bioihbjkbjnl/mcl2 huggingface dataset:
Cinnamon and Withania on Weight Loss
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      With the prevalence of obesity soaring and the absence of an effective and safe treatment
      that is low-cost and always feasible, the use of food supplements has gained attention for
      the potential benefits in the absence of significant safety concerns. Cinnamon (CC) and
      Withania somnifera (WS) are plant-based supplements reported to be effective in improving
      metabolic health and body composition, the first mainly acting on insulin resistance and the
      second on energy expenditure and leptin resistance, as shown in preclinical and some clinical
      studies. Their association, possibly synergistic leveraging different mechanisms of action,
      has never been studied.

      This was a double-blind placebo-controlled study. Patients with overweight or obesity were
      prescribed a mildly hypocaloric diet with CC 300 mg plus WS 150 mg tid for 4 weeks in a cross
      over design and anthropometric parameters together with safety outcomes were collected.
    


Intervention name(s): Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively); placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The study product, in a capsule formulation, was made by the extract of Cinnamomum cassia (CC) and Withania somnifera (WS) (300 mg+150mg, respectively) (Nutrintech Ltd., London, UK); cellulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants
Condition: Urea Cycle Disorders; Organic Acidemias
MeSH terms: Brain Diseases; Urea Cycle Disorders, Inborn; Hypothermia; Hyperammonemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a pilot study which will test the safety and feasibility of hypothermia treatment as
      adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates
      versus conventional treatment (dialysis, nutritional therapy, and ammonia scavenging drugs)
      only. The endpoint of the pilot study will be reached when either 24 patients have been
      enrolled and no serious adverse events were observed, when no patient has been enrolled in 5
      years, or when serious adverse events occur which are clearly linked to the use of
      hypothermia. These would be serious complications not seen in patients on conventional
      therapy (dialysis , nutritional therapy, ammonia scavenging drugs) for HAE.
    

Detailed description: 
      Children with neonatal onset Urea Cycle Disorders or Organic Acidemias develop hyperammonemia
      (high ammonia levels) and fall into coma often causing brain damage. For these children to be
      able to benefit maximally from available long-term treatment and solid organ transplant,
      outcome of the neonatal onset crisis must be improved. Animal experiments and small clinical
      trials have indicated that hypothermia protects the brain during hyperammonemia. This pilot
      study investigates whether adjunct hypothermia therapy in addition to standard of care
      treatment is feasible and safe in babies with high ammonia levels in coma.
    

Intervention name(s): Therapeutic Hypothermia; Standard of Care Therapy
Intervention type(s): Other; Other
Intervention description(s): After obtaining written consent, patients are cooled to 33.5°C (+/- 1°C ) for 72 hours and and then rewarmed by 0.5°C per every 3 hours over 18 hours.; Patients with hyperammonemia and encephalopathy requiring renal replacement therapy due to a urea cycle disorder or organic acidemia that were treated at Children's National Medical Center over the past 10 years.
Other intervention name(s): Hypothermia; Hypothermia Therapy; Cooling; Dialysis; Hemodialysis; CVVH; CVVHD
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High ammonia level; Hyperammonemia; Poor suck; Lethargy; Coma; Encephalopathy; Seizures; Brain edema; Urea Cycle Disorder; Ornithine Transcarbamylase Deficiency; Carbamoyl Phosphate Synthetase Deficiency; Citrullinemia; Argininosuccinic Aciduria; Organic Acidemia; Propionic Aciduria; Methylmalonic Aciduria; Isovaleric Aciduria
Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.
Condition: Contraception; Female Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate user experience with the EVRAÂ® Contraceptive
      Transdermal Patch; specifically, user satisfaction with the EVRAÂ® Patch, and if applicable,
      user preference of the EVRAÂ® Patch compared with the previous method of contraception. The
      study also evaluates contraceptive efficacy, safety and user compliance.
    

Detailed description: 
      EVRA is the first transdermal contraceptive patch to receive approval by Health Canada and
      Marketing Authorization throughout the European Union. This is an open-label, single-arm,
      multicenter clinical study with a treatment duration of 24 weeks (6 treatment cycles of 4
      weeks). Four clinic visits are scheduled: a screening Visit 1, in which subjects are asked to
      complete a set of questions about satisfaction with the current method of contraception, and
      questions about overall health status. Visits 2, 3, and 4 follow after Cycles 1, 3, and 6,
      respectively of EVRA treatment. At Visits 3 and 4, the subjects are asked to answer questions
      about satisfaction with EVRA, and about overall health status. At Visit 4 (final study visit)
      the subjects are asked to compare EVRA with previously used contraceptive methods. Compliance
      is assessed at all visits by returned boxes of study medication and a review of Diary Cards
      where subjects recorded the dates and sites of patch application, and details of any patch
      detachment. The study will generate the first large-scale, European dataset on women's
      experience with EVRA, including satisfaction, safety, efficacy, and compliance. These data
      will be compared with subjects' experience with previously used methods of contraception.
      Each EVRA patch, containing 6 mg NGMN and 600 ug EE, and delivering 150 microgram NGMN and 20
      ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks. The
      fourth week is patch-free. Subjects can wear EVRA on 1 of 4 areas: buttock, abdomen, upper
      torso, or upper arm.
    

Intervention name(s): norelgestromin + ethinyl estradiol
Intervention type(s): Drug
Intervention MeSH terms: Ethinyl Estradiol; Norelgestromin; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception; female contraception; hormonal contraception; transdermal contraception; EVRA; estrogen; progestin; ethinyl estradiol; norelgestromin
Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children
Condition: Diarrhea; Malnutrition
MeSH terms: Malnutrition; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Much has been learned in recent years about the mechanisms by which breastfeeding improves
      child health and survival. However, there has been little progress in using these insights to
      improve pediatric care. Factors that are important for protecting the breast fed infant might
      be expected to decrease the adverse effects of weaning on diarrhea, growth, and development.
      The proposed study is meant to begin addressing this important gap by a clinical trial of
      lactoferrin supplementation in previously weaned children. Lactoferrin,an iron-binding
      protein with multiple physiological functions (anti-microbial, anti-inflammatory, and
      immunomodulatory), is one of the most important proteins present in mammalian milk. Our
      hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those
      consumed if the child were still breastfed) will improve health by mimicking its protective
      roles in milk. The significance of these studies is that they will prove feasibility of
      improving child health after the end of breastfeeding by continuing ingestion of a major
      protective milk protein. Diarrhea and malnutrition after weaning is a global problem that may
      be amenable to this approach.
    

Detailed description: 
      The proposed community-based study will be conducted in a previously weaned population at
      risk for repeated intestinal infections. Infants who are 12-18 months of age living in the
      District of Independencia, Lima, Peru will be eligible for enrollment. We will conduct a
      randomized double blind placebo controlled trial comparing twice daily supplementation with
      bovine lactoferrin versus a placebo (maltodextrin) Therapy will be continued for 6 months
      with close monitoring of all study participants for diarrhea and growth.

      Specific aim 1: Determine the effect of bovine lactoferrin supplementation on prevention of
      diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously
      weaned Peruvian children enrolled at 12 to 18 months of age.

      Specific aim 2: Determine the effect of bovine lactoferrin supplementation on growth.
    

Intervention name(s): bovine lactoferrin; placebo [maltodextrin]
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1gm of lactoferrin will be given each day; placebo that appears identical to lactoferrin will be given daily
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: randomized controlled trial; lactoferrin; children; diarrhea; malnutrition; growth
Trial of a Health Promoting School Approach to Positive Youth Development and Wellness Promotion
Condition: Adolescent School Connectedness; Adolescent Health; Community Based Participatory Research Methods
Study type: Interventional

Summary: 
      Assess the effects of a school-based multi-component intervention on school connectedness,
      school engagement, and developmental assets through a group randomized, participatory trial.
    

Detailed description: 
      Health Promoting Schools intervention including pilot-tested teacher professional
      development, student-defined enhanced environment, and parent-defined enhanced
      community/family connection. The Coalition will finalize the intervention using a phased
      intervention map that integrates community perspectives with theoretical approaches to
      evidence based practices. The study aims will be accomplished through a group randomized
      trial in 10 urban schools with diverse populations representing approximately 1,900 students.

      Aim 1: Assess the effects of a school-based multi-component intervention on school
      connectedness, school engagement, and developmental assets through a group randomized,
      participatory trial.

      Hypothesis 1a: Students in the intervention schools will experience improved school
      connectedness, engagement and developmental assets compared to the control group.

