bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Condition: Knee Injury
MeSH terms: Wounds and Injuries; Knee Injuries
Intervention: Placement of allograft CR Plug in primary injury site
Intervention description: Core defect and implant allograft CR plug
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: allograft; knee injury; cartilage injury; Osteochondral defects in the articular femoral cartilage

Summary:

      Determine the ability of the allograft plug for the treatment of a cartilage injury in the
      knee
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Skeletally mature

          -  Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b,
             3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial
             Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain,
             pain with weight bearing and squatting, locking of joints, and/or swelling

          -  Functional meniscal tissue (defined as 5 mm or more width)

          -  A score of = or greater than 4 on the VAS questionnaire

        Exclusion Criteria:

          -  Associated tibial or patellar articular cartilage defect greater than 2 ICRS

          -  Osteoarthritis of either knee

          -  Mechanical axis malalignment of greater than 5 degrees

          -  Patellofemoral incongruity of Merchant view

          -  One or more multiple defects greater than 2.5 cm

          -  Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm

          -  Ligament treatments in the affected knee within one yer prior to current study

          -  Previous surgical meniscus treatments in the affected knee in the last 6 months

          -  Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment

          -  Use of any investigational therapy with in 30 days prior to the first visit

          -  Corticosteroid or viscosupplementation within the past 3 months

          -  A score of 3 or less on the VAS Questionnaire

          -  Active gout or pseudogout or systemic inflammatory condition
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM; MenACWY-CRM; Licensed meningococcal ACWY vaccine
Intervention description: 1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly; 2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age; 1 injection of the licensed meningococcal ACWY was administered intramuscularly
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2907.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; children; healthy; meningitis; meningococcal; prevention of meningococcal disease serogroups ACWY; Menveo

Summary:

      To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given
      to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein
      conjugate vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy 2-10 years of age children, inclusive and for whom, after the nature of the
             study has been explained, the parent or legal guardian has provided written informed
             consent

          -  who are available for all visits and telephone calls scheduled for the study

          -  who are up-to-date with age-appropriate routine childhood vaccinations

        Exclusion Criteria:

          -  whose parent or legal guardian is unwilling or unable to give written informed consent

          -  who had a previous or suspected disease caused by N. meningitidis;

          -  who have previously been immunized with a meningococcal vaccine or vaccine containing
             meningococcal antigen(s)

          -  who have received any investigational agents or vaccines within 90 days prior to
             enrollment

          -  who have any serious acute, chronic or progressive disease

          -  who have epilepsy or any progressive neurological disease or history of Guillain Barré
             Syndrome

          -  who have a history of anaphylaxis, serious vaccine reactions

          -  who have a known or suspected impairment/alteration of immune function, either
             congenital or acquired or resulting from

          -  who are known to have a bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time

          -  who have Down's syndrome or other known cytogenic disorders
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: RGN-259; Placebo
Intervention description: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days; It is composed of the same excipients as RGN-259 but does not contain Tβ4
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 601.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye Syndrome; Dry Eye; DES

Summary:

      The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic
      Solutions to placebo for the treatment of the signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age;

          -  Provide written informed consent;

          -  Have a subject reported history of dry eye for at least 6 months

          -  Have a history of use or desire to use eye drops for dry eye symptoms within 6 months

        Exclusion Criteria:

          -  Have any clinically significant slit-lamp findings at Visit 1 that may include active
             blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active
             ocular allergies that require therapeutic treatment, and/or in the opinion of the
             investigator may interfere with study parameters;

          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1;

          -  Have ab uncontrolled systemic disease:
Treatment of Erectile Dysfunction II
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Udenafil; Placebo
Intervention description: Tablets via oral administration before an attempt at sexual intercourse.; Tablets via oral administration before an attempt at sexual intercourse.
Intervention MeSH terms: Udenafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 601.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the
      safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of
      PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, at least 19 years of age

          -  Stable monogamous relationship for at least 6 months with a consenting female partner
             who is at least 19 years of age, vaginal intercourse is a required study activity

          -  History of ED (clinically defined as the inability to attain and maintain an erection
             of the penis sufficient to permit satisfactory sexual intercourse) of at least 3
             months duration

          -  Partner is not pregnant or lactating

        Exclusion Criteria:

          -  History of new-onset symptomatic coronary artery disease within the last 3 months or a
             history of myocardial infarction or cardiac surgical procedure within six months

          -  Cardiac arrhythmias requiring antiarrhythmic treatment

          -  Symptomatic congestive heart failure

          -  Taking nitrate medication in any form

          -  Uncontrolled diabetes (HbA1c ≥ 13%)

          -  Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors such as Viagra®,
             Cialis® or Levitra®

          -  Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®
Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage
Condition: Abscess
MeSH terms: Abscess
Intervention: oral trimethoprim/sulfamethoxazole; Placebo
Intervention description: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days; Placebo caps or suspension every 12 hours for 10 days
Intervention MeSH terms: Trimethoprim; Sulfamethoxazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 90 Days
Maximum age: 18 Years
Healthy volunteers: No
Keywords: abscess; Abscesses in the pediatric emergency population

Summary:

      The purpose of the study is to compare rates of cure of abscesses with and without antibiotic
      treatment after incision and drainage. The purpose of this study is to compare successful
      rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus
      non-antibiotic treatment after incision and drainage.
    

Eligibility criteria:

        Inclusion Criteria:

        1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage
        2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae

        Exclusion Criteria:

          1. Multiple abscesses

          2. Abscess located on the hands, face, or perineum

          3. Abscess as a result of a bite wound

          4. Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10
             days), etc.

          5. Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug
             allergy to TMP/SMX

        7.) Fever > or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on
        presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis,
        etc.

        9.) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
Condition: Hyperlipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bococizumab (PF-04950615; RN316); Placebo
Intervention description: 150 mg every 2 weeks, subcutaneous injection, 12 months; subcutaneous injection every 2 weeks for 12 months
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mixed dyslipidemia; high risk of cardiovascular events; multiple cardiovascular disease risk factors

Summary:

      This study is a multicenter, randomized study in subjects with high cholesterol receiving
      highly effective statins to assess the efficacy, safety and tolerability of Bococizumab
      (PF-04950615;RN316) to lower LDL-C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated with a statin.

          -  Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.

          -  High or very high risk of incurring a cardiovascular event.

        Exclusion Criteria:

          -  Pregnant or breastfeeding females.

          -  Cardiovascular or cerebrovascular event of procedures during the past 30 days.

          -  Congestive heart failure NYHA class IV.

          -  Poorly controlled hypertension.
Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: placebo; Ziprasidone oral capsules
Intervention description: Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.; Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg BID to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 284.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Adolescent Subjects With Schizophrenia

Summary:

      The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective
      for the treatment of adolescents (ages 13-17) with schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria
             for schizophrenia: Current symptoms were to be present for at least 7 days before
             screening.

          -  At the Screening and Baseline visits, subjects must have had a Brief Psychiatric
             Rating Scale - Anchored score ≥35 and a score of ≥4 on at least 1 of the following
             items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or
             conceptual disorganization.

          -  Age 13 - 17 years

        Exclusion Criteria:

          -  Imminent risk of suicide or homicide, as judged by the site investigator

          -  Any history of serious or unstable medical illness, including risk for QT prolongation
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Tamoxifen; Anastrazole (Arimidex); Goserelin acetate (Zoladex)
Intervention description: 20 mg once daily oral dose; 1 mg once daily oral dose; 3.6mg/month depot injection
Intervention MeSH terms: Tamoxifen; Goserelin; Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 197.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Breast Cancer; Breast Neoplasms; Tumors or cancer of the human BREAST; Tumor or cancer of the human MAMMARY GLAND

Summary:

      The purpose of this multi-centre, randomised, double-blind, parallel-group study is to
      compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative
      administration under goserelin acetate treatment for premenopausal breast cancer patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable
             and measurable breast cancer who have provided written informed consent

        Exclusion Criteria:

          -  Medical history of chemotherapy or endocrine therapy for breast cancer, or with
             treatment history of radiotherapy. Unwillingness to stop taking any drug known to
             affect sex hormone status (including hormone replacement therapy (HRT).
Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
Condition: Painful Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: pregabalin; placebo
Intervention description: 150 - 300 mg/day in divided dose (3 time a day) for 6 weeks; matching placebo 3 time a day
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to test the effectiveness of pregabalin in treating nerve pain caused by
      diabetes. The suitable subjects will be patients who also use an non-steroid
      anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or 2 diabetes with painful neuropathy

          -  Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain
             condition with a regular dose

          -  Meet pre-defined level of pain severity at entrance

        Exclusion Criteria:

          -  History of failed pregabalin treatment due to lack of efficacy at therapeutic dose

          -  Participated in a previous or ongoing pregabalin clinical trial

          -  Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment
             of distal neuropathic pain
A Study of S6G5T-3 in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: S6G5T-3; S6G5T-8
Intervention description: Once a day topical cream; Once a day topical cream
Intervention MeSH terms: Tretinoin; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 424.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: Acne Vulgaris

Summary:

      To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12
      weeks in participants with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Male and female 9 years of age and older.

          3. Have 2 or fewer cysts or nodules.

        Exclusion Criteria:

          1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or
             equal to 5 millimeter (mm) in diameter).

          2. Acne conglobata, acne fulminans, and secondary acne (for example, chloracne,
             drug-induced acne).

          3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia,
             multiple myeloma).

          4. Underlying disease that requires the use of interfering topical or systemic therapy.

          5. Other dermatological conditions that require the use of interfering topical or
             systemic therapy or that might interfere with study assessments such as, but not
             limited to, atopic dermatitis, perioral dermatitis, or rosacea.
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
Condition: Chronic Hepatitis C; Hepatitis C Virus; HCV
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-493/ABT-530
Intervention description: Tablet; ABT-493 coformulated with ABT-530
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 703.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV GT1; Non-cirrhotic; RBV Free; Without cirrhosis; Chronic Hepatitis C; Hepatitis C Genotype 1 (GT1); IFN free; Hepatitis C; Ribavirin Free; Interferon (IFN) Free; HCV; Hepatitis C virus; DAA

Summary:

      This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with
      Genotype 1 hepatitis C virus infection without cirrhosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age at time of screening.

          -  Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1)
             infection.

          -  Chronic HCV infection.

          -  Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of
             any approved or investigational regimen) or treatment-experienced (has failed prior
             interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or
             sofosbuvir (SOF) plus RBV with or without pegIFN therapy).

          -  Subjects must be non-cirrhotic.

        Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected
        patients:

          -  HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%)
             at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once
             during the 12 months prior to Screening.

        OR

          -  On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening,
             with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at
             Screening and at least once during the 12 months prior to Screening.

        Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to any excipients
             of the study drugs.

          -  Female who is pregnant, planning to become pregnant during the study or breastfeeding;
             or male whose partner is pregnant or planning to become pregnant during the study.

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg).

          -  HCV genotype performed during screening indicating co-infection with more than one HCV
             genotype.

          -  Chronic HIV type 2 (HIV-2) infection.