linjc16/ctgov huggingface dataset:
Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles

Study Overview
=================
Brief Summary
-----------------
This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.

Official Title
-----------------
An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.

Conditions
-----------------
Peri-oral Wrinkles

Intervention / Treatment
-----------------
* Device: Restylane and Perlane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Same Wrinkle Severity (either both Moderate [3] or both Severe [4]) of marionette lines and upper peri-oral rhytids Exclusion Criteria: Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry Permanent implant placed in the Nasolabial Fold area

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restylane and Perlane<br>Restylane and Perlane administered by injection. Recommended volume of 6.0 mL. Injection on study day 1 with an optional touch up on study day 14. | Device: Restylane and Perlane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and Systemic Adverse Events | To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of: All local adverse events as reported by healthcare professional All systemic adverse events (related and unrelated) | 2-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Correction of peri-oral wrinkles
Parkin Mutations and Their Functional Consequences

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease (PD) is the most frequent neurodegenerative disease with a prevalence of 2% over 65 years and because of this high prevalence as the population ages, it is a major problem of public health. An exhaustive repertory of not only parkin mutations in autosomal recessive forms of PD but also in other known genes such as DJ-1, PINK1 and LRRK2, is of major importance for both genetic counseling in families affected with PD and physiopathological approaches to this disease. Through a French network for the study of Parkinson's disease genetics and extended collaborations with European, Mediterranean and other various countries, a total of 2934 subjects including 1683 patients and 1251 unaffected individuals has been collected since 2002. These samples consisted of 122 families with autosomal recessive PD, 285 cases of isolated early onset PD, 110 autosomal recessive and 129 autosomal dominant families with late onset PD, 201 isolated late onset PD cases and 250 matched controls. DNAs from all subjects are now available, lymphocytes and lymphoblastoid cell lines have been stored for most patients from France and recently, fresh fibroblasts have been obtained for some individuals. The genetic approach to autosomal recessive PD is focused on the identification of mutations in the parkin gene but also on the screening of DJ-1, PINK1 and LRRK2 genes.

Official Title
-----------------
Parkin Mutations and Their Functional Consequences

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with Parkinson's disease, with a family history or not, Minors presenting clinical signs of the disease, Controls (without signs of the disease, matched by sex and age with the patients, relatives for the familial cases) Exclusion Criteria: Persons refusing to sign the informed consent, Lack of clinical information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
-----------------
Parkinson's disease, phenotype-genotype correlations, mutations spectrum, candidate genes
Titratable Dosing in Moderate to Severe Asthmatics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

Official Title
-----------------
A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol
* Drug: Symbicort pMDI + budesonide HFA pMDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol Exclusion Criteria: Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker. Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: budesonide/formoterol<br> <br> * Other names: Symbicort;|
| Sham Comparator: 2<br> | Drug: Symbicort pMDI + budesonide HFA pMDI<br>* Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. |  | 7 assessments within 12 month treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure changes in lung function tests, patient reported outcomes and usage of medical resource |  | 7 assessments within 12 month treatment period | 
| Blood levels of budesonide and formoterol |  | 10 blood samples taken at 1 visit in a sub-set of patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, adults, adolescents, safety, Symbicort, budesonide/formoterol, budesonide
Study of Prevalence of Proteinuria, Urinary Tract Infection or Hematuria in Athletes

Study Overview
=================
Brief Summary
-----------------
To understand the urine analysis of athletes

Detailed Description
-----------------
there maybe some genitourinary problem related to athletes, such as proteinuria, hematuria, scrotal pain, STD, etc. To explore these problems and give adequate management for them not only improved athletes' health, but also it can do their best in their exercise performance.

Official Title
-----------------
Urine Analysis in Different Types of Athletes

Conditions
-----------------
Proteinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proteinuria, hematuria, pyuria Exclusion Criteria: bacteriuria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| 1<br>tract and field athletes | |
| 2<br>swimming athletes | |
| 3<br>tennis athletes | |
| 4<br>football athletes | |
| 5<br>basketball athletes | |
| 6<br>Badminton athletes | |
| 7<br>control group | |

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
-----------------
hematuria, urinary tract infection
Patient Education in Pregnant Women With Asthma

Study Overview
=================
Brief Summary
-----------------
Pregnancy may impact treatment adherence in women with asthma. This is a major risk factor for asthma exacerbation, which may have an important impact for both women and the babies. This study aims to evaluate the impact of a targeted patient education action tailored for pregnant women with asthma.

Official Title
-----------------
Patient Education: Asthma and Pregnancy

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult pregnant women with asthma Exclusion Criteria: women not able to speak and/or read French language women protected by the law

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 |
| --- | --- |
| pregnant women with asthma<br> | Other: follow-up<br>* Questionnaire of Quality of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Asthma quality of life between two periods : before intervention and 3 month after the intervention | The physician gives Asthma quality of life questionnaire (AQLQ) before intervention and 3 month after the intervention | before and 3 month after the intervention |
PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study)

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with acute heart failure can identify patients at risk for recurrent admissions for heart failure.

Detailed Description
-----------------
Primary Objective Determine the ability of EKG voltage changes and pre discharge 6-minute walk test (6-MWT) to predict repeat heart failure hospitalization (HFH) in patients admitted with acute decompensated heart failure (ADHF). Secondary Objectives Determine the ability of EKG voltage changes and pre discharge 6-MWT) to predict a composite of 1 year mortality and HFH in patients admitted with ADHF. Determine the ability of proportionate pulse pressure, orthostatic blood pressure changes and pre discharge inferior vena cava (IVC) diameter by portable ultrasound to predict HFH and mortality

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Electrocardiogram
* Procedure: Six minute walk test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years of age, admitted with a diagnosis of ADHF and fulfilling the following criteria: Evidence of systemic congestion (manifested by any 2 of the following criteria: jugular venous distension, edema, pulmonary rales, Left ventricular S3, or radiographic evidence of pulmonary venous congestion) Elevated Brain natriuretic peptide Need for at least 1 dose of intravenous loop diuretic Exclusion Criteria: Cardiogenic shock, Acute coronary syndromes (patients with mild elevation in troponin related to heart failure will not be excluded), patients who are admitted for another principal problem and develop ADHF in the hospital, pregnant females, end stage renal disease on hemodialysis, expected survival < 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Heart Failure Admission<br>Patients admitted for acute decompensated heart failure | Procedure: Electrocardiogram<br>* EKG voltage changes between admission and discharge<br>* Other names: EKG;Procedure: Six minute walk test<br> <br> * Other names: 6-MWT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF) |  | 1 year | 
| Mortality | All cause mortality at 1 year | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of APSLXR in participants with Meniere's disease or other Verigo of vestibular origin. Pharmacokinetics will also be evaluated in a small group.

Official Title
-----------------
Multicentre, Open Label, Phase I Clinical Trial to Evaluate the Safety of APSLXR for the Treatment of Vertigo of Vestibular Origin or Meniere's Disease

Conditions
-----------------
Meniere Disease, Vertigo, Vertigo Vestibular

Intervention / Treatment
-----------------
* Drug: APSLXR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Meniere's Disease or Vertigo of Vestibular Origin; Voluntarily consent to participate in the study; Exclusion Criteria: Female patients who are pregnant or breastfeeding; Participants presenting uncontroled systolic hipertension (>140/90 mmHg); Participants presenting uncontroled diabetes (blood glucose >200 mg/dL).

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APSLXR<br> | Drug: APSLXR<br>* Oral coated tablets once a day for 60 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | during 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters in steady state | Cmáx_SS | at Day 60 |
Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether the supplementation of a medically supervised weight management program with a novel fibre supplement, improves body weight, body composition, and laboratory measurements in overweight and obese individuals. All subjects will participate in the medical weight management program however the intervention group will have 5 grams of a novel fibre supplemented to each meal while the control group will not.

Official Title
-----------------
A Randomized, Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program, on Body Weight in Overweight and Obese Individuals

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Novel fibre supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 27 - 30 Kg/m2 with 1 weight-related comorbidity and/or BMI 30 - 50 Kg/m2 Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation in English Exclusion Criteria: Medications and supplements that affect body weight and appetite Type 2 diabetes on insulin treatment Contraindications to low calorie diet Any allergies to study product ingredients Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel fibre supplement<br>The full dose of the study intervention is 15 grams per day. | Dietary Supplement: Novel fibre supplement<br>* The full dose of the study intervention is 15 grams per day.<br>|
| No Intervention: Weight management program<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | 52 weeks |
New Orleans Pulmonary Hypertension Biobank

Study Overview
=================
Brief Summary
-----------------
Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure >=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. The investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. Specimens will be stored for future investigations.

Official Title
-----------------
New Orleans Pulmonary Hypertension Biobank

Conditions
-----------------
Pulmonary Hypertension, Systemic Sclerosis, Mixed Connective Tissue Disease, Heart Failure With Normal Ejection Fraction, Healthy

Intervention / Treatment
-----------------
* Other: No intervention. Biospecimen collection only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR Undergoing outpatient right heart catheterization Exclusion Criteria: Age<18 Pregnant Unable to understand English Currently incarcerated Unwilling or unable to sign informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinic patients (Comprehensive Pulmonary Hypertension Center)<br>Pulmonary hypertension patients (WHO group 1-5) Systemic sclerosis patients without pulmonary hypertension Mixed connective tissue disease patients without pulmonary hypertension | Other: No intervention. Biospecimen collection only<br>* Biospecimen collection<br>|
| Outpatient right heart catheterization patients<br>-Outpatients undergoing right heart catheterization for any indication | Other: No intervention. Biospecimen collection only<br>* Biospecimen collection<br>|
| Healthy controls<br>Age>18 Not actively smoking No chronic medical conditions | Other: No intervention. Biospecimen collection only<br>* Biospecimen collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of biospecimens | Biospecimen collection only | 10 years |