      Aim 2: Assess the effects of a school-based multi-component intervention on emotional
      well-being, tobacco and other substance use, and academic outcomes through a group
      randomized, participatory trial.

      Hypothesis 2a: Students in the intervention schools will experience improved emotional
      well-being, course completion, attendance, and decreased disciplinary action and substance
      use compared to the control group.

      Aim 3: Evaluate the relationships between participatory factors , school intervention
      implementation, and study outcomes.

      Exploratory hypothesis 3a: Perceptions of quality of collaborative processes will be
      associated with degree of school intervention implementation and study outcomes.

      Exploratory hypothesis 3b: School capacities and context will be associated with school
      intervention implementation and study outcomes.

      Exploratory hypothesis 3c: School capacities and context will mediate the relationship
      between quality of collaborative processes and school intervention implementation.
    

Intervention name(s): Delayed Intervention; Intervention
Intervention type(s): Other; Other
Intervention description(s): Schools not receiving intervention until two years after implementation.; intervention at the beginning of study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Recombinant Human IL-4 Receptor Used in Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to measure the effectiveness of recombinant human interleukin-4 receptor
      (IL-4R) in treating asthma.

      Asthma can be caused by the allergic response from breathing in certain irritants.
      Interleukin 4 (IL-4), which is naturally produced by the body, plays a major role in this
      allergic response. Doctors feel that IL-4 activity may be stopped by giving IL-4R, a product
      that binds to IL-4, and thereby decrease the problems of asthma.
    

Detailed description: 
      A major factor in the pathogenesis of asthma is the development of an allergic inflammatory
      response to inhaled antigens. Interleukin-4 (IL-4) plays a key role in this response. Binding
      and inactivating the IL-4 molecule with IL-4R may diminish the allergic asthmatic response by
      inhibiting activities of IL-4.

      Patients are randomized to 1 of 3 treatment groups and, within each group, are stratified by
      baseline FEV1 cohort. Patients receive either dose level 1 of IL-4R, dose level 2 of IL-4R,
      or placebo, by aerosol drug delivery device, once a week for 12 weeks. There are frequent
      clinic visits and several follow-up visits. Physical exams and spirometry are done regularly;
      immunizations are administered on Day 28; and a skin tests panel is given on Day 84. Blood
      samples are collected at study visits during treatment and follow-up to test for
      immunology/serology parameters, chemistry profiles, and asthma-related DNA polymorphisms.
      Patients are provided with peak flow meters and must demonstrate their proper use so that a
      peak expiratory flow (PEF) diary and a symptoms diary can be maintained. Selected sites
      measure exhaled nitric oxide and collect induced sputum samples. Assessments for adverse
      events are conducted at 16 and 40 weeks following the first study drug treatment.
    

Intervention name(s): Recombinant human soluble IL-4 receptor; Placebo for Recombinant human soluble IL-4 receptor
Intervention type(s): Biological; Biological
Intervention description(s): Subjects were randomized to twelve once weekly nebulizations of 0.75, 1.5, or 3.0 mg dose of recombinant human soluble IL-4 receptor (rsIL-4R); Subjects were randomized to twelve once weekly nebulizations of placebo for recombinant human soluble IL-4 receptor (rsIL-4R). Identically prepared (to the recombinant human soluble IL-4 receptor) in the same volume
Other intervention name(s): Placebo Treatment
Intervention MeSH terms: Interleukin-4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Recombinant Proteins; Aerosols; Asthma; Receptors, Interleukin-4; Forced Expiratory Volume
Impact of Blueberry Consumption on Gastrointestinal Health
Condition: Obesity; Circadian Dysregulation
MeSH terms: Chronobiology Disorders
Study type: Interventional

Summary: 
      This study will evaluate the impact of blueberry consumption on markers of gastrointestinal
      health including gut microbiota, intestinal permeability, and gut-derived inflammation in
      those vulnerable to a unhealthy gut milieu. All participants will consume a blueberry powder
      and a placebo in this crossover study.
    

Detailed description: 
      The commensal bacteria that reside in the human gut, known as the gut microbiota, is a
      complex system that modulates local gut homeostasis and systemic biological processes.
      Several environmental factors have been shown to influence the gut milieu (including
      microbiota), and thus both gastrointestinal and host health. Relevant to the current proposal
      is the influence of body weight, diet, and circadian rhythms. In the current study, the
      investigators propose to use these common disruptors of gastrointestinal health through
      recruiting obese shift workers with a low-fiber diet to identify if these disrupted
      individuals can benefit from blueberry intake. Specifically, the study objectives are to
      determine if 24 g whole blueberry powder consumed daily can beneficially modify intestinal
      permeability, gut microbiota, microbial metabolites, and both gut-derived and systemic
      inflammation in those most susceptible to a pro-inflammatory milieu. This will be
      accomplished through a 14-week crossover study in which 28 individuals will be randomized by
      treatment group order to 4 weeks of whole blueberry powder and placebo powder, with a 4-week
      wash out in between the treatment periods.
    

Intervention name(s): Blueberry powder; Placebo powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart.; A placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This 14-week crossover study includes 4 weeks for each of the two supplementation periods (blueberries and placebo), with a 4-week wash out between.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blueberry; Microbiota; Intestinal permeability
Respiratory and Cardiovascular Effects in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to find out if subjects with chronic obstructive pulmonary
      disease have signs of accelerated ageing in their airways.
    

Detailed description: 
      The age-related impairment of innate immunity and antioxidant defenses likely impacts on
      development and disease progression of chronic obstructive pulmonary disease, COPD. It has
      been suggested that aging-related declines in function are accelerated in COPD due to
      recurrent cycles of inflammation, tissue injury and repair, associated with long-term
      exposure to cigarette smoke or other airway irritants. Here, the investigators aim to follow
      up on previous observations of impaired antioxidant responses in the lung of COPD patients,
      to establish the extent to which this reflects an accelerated aging phenotype, to
      characterize the molecular mechanisms resulting in this functional deficiency. The proposed
      studies will employ well-characterized patients with COPD of varying severity and smoking
      habits, as well as carefully age and smoking history-matched controls. Accelerated aging
      within the COPD lung will be assessed in endobronchial mucosal biopsies and airway
      macrophages by assessment of established senescence markers using immunohistochemical,
      biochemical and PCR-based methods. These markers of tissue age will then be related to the
      functional activation of transcription factors, known to be induced by oxidative stress and
      related to cytoprotection such as Nrf2 and AP1. The investigators will also examine whether
      COPD is associated with an enhanced secretion of inflammatory mediators from senescent cells,
      consistent with the accelerated aging paradigm and establish how this influences cell
      function. Deficiencies in metal handling, antioxidant defenses and diminished airway innate
      immune defenses at the air-lung interface will be assessed. The aim is to identify biomarkers
      for the risk of rapid lung function deterioration in COPD patients.
    

Intervention name(s): Bronchoscopy
Intervention type(s): Other
Intervention description(s): Sampling of airways
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Aging; Oxidative stress; Proteases; Bronchoscopy
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2831781 After an Intravenous (IV) Dose in Healthy Japanese and Caucasian Subjects, and a Subcutaneous (SC) Dose in Healthy Caucasian Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, placebo-controlled, randomized, parallel group, two-part study where
      single IV doses of GSK2831781 will be administered to healthy Japanese and Caucasian subjects
      in part A and SC doses will be administered to healthy Caucasian subjects in part B.
      GSK2831781 is a humanized, antibody-dependent cell cytotoxicity (ADCC) enhanced depleting
      monoclonal antibody that is specific to the lymphocyte activation gene-3 (LAG3) protein. LAG3
      is a transmembrane receptor, which is upregulated on T cells following activation. The
      objective of the study is to assess the safety, tolerability, PK, PD and immunogenicity post
      administration of GSK2831781 in healthy subjects. The duration of the study is approximately
      147 days for each subject enrolled. Approximately 36 subjects will be enrolled in the study,
      16 subjects in Part A and 20 subjects in Part B.
    


Intervention name(s): GSK2831781; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2831781 will be available as Dose-1 and Dose-2 as IV infusion or SC injection. Subjects will receive GSK2831781 Dose-1 IV diluted in 0.9% saline or GSK2831781 SC as multiples of Dose-2 SC.; Placebo will be 0.9% saline solution which will be administered in subjects as IV infusion or SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Japanese, Caucasian, pharmacokinetics, pharmacodynamics, GSK2831781, lymphocyte activation gene-3