linjc16/ctgov huggingface dataset:
Effect of Short-term Oxygen During CPET in GUCH

Study Overview
=================
Brief Summary
-----------------
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with grown-up congenital heart disease.

Official Title
-----------------
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Grown-up Congenital Heart Disease (GUCH)

Conditions
-----------------
Grown-up Congenital Heart Disease (GUCH)

Intervention / Treatment
-----------------
* Procedure: Oxygen application
* Procedure: Sham room air


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GUCH, stable medication for at least 4 weeks. Exclusion Criteria: instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplemental oxygen<br>Supplemental oxygen will be applied via a mask during CPET | Procedure: Oxygen application<br>* Oxygen application Supplemental oxygen via mask<br>|
| Sham Comparator: Sham room air<br>Room air will be applied similarly to oxygen | Procedure: Sham room air<br>* Room air applied via mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Rate (Watt) | Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air | 1 day | 
| Endurance Time (s) Endurance Time (s) Endurance Time (s) | Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen uptake | measured during cardiopulmonary exercise test oxygen vs. room air | 1 day | 
| Respiratory Exchange ratio | measured during cardiopulmonary exercise test oxygen vs. room air | 1 day | 
| Changes in arterial blood parameters | measured during cardiopulmonary exercise test oxygen vs. room air | 1 day | 
| muscle tissue oxygen | Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy | 1 day | 
| cerebral tissue oxygen | Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy | 1 day |
Perfusion Assessment Using BOLD MRI and PBV in Endovascular Treatment of Peripheral Arterial Occlusive Disease

Study Overview
=================
Brief Summary
-----------------
Current assessment of lower limb ischemia cannot reflect the location and degree of ischemia. Tissue perfusion assessment was used in the diagnosis and treatment of lower limb ischemia in this project, and the quantitative evaluation of ischemia degree was realized by using its advantages of quantitative analysis and perfusion imaging.

Official Title
-----------------
A Prospective Study: Perfusion Assessment Using Blood Oxygen Level Dependent Functional Magnetic Resonance Angiographic Imaging and Parenchymal Blood Volume Imaging in Endovascular Treatment of Peripheral Arterial Occlusive Disease

Conditions
-----------------
Peripheral Arterial Disease, Tissue Perfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has been diagnosed as PAOD by symptom and imaging; Subject intends to take endovascular treatment in PUMCH; Subjects without heavy stenosis in infrapopliteal artery (stenosis<30%), or with short length lesion(length≤5cm, stenosis≥30%); Age > 35 and < 80; Subject has been informed the study and has signed informed consent; Exclusion Criteria: Subject with MRI contraindications or allergic to iodinated contrast medium; Subject underwent intervention therapy or angioplasty in target vessel within the last 3 months; Subject after stent implantation in superficial femoral artery; Subject with severe heart dysfunction, renal dysfunction, or cancer;

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Perfusion of the index leg assessed by BOLD MRI before and after endovascular intervention. | BOLD evaluates perfusion noninvasively and can be used for long-term monitoring and postoperative follow-up. Improving the perfusion assessment will improve the evaluation system for endovascular treatment of PAOD. | 1 year | 
| Perfusion of the index leg assessed by PBV before and after endovascular intervention. | PBV can evaluate intraoperative perfusion quantitatively in real time. | During operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between perfusion and function of the lower limb in PAOD patients | The preoperative and postoperative motor functions of the patients were tested to analyze the functional impact of perfusion improvement. | 1 year |
Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients

Study Overview
=================
Brief Summary
-----------------
An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis

Detailed Description
-----------------
The purpose of the present study is to establish the efficacy and safety of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE in an alternate study population and to address the issue of peak time to response by measuring the proportion of patients achieving a ≥ 75% reduction in PASI at any time after completion of treatment.

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Alefacept (Amevive)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must give written informed consent Must be >= 16 years of age Must have been diagnosed with chronic plaque psoriasis at least one year and require systemic or phototherapy Must have CD4+ lymphocyte count at or above the lower limit of normal Must have a BSA >= 10% Exclusion Criteria: Current erythrodermic, generalized pustular, or guttate psoriasis Serious local infection or systemic infection within 3 months prior to the first dose of alefacept History of any clinical significant disease that would be contraindicated for this study as determined by the investigator Prior history of systemic malignancy, untreated localised skin canceer or a >10 squamous cell carcinoma Current enrollment in any other investigational drug study within 30 days prior to study drug administration Treatment with systemic immunosuppressant agents within the 4 weeks prior to study drug administration.

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

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alefacept (Amevive)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine TRR50, Quality of Life (QOL), the safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, alefacept
Surveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort

Study Overview
=================
Brief Summary
-----------------
The SCOLTA project is a system for online surveying of adverse events to recently commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events reactions arising during any antiretroviral treatment.Aim of the proposed study is: to evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV-infected patients enrolled in the SCOLTA project Tipranavir cohort and to identify possible risk factors the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason.

