linjc16/ctgov huggingface dataset:
Elbow Pain in Hemodialysis Patients and Its Effect on Daily Living Activities of the Patients

Study Overview
=================
Brief Summary
-----------------
The study will include the patients undergoing hemodialysis.

Detailed Description
-----------------
The study will include the patients undergoing hemodialysis. The patients with surgery at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases affect the interview will be excluded. Sociodemographic properties which include age, gender, duration of dialysis, educational level, comorbid diseases, vascular access area, hand dominancy will be asked. The Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP), the Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS) will applied to all patients. All the demographic results and vascular access area for hemodialysis will be detected. All data for normality will be tested by using Kolmogorov-Smirnov test. To compare the differences between groups, Mann Whitney U test will be used

Official Title
-----------------
Elbow Pain in Hemodialysis Patients and Its Effect on Daily Living Activities of the Patients

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Other: Presence of elbow pain in patients with end stage renal disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being over 18 years old having hemodialysis treatment Exclusion Criteria: any surgical operation at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases can affect the interview.

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

| Intervention/Treatment |
| --- |
|Other: Presence of elbow pain in patients with end stage renal disease|The Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP) scores were measured for all patients to evaluate depression symptoms and health-related quality of life. The elbow pain presence was asked to all the patients, the patients with elbow pain were also evaluated with The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS). VAS detected as pain during rest, activity, night and pain at last week.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kolmogorov-Smirnov test | All data for normality was tested by using Kolmogorov-Smirnov test | through study completion, an average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
musculoskeletal pain, elbow pain, hemodialysis
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease on Dialysis (HORTENSIA)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.

Official Title
-----------------
Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Chronic kidney disease, on dialysis for > 3 months Treatment-naïve or previous treatment with ESA Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician Exclusion Criteria: Participation in a clinical trial Anemia due to an associated malignant pathology

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin levels |  | Month 6 | 
| Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in haemoglobin/haematocrit |  | from baseline to Month 12 | 
| Biological parameters of anemia: transferrin saturation, serum ferritin, folates |  | 12 months | 
| Efficacy of dialysis (Kt/V, urea levels) |  | 12 months | 
| Safety: Incidence of adverse events |  | 12 months | 
| Compliance (treatment modification or discontinuation) |  | 12 months | 
| Quality of life: Short Form (SF-36) questionnaire |  | 12 months |
A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices

Study Overview
=================
Brief Summary
-----------------
With the number of individuals becoming overweight or obese, healthcare professionals are in need of accurate, reliable, and convenient tools to help personalize weight loss programs. Recently, a new indirect calorimeter (i.e. MedGem / BodyGem; aka Gem) was introduced as a convenient solution to determine resting metabolic rate (RMR) for assessment of daily energy needs. Several validation and comparison studies were conducted to determine if the Gem device is accurate and reliable. The purpose of this study was to conduct a systematic review of previous studies that evaluated the accuracy and reliability of the Gem devices.

Official Title
-----------------
A Systematic Review on the Accuracy and Reliability of a Hand-Held Indirect Calorimeter for Assessing Energy Needs in Adults & Children

Conditions
-----------------
Resting Metabolic Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Random or counterbalanced assignment of participants to eliminate measurement bias; similar subject positioning for both Gem and reference system measurement or adjustment to a measurement for positioning differences; and use of a measurement protocol that is similar to the established best practice guidelines for employing indirect calorimetry
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 |
| --- | --- | --- |
Lumbar Fusion Compared With Conservative Treatment in Patients With Chronic Low Back Pain: a Meta-analysis

Study Overview
=================
Brief Summary
-----------------
To determine the effect size of lumbar fusion measured by Oswestry Disability Index and compared with conservative treatment in patients with chronic low back pain. Meta-analysis using fixed effect model synthesis method. Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.

Conditions
-----------------
Comparison Between Effectiveness of Lumbar Fusion and Conservative Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: controlled randomized or non-randomized studies Exclusion Criteria: not specified

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 |
| --- | --- |
| Lumbar fusion group<br> | |
| Conservative treatment group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index |  | 2 years |
Sentinel(TM) Post-Market Registry

Study Overview
=================
Brief Summary
-----------------
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR. Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form. All Sentinel filters will be sent for histopathology at an independent core-lab.

Official Title
-----------------
Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement

Conditions
-----------------
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: SENTINEL (Cerebral Protection System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved indications for commercially available CE-Marked TAVR devices. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%). The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site. Exclusion Criteria: Vasculature in the right extremity precluding 6Fr sheath radial/brachial access Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium Currently participating in an investigational drug or investigational (non CE-mark) device study

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 |
| --- | --- |
| Treatment Group<br>TAVR + SENTINEL (Cerebral Protection System) | Device: SENTINEL (Cerebral Protection System)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Observational Endpoint | Capture rate, debris volume and histopathology analysis at day 1. | Post-Procedure (day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
selected for TAVR by heart team consensus, treated with CE-Marked TAVR devices
Study of Psychiatric Aspects in Women With Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
To identify the differences in psychopathology, personality traits among different female LUTS subtypes.

Conditions
-----------------
Psychiatric Aspects in Women With Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Other: No drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases with lower urinary tract symptoms Exclusion Criteria: nil

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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 |
| --- | --- |
| lower urinary tract symptoms<br> | Other: No drug<br>* Psychopathology, personality traits of patients with lower urinary tract symptoms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.

Detailed Description
-----------------
Rhinitis is a common condition associated with significant effects on quality of life. Rhinitis may be divided into two groups, those with concurrent allergy (allergic rhinitis, AR) and those without allergy but who still suffer from nasal symptoms (nonallergic rhinitis, NAR). Evidence indicated that adult with NAR can have de novo sensitization to aeroallergen (24%), suggesting that patients with NAR might evolve to AR. Thus the purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.

Official Title
-----------------
The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis

Conditions
-----------------
Allergic Rhinitis (Disorder)

Intervention / Treatment
-----------------
* Procedure: skin prick test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the age of 1 year and 15 years with the diagnosis of nonallergic rhinitis who are attending the pediatric allergy clinic during Jan 2005 - Dec 2007. Exclusion Criteria: Patients who have allergic rhinitis and underlying disease eg.chronic renal disease, liver disease, heart disease, cancer.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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 |
| --- | --- |
| Nonallergic rhinitis<br>Nonallergic rhinitis (negative skin prick test) | Procedure: skin prick test<br>* skin prick test to aeroallergen<br>* Other names: SPT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the development of AR in children who were previously diagnosed with NAR |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the persistence and severity of the symptoms, new comorbidities and triggering factors in children with nonallergic rhinitis |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nonallergic rhinitis, Allergic rhinitis, Development
Comparison of Retinal Nerve Fiber Layer (RNFL) Thickness Measurements by Time-Domain and Spectral-Domain OCT In Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
Measurement of RNFL thickness by OCT is at a cornerstone for the correct diagnosis and monitoring of progression of glaucomatous optic neuropathy. Spectral domain technology has enabled better reproducibility with better axial resolution in the measurement of RNFL thickness. A comparative study among Stratus, Cirrus and RT-View will enable clinicians to determine differences among various instruments.

Official Title
-----------------
Comparison of RNFL Thickness Measurements by Time-Domain and Spectral-Domain OCT In Glaucoma Patients

Conditions
-----------------
Primary Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Evidence of retinal disease Secondary glaucoma due to intraocular inflammation Lens induced glaucoma Neovascular glaucoma Tumor induced glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 10 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>Primary open angle glaucoma | |
| 2<br>Normal Controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RNFL thickness |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RNFL thickness
Identification and Evaluation of Circulating Tumor Cells and Tumor Related Rare Cells in Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is designed to evaluate the enumeration of circulating tumor cells and identify the potential biomarkers associated with clinical outcome. The secondary objective is to explore whether the changes of tumor related rare cells associates clinical outcome.

Official Title
-----------------
Identification and Evaluation of the Potential Biomarkers on Circulating Tumor Cells and Tumor Related Rare Cells in Cancer Patients Undergoing Immunotherapy

Conditions
-----------------
CTC and Tumor Related Rare Cell

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Over 20 years of age. Cancer patients on immune checkpoint inhibitors. Exclusion Criteria: Subjects who have other cancer history Pregnant females Subjects with active, known or suspected autoimmune disease. Known history of human immunodeficiency virus (HIV)

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Circulating tumor cell | Isolation and analysis of circulating tumor cells before and after immunotherapy | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor related rare cell | Isolation and analysis of tumor related rare cells before and after immunotherapy | 1 years |
Early Mechanical Ventilation for Guillain Barré Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.

Detailed Description
-----------------
Hospital acquired pneumonia is a common and severe complication of Guillain Barré Syndrome. Several factors have been recognized as predictors of respiratory failure in adults with Guillain Barré Syndrome. They include a time from disease onset and patient admission of less seven days, inability to lift head, impaired swallowing and a forced vital capacity of less than 60% of predictive value. We reasonned that early mechanical ventilation may prevent aspiration which is likely the main cause of pneumonia in these patients.

Official Title
-----------------
Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome

Conditions
-----------------
Guillain Barré Syndrome, Acute Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: mechanical ventilation
* Procedure: physiotherapy and oxygen if needed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Guillain Barré Syndrome Age of 18 years old or more Inability to lift head Time from onset of motor deficit less than 7 days Written informed consent Exclusion Criteria: Glasgow coma score of less than 8 Unstable hemodynamic status Current pneumonia Pregnancy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Physiotherapy, oxygen as needed | Procedure: physiotherapy and oxygen if needed<br>* oxygen will be delivered via facial mask whenever needed and physiotherapy<br>|
| Experimental: 2<br>Mechanical ventilation | Procedure: mechanical ventilation<br>* Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hospital acquired pneumonia from randomization to study day 90 |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on a ventilator |  | Day 90 | 
| Intensive care unit lenght of stay |  | Day 90 | 
| Hospital length of stay |  | Day 90 | 
| Tolerance |  | Day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Guillain Barré, Mechanical ventilation, invasive, Mechanical ventilation, non invasive, Pneumonia