bioihbjkbjnl/mcl2 huggingface dataset:
A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant
Condition: Influenza (Pandemic)
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years
      old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior
      influenza immunization within the past three months. Subjects 18 to 49 years of age will
      comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50
      to 64 years.

      Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0
      and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately
      385 days total, or approximately 13 months from the first dose.
    


Intervention name(s): Monovalent Avian Influenza VLP (H7N9); Matrix-M1™ adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: H7N9
Diabetes Prevention Program in Youth
Condition: Pre Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of an out-of-school diabetes
      prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2
      diabetes.
    

Detailed description: 
      The Insulin Superheroes Club (ISC) is based on the Diabetes Prevention Program for adults
      (Knowler WC et al., 2002), which was developed by the Centers for Disease Control and
      Prevention (CDC). We have adapted the curriculum for youth to serve a supplement to the adult
      program. This program lasts 12 months, and the goals are to improve participants' health and
      reduce their risk of developing pre-diabetes or type 2 diabetes. The ISC program includes 16
      weekly (Phase 1), 3 bi-weekly (Phase 2), and 6 monthly (Phase 3) sessions. Sessions include
      60 minutes of physical fitness and 30 minutes of education. The education portion includes
      interactive teaching of a health-related topic (e.g., nutrition, exercise, physiology,
      mindfulness, and stress reduction) using a hand-on learning activity (e.g., cooking, crafts,
      games, and role play). All physical fitness activities incorporate moderate intensity
      exercises (e.g., push-ups, yoga, basketball, tag, and dance).
    

Intervention name(s): Insulin Superheroes Club Curriculum
Intervention type(s): Behavioral
Intervention description(s): This curriculum promotes healthier physical activity, nutrition, sleep, and stress coping practices. The intervention lasts 12-months: registration, six evaluation sessions (2-3 hours per evaluation: Weeks 1, 8, and 16, 6-month, 9-month, and 12-month), and 16-weekly, 3-bi weekly, 6-monthly educational and physical activity sessions each lasting 90 minutes.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Teens; Adolescents; Type 2 diabetes; Impaired glucose tolerance; Exercise; Nutrition; Education
A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Major depressive disorder (MDD) is a serious medical illness associated with significant
      suicidal risk and marked disability. Despite the availability of numerous treatments,
      achievement of consistent and favorable long-term outcomes remains challenging.

      This study will assess the safety, efficacy and tolerability of brexpiprazole as adjunctive
      therapy to protocol-specific open-label antidepressant therapy.
    


Intervention name(s): Brexpiprazole; Antidepressant therapy
Intervention type(s): Drug; Drug
Intervention description(s): Administered as tablets.; Protocol-specified oral ADTs included:
citalopram hydrobromide (Celexa®) tablets, escitalopram (Lexapro®) tablets, fluoxetine (Prozac®) capsules, paroxetine (Paxil CR®) controlled-release tablets, sertraline (Zoloft®) tablets, duloxetine (Cymbalta®) delayed-release capsules, venlafaxine XR (Effexor XR®) extended-release (XR) capsules.
Other intervention name(s): OPC-34712; Rexulti
Intervention MeSH terms: Antidepressive Agents; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brexpiprazole; MDD
Diaphragmatic Movement Before and After Stellate Ganglion Block : A Ultrasonographic Study
Condition: Head Pain; Neck Pain; Shoulder Pain; Arm Pain; Neural Sensory Hearing Loss
MeSH terms: Shoulder Pain; Hearing Loss; Hearing Loss, Sensorineural; Neck Pain; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      The temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will
      be easily detected by M-mode ultrasonography
    


Intervention name(s): M-mode ultrasonography
Intervention type(s): Procedure
Intervention description(s): Evaluation of diaphragmatic movement using M-mode ultrasonography before and after stellate ganglion block with 1% lidocaine
Primary purpose: Treatment
Mechanism of Allogeneic UCB Therapy in Cerebral Palsy
Condition: Cerebral Palsy; Child Development
MeSH terms: Cerebral Palsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In our prior study on the therapeutic mechanism of UCB, changes in cytokine levels were
      observed but the results are inconclusive and further studies on animal models and changes of
      protein expression before and after UCB therapy in the clinical settings are required.

      The changes in protein expression will be assessed by multiplex RT-PCR mRNA assay. Clinical
      efficacy of UCB therapy will be evaluated with various functional assessment tools. Factors
      regarding UCB therapy (number of transplanted cells, HLA matching status, serum level of
      immunosuppressant, etc.) and patient factors (age, functional status, etc.) will be analyzed
      for correlation with protein expression after UCB therapy. Several target proteins for
      analysis are available. Pentraxin and toll-like receptor (TLR) 4 are receptors modulating
      intrinsic immune reaction and was shown to have a significant correlation with clinical
      efficacy of stem cell therapy. Ubiquitine is a regulatory protein that combines with the
      target protein and affects its degradation, interaction, localization and activation. The
      ubiquitine system controls total protein quantity for homeostasis and can be found in all
      tissues. Deubiquitination (DUB) enzyme down-regulates this ubiquitine and is known to
      modulate all cellular changes
    


Intervention name(s): allogeneic cord blood transplantation
Intervention type(s): Biological
Intervention description(s): UCB with total nucleated cell count ≤ 7x108/kg will be used for this clinical trial. Suitable UCB (i.e., containing total nucleated cell count ≥2x107/kg with three or less mismatch among HLA-A, -B, and -DR) will be selected. This criterion was selected upon the rationale that even though minimal HLA mismatch is preferred, prior studies indicate significant effects of UCB therapy for patients with 3 HLA mismatches.
Intervention model: Single Group Assignment
Intervention model description: Patients diagnosed with cerebral palsy volunteered for participation in this study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Umbilical cord blood transplantation; Cytokine changes
Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement
Condition: Alveolar Process Atrophy
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      Patients with long span, narrow edentulous ridge in the posterior mandible underwent
      piezotomed ridge splitting and osseodensification with simultaneous implant placement.
    

Detailed description: 
      This study is a single arm clinical trial. Patients of both genders, who are indicated for
      ridge splitting, were recruited from the outpatient clinic, Faculty of dentistry, Alexandria
      University.

      The PICO question: "What is the effect of piezotomed ridge splitting and osseodensification
      on implant placement in narrow posterior mandibular ridges?"

      Ethical approval for the study was obtained from the regional Ethical Review Board of the
      Faculty of Dentistry. All patients were informed about the procedure details, and each
      participant signed a written consent.

      Ridge expansion was accomplished by piezotomed ridge splitting and osseodensification.
      Simultaneous implant placement was done in the same procedure.

      Implant stability was assessed. Also, bone width gained and bone density were measured around
      the dental implants using cone beam computed tomography.
    

Intervention name(s): Piezotomed ridge splitting and osseodensification
Intervention type(s): Device
Intervention description(s): Ridge expansion using piezotomed ridge splitting and osseodensification
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Palatability of a Novel Oral Formulation of Prednsione
Condition: Palatability
Study type: Observational

Summary: 
      Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone
      to pediatric and adult patients. The rationale for this study is that palatability is the
      most important determinant of pediatric patient compliance, and therefore, it is critical
      that the Orbis formulation be perceived as significantly more palatable compared to today's
      commercially available products in order to warrant further development of the TP.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 24 healthy young adults (12 males and 12 females), ranging in age from 18 to 32
        years of age comprised of a convenience sample who meet study eligibility criteria.
      
Biospecimen description: 
      Whole Blood
Pharmacokinetic Study of ORM-12741 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy
      volunteers.
    


Intervention name(s): ORM-12741
Intervention type(s): Drug
Intervention description(s): i.v., oral solution and oral capsule forms. Oral capsule given with and without food.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette
      device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and
      consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study
      in adult smokers.

      Subjects are invited to participate to a second part of the study, for 5 additional days, to
      compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.
    


Intervention name(s): Myblu variant A; Myblu variant B; Myblu variant C; Myblu variant D; Myblu variant E; Myblu variant F; Myblu variant G; Myblu variant H
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Use of Myblu e-cigarette with flavor A 2.4% nicotine; Use of Myblu e-cigarette with flavor B 3.6% nicotine; Use of Myblu e-cigarette with flavor C 2.5% nicotine; Use of Myblu e-cigarette with flavor D 4.0% nicotine; Use of Myblu e-cigarette with flavor E 3.6% nicotine; Use of Myblu e-cigarette with flavor F 2.4% nicotine; Use of Myblu e-cigarette with flavor G 4.0% nicotine; Use of Myblu e-cigarette with flavor H 3.6% nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to:

        -  Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and
           tablet prototype test formulation)

        -  Compare the amount of study drug that is in the blood after taking either the capsule
           form of the drug or the tablet form of the drug while fasting.

        -  Determine the amount of study drug that is in the blood after eating a meal.

        -  Evaluate the safety of the tablet form of samatasvir in healthy people.
    

Detailed description: 
      Each participant will receive each of the formulations in a crossover design. Part A Periods
      1 and 2: Participants will receive either samatasvir capsules or tablets according to
      randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants
      will receive samatasvir tablets under fed conditons on Day 15.

      Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive
      samatasvir capsules under fed conditons on Day 1.
    

Intervention name(s): Samatasvir tablet; Samatasvir capsule
Intervention type(s): Drug; Drug
Intervention description(s): Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose); Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: HCV; Hepatitis C Virus
Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Rubella
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to study the safety and immune response to measles, mumps, and
      rubella in children who were vaccinated with an investigational measles-mumps-rubella live
      vaccine made with artificially made human protein.
    

Detailed description: 
      The duration of treatment is 6 weeks.
    

Intervention name(s): measles, mumps, and rubella virus vaccine live; Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
Intervention type(s): Biological; Biological
Other intervention name(s): V205C
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush
Condition: Gingivitis; Plaque, Dental
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      The objective of this clinical research study is to assess plaque and gingivitis reductions
      of Connected Toothbrush compared to Non-Connected Toothbrush over a six-week clinical study.
    

Detailed description: 
      A phase II randomized, single-center, two-cell, examiner-blind and parallel-group clinical
      study conducted in the Loma Linda, California area, to investigate the clinical efficacy of a
      connected power toothbrush as compared to a non-connected power toothbrush in reducing dental
      plaque and gingivitis as measured by the Rustogi Modification of the Navy Plaque Index and
      Löe and Silness Gingival Index over a 6-week period.
    

Intervention name(s): Electric Toothbrush; oral health care application
Intervention type(s): Device; Other
Intervention description(s): Electric Toothbrush used to remove dental plaque and resolve gingivitis; phone application that shows the user brushing efficiency real time
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem and
      placebo, on driving performance as assessed by the mean difference of standard deviation of
      lateral position (SDLP) after forced awakening using a validated driving simulator test at 2,
      4, 6 and 8 hours post-evening dose.
    

Detailed description: 
      This is a single center, double-blind (neither Investigator nor participant knows which
      treatment the participant receives), randomized (study drug assigned by chance), 3-way
      cross-over (the same medications provided to all participants but in different sequence),
      pilot study in healthy male and female participants. Participants will be randomly assigned
      to 1 of 6 treatment and planning sequences. The study will consist of 3 parts: Screening
      Phase (between 21 days and 1 day prior to the first dose administration), a 3-way crossover
      double-blind, single dose treatment Phase and follow-up Phase (7 to 10 days after last dose
      administration). The maximum study duration for each participant will not exceed 7 weeks. The
      double-blind crossover treatment phase will consist of 3 treatment periods separated by a
      washout period of at least 3 days between dosing. Participants will receive either Treatment
      A (2 capsules of 20 milligram [mg] JNJ-42847922), Treatment B (10 mg zolpidem and 1 placebo
      capsule) or Treatment C (2 placebo capsules) in each treatment period. Driving performance
      will be assessed primarily by the mean difference of standard deviation of lateral position
      (SDLP) from an on road driving test. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): JNJ-42847922; Zolpidem; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.; Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.; Matching Placebo will be administered orally.
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42847922; zolpidem; Placebo
Erythropoietin Effect on Ischemic_ Reperfusion Injury in Coronary Artery Bypass Graft Surgery
Condition: Myocardial Ischemic Reperfusion Injury
MeSH terms: Reperfusion Injury; Myocardial Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of this trail is to assess the safety and therapeutic effects of single EPO
      intervention in different times during coronary surgery in changes of inflammatory response.
    

Detailed description: 
      In addition to well-known effect of Erythropoietin (EPO) on erythropoiesis in hypoxic
      conditions, some lines of evidence suggest its protective effects against reperfusion injury
      in several tissues by its specific receptor.

      Preclinical studies have indicated a broad variety of cardioprotective actions for EPO. It
      improves cardiac function and exercise capacity in congestive heart failure, angiogenesis,
      limit myocardial inflammatory response, cardiac remodeling, infarct size and apoptosis
      extension induced by reperfusion injury. Activation of EPO receptor in endothelial and
      cardiac cells is suggested to attenuate proinflammatory cytokines production and inflammatory
      cells infiltration, and increasing nitric oxide production through possible mechanisms.

      Reperfusion injury is unavoidable event during cardiac surgery using cardiopulmonary
      bypass.It is associated with inflammation, cell injury and attenuate contractility property.

      Although it is an area of concern and many clinical studies have been designed by different
      interventions, it remains a major challenge. EPO intervention during heart reperfusion
      (surgery/ percutaneous angioplasty) as a new promise of cardioprotection strategy is the main
      design of several studies with conflicting results .
    

Intervention name(s): normal saline; erythropoietin
Intervention type(s): Drug; Drug
Other intervention name(s): N/S; epoietin alfa
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronary artery bypass; Erythropoietin; Inflammation; IL-6; Reperfusion injury; YKL- 40
Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
Condition: Ocular Infection and Inflammation
MeSH terms: Infections; Communicable Diseases; Eye Infections; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and
      1.0% prednisolone acetate association in eye drops in the prevention of infection and
      inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the
      efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0%
      prednisolone acetate as isolated eye drops formulations. The study treatment is randomized,
      double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days
      of study treatment administration after the ocular surgery is performed. Candidates for the
      study are patients with indication for ocular refractive surgery (Lasik) for correction of
      visual acuity.
    


Intervention name(s): 0.3% gatifloxacin and 1.0% prednisolone acetate association; isolated 0.3% gatifloxacin and 1.0% prednisolone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the association and another with placebo. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations.
This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15.; Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the 0.3% gatifloxacin eye drops and another with 1.0% prednisolone acetate eye drops. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations.
This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15.
Other intervention name(s): Zypred; Zymar; Pred Fort
Intervention MeSH terms: Gatifloxacin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment