bioihbjkbjnl/mcl2 huggingface dataset:
Treatment for Completers of the Study B7A-MC-MBCM
Condition: Diabetic Retinopathy
MeSH terms: Diabetic Retinopathy
Intervention: Ruboxistaurin
Intervention description: 32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.
Intervention MeSH terms: Ruboxistaurin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study
      (NCT00604383), and who are felt by the investigator to have the potential to benefit from the
      ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion
      of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine
      the long-term safety and effect of ruboxistaurin on vision.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients that completed Month 36 (Visit 15) of the study B7A-MC-MBCM, and the
             investigator believes he/she would benefit from ruboxistaurin treatment.

        Exclusion Criteria:

          -  Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not
             believe he/she would benefit from ruboxistaurin treatment.
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab [Avastin]; Docetaxel; Herceptin
Intervention description: 15mg/kg iv every 3 weeks; 100mg/m2 iv every 3 weeks; 8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Intervention MeSH terms: Bevacizumab; Trastuzumab; Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel,
      versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or
      metastatic breast cancer who have not received prior chemotherapy for their metastatic
      disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) +
      Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv
      q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until
      disease progression, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  HER2 positive breast cancer with locally recurrent or metastatic lesions;

          -  eligible for chemotherapy;

          -  baseline LVEF >=50%.

        Exclusion Criteria:

          -  previous chemotherapy for metastatic or locally recurrent breast cancer;

          -  previous radiotherapy for metastatic breast cancer (except for metastatic bone pain
             relief);

          -  other primary tumor within last 5 years, with the exception of basal or squamous skin
             cancer, or in situ cancer of the cervix;

          -  clinically significant cardiovascular disease;

          -  chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: GSP 301 NS; GSP 301 Placebo NS pH 3.7; GSP 301 Placebo NS pH 7.0
Intervention description: FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks; 2 spray in each nostril twice daily for 52 weeks; 2 spray in each nostril twice daily for 52 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 601.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS
      formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and
      older)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged ≥12 years and older inclusive of either sex.

          2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit
             [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at
             least 3 mm greater than negative diluent control wheal) to at least 1 allergen known
             to induce PAR. Documentation of a positive result within 12 months prior to the
             Screening Visit (Visit 1) is acceptable.

        Exclusion Criteria:

          1. Pregnant or lactating women.

          2. History of anaphylaxis and/or other severe local reaction(s) to skin testing.

          3. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

          4. Documented evidence of acute or significant chronic sinusitis or chronic purulent
             postnasal drip.

          5. Subjects with an active pulmonary disorder or infection.

          6. Subjects with posterior subcapsular cataracts or glaucoma
A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Olumacostat Glasaretil Gel, 5.0%; Olumacostat Glasaretil Gel, Vehicle
Intervention description: Gel containing Olumacostat Glasaretil; Vehicle (placebo) gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 744.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil
      Gel compared to vehicle in patients with acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent and, for subjects under legal adult age, signed assent

          -  Age ≥ 9 years

          -  Clinical diagnosis of facial acne vulgaris defined as:

               -  At least 20 inflammatory lesions, and

               -  At least 20 non-inflammatory lesions, and

               -  Investigator Global Assessment of 3 or greater

        Exclusion Criteria:

          -  Active cystic acne or acne conglobata, acne fulminans, and secondary acne

          -  Two or more active nodulocystic lesions on the face

          -  Clinically significant abnormal laboratory or ECG result

          -  Subjects who are actively participating in an experimental therapy study or who have
             received experimental therapy within 30 days or 5 half-lives (whichever is longer) of
             the Baseline visit

          -  Treatment with over-the-counter topical medications for the treatment of acne vulgaris
             including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids,
             α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline

          -  Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid
             within 4 weeks prior to Baseline

          -  Treatment with a new hormonal therapy or dose change to existing hormonal therapy
             within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to,
             estrogenic and progestational agents such as birth control pills).

          -  Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks
             prior to Baseline.

          -  Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A
             supplements greater than 10,000 units/day within 6 months prior to Baseline

          -  Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8
             weeks
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
Condition: Femoral Neck Fractures
MeSH terms: Fractures, Bone; Hip Fractures; Femoral Neck Fractures
Intervention: Sliding Hip Screw; Cancellous Screws; Vitamin D; Vitamin D Placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the impact of surgical fixation (cancellous screws
      versus sliding hip screws) and biologic intervention (Vitamin D versus placebo) on patient
      important outcomes.
    

Eligibility criteria:

        Inclusion Criteria

          1. Adult men or women ages 18 to 60 years.

          2. Fracture of the femoral neck.

          3. Fracture amenable to both surgical treatments (SHS and cancellous screws).

          4. Operative treatment within 7 days of injury.

          5. Provision of informed consent by patient or substitute decision maker.

        Exclusion Criteria

          1. Patients with previously diagnosed osteoporosis.

          2. Fracture-dislocation of the femoral neck and hip joint.

          3. Planned antegrade nailing of an ipsilateral femoral shaft fracture (if present).

          4. Current infection around the hip (i.e. soft tissue or bone).

          5. Stress fracture of the femoral neck.

          6. Pathologic fractures secondary to neoplasm or other bone lesion.

          7. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's
             disease, osteomalacia, osteopetrosis, osteogenesis imperfect, etc.

          8. Patients with hyperhomocysteinemia.

          9. Patient has an allergy to vitamin D or another contraindication to being prescribed
             vitamin D.

         10. Patient is currently taking an over counter drug and/or food supplement that contains
             vitamin D and is unable or unwilling to discontinue its use for this study.

         11. Likely problems, in the judgment of the attending surgeon, with maintaining follow up
             (e.g. patients with no fixed address, plans to move out of town). This may include
             patients with severe mental disorders and drug addictions without adequate support.

         12. Pregnancy.

         13. Patient is incarcerated.

         14. Patient is not expected to survive injuries.

         15. The attending surgeon believes the patient should be excluded because they are
             involved in a conflicting clinical trial.
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo
Intervention description: Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment; Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9341.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this
      trial is to determine the long term effect of liraglutide on cardiovascular events in
      subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Type 2 diabetes - Age min. 50 years at screening and concomitant
        cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or
        chronic heart failure OR age min. 60 years at screening and other specified risk factors of
        cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with
        one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or
        long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s)
        Exclusion Criteria: - Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor
        agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4
        (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin
        other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3
        months prior to screening. Short-term use of other insulin during this period in connection
        with intercurrent illness is allowed, at Investigator's discretion
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
Condition: Locally Advanced or Metastatic Medullary Thyroid Cancer; Medullary Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Carcinoma, Neuroendocrine; Thyroid Diseases
Intervention: Patient outreach; Vandetanib
Intervention description: Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner; Treatment 300mg vandetanib opel label.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Medullary Thyroid Cancer; Locally advanced; Metastatic; Vandetanib; Patient Outreach

Summary:

      The purpose of this study is to evaluate the effect of patient outreach program on the
      proportion of time patients with MTC experience moderate or severe AEs during first 12 months
      of treatment with vandetanib
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Female or male aged 18 years and over

          -  Previously confirmed histological diagnosis of unresectable, locally advanced or
             metastatic hereditary or sporadic MTC. Documentation must be provided in patient's
             medical chart

          -  WHO or ECOG Performance status 0-2

          -  Negative pregnancy test (urine or serum) for female patients of childbearing potential

        Exclusion Criteria:

          -  Unstable brain metastases or spinal cord compression that require treatment, unless
             treated at least 4 weeks before first dose and stable without steroid treatment for 10
             days

          -  Major surgery within 4 weeks before randomization

          -  The last dose of prior chemotherapy received less than 3 weeks prior to randomization

          -  Radiation therapy not completed prior to the first dose of vandetanib

          -  Significant cardiac event, superior vena cava syndrome, NYHA classification of heart
             disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that
             in the opinion of the Investigator increases risk of ventricular arrhythmia

          -  Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula),Patients with
             moderate renal impairment, defined as creatinine clearance ≥30 to <50 ml/min, must
             start vandetanib at a reduced dose of 200 mg
Oral Aripiprazole Open-Label Rollover Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole
Intervention description: Flexible dose between 5 mg and 30 mg Aripiprazole tablets.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Open Label; Aripiprazole

Summary:

      The purpose of this study is to test the long-term safety and tolerability of oral
      aripiprazole in adolescent patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed
             Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with
             schizophrenia

        Exclusion Criteria:

          -  Patients with a co-morbid serious, uncontrolled systemic illness

          -  Patients with a significant risk of committing suicide
A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo-matching Rapastinel
Intervention description: Rapastinel pre-filled syringes for IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1304.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams
      (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive
      treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in
      participants with Major Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Screening

          -  Have no more than partial response (< 50% improvement) to ongoing treatment with a
             protocol-allowed antidepressant

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Screening

          -  Lifetime history of meeting DSM-5 criteria for:

          -  Schizophrenia spectrum or other psychotic disorder

          -  Bipolar or related disorder

          -  Major neurocognitive disorder

          -  Neurodevelopmental disorder of greater than mild severity or of a severity that
             impacts the participant's ability to consent, follow study directions, or otherwise
             safely participate in the study

          -  Dissociative disorder

          -  Posttraumatic stress disorder

          -  MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator.
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Pregabalin; Lamotrigine
Intervention description: dose 150-600 mg/day given BID; dose 100-500 mg/day given BID
Intervention MeSH terms: Pregabalin; Lamotrigine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 660.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; partial seizures; pregabalin monotherapy; lamotrigine comparator; double-blind and randomized trial

Summary:

      The purpose of this study is to assess whether Lyrica is a safe and effective treatment for
      partial epilepsy in comparison with an established treatment, Lamictal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be diagnosed with partial epilepsy and have experienced at least 2
             partial seizures (simple partial, complex partial or partial seizure with secondary
             generalization) in the past year with one in the past 6 months.

        Exclusion Criteria:

          -  Treatable causes of seizures, for example identified etiologies including metabolic,
             neoplastic or active infectious origin.

          -  Primary generalized seizures.
Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum toxin type A
Intervention description: In this long-term extension study, a dose of 500 units Dysport was administered by intramuscular injection into the clinically indicated neck muscles in a single dosing session in the first treatment cycle. This was the same dose as given in the preceding study NCT00257660 (Y-47-52120-051). Based on individual safety & efficacy, subjects could then receive up to 3 subsequent injections with doses titrated in 250 unit steps, to a minimum of 250 units and a maximum of 1000 units. Retreatment occurred approximately 12-16 weeks after the previous injection, with the exact timing based on clinical need.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to assess longer term safety and effectiveness of Dysport®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up
             to Week 12, or up to Week 4 in the event of an early withdrawal

          -  Returned to pre-treatment status as judged by the Investigator

        Exclusion Criteria:

          -  Pure anterocollis or pure retrocollis

          -  Known antibodies to botulinum toxin type A

          -  Requirement for botulinum toxin injections to site(s) other than the neck and unable
             to avoid such treatment for the duration of the study

          -  Known significant underlying swallowing or respiratory abnormality which might be
             exacerbated by botulinum toxin treatment