bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety and efficacy of long-term administration of aripiprazole in combination
      with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I
      Disorder experiencing a manic or mixed episode
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): oral, 24mg/day
Other intervention name(s): OPC-14597
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
Condition: Pneumonia, Pneumococcal
MeSH terms: Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at
      the immune response in infants. In addition, the study will compare the immunogenicity of the
      Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.
    

Detailed description: 
      This is a randomized, active-controlled, double-blind, Phase 3 study in 2,250 healthy infants
      (6 to 8 weeks of age). Subjects will receive 3 doses of either PNEUMOSIL (3 groups receiving
      vaccine from different lots) or Synflorix (1 group) at 6, 10, and 14 weeks of age. The first
      675 randomized subjects will receive a booster dose of either PNEUMOSIL or Synflorix at 9
      months of age that matches the treatment assignment for the priming phase. Standard EPI
      vaccinations in The Gambia will be given concomitantly with all 4 doses of the study
      vaccines. Out of the 675 booster subjects, subjects who consented for further evaluation will
      participate for the assessment of immune persistence 12 (+1) months after the booster
      vaccination

      The primary objectives are to demonstrate that the three lots of the Pneumosil vaccine is
      consistent by evaluating the immune responses, and to demonstrate that the immune responses
      generated by Pneumosil are non-inferior to those generated by Synflorix. The safety and
      tolerability of Pneumosil will also be evaluated.
    

Intervention name(s): Pneumosil; Synflorix
Intervention type(s): Biological; Biological
Intervention description(s): 10-Valent Pneumococcal Conjugate Vaccine; Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human study of ETD002 a new drug being developed for the treatment of
      cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional
      study to assess the safety and tolerability of ascending single and repeat doses of inhaled
      ETD002 in healthy male and female subjects.
    


Intervention name(s): ETD002 - single dose; Placebo - single dose; ETD002 - 7 day repeat dose; Placebo - 7 day repeat dose; ETD002 - 14 day repeat dose; Placebo - 14 day repeat dose; Salbutamol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single ascending doses of ETD002; Single doses of placebo; Twice daily doses of ETD002 for 7 days; Twice daily doses of Placebo for 7 days; Twice daily doses of ETD002 for 14 days; Twice daily doses of Placebo for 14 days; Twice daily doses of salbutamol for 3 days (Days 5, 6 & 7)
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic fibrosis
Modulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional

Summary: 
      This study is designed to assess the effect of a new PPARgamma modulator on the expression
      and activity of the lactase enzyme in human intestinal epithelial cells. Based on their
      previous experimental results, the investigators hypothesized that modulating intestinal
      PPARgamma activity is a new pharmacological mechanism allowing the control of lactase
      expression and activity in the gut
    


Intervention name(s): GED
Intervention type(s): Drug
Intervention description(s): Four duodenal biopsies will be collected. Two biopsies will stimulated with GED (PPARgamma modulator) ex vivo during 6 hours. Two biopsies will be unstimulated (control).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PPARgamma; Lactose intolerance; Lactase
Prevalence of Sleep-Disordered Breathing in Children
Condition: Lung Diseases; Sleep Apnea Syndromes
MeSH terms: Sleep Apnea Syndromes; Lung Diseases
Study type: Observational

Summary: 
      To investigate the prevalence and clinical significance of sleep-disordered breathing (SDB)
      in children.
    

Detailed description: 
      BACKGROUND:

      SDB in children appears to be a common condition, affecting approximately 1 to 3 percent of
      children. Many aspects of childhood SDB remain understudied and poorly understood, including
      its precise prevalence, the optimal means of identifying children who should undergo
      polysomnography, and the potentially major impact of this condition on health, cognitive
      development, and behavior.

      DESIGN NARRATIVE:

      The population-based, cross-sectional study of 6- to 16-year-old schoolchildren in Dauphin
      County, Pennsylvania is a two-part study. In the first part of the study, parents of every
      child enrolled in local elementary schools will complete a questionnaire that will assess
      general sleep, behavior, and learning problems. In the second part of the study, 1,000
      children will be randomly selected based on their risk for SDB, as determined by the
      questionnaire. They will be evaluated in a sleep laboratory to determine the presence of SDB.
      A thorough pediatric ear, nose, throat, and pulmonary evaluation will be conducted; school
      records and behavior will also be assessed. The parents of the children will be interviewed,
      and information will be collected on the family history of risk factors associated with
      childhood SDB. This strategy will be beneficial in establishing the prevalence and clinical
      significance of SDB in children.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Random representative population sample of children in elementary school (K-5)
      
Keywords: Sleep-Disordered Breathing
The Effects of Passive Gait Training in Complete Motor Spinal Cord Injury (SCI)
Condition: Motor Complete Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether a three times per week, 2 month robotic
      assisted treadmill gait training program, will beneficially affect the fitness, physical and
      psychological well-being, and the vascular and metabolic cardiovascular risk factors in
      individuals with complete motor Spinal Cord Injury (SCI).
    

Detailed description: 
      Cardiovascular morbidity and mortality are a source of increasing concern among people with
      SCI and their health providers. The importance of physical activity in reducing the risk of
      heart disease in this population is indisputable, but exercise opportunities for persons with
      SCI are limited by physiologic and functional factors. Decreased functional muscle mass,
      impaired autonomic control of myocardial function, and decreased venous return limits
      training responses.
    

Intervention name(s): LOKOMAT
Intervention type(s): Device
Intervention description(s): Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session.
Other intervention name(s): driven gait orthosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: paraplegia; tetraplegia; passive gait training; O2 consumption; exercise capacity; CVD risk factors; spasticity; pain; bladder, bowel; well being
Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Observational

Summary: 
      Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem.
      The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most
      of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in
      the age group of 6 and less and about 1.5% above. The in-lab sleep study using full
      Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep
      Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full
      night PSG, together with long waiting lists for sleep studies, have led to the commonly used
      procedure of "split-night" for OSAS patients, as well as to the development of a variety of
      ambulatory sleep study systems. The primary study objective is to compare the efficacy of the
      WatchPAT (WP), as an ambulatory device for aiding in the diagnosis of sleep disorders for
      subjects from age 5 to 90, to the manual scoring of the PSG that serves as a "gold standard".
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults and children with and without sleep disorders, referred to Carmel Medical Center
        clinical sleep laboratory for an overnight sleep study
      
Keywords: sleep disorders; sleep apnea; ambulatory device; polysomnography; WatchPAT
Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      Study comparing the same drugs as a dual combination product (budesonide and formoterol)
      given via two different inhalers. To see which one results in the best effect on breathing.
    

Detailed description: 
      This is a Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study
      to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol
      Administered with a Spacer Compared with Symbicort® Turbuhaler® in Subjects with Severe to
      Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow to assess
      lung function
    

Intervention name(s): BFF; Symbicort Turbuhaler
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler); Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects
Condition: Influenza; Orthomyxoviridae Infections
MeSH terms: Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To describe the immunogenicity of an injection of the investigational inactivated,
      split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal
      transplant subjects identified as non-responder to previous vaccination with the IM reference
      vaccine (Vaxigrip®).

      Secondary Objective:

      To describe the safety of an injection of the investigational inactivated, split-virion
      influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder
      to previous vaccination with the IM reference vaccine
    

Detailed description: 
      The trial is a multicenter, randomized, controlled trial in renal transplant subjects aged 18
      to 60 years who are non-responders to vaccination with the reference vaccine. Subjects will
      be randomized to receive either the 2007-2008 15 µg investigational vaccine or the 2007-2008
      IM reference vaccine.
    

Intervention name(s): Inactivated, split-virion influenza virus; Inactivated, split-virion influenza virus
Intervention type(s): Biological; Biological
Intervention description(s): 0.1 mL, Intradermal. 2 vaccinations 12 months apart; 0.5 mL, Intramuscular. 2 vaccinations, 12 months apart
Other intervention name(s): Vaxigrip®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviridae Infections; Renal Transplant
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Condition: Vaginitis
MeSH terms: Vaginitis
Study type: Interventional
Phase: Phase 3

Summary: 
      POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated
      for the local treatment of vaginitis due to sensitive germs and treatment of non specific
      vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.

      Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study
      supporting the interest of the combination of antifungal and antibiotics agents versus
      antifungal agent alone.

      The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole
      in the treatment of women experiencing symptoms of infectious vaginitis.
    


Intervention name(s): POLYGYNAX®; GYNODAKTARIN®; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Occlusal Contact Trueness Affected by Six Chairside CAD/CAM Ceramic Materials
Condition: Tooth Defect
Study type: Interventional

Summary: 
      The aim of this clinic self-control study was to evaluate the trueness of occlusal contact
      affected by six ceramic materials during chairside fabricating process and offer
      recommendations for occlusal offset according to different ceramic materials in CEREC CAD/CAM
      design process.
    

Detailed description: 
      Ten participants were selected for this study. InCoris TZl(ZIR), Celtra Duo(CD), IPS
      e.max(EMA), UPCERA LICI (LC), Vita enamic(ENA), UPCERA RUNCI (RC) were used to produce crowns
      for everyone by CEREC chairside CAD/CAM system. The milling trueness, postprocessing trueness
      and clinical adjustment of occlusal contact were quantitatively analyzed by the ATOS
      high-precision scanner and Geomagic reverse engineering software.
    

Intervention name(s): Chairside CAD/CAM ceramic materials for dental restoration
Intervention type(s): Other
Intervention description(s): 6 crowns made from 6 chairside ceramic materials were milled by CEREC MCXL-EF mode for mandibular first molar of each participant.
The six materials are as follows:
ZIR: InCoris TZI (Dentsply Sirona, York, PA)， CD: Celtra Duo (Dentsply Sirona, York, PA), EMA: e.max CAD (ivoclar, Vivadent AG), LC: LiCi (UPCERA, China), ENA: Vita Enamic (Vita Zahnfabrik, Bad Sackingen, Germany) RC: RunCi (UPCERA, China)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Ten individuals with tooth defect of mandibular first molar were selected to participate in the study. 6 crowns made from 6 chairside materials were milled by CEREC MCXL-EF mode for each mandibular first molar.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chairside CAD/CAM; ceramic materials; trueness; occlusal contact
Functional Outcome After Arthroplasty
Condition: Fracture Neck of Femur
MeSH terms: Femoral Neck Fractures
Study type: Interventional

Summary: 
      Bipolar hemiarthroplasty (BA) has long been the preferred treatment and is performed in most
      fracture neck of femur (FNF) cases. It is justified by the reasonable operative time, low
      blood loss and acceptable functional outcomes. The dual mobility cup total hip replacement
      (DMTHA) has emerged as a relevant alternative to BA. Since then, there is an on-going debate
      on the best implant to use. Age, co-morbidities, patient independence and potential surgical
      complications must be considered when deciding between implants. The risk of dislocation is a
      crucial factor because of its important consequences. The investigators evaluated the
      functional and mechanical outcomes of BA versus DMTHA in FNF in active elderly patients.
    


Intervention name(s): arthroplasty
Intervention type(s): Procedure
Intervention description(s): arthroplasty for fracture neck of femur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy
Condition: Epilepsy; Epilepsies, Partial; Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on
      therapy in patients with difficult to control partial onset seizures who are taking one or
      two standard anti-epileptic drugs.
    

Detailed description: 
      Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain
      that temporarily disrupt normal brain function. Seizures are classified as "generalized,"
      originating in both sides of the brain simultaneously, or "partial-onset," starting in one
      area of the brain. Antiepilepsy medications, such as topiramate, are selected based on
      seizure type. This is a double-blind, placebo-controlled study that includes a baseline phase
      and a treatment phase. During the baseline phase (12 weeks duration), patients receive one or
      two of the following standard antiepileptic drugs (AEDs): phenytoin, carbamazepine,
      phenobarbital, or primidone. Patients who continue to have seizures during treatment with
      standard AEDs proceed into the double-blind treatment phase. Patients then receive placebo or
      topiramate at a dosage of 100-milligrams (mg) once daily, increasing to twice daily dosing at
      a maximum dose of 200 mg/day, 400 mg/day, or 600 mg/day or maximum tolerated dose (depending
      on treatment group), through Week 16 (total duration of double-blind phase), while continuing
      on their standard AED regimen. Assessments of effectiveness include the percent reduction in
      the average monthly seizure rate, percent of patients responding to treatment (having equal
      to or greater than 50% reduction in seizure rate), and, the patient's and investigator's
      global assessments of medication at end of study. Safety assessments include the incidence of
      adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry,
      urinalysis), neurologic examinations, and vital sign measurements (blood pressure, pulse,
      temperature) weekly during the treatment phase. The study hypothesis is that topiramate,
      taken as add-on therapy to treatment with AEDs, will significantly reduce seizure frequency,
      compared with placebo, in patients with refractory partial epilepsy and is well-tolerated.
      Topiramate, 100 milligrams[mg] oral tablets. Dosage begins at 100-mg once daily and increases
      gradually to twice daily dosing at a maximum dose of 200, 400, or 600 mg/day, and continues
      through Week 16 (total duration).
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: topiramate; epilepsy; partial epilepsies; partial epilepsy; seizures; epileptic seizures; partial seizure disorder; brain diseases
CD19-CAR-T in B-cell Malignancies Patients
Condition: B-cell Malignancy
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, single arm, open-lable phase I study to determine the safety and
      efficacy of CD19-CAR-T cells in patients with refractory and relapsed B-cell malignancies.
    

Detailed description: 
      This Phase I study is designed as a pilot trial evaluating the safety and of CD19-CAR-T cell
      therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive
      cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3
      followed by infusion of CD19-CAR-T cells. Safety and efficacy of CD19-CAR-T cells therapy
      will be monitored. The purpose of current study is to determine the clinical efficacy and
      safety of CD19-CAR-T cells therapy in patients with refractory and relapsed B-cell
      malignancies.
    

Intervention name(s): CD19-CAR-T cells
Intervention type(s): Biological
Intervention description(s): CD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment