linjc16/ctgov huggingface dataset:
Different Doses of Vitamin A and Childhood Morbidity and Mortality

Study Overview
=================
Brief Summary
-----------------
Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio vaccine in national campaigns. However, it is not clear which dose is optimal. The two studies that have investigated the impact of different doses of vitamin A have both found that a smaller dose was better than a large dose. We therefore investigated if a smaller dose given with oral polio vaccine gives equal or better effect.

Detailed Description
-----------------
Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no clear evidence that a large dose is better than a small dose, the tendency being the opposite in the two studies of different doses of VAS that have been published so far. With the global effort to eradicate polio, national immunization days with oral polio vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half this dose gives a better protection against childhood morbidity and mortality.

Official Title
-----------------
Randomised Study of the Impact of Different Doses of Vitamin A on Childhood Morbidity and Mortality

Conditions
-----------------
Mortality, Morbidity

Intervention / Treatment
-----------------
* Drug: Vitamin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Between 6 mo and 5 years old and thus eligible for OPV and vitamin A during national immunisation day - Exclusion Criteria:Children with overt signs of vitamin A deficiency will not be enrolled in the study, but treated according to the recommendations. -

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vitamin A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  |  | 
| Hospitalisations |  |  | 
| Morbidity |  |  | 
| Growth |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotavirus infection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin A, Mortality, Morbidity, Doses, OPV
Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

Official Title
-----------------
A Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopa

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

Intervention / Treatment
-----------------
* Drug: AFQ056
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinson's Disease Patients with L-dopa induced dyskinesia for at least 3 months Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum Exclusion Criteria: History of severe allergy to food or drugs Very low or high body weight. Prior surgery for Parkinson's Disease Smokers Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AFQ056<br> <br> |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's, L-dopa, dyskinesia
Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction. The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.

Official Title
-----------------
Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality

Conditions
-----------------
Myocardial Infarction, Heart Failure, Myocardial Revascularization, Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Pikasol
* Other: Corn oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute myocardial infarction discharged from hospital alive Exclusion Criteria: Being part of another randomized trial Documented intolerance for omega-3 fatty acids Additional disease state that is thought to be incompatible with compliance to the study drugs Additional disease state thought to reduce survival for the follow-up time of 2 years

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 82 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pikasol<br>Pikasol®, 3 capsules (1.8 g EPA+DHA)/day | Drug: Pikasol<br>* Pikasol®, 3 capsules (1.8 g EPA+DHA)/day<br>* Other names: polyunsaturated fatty acids;|
| Placebo Comparator: Corn oil<br>3x capsules of corn oil pr day | Other: Corn oil<br>* Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. |  | 24months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of new onset atrial fibrillation |  | 24months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatty Acids, Omega-3, Aged, Myocardial Infarction
MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors

Study Overview
=================
Brief Summary
-----------------
What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases.

Official Title
-----------------
Role of MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors

Conditions
-----------------
Parotid Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Minor subject (<18 years old) Operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020 Having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital. Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research. Exclusion criteria: Subject (or his parents) who expressed his (their) opposition to participating in the study Lack of pathological or MRi results Subject under guardianship, curatorship or safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases |  | Files analysed retrospectively from January 1, 2009 to June 30, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perfusion MRI, Parotid Tumor, Diffusion MRI, Aspiration cytology, Fine-needle biopsy
Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis

Study Overview
=================
Brief Summary
-----------------
Hypersensitivity pneumonitis (HP) is a complex immune mediated disorders caused by repeated inhalation of and sensitization to wide range of antigens including organic particles and chemical compounds, leading to exaggerated immuneresponse. Hypersenstivity pneumonitis is a common form of diffuse parenchymal lung diseases in Egypt .Pulmonary hypertension has been found as a complication of a number of diseases affecting the lung interstitium, including hypersensitivity pneumonitis, with subsequent affection of the life expectancy Rationale of the study: to find predictors for the development of pulmonary hypertension in patients with hypersensitivity pneumonitis

Detailed Description
-----------------
Cross sectional study included 60 patients with established diagnosis of HP , work up includes history of exposure, clinical examination, HRCT chest, ABGs,6MWD, desaturation degree , spirometry, echocardiography and right heart catheter in patients with high echo probability of PH.

Official Title
-----------------
Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis

Conditions
-----------------
Pulmonary Hypertension, Hypersensitivity Pneumonitis

Intervention / Treatment
-----------------
* Procedure: Right heart catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with confirmed diagnosis of Hypersensitivity pneumonitis Exclusion Criteria: Other interstitial lung diseases

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: HP without Pulmonary hypertion<br>HRCT chest , pulmonary functions and echocardiography | |
| Active Comparator: HP with Pulmonary hypertion<br>HRCT chest , pulmonary functions ,echocardiography and RT heart catheter in high echocardiographic probability of PH | Procedure: Right heart catheter<br>* Right heart catheterization was performed for 4 cases with high probability of pulmonary hypertension using multi-lumen swan ganz catheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of pulmonary hypertension in patients with HP | primary oucome | 6 months |
Summative Evaluation to Validate the LEAFix Device With Users

Study Overview
=================
Brief Summary
-----------------
The Laryngeal Endo-tracheal Airway Fixator(LEAFix) is a single use product designed to secure airway devices to patients during anaesthesia, with better infection control management and interaction with the patients skin. This study investigates the users of the LEAFix device interacting with the LEAFix device, its packaging and a simulated patient through different scenarios of securing an airway device. The aim is to understand the risks associated with the use of the device for CE marking purposes. This study is funded by Innovel Ltd. the manufacturer of the device.

Official Title
-----------------
Summative Evaluation to Validate That the Laryngeal, Endo-tracheal, Airway Fixator (LEAFix) Can be Used Safely and Effectively by Intended Users to Secure Airway Devices

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Other: nil intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Member of staff trained in placing airways Exclusion Criteria: Previous knowledge of the device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Group A<br>Selection of tasks | Other: nil intervention<br>* Users observation using medical device on manakin, different scenarios per group<br>|
| Group B<br>Selection of tasks | Other: nil intervention<br>* Users observation using medical device on manakin, different scenarios per group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of user against the predetermined standard | The users will be marked against a standard set to look for problems | 1 hour |
Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
As part of the post-marketing surveillance, information is to be gathered regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice

Official Title
-----------------
Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice

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

Intervention / Treatment
-----------------
* Drug: Tiotropium bromide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged at least 40 years presenting with the symptoms of COPD Exclusion Criteria: Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Symptoms of COPD<br>Patients with symptoms of COPD receiving Tiotropium bromide 18 micrograms | Drug: Tiotropium bromide<br>* Tiotropium bromide18 micrograms (capsule with powder for inhalation)<br>* Other names: Spiriva®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in breathlessness when walking/climbing stairs |  | Baseline, after 4 weeks | 
| Change from baseline in overall severity of the clinical picture |  | Baseline, after 4 weeks of treatment | 
| Occurrence of Adverse Events |  | up to 4 weeks | 
| Change from baseline in breathlessness on Physical exercise |  | Baseline, after 4 weeks | 
| Change from baseline in breathlessness during housework |  | Baseline, after 4 weeks | 
| Change from baseline in breathlessness during everyday activities |  | Baseline, after 4 weeks |
The Role of Gastric Content Microaspirations in the Pathogenesis of Idiopathic Pulmonary Fibrosis

Study Overview
=================
Brief Summary
-----------------
The pathogenesis of idiopathic pulmonary fibrosis (IPF) is debatable. Looking for an insult to lung parenchyma that generates the pathogenesis of the disease is challenging. Pepsin is a proteolytic enzyme present in the gastric juice. Microaspirations of gastric content were described as a potential factor for injury in many chronic lung disorders. Bronchoalveolar lavage (BAL) is a routine investigation technique in interstitial lung diseases. The presence of pepsin in the BAL fluid recovered from patients with IPF may indicate a possible role for gastric microaspirations in the pathogenesis of the disease.

Official Title
-----------------
Study of Pepsin Levels in the Broncho-Alveolar-Lavage Fluid of Patients With Idiopathic Pulmonary Fibrosis

Conditions
-----------------
IDIOPATHIC PULMONARY FIBROSIS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with interstitial lung disorders including IPF Exclusion Criteria: patients younger than 18 years or older than 85, pregnant women, patients that present with medical conditions contra -indicated for performing bronchoscopy including sedation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| IPF<br>IPF patients diagnosed according to clinical and radiological findings | |
| NON IPF<br>Other interstitial lung diseases such as sarcoidosis or hypersensitivity pneumonitis diagnosed as per clinical and radiological findings | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BAL Pepsin level |  | 18 MONTHS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IDIOPATHIC PULMONARY FIBROSIS, MICROASPIRATION
HS Students Mandatory Universal Student Instruction in CPR Appraised Learning- Is the Mandate Working?

Study Overview
=================
Brief Summary
-----------------
This study will help to provide better input to state health and education departments to improve the processes for CPR education. This will also help the EP council explore the opportunities to partner with other professional societies and other stake holders that have interest in this topic. Engagement of private-public partnerships for improving overall CPR education.

Detailed Description
-----------------
Schools should incorporate CPR education programs in the schools that will increase the knowledge, skills and awareness among high school children. It is important to note that, CPR training of young children, increases the self confidence, esteem, responsibility and contribution to their community.Moreover, it is clearly shown that, high school children has the required physical strength, maturity and positive attitude towards performing CPR in family members, friends and strangers in the community. Although some studies suggest benefit of periodic retraining, few studies have attempted to collectively identify contributing factors to comprehension.It is an attempt to identify national distribution of training efforts and factors implicated in comprehension among high school students.

Official Title
-----------------
Assessment of Factors Impacting High School Students Mandatory Universal Student Instruction in Cardiopulmonary Resuscitation Appraised Learning- Is the Mandate Working? (The High School MUSICAL Study)

Conditions
-----------------
Sudden Cardiac Arrest

Intervention / Treatment
-----------------
* Other: High School Students Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High school students completing voluntary survey Exclusion Criteria: Inability to give consent Inability to complete survey

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: High School Students Survey|To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students. | To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students. | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CPR Education, High School Students