cyrilzakka/clinical-trials huggingface dataset:
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg).

The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline
* Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
* Positive or negative for hepatitis B e antigen (HBeAg)
* HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants)
* Alanine aminotransferase (ALT) \> 54 U/L and ≤ 400 U/L for men and \> 36 U/L and ≤ 300 U/L for women
* Creatinine clearance ≥ 70 mL/min
* Negative serum pregnancy test for females of childbearing potential
* Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication
* Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product

Exclusion Criteria:

* Known bridging fibrosis or cirrhosis and/or decompensated liver disease
* Evidence of hepatocellular carcinoma
* Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
* Absolute neutrophil count \< 1,500/mm\^3, platelet \< 100,000/mm\^3, hemoglobin \< 10 g/dL (female) or \< 11 g/dL (male)
* History of severe depression or severe psychiatric disease
* Thyroid dysfunction
* Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
* Pregnant
Healthy Living in Overweight and Obese Adolescents ASGE-FABES Program in Development of Formats

The aim of this project is to develop multiple behavioral strategies for the prevention of obesity in adolescents.

ASGE-FABES \[Adolescent Health Promotion Physical Activity, Physical activity of overweight and obese youth of Nutrition, Stress Management\] Program,to evaluate its effects on nutrition and mental health. Program overweight and obeseadolescents to lose weight in a healthy way, healthy lifestyle behaviors make healthy choices, nutritional and physical activity knowledgecognitive and It aims to gain behavioral skills. In the study, "pretest-posttest in randomized groupswith control group, with repeated measures \& quot; experimental design type is used. The sample of the research,250 (125-experiment, 125-control) constituted an overweight and obese adolescent.

The aim of this project is to evaluate the impact of ASGE-FABES Program for the prevention of obesity in adolescents on physical activity, nutritional and mental health of overweight and obese adolescents. The program aims at promoting cognitive and behavioral skills for overweight and obese adolescents to lose weight in a healthy way, to promote healthy lifestyle behaviors, to make healthy choices, to increase their knowledge of nutrition and physical activity, to assume their own health responsibilities and to cope with stress. In the study, quot;experimental design type with randomized groups, pretest-posttest control group, repeated measurement\&quot; was used. The sample of the study consisted of 250 overweight and obese adolescents studying in the 6th grade of 10 secondary schools in Şişli district of Istanbul. The data of the study were collected using with Socio-Demographic Characteristics Form,Adolescent Nutrition Information Scale,Adolescent Physical Activity Information Scale, Adolescent Lifestyle Scale, Adolescent Healthy Lifestyle Choose Scale, Beck Anxiety Scale, Daily Food Consumption Form and Beverage Consumption Form.The data were collected before the application, at the first week after the application, and at the sixth and 12th months. Descriptive statistical tests, pearson chi-square tests, t-test in similar groups, repeated measures anova, and Cohen\&#39;s effect size tests were used in the analysis of the study. There was no significant difference between the experimental and control groups in terms of the descriptive characteristics, behavioral and cognitive variables of adolescents.

Eligibility Criteria:
Inclusion Criteria:

* being overweight or obese
* 11-12 age range
* children asked by their parents to participate in the study

Exclusion Criteria:

* having a genetic disease
* normal weight
* mental disability
Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease

The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.

All patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study ("Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667") between june 2012 and june 2016.

3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again.

The objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome.

Secondary objectives are the evolution of other parameters including pain, personality and behavior. All parameters measured have been determined of each patient in the Honeymoon study.

Eligibility Criteria:
Inclusion Criteria:

* patients who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667
* Patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months
* Patients with medical insurance
* signed informed consent

Exclusion Criteria:

* diagnosis other than Parkinson's Disease
* dementia (Mattis \<130)
* patients protected by law (i.e. pregnant or parturient women)
Culturally-Adapted Diet for Puerto Rican Adults

This pilot project will determine whether a diet culturally-adapted to Puerto Ricans can effectively decrease cardiometabolic risk for diabetes. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes.

This pilot intervention will culturally-tailor a diet to the Puerto Rican adult population based on staple foods as well as culturally-appropriate strategies to reduce cardiometabolic risk factors of type 2 diabetes and obesity. Based on preliminary results from studies in the island, investigators will conduct a 4-month, 2-arm intervention among 200 adults (100 per arm) ages 25-65 living in Puerto Rico with at least 2 of 5 cardiometabolic risk factors. The two arms are: (1) intervention group consisting of culturally-appropriate advice in an initial individual session with daily text messages for 2 months (delivery phase); (2) control arm of standard general nutritional advice at the initial individual session, and text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages. Investigators will measure changes in cardiometabolic risk factors and in eating-behaviors and psychological measures.

Eligibility Criteria:
Inclusion Criteria:

1. Age 25-65 y old at the time of enrollment
2. Non-institutionalized
3. Living in PR at the time of recruitment and for at least the previous year and not planning to move from the island within the next 6 months
4. Able to answer questions without assistance
5. Having a cellphone with the capacity to receive text messages
6. Having at least two of the following:

   1. elevated BMI
   2. elevated waist circumference
   3. self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure
   4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes
   5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia

Exclusion Criteria:

1. Under 25 or over 65 years of age
2. Currently do not live in Puerto Rico or have not lived in PR for at least 1 year or plan to move within 6 months
3. Institutionalized
4. Not able to answer questions without assistance
5. Not having at least 2 of the five listed metabolic criteria
6. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin), or diabetes-diagnosis values confirmed by laboratory.
7. Self-reported pregnancy
8. Gastrointestinal or chronic conditions
9. Food intolerance or allergies
Evaluation of Clinical Effectiveness of Roflumilast in Routine Practice, in Chronic Obstructive Pulmonary Disease (COPD) Patients in Greece

The purpose of this study was to examine the characteristics of patients selected for treatment with roflumilast and the effectiveness and safety of roflumilast in patients with severe or very severe COPD treated in Hospital and outpatient specialist ward settings in Greece.

The drug being observed in this study is called roflumilast. Roflumilast is used to treat people who have chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of worsening symptoms. This study looked at side effects and the lung function of people who take roflumilast. The study enrolled 2577 patients who were already prescribed roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial was conducted in Greece. The overall time to participate in this study was up to 6 months. Participants were evaluated during routine appointments with their healthcare provider.

Eligibility Criteria:
Inclusion Criteria

* Be diagnosed with COPD at stages 3 or 4 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
* Have the clinical phenotype of chronic bronchitis with cough and sputum production (with or without emphysema).
* Already be receiving treatment for their disease (inhaled bronchodilators (long-acting beta2-agonists (LABA), long-acting muscarinic antagonists (LAMA), short-acting beta2-agonists (SABA), short-acting muscarinic antagonist (SAMA)), inhaled corticosteroids (ICS), combination of inhaled bronchodilators and corticosteroids.
* Be aged over 40 years

Exclusion Criteria:

• None
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants

This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Chinese participants must have Chinese parents and grandparents, all of whom were born in China.
* Healthy status as defined by absence of evidence of any active or chronic disease
* Participants whose body weight is ≥50 to \<80 kg and body mass index is ≥18.5 to \<26 kg/m2

Exclusion Criteria:

* Participants with a history of stomach, vagus nerve, or intestinal surgery (except for appendectomy)
* Participants who have a history of allergic symptoms including food allergy (Note: Non-active allergic rhinitis will be allowed)
* Participants who require chronic drug therapy or those who have used drugs within 3 days prior to screening or within 14 days prior to Day -1
* Participants who have used alcohol-containing, caffeine-containing, grapefruit containing, or St. John's wort-containing products within 72 hours prior to Day -1
* Participants who have used tobacco- or nicotine-containing products within 24 weeks prior to screening
* Participants who have donated \> 400 mL of blood within 12 weeks or \> 200 mL of blood within 4 weeks prior to screening, or have donated any amount of blood between screening and Day -1
Genetic Variability and Biomarkers in Children With Acute Lung Injury

Acute Lung Injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000 children admitted to these units. These disorders carry with them high mortality rates as well as numerous long-term effects for the surviving children. As the effects of these diseases have significant social and economic ramifications for affected children and their families, research on the development of ALI/ARDS could significantly change how physicians understand the disease and treat patients.

There are a wide range of problems which make certain PICU patients more likely to develop either ALI or ARDS. This research aims to determine which of these children are at the greatest risk for ALI/ARDS by examining differences in plasma biomarkers and in DNA of a large number of PICU patients. We are hypothesizing that significant differences in the level of specific plasma biomarkers or in the frequency of specific DNA variants exist in children who develop ALI/ARDS.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive intubated pediatric patients (≥ 2 weeks of age and ≥ 42 weeks corrected gestational age and ≤ 18 years of age) supported on mechanical ventilation for acute pulmonary parenchymal disease enrolled in the RESTORE study.

Exclusion Criteria:

* Intubated and mechanically ventilated for immediate post-operative care and stabilization
* Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
* History of single ventricle at any stage of repair
* Congenital diaphragmatic hernia or paralysis
* Primary pulmonary hypertension
* Critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
* Ventilator dependent (including noninvasive) on PICU admission (chronic assisted ventilation)
* Neuromuscular respiratory failure
* Spinal cord injury above the lumbar region
* Pain managed by patient controlled analgesia (PCA) or epidural catheter
* Family/medical team has decided not to provide full support (patient treatment considered futile)
* Enrolled in any other sedation clinical trial concurrently or within the last 30 days
* Known allergy to any of the study medications
High-density Mapping-guided bOx Isolation and subsTrate Ablation

This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed.
* Age of 18 to 75 years old.
* Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
* Willing to have catheter ablation for atrial fibrillation.

Exclusion Criteria:

* Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
* Complete atrioventricular block.
* An acute stroke or contradiction of anti-coagulation.
* Hyperthyroidism.
* Having a history of catheter ablation of atrial fibrillation.
* Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
* Pregnancy or lactation.
* Planning for pregnancy in the near future.
* Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
* Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.
Environment Effect on Six-Minute Walk Test Performance

The purpose of this research study is to determine the effect of the environment on six-minute walk test performance in individuals with chronic obstructive pulmonary disease due to alpha-1 antitrypsin deficiency. The aim of the study is to determine the environmental impact on physical performance in this population to determine if any factors influence quality of life. This study was developed to evaluate the efficacy of the using the indoor six-minute walk test to determine eligibility for ambulatory oxygen therapy.

Participants will be asked to come to the Clinical Research Center (CRC) for a visit lasting about one hour. Participants will be asked to review and sign an informed consent document to participate in this trial. If participants agree to participate and sign the consent, the following procedures will be done. If they have not had pulmonary function testing performed in the past 18 months, standard spirometry testing will be performed. Participants will perform two six-minute walk tests, one indoors and one outdoors. First, they will be randomly assigned to perform either the indoor or outdoor testing first. Then participants will have their vital signs taken, perform the first six-minute walk study and immediately after have their vital signs taken again. Participants will have a rest period between the two six-minute walk tests of at least 30 minutes. Participants will then perform the second six-minute walk test with the same above procedures for the first test.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years.
2. Have a diagnosis of congenital Alpha-1 Antitrypsin Deficiency with an allelic combination of ZZ.
3. Have a Forced Expiratory Volume in 1 second (FEV1)\< 50% of predicted and FEV1/forced vital capacity (FVC) \< 70% (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] stage II, III, or IV).
4. Not currently prescribed Oxygen replacement at a rate of greater than 2 liters.
5. Willing and able to perform two six-minute walk tests.
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Subject has had a moderate or severe pulmonary exacerbation during the 4 weeks before the study visit.
2. History of lung transplant.
3. Severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease \[with the exception of skin cancers other than melanoma\], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis).
4. Unwilling or unable to perform six-minute walk testing.
5. Mentally challenged adult subjects who cannot give independent informed consent.
6. In the opinion of the investigator the subject may have compliance problems with the protocol and the procedures of the protocol.
7. American Thoracic Society listed absolute contraindications to six-minute walk test: unstable angina or myocardial infarction during previous month.
Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids

The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical research sites in the US, Mexico, and Canada. Study participants will have a number of visits to a research site over approximately a 4-month period.


Eligibility Criteria:
Inclusion Criteria:

* Persistent asthma for more than one year
* Current treatment for asthma with short acting inhaled beta 2 agonists (such as albuterol) only
* In good health ad demonstrated by medical history and physical exam
* Negative urine pregnancy test
* Commitment to use two forms of effective contraception simultaneously throughout the study duration and for one month after discontinuing therapy

Exclusion Criteria:

* Asthma necessitating treatment with inhaled corticosteroids for at least one month before the start of the study
* History of severe asthma necessitating the use of oral/injectable corticosteroids within the last 2 months and/and or two bursts in the last year
* Undergoing allergy shots unless on a stable maintenance dose for three months before the start of the study
* History of chronic pulmonary diseases other than asthma
* Treatment of conditions other than asthma with oral corticosteroids within one month of the start of the study
* Current tobacco use
* Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)
* History or evidence of drug or alcohol abuse
* Diagnosis or evidence of an infectious illness within one month of Visit 1
* Clinically significant diseases as assessed by the study doctor
* Participation in another clinical study with an experimental drug within one month of start of the study
Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population

RCT with two arms: (1) stretch fascia plantaris (6 weeks, n=30) (2) control (n=30); Outcome parameters: ROM ankle and first toe; visco-elastic behaviour of the fascia plantaris determined by means of myotonometry Study protocol: Outcome parameters were evaluated before and after the intervention/control with a 6 weeks interval. All participants were screened bilaterally and for the participants assigned to the intervention group stretching was only performed on the dominant side


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Lower extremity injury
Hypoxic Pulmonary Vasoconstriction Pilot Study

The purpose of this study is to determine if the events leading to smoking-associated centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced inflammation.

Overall goals of this study are to 1) determine the effects on sildenafil on the heterogeneity perfused blood volume in smokers susceptible to emphysema using dual energy CT 2) utilize pulmonary blood volume heterogeneity as an image-based biomarker to differentiate normal and susceptible smokers.

Eligibility Criteria:
Inclusion Criteria:

* Must be between the ages of 30 and 60.
* Must be currently smoking at least 1/2 pack/day (confirmed with cotinine level).
* Must have pulmonary function test (PFT) results that meet the following:
* Forced Expiratory Volume at one second (FEV1)/Forced Vital Capacity (FVC) \> 70%
* Forced Expiratory Flow at 25-75% (FEF25-75) \> 79% of predicted
* FVC greater than 80% of predicted
* Must be able to give informed consent for self.

Exclusion Criteria:

* Pregnant or breastfeeding females.
* Body Mass Index (BMI) greater than 32.
* Weight of greater than 220 pounds (100 kg).
* Allergies to shell fish, seafood, eggs or iodine.
* Heart disease, kidney disease or diabetes.
* Diagnosis of asthma.
* Usage of any medications that are known to affect the heart or lungs (contraceptives, anti-depressants, analgesics EXCEPT aspirin, antihypertensives, and medications for osteoporosis and gastrointestinal diseases will be allowed).
* Any metal in or on the body between the nose and the abdomen.
* Any major organ system disease (by judgment of study medical team).

For the subjects that will receive Sildenafil as part of the study, additional exclusion criteria are as follows:

* Nitroglycerin usage.
* Prior history of hypersensitivity to Sildenafil.