bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Condition: Pathological Myopia
MeSH terms: Vision Disorders; Vision, Low; Myopia; Choroidal Neovascularization; Myopia, Degenerative; Neovascularization, Pathologic
Intervention: Ranibizumab; Verteporfin PDT; Sham Ranibizumab; Sham verteporfin PDT
Intervention description: 0.5 mg ranibizumab intravitreal injection; Verteporfin (6 mg/m2) intravenous infusion; Empty vial to mimic the intravitreal injection; Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Intervention MeSH terms: Ranibizumab; Verteporfin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pathologic myopia; PM; choroidal neovascularization; CNV; ranibizumab; verteporfin PDT

Summary:

      This study is designed to evaluate the efficacy and safety of two different dosing regimens
      of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in
      patients with visual impairment due to choroidal neovascularization (CNV) secondary to
      pathologic myopia (PM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Visual impairment due to choroidal neovascularization (CNV) secondary to PM

          -  Best corrected visual acuity (BCVA) in the study eye > 24 and < 78 Early Treatment
             Diabetic Retinopathy Study (ETDRS) letters

          -  High myopia (> -6D), anterior-posterior elongation > 26 mm; posterior changes
             compatible with the pathologic myopia

          -  Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

        Exclusion Criteria:

          -  Patients with uncontrolled systemic or ocular diseases

          -  Blood pressure > 150/90 mmHg

          -  History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment
             with any anti-VEGF or vPDT in the study eye

          -  Intravitreal treatment with corticosteroids or intraocular surgery within last 3
             months in the study eye

        Other protocol-defined inclusion/exclusion criteria may apply
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: dabigatran etexilate 150 mg twice daily (BID); matching placebo twice daily (BID)
Intervention description: dabigatran etexilate capsules 150 mg BID; Matching placebo BID
Intervention MeSH terms: Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to
      placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in
      patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed
      6 to 18 months of treatment with vitamin K antagonist (VKA).
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been
             treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an
             oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER
             study medication up to the moment of screening for the current study.

          2. Written informed consent

        Exclusion criteria:

          1. Younger then 18 years of age

          2. Indication for VKA other than DVT and/or PE

          3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued

          4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis,
             chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN

          5. Creatinine clearance < 30 ml/min

          6. Acute bacterial endocarditis

          7. Active bleeding or high risk for bleeding.

          8. Uncontrolled hypertension (investigators judgement)

          9. Intake of another experimental drug within the 30 days prior to randomization into the
             study

         10. Life expectancy <6 months

         11. Childbearing potential without proper contraceptive measures*, pregnancy or breast
             feeding
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Condition: Acute Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: Canakinumab pre-filled syringe; Canakinumab lyophilized powder; Triamcinolone Acetonide; Placebo
Intervention description: Canakinumab pre-filled syringe; Canakinumab lyophilized powder; Triamcinolone Acetonide; Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Antibodies, Monoclonal; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Gout; arthritis; gout flare; acute gout; gouty; rheumatic disease; uric acid

Summary:

      This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison
      to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent
      flares of acute gouty arthritis.
    

Eligibility criteria:

        Inclusion criteria:

          -  3 or more gout flares within last year

          -  Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine

          -  Body mass index of less than or equal to 45 kg/m2

        Exclusion criteria:

          -  Use of the following therapies (within varying protocol defined timeframes):
             corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs
             (such as aspirin), colchicine.

          -  Hemodialysis

          -  Live vaccine within 3 months before first dose

          -  Donation or loss of 400 mL or more within 3 months before first dose

          -  Gout brought on by other factors such as chemotherapy, lead, transplant, etc.

          -  Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis

          -  Any conditions or significant medical problems that puts the patient at an
             unacceptable immunological risk to receive this type of therapy such as HIV,
             Hepatitis, Tuberculosis and other infections/conditions

          -  Significant cardiovascular conditions such as uncontrolled hypertension

          -  Significant medical diseases such as uncontrolled diabetes, thyroid disease

          -  History of malignancy of any organ system within the past 5 years

          -  Women who are pregnant or nursing

          -  Other protocol-defined inclusion/exclusion criteria may apply
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Risankizumab; Autoinjector
Intervention description: Risankizumab to be injected subcutaneously (SC); Single dose pre-filled autoinjector containing risankizumab for SC injection
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
Keywords: Psoriasis; Risankizumab; Plaque Psoriasis

Summary:

      The objectives of this study were to evaluate the usability of the combination product of
      risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and
      tolerability of risankizumab administered by AI for the treatment of adult participants with
      moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the
             baseline visit

          -  Participant meets following disease activity criteria:

               -  Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface
                  area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score
                  ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baseline
                  visit

               -  Candidate for systemic therapy as assessed by the investigator

        Exclusion Criteria:

          -  Participant has history of active skin disease other than psoriasis that could
             interfere with the assessment of psoriasis

          -  Participant has history of erythrodermic psoriasis, generalized or localized pustular
             psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset
             guttate psoriasis

          -  Participant has previous exposure to risankizumab
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Intervention: Zoledronic Acid; Placebo
Intervention description: Zoledronic acid 5 mg intravenous; Physiologic 0.9% normal saline
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 581.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Postmenopausal osteoporosis; osteopenia; zoledronic acid; Osteopenia (osteoporosis prevention)

Summary:

