bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
Condition: Asthma
MeSH terms: Asthma
Intervention: Ciclesonide; Placebo
Intervention description: Ciclesonide metered-dose inhaler; Ciclesonide placebo-matching metered-dose inhaler
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Ciclesonide; Exacerbation

Summary:

      The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of
      the number of asthma exacerbations in children with mild persistent asthma. Treatment
      medication will be administered as follows: ciclesonide will be inhaled once daily, using one
      of the two dose levels versus placebo together with other corticosteroids used as
      intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a
      treatment period (12 months). The study will provide further data on safety and tolerability
      of ciclesonide.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Outpatients

          -  Symptoms consistent with the diagnosis of asthma for at least 12 months

          -  Forced Expiratory Volume in one Second (FEV) at least 80% of predicted

          -  Participants who have a history of reversible airway obstruction

          -  Good health with the exception of asthma

        Main Exclusion Criteria:

          -  History of life-threatening asthma

          -  A hospitalization for asthma within the last 3 months, or more than two
             hospitalizations for asthma within the last year

          -  Concomitant severe diseases or diseases which are contraindications for the use of
             inhaled steroids

          -  Participants suffering from relevant lung diseases causing alternating impairment in
             lung function (e.g. chronic bronchitis or emphysema)

          -  Prematurely born children (<36 weeks of gestation)

          -  Smokers

          -  Pregnancy (or intention to become pregnant during the course of the trial), breast
             feeding or lack of safe contraception by female of child-bearing potential
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
Condition: Back Pain
MeSH terms: Back Pain
Intervention: Buprenorphine transdermal patch; Placebo oxycodone/acetaminophen tablets; OXY/APAP; Placebo transdermal patch (TDS)
Intervention description: Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.; Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.; 5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.; Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone; Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic back pain; opioid; transdermal

Summary:

      The objective of this study is to assess the safety of the buprenorphine transdermal system
      (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/
      acetaminophen in subjects with chronic back pain. The double-blind treatment intervention
      duration is 84 days during which time supplemental analgesic medication (non-steroidal
      anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical evidence of stable, chronic (>2 months) back pain related to intervertebral
             disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other,
             similar nonmalignant conditions.

          -  unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory
             drug considered at a therapeutic and/or tolerated dose or, subjects currently taking
             </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid
             doses per day.

        Exclusion Criteria:

          -  receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or
             receiving more than 12 tablets per day of short-acting opioid-containing products.

          -  scheduled to have surgery (including dental) involving the use of preoperative or
             postoperative analgesics or anesthetics during the study period.

        Other protocol-specific exclusion/inclusion criteria may apply.
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
Condition: Varicella
MeSH terms: Chickenpox
Intervention: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck); Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck); Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
Intervention description: VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart; VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart; M-M-R II in two 0.5 mL doses by injection ~6 weeks apart
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 598.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured
      with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly
      administered with M-M-R II in healthy children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is in good health based on medical history

          -  Subject has no history of measles, mumps, rubella, chickenpox, or shingles

        Exclusion Criteria:

          -  Subject has previously received measles, mumps, rubella, and/or varicella vaccine
             either alone or in combination

          -  Subject has history of immune disorders

          -  Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella
             within 4 weeks of study start

          -  Subject has received an inactivated vaccine within 14 days of first dose of study
             vaccine

          -  Subject has received a live vaccine within 30 days of first dose of study vaccine

          -  Subject has received a blood transfusion or blood-derived products within 3 months of
             receiving study vaccine

          -  Subject has had a fever within 72 hours of study start
Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Asenapine; Olanzapine
Intervention description: 5-10 mg sublingually twice daily for up to 26 weeks; 5-20 mg by mouth once daily for up to 26 weeks
Intervention MeSH terms: Olanzapine; Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 468.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Treatment with conventional antipsychotics such as haloperidol has little effect or may
      sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and
      poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as
      olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The
      purpose of this study is to compare an investigational compound (asenapine) with a marketed
      agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of
      schizophrenia for 6 months. Patients completing this study may be eligible to participate in
      an extension 6 months of treatment. Patients are required to have stable symptoms prior to
      entry into study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a documented current diagnosis of schizophrenia of paranoid, disorganized,
             catatonic, residual, or undifferentiated subtype with persistent negative symptoms.

          -  No increase in level of psychiatric care during the past few months due to worsening
             of symptoms of schizophrenia.

          -  Caregiver required.

        Exclusion Criteria:

          -  Have an uncontrolled, unstable clinically significant medical condition.

          -  Have any other psychiatric disorder other than schizophrenia as a primary diagnosis
             including depression.
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Condition: Irritable Bowel Syndrome With Constipation; Chronic Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide
Intervention description: Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Intervention MeSH terms: Linaclotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1743.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the long-term safety of linaclotide administered to
      patients with chronic constipation (CC) or irritable bowel syndrome with constipation
      (IBS-C).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have

               -  entered study MCP-103-303 or MCP-103-302 and at minimum completed the
                  pre-treatment period or

               -  completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201,
                  MCP-103-202

          -  Sexually active patients of childbearing potential agree to use birth control

          -  Females of childbearing potential must have a negative urine pregnancy test prior to
             dosing

          -  Lactating females must agree not to breastfeed

          -  Patient must meet protocol criteria for CC or IBS-C

        Exclusion Criteria:

          -  Patient must not use protocol-defined prohibited medicine

          -  Patient is planning to receive an investigational drug at any time during the study

          -  Patient has an unresolved adverse events or a clinically significant finding on a
             physical examination, 12-lead electrocardiogram, or clinical laboratory test
Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Active Comparator; ENA713
Intervention description: 1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day.; -3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
Intervention MeSH terms: Rivastigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Rivastigmine, Alzheimer's disease, Transdermal patch

Summary:

      To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration
      of Rivastigmine patch in the Japanese population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria

          -  A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria

          -  An MMSE score of ≥ 10 and ≤ 20 at baseline

        Exclusion Criteria:

          -  Any medical or neurological conditions other than AD that could explain the patient's
             dementia

          -  A current diagnosis of probable or possible vascular dementia

          -  A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)

          -  A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the
             patient's response to study medication.

          -  Treated with donepezil or galantamine within last 4 weeks before the efficacy
             assessment at baseline.

          -  an advanced severe progressive or unstable disease of any type that may interfere with
             efficacy and safety assessments or put the patient's at special risk

          -  Other protocol-defined inclusion/exclusion criteria may apply.
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Factor VIII (rFVIIIFc); Advate®
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc
      administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical
      treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm
      1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical
      treatment regimen. The secondary objectives of this study are: to characterize the PK profile
      of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to
      characterize the range of dose and schedules required to adequately prevent bleeding in a
      prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes
      in an on-demand, weekly treatment, or prophylaxis setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, ≥12 years of age with weight at least 40 kg

          -  Diagnosed with severe hemophilia A, defined as <1 IU/dL (<1%) endogenous Factor VIII)

          -  History of at least 150 documented prior exposure days to any Factor VIII product

          -  Platelet count ≥100,000 cells/μL

        Exclusion Criteria:

          -  History of Factor VIII inhibitors

          -  Kidney and liver dysfunction

          -  Diagnosed with other coagulation disorder(s) in addition to hemophilia A

          -  Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV
             immunoglobulin administration
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Intervention: GWP42003-P
Intervention description: Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open-label
Enrollment: 9.0
Sex: All
Minimum age: 1 Month
Maximum age: 24 Months
Healthy volunteers: No
Keywords: GWP42003-P; Cannabidiol

Summary:

      This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,
      and an open-label extension phase. The pilot phase only will be described in this record. 2
      cohorts of 5 participants will be enrolled sequentially. All participants will receive
      GWP42003-P.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant is aged 6- 24 months (inclusive) in the first cohort or aged 1-24 months
             (inclusive) in the second cohort, at the time of consent.

          -  Participant is diagnosed with IS and has failed to respond adequately following
             treatment with 1 or more approved IS therapies.

          -  To be considered hypsarrhythmia, as defined for use in the study, the
             electroencephalography (EEG) background must be slowed and have multifocal spikes. In
             addition, it must be either high voltage (above 300 µV) or have
             electrodecrement/discontinuity.

        Key Exclusion Criteria:

          -  Participant is currently taking or has taken clobazam or any mammalian target of
             rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit.

          -  Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB),
             of 460 msec or greater on ECG.

          -  Participant's caregiver is currently giving or has given recreational or medicinal
             cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the
             screening visit.

          -  Participant's caregiver is unwilling to abstain from giving the participant (including
             the participant's mother abstaining themselves, if breastfeeding)recreational or
             medicinal cannabis, or synthetic cannabinoid-based medications (other than the study
             drug) during the trial.

          -  Participant has any known or suspected hypersensitivity to cannabinoids or any of the
             excipients of the study drug, such as sesame oil.

          -  Participant has significantly impaired hepatic function at the screening visit.

          -  Participant has received an investigational medicinal product as part of a clinical
             trial within a minimum of 5 half-lives prior to the screening visit.
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide; Lacosamide
Intervention description: 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.; 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 426.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial Onset Seizures; Lacosamide; Monotherapy; Vimpat

Summary:

      The objective of this historical-controlled trial is to demonstrate the efficacy and safety
      of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are
      withdrawn from 1 to 2 marketed antiepileptic drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and
             or Complex Partial Seizures (with or without secondary generalization)

          -  Must be experiencing 2 to 40 seizures per 28-day period

          -  Stable dose of 1 or 2 marketed antiepileptic drugs

          -  Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum
             recommended maintenance dose per USA product label at screening

        Exclusion Criteria:

          -  Subject has a history of primary generalized or unclassified seizures

          -  Seizure disorder primarily characterized by isolated auras

          -  History of status epilepticus

          -  Seizures that are uncountable due to clustering

          -  Has greater than 5 seizures/day

          -  Subjects taking Benzodiazepines, Phenobarbital or Primidone

          -  Subject has Vagus Nerve Stimulation (VNS)

          -  Significant medical or psychiatric condition

          -  History of alcohol or drug abuse

          -  History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997
STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: 120, 200 or 360 micrograms iv monthly (starting dose)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy, safety and tolerability of once-monthly
      administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis
      participants with chronic renal anemia. Participants will receive monthly intravenous
      injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the
      dose of epoetin administered in the week preceding first study drug administration. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic renal anemia;

          -  Continuous stable intravenous maintenance epoetin therapy during previous month;

          -  Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3
             months.

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 2 months;

          -  Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100
             millimeter of mercury (mmHg) despite medication;

          -  Significant acute or chronic bleeding.
Study Of Adults And Adolescents With Vasomotor Rhinitis
Condition: Rhinitis, Vasomotor
MeSH terms: Rhinitis; Rhinitis, Vasomotor
Intervention: GW685698X
Intervention description: Aqueous Nasal Spray 100mcg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 352.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vasomotor Rhinitis; VMR; nonallergic rhinitis; GW685698X

Summary:

      The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg
      once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent
      subjects (12 years of age and older) with vasomotor rhinitis (VMR).
    

Eligibility criteria:

        Inclusion criteria:

          -  Must be outpatients.

          -  Diagnosis of VMR.

          -  Literate in English or native language.

        Exclusion criteria:

          -  Significant concomitant medical condition.

          -  Use corticosteroids or other allergy medications during the study.

          -  Used tobacco products within the past year.