bioihbjkbjnl/mcl2 huggingface dataset:
Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether lenalidomide can stop the growth of
      leukemia stem cells and can be used to prevent the return of leukemia cells after a
      transplant.
    

Detailed description: 
      The purpose of this study is determine whether lenalidomide can directly inhibit leukemic
      stem cells in vivo and can be used to prevent the relapse of leukemia stem cells after
      transplant. A concern with any post transplant intervention is the possibility of multiple
      drug interactions, potential for graft versus host disease exacerbation and/or induction of
      cytopenia. Therefore, the smallest doses of lenalidomide (5 mg) that has been used in this
      setting will be utilized as dose level 1. Starting six months post-transplant, patients will
      begin on a daily dose of lenalidomide. Dependent on the cohort, patients will receive 5 to 20
      mg of lenalidomide post transplant. The maximum tolerated dose (MTD) will be determined by
      the incidence of grade III-IV toxicities of all organs and grade II-IV GVHD. Duration of
      treatment is six months.
    

Intervention name(s): Lenalidomide
Intervention type(s): Drug
Intervention description(s): Lenalidomide will be taken orally once a day for 21 days continuously in 28 day cycles. The dose of the lenalidomide administered to each patient will be based on the group that the patient is enrolled. The dose cycles will be 21 days of a 28 day cycle.
Other intervention name(s): REVLIMID; CC-5013
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone marrow transplantation; Maintenance lenalidomide
A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
Condition: Skin Care
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      To determine the local cutaneous and ocular tolerance of a developmental cosmetic facial
      serum in healthy females with sensitive facial skin under normal conditions of use.
    

Detailed description: 
      This is a single-center, non-comparative clinical 'in-use' study to determine the local
      cutaneous and ocular tolerance of a developmental cosmetic facial serum formulation in
      healthy female subjects aged 18 to 65 years (inclusive) with clinically evaluated sensitive
      skin, as determined by a positive response to a Lactic Acid Sting Test (LAST), with minimal
      signs or symptoms of cutaneous irritation and no signs or symptoms of ocular irritation. A
      reference product, proven to be suitable for use in a sensitive skin population will also be
      used.
    

Intervention name(s): Developmental Serum; Physiogel Calming Relief Anti-Redness Serum
Intervention type(s): Other; Other
Intervention description(s): A 30millilitre (mL) bottle with a piston pump will be dispensed to the participants, to be used as a topical dermal (facial) application, twice daily as per normal home use.; A 30mL bottle with a piston pump will be dispensed to the participants, to be used as a topical dermal (facial) application, twice daily as per normal home use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Olanzapine Compared to Lamotrigine in the Prevention of Depressive Episode in the Patients With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesized that olanzapine will be superior to lamotrigine in the
      prevention of any kind of recurrence of bipolar disorder. On the other hand, lamotrigine
      group will have better prevention of depressive episode than olanzapine group. Meanwhile, the
      investigators supposed that there will be more concomitant medicine in lamictal group than
      olanzapine group. The comorbidity will influence the measurement of outcome such as time
      period of recurrence of depressive episode in both groups..
    

Detailed description: 
      Background:

      Bipolar disorder is a highly recurrent disease and has great impact on the function of
      patients. Depressive symptoms consist of more than 50% of life time during the illness and
      may lead to self harm or suicidal behaviors. Lamotrigine, a kind of mood stabilizer, was
      proved to be effective in preventing depressive episode in Bipolar disorder. However, it is
      still lacking evidence that monotherapy with atypical antipsychotics such as olanzapine had
      the efficacy of preventing the recurrence of depressive episode in the patients with bipolar
      disorder although it had demonstrated good prevention in manic episode of bipolar disorder.

      Methods:

      The investigators will enroll 60 patients who had bipolar disorder in remission state for at
      least two months and have already received olanzapine or lamotrigine as the maintenance
      treatment. The patients maintained with olanzapine will be applied to olanzapine group (N=30)
      whereas those maintained on lamotrigine will be applied to lamotrigine group (N=30) for one
      month before entering into this study. They will be followed up to 12 months. The demography
      data will be compared between two groups. The concomitant medicine in the maintenance period
      of the subjects recruited will be recorded and analyzed. The time period to recurrence of
      depressive episode will be compared between groups. In addition, they will investigate if
      there is any independent factor such as comorbid substance use disorder, alcohol use
      disorder, personality disorders, other psychiatric disorders (posttraumatic stress disorder,
      eating disorder), or medical illness correlating with higher recurrent rate of depressive
      episode in bipolar disorder.
    

