bioihbjkbjnl/mcl2 huggingface dataset:
A Study of SI-6603 in Patients With Lumbar Disc Herniation
Condition: Intervertebral Disc Disease; Lumbar Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Displacement
Intervention: Condoliase
Intervention description: 1.25 U, intradiscal injection, one time
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1011.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in
      patients with lumbar disc herniation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, L4-L5 or L5-S1) as assessed
             by MRI and clinical symptoms corresponding to position of the impaired nerve root.

          -  Patients assessed as positive in the Femoral Nerve Stretching (FNS) test for L1-L2,
             L2-L3, or L3-L4 and Straight Leg Raising (SLR) test.

          -  Patients with sciatica in either leg.

          -  Patients with no improvement from conservative treatment

        Exclusion Criteria:

          -  Patients who have 2 or more lumbar disc herniations as assessed by MRI.

          -  Patients in whom a rupture into the posterior longitudinal ligament is identified by
             MRI.

          -  Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or
             lumbar intradiscal therapies
Subject Preference for Scalp Psoriasis Treatment
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: C. propionate - Corticosteroid 1; C. propionate- Corticosteroid 2; C. propionate -Corticosteroid 3; Corticosteroid 1- C. propionate; Corticosteroid 2 - C. propionate; Corticosteroid 3 - C. propionate
Intervention description: Twice daily application; Twice daily application; Twice daily application; Twice daily application; Twice daily application; Twice daily application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 1 Galderma,; 2 Scalp Psoriasis; 3 Subject preference; 4 Clobetasol propionate; 5 Shampoo

Summary:

      The scalp is one of the most common affected sites in psoriatic patients as 79% of them have
      scalp involvement.It has also a psychological aspect with 31% of patients with scalp
      psoriasis indicating distress.

      Topical agents remain the mainstay of treatment for scalp psoriasis. However, they are not
      always ideal because they might be inconvenient and messy to use, stain or damage hair.

      The test shampoo, Clobetasol propionate Shampoo 0.05% (marketed in the USA under the
      tradename of Clobex®) was developed to provide the strongest available corticosteroid as a
      short-contact therapy in order to improve the chances of it being effective and reduce the
      potential for traditional side-effects.

      The objective of this study is to compare subject's overall preference between Clobetasol
      propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate
      to severe scalp psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, 18 years of age or older,

          -  Subjects with moderate to severe scalp psoriasis,

          -  Subjects who signed written informed consent prior to any study procedures.

        Exclusion Criteria:

          -  Subjects who need systemic treatment for their body psoriasis,

          -  Subjects who are at risk in terms of precautions, warnings and contra-indication,

          -  Female subjects who are pregnant, nursing or planning a pregnancy during the study,

          -  Subjects with a specific washout period for topical treatment(s) on the scalp,

          -  Subjects with a specific washout period for systemic treatment(s).
Phase III Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Apixaban; Placebo
Intervention description: Tablets, Oral, 5 mg, twice daily, until study end; Tablets, Oral, 0 mg, twice daily, until study end
Intervention MeSH terms: Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 7484.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NOS

Summary:

      The purpose of this study is to determine if apixaban is superior to placebo for preventing
      cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a
      recent acute coronary syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute coronary syndrome (ACS)

          -  Clinically stable

          -  Receiving standard of care for ACS

        Exclusion Criteria:

          -  Severe hypertension

          -  Active bleeding or high risk for major bleeding

          -  Hemoglobin < 9 g/dL
Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: 1=Etanercept; 2=Clobetasol propionate foam
Intervention description: 50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.; 0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses
Intervention MeSH terms: Etanercept; Clobetasol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 592.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Topical; etanercept; clobetasol propionate

Summary:

      The primary hypothesis of this trial is that the addition of short courses of clobetasol
      propionate foam to etanercept monotherapy in subjects with moderate to severe plaque
      psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by
      PASI 75 at Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had stable moderate to severe plaque psoriasis for at least 6 months

          -  Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline.

          -  Subject is a candidate for systemic therapy or phototherapy in the opinion of the
             investigator

        Exclusion Criteria:

          -  Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the
             screening visit.

          -  Subject has evidence of skin conditions at the time of the screening visit (eg,
             eczema) that would interfere with evaluations of the effect of etanercept
             and/orclobetasol propionate foam on psoriasis.

          -  Subject diagnosed with medication-induced or medication exacerbated psoriasis

          -  Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection

          -  Subject has a significant concurrent medical condition or laboratory abnormalities as
             defined in the study protocol.

          -  Subject has used any of the following therapies within 14 days of the first dose: UVB
             therapy or topical psoriasis therapies other than Class I or II topical steroids.

          -  Subject has used any of the following therapies within 28 days of the first dose:
             Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic
             psoriasis therapies

          -  Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23
             inhibitors) within 3 months of the first dose

          -  Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of
             etanercept

          -  Subject has ever used efalizumab (Raptiva®).
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: vedolizumab; Placebo
Intervention description: Vedolizumab for intravenous infusion; Placebo intravenous infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1116.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study was to determine the effect of vedolizumab induction
      treatment on clinical response and remission at 6 weeks and to determine the effect of
      vedolizumab maintenance treatment on clinical remission at 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 to 80

          2. Diagnosis of moderately to severely active Crohn's disease (CD)

          3. CD involvement of the ileum and/or colon

          4. Demonstrated, over the previous 5 year period, an inadequate response to, loss of
             response to, or intolerance of at least 1 of the following agents, within
             protocol-specified parameters:

               1. Immunomodulators

               2. Tumor necrosis factor-alpha (TNFα) antagonists

               3. Corticosteroids

          5. May be receiving a therapeutic dose of conventional therapies for irritable bowel
             disease (IBD) defined by the protocol

        Exclusion Criteria

          1. Evidence of abdominal abscess at the initial screening visit, other than a minimum of
             10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine

          2. Extensive colonic resection, subtotal or total colectomy

          3. History of >3 small bowel resections or diagnosis of short bowel syndrome

          4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

          5. Have received non permitted IBD therapies within either 30 or 60 days, depending on
             the medication, as stated in the protocol

          6. Chronic hepatitis B or C infection

          7. Active or latent tuberculosis
A Study of OV101 in Individuals With Angelman Syndrome (AS)
Condition: Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
MeSH terms: Angelman Syndrome; Syndrome
Intervention: Gaboxadol; Placebo
Intervention description: OV101 versus placebo once daily at bedtime for 12 weeks; Matching placebo capsules to OV101 capsules.
Intervention MeSH terms: Gaboxadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double (Participant/Care Giver and Investigator/Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in
      pediatric subjects with Angelman syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female and 2 to 12 years old (inclusive) at the time of informed consent

          -  Confirmed molecular diagnosis of AS

          -  Has a CGI-S-AS score of 3 or more at baseline.

          -  Meets the following age-appropriate body weight criterion:

               1. Subjects 2 to 3 years old must have a minimum body weight of 9 kg.

               2. Subjects 4 years and older must be between 17 kg and 64 kg (inclusive).

          -  Stable concomitant mediations for at least 4 weeks before study start

        Exclusion Criteria:

          -  Any condition that would limit study participation

          -  Clinically significant lab or vital sign abnormalities at the time of screening

          -  Poorly controlled seizures (weekly seizures of any frequency with a duration more than
             3 minutes, weekly seizures occurring more than 3 times per week, each with a duration
             of less than 3 minutes, or as defined by investigator assessment)

          -  Use of prescription medications for sleep, minocycline, or levodopa within the 4 weeks
             prior to Day 1 or during the study. Benzodiazepines chronically administered for
             seizure control are permitted.

          -  Cannot comply with protocol study assessments during screening or caregiver unable to
             comply with study requirements.

          -  Enrolled in any clinical trial or used any investigational agent within the 30 days
             before screening or concurrently with this study.
A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Sunitinib; paclitaxel; bevacizumab; paclitaxel
Intervention description: Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,; Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.; Bevacizumab 10 mg/kg IV every 2 weeks.; Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Bevacizumab; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 488.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; advanced; sunitinib; bevacizumab; paclitaxel; Phase 3

Summary:

      To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to
      determine which treatment works better against breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of advanced breast cancer.

          -  Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or
             bone-only disease.

          -  ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

        Exclusion Criteria:

          -  No prior treatment with cytotoxics in the advanced disease setting.

          -  HER2/neu positive disease unless trastuzumab was previously received or is
             contraindicated.

          -  Treatment with a taxane in the adjuvant setting unless disease free interval >12
             months after end of treatment.
Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Intervention: SD-101-6.0 cream
Intervention description: SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 1 Month
Healthy volunteers: No
Keywords: Amicus Therapeutics; Scioderm, Inc.; Simplex; Recessive Dystrophic; Junctional non-Herlitz; Epidermolysis Bullosa; SD-101 6%; SD-101-6.0; Allantoin 6%; Zorblisa

Summary:

      The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in
      participants with Epidermolysis Bullosa (EB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent Form signed by the participant or participant's legal representative;
             if the participant was under the age of 18 but capable of providing assent, signed
             assent from the participant.

          -  Participant (or caretaker) must have been willing to comply with all protocol
             requirements.

          -  Participants who completed the SD-005 study (on study drug at Visit 5, approximately
             90 days from baseline).

        Exclusion Criteria:

          -  Participants who did not meet the entry criteria outlined above.

          -  Pregnancy or breastfeeding during the study. (A urine pregnancy test was performed at
             the final visit for Study SD-005 for female participants of childbearing potential and
             repeated at screening/baseline visit of Study SD-006 if these visits did not occur on
             the same day).

          -  Female participants of childbearing potential who were not abstinent or not practicing
             a medically acceptable method of contraception.
Aripiprazole in Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole tablet, 10 mg; Aripiprazole tablet, 30 mg; Placebo tablet
Intervention description: Aripiprazole tablet 10 mg po qd x 42 days; Aripiprazole tablet 30 mg po qd x 42 days; Placebo tablet po qd x 42 days
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Schizophrenia; Aripiprazole

Summary:

      The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent
      patients with schizophrenia for a period of at least 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary diagnosis of Schizophrenia 1

        Exclusion Criteria:

          -  Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium,
             or bipolar disorder
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; Test Product (tiotropium bromide inhalation powder); Reference Product (Spiriva®)
Intervention description: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.; Double-Blind: Single dose of test product 18 mcg of test product Open-Label: once daily administration of test product (tiotropium bromide inhalation powder) 18 mcg administered by test dry powder inhaler.; Reference product (Spiriva®) 18 mcg.
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, double-dummy, placebo controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 377.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to show bioequivalence of test product to reference product
      based on baseline-adjusted forced expiratory volume in one second (FEV1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and non-pregnant female subjects (40 years of age and older).

          -  Patients with diagnosis of COPD according to the GOLD guidelines.

          -  Post-bronchodilator FEV1 <80% of the predicted value at the screening visit.

          -  Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit.

          -  Current or former smokers (e.g., with history of = 10 pack-years).

          -  Written informed consent.

        Exclusion Criteria:

          -  Known respiratory disorder other than COPD including, but not limited to the
             following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active
             bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema,
             or interstitial lung disease.

          -  History of allergy or hypersensitivity to anticholinergic/muscarinic receptor
             antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known
             hypersensitivity to any of the proposed ingredients or components of the delivery
             system.

          -  Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit.

          -  Treatment for COPD exacerbation within 12 weeks prior to the screening visit.

          -  Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus
             infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or
             illness within 6 weeks prior to the screening visit.

          -  Abnormal and significant ECG finding prior to the screening, during the run-in and
             treatment periods.
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
Condition: Vaccines; Pneumococcal Conjugate Vaccine
Intervention: 13-valent pneumococcal conjugate vaccine (13vPnC); 7-valent pneumococcal conjugate vaccine (7vPnC)
Intervention description: 13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.; 7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 168.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: No
Keywords: Prevention against pneumococcal disease

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal
      conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month-old infants (42 to 98 days)

          -  Available for the entire study period (14 months)

        Exclusion Criteria:

          -  Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib
             vaccines

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.