bioihbjkbjnl/mcl2 huggingface dataset:
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Diagnostic Bronchoscopy
Condition: Bronchoscopy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether diagnostic bronchoscopy can be safely and
      potentially more effectively performed without the use of tracheal intubation or a
      supraglottic airway, under completely unobstructed surgical conditions afforded by THRIVE:
      Transnasal Humidified Rapid- Insufflation Ventilatory Exchange. THRIVE provides patient's gas
      exchange through rapid insufflation of high-flow oxygen via specialized nasal cannula.
    


Intervention name(s): THRIVE; Endotracheal tube or Supraglottic airway
Intervention type(s): Device; Device
Intervention description(s): active nasal oxygen delivery system; Plastic devices for mechanical ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: airway management; high flow nasal oxygen; high flow nasal cannula; THRIVE
Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy male subjects to investigate whether repeated administrations of
      cimetidine (a medication which decreases the amount of acid in the stomach) can affect the
      fate in the body (amount and time of presence in the blood) of lucerastat. Safety of the
      concomitant administration of the two treatments will also be assessed.
    


Intervention name(s): Lucerastat; Cimetidine
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 500 mg lucerastat under fasted conditions; Twice daily oral dose of 800 mg cimetidine under fasted conditions
Intervention MeSH terms: Cimetidine
Intervention model: Sequential Assignment
Intervention model description: Fixed sequence
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A
      in treating overactive bladder in spinal cord injury or multiple sclerosis patients
    


Intervention name(s): botulinum toxin Type A (200U); botulinum toxin Type A (300U); Normal saline (Placebo); botulinum toxin Type A (200U); Normal saline (Placebo); botulinum toxin Type A (300U)
Intervention type(s): Biological; Biological; Other; Other
Intervention description(s): botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection > Week 12; injections into detrusor; botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor; Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks; injections into detrusor; Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
Other intervention name(s): BOTOX®; BOTOX®; BOTOX®; BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      No information was yet available over the effect of levocetirizine in children under 12
      years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and
      safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis
      due to house dust mites.
    


Intervention name(s): levocetirizine dihydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Levocetirizine dihydrochloride; Xyzal tablets
Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this project is to pilot test a behavioral intervention that includes a home
      visit component compared to a clinic only and standard of care for the treatment of obesity
      in preschool age children. The results of this study will inform the design of a larger
      randomized control trial.

      H1: The clinic + home intervention will result in a significantly greater decrease in BMIz
      compared to the in clinic only intervention or pediatric standard of care at 6 months
      post-treatment.
    


Intervention name(s): Clinic + Home Behavioral Intervention; Pediatrician Counseling; Clinic Only Behavioral Intervention
Intervention type(s): Behavioral; Other; Behavioral
Intervention description(s): A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.; A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.; A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Behavioral treatment; Preschool aged children; Obesity
Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange
Condition: Chronic Kidney Disease; Peritoneal Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a 7.5% Icodextrin
      peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing
      Continuous Ambulatory Peritoneal Dialysis (CAPD) in Chinese uremic patients.Patients were
      divided into Dianeal group or Extraneal group for long dwell time. Net ultrafiltration, small
      solute clearance and relationship between different transport group were used to evaluate
      efficacy of Icodextrin. Physical examination, vital signs and laboratory tests were used to
      evaluate safety of Icodextrin.
    

Detailed description: 
      A prospective, multicenter, randomized, double blind, parallel controlled study has been
      conducted for 5 weeks in 201 CAPD patients. These patients were randomized from 7 centers
      with 98 allocated to the Icodextrin group and 103 to the Dextrose group. Before study,
      conventional glucose-based solution was the only dialysate which can available in China.
      Extraneal® is one of peritoneal dialysate produced by Baxter which contains 7.5% Icodextrin.
      Patients involved the study were allocated to Dianeal group and Extraneal group in randomize.
      In Dianeal group, prescription was unchanged, while in Extraneal group, Extraneal dialysate
      was used instead of 2.5% Dianeal. Assessments at baseline, week 2, and week 4 included drain
      volume and levels of glucose, creatinine, and urea in the dialysate drained from the long
      dwell; physical examination; vital signs; drained body weight; laboratory analyses. Daily net
      peritoneal ultrafiltration, daily peritoneal creatine clearance and daily peritoneal urea
      nitrogen clearance were recorded prior to and 2 week, 4 week after commencing Extraneal.
    

Intervention name(s): Icodextrin
Intervention type(s): Drug
Intervention description(s): Icodextrin was used instead of Dianeal for long dwell time every day for 5 weeks.
Other intervention name(s): Extraneal dialysate
Intervention MeSH terms: Icodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Icodextrin; ultrafiltration; creatinine clearance; urea nitrogen clearance
The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction
Condition: Amphetamine Addiction
MeSH terms: Amphetamine-Related Disorders; Behavior, Addictive
Study type: Interventional

Summary: 
      The computerized cognitive rehabilitation therapy will be used to treat amphetamine-type
      stimulant (ATS) addiction.
    

Detailed description: 
      The deficits in executive functions related to prefrontal-striatal circuits play a vital role
      in ATS addiction and relapse, and proposed computerized cognitive rehabilitation therapy as
      the novel interventions. Focused on evaluating and training executive functions including
      working memory, inhibitory control, cognitive flexibility, and congitive bias concerning
      prefrontal-striatal circuits, neuropsychological tests, electroencephalography tests,
      magnetic resonance spectroscopy (MRS) and functional MRI will be used to evaluate the
      therapeutic effect of ATS addiction treatment as well as investigate the mechanisms. The
      study will be very helpful to develop novel interventions in clinical practice and decrease
      ATS-related harm for both the patients and their families.
    

Intervention name(s): cognitive function rehabilitation and bias modification
Intervention type(s): Behavioral
Intervention description(s): cognitive rehabilitation focus on the deficits executive funcitin and elevated cognitive bias
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Amphetamine-type stimulants; prefrontal-striatal circuits; cognitive rehabilitation therapy
Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject
Condition: Drug Use
Study type: Interventional

Summary: 
      The study was conducted to investigate whether 20 mg omeprazole capsules manufactured by PT.
      Dankos Farma for PT. Hexpharm Jaya is bioequivalent to its reference product, 20 mg Losec®
      capsules manufactured by AstraZeneca AB, Sweden, imported by PT. AstraZeneca Indonesia.
    

Detailed description: 
      Thirty six healthy subjects were given a single dose of 20 mg omeprazole capsules or 20 mg
      Losec® capsules with 240 mL of water. Then the blood samples for omeprazole were drawn and
      analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic
      evaluation.
    

Intervention name(s): Omeprazole 20 mg Capsules
Intervention type(s): Drug
Intervention description(s): Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production
Other intervention name(s): Losec® 20 mg capsules
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single blind, single dose, 2-treatment, 3-sequence, 3-period partial replicate design study with one week washout period in 36 healthy subjects under fasting condition.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Omeprazole; Bioequivalence Study
Functional MRI (fMRI) in CGRP Induced Migraine
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional

Summary: 
      In patients known with migraine without aura a migraine headache or migraine like headache
      will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then
      be stimulated with noxious heat via a thermode placed at the forehead. At the same time the
      Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic
      resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of
      interest (ROI) will be thalamic region and medulla oblongata.

      Then the patients will be given pain relif in form of injection of sumatriptan and the effect
      of this will also be registered via measuring the BOLD response at the RIO's previously
      defined. A 3-Tesla MRI scanner will be used in this trail.

      This study will give us key knowledge of the trigeminal pain pathway and the central
      processing i.e sensitization during a migraine attach.
    


Intervention name(s): infusion of calcitonin gene related peptide (CGRP)
Intervention type(s): Drug
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: migraine with out aura
Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence
Condition: Smoking Cessation; Alcohol-Related Disorders
MeSH terms: Alcohol-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment
      for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate
      the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving
      treatment for alcohol dependence.
    

Detailed description: 
      Past research suggests that over 75% of alcohol dependent individuals in early alcohol
      recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in
      this population. Many alcohol dependent individuals in early recovery are interested in
      smoking cessation treatment; however, studies indicate that these smokers find it very
      difficult to quit smoking. More effective treatment methods are needed for smokers in early
      alcohol recovery. Bupropion is a dopaminergic antidepressant that may be effective in
      treating nicotine dependent individuals. The purpose of this study is to evaluate the
      effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol
      dependence. In addition, this study will investigate the psychological mechanisms that may
      mediate the efficacy of bupropion in smoking cessation. We will also collect DNA from
      subjects in order to explore whether response to bupropion is mediated by particular genetic
      variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers.

      Participants will be randomly assigned to receive either 300 mg of bupropion or placebo,
      daily for 8 weeks. In addition, all participants will receive a nicotine patch for 7 weeks.
      This will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks,
      and a 7-mg nicotine patch for 1 week. All participants will undergo seven counseling
      sessions. Follow-up visits will occur at Weeks 7, 12, and 24. Pre-quit variables (e.g.,
      smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and
      negative effects) will be evaluated at all study visits.
    

Intervention name(s): Bupropion; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg QD; placebo
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Observational

Summary: 
      Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis,
      the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with
      AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy
      and safety of BD as the first-line treatment of patients with AL amyloidosis.
    

Detailed description: 
      This study included patients with newly diagnosed AL amyloidosis who were treated with a BD
      regimen in Jinling hospital. The AL amyloidosis diagnosis was confirmed by renal biopsy, and
      the assessment of organ involvement were based on consensus criteria. The clinical and
      laboratory data were collected at the beginning of each cycle and every 3 months thereafter.
      The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.)
      twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period
      (days 12-21). The investigators evaluated the efficacy and safety of BD as the first-line
      treatment of patients with AL amyloidosis.
    

Intervention name(s): bortezominb and dexamethasone
Intervention type(s): Drug
Intervention description(s): The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The dose of bortezomib and dexamethasone can be adjusted according to the patients' condition.
Other intervention name(s): Velcade
Intervention MeSH terms: Dexamethasone
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients from hospital，who were diagnosed AL amyloidosis by renal or other type biopsy.
Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma
Condition: Recurrent Osteosarcoma
MeSH terms: Osteosarcoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well eribulin mesylate works in treating patients with
      osteosarcoma that has come back after treatment (recurrent) or has not responded to treatment
      (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow the growth
      of tumor cells by disrupting the cell cycle.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the 4 month progression free survival rate and objective response rate in
      patients with recurrent osteosarcoma who are administered eribulin (eribulin mesylate)
      therapy on day 1 and day 8 of 21 day cycles.

      SECONDARY OBJECTIVES:

      I. To investigate the pharmacokinetics (PK) of eribulin in subjects with recurrent
      osteosarcoma.

      II. To further describe the tolerability of single agent eribulin.

      OUTLINE:

      Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8.
      Courses repeat every 21 days for up to 24 months in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up annually for 5 years.
    

Intervention name(s): Eribulin Mesylate; Pharmacological Study
Intervention type(s): Drug; Other
Intervention description(s): Given IV; Correlative studies
Other intervention name(s): E7389; ER-086526; Halaven; Halichondrin B Analog
Intervention MeSH terms: Halichondrin B
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of ONO-8577 in Patients With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to
      combination of solifenacin succinate and mirabegron or placebo for overactive bladder
    


Intervention name(s): ONO-8577; solifenacin succinate + mirabegron; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration of ONO-8577 once a daily for 4 weeks; Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks; Oral administration of Placebo once a daily for 4 weeks
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Refractive Change Induced by 2.8-mm Corneal Incision
Condition: Cataract; Refractive Surgery; Astigmatism
MeSH terms: Cataract; Astigmatism
Study type: Interventional

Summary: 
      The investigators' purpose is to study the induced refractive change caused by different
      2.8-mm corneal incision locations in phacoemulsification, because the investigators
      hypothesize that the effect may be different for nasal, temporal, and superior location,
      although they are considered astigmatism neutral.

      Patients will be randomized to nasal or temporal incision, or assigned to superior incision,
      depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam
      analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and
      after phacoemulsification.

      Outcome measures will be induced corneal refractive change (Fourier power vector analysis),
      ISV change, and visual acuity, at 6 months.
    


Intervention name(s): Nasal 2.8-mm corneal incision; Temporal 2.8-mm corneal incision; Superior 2.8-mm incision
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Phacoemulsification through a nasal 2.8-mm incision; Phacoemulsification through a 2.8-mm temporal incision; Phacoemulsification through a superior 2.8-mm corneal incision
Other intervention name(s): Phacoemulsification nasal incision; Phacoemulsification temporal incision; Phacoemulsification superior incision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Corneal incision; Cataract surgery; Phacoemulsification; Surgically induced astigmatism; Corneal Topography
Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of fecal microbiota transplantation
      (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.
    


Intervention name(s): Fecal transplantation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fecal transplantation; microbiota transplantation; irritable bowel syndrome; IBS