bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
Condition: Ocular Inflammation and Pain After Cataract Surgery
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: APP13007, 0.05%; APP13007, 0.1%; APP13007 Placebo, 0.05%; APP13007 Placebo, 0.1%
Intervention description: APP13007 eye drop, 0.05%; APP13007 eye drop, 0.1%; APP13007 placebo eyedrop, 0.05%; APP13007 placebo eyedrop, 0.1%
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose
      strength and dosing frequency in a randomized double-masked fashion for comparison to the
      respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05%
      APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42
      subjects who experience postoperative inflammation on the first day following routine,
      uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results
      of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1%
      APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1
      ratio, active vs. placebo. In each Part, subjects will return periodically for study
      assessments during the treatment period and then for a follow-up visit approximately 1 week
      after stopping the study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Expected to undergo unilateral uncomplicated cataract extraction via
             phacoemulsification and posterior chamber intraocular lens implantation in one eye.

          -  In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated
             potential of 0.7 (20/100) or better in study eye.

          -  Have > 10 and ≤ 30 cells in anterior chamber.

          -  Have an intraocular pressure ≤ 30 mmHg.

        Exclusion Criteria:

          -  Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.

          -  Have a score > 0 on Ocular Pain Assessment in either eye.
A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Bevacizumab [Avastin]; Capecitabine; Irinotecan
Intervention description: Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle.; Capecitabine was administered orally at a doses of 1000 or 1250, mg/m^2 twice daily (Day 2 to 15) or as 650 mg/m^2 twice daily on Days 1 to 21.; Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks.
Intervention MeSH terms: Bevacizumab; Capecitabine; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic
      cancer of the colon or rectum. The anticipated time on study treatment is until disease
      progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  colon or rectal cancer, with metastases;

          -  >=1 measurable lesion.

        Exclusion Criteria:

          -  previous systemic treatment for advanced disease;

          -  radiotherapy to any site within 4 weeks before study;

          -  daily aspirin (>325 mg/day), anticoagulants, or other medications known to predispose
             to gastrointestinal ulceration;

          -  co-existing malignancies or malignancies diagnosed within last 5 years (except basal
             cell cancer or cervical cancer in situ).
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: clofarabine
Intervention MeSH terms: Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: acute myelogenous leukemia; acute myeloid leukemia; clolar; evoltra; clofarabine; untreated acute leukemia; adult acute leukemia

Summary:

      The purpose of the study is to determine if treatment of older patients indicated with
      untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive
      chemotherapy, can effectively be treated with Clofarabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide signed, written informed consent

          -  Have untreated AML according to World Health Organization (WHO) classification

          -  Male or post-menopausal female ≥ 65 years of age

          -  Unsuitable for intensive chemotherapy

          -  Be able to comply with study procedures and follow-up examination

          -  Male patient who are fertile agree to use and effective barrier method of birth
             control to avoid pregnancies

          -  Have adequate liver and renal function as indicated by certain laboratory values

        Exclusion Criteria:

          -  Received previous treatment with clofarabine

          -  Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for
             pre-medication purposes are allowed)

          -  Have received prior treatment for leukemia. Growth factor, cytokine support,
             leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24
             hours prior to start of treatment with clofarabine

          -  Have a psychiatric disorder that would interfere with consent, study participation, or
             follow-up

          -  Have an active, uncontrolled systemic infection

          -  Are currently participating in other investigational drug studies or having received
             other investigational drugs within the previous 30 days

          -  Have symptomatic central nervous system (CNS) involvement

          -  Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]
Intervention description: Erlotinib tablets taken orally once daily in the morning.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of Tarceva in two groups of patients with
      non-small cell lung cancer who have not been pre-treated with chemotherapy. One group,
      consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other
      group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a
      maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  histologically documented advanced non-small cell lung cancer (stage IIIB/IV);

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2;

          -  no previous chemotherapy.

        Exclusion Criteria:

          -  previous therapy which acts on Epidermal Growth Factor Receptor (EGFR) axis;

          -  clinical evidence of brain metastasis;

          -  any unstable systemic disease;

          -  unable to take oral medication;

          -  any significant ophthalmological abnormality.
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: dalteparin
Intervention description: dalteparin subcutaneous injection
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: VTE

Summary:

      Three month treatment of acute VTE with Fragmin in pediatric cancer patients
    

Eligibility criteria:

        Inclusion Criteria:

        -

        Exclusion Criteria:

        -
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Condition: Pain Due to Osteoporosis
MeSH terms: Osteoporosis
Intervention: OPC-249
Intervention description: 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: Female
Minimum age: 46 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily
      inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to
      osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who fulfill all of the following items

               -  Patients with primary osteoporosis

               -  Patients who have existing 1-4 vertebral fractures

               -  Patients with back pain persisting for one week or more

               -  Postmenopausal women between 46 and less than 80 years of age
A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: rituximab [MabThera/Rituxan]; First line chemotherapy
Intervention description: 375mg/m2 iv every 3 weeks; As prescribed
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the benefit of adding MabThera to standard induction
      chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and
      tolerability of a MabThera-containing first line regimen will also be assessed. All patients
      will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard
      chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample
      size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically-proven mantle cell lymphoma;

          -  previously untreated disease at stage II, III and IV, requiring therapy.

