linjc16/ctgov huggingface dataset:
Coordination and Locomotor Problems in Patients With Covid-19 Virus

Study Overview
=================
Brief Summary
-----------------
Coordination and Locomotor Problems in Patients With Covid-19 Virus

Official Title
-----------------
Coordination and Locomotor Problems in Patients With Covid-19 Virus

Conditions
-----------------
Covid19, Motility Disorder, Balance

Intervention / Treatment
-----------------
* Diagnostic Test: Neurology test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID 19 diagnosis Exclusion Criteria: Severe heart problems severe demeanor alcoholism drug problems

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: COVID19<br> | Diagnostic Test: Neurology test<br>* movement examination of patients with covid19 disease<br>|
| Experimental: Controll<br> | Diagnostic Test: Neurology test<br>* movement examination of patients with covid19 disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ5D-5L | Questionnaire | 5 weeks-long | 
| Berg test | Fatigue questionnaire | 5 weeks-long | 
| SPPB test (gait, balance, leg stregth) | Walking and balance testing | 5 weeks-long | 
| 6MWT | Walking test | 5 weeks-long | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
6MWT, Berg balance, Beam Walking
Treatment of Exercise-induced Laryngomalacia in Elite Athletes

Study Overview
=================
Brief Summary
-----------------
Treatment of exercise-induced laryngomalacia (an obstruction of larynx during physical activity) in elite athletes using two different treatments. The study is randomized with control groups.

Official Title
-----------------
Treatment of Exercise-induced Laryngo Obstruction in Elite Athletes

Conditions
-----------------
Exercise-induced Laryngomalacia

Intervention / Treatment
-----------------
* Device: inspiratory muscle strength training
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laryngoscopically verified EIL, Elite athlete for a minimum of 1 year and continuing for a minimum 6 months after start of treatment Exclusion Criteria: Has to be able to run on treadmill

Ages Eligible for Study
-----------------
Minimum Age: 12 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: 1<br>Treatment 1, for those with high degree of EIL | Device: inspiratory muscle strength training<br> <br> |
| Experimental: 2<br>Treatment 2, for those with high degree of EIL | Procedure: Surgery<br> <br> |
| No Intervention: 3<br>Control group of those with high degree of EIL | |
| Experimental: 4<br>Treatment 1, for those with low degree of EIL | Device: inspiratory muscle strength training<br> <br> |
| No Intervention: 5<br>Control group of those with low degree of EIL | |

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
-----------------
EIL
Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and effectiveness of Humira® (Adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis patients under a routine treatment practice.

Official Title
-----------------
Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients According to the Standard for Re-examination of New Drugs

Conditions
-----------------
Non-infectious Intermediate, Posterior and Panuveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been diagnosed with Non-infectious intermediate, posterior and pan-uveitis Patients voluntarily signed a patient authorization & informed consent form. Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study. Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines. Exclusion Criteria: A patient who are contraindications to originator adalimumab (Humira®) as listed on the approved Korean label. A patient who is participating on other interventional clinical trials Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 99 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 |
| --- | --- |
| Participants who received Humira®<br>Non-infectious intermediate, posterior, or panuveitis patients who received Humira® | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of patients reported with serious adverse event | The patients reported with serious adverse event will be collected. | Up to Week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual acuity | The change in visual acuity is assessed from the best corrected visual acuity achieved after the first dose on visual acuity chart in each eye. | Up to follow-up week 22 | 
| Assessing Presence /absence of new active inflammatory chorioretinal lesions | Presence or absence of new active inflammatory chorioretinal lesions is assessed. | Up to follow-up week 22 | 
| Assessing Treatment Response | Treatment response is assessed as improvement, no improvement and aggravation. | Up to follow-up week 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-infectious intermediate, posterior and panuveitis, Post-Marketing Surveillance, Humira®
Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma

Study Overview
=================
Brief Summary
-----------------
Current guideline-based criteria defining bronchial asthma do not always meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used functional diagnostic approaches for the detection and therapeutic monitoring of patients with asthma.

Official Title
-----------------
Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma

Conditions
-----------------
Bronchial Asthma, Pulmonary Healthy Controls

Intervention / Treatment
-----------------
* Diagnostic Test: impulse oscillometry
* Diagnostic Test: multiple breath washout test
* Diagnostic Test: body plethysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known or suspected bronchial asthma known or suspected obstructive ventilation disorder pulmonary healthy controls Exclusion Criteria: pregnancy inability to participate

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bronchial asthma<br>Patients with known or suspected asthma. | Diagnostic Test: impulse oscillometry<br>* impulse oscillometry<br>Diagnostic Test: multiple breath washout test<br>* multiple breath washout test<br>Diagnostic Test: body plethysmography<br>* body plethysmography<br>|
| pulmonary healthy controls<br>Patients without known or suspected pulmonary disease | Diagnostic Test: impulse oscillometry<br>* impulse oscillometry<br>Diagnostic Test: multiple breath washout test<br>* multiple breath washout test<br>Diagnostic Test: body plethysmography<br>* body plethysmography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global ventilation heterogeneity | lung clearance index (LCI) derived from sulphur hexafluoride multiple breath washout | 30 minutes | 
| Local ventilation heterogeneity | Sacin, Scond (Phase III slopes) derived from sulphur hexafluoride multiple breath washout | 30 minutes |
Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

Study Overview
=================
Brief Summary
-----------------
Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus?

Detailed Description
-----------------
Nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing duration time of diarrhea in comparison to placebo in previous studies. In the current study, based in those results, we design a randomized single-blind controlled trial, in order to asses the effectiveness of nitazoxanide and probiotics in comparison with a control group

Official Title
-----------------
Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children

Conditions
-----------------
Diarrhea, Rotavirus Infection

Intervention / Treatment
-----------------
* Drug: Nitazoxanide
* Drug: Probiotic mix preparation
* Other: Oral hydration solutions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive stool sample for rotavirus test Exclusion Criteria: Severe malnourishment Severe dehydration History of diarrhea more than 3 days previous hospitalization Use of antibiotics, probiotics or nitazoxanide 3 weeks before admission Systemic infections Severe chronic disease Mixed enteric infections besides rotavirus

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 24 Months

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>This group will receive oral nitazoxanide preparation | Drug: Nitazoxanide<br>* Nitazoxanide 15mg/Kg/day twice day for 3 days<br>* Other names: Noxom; Givotan;|
| Active Comparator: 2<br>This group will receive a mix combination of probiotics | Drug: Probiotic mix preparation<br>* Probiotic preparation 1 gram twice a day for 5 days<br>* Other names: Probiotic;|
| Placebo Comparator: 3<br>This is the control group receiving only oral or systemic hydration solutions | Other: Oral hydration solutions<br>* Oral hydration solutions as needed<br>* Other names: 2.5% Glucosaline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea |  | Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization |  | hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitazoxanide, Probiotics, Diarrhea, Rotavirus, Children
Indiana University Gastric Electrical Stimulation Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future gastrointestinal therapies, medical procedures and diagnostics.

Detailed Description
-----------------
This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device The study will be conducted at one center and approximately 1,000 subjects will be enrolled. Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.

Official Title
-----------------
Indiana University Gastric Electrical Stimulation Registry

Conditions
-----------------
Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergo implantation of a new GES device for medical refractory gastroparesis Exclusion Criteria: Non-ambulatory patients: bed-ridden, nursing home resident, etc. Pregnancy Unable to give own informed consent. Prisoners

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop a clinical registry in patients with GES therapy | The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future clinical and translational research. Gastroparesis is an illness caused by a delay of stomach emptying. Symptoms of gastroparesis include nausea, vomiting, weight loss, the feeling of being full right away when you start eating, and abdominal pain. The disease may also lead to malnutrition and weight loss. GES has shown promise in patients with gastroparesis. However, how the GES works is unclear, but the patients who undergo GES show improvement in their symptoms. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GES, gastroparesis, gastric electrical stimulator, vomiting, nausea, bloating, post prandial fullness, epigastric pain
Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.

Official Title
-----------------
Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing completely resection of EGRF mutation-positive NSCLC Staging ⅠB (with high risk factor) to ⅢA PS<2 Adequate hematological, biochemical and organ functions. Exclusion Criteria: Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.

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: intercalated treatment<br>Patients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects | Drug: icotinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Effects |  | duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR tyrosine kinase inhibitor
Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.

Detailed Description
-----------------
PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment SECONDARY OBJECTIVE Evaluate the improvement for Depression which is one of the Nonmotor symptoms Evaluate the improvement of clinical symptoms between two groups Evaluate the improvement of Quality of Life between two groups

Official Title
-----------------
Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: pramipexole
* Drug: Bromocriptine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease patients in accordance with UK Queensquare Brain Bank modified Hoehn & Yahr stage <3 Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before. Exclusion Criteria: K-MMSE<24 History of drug-induced Parkinsonism secondary parkinsonism History of schizophrenia or hallucination Requirement of treatment with anti-depressants due to depressive disorder Pregnant and/or breeding women Renal inadequacy

Ages Eligible for Study
-----------------
Minimum Age: 30 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pramipexole<br>dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks | Drug: pramipexole<br>* pramipexole<br>* Other names: Sandoz Pramipexole;|
| Active Comparator: Bromocriptine<br>bromocriptine dosage form: white round tablet | Drug: Bromocriptine<br>* bromocriptine<br>* Other names: Parlodel tab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| K-NMSS | Evaluate The total and each category score of K-NMSS | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| K-MADRS | Evaluate the Improvement of the depression refering to the total score of K-MADRS | 24 weeks | 
| UPDRS I/II/III | Evaluate the improvement of UPDRS I/II/III | 24 weeks | 
| K-PDQ39 | Evaluate the improvement of Patient's QOL | 24 weeks |
VCRC Tissue Repository

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect existing tissue specimens from subjects enrolled in Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens and linked clinical data collected through VCRC studies may lead to the identification and development of a series of translational research projects. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.

Detailed Description
-----------------
Biopsy specimens collected as standard of care for these diseases will be retrieved and used in research. The most common biopsies performed are kidney, lung, skin, nerves, and vessels; however, other tissue is also of interest for the study. Biopsies are not performed as part of this protocol, rather we will request consent to collect biopsy specimens already collected under routine care.

Official Title
-----------------
VCRC Tissue Biorepository Collection Protocol

Conditions
-----------------
Aortitis, Cutaneous Vasculitis, Eosinophilic Granulomatosis With Polyangiitis, Giant Cell Arteritis, Granulomatosis With Polyangiitis (Wegener's), Henoch-Schonlein Purpura, IgA Vasculitis, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu Arteritis, Churg-Strauss Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A participant will be deemed eligible for this study if the participant is/was enrolled in another one of the VCRC observational/longitudinal protocols (5502, 5503, 5504, 5505, 5506, 5507, 5563) and/or one of the VCRC interventional studies (5522, 5523, 5526, 5527, or 5562). Exclusion Criteria: Inability to give informed consent (or their guardians in the case of children) and to sign the consent form. Unwilling to allow the use of their tissue for research.
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 |
| --- | --- | --- |
| Identify genes that increase the risk of developing vasculitis | Evaluating of clinical data and linked biopsy specimens to identify genes that increase the risk of developing vasculitis. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GPA, CSS, EGPA, GCA, MPA, PAN, TAK, HSP