bioihbjkbjnl/mcl2 huggingface dataset:
Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Leukotrienes play critical roles in the inflammatory process in allergic rhinitis and
      bronchial asthma, therefore, anti-leukotriene therapy is part of treatment for asthma.
      However, not all allergic rhinitis accompanied with or without asthma treated with
      anti-leukotriene were effective. So it is critical to develop a method to identify the
      response subgroup. In this study, it is assumed that nasal physiological responsiveness to
      leukotriene nasal provocation test (NPT) is able to gain evidence on the effect of
      leukotriene on the development of allergic rhinitis and asthma, and is helpful to the use of
      anti-leukotriene agent. The purpose of the study is to establish the methodology and
      diagnostic value of leukotriene D4 (LTD4) nasal provocation.
    

Detailed description: 
      Nasal provocation test induced by LTD4 will be conducted by measuring nasal airway resistance
      and airway symptoms in a stepwise concentration of LTD4 by nasal spray. Inflammation
      biomarkers, such as eosinophilic granulocyte in sputum and nasal lavage, fractional exhaled
      nitric oxide(FeNO), and lung function before and after nasal provocation will be studied to
      explore the impact of LTD4 nasal provocation test on airway inflammation.
    

Intervention name(s): leukotriene D4; histamine
Intervention type(s): Drug; Drug
Intervention description(s): Nasal challenge using 16% ethanol diluent, the concentration of which corresponded to the highest concentration of LTD4, was undertaken for exclusion of subjects hypersensitive to ethanol or saline. The LTD4 challenge could be initiated provided that NAR increase was <30%. Ranges of 4 to 16 mcg.mL-1 LTD4 diluents were applied for a double-fold increment approach at intervals of 6 minutes.; Nasal challenge using 0.9% saline, was undertaken for exclusion of subjects hypersensitive to saline. The histamine nasal challenge could be initiated provided that NAR increase was <30%. Ranges of 0.4 to 3.2 mg.mL-1 histamine diluents were applied for a double-fold increment approach at intervals of 3 minutes.
Other intervention name(s): Cayman chemical company (1-800-364-9897 Cat 20310).; Guangzhou chemical company (serial number: 1703 )
Intervention MeSH terms: Histamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Leukotriene D4; allergic rhinitis; nasal airway resistance; nasal provocation test; nasal hyperreactivity; airway inflammation; asthma
Increasing Vegetable Intake in Children
Condition: Obesity; Behavior; Food Habits
Study type: Interventional

Summary: 
      The purpose of this study is to test the feasibility of an innovative approach to increase
      the amount of vegetable's (V) intake consumed by preschool children who are predominately
      African-American (AA) and Hispanic-American (HA).
    

Detailed description: 
      The purpose of this study is to test the feasibility of an innovative approach to increase
      the amount of vegetable's (V) intake consumed by preschool children who are predominately
      African-American (AA) and Hispanic-American (HA).The primary endpoint will be changes in V
      consumption in high school children with the hypothesis that a puppet intervention will
      increase their V consumption by preschool children. To achieve the project goal, our specific
      aims (SA) are to: SA1: Successfully recruit 6 preschool (PS) centers and 168 AA and 168 HA
      children 3 to 5 y enrolled there. SA2: Conduct individual interviews for formative assessment
      of the PUPPET shows. SA3: Develop the manual of operation and intervention protocols SA4:
      Develop 4 videotaped theatre-based PUPPET shows that are developmentally and cognitively
      appropriate for use with 3- to 5-year-old AA and HA children SA5: Pilot-test the feasibility
      of the PUPPET intervention with 3 intervention and 3 control HS centers. SA6: Use the data
      collected in Aim 5 to estimate parameters required to conduct a group randomized trial for an
      evaluation of the efficacy of the intervention. The primary hypothesis (H1) to be tested is
      that children who receive the PUPPET intervention will demonstrate increased V consumption in
      HS compared to children in the control group.
    

Intervention name(s): Increase vegetable intake in pre-school children
Intervention type(s): Behavioral
Intervention description(s): 6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: vegetables; Head Start; preschool; children; theater; puppet
Study of an Orthotic Designed to Equalize Leg Lengths for Patients With Injuries Managed in Walking Boots
Condition: Joint Pain; Trouble Balancing
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      Patients who undergo foot and ankle surgery are often made weight-bearing as tolerated (WBAT)
      in a controlled ankle movement (CAM) boot during their recovery and rehabilitation process.
      However, some patients may experience pain and discomfort while wearing the CAM boot. A
      possible cause for this pain is that the boot elevates the injured foot higher than the other
      foot in the normal shoe. This uneven walking plane can lead to an abnormal gait or walking
      pattern, and may potentially lead to pain. Our goal is the investigate if using a
      leg-length-evening orthotic can improve balance and/or decrease the development of pain in
      the legs and spine for patients who are WBAT in a CAM boot.
    

Detailed description: 
      Patients with foot and ankle injuries are often made weight-bearing as tolerated (WBAT) in a
      controlled ankle movement (CAM) boot at some point during their recovery and rehabilitation
      period. While WBAT in a CAM boot, patients often experience an asymmetric gait associated
      with the effective leg length discrepancy between the booted extremity (longer) and the
      contralateral extremity with a regular shoe (shorter). This asymmetry may cause balance
      problems or place strain on the patient's joints resulting in back, knee, and hip pain.

      An orthotic has been designed that is added to the outside of a regular shoe in order to
      eliminate the effective leg length discrepancy between the booted extremity and the
      contralateral limb. Although this specific orthotic has not been studied, some proof of
      concept lies in studies that show that back pain can be managed with foot orthotics. The
      purpose of this study is to determine if using the leg-length-evening orthotic can improve
      balance and/or decrease the development of pain in the lower extremities and spine for
      patients who are WBAT in a CAM boot.
    

Intervention name(s): Evenup
Intervention type(s): Device
Intervention description(s): Orthotic which increases effective leg length.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are randomly assigned to two groups using a blocked randomization schedule.
Subjects assigned to the control group receive the standard treatment for their condition, which must be at least 2 weeks of weight bearing as tolerated in a controlled ankle movement boot in order for them to meet inclusion criteria.
Subjects assigned to the experimental group receive the orthotic for use on the contralateral limb, which is the only alteration to their treatment of at least 2 weeks of weight bearing as tolerated in a controlled ankle movement boot (required to meet inclusion criteria).
Masking: None (Open Label)
Primary purpose: Prevention
Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease; Fistula
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate an intravenous (by injection) investigational
      medication to treat Crohn's disease in patients with at least one perianal fistula. The
      research is being conducted at up to 5 clinical research sites in the US and Europe and is
      open to both men and women ages 18 to 70 years old. Participants in the study will have a
      number of visits to a research site over a 17 month period. All study-related care and
      medication is provided to qualified participants at no cost: this includes all visits,
      examinations and laboratory work.

      Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the
      immune system to help defend the body from infections and other foreign substances) that is
      directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing
      so, it may prevent them from causing inflammation. Visilizumab has also been observed to have
      a suppressive effect on the body's immune system (system in the body that reacts to foreign
      or occasionally one's own proteins).
    

Detailed description: 
      PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
    

Intervention name(s): Visilizumab
Intervention type(s): Drug
Intervention MeSH terms: Visilizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Administration of Microplasmin for Treatment of Acute Ischemic Stroke
Condition: Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the safety and preliminary efficacy of
      microplasmin when administered intravenously to patients who have suffered an acute stroke
      within 12 hours before randomization.
    

Detailed description: 
      While the primary objective of the trial is safety evaluation, efficacy assessments will also
      be obtained, including MRI/MRA (including DWI, PWI and T2 imaging) and plasma surrogate
      biomarkers. Clinical outcome will also be assessed at 7days, 30 days and 90 days
      post-treatment. At each of these visits, mortality and neurological assessments (NIHSS,
      Barthel index, mRankin scale) will be performed. In addition, vital status will be assessed
      vial a telephone contact at 60 days post-treatment.

      The trial will investigate three dose regimens of microplasmin, all of which are within the
      range of doses previously evaluated in a Phase I trial in healthy volunteers; the planned
      sample size for the trial is approximately 40 patients.

      The study will consist of 3 phases - the Baseline, In-hospital Phase and Follow up Phase.
      Baseline is from study entry through randomisation; the In-hospital phase is from treatment
      with study drug through hospital discharge or day 7, whichever occurs first. The follow up
      phase consists of visits to the hospital 30 days (+ 3 days) from the day of study drug
      administration. Hospital discharge is defined as the end of the discharge from the acute
      hospital setting. Discharge may be to home, to a rehabilitation setting or to a non-acute
      hospital setting.
    

Intervention name(s): Microplasmin; Microplasmin
Intervention type(s): Drug; Drug
Intervention description(s): 1mg/kg bolus of microplasmin solution followed by 1,2 or 3mg/kg infusion of mircroplasmin solution.; 1mg/kg bolus of placebo solution followed by 1,2 or 3mg/kg infusion of placebo solution
Intervention MeSH terms: Plasminogen; Fibrinolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stroke; Acute Ischemic Stroke
Drug-Drug Interaction Study: ASP2151 and Ciclosporin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      ASP2151 is an experimental treatment for herpes. Patients undergoing organ and tissue
      transplantation may be prescribed ciclosporin to suppress their immune system to give the
      transplant an increased chance of not being rejected. A patient with a compromised immune
      system is more susceptible to infections such as herpes, which will require treatment.
    


Intervention name(s): ASP2151 400mg + 100mg ciclosporin; ASP2151 1200mg + 100mg ciclosporin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HSV; Herpes; volunteers; drug-drug interaction; transplant
CSD170501: Study to Assess Biomarkers of Tobacco Exposure in Smokers During In-Clinic Confinement Switch to an Electronic Cigarette
Condition: Smoking
Study type: Interventional

Summary: 
      The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to
      tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of
      the three electronic cigarettes or abstinence.
    

Detailed description: 
      This will be a two-center, randomized, controlled, switching, open-label, parallel cohort
      study. The study will compare biomarkers of tobacco exposure from subjects at baseline levels
      of biomarkers of tobacco exposure after they have switched to one of three electronic
      cigarettes or abstinence for 5 days.
    

Intervention name(s): FT21039; FT21092; FT21018
Intervention type(s): Other; Other; Other
Intervention description(s): an electronic cigarette product; an electronic cigarette product; an electronic cigarette product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Montelukast as a Controller of Atopic Syndrome
Condition: Seasonal Allergic Rhinitis; Allergic Conjunctivitis; Atopic Eczema; Asthma
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic; Dermatitis, Atopic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to find out if montelukast can be used to treat the various
      symptoms of allergic syndrome.
    


Intervention name(s): montelukast
Intervention type(s): Drug
Intervention description(s): 10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Mechanical Heat Recovery Ventilation on House Dust Mite Sensitive Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Asthma has become increasingly common in the UK, demanding our consideration of the cause.
      Many patients with asthma are allergic to house dust mites, which thrive in modern housing.
      Improving ventilation in the home has been shown to reduce dust mite levels, by reducing
      humidity levels. It is hoped that, by removing the dust mites from homes, asthma may improve.
      In this study, 140 volunteers will have their carpets steam-cleaned and new allergy bedding
      provided, before a team of architects installs a ventilation system in the loft. Half of the
      units will be switched on at the beginning of the study. The other half will be switched on
      in 12 months time, but only the architects know which units are active. The medical team will
      compare the asthma, and measures of inflammation in the airways, over that year.

      It is due for completion in April 2007.
    

Detailed description: 
      The prevalence of asthma is rising sharply in the UK. The house dust mite is the most common
      trigger associated with asthma, thriving in the humid microclimate favoured by modern
      housing. Could this be redressed by investment in improved ventilation in local housing? In a
      pilot study in North Lanarkshire Council housing stock, we demonstrated that dust mite
      avoidance, in combination with installation of domestic mechanical heat recovery ventilation
      (MHRV), could inhibit the re-colonisation of house dust mites by reduction of indoor air
      humidity. In this second phase, a double blind randomized placebo- controlled trial will test
      the resultant effect on asthma. It will be complete in November 2006. 140 patients with
      asthma and house dust mite allergy are being recruited and all will have new bedding,
      mattress covers and carpets cleaned. All will have MHRV units installed in their home, but
      only half will be activated, before 12 months of environmental and clinical monitoring. The
      primary endpoint is morning peak flow rate. Secondary endpoints include symptom scores,
      spirometry, rates of exacerbations, quality-of-life, and economic evaluations. Demonstration
      that well ventilated, energy efficient dwellings improve the respiratory health of patients
      with allergic asthma could be of considerable importance in helping the NHS cope with the
      commonest chronic disease in Scotland.
    

Intervention name(s): Mechanical Heat Recovery Ventilation
Intervention type(s): Device
Intervention description(s): De-humidification without loss of heat
Other intervention name(s): Ventaxia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; house dust mite; allergy; housing; avoidance; humidity
Study Evaluating the Mass Balance And Biotransformation of Single Dose[14C] AST2818 in Chinese Healthy Male Volunteers
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Evaluate the Mass Balance and Biotransformation of Single Dose[14C] AST2818 in
      Chinese Healthy Male Volunteers
    

Detailed description: 
      A Phase I Mass Balance and Biotransformation Study of Orally Administered [14C]-Alflutinib
      Mesylate (AST2818) in Chinese Healthy Male Volunteers
    

Intervention name(s): [14]-AST2818
Intervention type(s): Drug
Intervention description(s): Volunteer will receive a single oral dose of 80 mg /100 u Ci [14C]-AST2818 as a solution on Day 1
Intervention MeSH terms: Aflutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Sublingual Nicotine Tablets Compared With Swedish Snus
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To compare each subject's AUCinf, after administration of one single dose of 6 mg of
      Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of
      SS containing 16 mg nicotine.
    

Detailed description: 
      Open, randomized, five-way cross-over. Single dose administration. The Nicorette 6 mg
      sublingual tablets and three strengths of SS are tested. Subjects are 18-50 years old,
      male/female (non-pregnant), healthy volunteer, using minimum 12 pouches of 1 g portion snus
      or half a can of loose snus per day. The treatments are given as single doses in randomized
      order. The subject keeps the sublingual tablets still under the tongue for 30 minutes.

      The subject keeps the pouch(es) of snus still between the upper lip and the gum for 30
      minutes. Serial blood samples are drawn before, and at regular time intervals up to 6 hours
      after administration.

      Amount of nicotine extracted, plasma nicotine concentration at 30 minutes (C30), Tmax, Cmax,
      AUCinf and heart rate for each treatment. The AUCinf area is based on plasma data corrected
      for background nicotine (time zero sample).

      Each subject's rating of subjective effects using a Visual Analogue Scale (VAS) on a palm top
      computer, anchored with "not at all" to "extremely".

      VAS scores will be obtained at the plasma concentrations sampling time points up to 30
      minutes for:

        -  craving intensity

        -  overall "product strength" (head rush, "buzz", "hit", feeling alert)

        -  increased salivation

        -  burning sensation in the mouth and/or throat
    

Intervention name(s): sublingual nicotine tablets; Smokeless tobacco
Intervention type(s): Drug; Other
Intervention description(s): 6 mg = 3 tablets; Swedish type moist snuff
Other intervention name(s): Nicorette Sublingual Tablets; PSWM 0.5 g; PSWL 1.0 g
Intervention MeSH terms: Lobeline; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Neural Mechanisms Underlying Children's Responses to Food Portion Size and Energy Density
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      Increased portion sizes of foods high in energy density (calories per gram of food) have been
      implicated in the obesity epidemic. Numerous studies show that children and adults eat more
      from larger portions of food than they do from smaller portions, a response known as the
      portion size effect. Despite the robust and consistent nature of these findings, the
      mechanisms underlying the portion size effect are not known. The long-term goal of this
      research is to identify the neural mechanisms involved in the portion size effect so that
      this information can be used to develop effective weight-management strategies. Differences
      in neural response to food cues, as demonstrated by functional magnetic resonance imaging
      (fMRI), can help clarify the factors that determine susceptibility to large portions. The
      goal of this study is to identify brain regions activated in response to portion size and
      energy density and relate these neural responses to laboratory eating behaviors in children.

      The investigators hypothesize that high relative to low energy density food images will be
      associated with increased activation in regions of the brain involved in reward- and sensory-
      processing and that large relative to small portion size food images will be associated with
      increased activation in regions of the brain involved in cognitive control. In addition, the
      investigators hypothesize that these brain responses will influence the relationship between
      portion size served and energy intake at laboratory meals.
    

Detailed description: 
      What this study will add to the literature: The response to food images that vary by portion
      size using fMRI has not been previously reported. Furthermore, how the brain response to food
      portion size and energy density is related to energy intake has not been previously reported.
      The goal of this study is to identify brain regions activated in response to portion size and
      energy density and relate these neural responses to laboratory eating behaviors in children.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children between the ages of 7-10 years old and their parents
      
Keywords: Magnetic Resonance Imaging; Portion Size; Energy Intake