bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of a Meal on Brain Activation in Reward Pathways
Condition: Brain Response to Visual Food Cues
Study type: Observational

Summary: 
      Scientists have studied how fasting and nutrients affect brain function in animals. The
      purpose of this study is to look at the effects of both fasting and food intake on brain
      function and memory in humans. To do this the investigators will use functional MRI to
      observe the brain and its function while fasting and after a meal. Understanding the action
      of these hormones in the brain may eventually lead to new ways to help people avoid obesity
      or lose weight.
    

Detailed description: 
      Potential subjects will participate in a short phone screening interview and if eligible,
      will come to the University of Washington hospital 2 times. At the first health screening
      visit, we will go over the subjects' medical history, weight and height, and eating habits.
      This visit will take an hour or so and eligible subjects will then schedule the study visit.
      For the study visit, subjects will have to fast overnight from 9:30 pm the night before and
      arrive at the hospital at 8:00am. At 8:30 am, the subject will have a 30 minute MRI scan of
      the brain done in the University of Washington Radiology Department. During the MRI scan they
      will see pictures of common objects and foods and be asked to remember the photos they saw.
      At 9 am subjects will eat a standard breakfast, and they will not eat again until after the
      second MRI. The time of their second MRI will be randomly assigned to one of seven time
      points anywhere from 15 minutes to 5 hours after the breakfast. After the MRI, subjects will
      be allowed to eat freely from food we provide. Subjects will receive $10 for the health
      screening visit, and $50-85 depending on the length of the visit.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We will enroll 21 healthy subjects. Participants will be recruited by flyers posted at the
        University and by newspaper advertisements.
      
Keywords: Obesity
A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled,
      parallel-group study followed by an eight-week open-label extension to evaluate the safety,
      tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to
      evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild
      to moderate rosacea.
    


Intervention name(s): Anatabloc Cream; Placebo Cream
Intervention type(s): Other; Other
Intervention description(s): subject will apply active cream topically, twice per day according to instructions; subject will apply placebo cream topically, twice per day according to instructions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rosacea; anatabine; Anatabloc; dermatology
A Multi-Site Trial of MS INFoRm (Fatigue Management Resource)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      People with MS commonly experience extreme fatigue that negatively impacts their ability to
      engage in a full range of daily activities, quality of life, and employment. A new website
      called MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) allows
      people with MS to take a personalized and active approach to learning about and managing
      their fatigue. The aims of this study are:

        1. To determine to determine whether 3-month use of the MS INFoRm website can reduce the
           impact of fatigue on daily life among persons with MS.

        2. To determine whether 3-month use of the MS INFoRm website results in improvement in
           self- efficacy/ confidence for managing MS fatigue, self-reported cognitive function,
           participation and autonomy/ independence, and depression.

        3. To determine whether benefits are maintained among the MS INFoRm users after 6-months.
    


Intervention name(s): MS INFoRm; Usual Care Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MS INFoRm incorporates principles of self-management and adult learning theory. The contents address the sources of fatigue, ways of monitoring fatigue, and strategies to reduce fatigue.; The usual care webpage will contain content from widely available resources about MS fatigue.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will use a randomized controlled trial design to test the efficacy and effectiveness of MS INFoRm. Two hundred participants from at least three sites across Canada will be randomly assigned to one of two groups: the experimental (MS INFoRm) group or usual care control group. After completing the study, participants in the usual care control group will be given access to MS INFoRm in order to provide them with any benefits of the website, if any are uncovered. Both groups will be evaluated on primary (fatigue impact) and secondary (self-efficacy, cognitive function, participation and autonomy, depression) outcomes at baseline (week 1), after 3-month use of the MS INFoRm website (week 12), and after 6-month follow-up (week 36).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; fatigue; self-management; rehabilitation
A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux
Condition: Pyelonephritis; Renal Scars
MeSH terms: Pyelonephritis; Vesico-Ureteral Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing
      pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36
      months with vesico-ureteral reflux (VUR).
    

Detailed description: 
      In recent years, the effectiveness of continuous antibiotic prophylaxis in children with
      vesico-ureteral reflux (VUR) has been intensely discussed. The question is not only whether
      antibiotics are effective in preventing recurrent urinary tract infections (UTI), but also
      whether they alter the natural history of disease and help to prevent the appearance of new
      kidneys scars. The evidence on the effectiveness of antibiotic prophylaxis is scanty:
      randomised controlled trials (RCT) published until now are poorly designed and carried out in
      very heterogeneous samples of children, i.e. spanning from 6 months to 14-18 years of age and
      pooling patients with and without VUR. A recently updated Cochrane Systematic Review
      concludes that high quality RCTs are needed to determine the effectiveness of long-term
      antibiotics for the prevention of UTIs in susceptible children. Moreover, the presence of VUR
      has not been firmly shown to be a risk factor for recurrence of pyelonephritis, and a direct
      association between VUR and the presence of scars or the appearance of new scars has not been
      demonstrated; there is just an association between VUR of grade IV-V and prenatal renal
      dysplasia, almost exclusively in male infants. In spite of this uncertainty, several practice
      guidelines recommend long term antibiotic prophylaxis in children with different degrees of
      VUR.

      The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing
      pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36
      months with VUR.

      Comparison: In a multicentre trial, 100 patients with VUR diagnosed with cystourethrography
      after a first episode of acute pyelonephritis or for prenatal evidence of pyelectasia will be
      assigned randomly to receive prophylaxis or not. Randomization will be carried out using a
      centralized minimization procedure to balance for sex, age group and VUR grade.
    

Intervention name(s): Sulfamethoxazole/trimethoprim
Intervention type(s): Drug
Intervention description(s): Sulfamethoxazole/trimethoprim prophylaxis
Intervention MeSH terms: Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Pyelonephritis; Renal scars; Vesico-ureteral reflux; Dimercaptosuccinic acid renal scan (DMSA)
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the dermal sensitization potential of azelaic acid
      pre-foam formulation.
    

Detailed description: 
      In an induction phase a three times weekly exposure over three weeks will be performed,
      followed by a resting phase. In a following challenge phase single exposure will be performed
      again and potential skin reactions observed. If skin reactions occur an optional re-challenge
      phase may be performed.
    

Intervention name(s): azelaic acid pre foam formulation; Vehicle pre foam formulation; Water
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Azelaic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: dermal sensitization potential
Zinc Pneumonia Outpatient Trial in Children < 2 Years
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether zinc can be used in combination with
      standard antibiotics to reduce the duration of illness and the likelihood of treatment
      failure among children less than two years old who have non-severe, outpatient pneumonia.
    

Detailed description: 
      This study is a follow up to an earlier study among hospitalised children less than two years
      old with severe pneumonia who were administered zinc as an adjuvant along with standard
      antimicrobial agents. That study found a 20% reduction in illness duration and
      hospitalisation, as well as a 3 - 9 fold reduction in treatment failure for children given
      zinc along with standard antimicrobial management. However, since most pneumonia is managed
      in an outpatient setting, it is important to know if it works in this setting as well. We
      hypothesise that zinc may act as an acute phase reactant in the early stages of outpatient
      non-severe pneumonia to reduce both the duration of illness and the likelihood of treatment
      failure.

      To test this, we will randomise children less than two years old to receive either zinc or
      placebo can as an adjuvant to standard oral antimicrobial agents in the acute treatment of
      non-severe pneumonia in an outpatient urban setting. Oral antibiotics will be given for a
      standard five-day course, while zinc (20 mg) or placebo will be administered once-daily for
      10 days. Patients will be followed up on a daily basis at home to monitor their progress and
      document compliance.

      Outcomes will be a comparison between zinc and placebo groups on duration of illness, as
      measured by specific signs of pneumonia, and treatment failure, as measured by change of
      antibiotics or hospitalisation for failure to improve or worsening condition.
    

Intervention name(s): Zinc sulphate (20 mg)
Intervention type(s): Drug
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: pneumonia; zinc; treatment; efficacy; children
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this study is that treatment with Trichuris suis ova will be safe and
      effective as an oral treatment of patients with relapsing multiple sclerosis.
    


Intervention name(s): Trichuris suis ova
Intervention type(s): Biological
Intervention description(s): 2500 ova per dose, orally, every second week, during 12 weeks
Other intervention name(s): TSO
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; safety; MRI; immunological; Helminths; Trichuris suis
Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The study consists in the application of 2 investigational products (one group per
      investigational product) under normal conditions of use, in adult participants with Atopic
      Dermatitis.

      It is carried out on cosmetic products, with the aim to further confirm safety of these
      products
    

Detailed description: 
      Probiotics are live micro-organisms which when administered in adequate amounts can exert a
      health benefit on the host. This health-promoting effects of Lactobacillus reuteri have been
      extensively studied in the gastrointestinal tract but it is clear that other areas are also
      interesting for the use of probiotics.

      Atopic Dermatitis is a relapsing inflammatory skin disease appearing on persons with a
      genetic predisposition of allergic pathology. AD generally starts in childhood, however in
      some cases can continue into adult hood, in at least 10% of cases. AD can effect a persons
      quality of life and in the chronic stage it can present with dry skin and lichenification.

      Research has shown that probiotics have an antimicrobial, anti-inflammatory and barrier
      function effect, and could therefore be used on subjects with Atopic Dermatitis to relieve
      and protect.
    

Intervention name(s): Topical Ointment with L. reuteri; Topical Ointment without L. reuteri
Intervention type(s): Other; Other
Intervention description(s): Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body; Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
Other intervention name(s): Probiotic ointment A; Non Probiotic ointment B
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of two cosmetic products
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Probiotic; Atopic Dermatitis; Lactobacillus reuteri
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
Condition: Acute Undifferentiated Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of
      17-N-allylamino-17-demethoxygeldanamycin in treating young patients with relapsed or
      refractory solid tumors or leukemia. Drugs used in chemotherapy, such as
      17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from
      dividing so they stop growing or die.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) and recommended phase II dose of 17-AAG
      administered as a 60 or 120-minute intravenous infusion on days 1, 4, 8, and 11, of a 21-day
      course, to children with refractory solid tumors or relapsed leukemia.

      II. To define and describe the toxicities of 17-AAG administered on this schedule.

      III. To characterize the pharmacokinetics of 17-AAG in children with refractory cancer.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of 17-AAG within the confines of a phase I
      study.

      II. To assess the biologic activity of 17-AAG. III. To examine the role of CYP3A5
      polymorphisms in the pharmacologic and clinical phenotypes observed following administration
      of 17-AAG to children, within the confines of a phase 1 study.

      OUTLINE: This is a dose-escalation, multicenter study.

      Patients with solid tumors receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over
      60-120 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 17 courses
      in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
      experience dose-limiting toxicity. Once the MTD is determined, up to 6 additional patients
      with leukemia receive 17-AAG at the MTD as above. If these 6 patients tolerate this regimen,
      another 6 leukemia patients receive 17-AAG IV over 60 minutes on days 1, 4, 8, 11, 15, and
      18.

      Treatment repeats every 28 days for 17 courses in the absence of disease progression or
      unacceptable toxicity. Patients are followed at 30 days.
    

Intervention name(s): tanespimycin
Intervention type(s): Drug
Intervention description(s): Given IV
Other intervention name(s): 17-AAG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Blood Levels, Drug Interaction and Effects of Repeated Doses of GSK1034702
Condition: Cognitive Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1034702 is being developed for improving cognitive impairment in diseases such as
      Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no
      child beading potential to investigate repeated doses of the study medicine. The study will
      investigate the following questions, do repeated doses of the study medicine have any
      important side effects when taken by mouth? How much of the study medicine gets into the
      bloodstream, and how quickly does the body get rid of it? Does the study medicine affect
      memory, attention and problem-solving skills? What are the effects when the study medicine
      and dextromethorphan are taken together.
    


Intervention name(s): GSK1043702; Dextromethorphan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose in liquid or tablet formulation; 30mg Oral dose; To match GSK1034702
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug interaction; Saftey; Pharmacokinetics; Cognition
Vestibular and Multisensory Influence on Bodily and Spatial Representations. Behavioral and Electrophysiological Investigations in Vestibular-defective Patients and Healthy Volunteers
Condition: Vestibular-defective Patients
Study type: Interventional

Summary: 
      The present project aims at describing how vestibular signals contribute to the multisensory
      mechanisms of bodily self-consciousness.

      There is a large body of data regarding the sensory and neural mechanisms of
      self-consciousness, but most studies have so far demonstrated the contribution of visual,
      tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have
      neglected the contribution of the vestibular system, a major sensory system for spatial and
      bodily representations. The vestibular system is sensitive to head motions in space and head
      inclinations with respect to gravity and it should therefore contribute significantly to
      several bodily experiences. This contribution should be put under neuroscientific scrutiny.
      We believe that the current neuroscientific models of bodily self-consciousness will be
      incomplete until they incorporate the contribution of vestibular signals.

      The present project specifically aims at testing the hypothesis according to which vestibular
      signals significantly influence bodily self-consciousness, in particular first-person and
      third-person perspective taking and the internal body models (i.e. the body schema and body
      image). The present project also aims at describing how cortical vestibular processing is
      modified during experimental changes of perspective taking and viewpoint. In addition, the
      present project will describe whether vestibular disorders change performances in
      third-person perspective taking tasks and modify internal body models. This should help
      understanding bodily symptoms in vestibular-defective patients. To this end, we will combine
      approaches from psychophysics and electrophysiology (electromyography,
      electroencephalography) in healthy volunteers and behavioral approached in patients with
      vestibular disorders.

      These studies should further the understanding of how the brain processes vestibular signals,
      which is to date poorly understood. In addition, the outcome of the present project should
      help understanding the multiple and complex symptoms reported by patients with vestibular
      diseases, and should therefore improve their treatment.
    


Intervention name(s): electromyography; electroencephalography; approaches from psychophysics
Intervention type(s): Other; Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after
      embryo transfer in patients treated with Menopur® Multidose
    


Intervention name(s): Menotrophin
Intervention type(s): Drug
Other intervention name(s): Menopur® Multidose
Intervention MeSH terms: Menotropins
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fertility clinics
An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome
Condition: Atypical Hemolytic-Uremic Syndrome
MeSH terms: Azotemia; Hemolytic-Uremic Syndrome; Atypical Hemolytic Uremic Syndrome; Syndrome; Hemolysis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients
      with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal
      impairment.
    


Intervention name(s): Eculizumab
Intervention type(s): Drug
Intervention description(s): Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
Intervention MeSH terms: Eculizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atypical Hemolytic-Uremic Syndrome