bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Montelukast on Smokers With Asthma
Condition: Asthmatic Smokers; Non-asthmatic Smokers
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is:

        1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices
           between smokers and non-smokers.

        2. To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.
    

Detailed description: 
      Many smokers have insufficient control of their symptoms due to inefficacy of ICS in this
      subpopulation of asthmatics. Cigarette smoking has been shown to stimulate production of
      cysLTs. CysLTs could activate production of IL-8 for neutrophilia as well as cause
      eosinophilia in the airway of asthmatics.

      LTRAs are felt to be less efficacious than ICS in smokers with asthma. However, LTRA's unique
      mechanism of action could be particularly efficacious in preventing worsening symptoms and
      lung function for smokers with asthma. Given this, along with the fact that ICS are less
      effective in smokers, targeting cysLT could lead to significant clinical benefits for
      asthmatic smokers.

      Data from this study may possibly serve as crucial data for the significant clinical benefits
      for asthmatic smokers and determination of the mechanism of corticosteroid resistance in
      smokers with asthma.
    

Intervention name(s): Fluticasone Propionate; Montelukast; Salmeterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DPI 250 mcg BID for 3 weeks; PO 10 mg QHS for 3 weeks; DPI 50mg BID for 3 weeks
Other intervention name(s): inhaled corticosteroid; leukotriene receptor antagonist; long-acting beta-agonist
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Montelukast; Leukotriene Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: asthmatics; smokers; inhaled corticosteroids; leukotriene receptor antagonists
Helping Young Children Sleep
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The investigators are conducting a randomized trial of behavioral treatments for young
      children with insomnia. The investigators are comparing the improvement in sleep patterns
      after families are given access to Internet sleep instructions compared to DVD sleep
      instructions.
    


Intervention name(s): Internet; DVD
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric; Insomnia
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers
Condition: Healthy; Pharmacokinetics of Enalapril
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2
      crossover method.
    


Intervention name(s): ASP1585; enalapril
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Renivace
Intervention MeSH terms: Enalapril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1585; Drug-drug interaction; enalapril; Healthy volunteer
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) in Healthy Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, caused by dengue viruses, is a major health problem in the tropical and
      subtropical regions of the world. The purpose of this study is to test the safety of and
      immune response to a new dengue virus vaccine in healthy adults.
    

Detailed description: 
      Dengue viruses, which cause dengue fever and dengue shock syndrome, are a major cause of
      morbidity and mortality in several of the world's tropical and subtropical regions. The
      rDEN3/4delta30(ME) vaccine is a live attenuated dengue virus vaccine that may be protective
      against dengue virus serotype 3 (DEN3). The purpose of this study is to evaluate the safety
      and immunogenicity of the rDEN3/4delta30(ME) vaccine in healthy adults.

      This study will last 40 weeks. Participants will be randomly assigned to receive one of three
      doses of rDEN3/4delta30(ME) or placebo. Participants in Group 1 will receive the middle dose
      of rDEN3/4delta30(ME) or placebo at study entry. Group 2a will begin enrollment after the
      immunogenicity review of all participants in Group 1. Participants in Group 2a will receive
      the highest dose of rDEN4delta30(ME) or placebo at study entry. Group 2b will begin
      enrollment after the immunogenicity review of all participants in Group 2a. Participants in
      Group 2b will receive the lowest dose of rDEN4delta30(ME) or placebo.

      After vaccination, participants in all groups will be followed closely every other day for
      the first 16 days of the study. Participants will take their temperature three times a day
      through Day 16 and record each measurement in a diary. After Day 16, participants will have
      study visits on Days 21, 28, 42, and 180; a physical exam and blood collection will occur at
      all visits. Some participants may be asked to join a skin biopsy substudy.
    

Intervention name(s): rDEN3/4delta30(ME); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated rDEN3/4delta30(ME) vaccine (one of three doses); Placebo for rDEN3/4delta30(ME)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue Vaccine; Dengue Virus; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
Acute Beetroot Juice Supplementation in Amateur Climbers
Condition: Dietary Supplement; Sport Performance
Study type: Interventional

Summary: 
      Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in
      endurance activities, its benefits in neuromuscular function and strength performance has
      been barely studied. In this cross-over randomized placebo-controlled study, we investigated
      the effects of BJ acute supplementation in improving neuromuscular performance in amateur
      climbers
    


Intervention name(s): Beetroot Juice (BJ) acute supplementation; Placebo Juice (PLA) acute supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One serving of 70 mL of BJ (6.4 mmol of NO3) 3h before initiating the testing session; One serving of 70 mL of juice (0.005 mmol of NO3) 3h before initiating the testing session
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the immunological memory against pneumococcal vaccine serotypes in children
      primed with conjugate vaccines by administering a booster dose of plain polysaccharide
      vaccine.
    

Detailed description: 
      2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK
      Biologicals' pneumococcal vaccine.
    

Intervention name(s): Pneumococcal vaccine
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Endothelial Cell Loss After Penetrating Keratoplasty
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This work aimed at the assessment of corneal endothelial cell loss after toric ICL
      implantation for correction of myopia and astigmatism after penetrating keratoplasty.
    

Detailed description: 
      Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed
      at the assessment of corneal endothelial cell loss after toric ICL implantation for
      correction of myopia and astigmatism after penetrating keratoplasty.
    

Intervention name(s): PKP
Intervention type(s): Procedure
Intervention description(s): The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery.
TICL loading into the STAAR injector cartridge
Temporal clear corneal 3 mm incision & 2-side ports then viscoelastic injection into the AC
Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris.
Pupil constriction with A.Ch.
Washing the viscoelastic &Wound hydration.
Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks
Intervention model: Single Group Assignment
Intervention model description: A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
Condition: Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a modified single-blind, randomized, parallel-group, comparative, multicenter study
      to test Menactra vaccine in toddlers.

      Primary Objectives:

        -  To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella
           (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.

        -  To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when
           administered alone or concomitantly with Menactra vaccine.

      Observational Objectives:

      Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6
      months after the last study vaccination[s]) in subjects in the study groups.

      Immunogenicity:

      - To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days
      after the first and second Menactra vaccine administration in a subset of subjects in the
      first study group.
    

Detailed description: 
      No meningococcal vaccine is presently licensed for the population aged < 2 years in the US,
      establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against
      invasive meningococcal disease in children aged < 2 years would address this important,
      currently unmet public health need.

      At enrollment, each 9-month old subject will be randomly assigned to a study group and
      vaccinated. A second vaccination will be administered at 12 months of age. Subjects will
      provide one blood sample during the trial.

      Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide
      one blood sample 30 days after vaccinations in the control group
    

Intervention name(s): Meningococcal Polysaccharide Diphtheria Conjugate Vaccine; Meningococcal Polysaccharide Diphtheria Conjugate Vaccine; Meningococcal Polysaccharide Diphtheria Conjugate Vaccine; Measles, Mumps, Rubella and Varicella
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL dose, intramuscular (IM); 0.5 mL dose, IM; 0.5 Ml dose, IM; 0.5 mL dose, SC
Other intervention name(s): Menactra®; Menactra®; Menactra®; ProQuad®; M-M-R®II
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Menactra vaccine; Meningococcal meningitis; Measles; Mumps; Rubella; Varicella vaccines; Haemophilus influenzae type b; Pneumococcal conjugate vaccine
Low Dose Aspirin in the Prevention of Preeclampsia in China
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 3

Summary: 
      Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over
      the world. The use of low dose aspirin has been mentioned in several studies with promising
      results. The investigators decided to evaluate the use of low dose aspirin in Chinese
      pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical
      characteristics aiming to reduce the incidence of preeclampsia.
    

Detailed description: 
      Detailed Description:

      The investigators will conduct a randomized control trial to estimate the efficacy of low
      dose aspirin in preventing preeclampsia in Chinese pregnant women who are evaluated with risk
      factors. The investigators will also obtain biological specimen including maternal blood,
      cord blood, placenta specimen and etc. for basic science studies.

      Rationale for Design:There is a lack of evidences or guideline of aspirin using in preventing
      PE for Chinese women. The investigators will conduct a randomized control trial, which is the
      'gold standard' of research design, hoping to answer the question.
    

