bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients
Condition: Allergy to House Dust Mite; Allergic Asthma
MeSH terms: Dust Mite Allergy; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be conducted as a randomized, double-blind, placebo-controlled, single-center
      study in adult patients with mild controlled allergic asthma and house dust mite allergy.
    

Detailed description: 
      This study will consist of a screening phase, a treatment phase and a follow-up phase.

      Eligible subjects will undergo a bronchial allergen provocation (BAP) with mite allergen to
      assess the asthmatic response before and after treatment. Subjects will be randomized to two
      parallel treatment groups. Each subject will be treated weekly over 12 weeks either with test
      product or with the reference product (placebo).
    

Intervention name(s): Tregalizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): a monoclonal antibody designed for the treatment of allergic asthma indication; Matched Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild asthma; House Dust Mite; Allergy
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
Condition: Epilepsy; Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release
      tablets under fasting conditions.
    


Intervention name(s): Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA); Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age
Condition: Prevention of Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine
      Administered to Healthy Premature and Non Premature Children of 3 months of age
    


Intervention name(s): Meningococcal C Conjugate Vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Meningococcal Meningitis; meningococcal vaccines; conjugate; Immunology; infant
The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Recovery of the cognitive functions and recovery features after general anaesthesia in Down
      syndrome patients. A comparison of Sevoflurane and Desflurane.
    


Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: cognitive functions; anaesthesia recovery; sevoflurane; desflurane
Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy
Condition: Complication Following Ectopic Pregnancy
MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature
Study type: Observational

Summary: 
      The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and
      change in patient with ectopic pregnancy who needs to surgical treatment.

      Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be
      included in the study. This is an observational study.The plasma Vascular Endothelial Growth
      Factor level will be measured first day and two day after the diagnosis of ectopic pregnancy.
    

Detailed description: 
      This study is a prospective, observational, single-center study. Ethical approval was
      obtained from the Institutional Review Board. This study will be completed with 30 patients
      with ectopic pregnancy. An intervenous cannula will be centrifuged for 15 minutes at 1000 g
      within 30 minutes of collection. Aliquots of plasma will be added to eppendorf tubes and
      stored at -20°C.

      Plasma Vascular Endothelial Growth Factor levels will be measured using a Human VEGF-A
      Platinum ELISA kit (bioscience company, Catalog No: 00122, Santa Clara, California, USA). All
      assays will be performed according to the manufacturer's instructions. The test kit
      sensitivity is 2.5 pg/ml. Intracycle variability is %4-6, intercycle variability is %8-10.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients with ectopic pregnancy
      
Keywords: VEGF, ectopic pregnancy.
Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study is to test the effectiveness of integrating and adapting two National Institute on
      Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving
      low-income youth: 1)the Youth Risk Index (YRI) and Transmissible Liability Index-Parent
      (TLI-P) nurse and/or research assistant-administered screening tools for high risk of
      substance use (SU) prior to high school and thus also for SUD and 2) the Family Check-Up
      (FCU) - a brief, family-based program to prevent SU/SUD with replicated efficacy.
    

Detailed description: 
      This study is to test the effectiveness of integrating and adapting two National Institute on
      Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving
      low-income youth: 1) the Youth Risk Index (YRI) and Transmissible Liability Index (TLI-P)
      nurse and/or research assistant-administered screening tools for high risk of substance use
      (SU) prior to high school and thus also for SUD and 2) the Family Check-Up (FCU) - a brief,
      family-based program to prevent SU/SUD with replicated efficacy.

      The following three aims focus on evaluating and refining the adaptation of the YRI & TLI-P
      program for primary-care use: 1) to replicate the effectiveness of the YRI & TLI-P screening
      tool in terms of concurrent and predictive validity and the engagement rate in the FCU; 2) to
      identify and address challenges in implementing and integrating the YRI & TLI-P/FCU
      prevention strategy within a primary care clinic serving urban, low-income youth; and 3) to
      test the effectiveness of the YRI & TLI-P/FCU on emerging SU, sexual activity, and conduct
      problems, as well as the putative mediators of these outcomes including parenting and
      parental well-being.

      Based on prior FCU efficacy studies, 500 dyads of parents and their 9 years, 9 months to 13
      years, 11 months old children from low-income, ethnically diverse families will be recruited
      from two large primary care clinics in an urban community. The FCU will be delivered for two
      or three years to test impact of dosage. Participants will be followed-up one year after
      completing FCU to evaluate longitudinal outcomes of the Integrated YRI & TLI-P/FCU .
    

Intervention name(s): Family Check-Up
Intervention type(s): Behavioral
Intervention description(s): The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Substance Use
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
Condition: Sleep Initiation and Maintenance Disorders; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to find the optimal (best) doses of GW679769 that could be given daily
      to promote sleep onset and maintain sleep during the night without significant next-day
      thinking impairment and drowsiness in subjects with primary insomnia.
    


