linjc16/ctgov huggingface dataset:
Preview Rapid Strep A Test Method Comparison Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.

Official Title
-----------------
Preview Rapid Strep A Test Method Comparison Study

Conditions
-----------------
Strep Throat

Intervention / Treatment
-----------------
* Diagnostic Test: Preview Rapid Strep A test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient presenting with symptoms of pharyngitis Fever Sore throat Swollen lymph nodes in neck Redness of throat/tonsils White/yellow patches on tonsils Not currently on antibiotics ≥3 years or older Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18. Exclusion Criteria: Currently taking antibiotics Previously enrolled in this study

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| Symptoms of Strep Throat<br>Any patient presenting with symptoms of pharyngitis Fever Sore throat Swollen lymph nodes in neck Redness of throat/tonsils White/yellow patches on tonsils Not currently on antibiotics | Diagnostic Test: Preview Rapid Strep A test<br>* Rapid assay for the detection of type A streptococcal infection of the throat.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Preview Strep A Rapid Test | Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A | 3 months |
Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With RR MS

Study Overview
=================
Brief Summary
-----------------
The primary objective is to directly estimate brain glutathione concentrations in vivo using H-MRS at 7T before and after initiation of Tecfidera in established multiple sclerosis (MS) patients considering switching therapy or being treatment-naive (first line).

Official Title
-----------------
Restoring Glutathione Synthesis With Tecfidera: An in Vivo H-MRS Single-Arm Study at 7T in Patients With Relapsing-Remitting Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Tecfidera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult patients 18-60 years of age Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010) Patients naive to MS therapy or patients switching from an FDA-approved MS therapy, including IFN-B formulations, Cop-1, Teriflunomide, and Fingolimod to BG-12 Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive Exclusion Criteria: Primary progressive multiple sclerosis patients Patients with previous exposure or known allergies to fumarates MS patients switching from natalizumab, cyclophosphamide, or mitoxantrone to BG-12 Contraindications for MRI/MRS Known presence of other neurological disorders that may mimic multiple sclerosis Pregnancy or lactation Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study History of or currently active primary or secondary immunodeficiency Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis_ History of progressive multifocal leukoencephalopathy Contraindications to or intolerance of oral or intravenous (IV) corticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Patients with relapsing MS<br> | Drug: Tecfidera<br>* Oral Tecfidera 240 mg bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glutathione Concentrations In Normal Appearing Gray Matter in Brain Measured by 7T Magnetic Resonance Imaging Scan |  | Before and 12 months after Tecfidera Initiation |
Systematic IPP VS Symptomatic IPP in GERD Prevention After POEM for Achalasia. . A Comparative Retrospective Analysis

Study Overview
=================
Brief Summary
-----------------
POEM is a minimally invasive endoscopic therapy that is highly efficacy in the treatment of achalasia of any type. POEM has an increased risk of GERD. Systematic PPI therapy has never been studied for the prevention of post-POEM GERD. The investigators wish to retrospectively compare patients who have received routine PPI therapy vs. patients who don't.

Official Title
-----------------
Interest of Systematic PPI Therapy After POEM vs Symptomatic Use of PPI Therapy in Prevention of Gastroesophageal Reflux Disease After POEM for Esophageal Achalasia. A Comparative Retrospective Analysis.

Conditions
-----------------
Achalasia, Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: > 18 years old Consent given Achalasia all types with eckhardt score > 3 Exclusion criteria: Patient who is a minor or under judicial protection Pregnant or breastfeeding woman Contraindication to PPIs Carrier of mediastinal and exogastric neoplasia Patient on PPIs prior to the procedure for indication that does not allow for their discontinuation Peptic esophagitis (Grade B, C or D) before or at the time of the procedure Previous treatment with Heller myotomy

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 |
| --- | --- | --- |
| Number of Esophagitis | Number of Esophagitis | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, POEM, Achalasia, PPI, Esophagitis
Sleep Disturbances as a Non-traditional Risk Factor in CKD-Actigraphy

Study Overview
=================
Brief Summary
-----------------
To test if usual at home night time sleep duration as measured with activity monitors and questionnaires will predict changes in kidney function as measured by kidney filtration rate and of cardiovascular function as measured by C-reactive protein in the blood. The study will explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk factor for the progression of CKD and for the development of cardiovascular disease in CKD.

Official Title
-----------------
Sleep Disturbances as a Non-traditional Risk Factor in CKD-Wrist Actigraphy

Conditions
-----------------
Chronic Kidney Disease, Sleep Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to Moderate CKD Healthy controls age and gender matched to CKD subjects Regular bedtimes of at least 6h/night, sedentary lifestyle Exclusion Criteria: Diabetes Current or previous dialysis for more than 1 month Uncontrolled hypertension Heart failure Liver disease HIV Hemoglobin < 10.5 g/dl Treatment with EProcrit, Epogen, or Aranesp Bone or organ transplant, Use of immunosuppressive drugs within past 6 months Current oral contraceptive use Current pregnancy Chemotherapy for malignancy within past 2 years

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 74 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 |
| --- | --- |
| 1<br>CKD subjects | |
| 2<br>Healthy Controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD, Kidney Disease, poor sleep, CKD progression
Probiotics for Birch Pollen Allergy

Study Overview
=================
Brief Summary
-----------------
Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic countries. Treatment consists of antihistamine use. Specific probiotic strains have been observed to modulate the immune system. Since the body has a common mucosal immune system; it was hypothesised that consumption of probiotics may affect also the respiratory mucosal immune response and hence affect respiratory allergy. Earlier studies with probiotics had been unable to show improvements in adults with pollen allergy. It was therefore hypothesised that children, who's immune system is not yet fully developed, might be better targets.

Official Title
-----------------
Probiotic Intervention for Children With Birch Pollen Allergy

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Biological: Lactobacillus acidophilus and Bifidobacterium lactis
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician verified birch pollen allergy Exclusion Criteria: Diagnosed asthma Habitual use of probiotics and/or prebiotics

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 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: A<br>Numbers 509-513, 700-709 and 900-909 Probiotic combination of L. acidophilus and B. lactis | Biological: Lactobacillus acidophilus and Bifidobacterium lactis<br>* Daily 5x10^9 CFU of a combination of L. acidophilus and B. lactis<br>|
| Placebo Comparator: B<br>Numbers 612-624 and 800-811 Microcrystalline cellulose | Biological: Placebo<br>* Microcrystalline cellulose As capsule which could be opened<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birch pollen allergy symptoms |  | March/April and June | 
| Nasal Eosinophilia |  | April/May and June | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiota composition |  | April/May and June | 
| Cytokine profile from serum |  | April/May and June | 
| Faecal recovery of administered probiotics |  | April/May and June | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
birch pollen
Music Pacing in Pediatric Exercise Testing

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: Music pacing improves the quality of exercise testing in children. Children tend to cycle in a non-constant pace during exercise testing, which might make the test less reliable. 20 boys will perform two exercise tests on a cycle ergometer. One test will be done with constant tempoed music, and the other without. Different parameters will be checked including pedaling cadence, aerobic fitness, level of work load obtained.

Official Title
-----------------
Music Pacing in Pediatric Exercise Testing

Conditions
-----------------
Exercise Testing With Music Pacing

Intervention / Treatment
-----------------
* Other: Music listening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male sex currently and generally healthy Exclusion Criteria: presence of chronic disease/ medication use BMI above 85% trained/competitive cyclists

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music pacing<br>Exercise testing with music pacing | Other: Music listening<br>* Listening to tempo music while cycling in an exercise test<br>|
| No Intervention: No music pacing<br>Exercise testing without music pacing | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak VO2 | peak Vo2 is the maximal oxygen consumption obtained during the exercise test, reflecting the level of aerobic fintess | end of the exercise test, approx.10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak power | maximal power obtained at the end of the exercise test | exercise test duration, approx.10 minutes | 
| anaerobic threshold | point of increase in anaerobic metabolism | exercise test duration, approx.10 minutes | 
| rating of perceived exertion | scale of perceived effort | exercise test duration, approx.10 minutes | 
| mechanical efficiency | oxygen consumption per work load | exercise test duration, approx.10 minutes | 
| cadence | pedaling rate | exercise test duration, approx.10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise testing, music, VO2 max
Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks. Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up visits at the end of each drug ingestion period.

Conditions
-----------------
Erythropoietic Protoporphyria

Intervention / Treatment
-----------------
* Drug: cysteine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented erythropoietic protoporphyria Determination of elevated protoporphyrin within the past year Experiencing photosensitivity --Prior/Concurrent Therapy-- No concurrent use of betacarotene --Patient Characteristics-- Other: Not pregnant or nursing Fertile female patients must use effective contraception while on study and for 3 weeks thereafter

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

| Intervention/Treatment |
| --- |
|Drug: cysteine hydrochloride|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
-----------------
erythropoietic protoporphyria, inborn errors of metabolism, porphyria, rare disease
Reference Values for Pulse Induced Continuous Cardiac Output (PiCCO) Variables in Children

Study Overview
=================
Brief Summary
-----------------
Pulse induced continuous cardiac output (PiCCO) is an established technology for measurement of advanced hemodynamic variables in critically ill patients. PiCCO is approved and designed also for use in children, but there is a lack of documentation of reference values in children not suffering from a critical illness. The goal of this study is to establish such values.

Official Title
-----------------
Reference Values for Cardiac Output and Blood Volume Variables in Children With Normal Cardiac Function Measured Under General Anesthesia.

Conditions
-----------------
Reference Values

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 15 years Scheduled for major neurosurgery in general anesthesia Exclusion Criteria: Cardiac disease Infection / sepsis

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| Children 0 - 15 years<br>Children undergoing neurosurgery in general anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reference values for PiCCO variables |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrathoracal blood volume, Cardiac output, Children
Self-Help Group for the Treatment of Hoarding Disorder

Study Overview
=================
Brief Summary
-----------------
The proposed study aims to investigate the efficacy of a facilitated self-help group for the treatment of hoarding disorder. Eligible participants will take part in a facilitated self-help group. The investigators aim to investigate the effects of a self-help group on hoarding symptoms. The investigators hypothesize that participants will demonstrate decreased hoarding symptoms over time.

Official Title
-----------------
Self-Help Group for the Treatment of Hoarding Disorder

Conditions
-----------------
Hoarding Disorder

Intervention / Treatment
-----------------
* Other: Self-Help Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically relevant symptoms of hoarding disorder Exclusion Criteria: under 18 psychotic disorders, bipolar disorder, substance abuse or dependence

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: Self-help group<br>The facilitated self-help group, which represents an empirically supported intervention for hoarding (Frost et al., 2011). | Other: Self-Help Group<br>* The facilitated self-help group may last approximately 13 sessions. This treatment represents an empirically supported intervention for hoarding (Frost et al., 2011), based on a Facilitator's Manual (Maxner et al., 2010), which is a treatment manual based on the book Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding (Tolin, Frost, & Steketee, 2007).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hoarding Rating Scale | Interviewer-rated measure of hoarding severity will be administered at Screening, Pre-Treatment, Mid-Treatment (approximately Week 7), Post-Treatment (approximately week 13), 1-month Follow-up The Hoarding Rating scale has a total score ranging from 0-40 with the higher score indicating higher symptoms of hoarding. | 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hoarding, Compulsive Hoarding, Self-Help