bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma
Condition: Severe Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, single arm study designed to evaluate the safety of tezepelumab
      administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with
      inadequately controlled severe asthma.
    

Detailed description: 
      This is open-label, single arm study designed to evaluate the safety of tezepelumab in adults
      and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one
      additional asthma controller medication with or without OCS. Approximately 66 subjects will
      be dosed in Japan. Subjects will receive tezepelumab administered via subcutaneous injection
      at the study site, over a 52-week treatment period. The study also includes a post-treatment
      follow-up period of 12 weeks.
    

Intervention name(s): Biological: Experimental: Tezepelumab
Intervention type(s): Drug
Intervention description(s): Tezepelumab subcutaneous injection every 4 weeks
Other intervention name(s): Tezepelumab
Intervention MeSH terms: Antibodies, Monoclonal
Intervention model: Single Group Assignment
Intervention model description: All subject will be dosed tezepelumab administered subcutaneously
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Uncontrolled Asthma; Severe Uncontrolled Asthma
Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional

Summary: 
      Primary Objective:

      To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a
      three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or
      Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.
    

Detailed description: 
      Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom
      parents or legal representatives had given authorization to use the sera taken from their
      child will be used for this study.
    

Intervention name(s): DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines; DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Intervention type(s): Biological; Biological
Intervention description(s): Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study; Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatitis B; Hexaxim®; Hexyon®; Hexacima®; Prevnar®; DTaP-IPV-HB-Hib hexavalent vaccine
Simulation of Consecutive Day Shift Work
Condition: Hyperthermia; Fatigue; Heat
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      The purpose of this study is to determine differences in physiological recovery between two
      consecutive days of simulated fire suppression work. The secondary purpose is to determine
      differences in heat gain and heat loss between two consecutive days of simulated fire
      suppression work. Subjects will complete two consecutive days of simulated structural
      firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects
      will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify
      parasympathetic tone and recovery from work.
    


Intervention name(s): 2 days of work heat stress
Intervention type(s): Other
Intervention description(s): 2 consecutive days of identical simulated structural firefighting tasks.
Intervention model: Single Group Assignment
Intervention model description: Repeated measures study
Masking: None (Open Label)
Primary purpose: Other
Vitrectomy for Branch Retinal Vein Occlusion
Condition: Vitrectomy
MeSH terms: Retinal Vein Occlusion
Study type: Observational

Summary: 
      To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal
      limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch
      retinal vein occlusion (BRVO).

      Results suggest the following hypothesis:

        -  PPV, with and without ILM peeling, appears to be beneficial in eyes with persistent
           macular edema due to BRVO

        -  Effectiveness is maintained long term

        -  ILM peeling does not significantly affect postoperative best corrected visual acuity
           (BCVA)
    


Intervention name(s): Vitrectomy w/o ILM peeling for macular edema with BRVO
Intervention type(s): Procedure
Intervention description(s): Concurrent phacoemulsification and intraocular lens insertion in the capsular bag was performed, followed by PPV with separation of the posterior hyaloid from the optic disk and posterior retina with a posterior vitreous detachment was not present. Indocyanine green (ICG)-assisted peeling was performed in all consecutive patients between April 2000 and June 2003. 0.1% ICG solution was injected over the macular region. Immediately after application, the dye was washed out using a vitreous cutter. Repeated injection of ICG was not required. Triamcinolone acetonide (TA)-assisted ILM peeling was performed in all consecutive patients from July 2003 to November 2006.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        70 consecutive patients who underwent PPV, with and without OLM peeling, for persistent
        macular edema associted with BRVO
      
Keywords: branch retinal vein occlusion; internal limiting membrane; macular edema; vitrectomy
Yoga Training in Allergic Rhinitis Patients
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The purpose of this study was to investigate effects of yoga training on rhinitis symptoms
      and cytokines in allergic rhinitis patients. Twenty-seven allergic rhinitis patients, aged
      18-45 year old, were randomized into 2 groups: control group (CON; n=14) and yoga group (YOG;
      n=13). The control group had normal life and the yoga group was required to complete protocol
      with yoga training for a period of 8 weeks, 60 minutes, 3 times a week. Physiological
      variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level
      in nasal secretion variables were analyzed during pre-test and post-test. The dependent
      variables between pre-test and post-test were analyzed by a paired t-test. The dependent
      variables between groups were analyzed by independent t-test. One way repeated measures ANOVA
      was used to compare the variables among pre-test, after 4 weeks, and after 8 weeks.
      Differences were considered to be significant at p < 0.05.
    


Intervention name(s): Yoga training
Intervention type(s): Other
Intervention description(s): Complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Twenty-seven allergic rhinitis patients, aged 18-45 year old, were randomized into 2 groups: control group (CON; n=14) and yoga group (YOG; n=13). The control group had normal life and the yoga group was required to complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-test and post-test.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Yoga; Cytokines; Rhinitis symptoms
Prospective Study to Determine the Factors Influencing Infant Colic
Condition: Infant Colic
MeSH terms: Colic
Study type: Interventional

Summary: 
      Randomized study to determine the effect of a commercialized combination of 2 probiotic
      strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type
      in babies diagnosed with colic under Roma IV criteria when administered for 21 days.
    

Detailed description: 
      Randomized, single-blind, interventional study with two parallel groups to determine the
      effect of two different commercialized probiotic products (Lactobacillus reuteri or a
      combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus))
      and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants
      meeting selection criteria are randomized 1:1 and stratified according to the type of feeding
      (breastfed or formula).

      Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical
      parameters during this 21 days. This parameters include colic-related symptoms, other
      functional gastrointestinal disorders symptoms, parental anxiety and adverse events.

      Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin
      levels.
    

Intervention name(s): AB-Kolicare; Reuteri gotas
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic multi-strain formulation containing Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8830 for 21 days, 5 drops/day preferably during the first intake of milk; Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multicentric, single-blind trial in infants between 2 and 12 weeks of age diagnosed with infant colic, who will be allocated to receive one of the two comercialized probiotic products B. Longum and P. Pentosaceus (branch one) or L. Reuteri (branch two) for 21 days
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Infant colic, probiotic
A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies
Condition: Relapsed or Refractory Lymphoid Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects
      with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and
      expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,
      biomarkers, and efficacy.
    


Intervention name(s): OMP-52M51
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; Dose escalation; relapsed or refractory; lymphoid malignancies
A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From Abdominal Aorta Surgery
Condition: Abdominal Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Summary Question: Does backward walking offer additional therapeutic value in patients after
      aortic aneurysm surgery? Participants: The study of backward walking as an addictive
      physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal
      aorta surgery. The patients were randomly divided into three subgroups and three various
      models of physiotherapy were applied. Control group has only routine physiotherapy since
      therapeutic group I and II have also walking exercises forward in group I and backward in
      group II respectively.
    


Intervention name(s): forward walking; backward walking
Intervention type(s): Procedure; Procedure
Intervention description(s): comparison forward walking vs backward walking in the physiotherapy after after abdominal surgery; physiotherapy with use a backward walking type of physiotherapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: abdominal aorta surgery; Physical Training; backward walking; physiotherapy
The Relationship of Abdominal Circumference and Trunk Length With the Level of Spinal Anesthesia in Obstetric Patients
Condition: Obstetrics for C/S
Study type: Observational

Summary: 
      The body shape might have influence on the spinal level. In this research we plan to
      investigate the relationship of abdominal circumference, trunk length and the level of spinal
      anesthesia in obstetric patients during Cesarean section.
    

Detailed description: 
      The level of spinal anesthesia in obstetric patients had been investigated in several
      studies. Increased cephalad spread of local anesthetics had been demonstrated with increased
      intra-abdominal pressure, changes in anteroposterior spinal curves and lumbar lordosis.
      Theoretically the body shape might have contribution to the above factors and might have
      influence on the spinal level. In this research we plan to investigate the relationship of
      abdominal circumference, trunk length and the level of spinal anesthesia in obstetric
      patients during Cesarean section. Only those C/S patients indicated and scheduled for spinal
      anesthesia will be observed. The spinal anesthesia will be performed as routine practice.
      This study will not change the clinical plan in any aspect. We will only passively record the
      abdominal circumference, trunk length and the level of spinal anesthesia and calculate the
      correlation between them.
    

Intervention name(s): spinal anesthesia
Intervention type(s): Procedure
Intervention description(s): spinal anesthesia with bupivacaine
Intervention MeSH terms: Anesthetics
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obstetric patients for C/S
A Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is
      absorbed in the body, distributed within the body, and how it is removed from the body) of
      the solution formulation to the tablet formulation; therefore the lowest dose available in
      the tablet formulation (250 mg) was selected.
    

Detailed description: 
      This is an open-label (volunteer and study staff will know the identity of the assigned
      treatment) study of two abiraterone acetate suspension formulations, compared to the
      abiraterone acetate tablet formulation in healthy volunteers. Approximately 30 healthy
      volunteers will participate in this study. Each volunteer will be randomly assigned to 1 of 6
      possible treatment sequences. The study consists of a screening phase (within 21 days before
      the first study drug administration of the first period); an open-label treatment phase
      consisting of 3 single dose treatment periods; and end-of-study or withdrawal assessments
      done upon completion of the 72-hour (Day 4 of Period 3, or upon withdrawal) sampling to
      evaluate how the drug is absorbed in the body, distributed within the body, and how it is
      removed from the body over time. A 7- to 14-day washout period will separate the study drug
      administrations. The duration of participation in the study for an individual healthy
      volunteer will be from 41 days to a maximum of 55 days (including screening). Safety will be
      monitored. Volunteers will receive a 250 mg dose of abiraterone acetate as a tablet,
      suspension Formulation 1, and suspension Formulation 2 according to their treatment sequence.
      Abiraterone acetate tablets must be swallowed whole and not chewed, divided, dissolved or
      crushed and will be taken with 240 mL of noncarbonated water. For the suspensions, the
      volunteer will drink the contents of the vial. The vial will be rinsed with 10 mL of water,
      and the volunteer will be asked to drink the rinse water.
    

Intervention name(s): Abiraterone acetate suspension Formulation 1; Abiraterone acetate suspension Formulation 2; Abiraterone acetate tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL; Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL; Type=exact, unit=mg, number= 250, form=tablet, route=oral use, as a single dose
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Abiraterone Acetate; ZYTIGA
Assessment of CR8020, a Monoclonal Antibody Against Influenza A Viruses
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess in healthy subjects the safety, tolerability,
      pharmacokinetics and immunogenicity of single escalating doses of CR8020, a monoclonal
      antibody against influenza A viruses.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled dose escalation study will enroll up to 5
      cohorts of healthy subjects. Eight subjects will be enrolled in each cohort and will receive
      a single 2-hour intravenous infusion of CR8020 (6 subjects) or placebo (2 subjects) on Day 1.
      Subjects will be dosed in pairs of two. Once all subjects in a cohort have completed Study
      Day 8, the preliminary safety data will be reviewed. Provided that no safety issues are
      identified, dose escalation to the subsequent cohort may be permitted. After the completion
      of Cohort 5 enrollment, and the preliminary safety and tolerability of the 50mg/kg dose is
      demonstrated, a sixth cohort will be enrolled. Cohort 6 will be comprised of 24 subjects
      (randomized 5:1 to CR8020 30 mg/kg or placebo) who will receive 2-hour intravenous infusions
      on Days 1 and 8.
    

Intervention name(s): 2 mg/kg CR8020; 5 mg/kg CR8020; 15 mg/kg CR8020; 30 mg/kg CR8020; 50 mg/kg CR8020; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): administered as a single 2-hour intravenous infusion; administered as a single 2-hour intravenous infusion; administered as a single 2-hour intravenous infusion; administered as a single 2-hour intravenous infusion; administered as a single 2-hour intravenous infusion; administered as a single 2-hour intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza; Virus; Monoclonal; Antibody; Immunization; Treatment
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared
      with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.
    

Detailed description: 
      A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared
      with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2
      Diabetes
    

Intervention name(s): Bydureon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.; Placebo
Other intervention name(s): exenatide
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)
Condition: Sleep Initiation and Maintenance Disorders; Mental Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is to investigate the effect on next-day driving performance and psychomotor
      performance in healthy volunteers.
    


Intervention name(s): Org 50081; Org 50081; Placebo; zopiclone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.5 mg on day 1-7; 4.5 mg on Day 1-7; Once daily on Day 1-7; Single dose of 7.5 mg
Intervention MeSH terms: Zopiclone; Mirtazapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Non-Crossover Study of the LMA Protector Versus Ambu AuraGain
Condition: Airway Morbidity
Study type: Interventional

Summary: 
      The LMA ProtectorTM is a new extraglottic airway device which brings together features of
      both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate
      ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM
      (single use - prevention of disease transmission). In the following randomized study the
      investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,
      fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and
      the Ambu AuraGainTM in paralyzed, anesthetized patients.
    


Intervention name(s): function tests; LMA ProtectorTM; Ambu AuraGainTM
Intervention type(s): Procedure; Device; Device
Intervention description(s): function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment