linjc16/ctgov huggingface dataset:
Mitral Valve Screening Survey

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).

Detailed Description
-----------------
Numerous transcatheter mitral valve interventions have emerged as a treatment option for patients with mitral valve disease. Development of transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) continues to progress with ongoing rigorous clinical trials of several experimental devices. However, despite being referred for TMVI, most patients do not pass stringent screening criteria for these investigational devices and are not offered TMVI. In this prospective multicenter registry, baseline demographics, anatomical/imaging characteristics, and clinical outcomes of patients who fail screening for TMVI will be prospectively collected into a registry database.

Official Title
-----------------
Mitral Valve Screening Survey (MVSS)

Conditions
-----------------
Mitral Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject failed screening for TMVI Exclusion Criteria: Under 18 years of age Subject unable or unwilling to give informed consent Subject proceeded with TMVI.

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 |
| --- | --- |
| Subjects fail screening for TMVI<br>Subjects with symptomatic mitral valve disease who after referral for TMVI, are deemed not to be candidates for TMVI. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for screen failure |  | Baseline | 
| All-cause mortality |  | 30 days, 1 year, and annually up to 5 years | 
| Hospitalizations |  | 30 days, 1 year, and annually up to 5 years | 
| Mitral intervention |  | 30 days, 1 year, and annually up to 5 years |
Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost 0.004% with and without BAK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects of either sex and any race 18 years or older with open-angle glaucoma or ocular hypertension. Patients with logMAR visual acuity not worse than 0.6 in either eye or any clinically relevant ophthalmic/systemic condition will be excluded. Exclusion Criteria: See Inclusion Criteria

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Travoprost 0.004% with and without BAK|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy of Mobic® Ampoules in the Initiation of Treatment of Painful Exacerbations of Osteoarthritis, Rheumatoid Arthritis and Other Similar Painful Inflammatory Conditions

Study Overview
=================
Brief Summary
-----------------
Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful inflammatory conditions.

Official Title
-----------------
Meloxicam (MOBIC®) Ampoule Post Marketing Surveillance Study

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Meloxicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful acute exacerbations of inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis), painful acute exacerbations of osteoarthritis and other similar conditions requiring acute treatment with an anti-inflammatory drug Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Meloxicam<br> | Drug: Meloxicam<br>* 7.5 mg or 15 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall assessment of degree of pain on a 3-point scale |  | up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 3 days |
Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify and validate the intrinsic diagnostic value in terms of sensitivity and specificity of proteomic profiles determined during a pre-study for discriminating between allergy related asthma and allergy related rhinitis.

Official Title
-----------------
The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis

Conditions
-----------------
Rhinitis, Allergic, Asthma, Allergic

Intervention / Treatment
-----------------
* Biological: Classification as asthmatic or rhinitis only via proteomic analysis
* Biological: Classification as asthmatic or rhinitis only according to a metacholine test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed consent never-smokers or non-smoking for at least 2 years + < 5 packs per year capable of understanding the study patient is affiliated with a social security system positive skin tests (at least one for Montpellier region pneumoallergens) treated with nasal or inhaled corticoids, leucotriene receptor antagonists, anti-IgE, Theophylline, anti-histamines, sodium cromoglycate, beta-blockers, benzodiazépine, oral corticoids: all these treatments must be interrupted for at least 72 hours Exclusion Criteria: Co-morbidities: none; no co-morbidities are accepted dental infections (any) during the 3 months preceding the study suspected alcoholism or drug abuse chronic viral infection (hepatitis, HIV) patient under guardianship

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>Allergy patients, asthma and rhinitis | Biological: Classification as asthmatic or rhinitis only via proteomic analysis<br>* Proteomic profiles are established for each patient using plasma and serum samples<br>Biological: Classification as asthmatic or rhinitis only according to a metacholine test<br>* A positive metacholine test indicating bronchial hyperresponsiveness is currently our Gold Standard for diagnosing asthma.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomic profile of each patient | The attribution of a proteomic profile as either asthmatic or rhinitis. Proteomic profiles are determined accordig to the SELDI-TOF method. This is a transversal study validating proteomic profiles as a new diagnostic test. | One day (snapshot) |
Quality Control and Evaluation in Standard COPD Management

Study Overview
=================
Brief Summary
-----------------
There is lack of quality control and evaluation indexes for standard COPD management in hospitals in China, leading to nonstandard in COPD management and discrepancy in therapeutic efficiency. This study focuses on establishing quality control and evaluation indexes for standard COPD management in hospitals in China, and evaluating the therapeutic efficiency after standard COPD management. This part is a prospective cohort which lasts 2 years. After standard COPD management according to GOLD 2017 by doctors in hospitals in China, patients will be followed up for their outcome after 1 year. Several indexes will be selected to evaluate the quality control of standard COPD management and its efficiency. The controls are from hospital-based subjects with a retrospective cohort study.

Official Title
-----------------
Quality Control and Evaluation in Standard COPD Management

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: GOLD 2017


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Clinical manifestation of COPD; post bronchodilator FEV1/FVC<0.70 Exclusion Criteria: 1. lung cancer. 2. Any history of psychiatric disorders. 3.HIV positive. 4.Breastfeeding, pregnancy or planning to be pregnant. 5.Estimated lifetime less than 1 years due to underlying diseases.

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 |
| --- | --- |
| Standard managed subjects<br>COPD patients accepted standard COPD management. | Other: GOLD 2017<br>* Standard COPD management according to GOLD 2017, and control the quality of management in one-year follow-up.<br>|
| Controls<br>COPD patients didn't accepted standard COPD management or quality control, who are from hospital subjects with a retrospective cohort study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spirometry | Spirometry will be assessed at baseline and through study completion | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity of acute exacerbation in 1 years | Morbidity of acute exacerbation completion will be assessed at baseline and through study | 1 year |
Validation of a New Sexuality Questionnaire for Patients With Urinary Incontinence or Pelvic Organ Prolapse

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to perform the linguistic validation of a new french questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

Official Title
-----------------
Validation of a New Sexuality Questionnaire: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse

Conditions
-----------------
Pelvic Organ Prolapse, Urinary Incontinence, Fecal Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is able to read and understand French The patient must be insured or beneficiary of a health insurance plan Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. Exclusion Criteria: Patient is pregnant The patient is under judicial protection, under tutorship or curatorship The patient does not understand French

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The study population<br>Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. See inclusion/exclusion criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comprehension | These tests assess patient understanding of the original formulation and patient understanding of the various terms used: a list of proposed rewording suggested by patients is made. | Baseline (Day 0; transversal study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
linguistic validation of a new questionnaire
Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women

Study Overview
=================
Brief Summary
-----------------
100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine concentrations were measured before intervention (basal), on 30 days (one month) and on 60 days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo and vitamin D group over time showed significant difference on 30 and 60 days of intervention. Mean comparisons of homocysteine concentrations and standard error of the means before and after intervention showed statistical significant decrease in homocysteine concentrations among vitamin D group.

Official Title
-----------------
Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail

Conditions
-----------------
Homocystinaemia, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: Vit D
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight (BMI between 25-29.99 kg/m2) Had 25(OH)D < 20 ng/mL Had normal vitamin B-12 and folic acid levels Not diagnosed with any chronic diseases Agreed to participat in the study Exclusion Criteria: age < 18 or > 49 years BMI > 30 kg/m2 or < 25 kg/m2 25 (OH)D level > 20 ng/ml tHcy levels greater than 100 µmol/L Abnormal vitamin B-12 or folic acid levels Chronic diseases Pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin D3<br>50,000 IU | Drug: Vit D<br>* 50,000 IU<br>* Other names: Biodal;|
| Placebo Comparator: Placebo<br>Similar in size, shape and color to vitamin D3 | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25(OH)D3 | vitamin D in serum | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homocysteine | serum total homocysteine | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCT, Homocysteine, Overweight, vitamin D3, Reproductive women
Attitudes and Feelings of Doctors Caring for Their Colleagues: a Qualitative Study in Picardy

Study Overview
=================
Brief Summary
-----------------
The sick doctor is a patient apart. His right of prescription and his knowledge of semiology easily lead him to self-medication.

