linjc16/ctgov huggingface dataset:
Does Extra-fine Hydrofluoroalkane-beclomethasone Dipropionate (HFA-BDP) Suppress Small Airways Inflammation in Chronic Obstructive Pulmonary Disease (COPD)?

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease or 'COPD' is a chronic disease, which means that it cannot be cured, but that inhalers and tablets can be used to control the symptoms. In COPD, the airways become inflamed which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in COPD. The airways of the lung start in the windpipe and branch like the branches of a tree, getting smaller and smaller. In COPD the inflammation is deep in the lungs, out to the very small airways. Different inhalers make the medicines into different sized particles. Most steroid inhalers used for COPD make the medicine into particles which are too big to get into the very small airways ('coarse particles'). Other inhalers make a mist, with much smaller particles ('fine particles'). These are as small as the smallest airways in the lungs. Doctors have recently found a way to measure the inflammation in the small airways that are affected in COPD. The investigators want to find out if taking one of these 'fine-particle' steroid inhalers can treat that inflammation.

Official Title
-----------------
Does Extra-fine HFA-BDP Suppress Small Airways Inflammation in COPD?

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

Intervention / Treatment
-----------------
* Drug: HFA-BDP
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current or ex-smokers > 40 years of age with a greater than 15 pack year history of smoking post-bronchodilator FEV1/FVC ratio < 0.7 FEV1 < 80% predicted CANO > 3 ppb at screening Informed consent and ability to perform exhaled nitric oxide assessment Exclusion Criteria: Oral steroid use or exacerbation within 6 weeks Greater than 2 exacerbations requiring treatment in the previous 6 months Requirement for domiciliary oxygen Pregnancy or lactation Known or suspected contra-indication to any of the IMP's Diagnosis of asthma

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extra-fine particle steroid inhaler<br> | Drug: HFA-BDP<br>* HFA-BDP 100 mcg bid for 3 weeks, then 400 mcg bid for 3 weeks<br>* Other names: Qvar;|
| Placebo Comparator: Placebo control<br> | Drug: Placebo<br>* 1 puff bid for 3 weeks, then 1 puff bid for 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar Nitric Oxide |  | 6 weeks |
Electronic Health Technology for Assessment of Physical Activity and Eating Habits in Children and Adolescents Who Are Overweight and Those With Obesity

Study Overview
=================
Brief Summary
-----------------
Aims: During the last decades overweight/obesity has increased markedly. They are associated with a high risk for diabetes and death. Effective intervention is mandatory. Following participation in treatment programmes children/adolescents often fail to reach sufficient long-term weight reduction. The present trial aims to integrate telemedical support in therapy to improve long term outcome. Methods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6 years, body mass index [BMI] 31.2±5.4kg/m², body mass index standard deviation score [BMI-SDS] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Device: motion detection with a motion sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children/adolescents with overweight/obesity were included admitted to our hospital

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: motion sensor integrated in a mobile phone<br>A motion sensor integrated in a mobile phone. The system analyses kind, intensity and duration of physical activity and eating habits. | Device: motion detection with a motion sensor<br>* To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone (DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.<br>|

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
-----------------
differences between patients´ self-assessment and objective perception of physical activity and eating habits
STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study

Study Overview
=================
Brief Summary
-----------------
This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in healthy subject in relation to the presence of HNF-4A G60D variant.

Detailed Description
-----------------
After a single oral administration of 2 mg tolterodine in 31 healthy subjects (6 with the heterozygous mutation of HNF-4A G60D vs 25 subjects with wild type of that whose CYP2D6 genotype and gender were matched with variant group), blood were collected for 24hrs. Assay of tolterodine and the metabolite, 5-hyroxymethyl tolterodine was conducted using LC/MS/MS.

Official Title
-----------------
STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study

Conditions
-----------------
Genotype Guided(HNF4a), Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Tolterodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subject whose HNF4a and CYP2D6 genotype ware determined Exclusion Criteria: Subject whose HNF4a and CYP2D6 genotype ware not determined

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolterodine<br> | Drug: Tolterodine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUC, CL, Vd, T1/2 |  | 24hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HNF4a, CYP2D6, Toterodine, Genetic polymorphism
Tunisian National Registry on Psoriasis

Study Overview
=================
Brief Summary
-----------------
National cross-sectional multicentric study to describe the epidemiological characteristics of patients with Psoriasis in Tunisia

Detailed Description
-----------------
PsoTReg is a Tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in dermatology departments and outpatients clinics, of both public and private sectors. The study will enroll hospitalized and ambulatory patients with psoriasis disease, by successive inclusions until the end of the recruitment period, set at six months. A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project. Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation). A local authorization by the National Agency of Personal Data Protection will be obtained prior to study kick-off.

Official Title
-----------------
Tunisian National Registry on Psoriasis

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with psoriasis Informed and written consent Exclusion Criteria: Any dermatology disease other than psoriasis
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis types | Number of subjects with each type of psoriasis (Plaque psoriasis, Inverse psoriasis, Erythrodermic, Guttate psoriasis, Nail psoriasis, Pustular psoriasis, Psoriatic arthritis) | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic | Demographic data (gender frequency, age mean, body mass index mean) of subjects with psoriasis | At inclusion | 
| Safety assessment of psoriasis medical treatment | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Occurrence of infection or tuberculosis or death or any other treatment-related side effect of psoriasis medical treatment | At inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Dermatology, Tunisia, Dacima
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration Holter in Comparison to Pressure Flow Study

Study Overview
=================
Brief Summary
-----------------
Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine Vibration Holter based on a Urine Flow Vibration Analysis technology. The acoustic vibration sensor is a small device that records the vibration due to urine flow. The patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. The analysis is performed off-line and the results are compared to the results of a standard pressure flow study. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.

Official Title
-----------------
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration Holter in Comparison to Pressure Flow Study

Conditions
-----------------
Bladder Outlet Obstruction

Intervention / Treatment
-----------------
* Device: Dynamic Urine Vibration Holter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of benign prostatic hyperplasia (BPH) has indication for urodynamic evaluation

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic Urine Vibration Holter<br>each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration Holter and then urodynamically by pressure flow study | Device: Dynamic Urine Vibration Holter<br>* each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration Holter and then urodynamically by pressure flow study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Holter to confirm or exclude of bladder outlet obstruction |  | one recording at the time of urodynamic testing.approximatly one minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benign prostatic hyperplasia (BPH), acoustic vibration
Pratical Assessment of DSAEK in the Management of Endothelial Decompensation Following Penetrating Keratoplasty

Study Overview
=================
Brief Summary
-----------------
Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty.

Detailed Description
-----------------
A retrospective and observational monocentric study fo six patients with DSAEK after prior penetrating keratoplasty (PK). The data collected are: demographic characteristics, ophthalmological comorbidities, initial indication of PK, delay between PK and DSAEK. Preoperative Visual Acuity and at 1, 3 and 6 months postoperative were collected in logmar for analysis. The central cornea and graft thickness measured in OCT as well as the postoperative complications were also collected.

Official Title
-----------------
Pratical Assessment of Descemet'Sstripping Automated Endothelial Keratoplasty (DSAEK) in the Management of Endothelial Decompensation Following Penetrating Keratoplasty

Conditions
-----------------
Descemet's Stripping Automated Endothelial Keratoplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with endothelial decompensation after penetrating keratoplasty surgery realised by the same surgeon Exclusion Criteria: None

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 |
| --- | --- | --- |
| visual acuity | pre and postoperative visual acuity in logmar | change from visual acuity at 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cornea thickness at 6 months | the central cornea and graft thickness measured in OCT | change from cornea thickness at 6 months | 
| cornea thickness at 10 years | the central cornea and graft thickness measured in OCT | change from cornea thickness at 10 years | 
| postoperative complications | all the postoperative complications were collected | month 6 | 
| visual acuity at 10 years | pre and postoperative visual acuity in logmar | change from visual acuity at 10 years |
Real Life Experience of the Use of Isomers as ALENCAL (Levamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients

Study Overview
=================
Brief Summary
-----------------
This is a Phase 4, observational, open study in patients whom their doctor for clinical practice prescribes levamlodipine. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8, or clinical practice.

Official Title
-----------------
Real Life Experience of the Use of Isomers as ALENCAL(Levoamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose primary physician based on their clinical condition and locally approved use will be eligible to participate in this study, and have been prescribe with Levamlodipine.

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 |
| --- | --- | --- |
| Effect of therapy in the management of hypertension and other cardiovascular diseases | The change from Baseline in Blood Pressure at 8 weeks will be measure to evaluate th efficacy of the therapy. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | The number of Participants with Serious and Non- seriuous Adverse Events wil be mesure to evaluate the tolerability and safety profile in 8 weeks follow up. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observational, Colombia
Genomic Predictors of Recurrent Pregnancy Loss

Study Overview
=================
Brief Summary
-----------------
The overall goals of this proposal are to determine the genetic architecture of recurrent pregnancy loss (RPL) and to discover genomic predictors of RPL.

Detailed Description
-----------------
The following specific aims are proposed: Aim 1: Collect clinically well-characterized samples from trios (product of conception (POC), biological mother, and biological father) with unexplained RPL. Specifically, a cohort of 1,000 trios that are rigorously-phenotyped will be recruited, and for which couples' RPL is not attributable to known causes. The POC and parental DNA samples will be collected. If it is necessary for the purpose of determining the pathogenicity of sequence variants from the trio, collecting DNA samples from other family members after consent will also be considered. The study team may also request DNA or POC tissues from a prior pregnancy loss(es) if available. Aim 2: A whole genome sequencing (WGS) at the Yale Center for Genome Analysis (YCGA) will be performed and bioinformatic analyses to identify pathogenic variants in included trios will performed as well. Pathogenic variants will be comprehensively defined and fully annotated variant maps in all included trios to provide the substrate for subsequent novel gene discovery, and ultimately, the development of clinical diagnostic tests will be generated.

Official Title
-----------------
Large Scale Genome Sequencing and Integrative Analyses to Define Genomic Predictors of Recurrent Pregnancy Loss

Conditions
-----------------
Recurrent Pregnancy Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Women with loss of a current singleton pregnancy at < 20 0/7 weeks gestation (documented by ultrasonography or histopathological examination) and one or more prior pregnancy losses. Euploid current pregnancy by karyotype or microarray (a limited number of aneuploid losses will be included as part of the pilot) No history of parental karyotype abnormalities No history of antiphospholipid antibody syndrome No evidence of uncontrolled diabetes No evidence of uncontrolled thyroid disease No history of autoimmune disease (SLE, RA) No history of uterine anomalies No history of cervical insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Determine genetic etiology for Recurrent Pregnancy Loss | The WGS tool will be used to analyze the POC sample and parental blood samples to determine the clinical reportable genetic cause for RPL | 5 years |
Piracetam for Treatment of Cocaine Addiction, Phase II - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to follow patients in Phase I of an inpatient study in an eight week open label assessment of piracetam in an outpatient treatment program.

Official Title
-----------------
Piracetam for Treatment of Cocaine Addiction, Phase II

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Piracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Adverse effects |  |  | 
| Clinical status |  |  | 

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