bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess
      the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted
      state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of
      the tablet formulation of GDC-0941 (Part 2). Approximately 18 subjects will be enrolled in
      Part 1 and up to 32 subjects will be enrolled in Part 2. Subjects who participate in Part 1
      are not eligible to participate in Part 2.
    


Intervention name(s): GDC-0941; rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral repeating dose; Oral repeating dose
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PI3K inhibitor; PI3 kinase; PI3 kinase inhibitor
Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate safety and tolerability, Pharmacokinetics and
      Pharmacodynamics, as well as exploratory efficacy of STP1, in a subgroup of patients with
      Autism Spectrum Disorder (ASD).
    

Detailed description: 
      After obtaining written informed consent, those patients who are deemed eligible for the
      study, will be randomized on Day 1, in a double-blinded manner, in a 3:1ratio to receive
      either oral STP1 (twice daily) or placebo (twice daily). The total study duration is 6 weeks,
      including a screening phase of up to 2 weeks, a treatment phase of 2 weeks and a
      post-treatment follow-up phase of 2 weeks.
    

Intervention name(s): STP1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor; Placebo medication (capsule and tablet) identical in appearance to active medication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASD; Autism Spectrum Disorder
Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
Condition: Insomnia, Secondary; Sleep Disturbance; Sleep; Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      There is an unmet medical need for monitoring sleep for multiple nights in a patient's home,
      without the inconvenience of traveling and staying overnight in a medical center, and without
      the need for a technician to set up a polysomnography (PSG) device at the patient's home.
      Several disorders, and particularly sleep disorders, are associated with insomnia symptoms,
      and longitudinal sleep assessment may support a better understanding and management of these
      patients, who currently seldom access sleep lab PSG.

      On one hand, this study aims at demonstrating whether the final device's user interface
      supports safe and effective use when being used at home over multiple nights.

      On the other, the study aims at confirming that stable and consistent data are measured in
      the device's actual use, for the records to be clinically usable in daily practice.
    


Intervention name(s): Dreem 3 System vs WatchPAT One; Usability Questionnaire
Intervention type(s): Device; Other
Intervention description(s): Dreem 3 System and WatchPAT One will be worn simultaneously during 3 nights by each study participant, in order to compare the TST automatically outputted by both devices.; After having undergone the 3 nights of measurement, an end of Study Questionnaire will be performed on a separate day to obtain Usability feedback from participants who have undergone simultaneous recordings with the Dreem 3 + WatchPAT devices.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Polysomnography; Sleep assessment; Dreem; EEG; dry EEG; Accuracy
A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients
Condition: Asthma; Mild Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced
      bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where
      patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments.
      Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of
      each treatment period and on treatment days 13 and 14 respectively.
    


Intervention name(s): FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: mild asthma; FLIXOTIDE; methacholine; bronchial challenge; leukotriene D4
Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence
Condition: Cardiovascular Diseases; Acute Coronary Syndrome
MeSH terms: Cardiovascular Diseases; Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a pilot study that was conducted to prove the efficacy and safety of ticagrelor
      generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. we
      advocate comparing the clinical efficacy rather than simple bioequivalence comparison.
    

Detailed description: 
      Cardiovascular diseases are the leading cause of death worldwide. Ticagrelor, is an oral
      antiplatelet drug used in acute coronary syndrome. Although generic drugs are approved for
      their bioequivalence to the original product, they are not necessarily to be therapeutically
      equivalent. This study was conducted to prove the efficacy and safety of ticagrelor
      generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. A
      loading dose of 180 mg ticagrelor named Brilique® or Ticaloguard® followed by a 90 mg twice
      daily regimen as maintenance dose was given to 14 and 15 volunteers in Ticaloguard and
      Brilique groups, respectively. The platelet aggregation on adenosine diphosphate (ADP)
      agonist was assessed at different time intervals .
    

Intervention name(s): Ticagrelor 90mg (Brilique); Ticagrelor 90mg (Ticaloguard)
Intervention type(s): Drug; Drug
Intervention description(s): compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers; compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers
Other intervention name(s): Brilique
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the short-term effectiveness of combined occipital
      and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.
    


Intervention name(s): OSTNS Neurostimulator; Placebo OSTNS Neurostimulator
Intervention type(s): Device; Device
Intervention description(s): Non-invasive transcutaneous neurostimulation.; Placebo non-invasive transcutaneous neurostimulation
Other intervention name(s): Transcutaneous Neurostimulator.; Transcutaneous Neurostimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      Quizartinib is an experimental drug. It is not approved for regular use. It can only be used
      in medical research.

      Adults might be able to join this study after bone marrow tests show they have a certain kind
      of blood cancer (FLT3-ITD AML).

      Participants will have an equal chance of receiving quizartinib or placebo along with their
      chemotherapy.
    

Detailed description: 
      This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of
      this study is to compare the effect of quizartinib versus placebo (administered with standard
      induction and consolidation chemotherapy, then administered as continuation therapy for up to
      36 cycles) on overall survival in subjects with FLT3-internal tandem duplication (ITD)
      positive AML.
    

Intervention name(s): Chemotherapy; Quizartinib; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Cytarabine; Daunorubicin; Idarubicin; Test Product; Placebo Control
Intervention MeSH terms: Cytarabine; Daunorubicin; Idarubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Newly diagnosed Acute Myeloid Leukemia; FLT3-ITD positive; Chemotherapy; Induction chemotherapy; Consolidation chemotherapy; Quizartinib; Feline McDonough sarcoma (FMS)-like tyrosine kinase 3; AC220; FLT3-ITD; AML
Nociceptive Pain Fiber Response
Condition: Painful Peripheral Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional

Summary: 
      This study is designed to evaluate the effectiveness of the Provant Therapy System in
      improving localized nerve growth and skin perfusion in subjects with painful peripheral
      diabetic neuropathy of the foot.
    

Detailed description: 
      The study is multi-site, randomized, double-blind, sham-controlled study of the safety and
      efficacy of multi-dose Provant therapy to evaluate neuronal and vascular response in the
      treatment of subjects with painful peripheral diabetic neuropathy. Subjects will be
      randomized in a 2:1 ratio to receive therapy with an active device or an identical inactive
      sham device. Subjects will treat at home twice daily for 60 days after which they will return
      to the clinic for final evaluations. Subjects will be evaluated at the research center for a
      Baseline/Enrollment visit and again at Day 61 where assessments for safety, concomitant
      medications, Sympathetic Skin Response (SSR), Nerve Conduction Velocity (NCV), Skin Perfusion
      Pressures (SPP), and Skin Biopsy will be completed. Subjects will be contacted via telephone
      at Day 14, Day 28 and Day 42 to assess adherence, safety, and concomitant medications.
      Subjects will also complete a Response to Study Device form which will capture their daily
      pain score.
    

Intervention name(s): Provant Therapy System
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain; Diabetic Neuropathy; Pulsed Electromagnetic Energy Field; PEMF; PPDN
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and
      tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to
      intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age
      with Primary Immunodeficiency.
    

Detailed description: 
      This study was a multi-center, open-label, single-sequence, crossover study to evaluate the
      pharmacokinetics (PK), safety and tolerability of SC-administered GAMUNEX-C in pediatric PI
      subjects (ages 2-16). The study consisted of a Screening Phase, Run-in Phase, two treatment
      phases (an IV Phase and a SC Phase), and an End of Study/Early Termination (EOS/ET) visit.
      Run-in phase: 3 - 4 months, IV Phase: ~ 4 - 5 weeks, SC Phase: 12 weeks, and End of
      Study/Early Termination (EOS/ET) visit: one week after SC Week #12.
    

Intervention name(s): GAMUNEX-C; GAMUNEX-C
Intervention type(s): Biological; Biological
Intervention description(s): GAMUNEX-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: 200-600 mg/kg per intravenous infusion every 3-4 weeks; GAMUNEX-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on subject's intravenous dose and dosing interval x 1.37 conversion factor
Intervention MeSH terms: Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the safety, tolerability and immunogenicity of a single dose of
      13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are
      considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal
      vaccines.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological
Intervention description(s): A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Other intervention name(s): 13vPnC
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Impact of Grapefruit Juice on the Response to Clopidogrel
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will measure the percentage of platelet aggregation inhibition with a loading dose
      of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank
      11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation
      inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay
      System in healthy volunteers who have drank 11 oz grapefruit juice daily.
    

Detailed description: 
      This study will examine the effect of GFJ on the loading dose (300 mg) of clopidogrel and
      will evaluate the effect of GFJ on the maintenance dose (75 mg/day) of clopidogrel. Subjects
      will be randomized to either initially receive GFJ prior to their loading dose of clopidogrel
      or receive GFJ prior to their second loading dose. The subjects who have been randomized to
      receive GFJ initially will drink two small cans (11 oz total) of regular strength GFJ in the
      morning, followed two hours later by a loading dose (300 mg) of clopidogrel and will then
      return to the clinic 6 hours after their loading dose to have their platelet inhibition
      measured. Subjects will have ~ 5 milliliters (1 teaspoonful) of whole blood drawn from an
      antecubital vein in their forearm via a 21 gauge needle attached to a blue-top plastic
      vacuette sodium citrate blood collection (Greiner, Monroe, NC) tube to test inhibition of
      platelet aggregation. After their first loading dose, a 2 week washout period will follow to
      allow for their platelet aggregation to return to normal. Following the washout period, the
      subjects will take their second loading dose of clopidogrel and again return to the clinic
      for platelet inhibition measurement. The same timing will be followed for the loading dose
      taken without prior GFJ.

      During the maintenance dose phase of this study, subjects will take 75 mg/day clopidogrel for
      7 days with or without GFJ. Subjects will be randomized to either GFJ during the first period
      or GFJ during the second period. A minimum 2 week washout period will occur between the two 7
      day courses of clopidogrel. Platelet inhibition measurement will occur at the end of each 7
      day period as described above.
    

Intervention name(s): Grapefruit juice; Clopidogrel 75 mg/day; Clopidogrel 300 mg
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention description(s): Participants received grapefruit juice during 1 of the 2 periods.
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Platelet Aggregation Inhibition
Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study
Condition: Cognition Disorders
MeSH terms: Amyloidosis; Nerve Degeneration; Cognition Disorders
Study type: Observational

Summary: 
      The LEARN study a multicenter, observational study will that will evaluate the rate of
      cognitive change in approximately 500 clinically normal older individuals who "screen-fail"
      for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of
      elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility criteria.
      This study will leverage the A4 infrastructure and maximize the data acquired in screening a
      large number of well-characterized older adults for the A4 trial.

      The LEARN observational cohort will provide a critical comparison group for the A4 placebo
      arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest
      that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it
      is important to demonstrate a differential rate of clinical decline between Aβe ("Aβ
      elevated") and Aβne ("Aβ not elevated") individuals on a standardized set of clinical
      outcomes. Over 2000 well-characterized, highly motivated older volunteers will "screen fail"
      for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely as
      possible to the two treatment arms, in this observation cohort. The LEARN study may
      selectively recruit from a specific range of SUVr that fall below the threshold for "elevated
      amyloid" in order to support analyses of the relationship of baseline SUVr to subsequent
      cognitive change and amyloid accumulation. The observational cohort will be followed for 384
      weeks with identical clinical/cognitive testing performed every 24 weeks, running parallel to
      the A4 treatment study and open label extension.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        500 subjects without evidence of elevated ABeta on screening PET scan. Subjects will have
        consented to participate in the A4 trial and previously met demographic, cognitive and
        clinical criteria and have an A4 screening PET scan results that fallows below the ABeta
        threshold levels required for randomization into the treatment arms for the A4 trials.
      
Biospecimen description: 
      blood, CSF
    
Keywords: amyloid imaging; biomarkers; cognition; longitudinal; cognitive decline; observational
Medical Adhesive Repeat Application Study
Condition: Healthy
Study type: Observational

Summary: 
      This study is to determine the relative effects imparted by different medical tapes to skin
      when comparing normal skin to skin after ten repeated tape applications and removals.
    

Detailed description: 
      This study is to evaluate changes to skin after repeated tape stripping on volar forearm with
      various medical tapes. Assessments of effects to skin include corneocytes, total protein
      (BCA), Trans-Epidermal Water Loss (TEWL), and cytokine analysis.

      The Study will involve the application of eight (8) test articles. In each case, the test
      articles will be applied to eight (8) sites on the healthy Subject's left and right volar
      forearms (four [4] sites on the left, and four [4] sites on the right) in a randomized
      fashion.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects will consist of men and women aged 18 to 65 years old, Fitzpatrick Skin Type I-VI.
        Candidates will be recruited from a pool of healthy men and women who meet the
        inclusion/exclusion criteria.
      
Biospecimen description: 
      Tape removed from the skin of subjects
    
Keywords: Skin stripping; TEWL
Determination of Protein Requirements in Elderly Female Subjects >75 Yrs Old
Condition: Healthy Females; Protein Requirement
Study type: Interventional

Summary: 
      Minimal data are available on protein requirements throughout the lifespan. Currently
      available recommendations are based on nitrogen balance data. The limitations of the nitrogen
      balance method have been well described. Importantly, nitrogen balanced underestimates
      requirements.

      The current DRI requirement for healthy adult males is based on the reanalysis of the
      nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by
      Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83
      (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group
      estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2
      g/kg/day (mean and RDA).

      Currently there are no studies on protein requirement in the elderly. In a recent nutrition
      survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70
      years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents
      about 15 % of calories. Depending on the calculations used for ideal body weight some older
      adults could be getting higher or lower than requirement. There is no scientifically derived
      protein estimate for older adults. Therefore there is a need to measurer protein requirement
      in that population.

      The goal of this study therefore is to measure the protein requirement of female elderly
      subjects >75 years using the IAAO technique.
    


Intervention name(s): Protein intake.
Intervention type(s): Dietary Supplement
Intervention description(s): protein intakes will be varied at 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8 and 2.0g/kg/day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment