linjc16/ctgov huggingface dataset:
Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

Study Overview
=================
Brief Summary
-----------------
In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.

Detailed Description
-----------------
Results of studies with animal tumor models and human clinical trials suggest that the essential nutrient selenium can be anti-tumorigenic if consumed at levels greater than nutritional requirements. If it is possible to increase plasma selenium concentrations above 120 nanograms per milliliter with less than 200 micrograms of selenium daily, then it is possible that supplementation can be accomplished through the use of selenium-containing foods.

Official Title
-----------------
Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels

Conditions
-----------------
Nutritional Requirements

Intervention / Treatment
-----------------
* Dietary Supplement: placebo
* Dietary Supplement: selenium as L-selenomethionine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to swallow capsules body mass index less than 40 Exclusion Criteria: Pregnancy Chronic liver or kidney disease taking medication that might affect liver and/or kidney blood pressure 140/90 or higher already taking more than 50 micrograms of selenium

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Capsule contains no selenium | Dietary Supplement: placebo<br>* daily placebo capsules for 12 months<br>|
| Active Comparator: Selenium as L-selenomethionine<br>50, 100, or 200 micrograms of selenium | Dietary Supplement: selenium as L-selenomethionine<br>* daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations |  | Baseline, and after 3, 6, 9, and 12 months of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of selenium status will be determined in urine, buccal cells, and plasma. White blood cells will be analyzed to identify DNA damage, reflecting the degree of oxidative damage and evaluate the status of antioxidant repair mechanisms. |  | Baseline and after 12 months of supplementation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
selenium
Study of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Pegaptanib Sodium in Patients With Exudative Age-Related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to characterize the safety, tolerability and pharmacokinetics of pegaptanib when given as 1 or 3mg/eye intravitreous injections every 6 weeks for 54 weeks in patients with subfoveal choroidal neovascularization (CNV) secondary to AMD.

Official Title
-----------------
A Randomized, Double-Masked, Multi-Center Trial of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Intravitreal Injections of Pegaptanib Sodium (Anti-Vegf Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients With Exudative Age-Related Macular Degeneration (AMD)

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: pegaptanib sodium (Macugen)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye. Subfoveal CNV, secondary to AMD, w/ a total lesion size [including blood, scar/atrophy & neovascularization] of less than or equal to 12 disc areas, of which at least 50% must be active CNV. Patients of either sex, aged greater than or equal to 50 years. Exclusion Criteria: Previous subfoveal thermal laser therapy. Any subfoveal scarring or atrophy & no more than 25% of the total lesion size may be made up of scarring or atrophy. More than one prior PDT w/ Visudyne is not permitted. Pts may not have rec'd their 1st PDT w/in less than 8 wks or more than 13 wks prior to the BSL angiography/photography for the study.

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pegaptanib sodium (Macugen)|nan|

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
-----------------
AMD, Macugen, Pharmacokinetics, Age-Related Macular Degeneration, PK
ClinicCompanion. Compared to the Use of a Goniometer

Study Overview
=================
Brief Summary
-----------------
In this study, the goal is to find out if the clinicCompanion™ is effective in measuring range of motion when compared to the goniometer. Currently, the goniometer is an approved device to measure range of motion by the FDA, but the clinicCompanion™ is not.

Detailed Description
-----------------
The study procedure will test the range of motion of the subjects shoulders two different ways: using a goniometer and using the clinicCompanion™. Both tools are designed to measure the degree of movement subjects are able to do. Researchers will take 12 measurements on each arm for each device, for a total of 24 measurements per device. That is a total of 48 measurements for both devices.

Official Title
-----------------
A Study of Effectiveness of clinicCompanion. Compared to the Use of a Goniometer for Range of Motion Measurement.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new or established clinic patients from PI's medical practice at Aurora St. Luke's Medical Center 18 years of age and older Exclusion Criteria: no use of limbs amputees

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 |
| --- | --- | --- |
| Control cost and enhance accuracy of measurement | By freeing the doctor from data collection, he or she will be able to spend more time with patient discussing medical conditions and providing pertinent information | The goal is to recruit 75 subjects in 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ROM, rotation, shoulder, joint, abduction,, internal rotation,, external rotation,, flexion, normal, joint movement, physical examination
Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk test and the 3 minute step test, for COPD patients.

Detailed Description
-----------------
The 6 minute walk test (6MWT) is the best field test to determine oxygen desaturation during effort, in COPD patients. However, the test need a 30m corridor. The 3 minute step test (3MST) is a other field test used in COPD patients. But no study shows that 3MST can be used to determine oxygen desaturation. The aim of this study is to compare oxygen desaturation during these to tests : the 6MWT and the 3MST. 50 patients will be included in this study. Patients realize two 6MWT and two 3MST, with rest between each test. Oxygen saturation, heart rate are registered during the tests, dyspnea, leg peniblility are notified before and after each test, distance or number of steps are noted.

Official Title
-----------------
Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in Chronic Obstructive Pulmonary Disease Patients

Conditions
-----------------
COPD, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable COPD patients hospitalized for pulmonary rehabilitation program Exclusion Criteria: acute exacerbation of COPD incapacity to realize the tests absence of written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| oxygen saturation | oxygen saturation is compared between 6MWT and 3MST at the end of the 2 tests | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | heart rate is compared between 6MWT and 3MST at the end of the 2 tests | 3 minutes | 
| dyspnea (Borg Scale) | dyspnea (Borg Scale) is compared between 6MWT and 3MST at the end of the 2 tests | 3 minutes | 
| leg penibility (Borg Scale) | leg penibility (Borg Scale) is compared between 6MWT and 3MST at the end of the 2 tests | 3 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Pulmonary rehabilitation, Evaluation, oxygen desaturation, exercise capacity
Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to examine the immediate effect of positive-word stimuli on the limits of stability during multi-direction reach operation in standing position in healthy young adults.

Official Title
-----------------
Immediate Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position: A Randomized Controlled Superiority Trial

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

Intervention / Treatment
-----------------
* Device: Smartphone Application (SPSRS)
* Device: Smartphone Application (YouTube)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between 18 and 24 years of age Males and Females Exclusion Criteria: Person with physical disability that is enough to interfere with daily life

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone Application (SPSRS)<br>Participants watch motion picture using an application that displays positive-word stimuli. | Device: Smartphone Application (SPSRS)<br>* Participants use application on iPhone and watch videos showing positive-word stimuli. This application repeats positive-word stimuli every 5 seconds. The participants watch 3-minute motion picture displaying positive-word stimuli.<br>|
| Active Comparator: Smartphone Application (YouTube)<br>Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture. | Device: Smartphone Application (YouTube)<br>* Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-Directional Reach Test | The limits of stability during multi-direction reach operation in standing position | Baseline and immediately after the intervention protocol |
Reproducibility of Retinal Nerve Fiber Layer Thickness Measurements Using the Eye Tracker and Retest Function of Spectralis® SD-OCT in Glaucomatous Eyes and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
PURPOSE. To evaluate the impact of self-acting eyetracking and retest software on the reproducibility of retinal nerve fiber layer (RNFL) thickness measurements in glaucoma patients and healthy control subjects using Spectralis® SD-OCT. METHODS. RNFL thickness was measured in 56 normal and 47 glaucomatous eyes by one operator within one session with a brief rest between measurements. Three measurements were taken with the eye-tracker and retest function, and three were taken without this function, alternating between measurement methods. Trial with medical device

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

Intervention / Treatment
-----------------
* Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Visual acuity of more or equal to 0.5 Snellen, refractive error less than ±5.00 diopters (D) spheric and ±3.00 D cylindrical and no history of ocular trauma or of any other severe ocular disease (particularly diseases affecting the optic nerve or surgery other than uncomplicated cataract surgery). Additional inclusion criteria for the glaucoma group were a diagnosis of primary open angle glaucoma (POAG) or PEX-glaucoma. Exclusion criteria: Exclusion criteria for the control group were history of glaucoma or intraocular pressure beyond 21 mmHg and optic disc cupping of more than 0.6

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal nerve fiber layer thickness measurement |  |  |
Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam

Study Overview
=================
Brief Summary
-----------------
Phase IV, observational, post-authorization, cross sectional, open-label, multicenter study to evaluate the acceptability of oral solution of levetiracetam in patients with partial epilepsy as assessed by a questionnaire.

Official Title
-----------------
Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam (Keppra®) (SOLUCION Study)

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 16 years old or older diagnosed with partial epilepsy with or without generalization receiving levetiracetam oral solution for at least 28 days before the study Exclusion Criteria: Patients with disturbances of the sense of taste and smell that can interfere with the assessment of the parameters of the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|nan|

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
-----------------
Cross sectional study, acceptability, levetiracetam, oral solution, Keppra
Menstrual Cycle Symptom Tracking

Study Overview
=================
Brief Summary
-----------------
This study will provide menstrual cycle symptom information from women over the course of three menstrual cycles to determine whether there are any noticeable physiological changes that can be related to stage of the menstrual cycle or onset of menstruation.

Official Title
-----------------
Menstrual Cycle Symptom Tracking Study

Conditions
-----------------
Menstrual Cycles

Intervention / Treatment
-----------------
* Device: Clearblue Connected Ovulation Test System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Aged 18 years and over Regular menstrual cycles Owns a compatible smart phone i.e. iPhones® and AndroidTM phones equipped with Bluetooth® 4.0/BLE Willing to use their own smartphone for the duration of this study and to download and install the study app Willing to give informed consent Exclusion Criteria: Currently trying to conceive Currently or recently pregnant or breastfeeding Taking any treatment which may affect the menstrual cycle (e.g. contraceptive pill, fertility medications or hormone replacement therapy) Taking or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI) Has abnormal liver or kidney function Taking antibiotics containing tetracycline Taking clomiphene citrate or other ovulation induction drugs

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Clearblue Connected Ovulation Test System|Clearblue Connected Ovulation Test System which is a CE marked device used for tracking the menstrual cycle|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual Cycle Symptoms | The primary objective of this study is to collect information from women on their experience of menstrual cycle symptoms | 3 months |
Safety and Effectiveness of tPA in Intra-abdominal Abscesses

Study Overview
=================
Brief Summary
-----------------
To determine if instillation of tissue plasminogen activator into a percutaneously drained intra-abdominal abscess cavity results in faster resolution of the abscess compared to normal standard of care.

Detailed Description
-----------------
On day 0 Subjects will have Tissue Plasminogen Activator injected into a drainage tube and allowed to dwell in the intra-abdominal abscess for one hour before allowing it to drain by gravity. This will be repeated on day 1 and 2.

Official Title
-----------------
Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial

Conditions
-----------------
Abscess

Intervention / Treatment
-----------------
* Drug: Tissue Plasminogen Activator
* Other: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intrabdominal abscess Exclusion Criteria: Hypersensitivity to tPA Recent stroke Uncontrolled htn Recent major hemorrhage Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Tissue Plasminogen Activator<br>tPA administered by drainage tube into abscess, allowed to dwell for one hour and then drained into drainage bag. Dose of tPA administered to be determined by the volume of drainage immediately post drain insertion. This intervention is done on day 0, 1 and 2. | Drug: Tissue Plasminogen Activator<br>* The dosage of tPA is determined by the volume of drainage obtained when abscess is first drained. The same dose will be repeated on day 1 and 2.<br>* Other names: tPA;|
| Sham Comparator: Instillation of Normal Saline<br>Insertion of abdominal drainage tube to drain intra-abdominal abscess. Normal Saline administered immediately post drain insertion. Normal Saline (10 cc) allowed to dwell for one hour, then allowed to drain into drainage bag. | Other: Normal Saline<br>* Normal Saline will be used rather than Tissue Plasminogen Activator for the Sham arm.<br>* Other names: sham arm;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to eating |  |  | 
| time to discharge |  |  | 
| radiological evidence of resolution |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost comparison |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tissue plasminogen activator, intraabdominal, abscess, percutaneous drainage