linjc16/ctgov huggingface dataset:
the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections.

Study Overview
=================
Brief Summary
-----------------
Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive in France, as 65%-85% of children below 11 years are being treated, frequently with Proton Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection rate but data in pediatry are scarce, especially in community medecine. Recently a study conducted in England brought up controversial results suggesting that the use of PPIs can be associated with a reduced risk of community acquired pneumonia. Our study was aimed to assess, on a population-based database, the association between PPI prescription and community infections in children of 11 years or under.

Official Title
-----------------
A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections

Conditions
-----------------
Community Infections

Intervention / Treatment
-----------------
* Other: all children with at least one prescription of PPI
* Other: all children with no prescription of PPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 11 years or below with at least 2 consultations during the follow up Exclusion Criteria: chronic pulmonary or cardiac muscoviscidosis immunodeficiency H. pylori infection Diabetes Denutrition known digestive upper tract malformation

Ages Eligible for Study
-----------------
Maximum Age: 11 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 |
| --- | --- |
| PPI exposed children<br>all children with at least one prescription of PPI | Other: all children with at least one prescription of PPI<br>* all children with at least one prescription of PPI<br>|
| non-exposed children<br>all children with no prescription of PPI | Other: all children with no prescription of PPI<br>* all children with no prescription of PPI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of overall infections | Comparison of number of infections between PPI exposed and non-exposed children. All infections are taken in account | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of specific infections | Comparison of number of infections between PPI exposed and non-exposed | 4 years |
Comparative Effectiveness of Stress Tests

Study Overview
=================
Brief Summary
-----------------
The primary objective of this project is to demonstrate that a new approach to cardiac stress imaging that combines treadmill exercise with cardiac magnetic resonance (CMR) provides valuable clinical information in a cost-effective manner.

Official Title
-----------------
EXACT-COST: Exercise CMR's Accuracy for Cardiovascular Stress Testing-Comparative Effectiveness of Stress Tests

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Diagnostic Cardiac Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient referred for stress SPECT known or suspected ischemic heart disease ability to perform adequate treadmill stress Exclusion Criteria: any contraindication to MRI (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/ICD, severe claustrophobia) renal insufficiency (GFR < 40) known allergy to gadolinium-based contrast or iodinated contrast (because of the research CTA in patients not referred for cath after 2 weeks)

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Diagnostic Cardiac Imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total patient direct and indirect medical costs for one year following stress testing will be less for patients undergoing stress CMR as compared to patients undergoing stress Nuclear. | Patients will undergo either Stress CMR or stress Nuclear testing. For each individual patient, the cost of the initial test, the subsequent follow-up costs, and the total costs over the follow-up period will be calculated. Total costs will be collected for direct medical, direct non-medical and indirect costs. Direct medical costs will include those applied for medications, imaging, invasive therapies and healthcare services; as well as costs resulting from side effects or complications from each of the testing strategies. Direct non-medical costs will include those incurred due to CAD-related illness or the need to seek care, such as caregiver costs and patient transportation costs. Indirect costs, will be defined as lost productivity due to time lost from work, early death or disability. | baseline |
Artificial Tears Study in Mild to Moderate Dry Eye Patients

Study Overview
=================
Brief Summary
-----------------
The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.

Official Title
-----------------
Artificial Tears Study in Mild to Moderate Dry Eye Patients

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
* Drug: Systane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate dry eye over 18 Exclusion Criteria: No concurrent ocular disease or meds

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Systane | Drug: Systane<br>* Drops<br>|
| Experimental: 2<br>Blink tears | Drug: (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400<br>* Drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective ocular comfort |  | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision quality |  | 1 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry, eyes, Amelioration of dry eye symptoms
Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice

Official Title
-----------------
Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are initiating treatment with Yervoy Exclusion Criteria: Not Applicable Other protocol defined inclusion/exclusion criteria could apply
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Population With Yervoy Exposure<br>Population With Yervoy Exposure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events (AEs) by types among the analysis population |  | 12 months | 
| The Overall Survival (OS) Rate |  | 12 months | 
| The factors that potentially affect safety or effectiveness | Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background | 12 months |
Lipid Based Food Additives for Treating Patients With Dry Mouth

Study Overview
=================
Brief Summary
-----------------
Over 10% of adult population suffers from dry mouth (xerostomia). The aim of this double blind prospective clinical trial is to examine a new lipid based food additive formulation to ease mouth dryness in these patients.

Official Title
-----------------
Lipid Based Food Additives for Treating Patients With Dry Mouth

Conditions
-----------------
Xerostomia

Intervention / Treatment
-----------------
* Device: lipid based additives based on vegetable oil & lecithin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry mouth patients Exclusion Criteria: Disabled patients Pregnant Full upper denture Under 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: lipid based additives based on vegetable oil & lecithin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in dry mouth symptom |  |  |
A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors

Study Overview
=================
Brief Summary
-----------------
This study is an observational study evaluating the clinical outcomes of mucosal sparing proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained baseline adverse event and Quality of Life (QOL) data will be collected and subjects will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No study-specific visits or evaluations will be required. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered on study until 24 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure.

