bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of the study was to evaluate the antiviral activity of tenofovir
      disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF
      combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the
      immune tolerant phase of HBV infection.

      The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was
      evaluated for suppression of the virus (decrease in HBV DNA), serological response
      (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and
      the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF
      monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events
      and changes in laboratory parameters.

      Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus
      tenofovir DF. All subjects were to continue on blinded study medication until the last
      subject reached Week 192. Participants who permanently discontinued study drug (on or before
      Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of
      alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or
      after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to
      antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their
      regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject
      reached Week 192.
    


Intervention name(s): Tenofovir DF; FTC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablet taken orally once daily; Emtricitabine (FTC) 200 mg capsule taken orally once daily; Placebo to match FTC taken once daily
Other intervention name(s): Viread®; Emtriva®
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tenofovir; monotherapy; emtricitabine; combination; hepatitis B
Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure
Condition: Surgical Wound Closure Technique
MeSH terms: Wounds and Injuries; Surgical Wound
Study type: Interventional
Phase: Phase 3

Summary: 
      the study is comparing the results of aesthetic surgery wound closure by a single layer
      versus the traditional multi-layer closure as regards the wound healing time, local wound
      complications, and the scar formed.
    

Detailed description: 
      The study puts in comparison the surgical wound closure of aesthetic procedures by single
      layer sutures technique, involving part of the subcutaneous tissue and the subdermal layer,
      with the multi-layer traditional closure, which involves subcutaneous layer closure by one or
      two raws of sutures and skin closure with any type of suturing techniques, then to evaluate
      the wound healing time, local wound complications, and the scar formed.
    

Intervention name(s): surgical wound suturing
Intervention type(s): Procedure
Intervention description(s): single layer surgical wound suturing in comparison with the traditional multi-layer wound suturing
Other intervention name(s): single layer wound closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: surgical wound closure; subdermal wound suturing; traditional wound closure
Effect of Oral Probiotic Yeast on the Composition of the Vaginal Microbiota in Healthy Women
Condition: Vaginal Health
Study type: Interventional

Summary: 
      This study is designed to evaluate the impact of oral consumption of the probiotic yeast CNCM
      I-3856 on healthy vaginal microbiota
    


Intervention name(s): Saccharomyces cerevisiae, dose 500; Saccharomyces cerevisiae, dose 1000; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Experimental arm; Experimental arm; Placebo comparator arm
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, 3 parallel-arms, pilot clinical study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Prevention of Childhood Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Observational

Summary: 
      This study is conducting preliminary testing to find out whether a particular educational
      program can alter parental overcontrol of their children's eating. There is evidence from
      previous studies that children who are irritable, cry a lot, tend to be overcontrolled and
      are at high risk for developing overweight. If the education program can change parental
      behavior the next study would examine whether this affects children's weight over a longer
      period of time.
    

Detailed description: 
      There are two main studies in this project. For both studies families with a child between 2
      and 4-years will be entered to the study although only the parents will participate. At least
      one parent will be overweight with a BMI>27.5, and the child will have a reactive temperament
      assessed by the Children's Behavior Questionnaire (CBQ) completed by the parent with a
      combined score on the approach/impulsivity scales of 4.65 (possible range 1 - 7). The
      cut-points for parental BMI and their child's temperament derive from our previous
      prospective risk factor study. Screening will consist of a brief telephone screen to
      ascertain willingness to participate in further screening and self-reported BMI. Both parents
      will be invited to the laboratory to ascertain whether they meet BMI criteria. In Study 1
      parents with a child with either reactive or non-reactive temperament patterns will be
      entered to this study. In Study 2 only parents with a child with a reactive temperament will
      be admitted to the study. There will be no randomization in Study 1. There will also be 2
      focus groups each lasting 90-minutes to ascertain typical child feeding problems, and a pilot
      administration of the interventions. In Study 2 parents will be randomized to receive either
      the experimental intervention or a health education program aimed at enhancing their
      children's health. Each group session will last 90-minutes and there will be 10 group
      sessions at weekly intervals. Assessments in both studies will be similar and will consist of
      questionnaires aimed at assessing family and children's feeding behaviors and parental
      attitudes and behaviors concerning their own weight/shape and dieting. We estimate that the
      assessments will take approximately 60-minutes to complete in Study 1 and 45-minutes each in
      Study 2 because extraneous questions will be removed as a result of findings in Study 1.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 2-4 years at risk for overweight with at least one overweight/obese parent
A Study on Pneumoconiosis Treated With Whole-lung Lavage Combined With Mesenchymal Stem Cells
Condition: Pneumoconiosis
MeSH terms: Pneumoconiosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Pneumoconiosis is a kind of lung disease due to inhalation of dust such as silica(common
      named Silicosis), coal and rock dust, characterized by inflammation, coughing, and fibrosis.
      Currently there is no effective drug treatment. The whole-lung lavage(WLL) can effectively
      clear the protein-like substances and inhaled dust deposited in the alveoli and bronchioles,
      as well as the pulmonary alveolar macrophage(PAM) and the resulting induced inflammation,
      fibrosis induced factor, serve to improve respiratory function, relieve symptoms of efficacy,
      but can't slow down or reverse the progression of pulmonary fibrosis.

      By taking large volume whole-lung lavage (WLL) as a conventional therapy, this study intends
      to observe and evaluate the safety and efficiency of combined large volume WLL with
      mesenchymal stem cell (MSC) transplantation for treatment of Pneumoconiosis. Moreover, the
      immune regulation effect between large volume WLL and combined large volume WLL with MSC
      transplantation will also be preliminarily investigated and discussed.
    


Intervention name(s): large volume whole-lung lavage (WLL); clinical grade umbilical cord mesenchymal stem cells
Intervention type(s): Procedure; Biological
Intervention description(s): Generally 1000 ~ 2000ml each time, 14 ~ 10 times totally, each side of the lung to 20 ~ 15 liters, until the lavage fluid from the black into a colorless clear clarification; 10^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after whole-lung lavage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pneumoconiosis; Mesenchymal Stem Cells; whole-lung lavage (WLL)
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the incidence of erythema and other local cutaneous irritation after
      administration of MK-0873 by patch or cream formulation in healthy participants and
      participants with mild psoriasis. Part I and Part II in healthy participants will be
      initiated prior to Part III in psoriasis participants. The primary hypotheses of the study
      are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with
      psoriasis and 2) that the maximum plasma concentration of MK-0873 is <20 nM in healthy
      participants and participants with psoriasis.
    


Intervention name(s): MK-0873 Patch; MK-0873 Cream; Placebo Patch; Placebo Cream; Plain patch
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873; MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873; Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches; Placebo cream matching MK-0873 0.05%, 0.5%, or 2%; Plain patch containing no MK-0873 or placebo
Intervention MeSH terms: MK 0873
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
N-Acetylcysteine for Pediatric Trichotillomania
Condition: Trichotillomania; Hair Pulling
MeSH terms: Trichotillomania
Study type: Interventional
Phase: Phase 2

Summary: 
      Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with
      trichotillomania can experience significant impairment due to peer teasing, avoidance of
      activities (such as swimming and socializing), difficulty concentrating on school work and
      medical complications due to pulling behaviors. Despite the fact that trichotillomania has a
      childhood onset, no randomized, controlled trials have been completed in childhood
      trichotillomania.

      Research in adults with trichotillomania has demonstrated that most commonly currently
      prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake
      inhibitors) is ineffective in treating this condition. By contrast, randomized controlled
      trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral
      treatments such as Habit Reversal Therapy.

      The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric
      trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign
      side-effect profile.
    


Intervention name(s): N-Acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks; placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trichotillomania; Hair pulling; glutamate; N-Acetylcysteine; Children
Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral
      density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the
      absence of disease progression or unacceptable toxicity.
    

Intervention name(s): Alendronate
Intervention type(s): Drug
Intervention description(s): Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.
Other intervention name(s): Fosamax
Intervention MeSH terms: Alendronate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arthritis & connective tissue diseases; idiopathic juvenile osteoporosis; rare disease
Sulodexide Efficacy in Chronic Idiopathic Subjective Tinnitus
Condition: Tinnitus, Subjective
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this prospective randomized and double blind controlled study is to evaluate
      the efficacy and safety of Sulodexide (25 mg) in the treatment of chronic idiopathic
      subjective tinnitus.
    

Detailed description: 
      Patients with chronic idiopathic subjective tinnitus, since at least 1 year, re recruited
      from our Ear, Nose and Throat (ENT) clinic. After verification of inclusion and exclusion
      criteria, patients consenting to enter the study are assigned randomly to one of the
      following groups: 1- Sulodexide 25 mg for 40 days 2- Placebo for 40 days. Clinical evaluation
      of the patient is performed; tinnitus is assessed according to Tinnitus Handicap Inventory
      score, Mini Tinnitus Questionnaire score. Adverse effects are also noted. Patients are
      followed at 40 days post-treatment and outcome measures are assessed.
    

Intervention name(s): Sulodexide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg morning and evening for 40 days; 1 tablet morning and evening for 40 days
Intervention MeSH terms: Glucuronyl glucosamine glycan sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
Condition: Humoral Immune Response
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in
      subjects aged 2-16 with primary immune deficiency disorders associated with defects in
      humoral immunity to generate additional data on these populations, and more specifically
      safety and pharmacokinetic (PK) assessments.
    


Intervention name(s): Bivigam
Intervention type(s): Biological
Intervention MeSH terms: Immunoglobulin G
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Measuring the Neuroimmune Response to Alcohol
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study uses positron emission tomography imaging of the 18-kDa translocator protein to
      measure the brain's immune response to alcohol.
    

Detailed description: 
      Alcohol Use Disorder affects nearly 14% of the population, accruing considerable cost to
      individual families and society. Much of this cost stems from alcohol's influence on the
      immune system. Alcohol impairs peripheral immune function, evidenced by increased
      susceptibility to infection related diseases such as liver cirrhosis and pancreatitis. The
      neuroimmune consequences of alcohol are subtler. Preclinically, alcohol triggers neuroimmune
      abnormalities that contribute to cognitive dysfunction, neurodegeneration, and alter alcohol
      drinking behaviors. Yet, limited experimental tools hamper translational efforts to study
      alcohol's effects on neuroimmune function in people. We propose to address this deficit by
      developing an innovative human imaging paradigm that measures neuroimmune response to
      alcohol.
    

Intervention name(s): Oral Alcohol Challenge
Intervention type(s): Drug
Intervention description(s): Subjects will drink an alcohol dose designed to achieve a BAL of 0.08
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Relationship Between Arsenic Methylation Capability and Blood Metals in Children With Developmental Delays
Condition: Developmental Delays
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to explore the relationship between arsenic methylation and
      blood metals in children with developmental delays and its correlation with health related
      quality of life.
    

Detailed description: 
      The investigators recruited children with developmental delays and children with normal
      development from Shin-Kong Ho-Su Memorial Hospital as controls. Information obtained from the
      interview included socioeconomic and basic demographic characteristics as well as children
      function, health condition, and quality of life. On the other hand, blood and urine samples
      of the participants were collected for the analysis of arsenic methylation related enzymes
      using polymerase chain reaction and restriction fragment length polymorphism. 2 ml blood were
      digested for the determination of mercury, lead and arsenic. The relationship between arsenic
      methylation and blood metals in children with developmental delays and its correlation with
      health related quality of were analyzed.
    

Intervention name(s): study group
Intervention type(s): Other
Intervention description(s): Explore the relationship of heavy metals and health related quality of life, including the relationship between the developmental delays and polymorphism of arsenic methylation enzymes, arsenic methylation capability and blood metals. Identify the interaction of children function, health condition, and quality of life and arsenic methylation and blood metals in children with developmental delays.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        children with developmental delays and children with normal development
      
Biospecimen description: 
      Blood and urine samples of participants were collected and urine used for the analysis of the
      arsenic species using high performance liquid chromatography linked hydride generator and
      atomic absorption spectrometry. Buffy coat were separated from plasma and extract DNA to
      analyze the genetic polymorphism of arsenic methylation related enzymes using polymerase
      chain reaction and restriction fragment length polymorphism. 2 ml blood were digested for the
      determination of mercury, lead and arsenic.
    
Keywords: arsenic; heavy metal
Exercise and Inflammation in the Elderly
Condition: Inflammation; Insulin Sensitivity
MeSH terms: Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      Persistent low-grade inflammation and impaired fibrinolysis, are independent predictors of
      several chronic diseases highly prevalent in the older Veteran population including
      cardiovascular disease (CVD), stroke, and diabetes. Inflammation is likely to be a causative
      underlying mechanism of insulin resistance. Lifestyle changes such as weight loss and
      physical activity are advocated for the treatment of these chronic diseases and endpoints,
      and data are emerging which suggest that these treatments may be beneficial, in part, due to
      their anti-inflammatory effects. Identification of effective therapies that reduce chronic
      inflammation for Veterans is important given the widespread adverse health effects of a
      chronically elevated inflammatory state.
    

Detailed description: 
      This study will compare the effects of 6 month trial of aerobic exercise (AEX) vs. weight
      loss (WL) in older individuals on:

        1. adipokine secretion and expression (tumor necrosis factor alpha, adiponectin);

        2. adipose tissue and skeletal muscle inflammatory proximal receptor expression
           (adiponectin and tumor necrosis factor alpha expression) and signaling pathways; and

        3. whether the changes in signal transduction are associated with changes in peripheral
           whole body insulin sensitivity by a hyperinsulinemic-euglycemic clamp.

      The prevention and treatment of insulin resistance, the metabolic syndrome, and their CVD
      complications through exercise and weight loss could improve Veterans' health and reduce
      health care costs. Knowledge of their effectiveness has important implications for the
      cardiovascular health of Veterans given the widespread adverse health effects of chronic
      inflammation on vascular biology, skeletal muscle function and insulin action.
    

Intervention name(s): Weight Loss; Aerobic Exercise Training
Intervention type(s): Other; Other
Intervention description(s): 6 months of weight loss; 6 months of aerobic exercise training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glucose Metabolism