        Exclusion Criteria:

          -  known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity
             or known hypersensitivity to murine antibodies;

          -  active malignancy other than mantle cell lymphoma within 5 years of start of study,
             with the exception of resected basal cell cancer, squamous cell cancer of the skin, or
             in situ cancer of the cervix;

          -  serious disorders interfering with full standard dosing chemotherapy;

          -  stage I disease.
A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
Condition: Autoimmune Hemolytic Anemia
MeSH terms: Anemia; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Hemolysis
Intervention: Parsaclisib
Intervention description: Parsaclisib administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: autoimmune hemolytic anemia; phosphatidylinositol 3-kinase (PI3K) inhibitor

Summary:

      The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered
      orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin
      and evidence of ongoing hemolysis that requires treatment intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidence
             of anti-erythrocyte antibodies, detectable by the direct antiglobulin test.

          -  Participants who have disease progression after treatment with standard therapies that
             are known to confer clinical benefit, or who are intolerant to treatment, or who
             refuse standard treatment. There is no limit to the number of prior treatment
             regimens.

          -  Hemoglobin 7 to 10 g/dL.

          -  No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying
             conditions.

          -  Eastern Cooperative Oncology Group performance status of 0 to 2.

          -  Willingness to avoid pregnancy or fathering children.

        Exclusion Criteria:

          -  Pregnant or breastfeeding women.

          -  Concurrent conditions and history of other protocol-specified diseases.

          -  ANC < 1.5 × 10^9/L.

          -  Platelet count < 100 × 10^9/L.

          -  Severely impaired liver function.

          -  Impaired renal function with estimated creatinine clearance less than 45 mL/min.

          -  Anti-phospholipid antibodies positive or elevated anti-streptolysin antibodies.

          -  Positive serology test results for hepatitis B surface antigen or core antibody, or
             hepatitis C virus antibody with detectable RNA at screening, consistent with active or
             chronic infection.

          -  Known HIV infection or positivity on immunoassay.

          -  History or presence of an abnormal ECG that, in the investigator's opinion, is
             clinically meaningful.

          -  Known hypersensitivity or severe reaction to parsaclisib or its excipients.
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg
Condition: Advanced Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant
Intervention description: intramuscular injection 250 mg & 500 mg
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 144.0
Sex: Female
Minimum age: 45 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: oncology; cancer; breast cancer

Summary:

      This study will assess the relationship between fulvestrant dose and efficacy in
      postmenopausal women with oestrogen receptor positive advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast Cancer has continued to grow after having received treatment with an
             anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor.

          -  Requiring hormonal treatment.

          -  Postmenopausal women (woman who has stopped having menstrual periods)

        Exclusion Criteria:

          -  Treatment with more than one previous regimen of systemic anticancer therapy other
             than endocrine therapy for advanced BC.

          -  Treatment with more than one previous regimen of endocrine therapy for advanced BC.

          -  An existing condition that prevents compliance.
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Goserelin acetate; Goserelin acetate
Intervention description: 3.6 mg intramuscular depot injection given every 4 weeks; 10.8 mg intramuscular depot injection given every 12 weeks
Intervention MeSH terms: Goserelin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oncology; cancer; breast cancer

Summary:

      The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to
      Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced
      breast cancer by assessment of progression-free survival at 24 weeks.

      Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg
      and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in
      Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of
      goserelin plasma concentration time profiles

      Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow
      recruitment. 98 (vs the planned 260) patients were randomised into the study and will be
      followed as per protocol for 2 years
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed
             oestrogen receptor positive (ER +ve) breast cancer

          -  World Health Organization (WHO) performance status of 0, 1, or 2

          -  Provided written informed consent

        Exclusion Criteria:

          -  Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC)
             adjuvant in the previous 24 weeks

          -  Received radiotherapy within the past 4 weeks

          -  History of systemic malignancy other than breast cancer within the previous 3 years

          -  Estimated survival less than 24 weeks
A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell; Thalassemia
Intervention: IMR-687; Placebo
Intervention description: Oral administration of IMR-687 once daily with or without HU.; Oral administration of placebo once daily with or without HU.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Study of IMR-687 in adult participants with sickle cell anemia (SCA) (homozygous HbSS or
      sickle-β0 thalassemia).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female participants with confirmed SCA

          -  Age 18 to 55 years, inclusive

          -  For participants on HU, must have been on a stable dose for at least 60 days prior to
             screening

        Key Exclusion Criteria:

          -  Total hemoglobin >12.5 or <6 grams/deciliter

          -  Red blood cell transfusion within 60 days of baseline

          -  >7 hospitalizations for vaso-occlusive crises (VOCs) within the last year

          -  Estimated glomerular filtration rate <50 milliliter/minute

          -  Aspartate aminotransferase/alanine aminotransferase >3x the upper limit of normal
Selegiline Patch for Treatment of Nicotine Dependence
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Selegiline; matching placebo
Intervention description: 6mg/24 hrs for 8 weeks; placebo/24hrs for 8 weeks
Intervention MeSH terms: Selegiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of
      this study is examine whether selegiline, given in the form of a skin patch, is effective in
      stopping smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smokes greater than 20 cigarettes per day

        Exclusion Criteria:

          -  History of Parkinson's disease, high blood pressure, or severe liver or kidney disease

          -  Current substance abuse

          -  Mental illness

          -  Skin conditions that could interfere with patch use

          -  Using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any MAO
             inhibitor)

          -  Pregnant or breastfeeding
Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: Fesoterodine
Intervention description: Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods
Intervention MeSH terms: Fesoterodine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Phase 2 stress urinary incontinence Fesoterodine

Summary:

      The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the
      treatment of the condition of stress urinary incontinence
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female, 18 - 65 years

          -  SUI symptoms for longer than 3 months

          -  Subjects must be non-pregnant and not breastfeeding

        Exclusion Criteria:

          -  Disease or medical condition affecting the bladder or urinary tract (other tan stress
             urinary incontinence)

          -  Subjects taking medication with effects on the bladder or urinary tract

          -  Subejcts with medical conditions which could be adversely affected by administration
             of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment