bioihbjkbjnl/mcl2 huggingface dataset:
Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous
Intervention: bortezomib
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent mycosis fungoides/Sezary syndrome; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma

Summary:

      RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with
      relapsed or refractory cutaneous T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed cutaneous T-cell lymphoma, including mycosis fungoides/Sézary
             syndrome

          -  Stage IB-IV disease

          -  Relapsed or refractory disease OR intolerant to ≥ 1 prior systemic therapy

          -  Measurable disease by radiological imaging or clinical finding

          -  Age Over 18

          -  Performance status Karnofsky 70-100%

          -  Hematopoietic

               -  WBC > 2,000/mm^3

               -  Absolute neutrophil count > 1,500/mm^3

               -  Platelet count > 75,000/mm^3

               -  Hemoglobin > 8.0 g/dL

          -  Hepatic

               -  Bilirubin < 2 times upper limit of normal (ULN)

               -  AST and ALT < 3 times ULN

          -  Renal

               -  Creatinine < 1.5 times ULN

               -  Creatinine clearance ≥ 30 mL/min

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  More than 3 months since prior high-dose chemotherapy

          -  More than 30 days since prior and no other concurrent investigational drugs

        Exclusion Criteria:

          -  history of myelodysplastic syndromes

          -  evidence of CNS disease

          -  pregnant or nursing

          -  peripheral neuropathy ≥ grade 2

          -  hypersensitivity to bortezomib, boron, or mannitol

          -  serious medical condition or psychiatric illness that would preclude study
             participation

          -  concurrent immunotherapy

          -  concurrent chemotherapy

          -  concurrent steroid dose > 10 mg/day of prednisone or its equivalent

          -  concurrent radiotherapy

          -  concurrent surgery for the malignancy
A Study of Chemotherapy Treatment for Patients With Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: LY573636-sodium
Intervention description: LY573636 dose is dependent on participant's height, weight, and gender and is adjusted to target a specific maximum concentration (Cmax) based on participant laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for participant discontinuation are met.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to determine whether LY573636-sodium (hereafter referred to as
      LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive
      an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and
      CA-125 tests will be done before the first dose and then after every other treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal
             cancer

          -  At least 18 years old

          -  Have received at least one but no more than 2 systemic treatment regimens containing
             platinum (does not include regimens received before surgery for this cancer)

          -  Have platinum-resistant disease

        Exclusion Criteria:

          -  Have received more than 2 systemic treatment regimens for platinum-resistant disease

          -  Serious pre-existing medical conditions

          -  Actively receiving warfarin (Coumadin) for treatment of venous thrombosis or other
             prothrombotic conditions
Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Intervention: PSMA-based 18F-DCFPyL PET tracer for PET/CT exams
Intervention description: 18F-DCFPyL whole body PET/CT scan administered at the following timepoints:
PET1 - Prior to scheduled nephrectomy
PET2 - to establish a new baseline PET before systemic therapy
PET2A - Post-surgery and prior to start of standard of care systemic therapy
PET2B - 12-16 weeks from start of first line systemic therapy (immune-based or anti-angiogenic)
PET3 - If first line systemic therapy did not include anti-angiogenesis therapy and new systemic therapy does include anti-angiogenesis therapy
PET3A - Prior to start of additional anti-angiogenesis therapy
PET3B - 12-16 weeks from the start of additional anti-angiogenesis therapy
PET4 - obtained at clinical progression or 2 years following initial systemic therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: This study is a single cohort study without randomization or stratification.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clear Cell; Kidney Cancer; RCC

Summary:

      The primary objective of this research is to evaluate response to systemic therapy, including
      anti-angiogenesis therapy and/or immune-based therapies via 18F-DCFPyL prostate-specific
      membrane antigen (PSMA)-based positron emission tomography/computed tomography (PET/CT) in
      patients with metastatic renal cell carcinoma (RCC) and to compare qualitatively with
      conventional imaging response criteria - Response Evaluation Criteria In Solid Tumors (RECIST
      1.1) and histopathological endpoints including isolation, enumeration and staining of
      Circulating Tumor Cells (CTC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with locally advanced (>/=cT3) or metastatic clear cell RCC as
             proven by biopsy.

          -  Adults, 18 years of age or older.

          -  Surgical candidates who have clinical indication for nephrectomy and standard-of-care
             biopsy of metastatic disease followed by possible standard of care systemic
             anti-angiogenesis based treatment regimen

          -  Have consented to participate in the University of Wisconsin Carbone Cancer Center
             Biobank.

        Exclusion Criteria:

          -  Patients who have received prior RCC systemic therapies

          -  Prior history of prostate cancer

          -  Prior history of any other malignancy within the last 2 years, other than skin basal
             cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
             superficial bladder cancer

          -  Unable to lie flat during or tolerate PET/CT

          -  Serum creatinine > 2 times the upper limit of normal
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: bempedoic acid 180mg; placebo; evolocumab
Intervention description: Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy; Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy; Monthly PCSK9i (evolocumab) background therapy
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Evolocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cholesterol; PCSK9; Repatha; evolocumab; LDL-C

Summary:

      The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9
      inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL
      cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years or legal age of majority depending on regional law

          -  Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70
             mg/dL

          -  Men and nonpregnant, nonlactating women

        Exclusion Criteria:

          -  Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia

          -  Total fasting TG ≥500 mg/dL

          -  Renal dysfunction or a glomerulonephropathy; eGFR <30 mL/min/1.73 m2

          -  Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or
             cerebrovascular disease (CD)

          -  History of type 1 or type 2 diabetes

          -  Uncontrolled hypertension

          -  Uncontrolled hypothyroidism

          -  Liver disease or dysfunction

          -  Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)

          -  History of hematologic or coagulation disorders

          -  History of malignancy (except non-metastatic basal or squamous cell carcinoma of the
             skin and cervical carcinoma in situ)

          -  Unexplained creatine kinase (CK) >3 × ULN

          -  Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months
             prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib

          -  Pregnant or breast feeding, or planning to become pregnant during treatment and/ or
             within 30 days after the end of treatment
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
Condition: Heart Transplantation; Liver Transplantation; Kidney Transplantation
Intervention: Tacrolimus
Intervention description: Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5.
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 1 Day
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Transplant; Pediatrics; Tacrolimus; Prograf

Summary:

      Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid
      organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus
      through genetics will help in early attainment and maintenance of the correct dosage level in
      the early post-transplant period. This pilot dose-finding trial will help to determine a
      dosing strategy guided by genotypes and age for solid organ transplant recipients that will
      be further validated through a multi-centre trial as an immediate next step. The study
      hypothesizes that dosage levels determined through age and genotype will be attained faster
      and more accurately than the standard dosing procedures in the 14-days after the transplant.
      Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster
      recovery (tested through the kidneys' ability to clear creatine from the blood) and result in
      lower frequencies of adverse effects and rejection of the transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 18 years old

          -  Assessed and/or listed for heart, kidney, liver transplantation

          -  Planned oral or enteral maintenance immunosuppression with tacrolimus post transplant

          -  Informed consent of legal guardian

        Exclusion Criteria:

          -  Contra-indications to oral or enteral tacrolimus

          -  Co-morbidities that preclude standard dosing e.g. significant renal or hepatic
             insufficiency

          -  Participation in other investigational drug trials within 30 days of study initiation
Ranibizumab and Reduced Fluence PDT for AMD
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: ranibizumab; verteporfin
Intervention description: 0.5 mg. given as an intraocular injection; Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.
Intervention MeSH terms: Ranibizumab; Verteporfin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Anti-VEGF therapy; photodynamic therapy; neovascularization

Summary:

      Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set
      the standard for visual outcomes in treating wet macular degeneration. However, they need to
      be administered frequently by intraocular injections with the attendant risk of
      endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of
      this trial is to see if using photodynamic therapy in combination with ranibizumab will
      decrease the number of treatments with ranibizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willingness to sign informed consent.

          2. Age greater than 50.

          3. Evidence of macular degeneration in the form of drusen in either eye.

          4. Visual acuity of 20/25 to 20/800.

          5. Subfoveal choroidal neovascularization. Both occult and classic subtypes will be
             allowed. If lesion is purely occult there has to be one of the following:

               1. Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)

               2. Documented enlargement of lesion on FA

               3. Increase of 50 microns or more in the central subfield on OCT

               4. New blood

          6. Total active lesion must be less than 12 disc areas in size. -

        Exclusion Criteria:

          1. Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision

          2. Previous treatment of the enrolled eye for CNV

          3. Intraocular surgery within 6 weeks of enrollment

          4. Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the
             fovea of the eligible eye

          5. Known hypersensitivity to verteporfin

          6. Medical condition that would preclude regular follow-up for one year.

          7. Previous vitrectomy

          8. Media opacities limiting visual acuity, retinal examination, or retinal imaging.

          9. A lesion where > 50% of the lesion is a pigment epithelial detachment. -
Miami Membrane for Potency (MMEP) Trial
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Amniotic Membrane Placement; EPIC 26; PSA Measurement; Sexual History Inventory for Men
Intervention description: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.; Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.; Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.; SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.
Enrollment: 24.0
Sex: Male
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Amniotic Membrane Placement; Robotic Assisted Radical Prostatectomy; RARP; Human Amniotic Membrane Allograft

Summary:

      The use of dehydrated human amnionic membrane allograft improves erectile function recovery
      (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic
      assisted radical prostatectomy (RARP) compared to a control group with no allograft.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve
             sparing RARP at the University of Miami

        Exclusion Criteria:

          -  Men with poor urinary control at baseline requiring the use of pads for leakage

          -  Previous treatment for prostate cancer

          -  Previous history of pelvic radiation

          -  Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous
             injections, MUSE, penile prosthesis.
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms
Intervention: bevacizumab [Avastin]; carboplatin; erlotinib [Tarceva]; paclitaxel
Intervention description: 15mg/kg iv every 3 weeks; AUC6 iv every 3 weeks for 6 cycles; 150mg/day po; 200mg/m2 iv every 3 weeks for 6 cycles
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of Avastin combined with first li ne
      paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with
      non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two
      cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks
      combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a
      maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks
      combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is
      until disease prog ression, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  stage IV non-squamous non-small cell lung cancer;

          -  asymptomatic, untreated brain metastasis;

          -  ECOG performance status 0-1.

        Exclusion Criteria:

          -  previous treatment for brain metastasis;

          -  history of migraine or epilepsy;

          -  previous treatment with angiogenesis inhibitors;

          -  for cohort 2, previous first line treatment with Avastin or Tarceva;

          -  current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or
             thrombolytic agent for therapeutic purposes.
Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes
Condition: Hepatitis C, Chronic
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Placebo; PF-04136309
Intervention description: Take 4 capsules twice daily 12 hours apart with water. Swallow whole.; Take 4 capsules twice daily 12 hours apart with water. Swallow whole.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic HCV infection; raised ALT; transaminitis; HCV infection

Summary:

      This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus
      infection and abnormal liver enzymes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HCV infection

          -  ALT >1.5 but <10 times upper limit of normal

        Exclusion Criteria:

          -  Decompensated or severe liver disease defined by one or more of the following
             criteria:

        Prior liver biopsy showing cirrhosis.

          -  International Normalized Ratio (INR) greater than or equal to 1.5.

          -  Total bilirubin greater than or equal to 1.5X ULN, or >2X ULN for unconjugated
             bilirubin.

          -  Serum albumin below normal.

          -  ALT or aspartate aminotransferase (AST) >10 x ULN.

          -  Evidence of portal hypertension including splenomegaly, ascites, encephalopathy,
             and/or esophageal varices.

          -  Presence of human immunodeficiency virus (HIV).

          -  Co-infection with hepatitis B virus (HBV).

          -  Co-infection with Epstein Barr Virus (EBV) and/or Cytomegalovirus (CMV).