Official Title
-----------------
SCOLTA: SURVEILLANCE COHORT LONG-TERM TOXICITY ANTIRETROVIRALS

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Tipranavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients > 18 years old HIV infected treated with tipranavir Exclusion Criteria:

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 |
| --- |
|Drug: Tipranavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV infected patients enrolled in Tipranavir cohort and to identify possible risk factors |  | 48wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason |  | 48wks |
Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail. We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo therapy has a significant effect on brain activity detectable by functional MRI.

Official Title
-----------------
Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial

Conditions
-----------------
Chronic Pelvic Pain Syndrome

Intervention / Treatment
-----------------
* Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)
* Device: placebo therapy (Placebo Sonodyn Medico Star)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CPSS III symptomatic >3 months NIH-CPSI total score =/>15 NIH-CPSI pain =/>8 Exclusion Criteria: post void residual >100mL urinary tract infection urethral stricture prostate cancer age <18 years claustrophobia pacemaker, neurostimulator, insulin / pain pump

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Combined sono-electro-magnetic therapy | Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)<br>* twice a day for 10 minutes during 12 weeks<br>* Other names: Sonodyn Medico Star;|
| Placebo Comparator: 2<br>placebo therapy | Device: placebo therapy (Placebo Sonodyn Medico Star)<br>* twice a day for 10 minutes during 12 weeks<br>* Other names: Placebo Sonodyn Medico Star device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) |  | before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity assessed by functional MRI |  | before treatment, after 12 weeks of treatment | 
| Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database |  | before treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pelvic pain syndrome, Neuromodulation, Brain effects, Neuroimaging
Vascular and Metabolic Effects of Vytorin vs Simvastatin

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that vytorin will improve insulin resistance compared with simvastatin

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: vytorin
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypercholesterolemic patients (LDL cholesterol levels>100 mg/dl) Exclusion Criteria: overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| Active Comparator: placebo<br>placebo | Drug: placebo<br> <br> |
| Active Comparator: vytorin<br>vytorin | Drug: vytorin<br> <br> |
| Active Comparator: simvastatin<br>simvastatin | Drug: simvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance
Effects of Pilates in Risk Fall in Older Population

Study Overview
=================
Brief Summary
-----------------
The intervention will consist in a 6 week of pilates practice in older population to check the prevention of fall effectiveness.

Detailed Description
-----------------
A study population of elder people will be randomly allocated to intervention or control group, consisted in Pilates and a booklet of balance tips respectively. The protocol will be performed for 6 weeks.

Official Title
-----------------
Effects of 6 Week of Pilates in Fall Prevention

Conditions
-----------------
Falling Injury

Intervention / Treatment
-----------------
* Other: Pilates and fall prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Elder population. Not to be a pilates practitioner previous to study enrollment. Exclusion Criteria: - Cognitive issues that dont allow to practice pilates method. Sensorial alteration or any disease that could altered balance. Any drug or medication that modify balance.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pilates group<br>Pilates based protocol for 6 weeks | Other: Pilates and fall prevention<br>* A 2 days per week during 6 week Pilates practice will be performed in experimental group in order to check the effectiveness in fall prevention<br>|
| No Intervention: control group<br>No treatment group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Falls Efficacy Scale International test (FES I) | FES as measure of fear of falling or patients confident of falling | pre intervention and post 6 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Star Excursion Balance Test (SEBT) | SEBT as measure of dynamic balance | pre intervention and post 6 weeks of intervention |
Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin

Study Overview
=================
Brief Summary
-----------------
Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.

Official Title
-----------------
Long-Term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin in Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection

Conditions
-----------------
Chronic Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants from Study SPC3649-207, including those who completed the study and those who discontinued or terminated the study early for any reason, or those who opted to receive other approved therapy for the treatment of hepatitis C virus (HCV) infection Exclusion Criteria: Participants who have received investigational drug therapy after discontinuation, termination, or completion of Study SPC3649-207
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Population<br>Participants who previously received 12 weeks of miravirsen monotherapy in Study SPC3649-207 will complete up to 36 months of safety and efficacy follow-up without investigational treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Up to 36 months | 
| Incidence of sustained virologic response (SVR) |  | 48 weeks after end of treatment (EOT) | 
| Change from Baseline in HCV ribonucleic acid (RNA) level |  | Up to 36 months | 
| Incidence of HCV resistance |  | Up to 36 months |
Multi-Slice CT of the Chest( MSCT Findings After Lung Transplantation)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare Multi-Slice Computer Tomography findings with histological and physiological changes observed in transplanted lungs with Progressive Graft Disfunction.

Conditions
-----------------
CT of the Lung After Lungetransplantation

Intervention / Treatment
-----------------
* Radiation: Computer Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients that have had a lung transplantation Exclusion Criteria: Under 18, Reduced kidney function, Known contrast allergy; and Language problems that make cooperation difficult.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Computer Tomography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |