bioihbjkbjnl/mcl2 huggingface dataset:
Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with
      severe itching. People who have atopic dermatitis often have complications from skin
      infections; these can include eczema herpeticum after herpes simplex virus infection or
      eczema vaccinatum after smallpox vaccination. People with atopic dermatitis may suffer from
      skin infections and may therefore respond differently to vaccinations.

      A new flu vaccine which is injected into the skin instead of into muscle has recently been
      approved by the Food and Drug Administration for vaccination of the general population
      including patients with atopic dermatitis. This new vaccine has been shown to work as well as
      the vaccine which is injected into muscle when tested in people without atopic dermatitis.
      The main purpose of this study is to compare how people with atopic dermatitis respond to
      this new flu vaccine compared to non-atopic volunteers without atopic dermatitis. The second
      purpose is to look at how people with atopic dermatitis respond to the new vaccine which is
      injected into the skin compared to the vaccine which is injected into muscle.
    


Intervention name(s): Fluzone® Intradermal Vaccine; Fluzone® (Intramuscular) vaccine
Intervention type(s): Biological; Biological
Intervention description(s): A 0.1mL single-dose, in a latex-free, pre-filled microinjection system with an ultra-fine micro-needle. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is approved for use in persons 18 through 64 years of age and will be purchased from Sanofi Pasteur, Inc.; A 0.5 mL single-dose delivered via syringe using single-dose vials. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® for intramuscular injection is approved for persons 6 months and older and will be purchased from Sanofi Pasteur, Inc.
Other intervention name(s): Influenza Virus Trivalent Vaccine (Types A and B) (Avian); Influenza Virus Vaccine, 2012-2013 Formula; Influenza Virus Trivalent Vaccine (Types A and B) (Avian); Influenza Virus Vaccine, 2012-2013 Formula
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza Vaccines; Dermatitis; Injections, Intradermal; Injections, Intramuscular; Skin Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic
Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass
Condition: Coronary Artery Disease; Cardiopulmonary Bypass; Coronary Artery Bypass Graft
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to
      several drugs, including propofol. Few studies, however, have tested if propofol
      pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic
      effect of propofol after CPB. This study was designed to test the hypothesis that changes in
      the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced
      by changes in bispectral index (BIS) values.

      Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1)
      CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood
      samples for plasma propofol concentration measurements will be collected along the surgery
      and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral
      index values and propofol PK will be compared between the groups.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Twenty patients undergoing elective coronary artery bypass graft surgery
      
Biospecimen description: 
      Blood samples
    
Keywords: Cardiopulmonary bypass; coronary artery bypass graft; coronary artery disease; propofol; pharmacokinetics; pharmacodynamics
Bioequivalence Study of Ciprofloxacin in Healthy Adult Subjects Under Fasting Condition
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence
      of two different immediate release products each containing Ciprofloxacin 750 mg, after
      administering a single oral dose, to healthy adult subjects under fasting conditions.
    

Detailed description: 
      Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive
      a single dose of the test product (T) or the reference product (R) at each phase, under
      fasting conditions, with a wash-out period of 7 days.

      Ciprofloxacin plasma concentrations were determined using a validated LC-MS-MS method,
      followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to
      determine the average bioequivalence.
    

Intervention name(s): Ciprofloxacin 750 mg; Ciproxin 750 mg
Intervention type(s): Drug; Drug
Intervention description(s): an immediate release film-coated tablet containing 750 mg Ciprofloxacin; an immediate release film-coated tablet containing 750 mg Ciprofloxacin
Other intervention name(s): Test product (T); Reference product (R)
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Bioequivalence; Randomized; Crossover; Ciprofloxacin
Acupuncture as Migraine Prophylaxis in Reducing Frequency, Duration and Intensity of Migraine With Minimum Acupoint, Seen up to Eight Weeks From Baseline
Condition: Migraine; Headache; Migraine Disorders
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with
      subjective manifestations both before and after the attack, a chronic type of headache with
      symptoms of recurrence, attacks at productive age and can cause a decrease in work
      productivity up to 80%, so that it will affect the quality of life, economic life and
      education globally which leads to losses for migraine sufferers and institutions where
      migraine sufferers attend school, work and in the lives of sufferers' families.
    

