bioihbjkbjnl/mcl2 huggingface dataset:
Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)
Condition: Inflammatory Bowel Diseases; Remission; Perceived Stress
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The investigators have designed a guided, online, tri-component, stress reduction
      intervention for participants with inflammatory bowel diseases.
    

Detailed description: 
      In a randomized controlled trial, the investigators assessed the impact of an online, 3-month
      stress reduction intervention (yoga, breathwork, and meditation). The primary outcome was the
      change in Cohen's Perceived Stress Scale (PSS) between the control and intervention arms. The
      following secondary outcomes were also assessed: anxiety, depression, IBD disease activity
      (e.g., changes in CRP, fecal calprotectin, medication, hospitalization, or surgery), serum
      inflammatory markers, serum and salivary markers of stress, stress-resilience, and health-
      related quality of life. Participant satisfaction and adherence to the intervention were also
      evaluated.
    

Intervention name(s): Stress Reduction Intervention
Intervention type(s): Other
Intervention description(s): The tri-component intervention is comprised of guided videos for breath-work (5-15 min), stretching (5-15 min), and meditation (10-30 min). The intervention will be delivered online via an access restricted website.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: ulcerative colitis; remission; perceived stress; fecal calprotectin; salivary stress biomarker; psychological stress; stress reduction; Crohn's disease; Inflammatory bowel diseases
Single Dose Pharmacokinetics of Egalet® Oxycodone
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet®
      oxycodone formulations and compare to a marketed oxycodone product.
    


Intervention name(s): Oxycodone hydrochloride; Oxycodone hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Extended release tablet; Extended release tablet
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability
      to CKD-519 new formulation in healthy male subjects.
    

Detailed description: 
      Open-label, Randomized, 3-period, 6-sequence, crossover study
    

Intervention name(s): CKD-519 50mg 2Tabs.; CKD-519 100mg 1Tab.; CKD-519 100mg 1Cap.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): after taking Standard meal, CKD-519 50mg 2Tabs. administration.; after taking Standard meal, CKD-519 100mg 1Tab. administration.; after taking Standard meal, CKD-519 100mg 1Cap. administration.
Other intervention name(s): Drug A; Drug B; Drug C
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery
Condition: Obesity
Study type: Observational

Summary: 
      The purpose of this study is to investigate mechanisms responsible for weight change in
      patients who have undergone weight loss surgery. Specifically, we will compare the gut
      microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in
      three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal
      weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a
      control group who has not had a weight loss surgery and are of similar age, gender, body mass
      index as the gastric bypass groups.
    


Intervention name(s): Meal challenge
Intervention type(s): Other
Intervention description(s): Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        3-5 years post gastric bypass patients and control subjects
      
Biospecimen description: 
      Fecal Samples and Plasma/Serum Samples
    
Keywords: Gut Microbiota; Weight Regain; Gastric Bypass
Evaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model
Condition: Hypercholesterolemia; Hypertension; Depression; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional

Summary: 
      Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of
      their size, experience a life-long battle and preoccupation with their weight. Despite the
      attention to weight and the increase in diet behavior, the incidence of obesity continues to
      rise. There is little data to show improved long term success for the majority of
      participants who engage in weight loss behaviors.

      The specific aim is to improve the psychological and metabolic health of obese women with a
      history of chronic dieting through encouraging "Health at Every Size" (HAES). This treatment
      model emphasizes "intutitive eating," i.e., internal regulation of eating (responding to cues
      of hunger, appetite and satiety). The HAES model is being compared to the current standard of
      care in obesity treatment, energy restriction dieting, which encourages cognitive control of
      eating and weight reduction.
    


Intervention name(s): Health at Every Size (HAES); Diet (Traditional, moderate energy restriction)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Self-Esteem
Cesarean Wound Closure in Women With BMI 40 or Greater
Condition: C.Delivery; Penetration, Pregnant Uterus, by Instrument; Obesity
Study type: Interventional

Summary: 
      The purpose of this randomized controlled prospective trial is to guide physicians on the
      most effective evidenced based skin closure during a cesarean section for the obese gravida,
      defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular
      sutures and surgical staples.
    

