bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This observer blind study will assess the safety and immunogenicity of different formulations
      of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a
      positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    


Intervention name(s): GSK Biologicals' AS01B adjuvant; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 3; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 1; GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 4 - Dosage 2
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tuberculosis vaccine
RADIESSE Injection in Perioral and Marionette Lines
Condition: Skin Quality
Study type: Interventional

Summary: 
      Following treatment with Radiesse, many patients mention an improvement in skin texture This
      observation is independent from the improvement observed on their facial shape. There is
      therefore a need to identify and quantify changes in skin parameters following treatment with
      Radiesse
    


Intervention name(s): Radiesse (calcium hydroxylpatite)
Intervention type(s): Device
Intervention description(s): RADIESSE® injectable implant is a sterile, non-pyrogenic, semi-solid, cohesive implant, whose principle component is synthetic calcium hydroxylapatite (CaHA) suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. RADIESSE injectable implant has a CaHA particle size range of 25-45 microns. RADIESSE is available in 1.5cc and 0.8cc pre-filled syringes.
RADIESSE injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy).
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of adding liraglutide to high dose
      insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated
      Type 2 diabetes with insulin requirements of > 100 units of insulin per day.
    

Detailed description: 
      40 subjects with Type 2 diabetes using > 100 units of insulin per day with or without
      metformin with HbA1c > 6.5% will be randomized into 2 treatment groups: treatment group will
      have liraglutide added to insulin and control group will have insulin uptitration only for 6
      months. Primary endpoint to be compared between groups will be HbA1c at 6 months. Secondary
      endpoints will include weight, total daily insulin dose, percent time in euglycemic,
      hyperglycemic, and hypoglycemic ranges by continuous glucose monitor (CGM), and effect on
      GlycoMark and hs-CRP. Safety endpoints will include incidence of hypoglycemia and incidence
      of gastrointestinal side effects.
    

Intervention name(s): Liraglutide; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): SC, 1.8mg,QD, six months to one year; SC, will be titrated during the study, 4 times a day, 1 year
Other intervention name(s): Victoza; U-500; Levemir; Novolog
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin; Type II Diabetes; liraglutide; Glucagon-Like Peptide 1
Efficacity of Incentive Spirometry in Elderly People
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficiency of incentive spirometry in elderly.
      Outcomes are lung function and chest expansion.
    


Intervention name(s): Incentive spirometry
Intervention type(s): Device
Other intervention name(s): Coach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Investigate Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of JNJ-54175446 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of JNJ-54175446
      versus placebo after single oral dose administration (ascending dose levels), to determine
      the maximal tolerated dose (MTD) or the safety and tolerability at exposures resulting in
      full target engagement for at least 24 hours in all participants (whichever comes first), to
      characterize the pharmacokinetics of JNJ-54175446 in plasma, cerebrospinal fluid (CSF) and
      urine and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics
      of JNJ 54175446 after single oral dose administration.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, single ascending dose study in
      healthy participants for JNJ-54175446. The study will consist of 3 phases: a screening phase
      (between 21 and 2 days prior to dose administration), a double-blind treatment phase (8 days;
      Part 1 and Part 3) or an open-label treatment phase (8 days; Part 2), and a follow-up
      examination (within 14 to 21 days after dose administration). The maximal study duration for
      a participant will not exceed 6 weeks. In each cohort of Part 1 (6 cohorts) and Part 3 (1
      cohort), participants will be randomly assigned to receive JNJ-54175446 or matching placebo
      and in cohort of part 2, all participants will be assigned to JNJ-54175446 treatment. In part
      1, primarily maximum tolerated dose (MTD) will be assessed, along with safety and
      tolerability of JNJ-54175446. In part 2, pharmacokinetics (PK) of JNJ-54175446 in
      cerebrospinal fluid (CSF) will be assessed. In part 3, the effect of food on the plasma PK of
      JNJ-54175446 in young healthy male participants will be assessed. Safety will be monitored
      throughout the study.
    

Intervention name(s): JNJ 54175446; Placebo; High fat/high Calorie Breakfast
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: JNJ-54175446; Healthy
A Study of SHR-1314 in Healthy Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5
      sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose
      levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of
      6 subjects receiving active drug and 2 subjects receiving placebo, for a total of
      approximately 40 subjects dosed at one study site.
    

Detailed description: 
      This study will consist of a 27-day screening period (Days -28 to -2), clinic check-in (Day
      -1), a treatment day (Day 1), a 10-week treatment period and a study completion evaluation
      (Day 71) as shown in above figure.

      A review of blinded interim PK data will be conducted by the Safety Review Committee (SRC) to
      confirm the study sampling schedule captures the full PK profile of SHR-1314. This interim
      analysis will be conducted for Cohort 1 and may be conducted for subsequent cohorts if serum
      SHR-1314 concentrations in Cohort 1 or any of the subsequent cohorts are below the limit of
      quantification of the assay preventing evaluation of the PK profile.

      The expected duration of participation for each subject will be up to 99 days. Subjects who
      are withdrawn for reasons other than safety may be replaced at the discretion of the sponsor.
    

Intervention name(s): SHR-1314; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.; Single subcutaneous injection of placebo at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
A Preference Study Comparing Kristalose® and Liquid Lactulose
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate whether patients have an overall preference for Kristalose® or
      liquid lactulose based on taste, consistency, and portability.
    

Detailed description: 
      This study will evaluate whether patients have an overall preference for Kristalose® or
      liquid lactulose based on taste, consistency, and portability.
    

Intervention name(s): lactulose (Kristalose®); liquid lactulose
Intervention type(s): Drug; Drug
Intervention description(s): Crystals to be dissolved in water and taken as prescribed.; Liquid to be taken as prescribed.
Other intervention name(s): Kristalose®
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: constipation; laxative; lactulose; Kristalose®
Anti-Mullerian Hormone (AMH) Versus Antral Follicle Count (AFC) Guided rFSH Dosing Study
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall objectives of this trial are to:

        -  To explore the efficacy and safety of using either antral follicle count (AFC) or
           anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian
           stimulation for Assisted Reproductive Technology (ART).

        -  To assess the differences in both ovarian response and clinical pregnancy rate between
           subjects with different AFC and AMH levels undergoing ART.
    

Detailed description: 
      Trial design

      This trial is a prospective, Phase IV 2 arm trial exploring the efficacy and safety of using
      either AFC or AMH to guide the starting GONAL-f® dose for the stimulation treatment of
      subjects undergoing ART.

      Throughout the trial period and before the start of a routine ART cycle, investigators will
      propose the trial to their potential subjects. All subjects who agree to participate in the
      trial must sign a consent form, irrespective of whether or not they ultimately agree to have
      their dose determined by the study protocol. Eligible subjects will be randomised in blocks
      of 4 at each site via a computer generated random number list to either the AFC guided arm
      (control) or the AMH guided arm (treatment). The starting doses of GONAL-f® for each arm will
      be based on the study algorithms, using AFC or AMH guidance.

      The investigator will then enter initiate ovarian stimulation with an individualised GONAL-f®
      dose for that specific subject. This will be maintained for the first 5 days of stimulation
      after which the dose can be modified based on investigator decision and in accordance with
      the site's routine clinical practice.

      Trial Population

      Female partners of infertile couples requiring Assisted Reproductive Technology (ART)
      treatment.

      Data Analysis and Statistics

      The primary end-point proportion of patients with desired number of retrieved oocytes (8-12)
      will be compared between the 2 arms using the chi -square test. The null hypothesis will be
      that there is no difference between the 2 arms in primary end-point, with the p level set at
      p=0.05. The secondary end-points will also be compared between the 2 arms using either the
      Student's t test or anova test.
    

Intervention name(s): FSH
Intervention type(s): Drug
Other intervention name(s): GONAL-f
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: follicle stimulating hormone; ovarian stimulation; antimullerian hormone; antral follicle count; assisted reproductive technologies
A Study to Investigate the Effect of ONO-8539 on Acid-Induced Oesophageal Hypersensitivity in Healthy Volunteers
Condition: Acid Reflux
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity
      in healthy male adult volunteers.
    

Detailed description: 
      This is a randomised, double-blind, placebo-controlled, two-period crossover study, to
      investigate the efficacy of ONO-8539 on acid-induced oesophageal hypersensitivity in healthy
      male adult volunteers. Each subject will be randomised to ONO-8539 or placebo twice daily in
      the first treatment period and the alternate treatment in the second treatment period. Dosing
      in each period will be for 15 days.
    

Intervention name(s): ONO-8539; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ONO-8539; Identical to ONO-8539 tablet but without active ingedient
Other intervention name(s): ONO-8539 acid hypersensitivity; 0mg ONO-8539
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a progressive disease for which there is no effective
      treatment. Interferon-gamma is a medication that has been used for other lung diseases to
      decrease scarring and fibrosis. Studies of interferon-gamma injected under the skin did not
      show any improvement in survival in patients with IPF. We hypothesize that giving
      interferon-gamma as a nebulized mist directly into the lungs can affect the immune system in
      a way that decreases fibrosis.
    

Detailed description: 
      Patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF) will be enrolled in a
      phase I study of aerosol interferon-gamma (IFN-γ). Prior to initiation of treatment, patients
      will undergo CT of the chest, pulmonary function testing, and bronchoscopy with
      bronchoalveolar lavage. They will also undergo a lung deposition study to determine the lung
      dose of IFN-γ that will be delivered with each treatment. Patients will then receive aerosol
      IFN-γ 100mcg delivered three times weekly via nebulizer for one year. Study patients will be
      followed monthly to monitor potential side effects, vital signs, and progression of IPF
      symptoms. Labs will be drawn at regular intervals to monitor for side effects and to measure
      cytokine levels. Bronchoscopy will be performed at the 6 and/or 12 month visit to compare
      cytokine levels pre-, during, and post-treatment.
    

Intervention name(s): aerosol interferon-gamma
Intervention type(s): Drug
Intervention description(s): aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year
Intervention MeSH terms: Interferons; Interferon-gamma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Diseases, Interstitial; Fibrosis; Interferons; Pulmonary Fibrosis; Pathologic Processes; Lung Diseases; Fibrosing alveolitis; Interferon-gamma, Recombinant; Aerosols
Mechanism of Insulin-Resistant in Lean Non-Diabetics
Condition: Insulin Resistance; Insulin Sensitivity; Type 2 Diabetes
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to test the following primary hypothesis:

        -  Aerobic exercise training will improve insulin sensitivity in insulin resistant subjects
           through changes in the major cellular signaling pathways and and/or their regulators.

      Accordingly, the proposed study is designed to accomplish the following specific aims:

        -  Quantitate how exercise training improves insulin sensitivity and decreases
           cardiovascular risk factors in a general population of lean, nondiabetic, insulin
           resistant subjects. Effects on known cardiovascular risk factors including blood
           pressure and serum lipoproteins will be evaluated. Change in regional adiposity will
           also be measured

        -  Determine the effects of a program of regular aerobic exercise on in the insulin
           receptor signaling pathway. Biopsies of vastus lateralis muscle from insulin resistant
           subjects will be obtained before and after a hyperinsulinemic glucose clamp. This
           procedure will take place in the untrained state and after exercise training. The
           investigators will measure changes in the insulin receptor and the activity of the major
           components of the intracellular insulin signaling pathway. The investigators will also
           look intracellular proteins that regulate this signaling pathway.
    


Intervention name(s): exercise; Non exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients exercise under supervision on either a treadmill, Stair Master, or LifeCycle apparatus. Exercise frequency, duration, and intensity will be incrementally increased to minimize the risk of injury. During weeks 1-3, you will exercise for 30 minutes 3 days per week at 70- 80 % of your maximum heart rate (MHR); weeks 4-7 will consist of exercising for 40 minutes 4 days per week at 70-80% of your MHR; and weeks 7-12 will consist of exercising for 45 minutes 4 days per week at 80-85% MHR; subjects randomized to this group will not undergo exercise training for 12 weeks supervised by exercise specialist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      This study investigates the efficacy of surfactant application during spontaneous breathing
      with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a
      gestational age of less than 27 weeks.
    

Detailed description: 
      80 % of extremely preterm infants with a gestational age of less than 27 completed weeks
      suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high
      risk of mortality and long term morbidity especially of the lung and the brain. At least
      death and chronic lung disease (CLD) are related to the need and the duration of mechanical
      ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to
      avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature
      infants. Early or prophylactic surfactant application is effective in the treatment of IRDS
      and is the only causal therapy, but it is usually related to intubation and mechanical
      ventilation that should be avoided.Therefore to overcome the dilemma between need for
      mechanical ventilation with surfactant administration on the one hand and surfactant
      withholding with the use of CPAP on the other hand, a strategy was developed to administer
      surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised
      controlled trial this strategy shall be compared with the recent gold standard in the therapy
      of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and
      surfactant administration. Based on the results of a feasibility (1) study and some clinical
      observations it is hypothesised that the new approach is superior in avoidance of death and
      chronic lung disease compared to the recent gold standard.
    

Intervention name(s): Curosurf; Curosurf
Intervention type(s): Drug; Drug
Intervention description(s): Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP; Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application
Intervention MeSH terms: Poractant alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous positive airway pressure (CPAP); extremely preterm infant; Idiopathic respiratory distress syndrome (IRDS); Surfactant
Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      During this project the effect of 3 different bran-based dietary platforms on the
      fermentation on a readily fermentable substrate will be investigated using stable isotope
      techniques.
    


Intervention name(s): Unmodified wheat bran; Wheat bran with reduced particle size; Destarched pericarp-enriched wheat bran; No wheat bran fraction
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Oxygen Reserve Index to Reduce Hyperoxia
Condition: Hyperoxemia
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      Excessive oxygen administration is known to cause oxidative stress, and absorption
      atelectasis. Hyperoxia is very common in general anesthesia settings. Even though there are
      concerns in using excessive oxygen during general anesthesia, the optimal fraction of
      inspired oxygen (FiO2) for general anesthesia is not well studied.

      The oxygen reserve index (ORI) is a parameter which can evaluate partial pressure of oxygen
      (PaO2) rating from 0 to 1. There are growing evidences in ORI that it might be helpful to
      reduce hyperoxia in critically ill patients in the intensive care unit, as well as in general
      anesthesia.

      The aim of this study is to evaluate efficacy of oxygen reserve index to reduce hyperoxemia
      in major abdominal surgery.
    


Intervention name(s): Titration of fraction of inspired oxygen (FiO2) guided by SpO2; Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
Intervention type(s): Procedure; Procedure
Intervention description(s): Titration of fraction of inspired oxygen (FiO2) guided by SpO2; Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
Other intervention name(s): SpO2; ORI+SpO2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention