bioihbjkbjnl/mcl2 huggingface dataset:
Promoting Tolerance to Peanut in High-Risk Children
Condition: Eczema; Egg Allergy; Food Allergy
MeSH terms: Eczema; Hypersensitivity; Food Hypersensitivity; Egg Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate whether early exposure to peanuts promotes tolerance and provides
      protection from developing peanut allergy in children who are allergic to eggs or who have
      severe eczema.

      This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).
    

Detailed description: 
      Allergic reactions to peanuts are potentially life-threatening and, in some children, can
      result from ingestion of only trace quantities of peanuts. At highest risk are children with
      eczema or who are allergic to eggs; these children have a 20% chance of developing peanut
      allergy by the age of five. The majority of children allergic to peanuts have their first
      reaction between the ages of 14 and 24 months, often at the time of their first exposure to
      peanut. Currently, there is no cure for peanut allergy.

      Peanut allergy has become an increasingly common problem in early childhood in the United
      States and the United Kingdom. Despite current public health guidelines in both countries
      recommending the avoidance of peanut consumption in the first years of life, the proportion
      of children with peanut allergy doubled in these countries over the period from 1998 to 2003.
      In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa,
      Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to
      be increasing. Peanut consumption by infants in these parts of the world may actually protect
      children from developing peanut allergy by promoting oral tolerance to peanuts.

      Participants in this study will be randomly assigned to either follow a peanut consumption
      regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group
      will be asked to consume an age-appropriate snack three times a week for the duration of the
      study and will be monitored closely during their first introduction to peanut.

      Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for
      the first three years of life. A physical exam, allergy testing, and other immune system
      tests requiring blood collection will occur at Years 1, 3, and 5 following study entry.
      During the study, parents will maintain regular contact with study dietitians.
    

Intervention name(s): Peanut Consumption Group
Intervention type(s): Biological
Intervention description(s): Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.
Other intervention name(s): Bamba
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peanut allergy; egg allergy; eczema; peanut; allergy; allergies; allergic reaction; anaphylaxis; infants; children
Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
Condition: Major Depressive Disorder, Recurrent, Unspecified
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives

        -  To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in
           healthy subjects.

        -  To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.
    

Detailed description: 
      This will be a randomized, double-blind, placebo-controlled, multiple ascending dose study to
      be conducted in the US. Approximately 48 healthy subjects will be enrolled into one of the
      four groups
    

Intervention name(s): LY03005; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LY03005 is a new investigational pro-drug of desvenlafaxine formulated as extended-release oral tablets for the treatment of major depressive disorder.; Placebo
Other intervention name(s): 4-Methylbenzoate of desvenlafaxine hydrochloride
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen
      therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding
      intolerance and shorten the time period that infants need to tolerate full enteral nutrition.
      We also hypothesize that this intervention will minimize the alterations in intestinal
      permeability that occur with these drugs and will improve the infants' hemodynamic response
      to enteral nutrition
    

Detailed description: 
      This study is a randomized controlled multi-center clinical trial to determine whether very
      low birth weight infants should receive feedings during indomethacin or ibuprofen treatment
      of a patent ductus arteriosus (PDA). Many neonatologists withhold feeds from premature
      infants receiving indomethacin or ibuprofen therapy for a PDA because of concerns that these
      drugs alter intestinal blood flow and permeability. However, there are no established studies
      which show that feeding during these medical treatments leads to bowel injury. At the same
      time, studies suggest that withholding feedings from premature infants may lead to intestinal
      atrophy and injury, leading to increased difficulty with feedings when they are initiated or
      re-started. Thus, this multi-center study evaluates whether feeding infants during
      indomethacin or ibuprofen therapy improves feeding tolerance by measuring the number of
      episodes of feeding intolerance and the number of days required to attain full feedings. In
      addition, this study will employ techniques to measure gastrointestinal permeability and
      mesenteric blood flow in patients who receive and don't receive feedings for their PDA
      treatment.
    

Intervention name(s): feeding; fasting
Intervention type(s): Other; Other
Intervention description(s): Study infants will receive trophic enteral nutrition (15 ml/kg/day) during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.; Study infants will be fasted during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: indomethacin; ibuprofen; preterm infant
Qigong Exercise May Benefit Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The long-term goal of our research program is to develop an effective and cost-saving
      mind-body therapy to help patients with FM. The objective of this pilot study is to gather
      pilot data of the effect on pain, fatigue, sleep quality, and quality of life in FM patients
      using a specific type of qigong exercise, i.e. "six healing sound" qigong. Changes in
      relevant brain activity will be monitored in study subjects before and after the qigong
      exercise program, which may help us in better understanding the underlying mechanism of the
      qigong exercise. Data collected in this pilot study will help the investigators in
      preparation for a future clinical trial with a larger sample size. Our central hypothesis for
      the future clinical trial is that qigong exercise will lead to a significantly greater
      improvement in pain, fatigue, sleep quality, and quality of life in the experimental group
      compared to the control group.
    


