linjc16/ctgov huggingface dataset:
PAP Therapy Sleep Apnea and Exercise

Study Overview
=================
Brief Summary
-----------------
Positive airway pressure (PAP) therapy is generally offered to patients with obstructive sleep apnea. The investigators suggest that beneficial effects of PAP therapy is by preventing apneas and therefore reducing cardiac and pulmonary morbidities. The investigators sought to verify this by assessing cardiac and pulmonary function during exercise.

Official Title
-----------------
Effects of Positive Airway Pressure Therapy on Exercise Parameters in Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstructive sleep apnea diagnosed by polysomnography CPAP therapy indicated Exclusion Criteria: obstructive or restrictive lung disease cardiac failure acute coronary syndrome inability to cycle

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 |
| --- | --- |
| CPAP compliant<br>CPAP (continuous positive airway pressure) compliant patients | |
| CPAP non-compliant<br>patients who did not use CPAP therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak oxygen uptake |  | 30-60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilatory equivalent for carbon dioxide at anaerobic threshold |  | 30-60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, continuous positive airway pressure, cardiopulmonary exercise test, VE/VCO2
Sleep Disordered Breathing in Children: Inflammation and Oxidative Stress

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to measure markers of inflammatory and oxidative stress known to be associated with cardiovascular morbidity in snoring children. In addition, to measure markers of local inflammation and to evaluate the response to treatment.

Conditions
-----------------
Sleep Disordered Breathing (SDB), Endothelial Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children ages 6 months-18 years suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy Exclusion Criteria: craniofacial abnormalities neurological disorders genetic disorders infectious disease chronic inflammatory disease any underlying chronic medical condition

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum 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 |
| --- | --- |
| SDB group<br> | |
| Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma inflammatory-markers | Sleep disordered breathing (SDB) in children is associated with increased markers of inflammation, atherogenesis and oxidative stress. | After the blood analyzed |
Study Evaluating MYO-029 in Adult Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.

Conditions
-----------------
Becker Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Limb-Girdle Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: MYO-029


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent. Confirmed clinical and molecular diagnosis of Becker Muscular Dystrophy (BMD), Facioscapulohumeral Muscular Dystrophy (FSHD), or Limb-Girdle Muscular Dystrophy (LGMD) Independently ambulatory Exclusion Criteria: Patients with certain clinical conditions Patients using steroids or other medications with the potential to affect muscle function History of sensitivity to monoclonal antibodies or protein pharmaceuticals Pregnant or lactating 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MYO-029|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment |  |  |
Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn whether women who use progestin-only methods of birth control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared to women using the non-hormonal copper IUC (ParaGard). The investigators primary hypothesis is that users of DMPA will gain excess weight and increase their BMI above the copper-IUC users; secondarily, the investigators will compare users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.

Official Title
-----------------
Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period

Conditions
-----------------
Weight Change

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in CHOICE between the ages of 18 and 45 who consented to future studies Chose levonorgestrel-releasing IUD, copper IUD, the implant, or DMPA as their CHOICE baseline method Has baseline height and weight data collected from the on-campus enrollment site Able to come back to the on-campus enrollment site for consent process and enrollment activities Exclusion Criteria: Recent history of DMPA use before starting their baseline CHOICE method Used current method for less than 11 months or more than 12 months and three weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Weight | Change in weight from baseline at 12 months. | Baseline and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight change, contraception, birth control, progestin, progestin only, weight gain, depo, Depo Provera, DMPA, IUD, IUC, Mirena, Paragard, Implanon, implant
Effect of Resistive Exercise on Insomnia in Post Menopausal Women

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women

Detailed Description
-----------------
Insomnia is a prevalent condition in post menopausal women.resistive exercise might play an important role in insomnia.this trial has two groups ;one will receive advices and the second will receive advices and resistive exercise for four week

Official Title
-----------------
Effect of Resistive Exercise on Plasma Estradiol , Sleep Quality and Insomnia in Post Menopausal Women

Conditions
-----------------
Sleep Disturbances and Insomnia

Intervention / Treatment
-----------------
* Behavioral: Resistive exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age from 50 to 65 years non smokers BMI 25:29.9 post menopausal women suffer from insomnia Exclusion Criteria: post menopausal women suffer from any medical problems lead to sleep disturbance and insomnia women on hormone replacement therapy those with diagnosed osteoporosis

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Resistive exercise on insomnia
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Receive advices to reduce insomnia | Behavioral: Resistive exercise<br>* advices and resistive exercise<br>|
| Active Comparator: Group B<br>Receive advices and resistive exercise | Behavioral: Resistive exercise<br>* advices and resistive exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh sleep quality index | To determine sleep quality | Four week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity index | To determine insomnia | Four week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistive exercise, insomnia, post menopausal women
Effect of Ursolic Acid of Loquat Extract on Function of Muscle

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks.

Detailed Description
-----------------
This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks. Change over time in muscle fuction was evaluated by four outcomes: assessment of appendicular skeletal mass using DEXA (dual energy X-ray absorptiometry); quadriceps muscle power by Biodex; hand grib power; and Short Physical Performance Battery, SPPB.

