bioihbjkbjnl/mcl2 huggingface dataset:
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: MCI-186; Placebo; MCI-186 in open label phase
Intervention description: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).; Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).; All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.
Intervention MeSH terms: Edaravone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Amyotrophic Lateral Sclerosis (ALS)

Summary:

      The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via
      intravenous drip infusion once a day in the patients with ALS based on the changes in the
      revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in
      double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186
      to the ALS patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients whose conditions are defined as "definite ALS"or "probable ALS"diagnostic
             criteria El Escorial and revised Airlie House.

          -  Patients who can eat a meal, excrete, or move with oneself alone, and do not need
             assistance in everyday life.

          -  Patients of less than 2 years after the onset of ALS.

          -  Patients whose progress of the condition during 12 weeks before administration meet
             other requirements.

        Exclusion Criteria:

          -  Patients with such complications as Parkinson's disease, schizophrenia, dementia,
             renal failure, or other severe complication, and patients who have the anamnesis of
             hypersensitivity to edaravone.

          -  Pregnant, lactating, and probably pregnant patients, and patients who want to become
             pregnant, and patients who can not agree to contraception.

          -  Patients who have participated in other trials within 12 weeks before consent, or who
             are participating in other clinical trials at present.

          -  In addition to the above exclusion criteria, patients judged to be inadequate to
             participate in this study by their physician.
Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51
Intervention description: 6 mcg im. at day 0 and day 28
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time
      points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV
      neutralizing antibodies at Day 56 after the first vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female healthy adults aged at least 18 years with written informed consent
             and either no childbearing potential or negative pregnancy test.

        Exclusion Criteria:

          -  History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug
             addiction including alcohol dependence, prior vaccination against JE
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Condition: Carcinoma; Non Small Cell Lung
MeSH terms: Lung Neoplasms
Intervention: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®); Placebo; Docetaxel (Taxotere®); Dexamethasone (pre- and post-medication for docetaxel)
Intervention description: 6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.; Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks.; 75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks.; As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).
Intervention MeSH terms: Dexamethasone; Docetaxel; Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 913.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lung cancer; angiogenesis inhibitor; chemotherapy

Summary:

      The primary objective of the study was to demonstrate overall survival improvement for
      aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for
      participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).

      The secondary objectives were to compare other efficacy parameters, to assess the overall
      safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV)
      aflibercept in this participant population and to determine immunogenicity of IV aflibercept
      in all participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological/cytological proven locally advanced or metastatic non-small cell lung
             cancer

          -  Disease progression during or after one, and only one, prior anticancer therapy which
             is platinum-based for advanced or metastatic disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

          -  Adequate renal, liver and bone marrow functions

        Exclusion Criteria:

          -  Squamous histology/cytology

          -  Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or
             chemotherapy to the time of randomization

          -  Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 25% of bone
             marrow

          -  Prior docetaxel treatment

          -  Uncontrolled hypertension

        The above information was not intended to contain all considerations relevant to
        participation in a clinical trial.
Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)
Condition: Asthma, Exercise-Induced
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Intervention: Comparator: Montelukast; Comparator: Placebo
Intervention description: Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge; Placebo tablet administered orally as a single witnessed dose before exercise challenge
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of an approved medication being studied
      in support of a new approach in the prevention of exercise-induced asthma (a worsening of
      asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who
      have a history of worsening asthma after exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with mild-to-moderate asthma

        Exclusion Criteria:

          -  Medical history of a lung disorder (other than asthma) or a recent upper respiratory
             tract infection
Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Condition: Keratoconjunctivitis Sicca; Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
Intervention: Tavilermide ophthalmic solution; Placebo
Intervention description: BID topical dosing; BID topical dosing
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 623.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1%
      tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the
      signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject-reported history of dry eye disease in both eyes for at least 6 months;

          -  History of use of artificial tear eye drops for dry eye symptoms;

          -  Total score of ≥40 on SANDE;

          -  TFBUT;

          -  Corneal fluorescein staining;

          -  Lissamine green conjunctival staining;

          -  Schirmer's test score.

        Exclusion Criteria:

          -  Have participated in a previous tavilermide (MIM-D3) study;

          -  Have clinically significant slit lamp findings at Visit 1;

          -  Have a history of lacrimal duct obstruction within 12 months of Visit 1;

          -  Have an uncontrolled systemic disease;

          -  Be a woman who is pregnant, nursing or planning a pregnancy;

          -  Be a woman of childbearing potential who is not using an acceptable means of birth
             control;

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study;

          -  Be currently enrolled in an investigational drug or device study or have used an
             investigational drug or device within 45 days prior to Visit 1.
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: K-Lens (generic name not established) and Ketotifen; Placebo Lens
Intervention description: combination drug-device product: contact lens (device) and anti-allergy drug; contact lens without drug
Intervention MeSH terms: Ketotifen
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 310.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal
      volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy normal, soft contact lens wearing volunteers

          -  normal ocular health

          -  contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or
             less in each eye

        Exclusion Criteria:

          -  active ocular infection

          -  history of ocular surgery

          -  use of topical ophthalmic preparations (including rewetting drops)

          -  pregnancy or lactation
Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin glargine
Intervention description: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.; Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1030.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in
      subjects with type 2 diabetes never treated with insulin followed by the extension trial
      investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin
      glargine in subjects with type 2 diabetes.

      All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant
      enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl
      peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment
      is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor
      treatment is also discontinued). Subjects who consent to participate in the extension trial
      will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to
      which they were randomly allocated in the 52 week main trial.

      The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension
      period is registered as NN1250-3643.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Treatment with oral antidiabetic drugs (OADs) for at least three months before trial
             start at an unchanged dose

          -  HbA1c: 7.0-10.0%

          -  Body Mass Index (BMI) no higher than 40.0 kg/m^2

          -  For the extension trial only: Completion of the 52 week treatment period in trial
             NN1250-3579 (NCT00982644)

        Exclusion Criteria:

          -  Treatment with exenatide or liraglutide within the last 3 months before trial start

          -  Cardiovascular disease within the last 6 months

          -  Uncontrolled treated/untreated severe hypertension

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures

          -  Cancer and medical history of cancer
The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Stannous Fluoride; Sodium Monofluorophosphate
Intervention description: dentifice; dentifrice
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing
      dentinal hypersensitivity over an eight week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who suffer from tooth sensitivity

        Inclusion Criteria:

        - none
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: SPD503 (1 mg); SPD503 (2 mg); SPD503 (3 mg); SPD503 (4 mg); Placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 324.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the
      treatment of children and adolescents aged 6-17 with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a primary diagnosis of ADHD

          -  Females of childbearing potential must have a negative serum beta human chorionic
             gonadotropin (HCG) pregnancy test

          -  Male or non-pregnant female subject who agrees to comply with any applicable
             contraceptive requirements

        Exclusion Criteria:

          -  Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant
             symptoms such as severe comorbid Axis II disorders or severe Axis I disorders

          -  Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35

          -  Subject has a history of seizure during the last 2 years or a serious tic disorder,
             including Tourette's Disorder

          -  Subject is pregnant or lactating
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
Condition: Chronic Pain
MeSH terms: Osteoarthritis; Chronic Pain
Intervention: OROS hydromorphone; Placebo
Intervention description: hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets; Placebo
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 343.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: OA; Chronic Pain; Osteoarthritis; OA Pain; Osteoarthritis Pain; Pain; Hip Pain; Knee Pain; Joint Pain

Summary:

      To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in
      patients with Osteoarthritis (OA) Pain
    

Eligibility criteria:

        Inclusion Criteria

          -  Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least
             6 months

          -  Patients required daily opioid medication to treat their chronic osteoarthritis pain

        Exclusion Criteria

          -  Joint replacement of the hip or of the knee that is the primary source of
             osteoarthritis Pain

          -  History drug or alcohol abuse

          -  Fibromyalgia

          -  Patients who have major depression or anxiety

          -  Women who are pregnant or breast feeding
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: CP-690,550; CP-690,550
Intervention description: 5 mg tablets, BID, for at least 12 months; 10 mg tablets, BID, for at least 12 months
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 944.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ulcerative colitis; open-label; long term treatment

Summary:

      This study is an open label, long-term extension study for subjects with moderate to severe
      ulcerative colitis designed to evaluate long term therapy of CP-690,550.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who completed induction studies A3921094 or A3921095 and were classified as
             not meeting clinical response criteria; OR

          -  Subjects who completed maintenance study A3921096 or who discontinued treatment early
             in Study A3921096 due to treatment failure.

        Exclusion Criteria:

          -  Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.

          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
             colitis, or clinical findings suggestive of Crohn's disease.

          -  Subjects who have had surgery for ulcerative colitis or in the opinion of the
             investigator, are likely to require surgery for ulcerative colitis during the study
             period.
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321); Macular Laser Photocoagulation
Intervention description: Laser therapy
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 466.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema; Diabetic Retinopathy

Summary:

      The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection
      (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early
      treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema
      (DME) with central involvement.
    

Eligibility criteria:

        Inclusion Criteria:

        The following is an abbreviated list of inclusion criteria:

          -  Adults ≥ 18 years with type 1 or 2 diabetes mellitus

          -  Decrease in vision determined to be primarily the result of DME in the study eye

          -  BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye

        Exclusion Criteria:

        The following is an abbreviated list of exclusion criteria:

          -  Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day
             1

          -  Previous use of intraocular or periocular corticosteroids in the study eye within 120
             days of day 1

          -  Previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium,
             bevacizumab, ranibizumab, etc.) within 90 days of day 1

          -  Active proliferative diabetic retinopathy (PDR) in the study eye

          -  Uncontrolled diabetes mellitus

          -  Only 1 functional eye even if that eye is otherwise eligible for the study