bioihbjkbjnl/mcl2 huggingface dataset:
Acute Effect of Salbutamol on Heart Rate and Blood Pressure During Exercise in Patients With Moderate or Severe Asthma and Healthy Subjects
Condition: Asthma; Heart Rate Fast
MeSH terms: Asthma; Tachycardia
Study type: Interventional
Phase: Phase 4

Summary: 
      Contextualization: Exercise is a common triggers of bronchospasm in patients with asthma and
      healthy subjects. To prevent these symptoms frequently they have to use Short-Acting
      Beta2-Agonists. However, the cardiovascular effects of salbutamol during and after exercise
      remain poorly known.

      Objective: To evaluate the effect of salbutamol on heart rate and blood pressure during
      exercise in patients with moderate or severe asthma and healthy individuals.

      Methods: A randomized, double-blind, crossover study will be conducted which 13 individuals
      with moderate or severe persistent asthma and 13 healthy individuals aged between 20 to 59
      years.

      Patients will perform a maximal effort test on 2 nonconsecutive days, with either 400mcg
      Salbutamol or 4 placebo puffs. The order of use of placebo or salbutamol will be drawn.
      During the protocol, heart rate, blood pressure, perception of exertion and peak expiratory
      flow will be monitored.
    


Intervention name(s): salbutamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Salbutamol or albuterol is a short-acting β2 adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease.; Neutral preparation for pharmacological effects, given in substitution of a medicine, for the purpose of provoking or controlling reactions, ger. Of a psychological nature, accompanying such a therapeutic procedure.
Other intervention name(s): Albuterol; Falso
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Clinical trial, controlled, double-blind and crossover
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Asthma; Salbutamol; Exercise; Heart Rate; Blood pressure
The Feasibility of Pertussis Immunization in a Canadian Emergency Department
Condition: Pertussis
MeSH terms: Whooping Cough; Emergencies
Study type: Interventional

Summary: 
      Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine to
      patients presenting to the emergency department. Rates of vaccination as well as effects on
      department efficiency will be measured.
    

Detailed description: 
      This study is a prospective randomized, controlled trial of two strategies to provide
      patients with the pertussis vaccine. Eligible adult patients with be offered pertussis
      vaccination in the Emergency Department vs. a referral to Public Health for pertussis
      vaccination. The effect of both strategies on triage time as well as measure of emergency
      department efficiency including length of stay, time to physician and left without being seen
      rates will be compared. At a four-month follow up, rates of pertussis vaccination will be
      measured.
    

Intervention name(s): Tdap
Intervention type(s): Behavioral
Intervention description(s): Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine
Other intervention name(s): Boostrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pertussis; Vaccination; Emergency Department
Early External Cephalic Version (ECV) 2 Trial
Condition: Breech Presentation
MeSH terms: Breech Presentation
Study type: Interventional

Summary: 
      For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and
      6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the
      likelihood of cesarean section (CS)?
    

Detailed description: 
      Primary Outcomes: Rate of Caesarean section

      Secondary Outcomes: Rate of preterm birth

      Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal
      mortality or serious neonatal morbidity, serious fetal complications, maternal death or
      serious maternal morbidity, non-cephalic presentation at birth, women's views, and health
      care costs.

      The Data Coordination for this study is being carried out at the Maternal, Infant
      Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.
    

Intervention name(s): Early ECV between 34 0/7 and 35 6/7 weeks; Delayed ECV at or after 37 0/7 weeks
Intervention type(s): Procedure; Procedure
Intervention description(s): Early external cephalic version between 34 0/7 and 35 6/7 weeks of gestation; Delayed external cephalic version at or after 37 0/7 weeks of gestation
Other intervention name(s): Early External Cephalic Version (ECV); Delayed External Cephalic Version (ECV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: External cephalic version; Cesarean section; pregnancy; labour; Breech pregnancy
Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis
Condition: Pertussis; Tetanus; Diphtheria; Poliomyelitis; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective:

        -  To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed
           combined with component pertussis and inactivated poliomyelitis vaccine grown on vero
           cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with
           component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV)
           and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age.

      Secondary objective:

        -  To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at
           11-14 years of age results in detectable immunologic interactions between components of
           the two vaccines.
    

Detailed description: 
      Participants will be randomized into one of 2 groups to receive either a dose of the TdcP-IPV
      on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group 1); or no
      vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B vaccine on Day
      28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2).

      All participants will be followed up for immunogenicity and safety
    

Intervention name(s): Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV; Hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 ml, Intramuscular
Other intervention name(s): TdcP-IPV; Recombivax HB®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis; Tetanus; Diphtheria; Poliomyelitis; Hepatitis B; Acellular Pertussis Vaccines
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects
      of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or
      intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects
      through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of
      serum levels of G-CSF and absolute neutrophil count - ANC).
    