Intervention name(s): Lamotrigine; Olanzapine
Intervention type(s): Drug; Drug
Other intervention name(s): lamictal
Intervention MeSH terms: Lamotrigine; Olanzapine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
SLeep and IMagery Correlates (SOMMEIL-IMAGERIE)
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to determine the neural networks underlying the sleep-related motor
      consolidation process following motor imagery practice. While beneficial effects of sleep are
      expected for sequential movement but not for adaptation motor tasks, the corresponding
      neuroanatomical correlates have not yet been investigated when participants acquired the
      motor tasks through mental practice. Data should substantially promote how designing motor
      imagery interventions targeting (re)learning and/or motor recovery in patients suffering from
      motor disorders.
    


Intervention name(s): Imagery and Sleep questionnaires; MEG recordings (pre-test); Practice session; MEG recordings (Post-test); MRI
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Participants complete a motor imagery questionnaire to assess their ability to form vivid mental images, as well as sleep questionnaires to control the quality of their sleep; Participants of the Day group perform two motor tasks (a finger sequential motor task and an adaptation motor task using a trackball) in the MEG, during a pre-test (Day 1 - 9h).
Task 1: Participants perform an 8-digit motor sequential task where each finger (except the thumb) is used twice. Performance is assessed by using a 4-keys keyboard. Participants are required to keep their fingers on the keys to minimize amplitude are instructed to tap the sequence as few errors as possible Task 2: Participants perform a motor adaptation task requiring scrolling a trackball to superimpose a geometric shape on another one, strictly similar but presented from another angle, as fast as possible.; Participants of the Day group perform a block of motor imagery practice of the two motor tasks.; Participants perform the two motor tasks in the MEG (post-test, strictly similar to the pre-test); The registration of the brain anatomy of each participant will be done by MRI 3D / T the week before the first experimental session.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Olanzapine Versus Clozapine in Treatment Refractory Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The study involves a six-month, double-blind protocol during which eighty patients, across
      three sites around the country, will be randomly assigned to receive clozapine or olanzapine.
      The specific aims of the study are to evaluate the relative effects of olanzapine and
      clozapine on clinical outcomes and cognition in patients diagnosed with schizophrenia or
      schizoaffective disorder who have demonstrated resistance to treatment in the past.
    


Intervention name(s): olanzapine vs. clozapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine; Clozapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.
Condition: Rheumatoid Arthritis; Healthy Volunteers
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the drug interaction between fostamatinib and
      rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib
      when administered alone and with rifampicin in healthy subjects
    


Intervention name(s): fostamatinib; rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets, 150mg (3 X 50mg) single dose per period; oral tablets, 600mg (2 X 300mg) 8 doses over 8 days
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; Rheumatoid arthritis; RA; Fostamatinib; Rifampicin; drug-drug interaction; Pharmacokinetics; Amount of Rifampicin in blood
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg,
      20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5
      days to healthy adult male Japanese participants. This was a single-center, open-label,
      randomized, four-treatment, four-way crossover study.
    


Intervention name(s): Rabeprazole sodium, 5 mg Tablets; Rabeprazole sodium, 10 mg Tablets; Rabeprazole sodium, 20 mg Tablets; Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Rabeprazole sodium Tablets, 5 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.; Rabeprazole sodium Tablets, 10 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.; Rabeprazole sodium Tablets, 20 mg administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.; Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days.
Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
Day 2 to Day 4: participants received a single dose with 200 mL of water, >=2 hours after the completion of breakfast.
Other intervention name(s): E3810, E3810-J081-040; E3810, E3810-J081-040; E3810, E3810-J081-040; E3810, E3810-J081-040
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rabeprazole; proton pump inhibitor; pharmacokinetics; pharmacodynamics; healthy adult male Japanese subjects
Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective
      for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared
      to placebo (inactive gel).
    

Detailed description: 
      The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel
      compared with placebo in reducing the severity and onset of primary dysmenorrhea in women
      with recurrent dysmenorrhea.

      The secondary objectives of this study are the following:

        -  to assess the safety of 10% (150 mg) lidocaine gel compared with placebo

        -  to evaluate electrocardiograms (ECGs) for potentially significant QT changes at
           approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg)
           lidocaine gel.
    

Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days; Placebo vaginal gel administered once daily for 4 days
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dysmenorrhea; Periods; Menstrual; Primary dysmenorrhea in women with recurrent dysmenorrhea
Young Hearts, Strong Starts
Condition: Cardiovascular Risk Reduction
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline
      implementation in 32 clinical practices
    

Detailed description: 
      Objective: The Young Hearts Strong Starts Study was designed to test strategies to facilitate
      adoption of the Integrated Guidelines for Cardiovascular Health and Risk Reduction in
      Children and Adolescents among pediatric and family medicine providers. The study compares
      quality measures based on the guidelines for two dissemination strategies: a multi-faceted,
      practice-directed intervention or standard dissemination.

      Methods: Two primary care research networks recruited practices and provided support for the
      intervention and outcome evaluations. Individual practices were randomly assigned to either
      the intervention or control groups using a cluster randomized design based on network
      affiliation, number of clinicians per practice, urban vs. nonurban location, and practice
      type. In this design, the units of observation are individual children because outcomes are
      abstracted from medical records for individual patients. The units of randomization are
      physician practices. This results in a multilevel design in which patients are nested within
      practices. Implementation The intervention practices receive toolkits, including guideline
      summaries and slides, a patient and family behavior change workbook, and a clinical decision
      support tool. Guideline implementation was promoted through an introductory academic
      detailing session and the use of an ongoing e-learning group. The intervention strategy was
      further enhanced by aligning this project with the American Board of Pediatrics quality
      improvement Maintenance of Certification (MOC) requirements and offers voluntary MOC
      participation to participants. MOC participation includes the creation of a practice aims
      statement, monthly physician self-abstraction to track progress throughout the intervention,
      and participation in webinar presentations and sharing of best practices.
    

Intervention name(s): Intervention; Control
Intervention type(s): Other; Other
Intervention description(s): Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems; Guideline summary and data feedback from a baseline medical record review
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular risk; lifestyle change; blood pressure; body mass index; tobacco
NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
Condition: Head Lice
MeSH terms: Dermatitis, Photoallergic
Study type: Interventional
Phase: Phase 1

Summary: 
      Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity
      response that requires the presence of ultraviolet irradiation. The predictive procedure is,
      therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate
      sets of patches of test articles are used with exposure of only one set to UV radiation and
      subsequent evaluation of both sets for skin reactions in order to compare irradiated versus
      non-irradiated test sites.
    

Detailed description: 
      The study consists of of following phases: screening, induction, rest, challenge, and
      re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind
      test design.
    

Intervention name(s): NatrOVA Creme Rinse - 1%; NatrOVA Creme Rinse Vehicle Only; Blank Patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NatrOVA Creme Rinse - 1% spinosad; NatrOVA Creme Rinse Vehicle - no spinosad; Blank Patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: head lice; NatrOVA Creme Rinse - 1% is intended for the treatment of head lice
Effects of Transcranial Direct Current Stimulation on Postural Control
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Parkinson's disease is a progressive, degenerative neurological disease associated with
      profound changes in the quality of life of its survivors. Recent evidence has demonstrated
      the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral
      excitability and movement control in neurological chronic conditions. However, few studies
      have investigated the effects of tDCS on postural control in patients with Parkinson's
      disease. This study aims to investigate the effect of bihemispheric tDCS on postural control
      in people with Parkinson's disease. Participants will be randomized to receive a single
      session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation).

      Primary clinical outcome (balance) will be collected before and immediately after tDCS. The
      data will be collected by a blind examiner to the treatment allocation.
    


Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Procedure
Intervention description(s): Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if a combination of an antibiotic plus a
      corticosteroid is safe and effective in treating middle ear infections in children with ear
      tubes.
    


Intervention name(s): DF289; DF277; DF289 plus DF277
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ear drops; Ear drops; Ear drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: with tubes
Study of Food on Evacetrapib (LY2484595) in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much of the drug gets into the blood stream and
      how long it takes the body to get rid of it when given to healthy participants. Information
      about any side effects that may occur will also be collected.

      The study has 2 periods. In each period, participants will take the study drug for 10 days,
      either with or without a meal. There is a minimum 14-day washout between each period.

      This study is approximately 50 days, not including screening. Screening is required within 28
      days prior to the start of the study.
    


Intervention name(s): Evacetrapib; High-fat Meal
Intervention type(s): Drug; Other
Intervention description(s): Administered orally; Administered orally, at breakfast.
Other intervention name(s): LY2484595
Intervention MeSH terms: Evacetrapib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Condition: Arteriosclerosis of Coronary Artery Bypass Graft
MeSH terms: Arteriosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical study has been developed to evaluate the clinical outcomes in patients
      undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a
      minimally invasive coronary bypass procedure that is done on a beating heart via a smaller
      chest incision, thus avoiding the invasiveness of the standard procedure.
    


Intervention name(s): Minimally invasive coronary artery bypass graft surgery
Intervention type(s): Procedure
Intervention description(s): The MICS CABG procedure can bridge the gap between percutaneous coronary intervention (PCI) and standard sternotomy. The key components are direct vision, creating anastomoses with traditional instruments and proximal aortic location.
Other intervention name(s): MICS CABG
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Minimally invasive coronary surgery; Coronary artery bypass grafting; MICS CABG