bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18
      months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in
      the primary study. The study will also assess the immunogenicity and reactogenicity of a
      booster dose of IPV in subjects primed with three doses of IPV.
    

Detailed description: 
      All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine
      (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care
      and will not be associated with any study endpoint.
    

Intervention name(s): PoliorixTM; Infanrix+Hib
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, intramuscular administration; Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IPV; PoliorixTM; China
Prevalence and Progression of Periodontitis in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis; Periodontitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Periodontitis
Study type: Observational

Summary: 
      1. Our hypotheses on the relationship between periodontitis and AS are as follows;

             -  The prevalence of periodontitis is higher in AS patients group than that of non-AS
                control group

             -  Anti-TNF-α therapy would favorably affect the disease course of periodontitis.

        2. Based on our hypotheses, the specific objectives of the present proposal are as follows;

             -  The primary objective is to compare the prevalence rate of periodontitis between AS
                patient group and non-AS group.

             -  The secondary objectives will be:

                  -  To observe the carriage rate of P. gingivalis in AS and non-AS groups

                  -  To identify clinical parameters associated with the severity of periodontitis
                     in AS group.

                  -  To compare the progression of periodontitis at weeks 12 and 24 between AS and
                     non-AS groups or between AS patients with and without anti-TNF-α treatment
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        1. AS group will consist of patients aged 18 years or more who meet the 1984 modified New
             York criteria for AS.

             i. AS group receiving anti-TNF-α agents will consists of AS patients who have received
             adalimumab, etanercept, or infliximab before enrollment (or begin anti-TNF-α agents at
             enrollment) and keep anti-TNF-α agents for 3 months or more after enrollment.

             ii. AS group not receiving anti-TNF-α agents will consists of AS patients who are
             treated with a non-steroidal anti-inflammatory drug, sulfasalazine, or
             non-pharmacological therapy and keep non-anti-TNF-α therapy for 3 months or more after
             enrollment.

          2. Control group will consist of age- (± 3 years) and gender-matched volunteers who do
             not have inflammatory arthropathy.
The Association Between Blood Eosinophilsp in Thai COPD Patients: A Prospective Study
Condition: Copd
Study type: Observational

Summary: 
      The association of blood eosinophil as a biomarker for eosinophilic Thai COPD patients, such
      as COPD exacerbation, hospital admission, lung functions and mortlity.
    

Detailed description: 
      The prospective one year study in Thai COPD patients for the clinical outcomes of COPD
      compare between eosinophilic and non-eosinophilic which determine by blood eosinophil counts
      equal or more than 300 cells/microliters. The primary outcomes was COPD exacerbation, the
      secondary outcomes were lung function, dyspnea and quality of life.
    

Intervention name(s): observatory
Intervention type(s): Other
Intervention description(s): observation for 1 year period
Other intervention name(s): clinical outcomes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thai COPD patients in out-patient department
Targeted Therapy of Bronchiolitis Obliterans Syndrome
Condition: Bronchiolitis Obliterans
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well giving fluticasone propionate, azithromycin, and
      montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans
      who previously underwent stem cell transplant. FAM may be an effective treatment for
      bronchiolitis obliterans
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine if the combination treatment of FAM administered in post hematopoietic cell
      transplantation (HCT) recipients after the diagnosis of new onset bronchiolitis obliterans
      syndrome (BOS) can decrease the rate of treatment failure relative to an estimated historical
      rate of 40% using current therapies.

      SECONDARY OBJECTIVES:

      I. To confirm the safety profile of FAM.

      II. To describe the effect on other standard pulmonary function test parameters: forced
      expiratory flow at 25%-75% of forced vital capacity (FVC) (FEF25-75), residual volume (RV),
      diffusion capacity of carbon monoxide (DLCO), forced expiratory volume in 1 second (FEV1)/FVC
      ratio and FEV1/slow vital capacity (SVC) ratio with FAM treatment.

      III. To determine the change in molecular markers of inflammation and fibrosis in the blood
      with FAM treatment.

      IV. To assess the impact of FAM on other chronic graft-versus-host disease (GVHD)
      manifestations.

      V. To assess the impact of FAM on functional status, and health-related quality of life
      (HRQOL).

      VI. To describe changes in steroid dosing.

      OUTLINE:

      Patients receive fluticasone propionate inhaled orally (PO) twice daily (BID), azithromycin
      PO 3 days a week, and montelukast sodium PO once daily (QD). Treatment continues for 6 months
      in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 6 months.
    

Intervention name(s): fluticasone propionate; montelukast sodium; azithromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Given inhaled PO; Given PO; Given PO
Other intervention name(s): Flonase; Flovent; Singulair; AzaSite; CP 62993; XZ-450
Intervention MeSH terms: Fluticasone; Xhance; Azithromycin; Montelukast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Evaluation of Ten Allergy Skin Prick Test Devices
Condition: Allergic Rhinitis; Asthma; Food Allergy; Skin Testing
MeSH terms: Rhinitis; Rhinitis, Allergic; Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      The goal of this study is to compare ten current and readily available FDA approved allergy
      skin prick devices to determine the most sensitive and specific product and methods used for
      the diagnosis of allergic disease. The primary outcome will be to determine the analytical
      sensitivity and specificity of all ten skin prick devices by measuring wheal and flare
      response to histamine and control diluent in 1mm increments. Secondary outcomes include
      comparison of skin prick technique, optimum histamine concentration, patient comfort,
      reproducibility, and the comparability of high-resolution digital images.
    


Intervention name(s): Histamine skin testing
Intervention type(s): Device
Intervention description(s): skin testing using histamine
Other intervention name(s): skin test device; skin prick test device
Intervention MeSH terms: Histamine
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: allergic; rhinitis; allergy; asthma; food allergy; skin testing; skin prick test
PRObiotic and Stress-related PERmeability
Condition: Permeability; Increased
Study type: Interventional

Summary: 
      This is a single-site exploratory study aiming to demonstrate the effect of a fresh fermented
      dairy drink containing a probiotic strain on stress-related intestinal hyperpermeability in
      students defending a bachelor's or master's thesis in front of a jury at the University of
      Leuven (Belgium).
    

Detailed description: 
      The study is conceived as a single-site exploratory study with a randomized, controlled,
      parallel group design. There will be a double blind with 2 intervention arms (Test product
      with probiotic and acidified milk Control) plus an extra open label arm without intervention
      in a 2:2:1 ratio. The goal of the open-label arm is to confirm our previous data on the
      effect of stress on small intestinal permeability (see reference), without powering the study
      to detect a significant difference within this open-label arm. The participants and the
      investigators are blinded to the allocation to the probiotic vs. acidified milk control arm.
      However, there is no blinding in the arm without intervention.

      In vivo intestinal permeability and salivary markers of psychological stress and activation
      of the autonomous nervous system will be measured and questionnaires will be completed at 4
      different test days: baseline (V2), two weeks after randomization (V3), during an oral
      defense of a master's or bachelor's thesis (V4) and finally after pretreatment with
      Indomethacin (V5).

      The 5 study visits are organized around the thesis defence (D0):

      V1 (screening + inclusion) takes place within 2 to 3 weeks prior to the randomization.

      V2 (baseline + randomization) will take place between D-35 to D-27. V3 (randomization + 2
      weeks) will take place at D-14 +/-1day. V4 (thesis defense) is D0 and organized by the
      University. V5 (Indomethacin) will take place at D+14 +/-1day.

      For subjects in the intervention arm (Test product with probiotic and acidified milk
      Control), products will be supplied (for 1 week). In addition, alternate product supply will
      take place at D-21, D-7 and D+7 (each one +/-1day).
    

Intervention name(s): Fresh fermented dairy drink containing probiotic strain; Acidified dairy drink without ferment
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks.; Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-site exploratory randomized, controlled interventional trial with a parallel group design: double blind with Test and Control arm + open label arm without intervention.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: probiotic; permeability; stress
Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling
Condition: Hypogonadotropic Hypogonadism; Healthy Postmenopausal Women; Agonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators are looking for subjects to complete a study on the role of kisspeptin in
      the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the
      body to produce other reproductive hormones. However, giving someone a continued amount of
      kisspeptin over a period of time can have the opposite effect and tell the body to, for a
      short time, stop making hormones needed for reproduction. By giving 24-hour infusions of
      kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way
      bodies function normally and the role it has in conditions that affect the reproductive
      system.
    

Detailed description: 
      Please contact study staff for a detailed description.
    

Intervention name(s): kisspeptin 112-121; GnRH
Intervention type(s): Drug; Drug
Intervention description(s): 24-h continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg); Single intravenous dose of GnRH (2.5-250 ng/kg)
Other intervention name(s): metastin 45-54; gonadotropin-releasing hormone
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Esmolol on Pain Due to Rocuronium
Condition: Injection Site Irritation
Study type: Interventional
Phase: Phase 4

Summary: 
      90 American society of anesthesiology (ASA) physical status I and II patients undergoing
      general anesthesia for elective surgery will be included in the study. Patients will be
      randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (0.5
      mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After
      intravenous induction with propofol, adequate muscle relaxation for intubation will be
      received by 0.5 mg/kg rocuronium.
    

Detailed description: 
      Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if
      they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the
      hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After
      the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain
      response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d)
      generalized pain response.
    

Intervention name(s): Lidocaine; Esmolol; rocuronium; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).; Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg); 0.05 mg/kg rocuronium; Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)
Other intervention name(s): Aritmal, Jetmonal; brevibloc
Intervention MeSH terms: Lidocaine; Rocuronium; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: esmolol, injection pain, lidocaine, rocuronium
Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy
Condition: Cholecystitis; Choledocholithiasis
MeSH terms: Cholecystitis; Choledocholithiasis
Study type: Interventional

Summary: 
      We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced
      haemodynamic variability during insertion compared to the tracheal tube, whilst still
      maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected
      patients.
    

Detailed description: 
      The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent
      airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the
      tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic
      disturbance during insertion.
    

Intervention name(s): Laryngeal Mask Airway-Supreme; Endotracheal Tube
Intervention type(s): Device; Device
Intervention description(s): Patients who receive the LMA-S; Patients who receive endotracheal intubation
Other intervention name(s): LMA-S; LMA-Supreme; LMA Supreme; ETT; Tracheal Tube
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, single-dose study to evaluate the safety,
      pharmacokinetics in healthy subjects
    

Detailed description: 
      This is a phase I, open-label, single-dose in healthy subjects conducted at single center.The
      objectives are to evaluate the metabolic and safety profile of EXPAREL®. Each volunteer will
      receive one dose of the investigational drug via subcutaneous injection at multiple points
      during the study period. Study duration is around 54 days, including screening, confinement,
      ambulatory visit and a phone follow up.
    

Intervention name(s): Bupivacaine liposome injectable suspension
Intervention type(s): Drug
Intervention description(s): Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL
Other intervention name(s): EXPAREL®
Intervention MeSH terms: Bupivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy
Condition: Brain Neoplasms
MeSH terms: Brain Neoplasms; Pain, Postoperative
Study type: Interventional

Summary: 
      Vitamin D is a hormone mainly synthesized in the skin in the presence of sunlight. Like other
      hormones, vitamin D plays a role in a wide range of processes in the body. Some studies have
      shown vitamin D has anti-inflammatory effects in the body by reducing the release of
      pro-inflammatory cytokines and suppressing T-cell responses. Therefore, vitamin D may be
      effective on reduce pain by such mechanisms. In this trial patients with brain tumor under
      craniotomy will receive a single high dose vitamin D compared to the control group.
    

Detailed description: 
      A randomized, double blind, controlled trial will be conducted in intensive care unit (ICU)
      and neurosurgery ward, in Shohada-E-Tajrish hospital,Tehran, Iran. First, patients will be
      carefully checked for inclusion and exclusion criteria. Then, the eligible patients will
      complete the consent form for this study. 60 eligible brain tumor patients diagnosed by
      surgeon that are ready for craniotomy will be selected.These patients will be divided into
      two groups. Intervention group will be received an intramuscular (IM) single dose of vitamin
      D (300000 IU),while another group will not receive. Pain in patients will be checked daily by
      up to 3 days after surgery. Finally, the VAS pain score will be compared in both groups.
    

Intervention name(s): vitamin D
Intervention type(s): Drug
Intervention description(s): Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Somatosensory Responses During Millimeter Waves Application
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The brain activity induced by a sensory stimulus and measured by magnetoencephalography will
      be compared before and after exposure to millimeter waves. We hypothesize that brain activity
      is modified after exposure to millimeter waves. The neuromodulatory effects of millimeter
      waves may lead to future development on therapeutic management in anxiety and pain.
    

Detailed description: 
      Several studies showed clinical efficacy of millimeter waves in pain management, with no
      side-effects.

      However, its mechanism of action is still partly unknown. Preclinical studies showed that the
      use of millimeter waves near highly-innervated areas stimulates subcutaneous receptors, even
      at low power.

      To achieve safe millimeter wave stimulation, we will use a bracelet (Remedee Labs) emitting
      millimeter waves, that has been developped for human use. It complies with radiofrequency
      exposure regulation (CE-marked).

      This study aims to provide a better understanding of the mechanism by which millimeter waves
      interact with somatosensory system in brain.

      For this purpose, the analysis of brain activity will focus on somatosensory responses
      elicited by electrical stimulation of the right thumb.

      Subjects will complete two sessions during which the brain activity will be recorded by
      magnetoencephalography (MEG) before, during and after the use of a bracelet emitting
      millimeter waves.

      Magnetoencephalography is chosen for its good temporal resolution, its sensitivity in the low
      frequencies and its accuracy to locate neural sources when matching with an Magnetic
      Resonance (MR) Imagery. It will allow us to study the shape and the delay of the
      somatosensory response in primary somatosensory cortex (SI) and secondary somatosensory
      cortex (SII) cortical areas of the brain.
    

Intervention name(s): Millimeter waves local exposure
Intervention type(s): Device
Intervention description(s): several blocks of somatosensory evoked potentials with or without Millimeter waves local exposure
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an exploratory and prospective study. Each volunteer will undergo two MEG examinations (4h-long each) without knowing the millimeter wave emitter status. Each volunteer acts as their own control. The status of exposure to millimeter waves is randomized.
The study is cross-over and double-blinded.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Somatosensory stimulus; Millimeter Waves; Magnetoencephalography
Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to compare the safety and effectiveness of switching treatment
      from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from
      patients who were taking lamivudine and then switched to telbivudine will be compared with
      the results from patients who continued on lamivudine alone.
    


Intervention name(s): Lamivudine; Telbivudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lamivudine; Telbivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Budesonide for Induction of Remission in Incomplete Microscopic Colitis
Condition: Incomplete Microscopic Colitis
MeSH terms: Colitis; Colitis, Microscopic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of
      active incomplete microscopic colitis.
    


Intervention name(s): Budesonide granules 9 mg; Placebo granules
Intervention type(s): Drug; Drug
Intervention description(s): per day; per day
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment