bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a regulatory requirement to evaluate the extent of reduction (if any) of growth
      velocity associated with inhaled corticosteroid (ICS) containing products that are to be
      administered to children, and to this end there is Food and Drug Administration (FDA)
      regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind
      (treatment period), parallel group, placebo controlled, multicentre study to assess the
      effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth
      velocity in prepubertal asthmatic children on a background therapy of open-label montelukast.
      This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in
      period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50
      mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The
      purpose of the study is to evaluate the magnitude of effect (with a level of precision) on
      growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to <9 years) following
      administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU)
      and United States (US) regulatory requirements for the evaluation of potential growth
      suppression in children.
    


Intervention name(s): Fluticasone furoate; Placebo; Montelukast; Short Acting Beta 2 Agonist
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fluticasone furoate will be supplied as 50 mcg per blister dry white powder for inhalation using ELLIPTA inhaler.; Placebo will be supplied as dry white powder Lactose for inhalation using ELLIPTA inhaler.; Montelukast will be supplied as 4 mg chewable tablet (5 year old subjects) and as 5 mg chewable tablet (>=6 year old subjects); Albuterol/salbutamol will be supplied as inhalation aerosol or nebulizer.
Intervention MeSH terms: Fluticasone; Xhance; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Growth Velocity; Prepubertal; Asthma; Paediatric
Hydrolized Protein Formula for Premature Infants
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Premature infants fed with a protein hydrolyzed formula will have better tolerance needing
      shorter time to achieve full feeds when compared to those fed with an intact protein formula.
    

Detailed description: 
      The study formula is a 100% whey protein partially hydrolyzed (vs 60/40 Whey:Casein ratio of
      regular premature formulas) Because the tolerance and availability of breast milk is not
      predictable at the time of enrollment all the eligible premature infants will be randomized
      and assigned to the study or control group. Infants will receive formula, either because
      breast milk is not available or because indicated by the attending physician and switched to
      formula, They will be fed, depending of the group to what they are assigned, with either the
      PH formula for the study group or regular premature formula for the control group.

      Randomization and blinding All eligible infants with parental consent will be randomized to
      either the study group to receive protein hydrolyzed formula (PH group) or to the control
      group to receive standard premature formula. Randomization will be stratified by 2 birth
      weight categories (500-1000 g and 1001-1500 g). The purpose of such stratification is to
      avoid imbalance between groups for factors that may influence outcome and is based on the
      different morbidity in different birth weight categories.

      Masked randomization will be performed in a way that avoids the possibility of knowledge of
      treatment assignment at the time that eligibility is assessed and consent is sought. Only the
      person in charge of preparing the control or study formula will be aware of the infant's
      assignment group. Caregivers will remain masked to treatment group.

      Study population Preterm newborns admitted to the neonatal intensive care unit with a birth
      weight 500-1500 g and who survive more than 3 days.
    

Intervention name(s): Protein Hydrolyzed Premature Formula
Intervention type(s): Other
Intervention description(s): Infants will be fed with a protein hydrolyzed premature formula until they reach full feeds
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Protein Hydrolized Formula
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: feeding intolerance; prematurity
Multidimensional Risk Factor Assessment in Constipation
Condition: Constipation; Risk Factors
MeSH terms: Constipation
Study type: Observational

Summary: 
      Constipation is a symptom based disorder with a prevalence of 15% in the adult population and
      its management remains challenging. Although not life threatening, constipation is associated
      with impaired quality of life, increased healthcare costs and excess work absenteeism.
      Constipation represents a heterogeneous disorder with a multifactorial pathogenesis. Several
      risk factors have been suggested to lead to the condition and are divided in 3 main
      categories: a) physiological, b) environmental and c) demographic. To date, there is lack of
      large epidemiological studies on proposed aetiological factors of constipation, especially
      studies assessing all proposed risk factors of constipation together.

      The overall aim of this study is to investigate the multidimensional (physiological,
      environmental and demographic) predictors of constipation with the use of a multivariate
      analysis statistical model.

      This is a large single centre case control study comparing constipated adults with healthy
      individuals matched for age, gender and ethnicity.

      The duration of the study is 2 weeks in total and includes a screening visit, a 2 week run-in
      period and a baseline visit at the end of the run-in period. Transit time between constipated
      and healthy individuals is assessed at baseline visit. Differences in gastrointestinal
      symptoms, dietary intake as well as differences in stool output (e.g. stool frequency and
      consistency) between constipated and healthy individuals are assessed over the baseline
      period (the week before the baseline visit). Differences in female sex hormone levels as well
      as stool markers and markers of fermentation (e.g. fecal water, stool pH, short chain fatty
      acids) between constipated and healthy individuals are assessed at baseline visit.
      Furthermore, differences in environmental measures (physical activity, anxiety, smoking) and
      differences in demographic measures (age, gender, body mass index) between patients suffering
      from constipation and healthy individuals are also assessed at baseline visit.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        100 patients with constipation (cases) and 100 healthy individuals without constipation
        (controls)
Reinforcement-Based Treatment and Abstinence-Contingent Housing for Drug Abusers
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose of the project is to examine the effectiveness of Reinforcement-Based Treatment (RBT)
      on drug abuse and psychosocial outcomes of iner city opiate abusers who have recently
      completed a brief detoxification.
    

Detailed description: 
      Participants are randomized into one of 3-groups: 1) those receiving intensive behavioral
      therapy plus abstinence-contingent housing, 2) those receiving recovery housing alone, and 3)
      those receiving standard care (referrals to community providers). For the two groups
      receiving recovery housing, rent payment is provided for a period of 3 months, as long as the
      participant remains drug-free.
    

Intervention name(s): Reinforcement Based Treatment
Intervention type(s): Behavioral
Intervention description(s): 3 group random assignment to receive standard care, recovery housing alone, or recovery housing plus behavioral treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Condition: Invasive Candidiasis; Esophageal Candidiasis; Oropharyngeal Candidiasis; Candidemia
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Study type: Interventional
Phase: Phase 1

Summary: 
      Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an
      antifungal drug. Safety and drug blood levels will be assessed
    

Detailed description: 
      This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive
      treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment)
      at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood
      samples for assessment of pharmacokinetics will be collected.
    

Intervention name(s): Micafungin (Mycamine)
Intervention type(s): Drug
Intervention description(s): IV
Other intervention name(s): FK463
Intervention MeSH terms: Micafungin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Antifungal; Echinocandin; Candidiasis; Micafungin
Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a
      single IV dose of GLYX-13, an N-Methyl-D-aspartate (NMDA) receptor glycine site functional
      partial agonist, in normal, healthy human volunteers.
    

Detailed description: 
      NMDA receptor glycine site partial agonists (GFPAs) have been demonstrated to be efficacious
      in animal models and/or in early human studies of several Central Nervous System (CNS)
      diseases including neuropathic pain, major depressive disorder, schizophrenia, Alzheimer's
      disease, anxiety including posttraumatic stress syndrome, and cognition in Down's syndrome
      and autism and others, without the psychomimetic side effects of NMDA receptor channel
      blockers. GLYX-13 has demonstrated a wide therapeutic ratio (500:1) between efficacy and side
      effects in animals. The purpose of this study is to evaluate the safety and pharmacokinetics
      of GLYX-13 following a single IV dose.
    

Intervention name(s): GLYX-13; IV normal saline
Intervention type(s): Drug; Drug
Intervention description(s): single IV or SC dose; Single IV dose of normal saline
Other intervention name(s): NMDA receptor glycine site partial agonist; Saline
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glycine site partial agonist; normal volunteers; safety in normal volunteers
A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD)
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and
      1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the
      topical treatment in adolescent and adult subjects with atopic dermatitis. Results from this
      study will be considered when selecting the most appropriate concentration of GSK2894512
      cream and application frequency in future clinical studies. This is a multicenter (United
      States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled,
      6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic
      dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream
      will be equally randomized and evaluated following application to all atopic dermatitis
      lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for
      12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks
      double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject
      participation will be approximately 16 to 20 weeks. Approximately 270 adolescent and adult
      males and females subjects with atopic dermatitis will be screened in order to have at least
      228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately
      204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to
      achieve at least 24 evaluable Japanese subjects.
    


