linjc16/ctgov huggingface dataset:
Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients (0954A-322)

Study Overview
=================
Brief Summary
-----------------
Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).

Official Title
-----------------
Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: losartan potassium (+) hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACEi or ARB naive or not taking ACEi or ARB concurrently for at least one month before the run-in period Be able to carry out his or her own daily activity - Be at least 50 years old at inclusion in the study Be diagnosed with mild to moderate hypertension, treated or untreated Literate Not taking any cognitive-enhanced agent at baseline Present with a memory complain ( spontaneous or informed by caregiver) Exclusion Criteria: Congestive heart failure with NYHA class >2 Renal failure or renal insufficiency with serum creatinine >1.4mg/dl chronic severe liver disease with abnormal GPT and GOT >2 times of upper normal limits Diagnosed with major depression when entering the study Foreign language as his or her mother tongue so that the test results will not be reliable History of stroke or transient ischemic attack (stroke is defined as focal neurological sign progressing stepwise) Hypersensitive to the active ingredient and any other component of losartan potassium and indapamide tablets Major hearing loss/deafness and/or major visual impairment/blindness preventing from performing the tests Myocardial infarction within the past 6 months Single functioning kidney Anuria

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- |
|Drug: losartan potassium (+) hydrochlorothiazide|losartan potassium (+) hydrochlorothiazide combination will be titrated upwards according to the following scheme: losartan potassium 50/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 25|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological tests and blood pressure after treatment of 12 weeks |  | after treatment of 12 weeks |
Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.

Study Overview
=================
Brief Summary
-----------------
Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).

Detailed Description
-----------------
A voiding cystourethrogram was performed for each child less than 3 years old with a first urinary tract infection. In case of vesico-ureteral reflux, a randomization was done between continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no antibioprophylaxis. Duration of follow up was 18 months.

Official Title
-----------------
Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Procedure: Antimicrobial prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children less than 3 years old First proved urinary tract infectionIsolated vesico-ureteral reflux Parents have been fully informed and have given written informed consent to participate in the study Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 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: Antimicrobial prophylaxis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End point : recurrence of urinary tract infection during the study period (0 è 18 months) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Type of urinary tract infection (pyelonephritis or cystitis) |  |  | 
| 2) Evaluation of the quality of life with a validated questionnaire done at 9 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary tract infection, Vesico-renal reflux, Child, Antimicrobial prophylaxis, Recurrence of urinary tract infection
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

Study Overview
=================
Brief Summary
-----------------
This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.

Official Title
-----------------
A Pilot, Multicenter, Open Label, Non Comparative Study of the Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media Twice Daily for Seven Days in Children With Tympanostomy Tubes

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Drug: ofloxacin otic solution 0.3%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 6 months of age to <12 years of age weight = or >4.5 kg Patent tympanostomy tube(s) in the affected ear(s) Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin Exclusion Criteria: Non-bacterial otic infection Known or suspected hypersensitivity to ofloxacin Cystic fibrosis HIV infection Neutropenia Receiving immunosuppressive therapy

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Floxin otic solution twice a day for 7 days | Drug: ofloxacin otic solution 0.3%<br>* ofloxacin otic solution 0.3% instilled twice a day for seven days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sponsor determined clinical cure of otitis media |  | 7 days | 
| Sponsor determined microbiological cure of otitis media |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator determined clinical cure |  | 7 days | 
| Overall per-subject microbiological outcome |  | 7 days | 
| Overall per pathogen microbiological outcome |  | 7 days | 
| sign and symptoms of otitis media |  | 7 days |
Azelaic Acid Versus Hydroquinone in Melasma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.

Detailed Description
-----------------
Melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. Hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. Azelaic acid gel is currently used to treat acne and rosacea.

Official Title
-----------------
Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma

Conditions
-----------------
Melanosis

Intervention / Treatment
-----------------
* Drug: azelaic acid gel
* Drug: hydroquinone cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have stable moderate-severe epidermal or mixed melasma involving the face all races males and females persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months Exclusion Criteria: if the person has only dermal melasma pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant a known allergy or sensitivity ot azelaic acid or hydroquinone the use of photosensitizing medications (ex. tetracycline) within 3 months of the study. starting or stopping hormonal medication within 3 months chemical peels, microdermabrasion, or laser treatment within 6 months worsening or improving melasma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azelaic Acid<br> | Drug: azelaic acid gel<br>* azelaic acid 15% gel twice a day for 6 months<br>* Other names: Finacea Gel;|
| Active Comparator: Hydroquinone<br> | Drug: hydroquinone cream<br>* hydroquinone 4% cream twice a day for 6 months<br>* Other names: Lustra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of melasma |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanosis, melasma, azelaic acid, hydroquinone
Sputum and Plasma Levels of Nociceptin and Substance P in Patients With Asthma, COPD and Chronic Cough

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance P with cough severity and airway hyperreactivity in patients with asthma, COPD and chronic cough.

Detailed Description
-----------------
Recent animal studies have found that nociceptin can inhibit cough responses induced by capsaicin. We hypothesize that sputum and plasma levels of these peptides may reflect some neurochemical alterations in airway cough reflex or neurogenic inflammation in asthma or COPD. The aims of this study are to investigate the association between sputum and plasma levels of nociceptin and substance P with cough severity and airway hyperreactivity in patients with asthma, COPD and chronic cough. We will enroll 260 patients (100 patients with asthma, 60 with COPD and 100 with chronic cough) as well as 40 healthy subjects for this study. Sputum and peripheral blood will be collected and concentrations of nociceptin and substance P will be measured by ELISA. These levels will be correlated with cough severity (symptom scores), and airway hyperresponsiveness to inhaled methacholine as measured by PC20. Sputum and plasma concentrations of both peptides will be rechecked after clinical improvements in cough or airway symptoms are achieved after therapy.

Official Title
-----------------
Association Between Sputum and Plasma Levels of Nociceptin and Substance P With Cough Severity and Airway Hyperreactivity in Patients With Asthma, COPD and Chronic Cough

Conditions
-----------------
Asthma, COPD, Cough

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:patients with asthma, COPD, chronic cough - Exclusion Criteria:patients refusing blood sampling

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nociceptin, sunstance P, asthma, COPD, cough
The Effect of Midazolam Premedication on Copeptine Concentration in Blood

Study Overview
=================
Brief Summary
-----------------
The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood.

Official Title
-----------------
The Effect of Midazolam Premedication on Copeptine Concentration in Blood

Conditions
-----------------
Preanesthetic Medication, Copeptin

Intervention / Treatment
-----------------
* Drug: Midazolam Oral Tablet
* Other: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective surgery Patients with no chronić illness and considered ASA 1 by anesthesiologist Patients with mild and controlled chronic illness considered ASA 2 by anesthesiologist Exclusion Criteria: Patient refusal Chronic illness requiring intense treatment or uncontrolled illness (ASA 3 or more)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MIDAZOLAM<br>Patients receive midazolam 7,5mg night before and 60 minutes prior to surgery as part of preanesthetic medication | Drug: Midazolam Oral Tablet<br>* Midazolam Oral tablet<br>|
| Placebo Comparator: PLACEBO<br>Patients receive 1000mg Glucose tablets night before and 60 minutes prior to surgery during premedication | Other: Placebo Oral Tablet<br>* Glucose 1000mg tablet night before surgery and 60 minutes before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in copeptin concentration | Change in the concentration of copeptine measured in blood serum | 48 hours |
Methylphenidate in the Treatment of Cocaine Dependent Patients With Adult Attention Deficit Hyperactivity Disorder - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the use of Methylphenidate in the treatment of cocaine dependence and Attention Deficit Hyperactivity Disorder (ADHD) comorbidity.

Detailed Description
-----------------
The objective of this study is to determine the safety and efficacy of methylphenidate in a population of patients who are cocaine dependent and suffer from attention deficit hyperactivity disorder.

Official Title
-----------------
Methyphendidate in the Treatment of Cocaine Dependent Patients With Adult ADHD

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cocaine-dependent. Meets the DSM-IV criteria for ADHD. Actively using cocaine within the past 30 days of screening. Exclusion Criteria: Symptoms of AIDS. Significant medical disorder. DSM-IV criteria for any substance other than cocaine, alcohol, nicotine, marijuana, caffeine. Requires detoxification from ETOH or benzos. History of seizures.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine use |  |  | 
| Methylphenidate retention |  |  | 
| Safety assessments |  |  | 
| Psychosocial counseling sessions |  |  |
Identification of the Cranberry Juice Compounds That Prevent Urinary Tract Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the substances in cranberry juice that make it effective in reducing urinary tract infections (UTIs) in women.

Detailed Description
-----------------
Urinary tract infections (UTIs) are a significant health issue, with one fourth of all women experiencing symptoms during their lifetimes. Cranberry juice has been shown to reduce the incidence of UTIs by preventing bacteria from adhering to the bladder. However, the compounds that direct this activity have not been identified. This study will identify and examine UTI-reducing compounds in cranberry juice. Participants in this study will drink a specified amount of water following an overnight fast. Their urine will be collected 1 to 3 hours after the water is consumed. Several days later, the women will be provided with cranberry juice to replace the water in the regimen. Urine samples will be analyzed for compounds that have antibacterial or antiadhesion activity against the bacteria that cause UTIs.

Official Title
-----------------
Cranberry Juice Metabolites in Urine

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Drug: Cranberry juice cocktail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good overall health Exclusion Criteria: History of urinary tract infections Use of cranberry products or antibiotics within 1 week of study start Current use of any other medication Hypertension Diabetes Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Cranberry juice cocktail|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccinium macrocarpon
Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration

Study Overview
=================
Brief Summary
-----------------
Various types of periodontal probes (e.g., metal probes, plastic/bendable probes, electronic periodontal probes) are used for peri-implant pocket depth registration; however, depending on the shape and size of the prosthetic restoration an accurate peri-implant pocket registration might be impeded with standard metal probes. There is currently no systematic assessment of which probe is more accurate in peri-implant pocket registration. Therefore, peri-implant pocket registration of 50 patients with a screw-retained prosthetic restoration will be recorded with 3 different periodontal probes; i.e., with a metal probe, with a plastic probe, and with an automatic periodontal probe, before and after removal of the prosthetic restoration.

Official Title
-----------------
Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration

Conditions
-----------------
Peri-implant Mucositis, Peri-Implantitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: screw-retained prosthetic implant restoration Exclusion Criteria: - cemented prosthetic implant restoration

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 |
| --- | --- | --- |
| peri-implant probing pocket depth | peri-implant probing pocket depth in mm | 1 day (single measurement) |