bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: dasatinib; dasatinib
Intervention description: Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression; Tablets, Oral, 100 mg, once daily (QD) treatment may continue until disease progression
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn if men with metastatic prostate cancer and rising
      Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing
      androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to
      dasatinib. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males, 18 or older

          -  proven advanced prostate cancer

          -  documented metastatic disease

          -  rising PSA levels

          -  castrate levels of testosterone

        Exclusion Criteria:

          -  symptomatic CNS (brain or spinal cord) metastasis

          -  medical condition which may increase the risk of toxicity

          -  any prior or ongoing anti-cancer medical therapy or immunotherapy for prostate cancer
             other than primary androgen deprivation agents

          -  unable to take oral medication
Supplementation With Cholecalciferol in Dialysis Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Cholecalciferol; Placebo
Intervention description: 100,000 IU/week for 12 weeks; 100 drops/ week for 12 weeks
Intervention MeSH terms: Cholecalciferol; Vitamin D
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cholecalciferol; Kidney diseases

Summary:

      Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially
      in those undergoing dialysis. The loss of protein to the dialysis solution seems to
      contribute significantly to the reduced serum levels of vitamin D in these patients. As a
      result of the disease and the dialysis procedure, there is high prevalence of chronic
      inflammation and high risk of infections. There is evidence in other populations, that
      vitamin D has immunomodulatory effects by stimulating the production of cathelicidin, an
      antimicrobial peptide and suppressing the production of proinflammatory cytokines. Thus, this
      study aims to investigate the effects of cholecalciferol supplementation on immunological
      markers in patients in hemodialysis and peritoneal dialysis with hypovitaminosis D . This is
      a randomized, double-blind, placebo-controlled trial in which patients who have vitamin D
      deficiency [25 (OH) D <20 ng / mL] will be allocated to the intervention group
      (cholecalciferol) or control (placebo). Patients will receive supplemented 100,000 IU / week
      cholecalciferol a period of 12 weeks. Before and after the intervention will be determined
      25(OH)D, cathelicidin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive
      protein serum. In monocytes, we will evaluate cathelicidin, IL-6 and TNF-α, 25(OH)D receptor
      and α 1-hydroxylase enzyme expression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25 (OH) < 20 ng/ml

          -  Peritoneal dialysis or hemodialysis > 3 months

        Exclusion Criteria:

          -  Use of vitamin D or its analogues, corticosteroids and immunosuppressive

          -  Peritonitis in the previous month at baseline

          -  Liver, neoplastic, infectious or autoimmune diseases and positive HIV

          -  Hypercalcemia
Amlodipine Plus Botulinum Toxin for Focal Dystonia
Condition: Focal Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Intervention: Amlodipine plus Botulinum toxin
Intervention MeSH terms: Amlodipine; Botulinum Toxins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Writer's Cramp; Calcium Channel Antagonists; Torticollis; Chemodenervation

Summary:

      Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of
      botulinum toxin injections in the treatment of focal dystonia.

      Study Population: 20 patients with cervical dystonia

      Design: Double-bind, placebo-controlled clinical trail.

      Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale,
      NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers:
      Amplitude of EDB MEP.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Patients enrolled in Protocol 85-N-0195, Efficacy and Pathophysiology of Botulinum Toxin
        for Treatment of Involuntary Movement Disorders are eligible for enrollment if they meet
        the following inclusion and exclusion criteria.

        Good general health

        Focal hand dystonia or cervical dystonia

        Stable response to botulinum toxin demonstrated through a series of at least 3 injections
        over a period of at least a year

        Benefit from the 3 immediately prior btx injections rated as 75% or less or a duration of
        benefit lasting less than or equal to 2 months

        No other medications for dystonia

        EXCLUSION CRITERIA:

        Cervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum
        toxin injection

        Present or past cardiac disease, hypertension, arrhythmia or congestive heart failure

        Anterocollis or other neck dystonia requiring bilateral anterior neck muscle injections

        Use of concomitant medications affecting calcium channels or those metabolized by the
        cytochrome p450 3A4 system including grapefruit juice, St. John's wort, HIV protease
        inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin),
        antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine,
        phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids

        Allergy to amlodipine or related compounds

        Pregnany/ nursing

        Age less than 18 years of age

        Abnormal EKG

        Abnormal coagulation profile or liver function tests

        Use of anticoagulants
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: PG-530742; Placebo; 50 mg PG-530742; 100 mg PG-530742; 200 mg PG-530742
Intervention description: One 25 mg PG-530742 tablet, twice daily for for one year; One placebo tablet, twice daily for for one year; One 50 mg PG-530742 tablet, twice daily for for one year; 100 mg PG-530742 tablet, twice a day for one year; 200 mg PG-530742 tablet, twice a day for one year
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 395.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Primary Disease: Knee Primary Osteoarthritis

Summary:

      Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742
      inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This
      study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate
      knee osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  mild to moderate knee osteoarthritis confirmed by a radiographic technique.

        Exclusion Criteria:

          -  secondary knee osteoarthritis;

          -  diseases other than osteoarthritis that could cause knee pain;

          -  any disease or intervention (surgery, intra-articular injection) that would have an
             impact on knee pain or mobility;

          -  drugs that act potentially on the bone or cartilage component of the knee joint.
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: VOX; SOF/VEL; RBV
Intervention description: 100 mg tablet(s) administered orally once daily with food; 400/100 mg FDC tablet administered orally once daily with food; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This primary objectives of the study are to evaluate the safety, tolerability, and efficacy
      of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ±
      ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals with chronic HCV infection

          -  HCV RNA ≥10^4 IU/mL at screening

          -  HCV genotype 1

          -  Cirrhosis determination; a liver biopsy may be required

          -  Screening laboratory values within defined thresholds

          -  Use of two contraception methods if female of childbearing potential or sexually
             active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female

          -  Current or prior history of hepatic decompensation

          -  Hepatocellular carcinoma (HCC) or other clinically significant malignancy

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment or compliance with the protocol

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: MEDI-546; MEDI-546; MEDI-546
Intervention description: Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks; Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks; Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Japan; Phase2; Safety; Tolerability; Systemic Lupus Erythematosus; SLE, MEDI-546

Summary:

      The purpose of this study is to assess safety, tolerability, pharmacokinetics and
      pharmacodynamics of MEDI-546 in Japanese SLE patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification
             criteria for SLE.

          -  Weight greater than or equal to 40.0 kg.

          -  Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing
             treatment or observation for ≥ 24 weeks prior to screening.

          -  Currently receiving stable dose of oral prednisone and/or
             antimalarials/immunosuppressives.

          -  Active moderate to severe SLE disease based on SLE disease activity score.

        Exclusion Criteria:

          -  Active severe or unstable neuropsychiatric SLE.

          -  Active severe SLE-driven renal disease or unstable renal disease.

          -  Clinically significant active infection including ongoing and chronic infections.

          -  Known history of a primary immunodeficiency or an underlying condition such as human
             immunodeficiency virus infection or splenectomy that predisposes the subject to
             infection.

          -  Confirmed positive tests for hepatitis B or positive test for hepatitis C.
Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
Condition: HIV Infections; Heart Disease
MeSH terms: Heart Diseases
Intervention: Lovaza; Placebo
Intervention description: Lovaza one gram twice a day for 24 weeks; Placebo
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Omega-3 Fatty Acids; HIV; Heart Disease; Treatment experienced

Summary:

      Several studies have shown that there is an increased risk of heart disease in people with
      HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid)
      on improving endothelial function and decreasing inflammation which may contribute to this
      increased risk. The investigators will also be doing studies to analyze coagulation and
      inflammation markers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV+

          -  Ages 18-70

          -  HIV-1 RNA <400 copies/ml.

          -  On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of
             modifying regimen, and cumulative ART before study entry of 12 mos.

        Exclusion Criteria:

          -  Active infection

          -  Inflammation or malignancy

          -  Uncontrolled diabetes or hypothyroidism

          -  LDL (low density lipoprotein) cholesterol >160 and triglyceride levels >750

          -  Framingham risk score <6.
An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: placebo; PH-797804; PH-797804; PH-797804; PH-797804
Intervention description: Capsule, once daily (QD) for 12 weeks; Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks; Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks; Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks; Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Arthritis; Rheumatoid

Summary:

      Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who
      have failed at least 1 DMARD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with RA and has failed at least 1 DMARD therapy

        Exclusion Criteria:

          -  Any other inflammatory arthritis and any significant history of acute or chronic
             infection with immunomodulatory etiology.
High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: 3F8 monoclonal antibody and 13-cis-Retinoic Acid
Intervention description: A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2.
Intervention MeSH terms: Tretinoin; Isotretinoin; Antibodies; Antibodies, Monoclonal
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 Months
Healthy volunteers: No
Keywords: GM-CSF; MAB 3F8; RETINOIC ACID (CIS-9 & 13); 09-158

Summary:

      The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than
      standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what
      effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the
      antibody works against a very small amount of neuroblastoma (minimal residual disease) that
      is left in the bone marrow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of
             Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine
             levels.

          -  High-risk NB as defined by risk-related treatment guidelines1 and the International NB
             Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age)
             MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified
             stage 4S.

          -  The patients are post-stem cell transplantation and in first CR/VGPR, including no
             measurable MIBG-avid soft tissue tumor assessable for response.

          -  Signed informed consent indicating awareness of the investigational nature of this
             program.

        Exclusion Criteria:

          -  Creatinine > 3.0 mg/dL

          -  ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal

          -  Bilirubin > 3.0 mg/dL

          -  Patients with grade 3 or higher toxicities (using the CTCAE v3.0) related to cardiac,
             neurological, pulmonary or gastrointestinal function as determined by physical exam.
             Patients must have normal blood pressure for age.

          -  Progressive disease

          -  History of allergy to mouse proteins.

          -  Active life-threatening infection.

          -  Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.

          -  Inability to comply with protocol requirements
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Telaprevir; Ribavirin; Pegylated Interferon Alfa 2a; Placebo
Intervention description: tablet; tablet; Solution for injection; matching placebo tablet
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa
      2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV)
      ribonucleic acid (RNA) levels
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA

          -  Have been infected with hepatitis C virus for greater than (>) 6 months

          -  Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2

          -  Must agree to use 2 methods of contraception, including 1 barrier method, during and
             for 24 weeks after the completion of the study (unless the subject is a female of
             documented non-child-bearing potential)

          -  Female subjects must have a negative pregnancy test at all visits before the first
             dose

        Exclusion Criteria:

          -  Received any approved or investigational drug or drug regimen for the treatment of
             hepatitis C

          -  Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy

          -  Any other cause of significant liver disease in addition to hepatitis C; this may
             include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis,
             autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis
             or primary biliary cirrhosis

          -  Diagnosed or suspected hepatocellular carcinoma

          -  Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a
             liver biopsy taken within 2 years before study start

          -  Alcohol abuse or excessive use in the last 12 months

          -  Participation in any investigational drug study within 90 days before drug
             administration or participation in more than 2 drug studies in the last 12 months
             (exclusive of the current study)