linjc16/ctgov huggingface dataset:
Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts

Study Overview
=================
Brief Summary
-----------------
An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.

Detailed Description
-----------------
The purpose of the present trial is to explore the safety, tolerability and efficacy when treating GW with Picato® 0.05% gel. The primary outcome measures will be related to safety and tolerability and consists of severity of any local reactions in the treated area; treatment-related adverse events (AEs) and serious AEs.

Official Title
-----------------
Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts

Conditions
-----------------
Anogenital Warts

Intervention / Treatment
-----------------
* Drug: Picato


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. A clinical diagnosis of external anogenital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations: In both sexes: inguinal, perineal, and perianal areas In men: penis shaft, scrotum, glans penis and foreskin In women: on the vulva 2. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2 3. Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment Exclusion Criteria: 1. Subject has received any topical and/or destructive treatments for external anogenital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment 2. Subject suffer from any of the following conditions: Known human immunodeficiency virus (HIV) infection An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas 3. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment 4. Prior quadrivalent HPV vaccination

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment of genetial warts with Picato<br> | Drug: Picato<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of incidence and severity of Local Skin Reactions (LSR) |  | Measured two weeks after every treatment and final measurement 2 weeks after last treatment |
The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.

Official Title
-----------------
The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances

Conditions
-----------------
Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Drug: Songha Night ®
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychophysiologic insomnia Severity: mild to moderate Duration: subacute to chronic Subjects age > 18 and < 65, men or women Subject had to give written informed consent Exclusion Criteria: Regular use of psycho-active drugs Work in shifts Use of psychoactive drugs during the past 30 days Any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.) known hypersensitivity to any of the ingredients of the study drug Pregnancy, lactation, women of childbearing potential not using an established contraceptive Drug and alcohol abuse Participation in another trial within the past 30 days

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Songha Night ®<br> | Drug: Songha Night ®<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quality on a 100 mm visual analogue scale (VAS) |  | baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeling refreshed score (six point rating scale) |  | up to week 5 | 
| Ability to concentrate and perform well score (six point rating scale) |  | up to week 5 | 
| Night-time total sleeping time |  | up to week 5 | 
| Difficulty in falling asleep (five point rating scale) |  | up to week 5 | 
| Number of awakenings during the night |  | up to week 5 | 
| Physical and mental health state by short form (SF-36) questionnaire |  | up to week 5 | 
| Anxiety by State-Trait Anxiety Inventory |  | up to week 5 | 
| Frequency of adverse events |  | up to week 5 | 
| Global clinical impression on insomnia by short questionnaire |  | up to week 5 |
Segmentation of Structural Abnormalities in Chronic Lung Diseases

Study Overview
=================
Brief Summary
-----------------
Lung structural abnormalities are complex, time-consuming, and may lack reproducibility to evaluate visually on CT scans. The study's aim is to perform automated recognition of structural abnormalities in CT scans of patients with chronic lung diseases by using dedicated software.

Detailed Description
-----------------
Three chronic lung diseases will constitute the target of the study, by using retrospective data from each lung disease: Cystic fibrosis Asthma and COPD Interstitial lung diseases Dedicated algorithms will be developped for each disease condition.

Official Title
-----------------
Segmentation of Structural Abnormalities in Chronic Lung Diseases

Conditions
-----------------
Asthma, Cystic Fibrosis, COPD, Interstitial Lung Disease

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic lung disease and clinical examination, pulmonary function test, and CT acquired during a routine follow-up Exclusion Criteria: In the Clinical Validation group, patients with exacerbation or part of the other groups

