bioihbjkbjnl/mcl2 huggingface dataset:
Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Cardiotoxicity
Intervention: Carvedilol; placebo
Intervention MeSH terms: Carvedilol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carvedilol; Anthracycline; HER2; 14-099

Summary:

      The purpose of this study is to find out the effects, good and/or bad, of a beta blocker
      (carvedilol) on heart function during treatment with anti-HER2 medication(s) including
      trastuzumab (Herceptin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Age ≥ 18 years

          -  Non-metastatic histologically confirmed primary invasive breast carcinoma

          -  Pathologically confirmed HER2-positive breast cancer

          -  Scheduled to receive anthracycline chemotherapy followed by anti-HER2 therapy at MSKCC

          -  Able and willing to provide informed consent

          -  Willing and able to comply with the requirements of the protocol

          -  Able to swallow capsules

        For Aim 2, all patients must meet the following criteria:

          -  Meet all inclusion criteria above

               -  LVEF > 50%

          -  Abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline)
             prior to initiation of planned anti-HER2 therapy

          -  Heart rate ≥ 50 beats per minute

          -  Sitting systolic blood pressure > 90 mmHg

        Exclusion Criteria:

          -  Patients are to be excluded from randomization for Aim 2 of this study if they meet
             any of the following criteria:

          -  Current treatment with ACE-inhibitors or beta blockers

          -  Allergies or inability to tolerate beta blockers previously due to bradycardia,
             hypotension, or AV block.

          -  Known history of NCI CTCAE (Version 4.0) Grade ≥ 2 symptomatic CHF, myocardial
             infarction within 12 months prior to randomization, significant symptoms (Grade ≥ 3)
             relating to left ventricular dysfunction, significant (moderate or severe) valvular
             disease, or significant cardiac arrhythmia (Grade ≥ 3)

          -  Pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks
             of starting treatment

          -  Enrollment in a therapeutic intervention trial in the Breast Medicine service
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: MEDI7183 low dose; MEDI7183 medium dose; MEDI7183 high dose; Matching Placebo
Intervention description: MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8; MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8; MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8; Placebo will be administered by SC on Day 1, Week 2,4, and 8
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis, Japanese, subcutaneously

Summary:

      This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase
      II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with
      moderate to severe UC
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Diagnosis of UC established by clinical and endoscopic evidence and corroborated by a
             histopathology report

          -  Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with
             rectosigmoidoscopy score ≥ 2 during screening period

          -  Demonstrated an inadequate response to, loss of response to, or intolerance to at
             least one of immunomodulators or Anti- TNF-α agents. etc.

        Exclusion Criteria:

          -  Disease limited to the rectum

          -  Toxic megacolon

          -  Crohn's Disease

          -  History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,
             Koch pouch, or ileostomy for UC

          -  Planned bowel surgery within 12 weeks from Visit 2

          -  Stool positive for C. difficile toxin at screening

          -  Primary Sclerosing Cholangitis

          -  History of gastrointestinal surgery within 8 weeks of Visit 2

          -  Any uncontrolled or clinically significant systemic disease

          -  Condition or disease that, in the opinion of the investigator would pose a risk to
             subject safety or interfere with study evaluation, procedures or completion

          -  Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc
Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cisplatin; Docetaxel; Pegfilgrastim
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dose-Dense Chemotherapy

Summary:

      Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less
      time between treatments than in standard chemotherapy. The two chemotherapy drugs used in
      this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given
      every 21 days. This study is exploring the response to chemotherapy when these drugs are
      given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens
      to identify signatures that may predict chemotherapy sensitivity or resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with documented stage III NSCLC (IIIA or IIIB, without malignant
             pleural/pericardial effusion) are eligible for enrollment if they are considered
             appropriate for treatment with chemotherapy, radiation, or surgery;

          -  IIIA: T1-3 N2 M0, T3 N1 M0

          -  IIIB: T4 N0-2 M0, T 1-4 N3 M0

          -  Measurable or evaluable disease

          -  Previously untreated with chemotherapy or radiotherapy for lung cancer;

          -  No brain metastases;

          -  No prior XRT

          -  Performance status 0-2

          -  ≥18 years of age

          -  Informed Consent

          -  Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

          -  Platelets ≥ 100 x 109/L

          -  Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN)

          -  SGOT and SGPT ≤ 2.5 x ULN for the institution

          -  Creatinine ≤ 1.6 mg/dL

          -  Hemoglobin ≥ 8.0 g/dL

          -  Peripheral neuropathy ≤ grade 1

        Exclusion Criteria:

          -  Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin,
             L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);

          -  Use of IV systemic antibiotics within 72 hours prior to chemotherapy;

          -  Known HIV infection

          -  Lithium or cytokines within 2 weeks prior of entry

          -  Additional concurrent investigational drugs

          -  History of myelodysplastic syndrome

          -  Pregnant, nursing or having unprotected sex

          -  Not available for follow-up assessment

          -  Unable to comply with protocol procedures

          -  Illnesses that may compromise ability to give informed consent.

