linjc16/ctgov huggingface dataset:
The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if applying a compression bandage on the leg alters early outcome following TKA. The primary objective of this study is to evaluate leg swelling by measuring leg circumference following simultaneous bilateral total knee arthroplasty (TKA) with and without the application of compression bandage.

Official Title
-----------------
The Need for Compression Bandage Following Total Knee Arthroplasty A Prospective Randomized Controlled Trial Conducted in Simultaneous Bilateral Total Knee Replacements

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Device: Compression bandage
* Device: Gauze dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients receiving elective simultaneous bilateral primary total knee arthroplasty, treated by Rothman physicians at the Thomas Jefferson University Hospital or Rothman Specialty Hospital. Exclusion Criteria: Previous venous thromboembolic event. Lymph edema in one or both legs. BMI > 40 Prior surgery (other than arthroscopy)

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Only bilateral knee replacements will be utilized so each patient can serve as their internal control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Compression bandage group<br> | Device: Compression bandage<br>* Compression bandage placed after total knee replacement<br>|
| Active Comparator: Standard gauze group<br> | Device: Gauze dressing<br>* standard of care gauze dressing placed after total knee replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| swelling of the knee | Swelling of the leg will be determined by measuring circumference of the leg | one day following surgery |
A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to monitor the effectiveness and used dosage of the 8% capsaicin patch in real-life clinical practice in the treatment of post-operative neuropathic pain.

Official Title
-----------------
A Non-interventional Post-registration Clinical Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain

Conditions
-----------------
Post-operative Peripheral Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: Qutenza


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed peripheral post-operative neuropathic pain Exclusion Criteria: hypersensitivity to capsaicin pregnancy diabetes mellitus treatment of face

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 |
| --- | --- |
| Qutenza patients w/ post-operative peripheral neuropathic pain<br> | Drug: Qutenza<br>* capsaicin patch<br>* Other names: Capsaicin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage rate of responders | at least 30% decrease in pain intensity as compared to the baseline | Baseline, Week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basic demographic parameters | age, gender, history of the disease, other diagnoses | Baseline | 
| Previous treatment of neuropathy | type of treatment, dosage, combination, treatment line number | Baseline | 
| Reason for a change in the therapy |  | Baseline | 
| Dose | number of patches, area of application and frequency of treatment with 8% capsaicin | Baseline, Week 13 and Week 26 | 
| Size of the area affected by neuropathic pain |  | Baseline, Week 13 and Week 26 | 
| Concomitant neuropathic medication |  | Baseline, Week 13 and Week 26 | 
| Efficacy of treatment | changes in NPRS score between weeks 0 and week 8, week 13 and week 26 | Baseline, Week 8, Week 13 and Week 26 | 
| Quality of life questionnaire (EQ-5D) |  | Baseline, Week 8, Week 13 and Week 26 | 
| Consumption of rescue analgesic medication |  | Baseline, Week 8, Week 13 and Week 26 | 
| Consumption of additional medical care for neuropathic pain | extra visits, hospitalisation | Baseline, Week 8, Week 13 and Week 26 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Qutenza, 8% capsaicin patch, Non-interventional, Post-operative peripheral neuropathic pain, Observational, Czech Republic
Development and Validation of the BVQ

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is the development of the Beliefs about Ventilation Questionnaire (BVQ).

Official Title
-----------------
Development and Validation of the Beliefs About Ventilation Questionnaire (BVQ)

Conditions
-----------------
Chronic Respiratory Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Indication to Non Invasive Ventilation (NIV), in three slots: <4; >4 e <12; <12 hours Outpatients or Inpatients Obstructive or restrictive reparatory disorder Voluntary agreement to be involved in the Study Exclusion Criteria: Psychiatric Disorder Glasgow Coma Scale (CGS) <14 Pure Obstructive Sleep Apnea Syndrome (OSAS) Tracheostomy with Invasive Ventilation (TIV) o Invasive Ventilation (IV)

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 |
| --- | --- | --- |
| Change from baseline in adherence NIV in COPD patients at 3, 6 and 12 months as measured by the Beliefs of Ventilation Questionnaire (BVQ) |  | Baseline + After 3, 6 and 12 months following the recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability of the questionnaire (duration / missing data) |  | Baseline + After 3, 6 and 12 months following the recruitment | 
| Reliability over time of the questionnaire |  | Baseline + After 3, 6 and 12 months following the recruitment | 
| External construct validity (The World Health Organization Quality of Life (WHOQOL); hours of Non Invasive Ventilation (NIV) prescribed, effective and referred by patients) |  | Baseline + After 3, 6 and 12 months following the recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adherence, Non Invasive Ventilation (NIV), Beliefs, Development, Validation
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Patients With Step Length Asymmetry After Stroke

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of anteroposterior weight shifting training with visual biofeedback on step length asymmetry. Reduced speed and asymmetry of stepping is a specific characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step length of the unaffected limb compared to the affected limb. Causes of this phenomenon are difficulty in weight bearing at the affected limb, weak propulsive force of the affected limb, and decreased strength of hip extensors. To correct these factors. we have developed an anteroposterior weight shifting training system with visual feedback and studied its effects.

Conditions
-----------------
Stroke, Hemiplegic Gait

Intervention / Treatment
-----------------
* Procedure: AP shifting training
* Procedure: Gait training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Independent standing Ability to walk 10m without manual assistance Asymmetric ratio of step length > 1.1 No severe perceptual, cognitive or cardiovascular impairments that could affect walking Exclusion Criteria: Quadriplegia or double hemiplegia Orthopedic or neurologic conditions in addition to the stroke Had more than 1 cerebrovascular accident

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: AP shifting group<br> | Procedure: AP shifting training<br>* AP shifting training in addition to gait training 3 times a week for 6 weeks<br>|
| Active Comparator: gait training group<br> | Procedure: Gait training<br>* Gait training only for 3 times a week for 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of step Length Asymmetric Ratio | paretic step length/non paretic step length | baseline, 3 weeks, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Step Length Asymmetric Index | paretic step length-non paretic step length/0.5[paretic step length +non paretic step length | baseline, 3 weeks, 6 weeks, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterioposterior, weight, shifting, training, patient
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study

Study Overview
=================
Brief Summary
-----------------
Cardiac rehabilitation programmes are a proven treatment for individuals with recent myocardial infarction, resulting in reduced morbidity and mortality compared to usual care. Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and lifestyle behaviours may deteriorate. The GOSPEL study investigates the benefits of a programme of continued educational and behavioural intervention to achieve optimal long-term secondary prevention goals.

Detailed Description
-----------------
Study partially sponsored by Società Prodotti Antibiotici

Official Title
-----------------
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Behavioral: multifactorial continued educational - behavioural programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent myocardial infarction (within 3 months after the index event) Standard rehabilitation program of 3-6 weeks performed Informed consent (obtained before any study specific procedure) Exclusion Criteria: Age > 75 years Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or be associated with poor adherence to the protocol; Presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: multifactorial continued educational - behavioural programme|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular mortality |  |  | 
| non fatal re-MI |  |  | 
| angina requiring hospitalization |  |  | 
| urgent revascularization procedures |  |  | 
| hospitalization for heart failure |  |  | 
| non fatal stroke |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac rehabilitation, lifestyle management, risk factor management, myocardial infarction, randomized trials
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Migraine Headaches

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Migraine Headaches.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Migraine Headaches

Conditions
-----------------
Migraine

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages. Diagnosis of migraine headaches by a physician Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Migraine<br>Patients with migraine headaches | Other: No intervention<br>* There is no intervention for this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with migraine headaches | Three years |
Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether weight-based or fixed starting doses result in comparable hemoglobin increases and treatment effects in patients with heart failure and anemia.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Effects of Treatment With 2 Regimens of Subcutaneous Darbepoetin Alfa (Weight-based Dosing and Fixed Dosing) on Hemoglobin Concentration Response in Subjects With Symptomatic CHF and Anaemia

Conditions
-----------------
Congestive Heart Failure, Anemia

Intervention / Treatment
-----------------
* Drug: Darbepoetin Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Darbepoetin Alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rise of hemoglobin concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular ejection fraction |  |  | 
| Change in 6-minute walk distance |  |  | 
| NYHA classification |  |  | 
| Patient-reported outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHF, Symptomatic Congestive Heart Failure, Anaemia, Anemia
Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied

Study Overview
=================
Brief Summary
-----------------
Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.

Detailed Description
-----------------
In this study, the diameter of each subjects' radial artery will be measured using MRI imagery at varying degrees of radial artery compression by adjusting the amount of air injected into a Terumo TR Band. In addition, using pulse oxymetry, the perfusion waveform will be measured and recorded also while the subjects have a TR Band in place on their wrists.

Official Title
-----------------
Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied

Conditions
-----------------
Poor Peripheral Perfusion

Intervention / Treatment
-----------------
* Device: TR Band


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male adult (has reached the legal majority age). Subject has provided his/her written informed consent to participate in the trial prior to any study -related procedure being conducted. Exclusion Criteria: Abnormal result of either baseline Barbeau or reverse Barbeau tests. Pregnant or breast feeding female. Subject with contraindication to MRI

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR Band<br>Each subject will have a Terumo TR Band applied to the wrist with MRI scans done at differing band pressure levels. The diameter of the radial artery will be measured at each level of band compression. | Device: TR Band<br>* The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Based Radial Artery Measurement | Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band. | Subjects will be followed up to one week post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand Perfusion as Measured by Pulse Oxymetry Waveform | pulse oxymetry waveform will be used to measure arterial perfusion | Subjects will be followed up to one week post procedure |
Comparison of Ultrasound Versus Radiography for Diagnosis of Nasal Fractures

Study Overview
=================
Brief Summary
-----------------
The standard imaging procedure to diagnose a nasal fracture still is radiography (lateral nasal view and occipitomental view). But technological advances in ultrasonography during the last few decades have made high-resolution ultrasound devices available to the majority of medical centers. It has been shown that the bony structures of the nose can be well examined by ultrasound in the last few years. The hypothesis: Is ultrasound of equal diagnostic accuracy in diagnosing nasal fractures as radiography is being tested in the investigators' study. Patients with suspected nasal fracture undergo ultrasound examination in addition to the routine x-ray imaging. After completion of treatment, the readings of both ultrasound and radiographs are compared in terms of sensitivity and specificity to diagnose nasal fractures.

Official Title
-----------------
Comparison of Ultrasound Versus Radiography for Diagnosis of Nasal Fractures

Conditions
-----------------
Nasal Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected nasal fracture Exclusion Criteria: further fractures pregnancy unstable condition refusal to undergo ultrasound examination
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 |
| --- | --- | --- |