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 70 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 |
| --- | --- |
| Train dataset<br>This group is dedicated to developing an automated algorithm | Other: Observational study<br> <br> |
| Test dataset<br>This group is dedicated to testing the performance of an automated algorithm | Other: Observational study<br> <br> |
| Clinical Validation<br>This group is dedicated to assessing the clinical validity of the measurement in an independent validation cohort | Other: Observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of automated measurement | Correlations and comparisons with other biomarker of the disease severity | From date of inclusion until the date of final quantification, assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with pulmonary function test | Correlation of quantitative measurement with pulmonary function | From date of inclusion until the date of final quantification, assessed up to 12 months | 
| Longitudinal variation over time | Comparison of quantitative measurement at two time points | From date of inclusion until the date of final quantification, assessed up to 12 months | 
| Reproducibility | Evaluation of measurements when performed twice | From date of inclusion until the date of final quantification, assessed up to 12 months |
Long-Term Follow-up Study of ADVM-043

Study Overview
=================
Brief Summary
-----------------
ADVM-043-03 is a long-term follow-up (LTFU) study of subjects who participated in the ADVM-043-01 multi-center gene therapy clinical study (ADVANCE) that evaluated ADVM-043 for the treatment of Alpha-1 Antitrypsin (A1AT) deficiency.

Detailed Description
-----------------
ADVM-043-03 was a multi-center, observational study without administration of the ADVM-043 investigational product. Subjects who participated in the ADVANCE study were enrolled into this LTFU study for continued safety monitoring for a 2-year period.

Official Title
-----------------
Post-treatment Long-term Follow-up Study of ADVM-043 Gene Therapy in Alpha-1 Antitrypsin Deficiency

Conditions
-----------------
Alpha-1 Antitrypsin Deficiency

Intervention / Treatment
-----------------
* Genetic: ADVM-043


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: The subject has A1AT deficiency and has previously received ADVM-043 gene therapy Key Exclusion Criteria: The subject is unwilling or unable to participate in all required study evaluations in the long-term follow-up protocol The subject is participating in another investigational treatment protocol The subject is unable to understand the purpose and risks of the study or cannot provide a signed and dated informed consent form (ICF)

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 |
| --- | --- |
| 1<br>Patients who received ADVM-043 in a treatment protocol | Genetic: ADVM-043<br>* Long term follow-up of subjects that received ADVM-043<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, frequency, severity, duration, and relationship to ADVM-043 of adverse events of interest and of serious adverse events related to ADVM-043 | Safety was assessed by collection of severity and relatedness of Adverse Events to ADVM-043, Adverse Events of Interest and Serious Adverse Events related to ADVM-043 | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alpha1AT, COPD, Alpha-1 Antitrypsin Deficiency, alpha1-antitrypsin deficiency, alpha 1-antitrypsin deficiency, A1AT, ADVM-043, AAVrh.10halpha1AT, AAVrh.10hA1AT, Gene transfer vector, Gene therapy, Lung disease, Emphysema, ADVANCE study, Long Term Follow Up
Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application

Study Overview
=================
Brief Summary
-----------------
A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). This virus causes a pathology ranging from simple flu-like symptoms in 80% of cases to acute respiratory distress syndromes requiring intensive care in 5% of cases and a death rate of 1.4 to 4% of cases. Viral contamination is airborne and fecal A first epidemic wave crossed France in March / April 2020 then a second in October / November with a source of contamination which began in mid-August 2020. The sources of propagation are not well known (what places, what times, what contacts…? ) In the context of the health crisis linked to the coronavirus, knowledge of the sources of propagation of this 2nd wave is an important issue to guide end of lockdown and second lockdown policies.

Official Title
-----------------
Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application: an Observational Study

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: users


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: users of the application not having objected to the use of their data Exclusion criteria: - user who does not have a complete questionnaire

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 |
| --- | --- |
| users<br>users of web-application | Other: users<br>* Data of users of the web-application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the methods of contamination of patients | Data and symptomes collected by the web applications self-questionnaire (patient reported outcome) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation in time of the spread of the virus during the 2nd epidemic wave. | Data and symptomes collected by the web applications self-questionnaire (patient reported outcome) | 2 months | 
| Evaluation in space of the spread of the virus during the 2nd epidemic wave. | Data and symptomes collected by the web applications self-questionnaire according to ZIP code (patient reported outcome) | 2 months |
Examination of Double-Lumen Tube Placement by Functional Electrical Impedance Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether functional electrical impedance tomography is suitable for examination of double-lumen tube placement compared with fibreoptic evaluation.

Official Title
-----------------
Examination of Double-Lumen Tube Placement: Functional Electrical Impedance Tomography Versus Fibreoptic Bronchoscopy

Conditions
-----------------
Double-Lumen Tube Placement, One-Lung Ventilation

Intervention / Treatment
-----------------
* Device: electrical impedance tomography
* Procedure: double-lumen tube placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consent of the patient intubation with left- or right-sided double-lumen tube age >= 18 years Exclusion Criteria: refusal by the patient contraindications for EIT-measurement (e.g. pacemaker, pregnancy)

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 |
| --- |
|Device: electrical impedance tomography|nan|
|Procedure: double-lumen tube placement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma

Study Overview
=================
Brief Summary
-----------------
This study investigates the effect of a inhaled corticosteroid (fluticasone or Flovent) on airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that fluticasone will be more effective in preventing saline-induced airway narrowing than methacholine-induced narrowing.

Official Title
-----------------
A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-saline Induced Bronchoconstriction in Asthmatic Subjects

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

Intervention / Treatment
-----------------
* Drug: Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of asthma Exclusion Criteria: Habitual cigarette smoking

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose steroid<br>Fluticasone, 100 mcg per day | Drug: Fluticasone<br>* Inhaled Fluticasone, either 100 or 1000 mcg per day<br>* Other names: Flovent;|
| Active Comparator: High dose steroid<br>Fluticasone, 1000 mcg per day | Drug: Fluticasone<br>* Inhaled Fluticasone, either 100 or 1000 mcg per day<br>* Other names: Flovent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  | Measured every 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PC20 methacholine |  | Measured every 2 weeks |
Clinical Significance and Diagnosis of Sarcopenia in Cardiac Patients

Study Overview
=================
Brief Summary
-----------------
Obesity sarcopenia, characterized by the coexistence of excess fat and muscle mass reduction, may contribute to the pathophysiology of exercise intolerance in patients with heart failure with preserved ejection fraction (HFpEF). The project will examine the impact of selected circulating miRNAs on processes that may form the pathophysiological basis for HFpEF development and obesity sarcopenia in correlation with biochemical markers, echocardiographic assessment and non-invasive assessment of hemodynamic parameters. In addition, the impact of LDL and HDL on these diseases will be assessed. Determinations of selected adipokines and asymmetric dimethylarginine will also be carried out and their effects on the cardiovascular system will be assessed.

Official Title
-----------------
Clinical Significance and Diagnosis of Sarcopenia in Patients With Heart Failure With Preserved Ejection Fraction

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction, Hypertension, Sarcopenic Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: control group: healthy volunteers study groups: patients with HFpEF. Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group. Exclusion Criteria: coronary artery disease unstable hypertension heart failure class IV NYHA condition after percutaneous or surgical revascularization pulmonary hypertension in echocardiography obstructive or restrictive lung diseases congenital heart disease arrhythmias (including atrial fibrillation) pacemaker or implantable cardioverter defibrillator hyperthyroidism or hypothyroidism pregnancy or lactation hemodynamically significant acquired heart defects cardiomyopathies GFR <60 ml/min/1.73 m2 other medical conditions such as: cancer, significant anemia, diabetes, alcohol and drug abuse, chronic inflammatory diseases and other the patient's inability to cooperate and / or give informed consent to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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 |
| --- | --- |
| Control<br> | |
| HFpEF group<br> | |
| Hypertensive group<br>Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of biochemical parameters |  | through study completion, an average of 1 year | 
| Left ventricular systolic and diastolic function |  | through study completion, an average of 1 year | 
| Arterial stiffness |  | through study completion, an average of 1 year |