linjc16/ctgov huggingface dataset:
Comparative Study of Static and Dynamic Back Supports for Lower Back Pain

Study Overview
=================
Brief Summary
-----------------
Lower back pain is one of the most common conditions affecting humans. Lower back supports are a common device used in order to alleviate the pain. All the available back supports are wrapped around the lower back and abdomen and act as static support devices. The hug is a new dynamic back support where the participant actively improves his/her posture and strengthens the muscle of the lower back. This trial compares both devices and their effect on reducing lower back pain.

Official Title
-----------------
Comparative Study of Static and Dynamic Back Supports for Lower Back Pain

Conditions
-----------------
Low Back Pain, Mechanical

Intervention / Treatment
-----------------
* Device: Dynamic back support
* Device: Static back support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent back pain use analgesics Exclusion Criteria: Pregnant women malignancy infection neurological condition surgical candidate

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic<br>Use of Dynamic back support | Device: Dynamic back support<br>* A dynamic back support which provides pressure on the lumbar without pressure on the abdomen<br>* Other names: hug by Koala;|
| Active Comparator: Static<br>Use of static back support | Device: Static back support<br>* A standard wrap-around sacro lumbar support<br>* Other names: Oppo sacro lumbar support;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in back pain |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
back pain, posture, lumbar support, dynamic support
Environmental Factors to Increase Patient Comfort During Urodynamics Testing

Study Overview
=================
Brief Summary
-----------------
Urodynamics is a comprehensive study of the lower urinary tract. Although the information obtained from urodynamics answers several questions and assists in guiding therapies for patients, the testing environments is unnatural and may be distressing for patients. This may impact the results of the study, as it is not uncommon for patients to be unable to void for the test due to their distress. Often to alleviate the distress, music or soothing noises are used in the background. The study aims to identify simple environmental factors which may improve patient experience with urodynamic testing. The population will include patients with existing appointments for urodynamics testing at the Mayo Urology Clinic. The investigators plan to assess patient satisfaction and comfort during this assessment using a visual analog scale questionnaire. The environmental variables will include music of the patients' preference, the sound of running water, or no background noise at all. By asking patients to complete a questionnaire, The investigators will be able to assess ways to improve patient comfort in a commonly used urologic assessment.

Official Title
-----------------
Environmental Factors to Increase Patient Comfort During Urodynamics Testing

Conditions
-----------------
Lower Urinary Tract Symptoms, Urologic Diseases

Intervention / Treatment
-----------------
* Other: Background Sounds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults undergoing urodynamics Must be able to understand and complete questionnaire Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Patient Undergoing Urodynamics<br> | Other: Background Sounds<br>* Background music or sound of running water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort level with test based off post-urodynamic survey | visual analog scale | 6 months |
Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.

Official Title
-----------------
Clinical Investigation Plan for the AVOPT Data Collection

Conditions
-----------------
Cardiac Pacemaker, Artificial

Intervention / Treatment
-----------------
* Device: Pacemaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker Possessing 1st or 3rd degree AV block Implanted with Biotronik bipolar RA and RV leads Implantation date should be at least 4 months prior to this study Exclusion Criteria: Patient is a minor (18 years old or younger) Patient is pregnant or breast-feeding Patient does not have the legal capacity to provide consent Patient has Mobitz type I or Mobitz type II heart block Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats. Patient is participating in other clinical studies during the clinical study Patient is strictly pacemaker dependent (physician discretion)

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: AVOPT Patient<br> | Device: Pacemaker<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation analysis between measured PWD and optimal AVD. | Data analysis will be performed on the collected data to relate P wave duration (PWD) measured from the far field IEGM to the optimal AVD determined from the hemodynamic assessment. | Up to 6 hours |
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.

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

Intervention / Treatment
-----------------
* Drug: ABT-143
* Drug: ABT-335
* Drug: rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A condition of general good health BMI 19 to 29 Exclusion Criteria: Currently enrolled in another clinical study Females who are pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ABT-143 capsules 5/45mg | Drug: ABT-143<br>* Once, please see Arm Description for more details.<br>|
| Active Comparator: B<br>ABT-335 45mg and rosuvastatin 5mg | Drug: ABT-335<br>* Once, see Arm Description for more detail<br>Drug: rosuvastatin<br>* once, see Arm Description for more detail<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. |  | 7 days | 
| To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults. |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse events, Pharmacokinetic
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.

Official Title
-----------------
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Clevudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years and older. Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive. Patient is HBeAg positive or negative. Patient has ALT levels ≥ 80 IU/L Patient who is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. Patients previously treated with interferon within the previous 3 months. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection. Patient is coinfected with HCV, HDV or HIV. Patient is pregnant or breast-feeding. Patient has a clinically relevant history of abuse of alcohol or drugs. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]

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

| Intervention/Treatment |
| --- |
|Drug: Clevudine|clevudine 30 mg qd|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HBV DNA below the assay limit of detection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of HBV DNA from the baseline. |  |  | 
| Proportion of patients with HBeAg loss and/or seroconversion. |  |  | 
| Biochemical improvement (e.g. ALT normalization). |  |  | 
| Proportion of sAg loss |  |  |
The Investigation of Public Awareness of Core Stroke Symptoms

Study Overview
=================
Brief Summary
-----------------
To investigate public awareness of core stroke symptoms in more than 40 years old population and its related factors.

Official Title
-----------------
The Investigation of Public Awareness of Core Stroke Symptoms

Conditions
-----------------
Stroke, Core Symptoms, Awareness, Health Knowledge, Attitudes, Practice, FAST

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 40 years old (born before December 31st 1976) without specific requirements. Be able to finish the questionnaire. Exclusion Criteria: Participants with disturbance of consciousness.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| awareness rate | The awareness rate of core symptoms (FAST: facial droop, arm weakness, speech disturbance, time to call an ambulance) | 2017-2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated factors | The associated factors with the stroke recognition/ correct action to stroke | 2017-2017 | 
| Subgroup analysis | Analysis of stroke recognition rate and correct action rate and their associated factor in subgroups. | 2017-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, core symptoms, public awareness, FAST
Immune Response Following COVID-19 Vaccination

Study Overview
=================
Brief Summary
-----------------
Few trials have reported the safety and efficacy of the COVID-19 vaccines. However, these trials were mostly focused on post-vaccination adverse events and short-term antibody detection with none monitoring the presence of immunoglobulin G (IgG) in blood at long-term follow-up after the vaccination. This study aims to evaluate the immune response in post-vaccinated individuals across a follow-up period of one year.

Detailed Description
-----------------
The COVID-19 pandemic started in December 2019 and since then has spread globally claiming over 550, 000 deaths, >12 million infections and an economic toll in the trillions of dollars to date. The urgent need for a global vaccination program to control this pandemic has prompted the development of several vaccines. Preliminary reports from few trials evaluating the safety and efficacy of the vaccines have been published (2-4). However, no trials have yet reported the long-term post-vaccination immune response that would potentially determine the necessity and timing for booster doses of the vaccine. Therefore, this study is designed to assess the presence of immunoglobulin (Ig) M and G at several time points after the first and the second dose of the vaccine.

Official Title
-----------------
Immune Response Following COVID-19 Vaccination (IFVAC)

Conditions
-----------------
IgM and IgG in Blood

Intervention / Treatment
-----------------
* Other: Rapid antibody test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Individuals that have received first dose of COVID-19 vaccine Exclusion Criteria: Unwilling to provide informed consent Unwilling for the follow-up serological test during the 1-year enrollment

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Rapid antibody test|Serial serology tests on day 21, 90, 180 and 365 following the first dose of the COVID-19 vaccine to detect the temporal trend of the IgM and IgG production in response to the vaccination.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-vaccination immune response | To assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination. | 1 year |
Nasal Obstruction in Sleep Apnea Patients Compared to the General Population

Study Overview
=================
Brief Summary
-----------------
Recent clinical findings of research at Trondheim University Hospital suggest that surgical correction of the nose septum in addition to volume reduction of the nose cavity may be beneficial in patients who suffer from both nose obstruction and obstructive sleep apnea syndrome(data not yet published). This study aims to compare nose obstruction prevalence in sleep apnea patients and the general population

Official Title
-----------------
A Comparative Study of Nasal Obstruction in a Sleep Apnea Population Compared to the General Population

Conditions
-----------------
Obstructive Sleep Apnoea Syndrome, Nasal Obstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ??? Exclusion Criteria: ???

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| sleep apnea<br>100 patients suffering from obstructive sleep apnea syndrome | |
| controls<br>100 subjects matching cases to age, sex, and body weight | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient reported nasal obstruction | assessed by a 10-point visual analogue scale (VAS) and Sino Nasal Outcome Score(SNOT-20) questionnaire. | 1 week | 
| objective nasal obstruction | measured by acoustical rhinometry and Peak Nasal Inspiratory Flow (PNIF). | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Norway, general population, prevalence
Proprioceptive Postural Control and Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Increased risk of falling is reported in individuals with chronic obstructive pulmonary disease. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. The aim of the study is to clarify whether proprioceptive postural control is impaired in individuals with chronic obstructive pulmonary disease.

Conditions
-----------------
Proprioceptive Postural Control, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria individuals with chronic obstructive pulmonary disease: Age: 40-80 years old Spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) Willingness to sign the informed consent Inclusion Criteria healthy controls: Age: 40-80 years old No COPD (spirometry based: FEV1/FVC ≥ 0.7 and FEV1 > 80%) Willingness to sign the informed consent Exclusion Criteria: History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder Respiratory disorder other than COPD α1-antitrypsin deficiency Known history of significant inflammatory disease other than COPD COPD exacerbation within 4 weeks prior to study Lung surgery Recent diagnosis of cancer Therapy with oral corticosteroids in the last 6 weeks Significant cardiovascular comorbidity

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| chronic obstructive pulmonary disease<br> | |
| healthy matched controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proprioceptive postural control | Center of pressure displacement (force plate) in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control. | 6 months |
The Burden of Lyme Disease (BOLD) in a Pandemic - Insights From an Online Cross-sectional and Prospective Cohort Survey

Study Overview
=================
Brief Summary
-----------------
A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors.

Detailed Description
-----------------
Primary research question: 1. Will the BOLD be worse for individuals who have taken the COVID-19 vaccine? Secondary research questions: Will the BOLD be worse for individuals who have been ill with COVID-19? What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ? If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both? What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine? What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine?

Official Title
-----------------
The Burden of Lyme Disease (BOLD) in a Pandemic

Conditions
-----------------
COVID-19, Lyme Disease, COVID-19 Vaccine

Intervention / Treatment
-----------------
* Other: Cross sectional survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥12 years old a self-report of having been diagnosed with Lyme disease. Exclusion Criteria: There are no exclusion criteria.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cross sectional survey|A cross-sectional descriptive survey of the Burden of Lyme disease for individual with a history of Lyme disease who contract COVID-19 or are vaccinated against COVID-19|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30) | Cross sectional | 7/21 to 7/23 |