bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Intervention: Trivalent Influenza Vaccine; Placebo
Intervention description: A single dose of 10^(7.0 ± 0.5) FFU of trivalent influenza vaccine will be administered as intranasal spray on Day 1.; A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy

Summary:

      This prospective annual release study is designed to evaluate the safety on new influenza
      virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 influenza
      season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 49 years

          -  Written informed consent

          -  Subject available by telephone

          -  Ability to understand and comply with the requirements of the protocol, as judged by
             the Investigator

        Exclusion Criteria:

          -  Concurrent enrollment in another clinical study up to 180 days after receipt of
             investigational product (Day 181)

          -  History of hypersensitivity to any component of the vaccine, including egg or egg
             protein or serious, life threatening, or severe reactions to previous influenza
             vaccinations

          -  Any condition for which the inactivated influenza vaccine is indicated, including
             chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma),
             chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or
             hemoglobinopathies that required regular medical follow-up or hospitalization during
             the preceding year

          -  Acute febrile (greater than [>] 100.0 degrees Fahrenheit [F] oral or equivalent)
             and/or clinically significant respiratory illness (example, cough or sore throat)
             within 14 days prior to randomization

          -  Any known immunosuppressive condition or immune deficiency disease, including human
             immunodeficiency virus infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barré syndrome
Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept
Intervention description: Administered by subcutaneous injection
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; etanercept; adalimumab

Summary:

      This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who
      have lost a satisfactory response to adalimumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe plaque psoriasis

          -  Loss of satisfactory response to adalimumab

          -  Currently receiving or recently discontinued treatment with adalimumab

        Exclusion Criteria:

          -  Active skin conditions that would interfere with evaluations of the effect of
             investigational product on psoriasis

          -  Serious medical conditions
A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients
Condition: COPD
Intervention: Indacaterol and glycopyrronium (QVA149); Tiotropium
Intervention description: Capsules for inhalation delivered via SDDPI; Capsules for inhalation delivered via HandiHaler® device
Intervention MeSH terms: Glycopyrrolate; Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 379.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; open-label; QVA149; symptomatic; tiotropium

Summary:

      To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once
      daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15
      min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal
             value and post-bronchodilator FEV1/FVC < 0.7 (COPD Grade 1 or 2 by severity of airflow
             limitation (GOLD 2015)

          -  Patients with CAT score ≥ 10 at Visit 0 and Visit 1.

          -  Patients who are on and have been on tiotropium monotherapy for the past 3 months.

          -  0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital
             admission).

        Exclusion Criteria:

          -  Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit 1.

          -  COPD exacerbation between Visit 0 and 1.

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of respiratory infection within 4 weeks prior to Visit 0.

          -  Prior or current diagnosis of asthma.

          -  Presence of any contraindication, warning, precaution, hypersensitivity to LABA and
             LAMA

        Other protocol-defined inclusion/exclusion criteria may apply
The Use of Probiotics to Evaluate Colonization With Antimicrobial Resistant Bacteria
Condition: Infectious Disease of Digestive Tract
MeSH terms: Communicable Diseases; Infections
Intervention: Lactobacillus rhamnosus GG
Intervention description: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Probiotics

Summary:

      The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus
      GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in
      patients on a ventilator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 years old

          -  Admission to the Medical ICU

          -  Expected to be on Mechanical Ventilation through an endotracheal tube for >48 hours

        Exclusion Criteria:

          -  Pregnancy

          -  Immunosuppression

          -  Prosthetic valve or vascular graft

          -  Cardiac trauma

          -  Pancreatitis

          -  History of rheumatic fever

          -  Endocarditis or congenital cardiac abnormality

          -  Gastroesophageal or intestinal injury or foregut surgery during the current admission

          -  Oropharyngeal mucosal injury

          -  Placement of a tracheostomy
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Axial Spondyloarthritis; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis
Intervention: Etanercept
Intervention description: 50 mg subcutaneous, once weekly, 24 weeks
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: non-radiographic axial spondyloarthritis

Summary:

      The purpose of this study is to study the benefits and risks of etanercept withdrawal in
      patients who have achieved a significant clinical response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of axial SpA duration of symptoms >3 months and <5 years back pain with a
             less than favorable response to NSAIDs

        Exclusion Criteria:

          -  radiological sacroiliitis previous treatment with TNF inhibitor, biologic,
             immunosuppressive
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
Condition: Transformed Migraine; Chronic Daily Headache
MeSH terms: Migraine Disorders; Headache Disorders; Headache
Intervention: SPG Block with 5% Lidocaine gel; Amitriptyline
Intervention description: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia; The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Intervention MeSH terms: Lidocaine; Amitriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Migraine Headache; Menstrual Migraine; Vascular Headache; Temporal Lobe Seizure

Summary:

      This study will compare a local anesthetic technique that has been used to treat subjects
      suffering from transformed migraines (chronic migraines) versus medical management with
      traditional antidepressant Amitriptyline / Elavil.

      Subjects will be randomized into one of two treatment groups to compare the safety and
      efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block
      with 5% lidocaine gel into the nasopharynx or medical management with traditional
      antidepressants, Elavil, to produce a reduction in the frequency and severity of the
      headache.

      We propose that there will be a difference in the outcomes when comparing the two methods of
      treating transformed migraines and that one research arm will result in more patient
      satisfaction and greater efficacy in the treatment of subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female age 18-90

          2. Subject have formal medical diagnosis of migraine headache

          3. Subjects currently require treatment for headache

          4. Subjects who have received optimal medical management from migraines including
             triptans (Imitrex, Amerge and Relpax)

          5. Subjects who have recieved optimal medical management for migraines including
             anticonvulsants (Depakote, Lamictal, klonopin

        Exclusion Criteria:

          1. Less than 18 years of age

          2. Subjects will be excluded if they are already being treated with lidocaine (patch or
             other vehicle) for chronic pain

          3. Untreated Heart Failure

          4. Pregnancy

          5. Individuals unwilling to comply with study procedures and follow-up
An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents
Condition: Onychomycosis; Tinea Unguium
MeSH terms: Onychomycosis
Intervention: Tavaborole 5% Topical Solution
Intervention description: topical solution for application to toenails
Intervention MeSH terms: Tavaborole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This was a single group study.
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 72 Months
Maximum age: 203 Months
Healthy volunteers: No
Keywords: Fungal infection of the nail

Summary:

      This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5%
      topical solution in treating distal subungual onychomycosis (a fungal infection) of the
      toenail in children and adolescents (ages 6 to 16 years).

      Following confirmation of eligibility, including laboratory evidence of a fungal organism in
      the toenail, tavaborole topical solution was applied once daily to all affected toenails for
      a 48-week treatment period.

      Clinical assessment of the extent of infection and safety assessments were performed
      periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after
      stopping the treatment).

      A subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small
      area of surrounding skin during the first 28 days. These subjects had blood samples analyzed
      to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical
      solution in children and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males or females, ages >/= 6 years and </= 16 years and 11 months

          -  clinical diagnosis of distal subungual onychomycosis affecting at least 20% of one of
             the great toenails (target nail); and with positive KOH and positive culture for T.
             rubrum or T. mentagrophytes from either great toenail

        Exclusion Criteria:

          -  the target toenail has proximal subungual onychomycosis, onychomycosis involving the
             nail lunula, superficial white onychomycosis, dermatophytoma, exclusively lateral
             disease, or yellow or brown spikes, or has co-infection with certain fungi or molds

          -  anatomic abnormalities of the toes or toenail

          -  current or past history of chronic moccasin-type tinea pedis

          -  current or past history of psoriasis or lichen planus

          -  history of significant chronic fungal disease (other than onychomycosis)

          -  diabetes

          -  immunodeficiency
Loteprednol vs. Prednisolone and Fluorometholone
Condition: Intraocular Pressure; Corneal Opacity
MeSH terms: Corneal Opacity
Intervention: Loteprednol Etabonate 0.5% Oph Gel; Prednisolone Acetate 1% Oph Susp
Intervention MeSH terms: Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Examiners are masked to the treatment arm when obtaining measurements of intraocular pressure (IOP) and grading corneal haze.
Enrollment: 131.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Photorefractive keratectomy

Summary:

      Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially
      vision-threatening postoperative complication of photorefractive keratectomy (PRK). Topical
      ophthalmic corticosteroids are routinely prescribed by most surgeons postoperatively to help
      prevent this complication.

      Goals of topical steroids use after PRK include effective modulation of the healing response
      to prevent corneal haze while at the same time minimizing side effects, such as intraocular
      pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that
      exerts its therapeutic effects and is then quickly changed into inactive metabolites. This
      relatively fast metabolism of loteprednol gives it a lower side effect profile than other
      steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature,
      there is currently no consensus on a standard regimen or which type of corticosteroid should
      be used after PRK.

      Investigators are conducting a prospective, randomized trial to compare the incidence of
      intraocular pressure rise and visually significant postoperative corneal haze after PRK with
      the use of loteprednol 0.5% gel compared to the use of earlier generation steroids,
      prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects who are deemed suitable candidates for PRK after routine refractive
             surgery screening will be considered eligible for participation in this study.

          -  Subjects must be at least 21 years of age and not pregnant or nursing (due to
             fluctuations in visual parameters during pregnancy).

        Exclusion Criteria:

          -  Selection will be consistent with the current standard of care for PRK. Any patient
             that is not a suitable candidate for PRK will not be included.
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Endoscopically guided PVI Ablation; RF PVI Ablation
Intervention description: Endoscopically Guided Ablation using the EAS-AC; Radiofrequency ablation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation

Summary:

      To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.

        1. visually guided ablation (VGA) using the EAS-AC and

        2. radiofrequency ablation
    

Eligibility criteria:

        -  Symptomatic, Paroxysmal Atrial Fibrillation (AF)

          -  18 to 75 Years of age

          -  Generally good overall health as determined by multiple criteria

          -  Willing to participate in a study

          -  Others
Split-face Tolerability Comparison Between Adapalene-Benzoyl Peroxide Gel Versus Tretinoin Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Epiduo Gel; Retin-A Micro Microsphere 0.1%
Intervention description: Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.; Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
Intervention MeSH terms: Tretinoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the tolerability of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% to
      Retin-A Micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3
      weeks in terms of local tolerability parameters (erythema, dryness, scaling,
      stinging/burning) and preference.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects of any race

          -  Subjects 18 years or older

          -  Subjects with acne vulgaris

        Exclusion Criteria:

          -  Subjects with an allergy to a component of the study drugs (refer to the package
             inserts for Epiduo Gel and Retin-A Micro 0.1%)

          -  Subjects with a washout period for topical treatment (less than 1 week for
             corticosteroids or 4 weeks for retinoids)

          -  Subjects with a washout period for systemic treatment (less than 1 week for
             medications that may have increased photosensitivity or 4 weeks for corticosteroids or
             24 weeks for oral retinoids)

          -  Subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or
             other topical conditions on the treatment area

          -  Subjects with planned unprotected and intense UV exposure during the study (mountain
             sports, UV radiation, sunbathing, etc)
Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone extended release (ER)
Intervention description: Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone Extended Release (ER); INVEGA

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of paliperidone
      extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of
      emotional instability, detachment from reality, often with delusions and hallucinations, and
      withdrawal into the self) participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for
             schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment
             from reality, often with delusions and hallucinations, and withdrawal into the self)

          -  Participants unsatisfied with their previous treatment

          -  Previously or currently on oral atypical antipsychotics

        Exclusion Criteria:

          -  Serious unstable medical condition, including recent and present clinically relevant
             laboratory abnormalities

          -  History or current symptoms of tardive dyskinesia (twitching or jerking movements that
             you cannot control in your face, tongue, or other parts of your body)

          -  History of neuroleptic malignant syndrome (high fever, rigid muscles, shaking,
             confusion, sweating more than usual, increased heart rate or blood pressure, or muscle
             pain or weakness)

          -  Pregnant or breast-feeding female

          -  Participation in an investigational drug trial within 30 days prior to selection