bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Fish Oil in Alleviating Health Hazards Associated With Ozone Exposure
Condition: Cardiovascular System; Respiratory System; Oxidative Stress; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study aims to evaluate whether dietary supplementation with fish oil can protect against
      the cardiopulmonary effects induced by ozone exposure.
    

Detailed description: 
      The investigators will conduct a randomized controlled trial among 64 healthy young adults in
      Shanghai, China. The eligible participants will be randomly assigned in a 2*2 factorial
      design to 1 of 4 groups: 1) fish oil and ozone exposure, 2) fish oil and shame exposure, 3)
      soy oil and ozone exposure, or 4) soy oil and shame exposure. The participants who take fish
      oil would receive 2.2 g/day (two 1.1-g capsules daily) in divided doses, and other
      participants will take the same amount of soy oil capsules. Two hour ozone exposure (200 ppb
      ozone) or shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of
      supplementation. Ozone is generated by a silent electric discharge method (HTU-500, AZCO
      Industries Ltd., Canada) and introduced into the chamber. The temperature and relative
      humidity in the chamber are maintained at 22±1℃ and 50%±5%, respectively. During the 2-hour
      exposure, each subject alternate 15 minutes of exercise on a treadmill and 15 minutes of
      rest. The exercise workload would be adjusted to achieve the targeted ventilation of 20±1
      L/min/m2 body surface area. Health examinations will be conducted immediately prior to
      exposure, immediately after exposure, 2 hours after exposure and again the next morning.
    

Intervention name(s): fish oil and acute ozone exposure; fish oil and sham exposure; soy oil and acute ozone exposure; soy oil and sham exposure
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): The participants will take fish oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour ozone exposure (200 ppb ozone) will be conducted in a chamber after four weeks of supplementation.; The participants will take fish oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation.; The participants will take soy oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour ozone exposure (200 ppb ozone) will be conducted in a chamber after four weeks of supplementation.; The participants will take soy oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ozone exposure; fish oil; 2*2 factorial design
The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia
Condition: Hemiplegia; Congenital
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation
      (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related
      quality of life outcomes in school-aged children with cerebral palsy
    

Detailed description: 
      A total of 52 primary schools were screened comprehensively to determine children conforming
      specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender,
      affected side) and severity of functional impairment dealing with cognitive /communication,
      manual ability and mobility were noted. After a comprehensive screening, a total of 30
      children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups
      (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and
      probability. Children blinded to group allocation were delivered activity-based upper limb
      training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training,
      at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3
      sessions per week was carried out in the school time (during the art or physical education
      class), while 2 out of 3 sessions were carried out in rehabilitation centers which the
      children regularly attend for regular care 2-day weekly. All participating children continued
      to receive their standard care (90 minutes per week) throughout the study period.

      During the 1-month screening period, physical characteristics of participants were described
      through classification systems including The Communication Function Classification System,
      The Manual Ability Classification System , and The Gross Motor Function Classification
      System. Participating children were evaluated before the study entry (T1), immediately
      postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27
      questionnaire
    

Intervention name(s): Modified Constraint-Induced Movement Therapy
Intervention type(s): Other
Intervention description(s): intensive use of more affected arm in structured setting
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (modified constraint-induced movement therapy or Bimanual training), at an equal number and probability
Masking: Single (Participant)
Primary purpose: Treatment
Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
Condition: Bacteremia
MeSH terms: Bacteremia
Study type: Interventional
Phase: Phase 4

Summary: 
      The intent of this study is to describe the safety and efficacy of daptomycin versus standard
      of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by
      Staphylococcus aureus (S. aureus).
    

Detailed description: 
      S. aureus causes a series of invasive diseases in adults and children, including bacteremia.
      Infections due to S. aureus in children, particularly those due to methicillin resistant S.
      aureus (MRSA), are a growing world-wide public health concern.

      Daptomycin, a cyclic lipopeptide antibacterial agent, shows rapid in vitro bactericidal
      activity with concentration-dependent killing for Gram-positive organisms, including S.
      aureus. Surveillance studies have demonstrated a daptomycin MIC90 of 0.5µg/ml for both
      methicillin-susceptible S. aureus (MSSA) and MRSA with >99% of MRSA isolates being
      categorized as susceptible by the Food and Drug Administration (FDA), European Committee of
      antimicrobial susceptibility testing (EUCAST) and Clinical and Laboratory Standards Institute
      (CLSI) breakpoints (5). Clinical trials in adults demonstrated that daptomycin was safe and
      efficacious in complicated skin and skin structure infections (cSSSI) and bloodstream
      infections caused by S. aureus, including right-sided infective endocarditis (RIE). However,
      information on the safety and efficacy of daptomycin for use in children is lacking.

      The intent of this study in children is to confirm the safety of daptomycin at mean steady
      state systemic exposures (AUC) similar to those reported for adults treated at 6 mg/kg for
      bacteremia.
    

Intervention name(s): Daptomycin; Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.; Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.
Other intervention name(s): Cubicin
Intervention MeSH terms: Daptomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate whether metabolic modulation improves left
      ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in
      chronic heart failure
    


Intervention name(s): acipimox; placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule, 250 mg, 4 times daily for 28 days; capsule, 250 mg, 4 times daily for 28 days
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of
      oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
    


Intervention name(s): Follitropin delta; Follitropin beta
Intervention type(s): Drug; Drug
Intervention description(s): Single daily subcutaneous administration through pre-filled injection pen; Single daily subcutaneous injection in the abdomen
Other intervention name(s): FE 999049; REKOVELLE; FOLLISTIM
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Feasibility of an Intermittent Weight Loss Program.
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The goal of the study is to measure the effect of an approach including phases of active
      weight loss broken by weight stabilisation periods (named intermittent weight loss) on the
      metabolic profile.

      First, the intermittent weight loss approach will contribute to create an artificial
      transitory steady state during the weight loss treatment that will help to minimize the
      adverse effects of the standard approach on muscle mass and resting metabolic rate. Second,
      despite a comparable fat mass loss, the intermittent weight loss approach will improve the
      metabolic profile to a greater degree compared to the standard approach. Finally, the
      intermittent weight loss approach will be associated with less weight regain after the
      treatment since the beneficial effect on muscle mass and metabolic rate.
    

Detailed description: 
      Excessive levels of body fat are associated with metabolic disturbances predictive of an
      increased risk of coronary heart disease (CAD). It is presently unclear as to the magnitude
      of weight loss needed to accrue metabolic benefits. Despite the effectiveness of weight loss
      to reduce obesity levels, studies have shown that only minor decreases in body weight (5-10%)
      are needed to clinically improve CAD risk factors. Our data suggested that a 10% reduction in
      body weight is as effective in improving the metabolic profile as a 20% decrease in body
      weight. Thus, the question are : " Is it possible to further improve the metabolic profile
      over that 5-10% weight loss threshold?" and "Could several 5-10% body weight loss
      (intermittent weight loss approach) have additive effects on the metabolic profile?". We
      would like to follow-up on these observation to better understand 1) the association between
      weight loss and improvements in the metabolic profile and 2) why minor decreases in body
      composition and body fat distribution are as effective as more important reduction.
    

Intervention name(s): calorie controlled diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet; Caloric restriction; Intermittent diet; Obesity; Postmenopausal women
PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors
Condition: Genital Infection Female
Study type: Interventional

Summary: 
      The study was conducted to investigate the effect of a training program based on the
      PRECEDE-PROCEED Model on improving genital hygiene behaviors.It was carried out using
      experimental research design with pre-test and post-test, randomized and a control group. The
      study was conducted at Erzurum Saltuklu Family Health Center between June 2017 and January
      2018. Of the women with genital infections, 120 women were included in the study, of which 60
      were in the experimental group and 60 were in the control group. The data were collected by
      "Personal Information Form," "Genital Hygiene Knowledge, Attitude and Beliefs, Questionnaire"
      and "Genital Hygiene Behavior Inventory". In study, genital hygiene training intervention
      prepared according to the Precede-Proceed model was applied to the women in the experimental
      group. The women in the experimental group were measured at three different times: pre-test
      before training, post-test through training completition, and follow-up test after 4 weeks.
      The women in the control group did not receive any training intervention, the pre-test at the
      first encounter in the family health center and the post-test 5 weeks later.
    


Intervention name(s): Precede-Proceed based Training Program on Genital Hygiene Behaviors
Intervention type(s): Behavioral
Intervention description(s): A Training Program for Genital Hygiene Behaviors prepared in line with the Precede-Proceed model was presented to the women in the experimental group. The trainings started one week after the pre-test data were collected and were conducted in a total of 5 sessions, each lasting an average of 40 minutes, once a week. At the end of the five-week training, a post-test was applied. In order to determine the behavior changes of the women in the experimental group, a follow-up test was applied 4 weeks after the training ended. At the end of the training, women were given a training booklet prepared by the researcher.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Genital hygiene behavior; Women's health; Precede-Proceed model; Health education; Nursing
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them
      or deliver tumor-killing substances to them without harming normal cells.

      PURPOSE: Phase II trial to study the effectiveness of ABX-EGF in treating patients who have
      prostate cancer that has not responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the clinical effect of monoclonal antibody ABX-EGF, determined by the PSA
           response, in patients with hormone-resistant prostate cancer with rising PSA values
           without metastasis.

        -  Determine the pharmacokinetics and safety profile (including immunogenicity) of this
           drug in these patients.

        -  Determine the overall survival of patients treated with this drug.

        -  Determine the time to disease progression and time to PSA progression in patients
           treated with this drug.

      OUTLINE: This is a multicenter study.

      Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly. Treatment continues
      every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable
      toxicity.

      Patients are followed every 3 months for 2 years.

      PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.
    

Intervention name(s): panitumumab
Intervention type(s): Biological
Intervention MeSH terms: Panitumumab
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer
UVB-Induced MVP Release in Human Skin
Condition: Ultraviolet B Radiation; Microvesicle Particles
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess if ultraviolet B radiation (UVB) found in sunlight causes
      the release of microvesicle particles in human skin, and if antioxidant vitamins can block
      their production.
    


Intervention name(s): Vitamin C; Vitamin E
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two Vitamin C tablets daily for 8 days.; One Vitamin E tablet daily for 8 days.
Intervention MeSH terms: Vitamins; Vitamin E
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Epidemiological Survey of Children With Prolonged Mechanical Ventilation.
Condition: Prolonged Mechanical Ventilation
Study type: Observational

Summary: 
      Mechanical ventilation is an effective treatment for respiratory failure, no more than ten
      percent of patients with respiratory failure need long-term mechanical ventilation.
    

Detailed description: 
      Mechanical ventilation is an effective treatment for respiratory failure, no more than ten
      percent of patients with respiratory failure need long-term mechanical ventilation. There is
      a lack of data on children with long-term mechanical ventilation in China.The investigators
      conducted this study to investigate the clinical characteristics of children with long-term
      mechanical ventilation in China. The investigators conducted a multicenter clinical
      epidemiological survey.The study included PICU wards in major children's hospitals in China
      and investigated the causes of prolonged mechanical ventilation, the outcome of long-term
      mechanical ventilation.PMV definition: continuous invasive or noninvasive ventilation time ≥
      21 days, daily ≥ 6 hours.
    

Intervention name(s): no intervention, it is an observational study.
Intervention type(s): Other
Intervention description(s): no intervention, it is an observational study.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients who need prolonged mechanical ventilation aged from one month to 18 years old.
      
Keywords: prolonged mechanical ventilation; Children
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
      parallel-group clinical trial with 12 weeks of study drug therapy.
    

Detailed description: 
      This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
      parallel-group clinical trial with 12 weeks of study drug therapy.

      Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow
      for any necessary diagnostic procedures, allow for required washout of medications and to
      determine study eligibility. If otherwise eligible based on screening criteria, patients will
      undergo a 2-week baseline assessment using an electronic diary where they will record daily
      assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS),
      abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary
      assessment just prior to the randomization visit will be used to confirm IBS-C and study
      eligibility as well as define the patient's baseline from which change will be determined.

      Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three
      blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of
      study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication
      use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will
      return to the clinic to undergo safety and efficacy assessments.

      Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily
      electronic diaries. Patients will then return to the clinical site for a final follow-up
      visit during Week 14 following randomization.

      The planned duration of participation in this study will be at least 116 days from signing of
      informed consent through post-treatment or up to approximately 135 days with visit windows
      considered.
    

Intervention name(s): Plecanatide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Plecanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Condition: Infants; Newborn
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate that a new infant formula for term infants
      supports age-appropriate growth. This study is designed in accordance with Good Clinical
      Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In
      this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be
      randomized to one of two infant formulas: a standard, commercially-available infant formula
      for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference
      group of human milk-fed infants will also be enrolled. The primary efficacy objective is to
      compare the growth of infants randomized to the study infant formula (SF) versus growth of
      infants randomized to the standard commercial infant formula (CF).
    


Intervention name(s): Study Formula (SF); Comparator Formula (CF)
Intervention type(s): Other; Other
Intervention description(s): New infant formula for term infants fed ad lib; Commercially available infant formula for term infants fed ad lib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Infant; Infant Formula; Healthy Subjects