Detailed description: 
      Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with
      subjective manifestations both before and after the attack, a chronic type of headache with
      symptoms of recurrence, attacks at productive age and can cause a decrease in work
      productivity up to 80%, so that it will affect the quality of life, economic life and
      education globally which leads to losses for migraine sufferers and institutions where
      migraine sufferers attend school, work and in the lives of sufferers' families. With the high
      prevalence and disability rates for migraine sufferers, on the other hand, the right
      treatment for migraine has not yet been obtained to the maximum, it is necessary to deepen
      the treatment and prevention of migraine is needed, and until now there has been no
      definitive cure, both for prevention and treatment, so it is necessary to develop therapies
      that can provide more accurate relief for migraine sufferers. The purpose of this study is to
      assess the success in managing migraine in reducing the frequency of attacks, reducing the
      intensity of attacks and reducing the duration of attacks from weeks 0, 4 to 8
    

Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled trial with control was conducted on 34 subjects with migraine who were randomly allocated into the manual group of acupuncture (n = 17), as well as the medicine group (n = 17). The assessment of frequency, duration and intensity of migraine attacks assessed at the time before treatment, at the fourth and eight week from baseline
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: migraine; acupuncture; visual analogue scale; headache
Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients
Condition: Chronic Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different
      hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice.
    

Detailed description: 
      In Thailand, the studies that were conducted to find the most useful target Hb have not
      included the cost effectiveness and/or cost utility analyses. The level at which quality of
      life is maximized and risk is minimized would be the optimal target. Dialysis patients carry
      higher risk of death than general population. Anemia is the common complication found in
      dialysis patients that could lead to mortality. Risk of anemia is occurred in HD patients
      more than CAPD patients because blood loss is less marked and residual renal function maybe
      better preserved in patients who receive peritoneal dialysis.Although EPO has been included
      in the National List of Essential Drugs (NLED) for the treatment of anemia caused by end
      stage renal disease for maintaining the target hemoglobin but the cost of EPO is so
      expensive. Cost utility analysis is economic technique for assessing the efficiency of
      healthcare intervention measuring combined outcomes as the effectiveness, i.e., survival and
      quality of life in combination as quality adjusted life years (QALYs).This study is a benefit
      measure at the care giving level by using as a part of planning patient management program
      and at the policy level for decision making.
    

Intervention name(s): erythropoietin
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HD patients use EPO at least 6 months with titration of EPO therapy is permitted
      
Keywords: erythropoietin; hemodialysis; cost utility; incremental cost-effectiveness ratio; Quality adjusted life year; quality of life
Effects of Dexmedetomidine on the Postoperative Experience in Children
Condition: Failed Moderate Sedation During Procedure
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: The study aim was to compare the efficacy of dexmedetomidine versus midazolam for
      sedation during the early postoperative period in children who underwent scoliosis surgery.

      Methods: We performed a prospective, randomized trial in an intensive care unit (ICU) in a
      tertiary care center. In this study, 42 patients (American Society of Anesthesiology physical
      status I and II) who underwent scoliosis surgery were divided into 2 groups according to
      sedation protocols: group DEX (n = 22) and group MDZ (n = 20). Children (12-18 years)
      requiring mechanical ventilation underwent a continuous infusion of either dexmedetomidine
      (group DEX; starting dose, 0.4 μg•kg-1•h-1) or midazolam (group MDZ; starting dose, 0.1
      mg•kg-1•h-1) with intermittent fentanyl, as needed. The efficacy of sedation was assessed
      using the Richmond Agitation Sedation Scale (RASS). Quality of pain relief was measured using
      the Numeric Visual Analog Scale (NVAS). During the arousal assessment, delirium was
      determined in patients in the RASS range of -2 to +1 using the Confusion Assessment Method
      for the ICU (CAM-ICU). Fentanyl consumption, incidence of delirium, NVAS scores, and
      hemodynamics were recorded postoperatively at 2, 4, 6, and 24 h in the ICU.
    


Intervention name(s): dexmedetomidine; Midazolam; fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: scoliosis, sedation, children, fentanyl consumption, pain
Developmental Dyslexia and Functional Maturation of Auditory Cortex
Condition: Developmental Reading Disorder; Dyslexia
MeSH terms: Dyslexia
Study type: Observational

Summary: 
      Developmental dyslexia is a frequent learning disability. The aim of this study is to compare
      auditory evoked cortical responses to syllables and tones in developmental dyslexia and
      controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10
      years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different
      in developmental dyslexia and controls.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with developmental reading disorders from 8 to 25 jears. Control groupes with
        healthy people in de same age
Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures
Condition: Smoking, Cigarette
Study type: Interventional

Summary: 
      The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on
      smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant
      exposure, among a sample of recent QL treatment failures. We will randomly assign N=372
      smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine
      replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches
      and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur
      12-weeks post baseline.
    

Detailed description: 
      There remains a lack of prospective and controlled research on the behavioral, toxicological,
      and physiological effects of electronic cigarettes (ECs) to help the public health community
      come to a clear and accurate consensus on their risk-benefit. In order to successfully
      execute the proposed study, the investigators plan to recruit and enroll recent smoking
      cessation treatment failures from a state QL, which predominately serves priority populations
      (e.g., low socioeconomic status, high levels of mental health conditions). The proposed study
      will randomly assign smokers who were recent QL treatment failures to a) EC (JUUL 5%) or b)
      QL treatment as usual with combination nicotine replacement therapy control (NRT).
    

Intervention name(s): JUUL; Treatment As Usual
Intervention type(s): Device; Other
Intervention description(s): Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.; Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned to one of two conditions randomly.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: e-cigarettes; harm reduction; smoking behavior
Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding
      patterns (cycle control), general safety and acceptability of the nomegestrol
      acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged
      18-50 years.
    


Intervention name(s): NOMAC-E2; DRSP-EE
Intervention type(s): Drug; Drug
Intervention description(s): Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).; Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
Other intervention name(s): SCH900121; ORG10486-ORG2317; Yasmin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults
Condition: Airway Morbidity
Study type: Interventional

Summary: 
      Study will evaluate the I-gel airway device standard insertion technique versus
      interventional (modified jaw thurst) insertion technique in adult patients. The half of the
      patients will receive standard and other half will receive the modified jaw thrust insertion
      technique
    

Detailed description: 
      The I-gel is used to provide the oxygenation and ventilation in anaesthetised patients. The
      inventor suggested insertion technique is called standard technique.

      Standard I-gel insertion technique: I-gel insertion will be performed by firmly grasping the
      lubricated I-gel along the integral bite block site. I-gel cuff outlet will face towards the
      patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will
      be introduced into patient's mouth in a direction towards the hard palate. Then I-gel will be
      slide downwards and backwards along the hard palate with a continuous but gentle push until a
      definitive resistance is felt.

      Modified jaw thrust technique: I-gel insertion will be performed by firmly grasping the
      lubricated I-gel along the integral bite block. I-gel cuff outlet will face towards the
      patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will
      be introduced into patient's mouth in a direction towards the hard palate and it slides
      gently into the oropharynx. I-gel will be left in oral cavity and both hands will be used to
      thrust the jaw by lifting the angle of mandible with little fingers and other fingers to
      stabilize the jaw then both thumbs will used to apply the balance force towards the final
      I-gel placement position by looking at the integral bite block mark at incisor teeth level.
    

Intervention name(s): Supraglottic airway device (I-gel) insertion
Intervention type(s): Device
Intervention description(s): Modified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: airway management; I-gel; anaesthesia
Immunologic Response to FluMist vs. Flucelvax
Condition: Influenza, Human; Immune Response
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate immunologic response to different types of influenza
      vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized
      controlled trial (RCT), that will assess immune response in about 440 participants (about 220
      per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine
      given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza
      vaccine).
    

Detailed description: 
      This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity
      response in children/adolescents/young adults aged 4-21 years given one of two FDA approved
      and licensed influenza vaccines: FluMist (live attenuated influenza vaccine by nasal
      administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine). This
      study will enroll about 440 healthy participants, about 220 per vaccine arm. Participants
      will be randomized in blocks of 4 using a 1:1 allocation to receive either FluMist or
      Flucelvax. Blood work will be conducted on all participants at baseline prior to vaccine
      receipt and post-vaccination at Day 7 (range 6-9 days) and Day 28 (range 21-35 days). The
      primary objective of the study is to determine pre- and post-serologic responses to each
      vaccine type.
    

Intervention name(s): FluMist live attenuated influenza vaccine; Flucelvax inactivated influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.; Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
Condition: Relapsing-remitting Multiple Sclerosis; RRMS
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of
      multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI
      scans over a 24 week period in patients with relapsing-remitting multiple sclerosis
    


Intervention name(s): AIN457; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): infusion 10 mg/Kg; infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: relapsing-remitting multiple sclerosis; RRMS