Intervention name(s): Aspirin; Blank
Intervention type(s): Drug; Other
Intervention description(s): Low dose aspirin（100mg）per day starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy,taking at night.; Routine examination during pregnancy.
Other intervention name(s): ASA; acetyl salicylic acid
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: preeclampsia; low dose aspirin; prevention
Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes
Condition: Lymph Nodes; Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Liver Cancer
Study type: Observational

Summary: 
      Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients
      with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer).
      When planning the optimal therapy in patients with upper gastrointestinal malignancies it is
      essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has
      been added to conventional EUS examination and may provide complementary information to
      distinguish benign for malignant lymph nodes.

      The N-stage relates to the treatment choice and the prognosis, and it is therefore of
      particular interest to know the interobserver agreement in operator dependent techniques.
      This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred for EUS examination on the basis of a malignant indication.
      
Keywords: Endoscopy; Endoscopic Ultrasound; Endoscopic Sonoelastography; Cancer; Interobserver agreement
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive 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 aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD,
      Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient
      evidences for the listed of the studied drug.
    


Intervention name(s): Ypeginterferon alfa-2b; Pegasys
Intervention type(s): Drug; Drug
Intervention description(s): sc, qw, 48 weeks.; sc, qw, 48 weeks.
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peginterferon; HBeAg Positive; Chronic hepatitis B
The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the clinical efficacy of a new toothpaste
      containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing
      gingivitis and dental plaque.
    

Detailed description: 
      This is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste.

      Qualified subjects will be enrolled and randomized to either one of the two study groups
      based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the
      products according to the instructions provided. Subjects will return to the dental office
      for evaluation after three and six months of product use. All subjects will be followed for
      adverse events throughout the study.
    

Intervention name(s): MFP Fluoride toothpaste; Stannous fluoride toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,; Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Other intervention name(s): Colgate Great Regular Flavor toothpaste
Intervention MeSH terms: Fluorides; Tin Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Tooth brushing study. Subjects brush their whole mouth 2x/day for 1 minute each time. The study duration is 6 months
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Irinotecan in Treating Children With Refractory Solid Tumors
Condition: Childhood Central Nervous System Germ Cell Tumor; Childhood Choroid Plexus Tumor; Childhood Craniopharyngioma; Childhood Grade I Meningioma; Childhood Grade II Meningioma; Childhood Grade III Meningioma; Childhood Infratentorial Ependymoma; Childhood Oligodendroglioma; Childhood Supratentorial Ependymoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Ependymoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Visual Pathway and Hypothalamic Glioma; Recurrent Childhood Visual Pathway Glioma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Neuroblastoma; Recurrent Osteosarcoma; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Glioma; Neuroblastoma; Astrocytoma; Osteosarcoma; Rhabdomyosarcoma; Meningioma; Sarcoma, Ewing; Ependymoma; Medulloblastoma; Oligodendroglioma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Rhabdomyosarcoma, Embryonal; Neuroectodermal Tumors, Primitive, Peripheral; Craniopharyngioma; Adamantinoma; Choroid Plexus Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial is studying irinotecan to see how well it works in treating children with
      refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells
      from dividing so they stop growing or die.
    

Detailed description: 
      OBJECTIVES:

      I. Determine the efficacy of irinotecan in children with refractory CNS or solid tumors.

      II. Assess the toxicity, pharmacokinetics, and pharmacodynamics of this regimen in this
      patient population.

      III. Determine patient UGT1A1 genotype and correlate genotype with toxicity and
      pharmacokinetic parameters of this regimen in these patients.

      OUTLINE: Patients are stratified according to type of solid tumor (Ewings/PNET vs
      neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas
      and brain tumors) or brain tumor (medulloblastoma/PNET vs brain stem glioma vs ependymoma vs
      other CNS tumors).

      Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks
      for at least 2 courses in the absence of disease progression or unacceptable toxicity.
      Patients are followed every 6 months for 4 years and then annually thereafter until death or
      until patient enters another POG study.
    

Intervention name(s): irinotecan hydrochloride
Intervention type(s): Drug
Intervention description(s): Given IV
Other intervention name(s): Campto; Camptosar; CPT-11; irinotecan; U-101440E
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment