linjc16/ctgov huggingface dataset:
Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II

Study Overview
=================
Brief Summary
-----------------
The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: bosentan
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAH NYHA Class II Significant elevation of mean pulmonary arterial pressure Significant elevation of pulmonary vascular resistance at rest Limited 6-minute walk distance Exclusion Criteria: PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt Restrictive or obstructive lung disease Significant vasoreactivity Treatments for PAH (within 4 weeks of randomization)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>62.5 mg table twice a day for 4 weeks followed by 125 mg tablet twice a day for 6 months followed by an open label period until end of study. | Drug: bosentan<br>* 65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study<br>* Other names: Tracleer;|
| Placebo Comparator: 2<br>placebo for 6 months followed by an open label period | Drug: placebo<br>* placebo for 6 months followed by an open-label period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity |  | Baseline to end of study | 
| cardiac hemodynamics |  | Baseline to end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary arterial hypertension, PAH, PPH, bosentan, early
Recurrent Crying Spells in Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.

Detailed Description
-----------------
This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.

Official Title
-----------------
Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study

Conditions
-----------------
Recurrent Crying Spells

Intervention / Treatment
-----------------
* Drug: Baclofen
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis. Age range 0-12 years. Exclusion Criteria: Crying due to known causes (like hunger, sleep, food intolerance etc.), Crying that responded to routine management (changes in food or feeding techniques, anticolic, analgesics), Fever of ≥100.4ºF (38ºC), The infant refuses to eat or drink for more than a few hours, vomits excessively, has bloody stools, or has a change in behavior (lethargy or decreased responsiveness). Colic Worst ever crying occurring for the first time Respiratory, renal and hepatic diseases, Progressive encephalopathies, Received Baclofen in the previous 30 days

Ages Eligible for Study
-----------------
Maximum 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baclofen<br>The starting dose was 0.75 mg/kg in four divided doses daily and was cautiously increased at three-day intervals until crying subsided or symptoms of over dosage or side effects appeared. The usual maximum dose was two mg/kg in four divided doses daily. | Drug: Baclofen<br>* Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.<br>|
| Placebo Comparator: placebo<br>Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen. | Other: Placebo<br> <br> * Other names: Fructose powder.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline cry duration in seconds over a 10-day period while on placebo. | Cry duration in seconds over a 10-day period while on placebo was compared to that of Baclofen. | 11th to 20th day and 51st day to 60th day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Baclofen, cerebral palsy, colic, crying infant, recurrent crying spells, spasticity, therapy
Real-life Experience of the Use of Isomers as METPURE XL (S (-) Metoprolol Succinate) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, observational, open study in patients who their doctor has prescribe METPURE XL (S (-)metoprolol succinate)by clinical practice. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8.

Conditions
-----------------
Hypertension, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were prescibed with s(-)metoprolol succinate(25mg, 50mg), depending on their clinical condition and use locally approved will be eligible to participate in this study

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of therapy in the management of cardiovascular diseases | The objective is to mesure the effect of Metpure XL in cadiovascular diseases as hypertension, post MI and coronary disease | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate and compare the rate of compliance with treatment | Evaluate the compliance with METPURE XL, to be able to identify possible reasons for noncompliance or quitting the treatment | 8 weeks | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | To assess the safety pattern in Colombian subjects using s(-)metoprolol succinate | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colombia, Observational, Metpure XL
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients

Study Overview
=================
Brief Summary
-----------------
This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.

Official Title
-----------------
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Procedure: early tracheotomy
* Procedure: prolonged endotracheal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under ventilation support for at least 4 days Patients needing ventilatory support for > 7 days Age > 18 years Informed consent signed Exclusion Criteria: Patients previously tracheotomised Major hemorrhagic risk Patients previously randomised in a trial

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: early tracheotomy|nan|
|Procedure: prolonged endotracheal intubation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days mortality |  |  | 
| cumulated incidence of nosocomial pneumonia between days 1 and 28 |  |  | 
| number of ventilatory free days between days 1 and 28 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time in the ICU |  |  | 
| time on mechanical ventilation |  |  | 
| 60 days mortality |  |  | 
| number of septic episodes |  |  | 
| accidental extubation |  |  | 
| amount of sedation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU patients needing prolonged ventilatory support
Apremilast in the Treatment of Uveitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.

Official Title
-----------------
An Open-label Trial to Assess the Efficacy and Safety of Apremilast in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression.

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: Apremilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with vision-threatening autoimmune uveitis failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects Exclusion Criteria: serious concomitant illness that could interfere with the subject's participation previous or current use of an alkylating agent use of CYP3A4 inhibitors during the trial TNF blocker use within the 8 weeks prior to enrollment

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: Treatment<br>Patients receiving apremilast. | Drug: Apremilast<br>* oral dose of 30 mg BID for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye |  | 6 months | 
| Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% |  | 6 months | 
| Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis) |  | 6 months | 
| Reduction in Cystoid Macular Edema |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uveitis, apremilast
Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.

Study Overview
=================
Brief Summary
-----------------
Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the macular area. Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be evaluated by its optical density. Reduced macular pigment level is a significant risk factor for age-macular degeneration. The nutritional intake can minimise the risk of age-macular degeneration.

Conditions
-----------------
High Myopia

Intervention / Treatment
-----------------
* Device: MPS II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years-old High axial myopia < -6 dioptries Presence or not of lacquer cracks in Bruch's membrane in one or both eyes Patients with social security coverage Exclusion Criteria: Age <18 years-old Amblyopia in the studied eye Prior ocular surgery Corneal disease or severe dry eye syndrome Other retinal disease: diabetic retinopathy, age-related macular degeneration, macular hole, epiretinal membrane central Extensive chorioretinal atrophy Allergy to tropicamide Pregnancy

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

Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High myopic patients with lacker craks<br> | Device: MPS II<br> <br> |
| Other: High myopic patients without lacker cracks<br> | Device: MPS II<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between lacquer cracks related to high myopia and the macular pigment optical density |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The macular pigment optical density among high myopic patients |  | 1 day |
Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.

Conditions
-----------------
Apical Periodontitis

Intervention / Treatment
-----------------
* Procedure: Root Canal Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a permanent, single or multi-rooted mature tooth clinical diagnosis of irreversible pulpitis diagnosis of apical periodontitis Exclusion Criteria: subjects with immune-compromised status subjects with an overall poor prognosis for their treatment

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydraulic Sealer Group<br>The single-cone obturation technique is based on a master cone of gutta-percha in conjunction with a hydraulic sealer. Hydraulic endodontic cements exhibit excellent hydraulic properties, biocompatibility and bioactivity. | Procedure: Root Canal Treatment<br> <br> |
| Active Comparator: Zinc oxide-eugenol Sealer Group<br>The continuous wave of condensation of gutta-percha and a zinc oxide-eugenol (ZOE) sealer is a gold standard in endodontic obturation. | Procedure: Root Canal Treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periapical Healing | Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score <2) | 4 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tooth survival | Success was defined if the tooth was asymptomatic and considered to be functional regardless of its PAI score | 4 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
root canal obturation, hydraulic sealer, single cone, endodontic outcome
Efficiency of Inspiratory Muscle Training in Elderly People

Study Overview
=================
Brief Summary
-----------------
Efficiency of inspiratory muscle training in elderly people. Outcomes are lung function, muscle strength and chest expansion.

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

Intervention / Treatment
-----------------
* Device: Threshold inspiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: pulmonary diseases cognitive disorders

Ages Eligible for Study
-----------------
Minimum Age: 60 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: inspiratory muscle training<br>Muscle training | Device: Threshold inspiratory muscle training<br>* Inspiratory muscle training<br>|
| No Intervention: control<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function will be measured by spirometry |  | One month | 
| chest expansion will be measured by a tape measure |  | One month |
Life Style Modification for Breast Canccer Survivors Using Mobile App-based Human Coaching Program

Study Overview
=================
Brief Summary
-----------------
This study is aimed to investigate whether mobile app-based human coaching program for 6 months is effective for reducing BMI in breast cancer survivors with overweight and obesity.

Official Title
-----------------
A Prospective Study on the Effect of Quality of Life and Life Style Modification for Breast Cancer Survivors Using Mobile App-based Human Coaching Program

Conditions
-----------------
Breast Cancer Survivors

Intervention / Treatment
-----------------
* Other: mobile application program with human coach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer survivors who have completed acute treatment of breast cancer Age: 18   70 year old stage: I, II, III BMI≥25.0 Kg/m2 breast cancer survovrs who can use mobile application program breast cancer survovrs who agree with this study's consent Exclusion Criteria: Stage IV, carcinoma in situ breast cancer survivors who don't use smartphone breast cancer survivors with previous other malignant disease breast cancer survivors with multiple malignancies breast cancer survivors with uncontrolled chronic comorbid disease breast cancer survovrs who disagree with this study's consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer survivors with over-weight or obesity<br>Breast cancer survivors with 25 and more than 25 of BMI will be supported with 6 months life style modification program using mobile application including human coach for reducing BMI. | Other: mobile application program with human coach<br>* 6-months mobile application program with human coach for life-style modifiation including diet and exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of body mass index (BMI) | whether the 6-month mobile program can be effective for reducing BMI | Baseline and 6 month |