      Osteoporosis prevention is important in patients with osteopenia (low bone density). This
      study will test the safety and efficacy of zoledronic acid in patients diagnosed with
      osteopenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal

          -  Greater than or equal to 45 years of age

          -  Osteopenia (lumbar spine bone mineral density [BMD] T-score between -1.0 and -2.5, and
             BMD T-score > -2.5 at the femoral neck)

        Exclusion Criteria:

          -  Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients
             with one Grade 1 vertebral fracture are eligible to participate)

          -  Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)

          -  Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization

        Other protocol-defined inclusion/exclusion criteria may apply.
Double-blind Sitagliptin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin (MK-0431J-842)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Placebo; Ipragliflozin
Intervention description: 50 mg tablet administered orally; Placebo to sitagliptin administered orally; 50 mg tablet administered orally as background medication
Intervention MeSH terms: Sitagliptin Phosphate; Ipragliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 141.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese
      participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on
      ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the
      addition of sitagliptin once daily compared with placebo provides greater reduction in
      hemoglobin A1C (HbA1c) as assessed by change from baseline (Week 0) to Week 24.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Inadequate glycemic control on diet/exercise therapy and ipragliflozin monotherapy

          -  HbA1c ≥7.0% and ≤10.0% before study start

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis

          -  History of any of the following medications: thiazolidinediones (TZD) and/or insulin
             within 12 weeks prior to study participation, sitagliptin within 8 weeks prior to
             study participation.

          -  Currently has a urinary tract infection or genital infection with subjective symptom
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Intervention: Quetiapine XR; Placebo
Intervention description: Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.; Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 450.0
Sex: All
Minimum age: 66 Years
Healthy volunteers: No
Keywords: Generalised Anxiety Disorder; GAD

Summary:

      The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR)
      quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve
      elderly patients with generalised anxiety disorder.

      PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The
      SR designation was changed to XR after consultation with FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, 66 years or older, with a documented clinical diagnosis of
             Generalised Anxiety Disorder (GAD).

          -  Absence of current episode of major depression.

        Exclusion Criteria:

          -  The presence of dementia or other mental disorder than GAD.

          -  Serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse.

          -  A current diagnosis of cancer or current or past diagnosis of stroke.
Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: olanzapine; olanzapine pamoate depot
Intervention description: 10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.; 405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 524.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To compare the health outcome of patients with schizophrenia, who are at risk for relapse,
      when treated with a long acting injection form of olanzapine versus treatment with oral
      olanzapine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of schizophrenia

          -  Must be an outpatient (not requiring hospitalization) now and for at least the past 8
             weeks.

          -  Disease symptoms must meet a certain range as assessed by the clinician.

          -  Patient has experienced at least two episodes of clinical worsening of their
             condition. This could mean admission to a hospital or an emergency room visit. This
             could mean that a new medication was added, medication dose was increased, or
             medication was switched in order to better control symptoms of the condition.

          -  The patient must have an unsatisfactory response to their current medication or be
             experiencing negative effects of their current medication or not always take their
             current medication so that a change in current medication is desired.

        Exclusion Criteria:

          -  Patients who are actively suicidal.

          -  Patients who are pregnant or nursing.

          -  Patients who have stopped past treatment with olanzapine because of adverse events,
             are treatment resistant or allergic to olanzapine, or have a condition which would
             prevent use of a long acting form of olanzapine.

          -  Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes,
             certain diseases of the liver, uncontrolled thyroid condition or other serious or
             unstable illness.

          -  Patients with Parkinson's disease, psychosis related to dementia or other related
             disorders.
Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: dapagliflozin; glipizide; metformin hydrochloride
Intervention description: Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks; Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks; Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Intervention MeSH terms: Metformin; Dapagliflozin; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dapagliflozin; efficacy; safety; metformin; Type 2 diabetes

Summary:

      This study is being carried out to see if dapagliflozin as an addition to metformin is
      effective and safe in treating patients with type 2 diabetes when compared to glipizide
      (sulphonylurea) as an addition to metformin treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes

          -  Treated with oral anti-diabetic drug therapy therapy including Metformin for at least
             8 weeks prior to enrolment

          -  HbA1c >6.5% and </=10%

        Exclusion Criteria:

          -  Type 1 Diabetes

          -  Insulin therapy within one year of enrolment

          -  Renal (kidney) failure or dysfunction
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-445/TEZ/IVA; IVA; Placebo
Intervention description: Participants received VX-445/TEZ/IVA orally once daily in the morning.; Participants received IVA orally once daily in the evening; Participants received placebo matched VX-445/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 405.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor
      (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for
      F508del and a minimal function mutation (F/MF subjects).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Heterozygous for the F508del mutation (F/MF)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: ibandronate [Bonviva/Boniva]
Intervention description: 3 mg intravenously every 3 months
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This single arm, open label study will assess the efficacy and safety of and compliance to
      treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with
      post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg
      intravenously every three months. Anticipated time on study treatment is 12 months with a
      follow-up of 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients, > 50 years of age

          -  Diagnosed osteoporosis

          -  Bone mineral density < minus 2.5 SD or osteoporotic fracture

          -  At least 3 years after menopause

        Exclusion Criteria:

          -  Impaired renal function

          -  Contra-indication to Calcium or Vitamin D therapy

          -  Previous or current treatment with biphosphonates