bioihbjkbjnl/mcl2 huggingface dataset:
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Condition: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450; ABT-333; ABT-267; Ribavirin; Ritonavir
Intervention description: ABT-450 tablets; ABT-333 tablets; ABT-267 tablets; Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).; Ritonavir capsules
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 580.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C Genotype 1; Hepatitis C; Interferon-Free; HCV; Chronic Hepatitis C

Summary:

      This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin
      (RBV) in patients with chronic Hepatitis C Virus (HCV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18-70 years old, inclusive

          -  Females must be post-menopausal for more than 2 years or surgically sterile or
             practicing specific forms of birth control

          -  Chronic hepatitis C virus (HCV), genotype 1 infection

          -  Treatment-naive OR null-responders to previous treatment with pegylated interferon
             (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2
             log10 HCV RNA decrease at Week 12)

          -  No evidence of liver cirrhosis

        Exclusion Criteria:

          -  Significant liver disease with any cause other than HCV as the primary cause

          -  Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody

          -  Positive screen for drugs and alcohol

          -  Significant sensitivity to any drug

          -  Use of contraindicated or prohibited medications within 1 month of dosing

          -  Abnormal laboratory tests
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: MK-6096; Dose-matched Placebo to MK-6096
Intervention description: MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and
      effectiveness of different doses of MK-6096 in the treatment of participants with primary
      insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior
      to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of
      4 weeks of treatment (Week 4).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is willing to stay overnight at a sleep laboratory on 6 separate nights
             and is willing to stay in bed for at least 8 hours each night while at the sleep
             laboratory

          -  Participant's regular bedtime is between 9 PM and 12 AM (midnight)

          -  Participant is able to read and complete questionnaires and diaries

          -  Participant is willing to refrain from napping during the study

        Exclusion Criteria:

          -  If female, participant is breast feeding, pregnant, or planning to become pregnant

          -  Participant is expecting to donate eggs or sperm during the study

          -  Participant has any history of a neurological disorder

          -  Participant has a history within the past 6 months of a cardiovascular disorder such
             as unstable angina, congestive heart failure or acute coronary syndrome.

          -  Participant has difficulty sleeping due to a medical condition

          -  Participant has donated blood products within the 8 weeks prior to the study

          -  Participant plans to travel across 3 or more time zones during the study

          -  Participant is currently participating or has participated in a study with an
             investigational compound or device within the last 30 days
Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: modified Hyper-CVAD
Intervention description: rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: untreated mantle cell lymphoma

Summary:

      rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by
      rituximab maintenance therapy consisting of four weekly doses every six months for two years
    

Eligibility criteria:

        Inclusion Criteria:

          -  Untreated mantle cell lymphoma

        Exclusion Criteria:

          -  Pregnant or breast feeding
Efavirenz in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: efavirenz
Intervention MeSH terms: Efavirenz
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Efavirenz 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 efavirenz works in treating patients with
      metastatic prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed prostate cancer

               -  Metastatic disease

               -  Castration-refractory disease

          -  No clinical symptoms related to disease progression

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

        PRIOR CONCURRENT THERAPY:

          -  Not specified
Tofacitinib for Inflammatory Eye Disease
Condition: Uveitis; Scleritis
MeSH terms: Eye Diseases; Uveitis; Scleritis
Intervention: tofacitinib
Intervention description: tofacitinib extended release, 11mg, daily, oral
Intervention MeSH terms: Tofacitinib
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

Summary:

      Non-infectious inflammatory eye disease, such as uveitis and scleritis, is a chronic,
      auto-immune process that leads to vision loss. While steroids are effective in the short
      term, the side-effect profile of chronic steroid use necessitates the identification of
      effective steroid-sparing therapies. Tofacitinib is a small molecule that inhibits the
      signaling pathways of multiple inflammatory cytokines. The investigators plan to evaluate
      whether tofacitinib may have efficacy for patients with uveitis and / or scleritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of uveitis

          -  a clinical response to steroids

          -  active disease requiring at least 10mg of prednisone daily (or steroid equivalent)

        Exclusion Criteria:

          -  suspected or confirmed ocular infection

          -  chronic or recurring infections, such as HIV

          -  renal insufficiency that would preclude safe administration of tofacitinib
Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy Type 1
MeSH terms: Myotonic Dystrophy
Intervention: rhIGF-I/rhIGFBP-3; placebo
Intervention description: 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.; 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance,
      ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and
      strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients
    

Eligibility criteria:

        Inclusion Criteria (list is not inclusive):

          -  A diagnosis of DM1, confirmed by DM1 genetic mutation

          -  Ability to walk 30 feet - assistance with cane and/or leg bracing permitted

          -  Able to self-administer study medication by subcutaneous injection or caregiver is
             available to administer study medication

        Exclusion Criteria (list is not inclusive):

          -  Congenital DM1

          -  Weight greater than 100 kg or body mass index greater than 30 kg/m2

          -  Prior treatment with glucocorticoids, anabolic steroids, testosterone, growth hormone,
             investigational agent within 60 days of screening

          -  Current diagnosis or history of malignancy expect for surgically cured skin cancer or
             pilomatricoma

          -  Changes in lipid lowering medications during the 3 months prior to screening

          -  Diaphragmatic weakness such that patients are unable to tolerate the supine position,
             or swallowing impairment such that patients are unable to maintain nutrition without
             use of gastrostomy.

          -  Major psychiatric illness (major depression, bipolar disorder or schizophrenia) within
             twelve months of screening

          -  History of non-compliance with other therapies
Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide
Condition: Metastatic Progressive Castration-resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to determine the effect of enzalutamide on the androgen
      signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify
      potential predictors of response or resistance to therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed prostate cancer

          -  Presence of metastatic disease to the bone

          -  Ongoing androgen deprivation therapy

        Exclusion Criteria:

          -  Severe concurrent disease

          -  Metastases in the brain
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Clostridium Infections
Intervention: FMT; Antimicrobials
Intervention description: Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.; Patients randomized to the control group will receive antimicrobials targeting C. difficile.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CDI; C difficile; C diff; Clostridium difficile

Summary:

      The purpose of the study is to determine the safety and efficacy of Fecal Microbiota
      Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI)
      as compared to standard antibiotic therapy. Patients who have tested positive for CDI within
      90 days of an admission for relapse of CDI will be approached to participate in this
      open-label, randomized controlled trial. Patients will either be randomized to the
      intervention group (receive FMT via retention enema) or the control group (receive
      antimicrobials targeting CDI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active C. difficile infection, defined as > 3 diarrheal stools per day
             and a positive C. difficile PCR assay

          -  Hospitalized patient presenting with first relapse of CDI occuring between 15 and 90
             days after an index episode of CDI

        Exclusion Criteria:

          -  Pregnancy

          -  Neutropenia (absolute neutrophil count <1000/microliters)

          -  Contraindication for retention enema

          -  Food allergy not controlled in the donor diet
Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Cohort 1 neo-adjuvant; Cohort 2 neo-adjuvant; Cohort 1 adjuvant; Cohort 2 adjuvant
Intervention description: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16; Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16; Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians; Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
Intervention MeSH terms: Paclitaxel; Carboplatin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable
      and unresectable HER2+ (stage IIa-IIIb) breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented adenocarcinoma of the breast

          -  ANC > 1000 cells

          -  Female; age > 18; Zubrod PS 0-1

          -  Platelets > 100,000

          -  Stage IIA-IIIB disease

          -  Total bilirubin < or = ULN

          -  No evidence of metastatic disease Not pregnant or lactating

          -  No prior systemic therapy for this breast cancer

          -  Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min

          -  Serum ALT < 2.5 x ULN

          -  ER, PR and HER2 status required

          -  LVEF (MUGA/echo)WNL

          -  No baseline > 2 neuropathy

          -  Hemoglobin > 9.0 gm/dl

          -  HER2+, defined by IHC 3+ or FISH ratio > 2.0
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Beraprost Sodium Modified Release
Intervention MeSH terms: Epoprostenol; Beraprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an open-label extension study for patients who participated in the BPS-MR-PAH-201
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who remained on study drug and completed all assessments during the Treatment
             Phase of Study BPS-MR-PAH-201 are eligible for this study.

          -  Female patients must either be physiologically incapable of childbearing or be
             practicing an acceptable method of birth control (e.g. approved hormonal
             contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or
             an intrauterine device).

        Exclusion Criteria:

          -  Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) for
             any reason (e.g. treatment related adverse events) are not eligible for entry into
             this study.

          -  Patients who are pregnant or lactating are excluded from participation in the
             open-label extension.
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Dovitinib; Fulvestrant; Dovitinib Placebo
Intervention description: Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule; Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week.; Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 97.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; HER2-, HR+; post-menopausal; Locally advanced or metastatic Breast Cancer (HER2-, HR+)

Summary:

      This trial is designed to enroll postmenopausal patients with locally advanced or metastatic,
      HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy,
      and whose disease has progressed on or after prior endocrine therapy.

      Patients must undergo molecular pre-screening prior to entry.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with HER2-, HR+ locally advanced or metastatic breast cancer

          -  Progression on or after endocrine treatment

          -  Measureable disease as per RECIST

          -  ECOG 0, 1 or 2

        Exclusion Criteria:

          -  Evidence of CNS or leptomeningeal metastases

          -  Previous treatment with fulvestrant

          -  Previous chemotherapy for locally advanced or metastatic breast cancer

          -  Cirrhosis or chronic active/persistent hepatitis

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Prednisolone
Intervention description: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.; Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.
Intervention MeSH terms: Prednisolone; Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Metastatic-castration resistant prostate cancer; Prostate specific antigen; Abiraterone acetate; JNJ-212082; Abiraterone; Prednisolone; Androgen Deprivation; Docetaxel-based chemotherapy

Summary:

      The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral
      abiraterone acetate and oral prednisolone in men with metastatic-castration resistant
      prostate cancer (mCRPC) and with disease progression following treatment with a
      docetaxel-containing chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)

          -  Has documented Prostate Specific Antigen (PSA) progression according to
             protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria

          -  Has undergone prior chemotherapy for prostate cancer with regimen(s) containing
             Docetaxel

          -  Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL

          -  Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior
             to the treatment

          -  Eastern Cooperative Oncology Group Performance Status less than or equal to 2

        Exclusion Criteria:

          -  Active or uncontrolled autoimmune disease that may require corticosteroid therapy

          -  Serious or uncontrolled co-existent non-malignant disease, including active and
             uncontrolled infection

          -  Uncontrolled hypertension

          -  Hemoglobin less than or equal to 9.0 g/dL independent of transfusion

          -  Has abnormal liver function tests

          -  Surgery or local prostatic intervention within 30 days of the first dose