Detailed Description
-----------------
The sick doctor is a patient apart. His right of prescription and his knowledge of semiology easily lead him to self-medication. Several factors linked to his profession may also lead to a delay in care: overworking with schedules that are not compatible to organize follow-up, poor access to prevention or occupational medicine for liberal doctors but also modesty And ashamed of being sick (and especially unfit to heal). Specialized centers and specific training courses concerning burnout, addictions and psychiatric pathologies of doctors are currently emerging. To look after a colleague also seems to imply certain specificities like the sharing of knowledge or the medical vocabulary. The physician-patient relationship may seem easier, but it can also lead to confusion of roles and create ambiguity. In this case, the doctor may feel too close to the doctor-patient to maintain his objectivity and to treat him properly. In the same way, the relationship of trust can be altered by sharing medical knowledge, communication techniques or confidence building which can thus lose their effectiveness. This physician-caregiver relationship has already been the subject of some qualitative research demonstrating the difficulty from the point of view of the treated. The feelings and attitudes of the doctor caring for his colleague remains a field very little studied. The research hypothesis is that there are specificities to this relationship.

Official Title
-----------------
Attitudes and Feelings of Doctors Caring for Their Colleagues: a Qualitative Study in Picardy

Conditions
-----------------
Feelings, Attitude

Intervention / Treatment
-----------------
* Other: Feelings Determination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Practicing general practitioners, registered with the Order, caring for or having treated other doctors whatever their specialties Exclusion Criteria: No

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

| Intervention/Treatment |
| --- |
|Other: Feelings Determination|Determine the feelings of doctors caring for their colleagues|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the feelings of doctors who care for their colleagues through a questionnaire | Analyze the feelings of doctors who care for their colleagues through a questionnaire | 10 months |
The Accuracy of CHOLINE PET CT in the Diagnosis of Urological Malignancies

Study Overview
=================
Brief Summary
-----------------
PET CT is one of the imaging tools that are used for staging of urological malignancies. C11 Choline is a novel isotope with the advantage of its minimal secretion in the urine. This advantage makes it a potentially better metabolic marker then others such as FDG. Preliminary studies showed  95% sensitivity in the diagnosis of TCC. Our Goal is to continue the evaluation of this method as a diagnostic and follow up tool in different urological malignancies.

Official Title
-----------------
A Comparative Study to Examine the Accuracy of CHOLINE PET CT in the Diagnosis

Conditions
-----------------
Urological Malignancies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older then 18 years of age Full consciousness and awareness suspected to suffer from urological malignancy and a candidate for a surgical procedur Exclusion Criteria: known secondary malignancy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment of Hypertrophic Scars With Intradermal Botox

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open label, single center, self-controlled clinical study to demonstrate the safety and efficacy of intradermal botulinum toxin in treating hypertrophic scarring.

Official Title
-----------------
Treatment of Hypertrophic Scars With Intradermal Botox

Conditions
-----------------
Hypertrophic Scar

Intervention / Treatment
-----------------
* Drug: Botox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female and male subjects between the ages 18-75. Non-Smoker. Fitzpatrick skin type I-VI. Desire to improve hypertrophic scarring. Able and willing to comply with all visit, treatment and evaluation schedules and requirements. Able to understand and provide written Informed Consent. Exclusion Criteria: Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. Presence of any active systemic or local infections. Presence of active local skin disease that may alter wound healing. Known allergy to botulinum toxin. History of smoking in past 10 years. History of chronic drug or alcohol abuse. Inability to understand the protocol or to give informed consent. History of cosmetic treatments in the area to be treated, including injectable filler of any type within the past year; Botox in the treatment area within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep peels within the past 6 months; surgery to the area within the past 6 months. History of intralesional corticosteroids or any other injectable medication to the area within the last 3 months. History of topical corticosteroids to the area within the past 4 weeks. History of any musculoskeletal disease or any weakness in the area to be treated. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Botox<br> | Drug: Botox<br>* Intradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale |  | change from baseline at 6 months after treatment |