Official Title
-----------------
A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors

Conditions
-----------------
Oropharyngeal Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resection of oropharyngeal tumor by transoral surgery using frozen section margin analysis resulting in a negative margin resection No extensive perineural invasion after review by head and neck pathologist No lymphovascular invasion after review by head and neck pathologist Pathologic stage T1-2 N1-3 M0 disease Exclusion Criteria: T3 or T4 primary stage disease Prior radiation therapy to the head and neck

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control Rate in Patients Treated with Proton Beam Therapy after Resection Using Transoral Surgery | Local control rate will be assessed by standard of care head and neck clinical examination during routine followup visits | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proton
Efficacy of Selegiline in Negative Symptoms of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however their efficacy in treating negative symptoms is limited. This study wants to evaluate efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients will select to receive selegiline or placebo. Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1- Patients with moderate to severe negative symptoms 2- Patients with at least one year antipsychotic drug therapy, at the current dose >= 1 month. 3- No other psychotropic drugs during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse, severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during past month.

Official Title
-----------------
Efficacy of Selegiline Augmentation of Antipsychotic Medication to Treat Negative Symptoms in Inpatients With Chronic Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Selegiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate to severe negative symptoms Patients with at least one year antipsychotic drug therapy, at the current dose >= 1 month. No other psychotropic drugs during past month Exclusion Criteria: Severe major depressive disorder Substance abuse Severe positive symptoms of schizophrenia Treatment of MDD with antidepressant drugs during past month.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: Selegiline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreasing in negative symptoms in case group |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seligiline, Negative symptoms, Schizopherenia
Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
Diabetes mellitus is a chronic disease that affects 366 million people worldwide ( 6.4 % of the adult population ) and is expected to rise to 522 million by 2030 . Diabetic nephropathy occurs in approximately one - third of all people with diabetes and is the leading cause of renal failure in developed and developing countries Diabetic nephropathy is a severe complication occurring in diabetic patients and it is associated with an increased risk of all- cause mortality , cardiovascular disease and progression to end stage renal disease , requiring costly renal replacement therapy in the form of dialysis or transplantation

Official Title
-----------------
Serum Immunoglobulin (G ) as a Predictive Marker of Early Renal Affection in Type 2 Diabetic Patients

Conditions
-----------------
Diabetic Nephropathies

Intervention / Treatment
-----------------
* Diagnostic Test: serum immunoglobulin G level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetic patients Exclusion Criteria: patients with diabetes type 1 , pregnant and lactating females , patients with any congenital disease , Infection , Smokers , alcoholics , and drug abusers .

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>25 diabetic patients without diabetic nephropathy | Diagnostic Test: serum immunoglobulin G level<br>* measurement of the serum level as a marker of diabetic complications<br>|
| Experimental: group 2<br>25 type 2 diabetic patients with diabetic nephropathy | Diagnostic Test: serum immunoglobulin G level<br>* measurement of the serum level as a marker of diabetic complications<br>|
| Sham Comparator: group 3<br>25 healthy subjects | Diagnostic Test: serum immunoglobulin G level<br>* measurement of the serum level as a marker of diabetic complications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with high level of immunoglobulin in serum |  | 24 hours |
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications To determine the associations between serum-prolactin and sex hormones / metabolic biomarkers/ clinical symptoms in this population. If clinically relevant associations are found: To determine a potentially existing no harm serum-prolactin threshold To determine associations between previous cumulative prolactin-exposure and current pubertal development / growth

Official Title
-----------------
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics

Conditions
-----------------
Hyperprolactinemia, Puberty Disorders, Metabolic Syndrome, Growth Disorders, Antipsychotics and Neuroleptics Toxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • In daily treatment with antipsychotic medication belonging to Anatomical Therapeutic Chemical (ATC) group N05A (except N05AN lithium) for a minimum duration of 3 months prior to inclusion Exclusion Criteria: Eating Disorder Medical treatment to change sex Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum 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 |
| --- | --- | --- |
| Prevalence of hyperprolactinemia |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| associations between serum-prolactin and sex hormones / metabolic biomarkers / clinical symptoms |  | 2 years | 
| associations between previous prolactin-exposure and current pubertal development / growth |  | 2 years |
Bioequivalency Study of Sertraline Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fasting Conditions

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. Treatment with any triptan within 30 days prior to or during the study. History of allergic or adverse response to sertraline or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sertraline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Fourteen day washout |
Aripiprazole in Patients With Acute Mania

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to test the safety & efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Acute Bipolar I Mania Exclusion Criteria: Patients with a DSM-IV diagnosis other than Bipolar I Mania

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aripiprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in a mania rating scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate and Clinical Global Impression scale at endpoint |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Mania