bioihbjkbjnl/mcl2 huggingface dataset:
Secondary Adjuvant Long Term Study With Arimidex
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Anastrozole
Intervention description: 1mg tablet daily
Intervention MeSH terms: Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3484.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hormone receptor positive breast cancer

Summary:

      The study assesses the effect of further 2 years vs further 5 years of adjuvant treatment
      with anastrozole after initial 5 years of adjuvant endocrine therapy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Postmenopausal patients with histologically confirmed, local radically treated
             invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie
             and/or radiotherapie.

          2. No distant metastasis at randomization

          3. No relapse at randomization

          4. TNM- classification at time of diagnosis: T1-3, N0 and N+, M0

          5. Estrogen- and or progesterone positive before the beginningof primary endocrine
             therapy

          6. Endocrine therapy for 5 years (maximum deviation ±12 months)

          7. Therapy break (from the preliminary therapie) maximum 12 months.

          8. Informed Consent before the randomisation

        Exclusion criteria:

          1. Premenopausal patients or patients with non definable menopausal statusat time of
             randomisation

          2. Apparent secondary malignant tumor or status after secondary malignant tumor
             (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or
             progesteronereceptor positive on both sides at the time of diagnosis; in situ
             carcinomaof the cervix and basal cell carcinoma of the skin)

          3. General contraindication respectively hypersensitivity to Anastrozol.

          4. In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4
             tumor at the time of first diagnosis.

          5. Receptor unknown or negative at time of diagnosis respectively at beginning of primary
             endocrine therapy

          6. Known liver- and/or kidneyinsufficiency

          7. Performance Index >2 according to WHO

          8. Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more
             than 6 months since primary surgery of the mamma carcinoma

          9. Serious accessory disease, that prevents the adjuvant therapy according to protocol
             and/or the regular follow-up care.

         10. Lacking compliance of the patient

         11. Legal incompetence and/or other circumstances, that prevent the patient from
             understanding the nature, meaning and consequences of the clinical trial

         12. Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the
             time of admission into the study
A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: FKB327; Humira®
Intervention description: Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.; Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 645.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid; Arthritis

Summary:

      The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity
      of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study
      FKB327-002 and have inadequate disease control on methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791)
             and are continuing with methotrexate

          2. In the investigator's opinion, the patient showed a clinical response to treatment
             during Study FKB327-002 (NCT02260791)

        Exclusion Criteria:

          1. Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002

          2. Patient has presence of active and/or untreated latent tuberculosis (TB)

        Other Inclusion/Exclusion criteria may apply.
A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]; Epoetin alfa
Intervention description: 120, 200 or 360 micrograms sc monthly (starting dose); As prescribed
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of monthly administration of
      subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis
      patients with chronic renal anemia. Patients currently receiving maintenance treatment with
      epoetin alfa will be randomized to receive either monthly injections of Mircera with a
      starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were
      receiving in the week preceding study start, or to continue on epoetin alfa treatment. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia;

          -  regular hemodialysis with the same schedule of dialysis for >=12 weeks;

          -  maintenance therapy with subcutaneous epoetin alfa at the same administration interval
             for 4 weeks.

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months;

          -  poorly controlled hypertension requiring interruption of epoetin alfa in previous 6
             months;

          -  acute or chronic bleeding;

          -  active malignant disease (except non-melanoma skin cancer).
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
Condition: Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 210 mg brodalumab; 140 mg brodalumab; ustekinumab; placebo
Intervention description: 210 mg brodalumab administered SC; 140 mg brodalumab administered SC; 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.; Placebo administered SC
Intervention MeSH terms: Ustekinumab; Brodalumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1831.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: psoriasis, brodalumab, AMG 827

Summary:

      The purpose of this study is to assess the safety and efficacy of brodalumab at two different
      doses
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had stable moderate to severe plaque psoriasis for at least 6 months

          -  Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at
             screening and at baseline

        Exclusion Criteria:

          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication-induced psoriasis, or other skin conditions at (eg, eczema) that would
             interfere with study evaluations

          -  Subject has known history of Crohn's disease

          -  Subject has any other significant concurrent medical condition or laboratory
             abnormalities, as defined in the study protocol

          -  Subject has not stopped using certain psoriasis therapies as defined in the study
             protocol

          -  Subject has previously used ustekinumab or any anti-IL-17 biologic therapy

          -  Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in
             the study

          -  Female subject is unwilling to use highly effective methods of birth control unless 2
             years post-menopausal or surgically sterile
Multicenter, Safety Study Of Maraviroc
Condition: Acquired Immunodeficiency Syndrome; HIV Infection
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: Maraviroc
Intervention description: Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.
Intervention MeSH terms: Maraviroc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multicenter; Open Label; Non-Comparative Safety Study Of Maraviroc; Treatment Experienced

Summary:

      To collect safety and tolerability data in a more diverse patient population of patients with
      HIV/Aids, who have limited therapeutic options.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with limited or no approved treatment options available to them due to
             resistance or intolerance;

          -  Subjects must be failing to achieve adequate virologic suppression on their current
             regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening.

          -  Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay.

        Exclusion Criteria:

          -  Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having
             previously discontinued Maraviroc in trials

          -  Potentially life threatening (Grade 4) laboratory abnormality or medical condition
             (according to the Division of AIDS table for grading severity of adult adverse
             experiences) still under investigation unless a diagnosis has been established and
             felt not to affect risk/benefit assessment or eventual interpretation of safety
             results, based on discussion between the investigator and Pfizer.
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Condition: Age Related Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 531.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD, ranibizumab

Summary:

      Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human
      vascular endothelial growth factor A. This study will assess the safety and efficacy of
      ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal
      neovascularization (CNV) secondary to age-related macular degeneration (AMD).
    

Eligibility criteria:

        Patients who participated in this study included those who had completed participation in
        the study CRFB002A2301 (ANCHOR; NCT00061594), newly diagnosed patients, as well as
        previously diagnosed patients who had had recent disease progression.

        Inclusion Criteria:

          -  Male or female patients > 50 years of age

          -  Diagnosis of active primary or recurrent CNV secondary to AMD, including those with
             predominantly classic, minimally classic or occult lesions with no classic component

          -  The total area of CNV (including both classic and occult components) encompassed
             within the lesion must be >= 50% of the total lesion area

          -  The total lesion area must be <= 12 disc areas

          -  Patients who have a BCVA (best corrected visual acuity) score between 73 and 24
             letters, inclusive, in the study eye using ETDRS-like (Early Treatment of Diabetic
             Retinopathy Study) grading charts (approximately 20/40 to 20/320)

        Exclusion Criteria:

          -  Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as
             bilateral vision below 20/200 or less than 34 letters)

          -  Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo
             dynamic therapy or pegaptanib sodium in the study eye within 30 days preceding Day 1

          -  Previous participation in a clinical trial (for either eye) involving anti-angiogenic
             drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

        Other protocol-defined inclusion/exclusion criteria may apply.
Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A
Condition: Severe Haemophilia A
MeSH terms: Hemophilia A
Intervention: Human-cl rhFVIII
Intervention description: Human-cl rhFVIII was provided as a freeze-dried concentrate to be reconstituted in water for injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line
      recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients
      who received Human-cl rhFVIII as on demand treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe haemophilia A (FVIII:C < 1%) according to medical history.

          -  Male patients ≥ 18 years old.

          -  Previous treatment with a FVIII concentrate (regular prophylaxis with good compliance
             or on-demand treatment) for at least 150 exposure days (EDs).

          -  Good documentation regarding dosing and bleeding frequency in the 6 months preceding
             study start.

          -  Immunocompetence (CD4+ count > 200/microliter).

          -  HIV-negative, if positive, viral load < 200 particles/microliter or < 400,000
             copies/mL.

          -  Freely given written informed consent

        Exclusion Criteria:

          -  Any coagulation disorder other than haemophilia A.

          -  Present or past FVIII inhibitor activity (> 0.6 Bethesda Unit [BU])

          -  Severe liver or kidney disease.
Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Condition: Rosacea
MeSH terms: Rosacea; Erythema
Intervention: CD07805/47 gel 0.5%
Intervention description: In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rosacea

Summary:

      A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5%
      once daily in subjects with moderate to severe facial erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female who is at least 18 years of age or older.

          -  A clinical diagnosis of facial rosacea.

          -  A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior
             to study drug application).

          -  A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to
             study drug application).

        Exclusion Criteria:

          -  Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated
             rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses
             that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial
             keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
             telangiectasia.

          -  Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
             hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
             or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.

          -  Previous refractive eye surgery such as photorefractive keratectomy (PRK),
             laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ
             keratomileusis (LASIK).

          -  Current treatment with monoamine oxidase (MAO) inhibitors.

          -  Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or
             alpha-agonists.

          -  Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac
             glycosides, beta blockers or other antihypertensive agents.
Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Arsenic trioxide; Low-dose cytarabine alone
Intervention description: Arsenic trioxide will be administered intravenously (iv) at a dose of 0.25 mg/kg.; Cytarabine will be administered at a dose of 10 mg/m^2 subcutaneously (sc) twice a day (bid).
Intervention MeSH terms: Cytarabine; Arsenic Trioxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: acute myeloid leukemia, cytarabine, arsenic trioxide.

Summary:

      The primary objective of this study is to determine whether low-dose cytarabine in
      combination with arsenic trioxide is more effective than low-dose cytarabine alone in
      achieving complete remission in elderly patients (≥60 years of age) with acute myeloid
      leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has confirmed acute myeloid leukemia (AML).

          -  The patient is unwilling or unable to tolerate conventional induction chemotherapy.

          -  The patient has no comorbid conditions that would limit life expectancy to less than 3
             months.

          -  Patient must meet specific laboratory parameters for study inclusion.

        Exclusion Criteria:

        - The patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (AML) or
        myelodysplastic syndrome (MDS).

        Previous treatment with low-dose cytarabine is not permitted.

          -  The patient has a QT interval outside of the protocol-specified range.

          -  The patient has laboratory values outside of protocol-specified ranges.

          -  The patient is concurrently treated with cytotoxic therapy, radiation, or
             investigational agents.

          -  The patient has uncontrolled, severe cardiovascular or pulmonary disease or other
             uncontrolled medical condition.

          -  The patient has known central nervous system involvement with AML.
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: inotuzumab ozogamicin; FLAG (fludarabine, cytarabine and G-CSF); HIDAC (high dose cytarabine); cytarabine and mitoxantrone
Intervention description: Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6; Dose: cytarabine 2.0 g/m^2/day IV days 1-6 fludarabine30 mg/m^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4; cytarabine 3 g/m^2 IV every 12 hours for up to 12 times; mitoxantrone 12 mg/m^2 IV days 1-3 cytarabine 200 mg/m^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4
Intervention MeSH terms: Cytarabine; Fludarabine; Mitoxantrone; Inotuzumab Ozogamicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy, in terms of complete responses and overall survival, of
      inotuzumab ozogamicin versus investigator's choice of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CD22 expression

          -  Adequate liver and renal functions

        Exclusion Criteria:

          -  Isolated extramedullary disease

          -  Active Central Nervous System [CNS] disease