Intervention name(s): Intervention Group; Placebo Comparator: Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The study will include one week baseline phase, 6-week intervention phase, and a 3-month follow-up evaluation. Subjects in the intervention group will go through three training sessions during the baseline phase, weekly group exercise sessions once per week and daily home exercises two times each day during the intervention phase, and a follow-up evaluation in three months after the intervention phase.; Subjects in the control group will be monitored during the baseline and intervention phase without participating in the interventional exercise. At the end of intervention phase, the subjects will have the option to stop their participation or switch to the intervention group.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after
      single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.
    


Intervention name(s): AMG 133
Intervention type(s): Drug
Intervention description(s): Solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AMG 133; Japanese participants; Caucasian participants
Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last
      approximately 2 - 4 months.
    


Intervention name(s): Investigational senofilcon A C3 Multifocal Lens; delefilcon A Multifocal Lens
Intervention type(s): Device; Device
Intervention description(s): TEST; Dailies Total 1® Multifocal Contact Lens
Other intervention name(s): CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care
Condition: Cancer
MeSH terms: Emergencies
Study type: Observational

Summary: 
      Significant challenges and gaps remain in navigating transitions between acute care and
      outpatient care for many cancer survivors. This study underscores 1) implementation of
      Emergency Department (ED) risk-stratified treatments protocols that standardize patient care
      and would allow for rapid re-assessment and access to specialist care with well-coordinated
      cancer care plans, and 2) the significant numbers of minority cancer survivors seeking
      episodic care in the ED that are at increased risk of not receiving recommended post cancer
      treatment surveillance.
    

Detailed description: 
      The over-arching goal of this study is to develop a portable model for ED cancer treatment
      guidelines and management using evidence based protocols in a population at high risk for
      poor cancer -related outcomes by identifying & overcoming specific barriers to enhanced
      survivorship. Based on the demographics of ED population (currently, 70% racial/ethnic
      minorities), the majority of participants will be underrepresented (African-American and
      Hispanic) and low-income individuals. The investigators propose a feasibility study of 150
      patients in the ED over a 1 year period.

      The specific aims are:

      Aim 1: Evaluate the effectiveness of ED Risk-Stratified, Evidence-Based Treatment protocols
      on the primary outcome of ED utilization rates and subsequent acute inpatient admissions at 6
      -months post-intervention.

      Aim 2: Evaluate the effectiveness of an ED-based Cancer Patient Navigator on the secondary
      outcomes of patient engagement and primary care engagement at 6 -months post-intervention.

      Aim 3: Examine barriers and facilitators to compliance for cancer survivorship
      recommendations that occur in an ED setting at 6-months post intervention.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patient recruitment will be completed in the UI Health ED with ED patients who have had
        a cancer in their lifetime.
A Study to Assess the Pharmacokinetics of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the
      body does to the medication) of esketamine when given by the intranasal route (through the
      nose) to healthy adult Japanese and Caucasian participants.
    

Detailed description: 
      This is an open-label single-center study with 2 cohorts (groups). The study will consist of
      a screening phase, a treatment phase, and a follow-up visit (9 to 13 days after the last dose
      of the study drug). During the screening phase, participants will be evaluated to determine
      if they meet the study eligibility criteria. A target of 14 healthy Japanese and 14 healthy
      Caucasian adult participants (20 to 55 years of age inclusive) will be enrolled in Cohort 1
      and Cohort 2, respectively.

      The participants in each cohort will self-administer each of the 3 different single-dose
      regimens of intranasal esketamine (Treatments A, B, and C) over the 3 treatment periods (ie,
      1 treatment per period) in an open-label manner (both the investigator and the participant
      knows which intervention the participant receives). The participants will be randomly (like
      the toss of a coin) assigned to receive Treatment A and Treatment B in the first two periods
      (ie, Treatment A in Period 1 and Treatment B in Period 2, or the reverse order). All
      participants will receive Treatment C in Period 3. The regimens differ in the number of
      sprays to achieve the total dose and the total esketamine dose administered.

      Safety and tolerability will be evaluated throughout the study and will include assessment of
      adverse events, targeted nasal examinations, laboratory tests, electrocardiogram, physical
      examination, pulse oximetery, and vital signs.
    

Intervention name(s): Esketamine
Intervention type(s): Drug
Intervention description(s): Fourteen percent esketamine solution (14 mg of esketamine per 100 microliter) will be administered intranasally by nasal spray pump.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Japanese; Caucasian; Anesthetics; Intranasal; Esketamine; Pharmacokinetics
Predictors for Retreatement of OAB After DC Mirabegron
Condition: Recurrence of Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive; Syndrome; Recurrence
Study type: Observational

Summary: 
      Recurrence of female overactive bladder syndrome (OAB) is not uncommon. It is important to
      decrease the recurrence of female OAB. However, factors predicting recurrence of female OAB,
      especially for those women who need retreatment is undetermined. Thus, the aim of this study
      was to elucidate factors predicting retreatment of female OAB.
    

Detailed description: 
      The medical records, including pad testing, urodynamic studies, lower urinary tract symptoms
      related questionnaires and bladder diaries of all consecutive women with OAB, who visited
      urogynecologic clinics in a tertiary referral center, were reviewed. Persistence interval was
      defined from the date of prescription of mirabegron to the date of discontinuation of
      mirabegron treatment. Statistical analysis was performed with Kaplan-Meier estimator.
      Multivariable Cox proportional-hazard model with all variables with p < 0.25 in the
      univariate analysis was performed to predict OAB retreatment probability.
    

Intervention name(s): Mirabegron 25mg
Intervention type(s): Drug
Intervention description(s): Mirabegron 25 mg per day
Other intervention name(s): Betmiga
Intervention MeSH terms: Mirabegron
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with overactive bladder syndrome who completed urodynamic study and bladder diary and
        received Mirabegron 25 mg per day
      
Keywords: overactive bladder syndrome; beta-3 agonist; retreatment
DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA
      (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream
      when applied twice daily for 15 days.
    

Detailed description: 
      This was a 15-day, randomized, multicenter, comparator-controlled, open-label study.
      Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to
      treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products
      were applied twice daily for 15 days to all affected areas on the body excluding face, scalp,
      groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening,
      Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical
      determinations of disease severity were conducted using the Investigator's Global Assessment
      (IGA) for overall severity at each visit.
    

Intervention name(s): DFD06 Cream; Clobetasol Propionate Cream 0.05%
Intervention type(s): Drug; Drug
Other intervention name(s): Clobetasol Propionate 0.025% Cream; Temovate Cream
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis
Bacteriotherapy to Improve Underarm Odor
Condition: Bromhidrosis
MeSH terms: Body Odor
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal is to improve the underarm odor by changing the microbiome. The autochthonous
      bacterial community is replaced by a non-smelling microbiome, by daily application of
      bacteria in a spray.
    

Detailed description: 
      Participants are recruited and selected based on their initial underarm odor and underarm
      microbiome. The participants use two sprays: one spray containing the bacteria, and the other
      nothing (placebo). Participants do not know which spray they have. They use one spray during
      one month, and meanwhile take samples of their underarm microbiome (for sequencing), volatome
      (for GC/MS analysis) and odor (for odor panel analysis). Samples are stored in the freezer
      and brought to the university after one month, when they receive the second spray. The
      bacterial spray contains bacteria that are correlated with good underarm odor.
    

Intervention name(s): Bacterial spray
Intervention type(s): Biological
Intervention description(s): Bacterial spray containing bacteria that do not cause underarm malodor
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two groups of 30 people, one month of bacterial spray use and the other month placebo.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the long-term efficacy and safety of an aliskiren based
      regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients
      with essential hypertension
    


Intervention name(s): Aliskiren
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hypertension, aliskiren, hydrochlorothiazide, amlodipine
Educational Program for Hearing Aid Users With Internet Support
Condition: Hearing Impaired
MeSH terms: Deafness; Hearing Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine the short-term effects of complementing an
      educational program for hearing aid users with Internet support.
    

Detailed description: 
      Aural rehabilitation aims to improve communication for people with hearing impairment.
      Education is widely regarded as an integral part of rehabilitation, but the effect of the
      delivery method of an educational program on the experience of hearing problems has rarely
      been investigated in controlled trials. Internet as a complement to aural rehabilitation has
      been tested in different studies with promising results. Though, until now not applied
      clinically as a part of an aural rehabilitation, focusing on hearing aid users with
      persistent self- reported hearing problems.

      The purpose of this study was to evaluate the effect of an internet-based aural
      rehabilitation for hearing aid users from a clinical population.

      Participants were randomly assigned to an intervention or control group. The intervention
      group followed a five-week program that consisted of reading material, home training
      assignments, online and telephone interaction with an audiologist, and participation in a
      discussion forum. The control group only had access to reading material.

      The Hearing Handicap Inventory for the Elderly (HHIE), the Hospital Anxiety and Depression
      Scale (HADS) and the Communication Strategies Scale (CSS) were used to measure the outcomes
      of this study; and were recorded before and directly after the intervention as well as 6
      months post-intervention.
    

Intervention name(s): Intervention group; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum.; The control group only had access to reading material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: audiologic rehabilitation; hearing loss; patient education; patient participation; structured rehabilitation; counseling; Internet