Detailed description: 
      The study will screen and attempt to enroll pregnant women admitted to labor and delivery who
      have a BMI of 40 or greater. The participants will be randomized to receiving skin closure
      with subcuticular sutures or surgical staples if they undergo cesarean section. Either
      technique is currently standard of care. Participants who end up undergoing cesarean section
      will be included in the final data analysis. The participants will be followed for wound
      complication in the first 6 weeks post operatively. Wound complication will be defined as
      wound disruption or infection within 6 weeks post operatively.

      Design and Project Type This study is a randomized controlled trial. At the study facility,
      in 2012 and 2013, over 300 cesarean sections were performed each year in women with BMI of 40
      or greater. Based on this, the investigators expect the duration of the study to be 2 years.
      Randomization and data collection will be completed on 420 women.

      Description of Intervention Two interventions will be used in this project: subcuticular
      suture and surgical staples. The subcuticular suture will be the size and type of suture
      chosen by the surgeon at the time of cesarean. The surgical staples will be the standard
      staples used on the labor and delivery unit.
    

Intervention name(s): Randomizing to Suture or Staple closure of Cesarean section
Intervention type(s): Procedure
Intervention description(s): Randomizing to either surgical subcuticular suture or surgical staples in women of BMI greater than 40 undergoing Cesarean section delivery.
Other intervention name(s): suture or staples for skin closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of
      PT003 compared with its individual components (PT001 and PT005), placebo and two active
      comparators to demonstrate superiority of the combination to its components, and to assess
      the relative contribution of the components compared with placebo, in patients with moderate
      to very severe COPD.
    


Intervention name(s): PT003 MDI; PT005 MDI; Placebo MDI; Tiotropium bromide 18 μg (Spiriva Handihaler®); Formoterol Fumarate 12 μg (Foradil® Aerolizer®); PT001 MDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled PT003 MDI administered as two puffs BID for 7 days; Inhaled PT005 MDI administered as two puffs BID for 7 days; Inhaled placebo administered as two puffs BID for 7 days; Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days; Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days; Inhaled PT001 MDI administered as two puffs BID for 7 days
Intervention MeSH terms: Bromides; Formoterol Fumarate; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COPD
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia
Condition: Cognitive Deficits in Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an efficacy and safety study evaluating an experimental treatment for cognitive
      deficits in adults with schizophrenia.
    

Detailed description: 
      This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in
      approximately 210 adults with schizophrenia. Subjects will be randomized to one of three
      treatment groups (ABT-126 Dose 1, ABT-126 Dose 2 or placebo) for a 12-week Treatment Period.
      The purpose of this research study is to find out whether ABT-126 compared to placebo can
      improve cognition and what side effects ABT-126 may cause. Cognition is the way a person
      thinks, and it includes abilities like paying attention, focusing, remembering things, and
      solving problems. Acronyms listed in the Outcomes and/or Eligibility sections for this study
      are defined below: • MCCB: Measurement and Treatment Research to Improve Cognition in
      Schizophrenia (MATRICS) Consensus Cognitive Battery • UPSA-2: University of California at San
      Diego (UCSD) Performance-Based Skills Assessment-2 • CANTAB: Cambridge Neuropsychological
      Test Automated Battery • PANSS: Positive and Negative Syndrome Scale • NSA-16: Negative
      Symptom Assessment-16 • CGI-S: Clinical Global Impression - Severity
    

Intervention name(s): ABT-126; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ABT-126 Dose 1, ABT-126 Dose 2; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients
Condition: Pulmonary Disease, Chronic Obstructive; Major Depression
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major
      depression, a condition that contributes to suffering but also to poor treatment adherence
      leading to increased disability and morbidity. This study investigates the effectiveness of a
      care management intervention aimed at facilitating adherence to a treatment algorithm based
      on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators
      hypothesize that this intervention, in comparison to usual care, will increase the
      prescription of adequate antidepressant treatment by physicians, enhance treatment adherence
      by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week
      follow-up period.
    


Intervention name(s): Treatment Adherence Intervention; Enhanced Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The care management intervention aims at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability.; For subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the Agency for Health Care Policy and Research (AHCPR) guidelines for the treatment of depression in primary care with an addendum updating the tables describing Selective Serotonin Reuptake Inhibitors (SSRI) side effect and dosage profiles. The investigators expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in chronic obstructive pulmonary disease patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Individual Patient Data Meta-analysis of CSII vs. MDI in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study aims to compare glycaemic control during continuous subcutaneous insulin fusion
      (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to
      identify patient-level characteristics that predict the best improvement in control and any
      change in insulin dose or other outcome.
    

Detailed description: 
      The investigators will identify randomised controlled trials without language restriction
      that meet the inclusion criteria by searching the Cochrane database, Ovid Medline, Google
      Scholar and other sources. The investigators will exclude observational studies, short-term
      trials <2 months duration, studies in pregnant diabetic subjects, newly diagnosed type 2
      diabetes, trials in type 1 diabetes and extensions of previous studies.

      Data on individual participants will be obtained directly from trialists and from funding
      sponsors who hold the trial data and will include age, sex, duration of diabetes, treatment
      group, baseline and final HbA1c, baseline and final insulin dose, baseline and final BMI.

      A 'two-step' meta-analysis will be performed to estimate overall mean differences in HbA1c,
      insulin dose and weight/BMI for the trials. Then, a 'one-step' meta-regression analysis will
      be conducted by creating a single large dataset from the individual patient data.
      Determinants of final HbA1c, BMI/weight and insulin dose will be explored using Bayesian
      approaches with covariates that include baseline HbA1c, age, diabetes duration, BMI, insulin
      dose and interactions between the covariates.
    

Intervention name(s): Continuous subcutaneous insulin infusion
Intervention type(s): Device
Intervention description(s): Infusion of short-acting insulin from a portable pump
Other intervention name(s): Insulin pump therapy
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        People with type 2 diabetes
      
Keywords: Type 2 diabetes; Continuous subcutaneous insulin infusion; Meta-analysis; Insulin pump therapy; Multiple daily insulin injections
Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI
Condition: Sperm DNA Fragmentation
Study type: Interventional

Summary: 
      On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell
      sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in
      solving this problem by using two known techniques to achieve that purpose.
    

Detailed description: 
      Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo
      quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st
      trimester.

      Sperm selection methods like PICSI and MACS have been developed for selecting a healthy
      mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best
      embryo quality and achieve higher ongoing pregnancy rates.

      A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish),
      the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining
      better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on
      Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to
      phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa
      without DNA fragmentation.

      In order to determine which sperm selection technique is better for dealing with DNA
      fragmentation patients we need to study both techniques on two different groups of patients
    

Intervention name(s): PICSI; MACS
Intervention type(s): Other; Other
Intervention description(s): sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index; sperm selection using MACS for selecting sperm with lower DNA fragmentation index
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SDF; DFI; sperm selection; PICSI; MACS
Study on Out of School Nutrition and Physical Activity Environments
Condition: Child Physical Activity; Child Nutrition
Study type: Interventional

Summary: 
      The purpose of this study is to design and conduct research to tailor out of school time
      evaluation materials so they are applicable to various settings in Boston, are efficient in
      that minimal resources and time are used, and are useful to participants.
    

Detailed description: 
      Nearly half of Boston's school age children (49%) participate in out of school time programs,
      a critical time to intervene on physical activity and nutrition. Previous research has mostly
      focused on during-school-day efforts, or on child care policies and practices for very young
      children, leaving a gap in the knowledge of what might work with programs serving school-age
      children during out of school time. OSNAP aims to implement low cost and sustainable policy
      and environmental interventions to improve physical activity and healthy eating/beverage
      environments. Data will be collected via observations, plate waste and accelerometers on
      program policies, environments, practices and behavioral outcomes related to physical
      activity, beverage, snack and screen time outcomes.
    

Intervention name(s): Policy and Environmental Change
Intervention type(s): Behavioral
Intervention description(s): Afterschool programs participate in an assessment of physical activity and nutrition practices and policies. Study staff work with teams of afterschool programs in a participatory manner to identify areas in which programs would like to take practice, policy and communication efforts to meet physical activity and nutrition goals. Teams share progress and barriers during ongoing collaborative meetings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: afterschool; accelerometers; plate waste; policy; environment
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective
      for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or
      mixed).
    


Intervention name(s): Ziprasidone oral capsules; placebo oral capsules
Intervention type(s): Drug; Drug
Intervention description(s): Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.; Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment