bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Priming During Induction and Consolidations in Younger Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is:

        1. To compare priming with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) during
           induction and consolidation courses versus no priming.

        2. To compare as consolidation timed sequential chemotherapy versus four courses of high
           dose cytarabine.
    

Detailed description: 
      Patients aged 15-50 are enrolled and randomly assigned to receive GM-CSF or no GM-CSF during
      all remission-induction and consolidation courses of chemotherapy. Induction chemotherapy
      consists of a timed-sequential chemotherapy including a first sequence of chemotherapy
      combining daunorubicin, 80 mg/m2 per day, administered IV as a short infusion over 3 days
      (days 1-3), and cytarabine, 500 mg/m2 per day IV as a continuous infusion over the same
      period. The second sequence, administered after 4-day free interval, consists of
      mitoxantrone, 12 mg/m2 per day, administered IV as a short infusion over 2 days (days 8 and
      9), and cytarabine, 500 mg/m2/12h, administered as a 3-hour infusion for 3 days (days 8-10).
      Salvage therapy consists of cytarabine, 3 g/m2/12h on days 1,3,5,7, combined with amsacrine,
      100mg/m2 per day on days 1 to 3. GM-CSF (Leucomax, recombinant human GM-CSF from Escherichia
      Coli, Schering Plough, Kenilworth,N.J., USA) is given at a dose of 5µg/kg per day,
      intravenously beginning at day 1 of each chemotherapy course and continuing until the last
      day of chemotherapy of each course.

      Patients who achieve CR after induction chemotherapy or salvage therapy are randomly assigned
      to consolidation courses consisting of either a timed sequential chemotherapy similar to that
      of the ALFA-9000 trial (P2 arm) or the CALGB postremission chemotherapy (P1 arm), which
      includes 4 cycles of high-dose cytarabine, followed by 4 additional maintenance courses.
    

Intervention name(s): GM-CSF
Intervention type(s): Drug
Intervention description(s): Randomization 1: GM-CSF (5micogram/Kg/d) versus no GM-CSF during induction chemotherapy and all consolidation courses.
Randomiization 2: Consolidation high dose AraC versus consolidation EMA
Other intervention name(s): GM-CSF: molgramostim; AraC: Cytarabine; Daunorubicine: Cerubidine; EMA: etoposide, mitoxantrone, cytarabine
Intervention MeSH terms: Cytarabine; Etoposide; Mitoxantrone; Daunorubicin; Molgramostim; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myeloid leukemia; Priming; GM-CSF; Timed-sequential chemotherapy; Prognosis
A Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD4831 in Fasted State in Healthy Volunteers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the relative bioavailability and safety of different formulations of
      AZD4831 in fasted state in healthy volunteers.
    

Detailed description: 
      This study will be a randomized, open-label, 2-period, 2-treatment, single-dose,
      single-center, crossover study conducted at a single Clinical Unit. A total of 30 healthy
      male and female participants will be randomized to ensure that at least 26 participants are
      evaluable .

      The study will comprise of:

        -  A Screening Period of maximum 28 days.

        -  Period 1: single oral dose AZD4831 Formulation A or B on Day 1.

        -  Period 2: single oral dose AZD4831 Formulation A or B on Day 1.

        -  A final Follow-up Visit after the last administration of Investigational medicinal
           product (IMP) (14 days [+ 3 days] post final dose).

      There will be a minimum washout period of at least 14 days from the first dose of AZD4831.

      Participants will receive single doses of AZD4831 (2 different formulations) on 2 occasions
      under fasted conditions.

      Participants will be given the following treatments and randomly assigned to the treatment
      sequence(s): AB, BA

        -  Treatment 1 (Reference), AZD4831 Formulation A, oral dosage form), fasted.

        -  Treatment 2 (Test), AZD4831 Formulation B, oral dosage from), fasted.
    

Intervention name(s): AZD4831
Intervention type(s): Drug
Intervention description(s): Participants will receive a single oral dose of AZD4831 Formulation A Or a single oral dose of AZD4831 Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of AZD4831 Formulation A Or a single oral dose of AZD4831 Formulation B on Day 1 of Period 2. Each period lasts for 8 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relative Bioavailability; AZD4831; Heart failure with preserved ejection fraction; Cardiovascular disease
Serum Tryptase Concentration During General Anaesthesia With Rocuronium
Condition: Hypersensitivity Reaction
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Rocuronium is a aminosteroid structured, non-depolarizing neuromuscular blocking agents
      (NMB). Epidemiological data presents that the frequency of hypersensitivity reactions caused
      by rocuronium have been increased. Determinations of serum tryptase concentrations are
      interdisciplinary recommended in diagnosis of its adverse reactions. No studies have been
      performed to explain specific role of rocuronium doses on serum tryptase values. The aim of
      this study was to investigate the potential effect of rocuronium on serum tryptase
      concentrations.
    

Detailed description: 
      The greatest risk of hypersensitivity occurs during anesthesia for female patients and it is
      connected with the induction phase using skeletal muscle relaxants . Epidemiological data
      presents that the frequency of hypersensitivity reactions caused by rocuronium have been
      increased. Due to the multiple advantages reports of triggering allergic or hypersensitivity
      reactions caused by rocuronium create doubts about the safety of application .
    

Intervention name(s): Rocuronium; general volatile anaesthesia
Intervention type(s): Drug; Drug
Intervention description(s): using rocuronium as a relaxants during general anaesthesia; method of anaesthesia
Intervention MeSH terms: Rocuronium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study included 126 women given a general volatile anesthesia: group I - 66 - using the rocuronium and group II - 60 - without neuromuscular relaxants. Informations about perioperative fluid therapy and doses of rocuronium were noticed. The blood samples were collected to perform tryptase concentration analysis: preoperatively - before anesthesia and postoperatively - after recovery from anesthesia.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: general anaesthesia; mast cell; rocuronium; tryptase
Effect of Ceftobiprole on Human Intestinal Microflora
Condition: Antimicrobial Agent; Cephalosporins; Drug Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal
      microflora in healthy volunteers.
    

Detailed description: 
      This is an open-label, single center study to investigate the effect on human intestinal
      microflora of multiple doses of ceftobiprole treatment administered at 8 hours intervals for
      7 consecutive days. Careful investigation of the effect of Ceftobiprole treatment on the
      intestinal microflora is of importance since alteration of the intestinal microflora balance
      may facilitate colonization by pathogenic bacteria strains or enable microorganisms already
      present in the normal microflora to develop resistance. A total of 7 fecal samples will be
      collected on day 2, 4, 7, 10, 14 and 21 for determination of ceftobiprole concentration in
      fecal, intestinal microflora pattern and measuring the susceptibility for Ceftobiprole of
      isolated bacterial strains. A total of 13 plasma samples will be collected on day 1, 4, 7,
      10, 14 and 21 for determination of ceftobiprole concentration in plasma. Safety evaluations
      including physical examination, vital signs, clinical laboratory tests, electrocardiogram and
      adverse event monitoring will be performed throughout the study. 500 mg ceftobiprole,
      intravenous infusion over 120 minutes, every 8 hours for 7 consecutive days
    

Intervention name(s): Ceftobiprole
Intervention type(s): Drug
Intervention description(s): ceftobiprole 500 mg by intravenous infusion every 8 hours for 7 days
Intervention MeSH terms: Ceftobiprole; Ceftobiprole medocaril
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ceftobiprole; ZEVTERA; ZEFTERA; Intestinal Microflora
The Use of the VOMS Tool With Military Personnel to Track mTBI Recovery and RTD Status
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The purpose of the proposed project is to determine if the VOMS is an effective screening
      tool to identify and track recovery of vestibular and ocular motor impairment and symptoms
      following mTBI, that corpsman-level medical personnel can successfully implement in combat
      and non-combat environments. A second purpose of the project is to determine if impairment
      and symptoms on the VOMS is more pronounced following blast compared to blunt mTBI.
    

Detailed description: 
      Vestibular impairment and symptoms are prevalent following mild traumatic brain injury (mTBI)
      and may play a role in prolonged recovery. Researchers have indicated that ocular motor
      dysfunction and symptoms are common among personnel exposed to blast mTBI. In fact,
      researchers have suggested that vestibular and ocular motor outcomes such as VOR and
      vestibulo-spinal reflex (VSR) may be useful in identifying the effects of blast from blunt
      mTBI. There are currently no brief, clinical screening tools to identify vestibular/ocular
      motor impairment and symptoms in military personnel following mTBI. Our research team
      recently developed the Vestibular/Ocular Motor Screening (VOMS) tool to screen for
      vestibular/ocular motor impairment and symptoms following mTBI. Our preliminary research
      indicates that VOMS- a 5-min clinical screening tool that can be deployed by corpsman-level
      (i.e., Special Operation Combat Medics [SOCM], Special Forces Medical Sergeants [18D])
      medical personnel with minimal training and materials- was nearly 90% accurate in identifying
      patients with mTBI from healthy controls. These preliminary findings suggest that VOMS may
      augment current clinical screening tools- such as the MACE- used by the U.S. Military. The
      proposed project addresses the "studies to develop standardized metrics for vestibular
      assessment and monitoring for return to duty" area in the Diagnostics subsection of the
      Hearing Loss/Dysfunction, Balance Disorder, and or Tinnitus section under the Clinical Trial
      Research Focus Area.
    

Intervention name(s): Vestibular Ocular Motor Screening Tool (VOMS)
Intervention type(s): Diagnostic Test
Intervention description(s): Vestibular Ocular Motor Screening Tool (VOMS)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Concussion; Vestibular; Ocular-Motor
Time of Effect Onset in Treating Overactive Bladder or Non Obstructive Urinary Retention by Sacral Neuromodulation
Condition: Overactive Bladder; Non Obstructive Urinary Retention
MeSH terms: Urinary Bladder, Overactive; Urinary Retention
Study type: Interventional

Summary: 
      Sacral neuromodulation (SNM) is a minimally invasive secondary treatment for overactive
      bladder syndrome (OAB) or for non-obstructive urinary retention (NOR), when refractory to
      conservative treatment. Success rates range from 70 to 80%, and good long-term results are
      reported. The working mechanism of SNM is not completely understood, and the only prognostic
      factor for good response to this treatment is a successful test stimulation period. There is
      no consensus on the duration of this test stimulation period. The experience in our clinic
      during test stimulation period is that for responders it takes up to one week to achieve
      maximal effect, after the system is turned 'on'. On the other hand the investigators notice
      that after turning the neuromodulation system 'off', it will take a few hours for symptoms to
      return to the baseline situation. The fact is: no information concerning the so called "time
      of onset" and "time of offset" (or popular called: wash-in / wash-out) of sacral
      neuromodulation is available in current literature.
    


Intervention name(s): Filling out voiding diaries.
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive bladder; Non obstructive urinary retention; Sacral neuromodulation
Perindopril Amlodipine for the Treatment of Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination
      drug compared to two other drugs (monotherapies) in controlling hypertension.
    


Intervention name(s): XOMA 985; Amlodipine Besylate; Perindopril Erbumine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PERa/AMLb capsule taken once daily by mouth for six weeks; AMLb capsule taken once daily by mouth for six weeks; PERe capsule taken once daily by mouth for six weeks
Intervention MeSH terms: Amlodipine; Perindopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Essential Hypertension
Donepezil and Brain Activity Patterns in Those at Risk For Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to examine patterns of brain activity in people who are at risk
      for memory problems (e.g., Alzheimer's disease or dementia)before and after the medication
      donepezil. Although genetic testing will be done, the results will not be shared with study
      participants.

      Once the genetic testing is completed subjects may continue to the second phase of the study.
      During this time they will be asked to take the medication donepezil (which is approved by
      the FDA for the treatment of Alzheimer's disease).

      Donepezil is not FDA approved for healthy volunteers and is therefore considered
      investigational in this study.
    

Detailed description: 
      HYPOTHESIS

        1. Cognitively intact individuals with normal brain morphology at genetic risk for
           developing Alzheimer's' Disease (AD) show alterations in brain activation patterns
           during tasks that require memory compared to similar individuals with lower risk for
           developing AD.

        2. Donepezil, a cholinesterase inhibitor, can normalize such brain activation patterns in
           subjects at risk for AD.

      SPECIFIC AIMS

        1. To replicate a recent study1, and compare brain activation in subjects genetically at
           risk for AD (carriers of the є4 allele of the apolipoprotein E gene (APOE)) with
           subjects at lower risk for AD (lacking the є4 allele) during tasks that require memory,
           via functional magnetic resonance imaging (fMRI).

        2. To determine if administration of a drug currently indicated in the treatment of AD,
           donepezil, can reverse fMRI brain activation patterns of at risk subjects to patterns
           similar to those of subjects at lower genetic risk for AD.
    

Intervention name(s): donepezil
Intervention type(s): Drug
Intervention description(s): donepezil 5 mg tablets, total dose per day 10 mg for 6 week duration of study. Taken once per day.
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: memory loss; memory problems; alzheimer's; forgetfulness; forgetting
CC-10004 For The Treatment Of Vulvodynia
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Interventional
Phase: Phase 2

Summary: 
      Vulvodynia is characterized by persistent vulvar pain, which often occurs upon touch or
      pressure. The cause of vulvodynia is unknown but is presumed to involve many factors. Some of
      these factors may include altered immune response, infections, altered vaginal acid-base
      balance, allergic reactions and psychosexual disorders. Women are generally treated with
      medications such as anti-histamines, anti-depressants and anti-inflammatories, or with
      physical therapy to minimize symptoms. Other therapies for vulvodynia include topical agents
      (lidocaine, or compounded medications such as baclofen, gabapentin and amitriptyline), oral
      medications (gabapentin, pregabalin, calcium citrate), complementary therapies (yoga, guided
      imagery, cognitive behavioral therapy) or a low-oxalate diet, but these are often
      ineffective. Surgery for vulvodynia may be helpful in the hard to manage cases, but is
      utilized as a last resort.
    

Detailed description: 
      CC-10004 is a well-tolerated, selective PDE4 inhibitor with a demonstrated inhibitory effect
      on inflammatory mediators and is under development for the treatment of inflammatory and
      immune mediated conditions.

      This is an open-label, one arm, phase II study at William Beaumont Hospital. Twenty female
      subjects aged 18 or older meeting criteria for diagnosis of vulvodynia or vulvar vestibulitis
      (vestibulodynia) will be treated with CC-10004 at 20mg orally twice a day for 12 weeks.The
      patient will be seen for a total of ten visits by the study coordinator.
    

Intervention name(s): CC-10004
Intervention type(s): Drug
Intervention description(s): CC-10004 20 mg. twice a day for 12 weeks
Other intervention name(s): Study Drug
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vulvodynia; pelvic pain; vulvar pain
Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration
Condition: Zinc Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the use of plasma zinc concentration for assessing
      the impact of mass zinc fortification programs.
    

Detailed description: 
      The objectives of the present study are to determine whether plasma zinc concentration
      changes in response to additional zinc consumption, as provided by zinc-fortified
      cereal-based complementary foods fed to adult men (fortified at a level consistent with
      currently proposed levels). The following specific steps will be completed:

        1. Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with
           assistance from experts in food technology.

        2. A four-week feeding trial will be implemented to assess the change in plasma zinc
           concentration among young adult men who receive: a) bread fortified with a moderate
           amount of zinc and a liquid vitamin preparation between meals; b) bread fortified with a
           large amount zinc and a liquid vitamin preparation between meals; c) non-zinc-fortified
           bread and a liquid vitamin preparation between meals [negative control group]; and d)
           non-zinc-fortified bread and a zinc-containing liquid vitamin preparation between meals
           [positive control group].
    

Intervention name(s): Zinc-fortified bread; Zinc supplement; Non-fortified bread; Placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Bread made with zinc-fortified wheat flour; Liquid supplement with zinc; Daily consumption of non-fortified bread; Daily intake of placebo supplement
Other intervention name(s): Les Grands Moulins de Dakar; Zinc sulfate and B vitamins, DSM; Les Grands Moulins de Dakar; B-vitamins, DSM
Intervention MeSH terms: Vitamins; Zinc; Vitamin B Complex; Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: zinc fortification; zinc supplementation; plasma zinc concentration
Studying Physiological and Anatomical Cerebral Effects of Carbon Dioxide and Tilt
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the effects of carbon dioxide combined with head down
      tilt on cerebral physiology and anatomy. This paradigm will help establish a ground-based
      analog for spaceflight, and also evaluate the ability of non-invasive devices to monitor
      brain physiology.
    

Detailed description: 
      Many of the long duration astronauts develop visual changes, associated with
      neuroophthalmological abnormalities suggesting elevated intracranial pressure. There is
      currently no suitable ground based analog to simulate these changes on Earth, or a standard
      methodological approach to monitoring the combined effects of head down tilt and atmospheric
      carbon dioxide. Given that carbon dioxide and cephalad fluid shifting are known factors in
      spaceflight, we sought to evaluate an approach to monitoring these effects in healthy subject
      in a ground based analog on Earth.
    

Intervention name(s): 0.5% CO2; ambient air
Intervention type(s): Other; Other
Intervention description(s): The subjects will be randomized to breath 0.5% carbon dioxide during one of the -12 degree head down tilt body position periods in crossover design; The subjects will be randomized to breath ambient air during one of the -12 degree head down tilt body position periods in crossover design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Brain physiology; Intracranial pressure; Cognition; Cerebrovascular; Head down tilt; Space flight