bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objectives of this study are to determine vaccine efficacy against severe rotavirus
      (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two
      years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to
      definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.
    

Detailed description: 
      The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy
      infants who are 6-12 weeks of age in Hongkong and Taiwan or 11-17 weeks of age in Singapore,
      according to a 0, 1 to 2-month schedule. Routine vaccinations are given concomitantly with
      the study vaccines at 2 or 3 and 4 months of age according to each local country regulation.
      Whenever OPV is used, a minimum 2-week interval should be observed between HRV vaccine and
      OPV doses.
    

Intervention name(s): Rotavirus
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether magnesium preloading reduce incident of
      cisplatin induced acute kidney injury in head and neck cancer who receiving low dose
      cisplatin (40 mg/m2 weekly for 7 weeks).
    

Detailed description: 
      Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline
      for prevention of acute and chronic nephrotoxicity of cisplatin.
    

Intervention name(s): Magnesium; Control
Intervention type(s): Drug; Other
Intervention description(s): Pre loading fluid with Magnesium sulphate 16 milliequivalent plus potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration; Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
Other intervention name(s): Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cisplatin nephrotoxicity; Acute kidney injury
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purposes of this study are to evaluate the safety and tolerability and to model the
      single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children
      ages 6 to <17 years experiencing mild to moderate acute postoperative pain.
    


Intervention name(s): Diclofenac Capsules low dose; Diclofenac Capsules high dose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Diclofenac
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. Comparisons
      between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine
      sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and
      psychomotor performance.
    


Intervention name(s): 15 % Nitrous oxide; 0.3 % Sevoflurane; 30% Nitrous oxide; 0.6% Sevoflurane; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention MeSH terms: Nitrous Oxide; Sevoflurane
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: sevoflurane; nitrous oxide; subjective effects; healthy volunteer
Cause and Importance of the Age-dependent Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      The goal of this cross-sectional study is to evaluate the difference in cytokine profiling
      approach and mitochondrial function between geriatric sarcopenic patients (group 1) and
      geriatric non-sarcopenic patients (group 2) and healthy (group 3) geriatric participants.
    

Detailed description: 
      Study participants (group 1&2) are assessed during the hospital stay and age-matched controls
      (group 3) will be recruited through Flyers.

      The investigators aim to isolate and cryopreserve peripheral blood mononuclear cells (PBMCs)
      from whole blood to perform functional assays on mitochondrial respiratory capacity and ROS.
      Furthermore, the investigators will investigate the association between biomarkers and
      frailty, quality of life, functional performance, fatigue and risk of depression.

      The investigators hypothesize that this profiling approach will allow the evaluation of the
      progression of age-dependent sarcopenia and uncover novel therapeutic targets.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Group 1: sarcopenic patient Group 2: non-sarcopenic patient Group 3: healthy control
      
Keywords: Sarcopenia; Geriatrics; Biomarker
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
Condition: Discoid Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Discoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the clinical and immunological effects of the
      phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous
      lupus erythematosus.
    

Detailed description: 
      Discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a
      chronic, immune mediated disease of unknown etiology. The immune processes underlying
      cutaneous lupus remain largely unexplored, but recent evidence suggests a role for dendritic
      cells (DCs), type 1 interferons (IFN) and Th1-type immune processes. Treatment of cutaneous
      lupus remains limited primarily to anti-malarials, with thalidomide an effective secondary
      agent. However, side effects associated with these treatments are potentially problematic
      with chronic use. Phosphodiesterases (PDE) are critical enzymes that degrade cAMP. In
      particular, PDE type 4 (PDE4) activity is found in inflammatory and immune cells, including
      DCs. The immune modulator CC-10004 is a PDE4 inhibitor with demonstrated low toxicity in
      phase I and II clinical studies with potential efficacy in cutaneous lupus. CC-10004 is a
      well-tolerated, selective PDE4 inhibitor with demonstrated inhibitory effects on Th1-type
      cytokines and other inflammatory mediators and is under development for the treatment of
      inflammatory and immune mediated conditions. Prior studies include pilot trials in psoriasis
      and exercise-induced asthma, with results suggesting clinical efficacy in the former study.
      This open label, pilot study of 16 weeks duration will explore the clinical and
      immune-modulating effects of CC-10004 in 10 cutaneous discoid lupus patients. Patients
      meeting study criteria will receive the drug for 12 weeks, followed by a 4-week washout
      period. Study visit time points will include weeks 0, 1, 2, 4, 6, 8, 10, 12 and 16, during
      which we will measure outcomes for clinical, immunological and safety parameters. To
      investigate early immunological changes occurring in response to treatment, we will also
      perform skin punch biopsies of lesional sites at week 0 and week 4 for immunohistochemical
      and molecular analysis.
    

Intervention name(s): CC-10004
Intervention type(s): Drug
Intervention description(s): 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Other intervention name(s): Apremilast
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cutaneous lupus; Intervention; Discoid lupus; Phosphodiesterase 5 inhibitor
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety, tolerability, drug levels and drug
      effects of BMS-986196 in healthy participants. In addition, an evaluation of food and
      formulation effects on BMS-986196 absorption will be performed.
    


Intervention name(s): BMS-986196; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy participants; BMS-986196
A Pilot Study Evaluating Oat Polyphenols on Post-prandial Glucose Response
Condition: Blood Glucose
Study type: Interventional

Summary: 
      The trial will use a two period acute double-blind cross-over design to compare the effects
      of a serving of oatmeal containing high or low amounts of avenanthramides (AV) on
      post-prandial blood glucose response in healthy adults.
    

Detailed description: 
      The clinical trial will follow a two period acute double-blind cross-over design. It will
      take place at Richardson Centre for Functional Food and Nutraceuticals (RCFFN) at University
      of Manitoba, Winnipeg, Canada.

      The trial will recruit healthy adult participants. Participants will consent to participate
      in two acute feeding sessions. Participants will be randomized to either control (low
      avenanthramides) then treatment (high avenanthramides) or treatment then control.
      Participants will arrive at the study center fasted between 8 and 10:30 am on the session
      days. They will be provided either the study treatment or control product based on
      randomization sequence for their first study visit. Baseline blood glucose (0 min) will be
      measured in duplicate via finger stick blood sample right before their first bite of the
      treatment product, and at 15, 30, 45, 60, 90 and 120 mins after baseline. The timer will be
      started when they take their first bite. During the second visit participant will consume the
      other treatment based on the randomization (the oatmeal that they didn't receive in their
      first visit and follow exactly the same procedure as the first visit). There will be a
      minimum of 5 days between sessions. Female participants will be scheduled during the luteal
      phase of their menstruation cycle. There will be a maximum of 8 weeks between the two
      sessions, therefore, participants will finish the both sessions within an 8 week period.
    

Intervention name(s): Serving of oatmeal made from low avenanthramides oats and water; Serving of oatmeal made from high avenanthramides oats and water
Intervention type(s): Other; Other
Intervention description(s): One serving size (40 grams dry weight) of low avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.; One serving size (40 grams dry weight) of high avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
Condition: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis
MeSH terms: Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the long term immunogenicity produced in children by
      the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT
      00362336).

      Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age
      following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™
      + Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a
      booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months
    

Detailed description: 
      All participants must have received the primary series of vaccinations and a booster
      vaccination in Study A3L15 (NCT 00362336).

      Participants will receive no vaccination in this study but will undergo immunologic
      assessments at 3.5 and 4.5 years of age.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants aged 3 years and a half on the day of inclusion and must have received the
        primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336). No
        vaccination will be provided or administered in this study.
      
Keywords: Diphtheria; Tetanus; Whooping cough; Hepatitis B; Poliomyelitis; Diphtheria-Tetanus-acellular Pertussis Vaccines
Kinetics of the Immune Response to Inactivated Influenza Vaccine in Healthy Adults
Condition: Influenza; Influenza, Human; Vaccine Reaction; Influenza A; Influenza Type B; Influenza A H1N1; Influenza A H3N2
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the body's immune response at different time points
      to an FDA-approved seasonal influenza vaccine. By better understanding the way the immune
      system responds to the influenza vaccine, the investigators can design more effective
      vaccines against influenza.
    

Detailed description: 
      This is an observational study of seasonal, cell-cultured inactivated influenza vaccine
      (cc-IIV4) in healthy males and non-pregnant females aged 18 to 45 years old, inclusive. This
      clinical study is designed to comprehensively evaluate the characteristics and kinetics of
      the immune response to influenza vaccine.

      By developing a comprehensive understanding of the mechanisms by which the immune system
      responds to influenza vaccine, including innate immune system responses, the effect of early
      influenza exposures, and (eventually) the effect of potent adjuvants, the investigators will
      be better equipped to design more highly effective vaccines to conquer seasonal influenza and
      prevent influenza pandemics.

      Data from this pilot observational study will guide the design of global studies addressing
      age-specific responses, the impact of sex and geography, and the role of adjuvants on
      influenza immunity.
    