Official Title
-----------------
Effect of Ursolic Acid of Loquat Extract on Function of Muscle in Human

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Dietary Supplement: UA group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18.5-30KG/M2 Exclusion Criteria: > SERUM creatinine 1.2mg/dL > AST or ALT 60IU/L DM Patients

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UA group<br>UA group who takes Ursolic acid of Loquat Extract , 500 mg/ day during 12 weeks for treatment of muscle function improvement with relatively health adults | Dietary Supplement: UA group<br>* Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks<br>|
| Placebo Comparator: placebo group<br>placebo group who takes a placebo, 500 mg/day for 12 weeks | Dietary Supplement: UA group<br>* Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quadriceps muscle function |  | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASM(appendicular skeletal mass) marker |  | 12weeks | 
| Short Physical Performance Battery, SPPB |  | 12weeks |
Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition. However, in COPD sildenafil may also impair gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research project is aimed to evaluate these effects. It is a prospective, randomized, double-blind study to evaluate the acute effects of a single dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20 patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and ventilation-perfusion distributions; at rest and during sub-maximal exercise.

Official Title
-----------------
Acute Effects of a Single Dose of Sildenafil (20mg/40mg) on Pulmonary Haemodynamics and Gas Exchange at Rest and During Exercise in COPD Patients With Pulmonary Hypertension

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Sildenafil
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD (FEV1/FVC<0.7) Age 40-75 Pulmonary hypertension (Vmax TI>=2.8m/sec) Exclusion Criteria: Treatment with CYP3A4 inhibitors, nitrates, PDE-5 inhibitors Coronary disease Ischemic optical neuritis

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Sildenafil 20mg | Drug: Sildenafil<br>* sildenafil 20 mg orally<br>|
| Active Comparator: 2<br>Sildenafil 40mg | Drug: Sildenafil<br>* sildenafil 40 mg orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of mean PAP and PVR |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CO, PaO2, V/Q |  | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients

Study Overview
=================
Brief Summary
-----------------
Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local treatment available is intralesional (IL) Pentostam injection. During the current study the investigators will monitor the adverse effects of this treatment and will follow up the recovery of the lesions after Pentostam injections.

Detailed Description
-----------------
Cutaneous leishmaniasis is usually treated by topical intervention. In more severe cases intralesional Pentostam injection may be applied. This treatment is extremely efficient but painful, however without the known adverse effects of IV Pentostam treatment. In this study the investigators will follow systematically all leishmania patients who are receiving the intralesional treatment. A structured questionnaire will be filled up in each doctor visit. The current study goal is to examine the adverse effects and the patient reaction to this treatment, and to follow the recovery of lesion(s) after this treatment including the number of IL injections which was needed.

Official Title
-----------------
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients

Conditions
-----------------
Cutaneous Leishmaniasis

Intervention / Treatment
-----------------
* Drug: Pentostam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cutaneous leishmaniasis patients Treatment by IL Pentostam Age above 18 years Exclusion Criteria: Children and pregnant women will not participate in the study

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Research group<br>The study group includes all CL cases for whom the treating physician decides to treat by IL Pentostam. The patients will return to follow up and additional treatment every 3 weeks until full recovery [as our current policy]. | Drug: Pentostam<br>* Intralesional injection of Pentostam<br>* Other names: Pentavalent antimonials;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | The adverse effects of IL Pentostam treatment will be monitored during the follow up period. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion healing | Lesions number and size will be recorded and response to treatment will be monitored. | 1 year |
Personalizing Docetaxel Dosing in Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with advanced prostate cancer are often treated with the chemotherapy drug docetaxel. The manufacturers of this drug suggest using the same dose of drug per m² body surface area for all patients. However we know that individuals end up with more or less of the drug circulating in their blood even after they have been given the same dose. A software program (a Dosing Tool) has been developed to provide information to doctors on how docetaxel will affect individual patients. The program may help doctors to make informed decisions about exactly how much drug to give to different people. The purpose of the PARTNER study is to gather information from blood tests on patients being treated with docetaxel to help in the further development of the Dosing Tool. Some of these blood tests would have been taken anyway as part of patients' routine treatment. Others are extra for this study. Apart from the additional blood tests, everyone who enters the study is treated just as they would normally be if they were not taking part in the study.

Official Title
-----------------
Personalizing Docetaxel Dosing in Advanced Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with metastatic prostate cancer (hormone sensitive or castrate resistant) and histologically confirmed Metastatic at disease onset or relapsed disease A treatment decision has been made to start a course of docetaxel as part of their standard of care treatment in accordance with the drug's label and the treating clinician's judgement Patient has not received a previous cycle of docetaxel within 8 weeks of the date of enrolment Life expectancy > 12 weeks Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: - Patients with autoimmune disease receiving active treatments Participant is unable to give informed consent

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

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

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 |
| --- | --- | --- |
| Measured vs predicted absolute neutrophil count over time between weeks three and six of docetaxel treatment |  | The tool will be used to predict the level of neutropenia between the second and third doses of docetaxel (so between weeks three and six of treatment) |