bioihbjkbjnl/mcl2 huggingface dataset:
Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma
Condition: Unresected Stage IIIb to IVM1c Melanoma
MeSH terms: Melanoma
Intervention: Talimogene Laherparepvec
Intervention description: The initial dose of talimogene laherparepvec is up to 4.0 mL of 10^6 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 10^8 PFU/mL.
Intervention MeSH terms: Talimogene laherparepvec
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T-VEC; CD8+ cell density; objective response rate; unresected; Melanoma

Summary:

      The study is a phase 2, multi centered, single arm study designed to evaluate the correlation
      between cluster of differentiation 8-positive (CD8+) cell density and objective response rate
      in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the
      safety and tolerability profile of talimogene laherparepvec.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provided informed consent prior to initiation of any study-specific
             activities/procedures

          2. Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended

          3. Candidate for intralesional therapy

          4. Measurable disease with greatest diameter ≥ 10 mm

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          6. Adequate organ function

        Other Inclusion Criteria May Apply

        Exclusion Criteria:

          1. Clinically active cerebral metastases.

          2. Bone metastases

          3. Primary ocular or mucosal melanoma

          4. Active herpetic skin lesions or prior complications of herpes simplex virus type 1
             (HSV-1) infection (eg, herpetic keratitis or encephalitis)

          5. Requires intermittent or chronic systemic (intravenous or oral) treatment with an
             antiherpetic drug (eg, acyclovir), other than intermittent topical use

          6. Female subject is pregnant or breast-feeding, or planning to become pregnant during
             study treatment and through 3 months after the last dose of talimogene laherparepvec

          7. Female subject of childbearing potential who is unwilling to use acceptable method(s)
             of effective contraception

        Other Exclusion Criteria May Apply
Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
Condition: Advanced Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Temsirolimus (CCI-779); Temsirolimus (CCI-779)
Intervention description: 20 mg/m2 IV TEMSR weekly (Japan, n=6); 25 mg IV TEMSR weekly (all other pts)
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in
      Asian patients with advanced renal cell carcinoma. The trial is only being conducted in
      Japan, Korea, and China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC.
             The American Joint Committee on Cancer (AJCC) staging and classification criteria will
             be used.

          -  ECOG performance status of 0-1.

          -  At least one measurable lesion per RECIST.

          -  Age greater than or equal to 20 years.

          -  Japanese, Chinese, or Korean ethnicity.

        Exclusion Criteria:

          -  CNS metastases at screening or history or CNS metastases.

          -  Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for
             the treatment of RCC within 4 weeks before first dose of test article. Subjects must
             have documented objective progressive disease after any prior systemic RCC treatment
             and have recovered to grade 1 or lower toxicities from effects of prior systemic
             therapy for RCC.

          -  In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell
             carcinoma of the skin, or cervical carcinoma in situ).
18F-FLT-PET in Breast Cancer (MK-0000-139)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: 18F-FLT-PET/CT Imaging
Intervention description: Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy.
Intervention MeSH terms: Alovudine
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: Female
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell
      proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'[18F]-fluorothymidine
      (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy
      in participants with breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has newly-diagnosed stage IIB/IIIA/IIIB locally advanced breast cancer

          -  Is eligible for pre-operative (neo-adjuvant) chemotherapy

        Exclusion Criteria:

          -  Has a contraindication to magnetic resonance imaging (MRI)

          -  Any condition that would limit ability to undergo MRI or PET scans

          -  Is a nursing mother

          -  Has moderate to end-stage renal disease and is not on dialysis or has renal failure on
             chronic dialysis
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Condition: Acute Lymphoid Leukemia; Acute Myeloid Leukemia; Anemia, Refractory, With Excess of Blasts; Solid Tumors
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts
Intervention: brentuximab vedotin; brentuximab vedotin; brentuximab vedotin
Intervention description: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion; 2.4 mg/kg every 3 weeks by intravenous (IV) infusion; 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Intervention MeSH terms: Brentuximab Vedotin; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Acute Lymphoid Leukemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia; Solid Tumors; Anemia, Refractory, with Excess of Blasts; Antibodies, Monoclonal; Antibody-Drug Conjugate; Antigens, CD30; Drug Therapy; Hematologic Diseases; Immunotherapy; Monomethyl Auristatin E

Summary:

      This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity
      of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous
      malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy

          -  Have failed, refused, or have been deemed ineligible for standard therapy

          -  Measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a
             Karnofsky or Lansky Performance Status score greater than or equal to 70

        Exclusion Criteria:

          -  Primary diagnosis of lymphoma or central nervous system (CNS) malignancy

          -  History of another primary invasive malignancy that has not been definitively treated
             or in remission for at least 3 years

          -  Evidence of active cerebral/meningeal disease
LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS)
Condition: Myelodysplastic Syndrome (MDS)
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: LBH589; Epoetin Alfa
Intervention description: LBH589 was supplied at dose strengths of 5 mg or 20 mg hard gelatin capsules.; Epoetin alfa was supplied as 10000 IU/1 mL in a ready-to-use syringe.
Intervention MeSH terms: Panobinostat; Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MDS; bone marrow; anemia; cytopenia; transfusion dependance; EPO; ESA; erythropoietin; LBH589; Myelodysplastic Syndromes; hematopoietic improvement; IPSS Low; IPSS Int-1; HI-E; HDAC Inhibitor; HDAC-I; DAC-I; Deacetylase-Inhibitor; Histone Deacetylase-Inhibitor; red blood cell transfusions

Summary:

      This study assessed the efficacy and safety of LBH589 as single agent and in combination with
      ESA in red blood cell transfusion-dependent Low and Int-1 MDS patients being either
      refractory to ESA or with a low probability of response. The study had a non-randomized core
      phase followed by a randomized phase.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients with a lower risk MDS (LOW or INT-1 according to IPSS)

          -  Red blood cell transfusion dependency of at least 4 Units/8 weeks.

          -  Not responding to Erythropoietin stimulating agents (ESA) or having a low chance to do
             so

          -  Age-adjusted normal cardiac, kidney, liver function

        Key Exclusion Criteria:

          -  Concomitant use of ESA

          -  Concomitant use of any other investigational drug

          -  Other malignancy that is not in remission for at least 1 year

          -  Platelet Count < 75 x 109/L

          -  Impaired cardiac function or clinically significant cardiac diseases
Trial of Sunitinib for Refractory Malignant Ascites
Condition: Ascites
MeSH terms: Ascites
Intervention: Sunitinib
Intervention description: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: malignant ascites

Summary:

      The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in
      patients with refractory malignant ascites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Solid tumor malignancy and failure of at least one biologic or cytotoxic regimen, or
             the inability to receive standard treatment due to performance status (PS>2).

          -  Ascites based on paracentesis or CT scan within one month prior to enrollment

          -  Life expectancy > 3 months

          -  Indwelling paracentesis catheters are permitted, paracentesis is permitted at the
             investigators discretion

          -  Negative urine pregnancy test for females

          -  All subjects must agree to use birth control

          -  All subjects must abstain from eating grapefruit and grapefruit juice. They must tell
             their physicians about any changes in their medication including over-the-counter and
             herbal supplements.

        Exclusion Criteria:

          -  History of congestive heart failure

          -  Creatinine > 2.0

          -  Pregnant or nursing

          -  ALT > 2.5 times the upper limit of normal

          -  Blood pressure > 160/90 (antihypertensives permitted)

          -  Gastrointestinal or intra-abdominal hemorrhage within the last 6 months

          -  History of QTc > 450 milliseconds

          -  Brain metastasis
Testosterone and Alendronate in Hypogonadal Men
Condition: Hypogonadism; Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Hypogonadism
Intervention: Testosterone; Alendronate; Placebo Alendronate; Placebo Testosterone
Intervention description: Testosterone Gel (Fortesta) 40mg daily.; Alendronate (Fosamax) 70mg every week.; A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.; Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
Intervention MeSH terms: Alendronate; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 44.0
Sex: Male
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate the hypothesis that the combination of testosterone replacement
      and alendronate will improve bone density and parameters of bone quality more than either
      medication alone in older men with low testosterone levels and low bone density.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male sex

          -  Age 60 or above

          -  Testosterone <300 ng/dL

          -  DXA T score < -1 OR FRAX Score of 3% or greater for hip fracture or 20% or greater for
             major osteoporotic fracture

        Exclusion Criteria:

          -  Significant liver or kidney disease

          -  Elevated prolactin level

          -  Abnormal TSH

          -  Abnormal 25-Vitamin D

          -  PSA > 2.5

          -  History of malignancy

          -  Calcium > 10.6

          -  Alkaline Phosphatase > 150

          -  Fracture within the last 6 months

          -  History of acute urinary retention

          -  Hematocrit < 32% or > 50%

          -  Fracture within the past 6 months

          -  American Urological Association BPH symptom index > 21

          -  Sleep apnea

          -  Abnormalities of the esophagus which delay esophageal emptying

          -  Significant cardiopulmonary disease
A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome
Condition: Hemophagocytic Syndrome (HPS)
MeSH terms: Lymphohistiocytosis, Hemophagocytic; Syndrome
Intervention: Ruxolitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study to determine the efficacy of Ruxolitinib in secondary hemophagocytic
      syndrome. The primary objective is to assess the efficacy of ruxolitinib 15 mg PO twice daily
      in patients with HPS. The primary endpoint is overall survival at two months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, or their legally authorized representative, must voluntarily provide written
             IRB-approved informed consent.

          -  Males and females, 18 years of age or older at the time of enrollment.

          -  Patients must meet the diagnostic criteria for HPS (at least 5 of the following):
             fever, splenomegaly, cytopenia involving ≥2 cell lines (Hemoglobin <9 g/dL; platelets
             <100,000/μL; absolute neutrophil count <1000/μL), hypertriglyceridemia or
             hypofibrinogenemia, tissue demonstration of hemophagocytosis, low or absent NK
             (Natural Killer) cell activity, serum ferritin ≥3000 ug/L, soluble IL-2 receptor
             (CD25) >2400 U/mL.

          -  In the investigator's opinion, the patient has the ability to participate fully in the
             study, and comply with all its requirements.

        Exclusion Criteria:

          -  CNS (Central Nervous System) involvement

          -  Malabsorption

          -  Known secondary HPS (Hemophagocytic Syndrome) that is otherwise treatable (e.g.
             non-Hodgkin's lymphoma).

          -  Pregnant or lactating female: all females of child-bearing potential must have a
             negative serum pregnancy test within 7 days of treatment; lactating females must
             discontinue breast feeding.

          -  Estimated creatinine clearance <15mL/min

          -  Has received any prior systemic therapy, excluding corticosteroids, within 7 days (or
             5 half-lives) of treatment.

          -  No active malignancy at the time of enrollment, except nonmelanoma skin cancers or
             carcinoma in situ. Patients with a prior history of malignancy are eligible if their
             malignancy has been definitely treated or is in remission and does not require ongoing
             adjuvant or cancer-directed therapies.

          -  Active hepatitis B or hepatitis C or known HIV infection

          -  Known (and biopsy-confirmed) liver cirrhosis; or, a reported history of liver
             cirrhosis with a Model for End-stage Liver Disease (MELD) score >20.
Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Condition: Myocardial Infarction; Percutaneous Coronary Intervention
MeSH terms: Myocardial Infarction; Infarction
Intervention: Clopidogrel; Clopidogrel
Intervention description: Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype; Clopidogrel 75 mg daily, 150 mg daily
Intervention MeSH terms: Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 335.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Myocardial infarction; Percutaneous coronary intervention; Clopidogrel; Genetics; Platelet Function

Summary:

      To determine whether higher as compared with lower maintenance doses of clopidogrel can
      adequately improve the degree of platelet inhibition in carriers of a reduced-function
      CYP2C19 allele.
    

Eligibility criteria:

        Inclusion Criteria (major):

          1. Between 18 and 75 years of age, inclusive.

          2. Have an indication for the use of clopidogrel defined as either spontaneous MI
             [hospitalized with final diagnosis of MI, excluding periprocedural or definite
             secondary MI (e.g., due to anemia or hypertensive emergency)] or PCI within the past 6
             months.

          3. Clinically stable and at least 4 weeks following the MI or PCI.

        Exclusion Criteria (major):

          1. Conditions that alter platelet function.

          2. Conditions that increase bleeding risk.
Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Degarelix; Degarelix
Intervention description: Given as a subcutaneous injection once every 4 weeks.; Given as a subcutaneous injection once every 4 weeks.; Given as a subcutaneous injection once every 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Androgen ablation therapy

Summary:

      To investigate the long-term safety and tolerability of repeated doses of degarelix to
      prostate cancer patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed study treatment in study FE200486 CS02.

          -  Has completed visit 16 in study FE200486 CS02.

          -  Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02
Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: GW823093 15mg; GW823093 placebo capsule; GW823093 30mg
Intervention description: White opaque capsule containing 15mg of GW823093 as free base; Matching placebo of GW823093 capsule or 15mg capsule; White opaque capsule containing 15mg of GW823093 as free base
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: pharmacodynamics; Diabetes; pharmacokinetics

Summary:

      To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of
      GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes
      mellitus (T2DM) patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG)
             level <280mg/dL at the Screening visit.

          -  Concurrent T2DM therapy: Must be diet controlled - OR - not taking more than 2 oral
             anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to
             the first dosing.

        Exclusion criteria:

          -  Must not have any other major illness other than diabetes