Intervention name(s): Influenza Vaccine Recipients
Intervention type(s): Biological
Intervention description(s): 0.5 mL intramuscular injection
Other intervention name(s): Flucelvax (ccIIV4)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ten (10) individuals 18-45 years of age, 5 males and 5 non-pregnant females, who are in
        good health by history and meet all eligibility criteria, will be enrolled at one site
        participating in this study. The target population will reflect the community at large at
        the participating site.
      
Biospecimen description: 
      Serum, plasma, and peripheral blood mononuclear cells will be collected and stored according
      to protocol for a variety of immune interrogations.
    
Keywords: Influenza Vaccine; Influenza
Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily
      (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.
    

Detailed description: 
      There are approximately 19 million people in the United States who have been diagnosed with
      diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies
      among racial and ethnic populations and has been shown to correlate with age, obesity, family
      history, history of gestational diabetes, and physical inactivity. Over the next decade, a
      marked increase in the number of adults with diabetes mellitus is expected.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of
      2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2
      diabetes.

      The aim of the current study is to evaluate the effectiveness of alogliptin in combination
      with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone.
      Individuals who participate in this study will be required to commit to a screening visit and
      up to 14 additional visits at the study center. Study participation is anticipated to be
      about 34 weeks (or 8.5 months).
    

Intervention name(s): Alogliptin and glyburide; Alogliptin and glyburide; Glyburide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.; Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.; Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
Other intervention name(s): alogliptin; SYR110322; SYR-322; alogliptin; SYR110322; SYR-322
Intervention MeSH terms: Alogliptin; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy
A Study on the Effects of Dextrose Solutions on the Course of Labor
Condition: Labor
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to determine in term nulliparas with singletons that present in active labor
      (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to
      normal saline improves or expedites the course of labor. The researchers' hypothesis is that
      the addition of a carbohydrate substrate will shorten the length of labor and facilitate a
      vaginal delivery.
    

Detailed description: 
      Factors that affect the course of labor have been studied extensively. Surprisingly, there is
      little data on the effect that different types and rates of intravenous (IV) fluids have
      during labor. Exercise physiologists have shown that increased fluid intake and carbohydrate
      replacement improve skeletal muscle performance in prolonged exercise. In a 1992 randomized,
      controlled study comparing IV fluid rates, Garite et al. showed a lower frequency of
      prolonged labor, and possibly a decreased need for oxytocin, with higher IV fluid rates in
      labor. Inadequate hydration may contribute to dysfunctional labor and possibly an increased
      rate of cesarean section.

      We propose that inadequate carbohydrate replacement in labor may also contribute to
      prolongation of labor and increased need for operative delivery. Glucose is the main energy
      supply for the pregnant uterus. Physiological requirements for glucose during labor are
      approximately 10 grams per hour. Adequate supplies of glucose are needed to maintain exercise
      tolerance and muscle efficiency, which are important factors in the progress of labor.
      Dysfunctional labor or dystocia, which is the leading indication for primary cesarean
      delivery, is caused by uterine forces insufficiently strong or inappropriately coordinated to
      efface and dilate the cervix. Dystocia can also be a result of inadequate voluntary muscle
      effort in the second stage of labor. It contributes to increased risk for chorioamnionitis,
      which is a leading cause of maternal and fetal morbidity and mortality. Supplying
      carbohydrate fuel for working uterine and skeletal muscle may improve progress in labor and,
      therefore, diminish risk for chorioamnionitis and need for cesarean delivery.
    

Intervention name(s): D5NS; D10NS; NS
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5% Dextrose in Normal Saline (6.25 gr/hr) at 125 cc/hr; 10% Dextrose Solution (12.5 gr/h) in Normal Saline at 125 cc/hr; Normal Saline solution at 125 cc/hr
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Labor; Carbohydrate; Dystocia
Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study in PD patients is designed to assess the affect food has on the absorption,
      distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted
      state and other patients following a high-fat breakfast), and to assess the difference in
      absorption, distribution, metabolism and excretion of ropinirole if patients are given three
      4mg ropinirole tablets versus one 12mg tablet.
    


Intervention name(s): Ropinirole
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ropinirole PR/CR,; pharmacokinetic,; formulation,; food effect,; SK&F101468,; PD
Herbal Extract Study
Condition: Normal Controls
Study type: Interventional

Summary: 
      The objective of this study is to assess the effects of an herbal extract on mental energy in
      healthy human subjects.
    


Intervention name(s): Herbal Beverage
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)