bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod
Intervention description: Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing-Remitting

Summary:

      This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg
      in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data
      in Multiple Sclerosis (MS) patient population that closely resembles the clinical population
      seen in routine medical care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with relapsing remitting Multiple Sclerosis

          -  Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.

        Exclusion Criteria:

          -  Patients with MS other than relapsing remitting MS

          -  Patients with a history of chronic disease of the immune system other than MS, which
             requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.

          -  Patients who have been treated with:

               -  systemic corticosteroids or immunoglobulins within 1 month prior to baseline;

               -  immunosuppressive medications within 3 months prior to baseline;

               -  monoclonal antibodies within 3 months prior to baseline;

               -  cladribine, mitoxantrone or alemtuzumab at any time.

          -  Uncontrolled diabetes mellitus at screening

          -  Diagnosis of macular edema during Screening Phase

          -  Patients with active systemic bacterial, viral or fungal infections, or known to have
             AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B
             surface antigen or Hepatitis C antibody tests.

          -  Patients who have received total lymphoid irradiation or bone marrow transplantation.

          -  Patients with certain cardiovascular conditions and/or findings in the screening ECG

          -  Patients with certain liver conditions

          -  Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women

          -  Other protocol-defined inclusion/exclusion criteria may apply.
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
Condition: Fibromyalgia; Sleep Disorders
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Sleep Wake Disorders
Intervention: Pregabalin; Placebo
Intervention description: Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day; Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibromyalgia sleep maintenance disturbance pregabalin

Summary:

      The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in
      subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must meet diagnostic criteria for fibromyalgia;

          -  Subjects must report difficulty in maintaining sleep at least 3 times per week and
             meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject
             diary, and meet PSG inclusion criteria at visit 3.

        Exclusion Criteria:

          -  History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia
             criteria or any sleep or circadian rhythm disturbance;

          -  Use of medications known to affect sleep wake function by Visit 2;

          -  Involved in night or rotating shift work, or travel across >4 time zones 14 days prior
             to screening and during study; regular daytime napping

          -  PSG finding of apnea/hypopnea or periodic limb movement with arousal index >10/hr on
             either night of PSG.
Efficacy of Salivary Bacteria and Post Brushing
Condition: Salivary Bacteria Levels
Intervention: Fluoride; Triclosan/Fluoride
Intervention description: Whole mouth brushing for 7 days; Brush whole mouth twice daily for 7 days
Intervention MeSH terms: Listerine; Triclosan; Fluorides; Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Research study to compare the effects of brushing with two commercially available toothpastes
      on salivary bacteria after brushing
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers 18-65 years of age

          -  Good general health

          -  Must sign informed consent form

          -  Must discontinue oral hygiene on the mornings of each appointment and between sampling
             periods.

          -  No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

        Exclusion Criteria:

          -  Medical condition which requires pre-medication prior to dental procedures/visits

          -  Medical condition which precludes eating/drinking for 12 hrs.

          -  History of allergy to common dentifrice ingredients

          -  Subjects unable or unwilling to sign the informed consent form.

          -  Moderate or advanced periodontal disease.

          -  2 or more decayed untreated dental sites at screening.

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that can currently affect salivary flow

          -  Current use of antibiotics

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

          -  Pregnant or nursing women.

          -  Participation in any other clinical study within 30 days prior to enrollment into this
             study.

          -  Use of tobacco products

          -  Subjects who must receive dental treatment during the study dates.

          -  Current use of Antibiotics for any purpose.

          -  Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy)
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; Comparator: Placebo
Intervention description: montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.; Placebo. Up to 3 weeks of treatment
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 421.0
Sex: All
Minimum age: 6 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma
      which is also active during allergy seasons in pediatric patients with seasonal aeroallergen
      sensitivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients, ages 6 to 14 years, with persistent asthma that is also
             active during allergy season

          -  Patients must demonstrate positive skin prick tests to seasonally relevant geographic
             aeroallergens

        Exclusion Criteria:

          -  Patient cannot have any other acute or chronic pulmonary disorder
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rosiglitazone XR
Intervention description: Experimental drug
Intervention MeSH terms: Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1461.0
Sex: All
Minimum age: 51 Years
Maximum age: 91 Years
Healthy volunteers: No
Keywords: cognition; Alzheimer's disease; Rosiglitazone extended-release (XR); safety; adjunctive therapy; BRL-049653; tolerability; open-label extension

Summary:

      This is a Phase III, multicenter, open-label extension, single-group study in male and female
      outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either
      AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg
      once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to
      their existing dose of acetylcholinesterase inhibitor. Subject participation will last until
      one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend
      a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this
      study is to evaluate the long-term safety and tolerability of RSG XR in subjects with
      mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective
      of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive
      function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele
      status.
    

Eligibility criteria:

        Inclusion criteria:

          -  Successful completion of AVA102670 or AVA102672 without safety or tolerability issues.
             Regular caregiver.

        Exclusion criteria:

          -  Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other
             neurological conditions that might disqualify participation. SAE, clinically
             significant laboratory abnormality or significant cardiovascular event during prior
             study.
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg iv every 4 weeks, 104 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No

Summary:

      This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra
      (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who
      completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8 mg/kg
      intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed visit 33 (week 104) of WA19977 study and who may benefit from
             study drug treatment according to the investigator's assessment

          -  Patients have to receive the first RoActemra/Actemra infusion in this study at the
             Week 8 visit at the latest

          -  Females of child-bearing potential and males with female partners of child-bearing
             potential must agree to use effective contraception as defined by protocol

        Exclusion Criteria:

          -  Patients with, according to investigator judgment, not satisfactory benefit from
             RoActemra/Actemra therapy within WA19977

          -  Treatment with any investigational agent since the last administration of study drug
             in the core study WA19977

          -  Patient developed any other autoimmune rheumatic disease or overlap syndrome other
             than the permitted polyarticular-course Juvenile Idiopathic Arthritis (JIA) subsets:
             rheumatoid factor positive or negative JIA or extended oligoarticular JIA

          -  Patient is pregnant , lactating, or intending to become pregnant during the study and
             up to 12 weeks after the last administration of study drug

          -  Any significant concomitant disease or medical or surgical condition

          -  History of significant allergic or infusion reactions to prior biologic therapy

          -  Currently active primary or secondary immunodeficiency

          -  Any infections with contraindications to RoActemra/Actemra therapy according to
             investigator judgment

          -  Inadequate hepatic, renal or bone marrow function
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Medisorb naltrexone 380 mg; Medisorb naltrexone 190 mg
Intervention description: Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.; Administered via IM injection once every 4 weeks for up to 3.5 years.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol dependence

Summary:

      This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to
      further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone
      (VIVITROL®).
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections

          -  Willing and able to return for scheduled clinic visits and study assessments

          -  Noncustodial, stable address and phone

          -  Written, informed consent

        Primary Exclusion Criteria:

          -  Pregnancy or lactation

          -  Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Montelukast; Comparator: Placebo
Intervention description: one 10 mg tablet, taken once daily at bed time for 6 weeks; one placebo tablet, taken once daily at bed time for 6 weeks
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1992.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of an approved medication on the
      symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose
      similar to that found in hay fever except that symptoms persist throughout the year), in
      patients who have a history of perennial allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smoker with a 2-year documented history of perennial allergic (symptoms that
             persist throughout the year) rhinitis symptoms and positive allergy testing

        Exclusion Criteria:

          -  Medical history of a lung disorder (other than asthma) or a recent upper respiratory
             tract infection
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Gastric Electrical Stimulator, Enterra, Medtronics, Inc.
Intervention description: All patients received a GES electrode, endoscopically placed and connected to an external device at baseline. The device was turned ON to provide 72 continuous hours of active stimulation and OFF to deactivate stimulation
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Nausea; Vomiting; Delayed gastric emptying; Diabetes Mellitus; Post-Surgical; Idiopathic

Summary:

      The purpose of this research is to determine if temporary gastric electrical stimulation will
      help improve symptoms of gastroparesis (abnormal stomach emptying). We hypothesize that when
      the device is ON, Gastrointestinal symptoms will decrease by at least 50% from baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sex: Male of Female

          -  Age Range: 18 to 70 inclusive

          -  Patients with GP of diabetic, surgically related or idiopathic etiology.

          -  Symptoms of GP for >/= 1 year.

          -  Refractory or intolerant to antiemetic drug classes (antihistamines and
             phenothiazines, serotonin receptor antagonists, dopamine receptor antagonists)

          -  Chronic vomiting and/or nausea with 7 or more episodes per week for either symptom
             irrespective of GET values.

          -  The patient is willing and able to provide informed consent.

          -  The patient is willing and able to return for required follow-up visits.

        Exclusion Criteria:

          -  Patients < 18 or >70 years in age.

          -  Patients with an active infection of any kind.

          -  Patients who the investigator determines are not candidates for endoscopic procedures.

          -  Women who are pregnant

          -  Inability or unwillingness to provide informed consent

          -  Unwilling or unable to return for required follow-up visits and examinations.

          -  Patients who are currently enrolled in another investigation of a medical device or
             drug.
A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: TIVc; TIV
Intervention description: Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain [A/H1N1-like, A/H3N2-like, and B-like]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere; A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain [A/ H1N1-like, A/H3N2-like, and B-like]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 430.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Vaccine; Flu; Children; Adolescents

Summary:

      The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to < 18
      years of age who are at risk of complications of influenza disease due to underlying
      diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals 3 to <18 years of age with underlying medical conditions that indicate an
             increased risk of complications from influenza infection.

          -  Further eligibility criteria may be discussed by contacting the site(s)

        Exclusion Criteria:

          -  Individuals with any fatal prognosis of an underlying medical condition (<12 month
             life expectancy).

          -  Individuals hospitalized at the time of enrolment.

          -  Individuals with a history of any anaphylaxis, serious vaccine reactions, or
             hypersensitivity to any of the vaccine components.

          -  Further eligibility criteria may be discussed by contacting the site(s)
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Intervention: nonacog beta pegol; nonacog beta pegol; nonacog beta pegol
Intervention description: One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.; One single dose administered intravenously (into the vein). Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode.; One single dose administered intravenously (into the vein) every second week. Patients will receive instruction on how to treat any bleeding episode they may experience.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Male
Minimum age: 13 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to
      evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term
      exposure in patients with haemophilia B.

      This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773
      (NCT01386528/paradigm™ 3).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773

        Exclusion Criteria:

          -  Known history of FIX inhibitors based on existing medical records, laboratory report
             reviews and patient and LAR (legal acceptable representative) interviews

          -  Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units)

          -  Congenital or acquired coagulation disorders other than haemophilia B

          -  Previous arterial thrombotic events (e.g. myocardial infarction and intracranial
             thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by
             available medical records)

          -  Any disease (liver, kidney, inflammatory and mental disorders included) or condition
             which, according to the Investigator's (trial physician) judgement, could imply a
             potential hazard to the patient, interfere with trial participation, or interfere with
             trial outcome