bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Dietary Intake of Cod Residual Material Meal on Lipid Regulation, Glucose Regulation and Body Composition in Physically Active Adults
Condition: Physical Activity; Healthy
Study type: Interventional

Summary: 
      A high intake of fish is associated with positive health effects, including prevention and
      treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and
      type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty
      acids in fatty fish, but recent studies have suggested that also fish proteins may improve
      biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial
      effects on blood lipids, glucose regulation and body composition in adults with overweight or
      obesity. Health effect of cod residual material from fillet production (i.e., head, backbone,
      skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish
      species have shown promising effects on glucose regulation in rats. The main aim of the
      current study is to investigate the effects of cod residual meal on serum lipids and glucose
      regulation in healthy, physically active adults.
    


Intervention name(s): Cod meal from residual material; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cod meal from residual material, 8 g protein daily for 8 weeks; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Alternate Dosing Schedules Study for HPV Vaccine (ADS)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata; Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The purpose of this study was to determine if delayed dosing of recombinant human
      papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls
      elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as
      measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine
      delivered according to the recommended dosing schedule.

      This was a prospective observational study of healthy 9-18 year old female patients receiving
      either a second or third dose of HPV vaccine as part of their well child care. Immune
      responses to HPV types 6, 11, 16 and 18 were measured both before and 1 month after the third
      dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when
      administered at naturally occurring longer dosing intervals to the immune response to HPV
      vaccine when administered as routinely recommended.

      In addition, girls receiving a 3rd dose of HPV vaccine as well as concomitantly administered
      vaccines by injection were randomized to receive either the HPV vaccine first or their
      concomitantly administered vaccines first. Pain following vaccination was assessed in each
      arm using the Faces Pain Scale - Revised.

      Please note: This record refers only to the observational portion of the study. Please refer
      to NCT00862810 for the results of the randomized portion of the study.
    


Intervention name(s): Both 2nd and 3rd doses on time; 2nd dose late and 3rd dose on time; 2nd dose on time and 3rd dose late; Both doses late
Intervention type(s): Biological; Biological; Biological; Biological
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescent females attending primary care clinics in central North Carolina
      
Biospecimen description: 
      Serum
    
Keywords: Human papillomavirus; Cervical cancer; Genital warts; Vaccine; Immunogenicity
Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
Condition: Adolescent Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the academic and psycho-social benefits of a
      yoga-informed health and wellness program (HWP) to a standard physical education program for
      middle and high school students within New York City (NYC) schools.
    

Detailed description: 
      Approximately 100 students at a public New York City High School will be randomized at the
      level of class into either the experimental (yoga-informed health and wellness program) or
      control arm (physical education class). Students will receive two classes per week of
      approximately 45 minutes throughout the academic year. Data will be collected in September
      2014 and February and May of 2015.
    

Intervention name(s): Yoga-informed Health and Wellness Program; Physical Education Class
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June).; Standard physical education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: stress; alternative; complementary; self-regulation
Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y.
      Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell
      dependant immune response while the existing polysaccharide vaccines induce a T-cell
      independent response, i.e. with no immune memory response. GSK Biologicals has developed a
      combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to
      serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT
      conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as
      control. In the long-term follow-up phase (extension phase) of the study, the long-term
      protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years
      after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This
      protocol posting deals with objectives & outcome measures of both the primary & extension
      phases.
    

Detailed description: 
      All subjects will have 7 blood samples taken: prior to and one month after vaccination and
      one, two, three, four and five years after vaccination. No new subjects will be enrolled in
      the extension phases of this Phase IIb study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
      September 2007.
    

Intervention name(s): meningococcal ACWY (vaccine); Mencevax™ ACWY
Intervention type(s): Biological; Biological
Intervention description(s): One intramuscular dose.; One subcutaneous dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Healthy; Persistence; Meningococcal vaccine; Non-inferiority; Meningococcal A C W Y Diseases; meningococcal serogroups A, C, W & Y diseases
Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress
Condition: Type 2 Diabetes; Prediabetes; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Metabolic Syndrome; Prediabetic State; Glucose Intolerance
Study type: Observational

Summary: 
      "The goal of this work is to critically test the hypothesis that there exists a different
      profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with
      normal controls. Through confirmation of different profile of BAs in T2DM, investigator will
      suggest modulation of specific bile acids as a new possible treatment target in patients with
      T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before
      hyperglycemia.

      In addition, investigator will evaluate the association between each BA species and serum
      total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations
      to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration
      in serum. Investigatr also evaluates the correlation between each BA species and metabolic
      profiles and oxidative stress marker to find possible roles of each BA component in glucose
      metabolism.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are recruited from either patients who visit out-patient clinics (Diabetes center
        in Severance hospital) or healthy volunteers.
      
Biospecimen description: 
      serum (blood), whole blood
    
Keywords: type 2 diabetes; prediabetes; bile acids profile; GLP-1; FGF-19
Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI)
Condition: Pregnancy
Study type: Interventional

Summary: 
      Although the essential role of iron during pregnancy is well established, concerns have been
      raised that current iron supplements given routinely during pregnancy may also have harmful
      consequences, such as increased oxidative stress and enhanced risks of infection,
      pre-eclampsia and impaired glucose regulation. A potential mechanism for the production of
      adverse effects is the appearance of non-transferrin-bound iron after oral administration of
      iron supplements. Non-transferrin-bound iron is more readily available to pathogens and could
      promote injurious free radical reactions that might add to the oxidative stress of pregnancy.

      The present study will determine if oral administration of 60 mg of iron as ferrous sulfate
      during the second trimester of pregnancy is followed by the appearance of
      non-transferrin-bound iron two hours later. The investigators will examine the influence of a
      variety of factors, including iron status and previous use of iron supplements. Detection of
      non-transferrin-bound iron after administration of an iron supplement to pregnant women would
      be an important new observation that could lead to re-evaluation of current methods of iron
      supplementation.
    


Intervention name(s): Ferrous Sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): 60 mg with 200 mL water, single administration
Other intervention name(s): FeSO4, Dr. Paul Lohmann, Emmerthal, Germany
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Iron Supplementation,; week 24 to 28 at study day
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe and North America. The aim of this clinical trial is to
      assess and compare the effect of insulin detemir in combination with liraglutide and
      metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will
      continue their own pre-trial metformin treatment during the trial.
    


Intervention name(s): liraglutide; insulin detemir; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.; Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm; Metformin tablets, at least 1500 mg/day
Intervention MeSH terms: Metformin; Liraglutide; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Persistence of Protective Antibody Titers 12-24 Months After NmVac4-A/C/Y/W-135-DT Vaccination: Follow Up Study
Condition: Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Observational

Summary: 
      To determine the persistence of protective antibody levels for subjects who seroconverted
      after vaccination with NmVac4-A/C/Y/W-135-DT™

      Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted
      and asked to provide a blood sample at 12-24 months after vaccination with
      NmVac4-A/C/Y/W-135-DT.

      Serum Bactericidal Assays will be performed to evaluated duration of protective antibody
      titer for NmVac4-A/C/Y/W-135-DT for all four serogroups. To determine if subjects who
      seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24
      months after vaccination.
    

Detailed description: 
      The purpose of this study is to collect serum samples to evaluate duration of protection for
      NmVac4-A/C/Y/W-135-DT, based on titers determined by Serum Bactericidal Assay with human
      complement (hSBA). This assay is used to evaluate immunogenicity of meningococcal vaccines,
      as a surrogate for efficacy. A titer ≥ 1:8 is considered protective.

      Objectives are to evaluate duration of protective antibody titer for NmVac4-A/C/Y/W-135-DT
      for all four serogroups, and determine if subjects with lower titers, but ≥:8 retain
      protective levels of antibody at 12-24 months.

      Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted
      and asked to provide a blood sample at 12-24 months after vaccination with
      NmVac4-A/C/Y/W-135-DT™.

      Serum Bactericidal Assays will be performed to evaluated persistence of protective antibody
      titer for NmVac4-A/C/Y/W-135-DT for all four serogroups, to determine if subjects who
      seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24
      months after vaccination.
    

Intervention name(s): NmVac4-A/C/Y/W-135-DT™
Intervention type(s): Biological
Intervention description(s): no intervention in this study, received test vaccine in trial JN-NM-002
Other intervention name(s): meningococcal meningitis conjugate vaccine quadrivalent
Intervention MeSH terms: Vaccines
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who seroconverted for serogroups A and C after vaccination with
        NmVac4-A/C/Y/W-135-DT in study JN-NM-001
      
Biospecimen description: 
      Serum samples used for antibody assays.
Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy
Condition: Intubation; Laryngoscopy
Study type: Interventional

Summary: 
      The investigators will evaluate the endotracheal intubation using video laryngoscopy versus
      conventional direct laryngoscopy on intubation success, quantified by the number of
      intubation attempts. The question is important because video laryngoscopes are more expensive
      than conventional direct laryngoscopes. The additional cost might be justified if video
      systems improve intubation success and reduce airway trauma. But if they do not, the extra
      cost would not be justified
    

Detailed description: 
      The investigators propose to enroll participants scheduled for elective or emergent cardiac,
      thoracic, or vascular surgery in the designated operating room suite who require endotracheal
      intubation for general anesthesia.

      The investigators plan a cluster randomized multiple crossover design, where each cluster is
      crossed over to the other treatment in the next period. The operating suites will be divided
      into 2 separate clusters consisting of 11 operating suites each. Randomization will consist
      of randomizing cluster 1 to use either video laryngoscope or direct laryngoscope, and cluster
      2 to the alternative device in one-week blocks.
    

Intervention name(s): GlideScope videolaryngoscope (Verathon, Bothell, WA 98011); Direct laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.; After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cluster randomized multiple crossover design
Masking: None (Open Label)
Primary purpose: Other
Keywords: Airway; Videolaryngoscope; Direct Laryngoscope
Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder
Condition: Prediabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      This study is designed to evaluate the effect of ume paste and ginger powder on glucose
      metabolism in prediabetic subjects.
    


Intervention name(s): Placebo; Ume paste and ginger powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Methylphenidate for Attention Problems After Pediatric TBI
Condition: Traumatic Brain Injury; TBI; ADHD
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      Traumatic Brain Injury (TBI) - methylphenidate treatment
    

Detailed description: 
      The objectives of the study are to (1) determine the efficacy and dose-response of
      methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI)
      and (2) provide a better understanding of the relationship of a prior history of attention
      deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and
      attentional control to treatment efficacy. The proposed clinical trial will enroll 50
      children, age 6-17 years, with attention problems >6 months after moderate to severe TBI into
      a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose
      conditions (low, medium, and high).
    

Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TBI; traumatic brain injury; ADHD; methylphenidate; Concerta; attention problems
Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
Condition: Healthy Normals
Study type: Interventional

Summary: 
      Study objective: The primary objective of the clinical investigation is to evaluate the
      accuracy of BioStamp nPoint system algorithm measurements.

      Study design: A single-site, non-significant risk, open-label, prospective non-randomized
      clinical investigation designed to validate the accuracy of the various physiological
      parameters that the Wearable Sensor Patches acquire and the system processes.
    


Intervention name(s): Physiological signal monitor; Heart rate and heart rate variability comparison device; Respiration rate comparison device; Activity classification
Intervention type(s): Device; Device; Device; Other
Intervention description(s): Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.; FDA cleared reference device that monitors heart rate and heart rate variability in subjects; FDA cleared reference device that monitors respiration rate in subjects; Visual annotation of subject posture and other activities used for reference
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional

Summary: 
      The purpose of this study is to identify whether or not the addition of a numbing medicine
      that is injected directly into the site of the bone marrow procedure can reduce pain and the
      use of opioid pain medication after bone marrow procedures. The addition of this medicine,
      called ropivacaine, is the experimental part of this study. This is the first time
      ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.
    


Intervention name(s): propofol; ropivacaine; Wong-Baker FACES® Pain Rating Scale; Post-procedural quality of life (QOL)
Intervention type(s): Device; Drug; Behavioral; Behavioral
Intervention description(s): Nurses will record patient-reported pain scores.
Intervention MeSH terms: Propofol; Ropivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: local Injection; pain Medication; propofol; ropivacaine; 16-1417