          -  Patients with a history of severe hypersensitivity reaction to Taxotere® or other
             drugs formulated with polysorbate 80.
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: tisagenlecleucel
Intervention description: Tisagenlecleucel is single infusion.
Intervention MeSH terms: Tisagenlecleucel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Refractory or relapsed Follicular Lymphoma; Refractory; Relapsed; Follicular lymphoma; CTL019; Tisagenlecleucel; Chimeric antigen receptor; CAR19; CAR-T

Summary:

      This is a multi-center, phase II study to determine the efficacy and safety of
      tisagenlecleucel in adult patients with relapsed or refractory FL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)

          -  Radiographically measurable disease at screening

        Exclusion Criteria:

          -  Evidence of histologic transformation

          -  Follicular Lymphoma Grade 3B

          -  Prior anti-CD19 therapy

          -  Prior gene therapy

          -  Prior adoptive T cell therapy

          -  Prior allogeneic hematopoietic stem cell transplant

          -  Active CNS involvement by malignancy

        Other protocol-defined Inclusion/Exclusion criteria may apply.
Open-Label Extension and Safety Study of Talazoparib
Condition: Cancer
Intervention: Talazoparib
Intervention description: Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol
Intervention MeSH terms: Talazoparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single-arm, open-label, extended treatment, safety study in patients treated with
      talazoparib in qualifying studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          -  Female patients of childbearing potential must have a negative pregnancy test before
             the first dose of talazoparib and must agree to use a highly effective birth control
             method from the time of the first dose of talazoparib through 45 days after the last
             dose.

          -  Male patients must use a condom when having sex with a pregnant woman or with a woman
             of childbearing potential from the time of the first dose of talazoparib through 105
             days after the last dose. Contraception should be considered for a nonpregnant female
             partner of childbearing potential.

          -  Female patients may not be breastfeeding at the first dose of talazoparib and must not
             breastfeed during study participation through 45 days after the last dose of
             talazoparib.

        Exclusion Criteria:

          -  Permanently discontinued from any Medivation sponsored study with talazoparib alone or
             in combination with another agent.

          -  Received an antineoplastic therapy or investigational agent after treatment with
             talazoparib in the originating protocol.

          -  Has a clinically significant cardiovascular, dermatologic, endocrine,
             gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or
             pulmonary disorder or any other condition, including excessive alcohol or drug abuse,
             or secondary malignancy, that may interfere with study participation in the opinion of
             the investigator.

          -  Diagnosis of myelodysplastic syndrome (MDS).
Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: anastrozole; fulvestrant
Intervention description: Given orally; Given intramuscularly
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer

Summary:

      RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
      anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.
      Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given
      the lack of clinical data on fulvestrant in patients with large operable or locally advanced
      hormone-receptor-positive breast cancer, and the potential to identify differences in the
      mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre
      randomised phase II clinical trial of anastrozole and fulvestrant.

      PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and
      fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast
      cancer not eligible for initial breast-conserving surgery, and to identify genomic changes
      occurring after treatment.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:

               -  SBR grade I-II disease (patients < 65 years of age)

               -  SBR grade I-III disease (patients > 65 years of age)

          -  T2 (2-5 cm), T3, or T4B, and N0-1 disease

          -  No metastatic disease

          -  Breast lesion not amenable to breast-conserving resection

          -  No inflammatory breast cancer

          -  No prior breast cancer

          -  Hormone receptor status:

               -  Estrogen receptor- and/or progesterone receptor-positive

        PATIENT CHARACTERISTICS:

          -  Postmenopausal

          -  No other cancer within the past 5 years except for adequately treated skin carcinoma
             or carcinoma in situ of the cervix

          -  No contraindication to anti-hormonal treatment

          -  No psychological, familial, social, or geographical reasons that would preclude follow
             up

        PRIOR CONCURRENT THERAPY:

          -  At least 8 days since prior hormone replacement therapy

          -  No concurrent anti-vitamin K treatment
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
Condition: Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Intervention: Erenumab; Placebo
Intervention description: A single dose of erenumab 140 mg infused over approximately 60 minutes.; A single dose of a matching volume of placebo infused over approximately 60 minutes.
Intervention MeSH terms: Erenumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Angina; Stable Angina; Cardiovascular Disease; Exercise-induced Angina

Summary:

      A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in adults with
      stable angina to evaluate the effect of erenumab (AMG 334) compared to placebo on exercise
      time during an exercise treadmill test.
    

Eligibility criteria:

        Inclusion Criteria

          -  History of chronic stable angina or at least 3 months prior to screening, with at
             least 1 angina episode per month

          -  Ischemic heart disease documented by myocardial infarction, coronary angiography or a
             revascularization procedure

          -  Receiving stable doses of cardiac medication

          -  Completes 2 exercise treadmill tests during screening meeting protocol requirements

        Exclusion Criteria:

          -  Participating in another investigational study

          -  Current or prior malignancy within 5 years of randomization

          -  Known sensitivity to any components of the investigational product

          -  Not able to complete all protocol required study visits

          -  Having the following within 3 months prior to or during screening: Unstable angina or
             acute coronary syndrome, transient Ischemic attack (TIA) or stroke, revascularization
             procedure, or instability in ST-segment depression between screening exercise
             treadmill tests, as assessed by the core electrocardiograph (ECG) laboratory
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
Condition: Gout
MeSH terms: Gout
Intervention: Rilonacept; Placebo (for Rilonacept)
Intervention description: Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.; Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
Intervention MeSH terms: Rilonacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a clinical research study to determine the safety and effectiveness of an
      experimental drug called rilonacept in participants with gout who were beginning another
      additional treatment. Participants participated in this study for approximately 24 weeks.
      Rilonacept was being studied for use in preventing gout attacks in participants who had gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female greater than 18 years of age;

          -  Previously met the preliminary criteria of the American Rheumatism Association (ARA)
             for the classification of the acute arthritis of primary gout;

          -  At least 2 gout flares in the year prior to the screening visit.

        Exclusion Criteria:

          -  Acute gout flare within 2 weeks of the screening visit and during screening;

          -  Persistent chronic or active infections;

          -  History of an allergic reaction to allopurinol;

          -  History or presence of cancer within 5 years of the screening visit.
Evaluation 2% Chlorhexidine Gluconate
Condition: Skin Coverage
Intervention: 2% CHG
Intervention description: Chlorhexidine Gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The
      investigational test article was applied topically by vigorously scrubbing the skin in a back
      and forth motion for three minutes (and halfway through the 3-minute application time, the
      cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin
      was allowed to air dry.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy males of at least 18 years of age having skin within 6 inches of the test regions
        that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders,
        with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Ozanimod; Placebo
Intervention description: Ozanimod capsules by mouth daily.
Intervention MeSH terms: Ozanimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Maximum age: 73 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether RPC1063 is effective in the treatment of
      ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ulcerative colitis (UC) confirmed on endoscopy

          -  Moderately to severely active UC (Mayo score 6-12)

        Exclusion Criteria:

          -  Current use of anti-TNF agents
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Intervention: BI 671800; Placebo; Montelukast
Intervention description: Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma; Patients receive placebo capsules and/or encapsulated tablets; Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma
Intervention MeSH terms: Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a
      double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main
      objective is to assess the effect on lung function. The study will also provide data on the
      pharmacokinetics of BI 671800.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed informed consent consistent with ICH-GCP

          2. Three month history of reversible (12% and 200 mL in forced expiratory volume in one
             second - FEV1) asthma (according to GINA) with following spirometry at randomisation:
             FEV1 60%- 85%.

          3. Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.

          4. Diagnosis of asthma prior to 40 years.

          5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.

          6. Male or female 18 to 65 years.

          7. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine
             screen.

          8. Able to perform pulmonary function testing.

        Exclusion criteria:

          1. Significant diseases other than asthma or allergic rhinitis.

          2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.

          3. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.

          4. Uncontrolled asthma on iCS + other controller.

          5. Respiratory tract infection or exacerbation within 4 weeks.

          6. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive
             days, or asthma exacerbation during run-in period.

          7. Participation in another interventional study.

          8. Pregnant or nursing women.

          9. Women of child bearing potential not using appropriate methods of birth control as
             defined by the study protocol.