Intervention name(s): GW679769
Intervention type(s): Drug
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cognition; Polysomnography; Primary Insomnia; Electroencephalography; Sleep
A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
Condition: Cerebral Palsy
MeSH terms: Contracture; Cerebral Palsy
Study type: Interventional

Summary: 
      This study is looking at new ways to stretch knee contractures in children with cerebral
      palsy using a specially designed splint.
    

Detailed description: 
      When using active orthoses to treat contractures, is the effectiveness of treatment improved
      by heating the contracted tissue prior to treatment?
    

Intervention name(s): With heat; No heat
Intervention type(s): Device; Device
Intervention description(s): heat pad followed by dynamic splinting; No heat added to tissue prior to dynamic splinting
Other intervention name(s): heat pad followed by dynamic splinting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; dynamic splinting; contractures; heat therapy
The Antiplatelet and Immune Response Trial
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Platelets are the main type of blood cell involved in the formation of blood clots that cause
      heart attacks. The investigators give antiplatelet drugs (aspirin, for example) to reduce the
      risk of another clot forming in the future and causing another heart attack. Platelets are
      known to have a role in inflammation and infection as well as clotting. In a recent large
      clinical trial, known as the PLATO study, it was also shown that patients treated with a new
      antiplatelet medication (ticagrelor) developed fewer lung infections, as well as fewer heart
      attacks, compared to the current standard treatment (clopidogrel). The investigators would
      therefore like to investigate the reasons behind this and look at the effect of these
      medications on immune response. This may help us develop new drugs that have a better effect
      on immune response. The investigators are planning a clinical trial that investigates the
      effect of these medications on the immune response of healthy volunteers aged 18 to 65.

      Only volunteers with no significant past medical history and not taking any medications will
      be included.

      Thirty volunteers will receive either a normal dose of ticagrelor or clopidogrel or no
      antiplatelet medication for 1 week.

      They will then attend the Sheffield Clinical Research Facility where their immune response
      will be stimulated using a safe, well established method. The investigators will do this with
      an injection of a low dose of endotoxin, which is part of the surface coating of some
      bacteria and has been used extensively in similar studies, in over a thousand volunteers over
      the past 20 years to investigate immune response. It is known to cause temporary flu-like
      symptoms that last approximately 68 hours. The investigators will take measurements of
      inflammatory markers, white blood cell function and platelet function and compare the effect
      of ticagrelor and clopidogrel on this immune response.
    


Intervention name(s): Endotoxin; Clopidogrel; Ticagrelor
Intervention type(s): Biological; Drug; Drug
Intervention description(s): E.coli Endotoxin Day 7 - 2 ng/kg; Clopidogrel (tablet) over 8 days Day 1: 300 mg loading dose Day 2-7: 75 mg orally once daily; Ticagrelor over 8 days (tablet) Day 1: 180 mg loading dose Day 2-7: 90 mg orally twice daily
Other intervention name(s): E.coli Endotoxin; Brilique
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Immune system processes
CKD Report Card Pilot Trial
Condition: CKD
Study type: Interventional

Summary: 
      The investigators will study physician-patient communication at the UCMC nephrology fellow
      clinic and to test an intervention, the CKD Report Card, to improve that communication and
      patient knowledge of CKD.
    

Detailed description: 
      The goals of the study are to 1) characterize the effectiveness and patient-centeredness of
      patient-physician interaction during a nephrology clinic visit both with and without use of
      the CKD Report Card, and 2) to determine which physician and patient characteristics are
      associated with effective and patient centered communication. There will be block enrollment.
      For Nephrology physicians who agreed to participate will complete a baseline questionnaire.
      Research assistants will approach patients of participating providers in clinic waiting
      rooms, with the goal of enrolling patients for each provider For half of the study,
      investigators will enroll patients in the study and observe patient-physician communication
      and use a survey measure CKD knowledge pre-visit and post-visit. For the second half of the
      study, investigators will give participants the CKD Report Card, an investigator-developed
      handout, to use during the clinic visit. Investigators will observe patient-physician
      communication and use a survey to measure CKD knowledge pre-visit and post-visit. For both
      groups, eligible participants will give informed consent and will complete a baseline
      questionnaire; research assistants will place a digital audio-recording device in the
      examination room to record the patient-provider encounter. Following the medical encounter,
      research assistants will administered an interview with patients, assessing demographic,
      social, and behavioral characteristics, as well as their experience of care and ratings of
      provider communication.
    

Intervention name(s): CKD Report Card
Intervention type(s): Behavioral
Intervention description(s): The CKD Report Card is a handout based on a NKDEP Educational Sheet that includes basic information about kidney disease and spaces where patient can record information about their own kidney disease
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: During the first half of the study, participants will be surveyed and observed without the intervention. During the second half, participants will be surveyed and observed with the intervention (CKD Report Card)
Masking: None (Open Label)
Primary purpose: Health Services Research
A Tolerability Assessment Study of Three Wash Products in Infants
Condition: Skin Care
Study type: Interventional

Summary: 
      This will be a single centre, evaluator blind, randomized, parallel group, stratified, two
      week study in healthy participants. The clinical study is designed to provide reassurance
      that the formulations developed for children and babies with mild to moderately dry skin and
      for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the
      target population, babies and young children with dry skin.
    


Intervention name(s): Test shampoo; Test bath foam; Test head to toe wash
Intervention type(s): Other; Other; Other
Intervention description(s): Participants used Oilatum Soothe & Protect Shampoo at home in place of their usual wash product at least twice weekly for a two week period.; Participants used Oilatum Soothe & Protect Bath Foam at home in place of their usual wash product at least twice weekly for a two week period.; Participants used Oilatum Soothe & Protect Head to Toe Wash at home in place of their usual wash product at least twice weekly for a two week period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Effect of Stimulant Drugs on Social Perception
Condition: Healthy; MDMA ('Ecstasy')
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will improve our understanding of the "prosocial" effects of ±
      3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant,
      methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of
      MDMA.
    


Intervention name(s): 3,4-Methylenedioxymethamphetamine; methamphetamine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given 0.75mg/kg of 1.5mg/kg MDMA; Please see above.
Intervention MeSH terms: Methamphetamine; N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine
      administered at 2 different time points. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): Pandemic influenza vaccine (GSK1119711A)-formulation 1; Pandemic influenza vaccine (GSK1119711A)-formulation 2
Intervention type(s): Biological; Biological
Intervention description(s): 2 or 3 doses, intramuscular injection, at different time points.; 2 or 3 doses, intramuscular injection, at different time points.
Other intervention name(s): VT strain; IN strain
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pandemic Flu; Pandemic influenza vaccine (GSK1119711A)
A Drug-Drug Interaction Study of Omeprazole and PA21
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if Omeprazole is affected by PA21.
    


Intervention name(s): PA21 and Omeprazole with food; No PA21; Omeprazole with food; PA21 with food, Omeprazole 2hrs later
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day; The maximum dosage of Omeprazole will be 40 mg/day; The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction; Pharmacokinetics; PA21; Drug Interaction Potentiation
Effects of Treatment of Sleep Apnea on Metabolic Syndrome
Condition: Impaired Glucose Tolerance; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators performed a randomized, cross-over controlled clinical trial comparing 8
      weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with
      moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A
      rigorous assessment of metabolic responses to SDB treatment in this group is of great
      clinical significance because this sample is at high risk for developing diabetes. The
      paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of
      both primary care and sleep medicine.
    

Detailed description: 
      There are few controlled studies that address whether treatment of sleep apnea improves
      glucose tolerance. This is a randomized, double-blind cross-over study of subjects with sleep
      apnea (apnea hypopnea index > 15) and impaired glucose tolerance. Subjects will be randomized
      to 8 weeks of Continuous Positive Airway Pressure (CPAP) or sham-CPAP, followed by the
      alternate therapy after a one month wash-out. After each treatment, subjects will undergo
      2-hour oral glucose tolerance testing, polysomnography, actigraphy, and measurements of
      indices of glucose control. The investigators intend to analyze the changes in glucose
      metabolism and insulin sensitivity in patients with sleep apnea with CPAP intervention.
    

Intervention name(s): Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP); Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)
Intervention type(s): Device; Device
Intervention description(s): Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.; Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
Other intervention name(s): Philips-Respironics RemStar Pro® CPAP; Philips-Respironics Sham CPAP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess Benign Joint Hypermobility Syndrome in Children With a History of Wheezing or Asthma
Condition: Benign Joint Hypermobility Syndrome; Wheezing; Asthma
MeSH terms: Joint Instability; Asthma; Syndrome; Respiratory Sounds
Study type: Observational

Summary: 
      The purpose of this study is to assess benign joint hypermobility syndrome (BJHS) in children
      with a history of wheezing or asthma. BJHS is a common syndrome of joint and connective
      tissue laxity without any other rheumatologic disease. This assessment will be performed by
      using either method below depending upon if the child has a history of wheezing or severe
      asthma:

        1. Determine the correlation, if there is an increased rate of BJHS in children with a
           history of wheezing as well as if there is an increased history of wheezing in children
           with BJHS; or

        2. Determine asthma control, lung function and asthma exacerbations (a flare up or acute
           worsening of symptoms) in children with BJHS compared to children with asthma without
           BJHS, to assess if it BJHS is associated more with children with severe asthma.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children ages 6-16 in Primary Care Clinic and Pediatric Subspecialty Clinics of Pulmonary
        and Allergy/Immunology.