. The subject is willing to wear a daily activity and sleep tracker wristband (Fitbit ™ wristband) for 6 months. Exclusion Criteria: • Life expectancy of < 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Sarcoidosis<br>Patients with sarcoidosis willing to participate | Diagnostic Test: Quality of Life<br>* Quality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT)<br>* Other names: Pulmonary function testing;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSQ | Change in KSQ | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAT | Change in SAT | 6 Months | 
| Visual Analog Scale (VAS) | Change in VAS | 6 Months | 
| Forced Vital Capacity (FVC) | Change in FVC percent predicted | 6 months |
Somatosensory Evoked Potential Algorithm for Detection of Intraoperative Positional Neuropraxia

Study Overview
=================
Brief Summary
-----------------
This study hypothesizes that an automated device using small electronic impulses can detect nerve impairment in unconscious patients.

Detailed Description
-----------------
Application of SSEP probes to bilateral ulnar and popliteal nerve areas with sensors at (1) bilateral brachial plexus (clavicles), (2) Erb's point (posterior C8 cervical spine) and (3) on forehead will permit microvolt current to to be detected and analyzed against a proprietary algorithm. Neuropraxia will be detected based on abnormalities developing in received SSEP signals.

Official Title
-----------------
A Feasibility Study of Integrated SSEP and Detection Algorithm for Detection of Intraoperative Positional Neuropraxia

Conditions
-----------------
Neuropraxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery Exclusion Criteria: neuromuscular disease stroke

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Neuropraxia | Correlation between postoperative neuropraxia and intraoperative alert of impaired neural transmission detected via EPAD | postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SSEP, neuropraxia, intraoperative, automated
Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound

Study Overview
=================
Brief Summary
-----------------
Transoesophageal ultrasound examination before and after prone position.

Detailed Description
-----------------
Patients undergoing spinal surgery in the prone position are anaesthetized and then an ultrasound probe is placed in the oesophagus and the heart physiology is examined. Following prone position the examination is repeated.

Official Title
-----------------
Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound

Conditions
-----------------
Obesity, Spinal Surgery, Anaesthesia, Changes in Left and Right Ventricle Dimension, Changes in Bloodflow Across Cardiac Valves, Changes in Dimensions of Inferior Caval Dimension and Hepatic Venous Bloodflow, Changes i Myocardial Velocities, Changes in Diastolic Function

Intervention / Treatment
-----------------
* Other: Change from supine to prone position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients scheduled for spinal surgery in the prone position. Body mass index above 30. Exclusion Criteria: significant cardiomyopathy or valvular disease heart rhythm other than normal sinus rhythm coagulopathy increased risk of oesophageal injury during probe insertion

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Supine position<br>Examination in the supine position | |
| Prone position<br>Change from supine to prone position | Other: Change from supine to prone position<br>* Change from supine to prone position<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End systolic and diastolic dimension of the left and right ventricle. | Studied after induction of anaesthesia, before and after the patient is placed in the prone position. | The day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left and rigth ventricle eccentricity index. |  | The day of surgery |
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets under non-fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)
* Drug: Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)
* Drug: Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc) | Drug: Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)<br> <br> |
| Experimental: 2<br>Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc) | Drug: Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)<br> <br> |
| Active Comparator: 3<br>Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) | Drug: Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 31 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-inflammatory
MultipOlar Left Ventricular Electrode Instability Trial

Study Overview
=================
Brief Summary
-----------------
Characterization of pacing thresholds in available pacing vectors of quadripolar leads used for cardiac resynchronization therapy in a short term follow-up.

Detailed Description
-----------------
Multipolar left ventricular leads are increasingly used in cardiac resynchronization therapy. Lead dislodgment requiring re-intervention is rare. However, data on minor lead movements which may affect pacing capabilities and application of new pacing algorithms is scarce. Aim of the study is to characterize pacing thresholds of each of the implanted electrodes on quadripolar leads in a short term follow-up.

Official Title
-----------------
Multipolar Left Ventricular Electrode Instability Trial

Conditions
-----------------
Pacemaker Electrode Lead Displacement

Intervention / Treatment
-----------------
* Device: Multipolar left ventricular lead implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo implantation of left ventricular multipolar leads. Exclusion Criteria: Cardiogenic shock Device infection Revision for previously dislodged left ventricular lead Age below 18 years Pregnancy Patients under tutelage

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recipients of cardiac resynchronization therapy<br>Consecutive patients with de novo implantation of a cardiac resynchronization defibrillator or pacemaker. | Device: Multipolar left ventricular lead implantation<br>* Multipolar left ventricular lead implantation with measurements of pacing thresholds in varrious pacing configurations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microdislodgement of leads | Change of pacing threshold | 3 months |
Anogenital Wart Burden and Cost of Illnesses

Study Overview
=================
Brief Summary
-----------------
The study will be a prospective study of patients presenting with anogenital warts. The objective are to assess proportion of anogenital warts to the total number of sexual transmitted infection patients, to quantify direct and indirect cost of illnesses and psychological burden associated with anogenital warts and to estimate government program expenditure for the prevention and control and treatment of the STI/anogenital HPV infection.

Detailed Description
-----------------
An observational study, multiple visit, 2-center study will be conducted in Rajavithi General Hospital, and Bangrak Hospital. One hundred and fifty subjects will be enrolled from both hospitals. Anogenital wart patients presented in Rajavithi General Hospital and the STI clinic at Bangrak Hospital will be recruited prospectively. All patients will be treated according to standard medical guidelines or usual care of the institutes. After the baseline assessment, the patients will have follow up visits with their physicians and will also be interviewed at the clinical sites three time approximately at day 7 (-2+7 days), month 1 (+-7 days), and month 6 (+-7 days) until they are cure. At month 6 (+-14 days), telephone assessment for the capture of any signs of disease recurrence will be done. All patients will be followed for 6 months under the same schedule.

Official Title
-----------------
Measurement of Anogenital Wart Burden, and Cost of Illnesses in Bangkok

Conditions
-----------------
Warts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years of age or older and has anogenital warts Physician confirmed clinical diagnosis of anogenital warts Subject is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent Subject will be available for the study follow up period Exclusion Criteria: Subject is unable to give informed consent Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives such as other concurrent/active STI

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Observation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Exercise on Muscle Proteome Signature

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate skeletal muscle proteome signature changes induced by exercise training in young men

Detailed Description
-----------------
Advances in omics technologies have allowed for the identification of biomarkers with importance for the beneficial adaptations imposed by exercise training. Skeletal muscle exhibits remarkable plasticity to exercise training, as illustrated by pronounced alterations to the proteomic landscape, such as mitochondrial biogenesis. However, despite recent advances that have helped describe the proteomic landscape in response to a period of exercise training, our understanding of the processes pertaining to post-translation modification is scant. In this study, we aim to investigate the human acetylome and proteome in response to exercise training.

Official Title
-----------------
Effect of Exercise Training on Skeletal Muscle Proteome Signature of Young Men

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

Intervention / Treatment
-----------------
* Other: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy VO2max of 45-55 ml/kg/min (+/- SD) / 3000-4000 ml/min (+/- SD) Body mass index (BMI) of 19-26 kg/m2 Normal ECG (electrocardiography) Exclusion Criteria: Serious adverse effects to exercise Chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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 |
| --- | --- |
| Experimental: Exercise<br>12-15 training sessions of 30 min over 4-5 weeks | Other: exercise training<br>* subjects complete 4-5 weeks of training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle proteome signature | proteomics | Change from baseline proteome signature at 5 weeks |
Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Primary objective: - To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD). Secondary objective: - To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD.

Official Title
-----------------
A Fifty-Two-Week Multicenter, Open-Label, Study Evaluating the Long-Term Safety and Tolerability of SR58611A 350 mg q12 in Patients With Major Depressive Disorder.

Conditions
-----------------
Major Depressive Disorders

Intervention / Treatment
-----------------
* Drug: amibegron (SR58611A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of > 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: amibegron (SR58611A)<br>* oral administration of 300 mg twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists |  | 54 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 17-item Hamilton Depression rating Scale, Clinical Global Impression, Sheehan Disability Scale, Qol Enjoyment and satisfaction Questionnaire - Short Form,Medical Outcomes Study Short Form, Endicott Work Productivity Scale. |  | 54 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression
Omega-3 Supplementation and Attention-deficit-hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end assessments will include ADHD-related questionnaires and a computerized test. The investigators hypothesize that ALA supplementation will prove beneficial for children with ADHD.

Official Title
-----------------
The Effect of Omega-3 Fatty Acid Supplementation on Behavior of Children With ADHD

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: omega-3 fatty acid alpha-linolenic acid (ALA)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD diagnosis informed consent Exclusion Criteria: refusal of any testing any comorbidities any medication or supplement use

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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 |
| --- | --- |
| Experimental: ALA<br>This group will receive the ALA supplement | Dietary Supplement: omega-3 fatty acid alpha-linolenic acid (ALA)<br>* 3 grams of ALA-containing plant oil<br>|
| Placebo Comparator: Placebo<br>This group will receive the placebo supplement | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD symptoms | scores of DSM and Conners questionnaires | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computerized test performance | performance in a computerized test of attention | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, methylphenidate, omega-3