Intervention name(s): Filgrastim; Filgrastim; Filgrastim; Filgrastim
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): filgrastim, single dose, s.c., dosage: 5 mcg/kg; filgrastim, single dose, s.c., dosage: 10 mcg/kg; Filgrastim, i.v., single dose, dosage: 5 mcg/kg; Filgrastim, i.v., single dose, dosage: 10 mcg/kg
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"Novo C Plus" Vitamin C Containing Dietary Supplement Bioavailability in Healthy Subjects
Condition: Vitamin C Deficiency
MeSH terms: Scurvy; Ascorbic Acid Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C
      containing dietary supplement compared to licensed vitamin C medications. The novelty of this
      product is the liposomal formulation.
    


Intervention name(s): Ascorbic Acid
Intervention type(s): Drug
Intervention description(s): Ascorbic acid in different ways and doses
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitamin C supplementation
Advancing Community Level Action for Improving MCH/PMTCT
Condition: HIV
Study type: Interventional

Summary: 
      The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is
      to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH)
      and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country
      progress toward elimination of pediatric HIV/AIDS.
    

Detailed description: 
      This study will undertake a three-arm randomized trial in Swaziland, Uganda and Zimbabwe.
      Districts/regions (n=9) with 45 PMTCT-implementing health facilities and their catchment
      areas (populations 7300-27500), will be randomly allocated to three intervention arms: 1)
      community leader engagement, 2) community leader engagement with community days, or 3)
      community leader engagement with community days and male and female community peer groups.
      The primary study outcome is HIV exposed infants (HEI) returning to the health facility
      within two months for early infant diagnosis (EID) of HIV. Secondary study outcomes include:
      gestational age of women attending for first antenatal care, male partners tested for HIV,
      and HEI receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes,
      practices and beliefs on MCH/PMTCT will be assessed through household surveys.
    

Intervention name(s): Community leader engagement; Community days; Community Peer Groups
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH; The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day; Pregnant women in community peer groups receiving information and education on PMTCT/MCH through 4 weekly peer-led classes . Men in community peer groups receiving information and education on their role in supporting women and families through 4 peer-led education sessions.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV; AIDS; PMTCT
Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy
Condition: Pain During Hysteroscopy
Study type: Interventional

Summary: 
      Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables
      the doctor to do minor operative procedures. Although it causes little discomfort, sometimes
      it may be disturbing for the patient. This pain is usually perceived during the passage of
      the instrument through the cervix (neck of the womb). The investigators would like to
      minimize this pain by two drugs: Misoprotol and lidocaine
    

Detailed description: 
      Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the
      intrauterine abnormalities. This minimal invasive modality provides brilliant and clear
      visualization of the entire uterine cavity and besides this, by the operative channel, minor
      procedures may easily be performed in the office setting which is priceless for the
      gynecologist. However, pain related to the procedure may make the procedure uncomfortable for
      the patient and the physician. Together with the operative time, hysteroscope diameter is
      considered as the main factor influencing pain. The pain perceived during hysteroscopy may be
      reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain
      perception.

      In this prospective, randomized, double blind, placebo controlled study, we aim to compare
      the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief
      during office hysteroscopy.
    

Intervention name(s): Sublingual Misoprostol; Lidocaine pump spray; Placebo (for Misoprostol); Placebo (for Lidocaine)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lactose filler, the pharmacy-produced pills identical to original misoprostol pill; The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray
Other intervention name(s): Cytotec; Xylocaine %10 pump spray
Intervention MeSH terms: Lidocaine; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hysteroscopy; Misoprostol; Lidocaine; Visual analogue score
Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2
Condition: Visual Acuity
MeSH terms: Seizures
Study type: Interventional

Summary: 
      This study is a single arm, non-randomized, open label, bilateral, non- dispensing clinical
      trial with only one visit. The Eye Care Providers will be provided with a fitting guide and
      will determine the initial study lens selection. Each subject will wear either the
      investigational contact lenses or marketed contact lenses for approximately 30-90 minutes.
      This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal
      lens and also their success in fitting the lenses.
    


Intervention name(s): JJVC Fitting Guides
Intervention type(s): Device
Intervention description(s): Subjects who are habitual soft spherical or toric contact lens wearers, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guide, with either the Multifocal Contact Lens or an Investigational Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes during a 1 day visit.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: While this study utilizes two contact lenses, the purpose was to evaluate the JJVC fitting guide. This was a non-randomized study in which eye care practitioners used the JJVC fitting guide to fit subjects with a study contact lens. Subjects may fit either in a bilateral or a contralateral fashion.
Masking: None (Open Label)
Primary purpose: Treatment
A Worldwide Survey on the Understanding of Psoriatic Disease Among Patients With Psoriasis and Psoriatic Arthritis
Condition: Plaque Psoriasis, Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Study type: Observational

Summary: 
      The study is a Worldwide Survey on the Understanding of Psoriatic Disease among Patients with
      Psoriasis and Psoriatic Arthritis.
    

Detailed description: 
      This is a cross-sectional, quantitative online survey of patients with psoriasis with or
      without concomitant psoriatic arthritis. Following assessment of participant eligibility via
      a 5-minute online screener, the 25-minute internet-based survey will be conducted without any
      follow-up.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of adults with self-reported Psoriasis and/or Psoriatic
        Arthritis. Screening questions will be used to determine the eligibility for each
        respondent to the survey.
Universal HIV Screening and Targeted HCV Screening in Emergency Department
Condition: Hepatitis C; Hiv
MeSH terms: Hepatitis C; Emergencies
Study type: Interventional

Summary: 
      Cross-sectional study of patients consulting in the emergency room of the Centre hospitalier
      de l'Université de Montréal (CHUM), to assess the implementation of an "opt-out" screening
      program for HIV and HCV and prospective follow-up for 3 months of positive cases.
    

Detailed description: 
      The purpose of this study is to evaluate the feasibility of routine HIV and HCV screening
      using an "opt-out" approach at the emergency room of the CHUM and to determine the rate of
      new positive HIV and HCV cases. A sub-analysis will focus more specifically on HCV in the
      Quebec equivalent of "baby boomers" (1945-1975) since this is the group that was targeted in
      the United States. The second phase of this study will evaluate the effectiveness of the
      linkage to the healthcare system for people diagnosed with HIV or HCV and how fast these
      people are taken care of and put on treatment.
    

Intervention name(s): HIV and HCV screening
Intervention type(s): Diagnostic Test
Intervention description(s): HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Screening; Linkage to care
Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the
      treatment of psoriasis.After single asending dose and mutiple asending dose in health
      subjects. And the patients with moderate to severe plaque psoriasis will be randomized into 4
      cohorts(15mg, 30mg, 60mg and placebo) approximately 216 subjects will be enrolled (52 for
      each cohort ). This study includes an 16-week treatment Period, then a 36-week Treatment
      Period without placebo.
    


Intervention name(s): 15mg Hemay005; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Hemay005 is a small molecule PDE4 inhibitor.; Placebos are the same as drugs, but contain no Hemay005.
Other intervention name(s): No other intervention name.; No other intervention name.
Intervention MeSH terms: Hemay005
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis; PDE4
Remifentanil and Stress Hormones Response
Condition: Stress Response
Study type: Interventional

Summary: 
      Perioperative adequate analgesia reduces neuroendocrine stress response and postoperative
      complications. Because opioids are the most effective parenteral drugs to control pain and
      stress response, in this prospective randomized double-blinded controlled study we supposed
      that higher dose of remifentanil may reduce stress marker variations compared to lower dose
      in patients undergoing laparoscopic cholecystectomy.
    

Detailed description: 
      Fifty Caucasian patients, aged 20-70 years, with American Society of Anesthesiologist
      physical status I-II, undergoing laparoscopic cholecystectomy were enrolled. Exclusion
      criteria were: patient refusal, thyroid disorders, diabetes mellitus, BMI > 30, use of
      corticosteroids, benzodiazepines or antipsychotics drugs. No patient received premedication.
      Before entering the operating room, venous access was established (18 G in the antecubital
      vein) where the first blood sample (Time 0) was collected to measure adrenocorticotropic
      hormone (ACTH), Cortisol, Growth hormone (GH) and prolactin (PRL) levels. Then a second
      venous access was established (18 G on the other arm) to start a fluid infusion (normal
      saline to replace half of the water deficit from preoperative fasting followed by a
      maintenance infusion of 2 ml/kg/h). Heart Rate (HR), Non Invasive Blood Pressure (NIBP),
      Bispectral Index (BIS), End-tidal CO2 (EtCO2) were recorded every 5 minutes. Patients were
      randomly assigned to receive two different dosages of remifentanil: 0,15 mcg/kg/min (group A)
      and 0,30 mcg/kg/min (group B) for the induction and the maintenance of anesthesia, using a
      computer generated randomization table (Table I). Anesthesia was induced with propofol 2
      mg/kg, cisatracurium 0,15 mg/kg and remifentanil infusion of 0,15 mcg/Kg/min (Group A) or 0,3
      mcg/Kg/min (Group B) was started. Anesthesia was maintained with desflurane at a variable
      concentration in order to maintain the BIS between 40 and 60. The second blood sample was
      collected at the trocar insertion (Time 1), and the third sample one hour after the end of
      the surgery (Time 2). Postoperative analgesia was standardized using intravenous
      acetaminophen 1 g and morphine 0,1 mg/kg 30 minutes before the end of the surgery. Rescue
      analgesia in Recovery Room was provided by intravenous tramadol 1 mg/Kg.
    

Intervention name(s): Remifentanil Injectable Product
Intervention type(s): Drug
Intervention description(s): remifentanil: 0,15 mcg/kg/min
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate whether administration of bimekizumab has an effect
      on the expected production of antibody titers to the influenza vaccine.
    


Intervention name(s): Bimekizumab
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.
Other intervention name(s): BKZ; UCB4940
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: BKZ; UCB4940; Healthy Subjects