bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fingolimod; Placebo; Seasonal influenza vaccine; Tetanus toxoid vaccine
Intervention description: Fingolimod 0.5 mg capsules for oral administration.; Matching placebo capsules for oral administration.; Commercially available injectable influenza vaccine for the 2010/11 influenza season.; Commercially available tetanus toxoid vaccine booster injection.
Intervention MeSH terms: Vaccines; Fingolimod Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; MS; Immune response

Summary:

      This study will evaluate the effect of treatment with fingolimod on the immune response
      following seasonal influenza vaccination and tetanus booster injection in patients with
      relapsing MS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have relapsing MS

          -  Must have lifetime tetanus vaccination

          -  Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster
             injection

        Exclusion Criteria:

          -  Patients with a type of MS that is not relapsing

          -  Patients with history of chronic immune disease

          -  Certain cancers

          -  Diabetic patients with certain eye disorders

          -  Patients who are on certain immunosuppressive medications or heart medications

          -  Patients with certain heart conditions

          -  Patients with certain lung conditions

          -  Patients who have already received the 2010/2011 seasonal influenza vaccine

        Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of an Investigational Multi-Purpose Solution (MPS)
Condition: Study Focus is Healthy Contact Lens Wearers
Intervention: Investigational MPS; Opti-Free
Intervention description: Multi-purpose solution; Multi-purpose solution
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adapted contact lens wearers

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of an investigational
      multi-purpose contact lens solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have successfully worn hydrogel contact lenses of the same material to be worn during
             the study

          -  Have normal eyes (with the exception of unaided visual acuity)

          -  Have successfully used a multi-purpose contact lens care solution

          -  Have acceptable visual acuity and lens wearing comfort at time of enrollment

        Exclusion Criteria:

          -  Concurrently enrolled another clinical trial

          -  Have a known sensitivity to any study product ingredient(s)

          -  Have a condition that may put them at significant risk
Study Utilizing Rilonacept in Gout Exacerbations
Condition: Acute Gout Flare
MeSH terms: Gout
Intervention: Rilonacept; Indomethacin; Placebo (for Indomethacin); Placebo (for Rilonacept)
Intervention description: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).; Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).; Placebo (for Indomethacin) orally TID for 12 days.; Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).
Intervention MeSH terms: Indomethacin; Rilonacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Metabolism, Inborn Errors; Allopurinol; Metabolic Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Metabolic disorder; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Flare

Summary:

      This purpose of this clinical research was to determine the efficacy and safety of an
      experimental drug called Rilonacept in participants with an acute gout attack. Participants
      participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin
      alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 - 70 years of age

          2. Previously met the preliminary criteria of ARA for the classification of the acute
             arthritis of primary gout

          3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain
             of at least moderate severity

          4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments
             of the gouty index joint

          5. Current presentation of acute gout flare in 3 joints or less

        Exclusion Criteria:

          1. Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48
             hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month
             prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and
             indomethacin SR within 5 days prior to baseline visit.

          2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment
             with topical analgesics within 12 hours before baseline assessments

          3. History of NSAID intolerance

          4. Participants with history of chronic, gouty arthritis
Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; metformin; biphasic insulin aspart 50
Intervention description: Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner; Tablets, 500 - 2000 mg, once, twice or three times daily; Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 441.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The trial aims to investigate if the blood glucose control
      of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin
      aspart 30 both in combination with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Currently treated with premix human insulin twice daily with or without oral
             antidiabetic drugs for at least 3 months

          -  HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)

          -  FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L

          -  BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

        Exclusion Criteria:

          -  Metformin contraindications according to local practice

          -  Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior
             to this trial
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide
Intervention description: subcutaneous injection, 5mcg or 10mcg, twice a day
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: exenatide; Byetta; antibodies; Amylin; Lilly

Summary:

      The primary purpose of this study is to assess the anti-exenatide-antibody response to
      exenatide re-exposure as measured by anti-exenatide antibodies and incidence of
      treatment-emergent allergy and hypersensitivity reactions following a period of treatment
      interruption, in patients previously exposed to exenatide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes.

          -  Have been exposed to exenatide for at least 3 months in previous Amylin/Lilly Studies
             H8O-MC-GWAO, H8O-MC-GWAP, H8O-MC-GWAT, or H8O-MC-GWBA.

          -  Have interrupted exenatide treatment for a period of at least 2 months.

          -  HbA1c of ≤10.5%.

        Exclusion Criteria:

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Have previously completed or withdrawn from this study.

          -  Have taken marketed exenatide (Byetta) during the interim period between studies GWAO,
             GWAP, GWAT, or GWBA and the current study.

          -  Used drugs for weight loss (for example, Xenical® [orlistat], Meridia® [sibutramine],
             Acutrim® [phenylpropanolamine], Accomplia® [rimonabant], or similar over-the-counter
             medications) within 3 months of screening.

          -  Are currently treated with any of the following excluded medications: Drugs that
             directly affect gastrointestinal motility, including, but not limited to: Reglan®
             (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.

          -  Use insulin with daily dosage exceeding 1 U/kg.
Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Secukinumab (AIN457); Placebo
Intervention description: Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis, RA, IL-17 blocker, subcutaneous, self-injection, AIN457, AIN457F, secukinumab, anti-TNFα, pre-filled syringe

Summary:

      This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS)
      for subcutaneous self-administration in patients with active rheumatoid arthritis who are
      intolerant to or have had an inadequate response to anti-TNF-α agents.
    

Eligibility criteria:

        Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised
        criteria for at least 3 months •Disease activity defined by ≥6 tender joints out of 68 and
        ≥ 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR
        Rheumatoid Factor positive AND WITH Either hsCRP ≥ 10 mg/L OR ESR ≥28 mm/1st hr •Intake of
        at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or
        golimumab for at least 3 months before entering the study and to have experienced an
        inadequate response to treatment or to have been intolerant to at least one administration
        Exclusion Criteria:

          -  Current RA functional status class IV according to the ACR 1991 revised criteria
             •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17
             receptor and/or any history of hypersensitivity to secukinumab or its excipient or to
             drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria
             may apply
Safety and Efficacy of NT 201 (IncobotulinumtoxinA [Xeomin]) in the Treatment of Glabellar Frown Lines
Condition: Glabellar Lines
Intervention: IncobotulinumtoxinA (Xeomin) (20 units)
Intervention description: Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 801.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study objective was to investigate the safety and efficacy of incobotulinumtoxinA
      (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with
      moderate to severe glabellar frown lines at maximum frown who completed participation in one
      of the studies in this program, i.e. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or
      MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants with 'moderate' or 'severe' glabellar frown lines at maximum frown at the
        beginning of each treatment cycle (as assessed by the investigator according to FWS) ,
        stable medical condition; Completion of one former study in the Merz NT 201 glabellar
        program

        Exclusion Criteria:

        Participants with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton
        syndrome) putting the participant at risk, History of Facial Nerve Palsy, Previous
        treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous
        treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo
        rejuvenation) in the glabellar area during the last 12 months, Previous insertion of
        permanent material in the glabellar area; Planned treatment with Botulinum toxin of any
        serotype in any body region during the study period, Any other planned facial aesthetic
        procedure in the glabellar area during the trial period; Any surgery in the glabellar area
        including surgical removal of the corrugator, procerus or depressor supercili muscles or a
        combination of these or scars in the glabellar area, Inability to substantially lessen
        glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis
        of eyelid and/or eyebrow; Any infection in the area of the injection sites.
Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
Condition: Macular Edema; Central Retinal Vein Occlusion
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Ranibizumab 0.5 mg/0.05 ml
Intervention description: Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ophthalmology; Ranibizumab; Central Retinal Vein Occlusion

Summary:

      The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using
      as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema
      secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical
      coherence tomography (OCT) images was analyzed to gain insights into predictive factors for
      disease progression and the possibility of reduced monitoring was assessed in Year 2. The
      results of this open-label study provided long-term safety and efficacy data to further guide
      recommendations on the use of ranibizumab in this indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years of age

          -  Diagnosis of visual impairment exclusively due to ME secondary to CRVO

          -  BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment
             Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent
             of 20/40 and 20/400)

        Exclusion Criteria:

          -  Uncontrolled blood pressure defined as systolic value of > 160 mm Hg or diastolic
             value of > 100 mm Hg at Screening or Baseline.

          -  Any active periocular or ocular infection or inflammation at Screening or Baseline in
             either eye

          -  Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before
             Baseline in either eye

          -  Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6
             months before Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab
             [Avastin®])
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: Alpha-1 MP; alpha-1 proteinase inhibitor (human)
Intervention description: alpha-1 proteinase inhibitor (human), 60 mg/kg body weight; Prolastin
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin; Protein C Inhibitor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: alpha 1-Antitrypsin Deficiency; alpha 1-Antitrypsin; pulmonary emphysema

Summary:

      The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1
      Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1
      Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult
      Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug
      on a weekly schedule for 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of congenital Alpha1-antitrypsin deficiency

          -  Must be receiving augmentation therapy with plasma-derived (human) Alpha1-Proteinase
             Inhibitor (Prolastin®) for at least one month prior to study entry.

          -  Signed written informed consent prior to initiation of any study related procedures

        Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling
             to practice adequate contraception throughout the study

          -  Use of systemic steroids within the 2 weeks prior to receiving study treatment (this
             does not include the use of inhaled steroids used on a routine or as needed basis).

          -  Subjects who have had exacerbations of their disease within one month of trial entry.
Contrast-enhanced MRI in Children 2 Months to <2 Years
Condition: Magnetic Resonance Imaging
Intervention: Gadopentetate dimeglumine (Magnevist, BAY86-6661)
Intervention description: For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 2 Months
Maximum age: 23 Months
Healthy volunteers: No
Keywords: MRI agents; Magnevist

Summary:

      The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist
      in children 2 months to < 2 years of age
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 2 months to < 2 years (23 months)

          -  Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI

          -  Able to comply with the study procedures

        Exclusion Criteria:

          -  Clinical unstable participants (eg, intensive care unit)

          -  Renal Insufficiency

          -  Participants undergoing chemotherapy </= 48 hours prior to and up to 24 hours after
             the administration of Magnevist.
An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Metformin XR; Metformin XR
Intervention description: 5mg oral tablet once daily; 500mg oral tablet once daily; 750mg, 2 tablets once daily
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: T2DM; Metformin; A1c

Summary:

      The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and
      Metformin XR vs. uptitrated Metformin XR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less
             than or equal to 1500mg only for at least 8 weeks prior to screening

          -  A1c: 7.5-11% (at screening)

          -  BMI less than or equal to 45 kg/m2

        Exclusion Criteria:

          -  Significant cardiovascular history

          -  Active liver disease, renal impairment