bioihbjkbjnl/mcl2 huggingface dataset:
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
Condition: Gastric Cancer; Stomach Cancer
MeSH terms: Stomach Neoplasms
Intervention: Cetuximab; Irinotecan; Cisplatin; Surgery; 5-FU; Radiation
Intervention MeSH terms: Irinotecan; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stomach cancer; biologics; antibody; chemotherapy; chemoradiation; adjuvant therapy; neoadjuvant therapy; epidermal growth factor receptor; combination therapy

Summary:

      This study intends to evaluate the feasibility and treatment efficacy of adding an antibody
      blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven
      efficacy developed at New York University.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have signed an approved informed consent.

          -  must have histologically documented untreated gastric/GEJ carcinoma (clinical stage T3
             N0 or T4, or any T with N1-N3 M0)

          -  Patients with tumor tissue available for assessment of EGF receptor status by
             immuno-histochemistry (IHC).

          -  Patients with Performance Status 0-2.

          -  Patients, 18 years and older, must either be not of child bearing potential or have a
             negative pregnancy test within 7 days of treatment. Patients are considered not of
             child bearing potential if they are surgically sterile (they have undergone a
             hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
             postmenopausal.

          -  Bone marrow function: absolute neutrophil count (ANC) at least 1,500/ul; platelets at
             least 100,000/ul.

          -  Renal function: creatinine not greater than 1.5 x institutional upper limit of normal
             (ULN).

          -  The PT and PTT should be within the range of normal values

          -  Hepatic function: bilirubin not greater than 1.5 x ULN; aspartate aminotransferase
             (AST) not greater than 2.5 x ULN.

        Exclusion Criteria:

          -  Acute hepatitis or known HIV.

          -  Active or uncontrolled infection.

          -  Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
             unstable angina, and congestive heart failure.

          -  Prior therapy that affects or targets the EGF pathway.

          -  Prior allergic reaction to chimerized or murine monoclonal antibody therapy or
             documented presence of human anti-mouse antibodies (HAMA).

          -  Any concurrent chemotherapy not indicated in the study protocol or any other
             investigational agent(s).
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Decitabine
Intervention description: 20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.
Intervention MeSH terms: Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute Myeloid Leukemia; AML; Decitabine; Dacogen; MGI PHARMA, INC.

Summary:

      The purpose of this study is to estimate the rate of complete remission, as well as overall
      survival, in older patients with Acute Myeloid Leukemia (AML).
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks
             of study enrollment.

          2. Ineligible to receive intensive chemotherapy for their disease.

          3. Have not received any chemotherapy within 4 weeks of study enrollment and must have
             recovered from any treatment-related toxicities.

        Exclusion Criteria:

          1. Received previous treatment for AML.

          2. Previously received Vidaza.

          3. Received any other investigational agents within 30 days of first dose of study drug.

          4. Uncontrolled intercurrent illness.

          5. Had radiotherapy within 14 days prior to study enrollment.
Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: 150 mg; 75 mg; 100 mg
Intervention description: 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.; 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast; 100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 205.0
Sex: Female
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study
      in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also
      participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized
      to 1 of 3 treatment regimens for 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female, 45 to 80 years of age, in good general health

          -  postmenopausal ≥2 years, surgically or naturally

          -  body mass index less than or equal to 32 kg/m^2 at screening

        Exclusion Criteria:

          -  no use within 3 months prior, nor use for more than 1 month at any time within 6
             months of: glucocorticoids, anabolic steroids, estrogens, selective estrogen-receptor
             modulators (SERMs), or estrogen-related drugs, progestins, calcitonin, vitamin D
             supplements (>1200 IU per day), calcitriol, calcidiol, or alfacalcidol at any dose,
             any bisphosphonate. fluoride (≥10 mg/day), strontium (≥50 mg/day), parathyroid
             hormone, investigational bone active agents.

          -  allergic or abnormal reactions to bisphosphonates

          -  history of cancer within 5 years, excluding squamous and basal cell carcinoma with 6
             month remission

          -  positive pregnancy test

          -  no depot injection >10,000 IU vitamin D in previous 9 months.

          -  no history of GI disease that requires medication, or history of Crohn's disease,
             ulcerative colitis, diverticular disease, polyps, or surgery that could have changed
             GI structure or motility.

          -  no history of frequent diarrhea or constipation that requires regular laxative use.

          -  no history of alcohol or durg abuse, hyperparathyroidism, cancer previous 5 years,
             major surgery within 1 month prior to screening, diabetes, uncontrolled hypertension,
             cardiovascular, hepatic, renal or GI disease.

          -  no active hyperthyroidism, osteomalacia, use of anticonvulsant medication, or allergic
             reaction to bisphosphonates
Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer
Condition: Early Breast Cancer (Phase 2); Advanced Breast Cancer (Phase 1b)
MeSH terms: Breast Neoplasms
Intervention: PF-04691502; PF-04691502 in combination with Letrozole; Letrozole
Intervention description: PF-04691502 administered as single agent for 2 weeks. After this period, patients in this arm will take PF-04691502 in combination with Letrozole until Week 6. Beyond Week 6, if considered appropriate, patients can be treated with the combination for up to 10 additional weeks until breast surgery.; PF-04691502 in combination with Letrozole will be administered for 6 weeks. Beyond Week 6, if considered appropriate, patients can be treated for up to 10 additional weeks until breast surgery.; Letrozole will be administered for 6 weeks. Beyond Week 6, if considered appropriate, patients can be treated for up to 10 additional weeks until breast surgery.
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ki-67; postmenopausal early breast cancer; ER positive/HER2 negative early breast cancer

Summary:

      PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis
      that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or
      acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high
      Ki-67) patient population of hormone-sensitive breast cancers. In addition, Ki-67, a marker
      of cellular proliferation, could be used to select those patients who benefit from treatment
      with a PI3K-pathway inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Phase 1 - Postmenopausal women with diagnosis of breast cancer, metastatic disease or
             locally advanced disease / Estrogen Receptor positive and HER-2 negative / candidate
             to receive Letrozole

          -  Phase 2 - Postmenopausal women with newly diagnosed primary breast cancer / Estrogen
             Receptor positive and HER-2 negative / Ki-67 levels >10% positive cells

          -  Phase 1 & 2 - Glucose control, adequate bone marrow, liver, renal, and cardiac
             function

        Exclusion Criteria:

          -  Inflammatory carcinoma / Prior therapy with an agent active on PI3K and/or mTOR /
             Significant gastrointestinal abnormalities, which may impair intake, transit or
             absorption of the study drugs / Current or anticipated need for food or drugs that are
             known inhibitors or inducers of CYP3A4
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: SEP-363856
Intervention description: One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      An extension study of safety and tolerability of SEP-363856 in adult subjects with
      schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

        Subject must give written informed consent and privacy authorization prior to participation
        in the study and able to comply with the protocol, in the opinion of the investigator.

          -  Subject has completed Study SEP361 201 through Week 4

          -  Subject has not taken any medication other than the study drug for the purpose of
             controlling schizophrenia symptoms during Study SEP361 201.

          -  Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361
             201; females who are post-menopausal (defined as at least 12 months of spontaneous
             amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will
             be exempted from the pregnancy test.

          -  Male subjects with female partner(s) of childbearing potential must agree to avoid
             fathering a child and use acceptable methods of birth control from screening until at
             least 30 days after the last study drug administration

        Exclusion Criteria:

          -  Subject answers "yes" to "suicidal ideation" Item 4 (active suicidal ideation with
             some intent to act, without specific plan) or Item 5 (active suicidal ideation with
             specific plan and intent) on the C-SSRS assessment at Visit 7 of Study SEP361 201.
             Subjects who answer "yes" to this question must be referred to the Investigator for
             follow up evaluation.

          -  Subject has a clinically significant abnormality including physical examination, vital
             signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in
             consultation with the medical monitor considers to be inappropriate to allow
             participation in the study.

          -  Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of
             Study SEP361 201.

          -  Subject is pregnant or lactating.

          -  Subject is at high risk of non-compliance in the Investigator's opinion.

          -  Subject is in the opinion of the Investigator, unsuitable in any other way to
             participate in this study.
A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: OCV-501; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: OCV-501; Acute Myeloid Leukemia; Antigen specific cancer immunotherapeutic

Summary:

      To compare disease-free survival in patients 60 years or older with acute myeloid leukemia
      (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with AML who achieved first complete remission within one or two courses of
             standard induction therapy, and completed standard consolidation therapy (more than
             one course).

          -  Patients who are 60 years or older.

          -  Patients who have provided written informed consent within 90 days from the last dose
             of consolidation therapy on an informed consent form that has been approved by an
             institutional review board or independent ethics committee.

        Exclusion Criteria:

          -  Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12),
             (PML/RARA) karyotype abnormalities, and other variant types.

          -  Patients who are scheduled for hematopoietic stem cell transplantation.

          -  Patients who have received drugs potentially affecting the immune system within 4
             weeks before starting IMP administration or who may receive such drugs after start of
             the trial.

          -  Patients who have a severe concurrent disease or psychiatric illness likely to
             interfere with participation in this trial.

          -  Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic
             hepatitis C with positive HCV antibody.

          -  Patients who have cirrhosis.

          -  Patients judged to be ineligible by the investigator (or subinvestigator) for any
             other reasons.
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
Condition: Staphylococcal Vaccine
Intervention: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine; Placebo
Intervention description: SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery; Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 3450.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Staphylococcal Vaccine; Post-operative Surgical Site Infection; Spinal Surgery; MRSA; Staphylococcus aureus

Summary:

      The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent
      postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal
      fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective
      spinal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be scheduled to undergo an elective open posterior spinal fusion
             procedures with multilevel instrumentation, 10 to 60 days after study vaccination.

          -  Subject must be available for the entire duration of the study, and able to comply
             with scheduled visits, treatment plan, laboratory tests, and other study procedures
             including completion of the electronic diary for 10 days after study vaccination.

          -  Aged 18 to <86 years old

        Exclusion Criteria:

          -  Planned spinal fusion procedure requiring separate operations performed on separate
             days (ie, staged procedure).

          -  Surgical indication of malignancy, infection or acute or emergency trauma.

          -  History of major surgery within 3 months prior to enrollment, or anticipated major
             surgery other than the Index Surgical Procedure between study enrollment and
             completion of study participation.

          -  History of any spinal surgery performed within 6 months prior to study enrollment.

          -  History of any previous spinal surgery resulting in postoperative BSI or SSI.

          -  Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other
             illness requiring chronic treatment with known immunosuppressant medications,
             including monoclonal antibodies within a year of enrollment or the use of systemic
             corticosteroids for > 14 days within 30 days prior to enrollment.

          -  History of leukemia, lymphoma, underlying bone marrow disorder or history of bone
             marrow transplant.
A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: PF-06826647 or Placebo; PF-06826647
Intervention description: Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period; Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This multicenter study is being conducted to provide additional PF-06826647 safety and
      tolerability data, and to further explore the clinical efficacy of PF-06826647 in the
      treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to
      enable selection of oral dose and dosing regimen for the future clinical development of
      PF-06826647.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of 18 and 75 years.

          -  Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6
             months.

          -  Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3
             (moderate) or 4 (severe).

          -  Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

        Exclusion Criteria:

          -  Have non-plaque forms of psoriasis.

          -  Drug-induced psoriasis.

          -  Current active infection.

          -  Infected with Mycobacterium tuberculosis (TB).

          -  Have any history of malignancies.

          -  Require treatment with prohibited concomitant medications(s).

          -  Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Fatigue; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Paroxetine, Sertraline, Citalopram or Fluoxetine.; Placebo
Intervention description: Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks; Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks; Matching placebo capsules, oral administration, once daily dosing
Intervention MeSH terms: Milnacipran; Sertraline; Fluoxetine; Paroxetine; Citalopram; Levomilnacipran
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 262.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Fatigue; Major Depressive Disorder

Summary:

      The purpose of the study is to evaluate the efficacy, safety and tolerability of
      Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder
      (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-65 years old

          -  Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder

          -  The patient's current depressive episode must be at least 4 weeks in duration

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women of
             child-bearing potential who are not practicing a reliable method of birth control

          -  Patients with a history of meeting DSM-IV-TR criteria for:

               1. any manic or hypomanic episode;

               2. schizophrenia or any other psychotic disorder;

               3. obsessive-compulsive disorder.

          -  Patients who are considered a suicide risk