Intervention name(s): GSK2894512 1% Cream; GSK2894512 0.5% Cream; Vehicle cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically; 0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically; White to off-white vehicle cream base to be applied topically
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vehicle-Controlled; GSK2894512; Double blind; Dose-finding; Atopic Dermatitis
Safety and Efficacy Study of Mix Vaccine in Hepatocyte Carcinoma Patient
Condition: Liver Neoplasms
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).
      Enrolled patients will receive standard treatment according to National Comprehensive Cancer
      Network (NCCN) guide line with or without combining MV injection. The efficacy and side
      effect will be compared between the two groups.
    

Detailed description: 
      In the study, after evaluation of the general and physical status, eligible patients will be
      enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients
      will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN)
      guide line (control group) and in experimental arm, patients will be receiving simultaneous
      standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease
      progression.

      Blood sample will be obtained at baseline and every week before MV injection for the
      assessment of clinical hematology, biochemistry measurements and immunology index (including
      immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout
      the study. Side effect, progression free survival, immunology index and general status will
      be recorded.
    

Intervention name(s): MV; Standard Treatment
Intervention type(s): Biological; Other
Intervention description(s): MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.; Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mix vaccine, liver neoplasms, immunotherapy
to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x
      200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.
    


Intervention name(s): CJ Imatinib mesylate tablet; Gleevec film-coated tablet 2 x 100mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Safety
Feasibility Study Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      This study examines a parent only Guided Self-Help for Family Based Treatment (GSH-FBT) for
      adolescents between the ages of 12 and 18 diagnosed with Anorexia Nervosa. Preliminary data
      collected in a previous study suggest that a Guided Parental Self-Help Version of FBT
      (GSH-FBT) has similar outcomes as therapist provided FBT.
    

Detailed description: 
      In this study, families will be randomized to either receive 12 weekly online sessions of
      Guided Self-Help for Family Based Treatment (GSH-FBT), or 15 sessions of online,
      professionally delivered, standard FBT over the course of 6 months. Potential subjects will
      be recruited from Stanford University, McMaster University, other local medical programs and
      clinics, and online advertisement to the population at large. If participants are deemed
      eligible, participants will be invited for a baseline interview during which the
      investigators will conduct interviews and collect questionnaire measures. Participants will
      complete a follow-up interview at the end of treatment and 3-month after end of treatment.
    

Intervention name(s): Guided Self-Help for Family Based Treatment; Family Based Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.; Standard Family Based Treatment provided for up to 15 sessions.
Other intervention name(s): FBT-GSH; FBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: FBT; Family Based Treatment; Guided Self-Help
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
Condition: Neonatal Jaundice
MeSH terms: Jaundice, Neonatal; Jaundice
Study type: Interventional

Summary: 
      The general objective of this study is to evaluate the accuracy of a novel smartphone
      application that estimates bilirubin levels in newborns at HICH Mbarara.

      The specific objectives for this study are:

      To evaluate the correlation between bilirubin estimates from a smartphone application and
      bilirubin measurements in serum in newborns with varying degree of jaundice To evaluate the
      correlation between bilirubin estimates from a smartphone application and bilirubin estimates
      from a standard transcutaneous device in newborns with varying degree of jaundice To evaluate
      the correlation between bilirubin estimates from a smartphone application and bilirubin
      estimates from visual inspection in newborns with varying degree of jaundice
    


Intervention name(s): smartphone-based screening tool for neonatal jaundice
Intervention type(s): Device
Intervention description(s): In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors. .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety is known to be one of the most common health concerns in in the general population,
      and the most common mental health issue, and has been associated with several health
      consequences. Medications are known to be effective, and currently serve as the primary
      treatment for anxiety but comes with a risk of adverse effects. Cognitive Behavioral Therapy
      (CBT-1) has also been shown to be effective and safer in the treatment of anxiety but
      presents its own limitations such as the time, cost, and training required. The relationship
      between vestibular stimulation and anxiety continues to be explored, however its usefulness
      in the treatment of anxiety is still unknown. Vestibular stimulation itself has been shown to
      be safe across multiple populations. If vestibular stimulation is shown to be effective in
      the treatment of anxiety, it could serve as a safer alternative to medications. It could also
      require less cost, time, and training than CBT-1, providing a treatment option that is not
      only safe and effective, but broadly available to the general population. It also could
      present an alternative intervention for patients who are non-responsive or refuse medication.
      Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular
      nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham
      control, in patients newly diagnosed with anxiety.
    


Intervention name(s): VeNS
Intervention type(s): Device
Intervention description(s): The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment