bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Ertapenem
Intervention description: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn
Intervention MeSH terms: Ertapenem
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 88 Years
Healthy volunteers: No
Keywords: ertapenem; pharmacokinetic; pharmacodynamics; hemodialysis; requires hemodialysis three times a week

Summary:

      The purpose of this study is to determine the amount of ertapenem in the blood over time
      between hemodialysis session.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age between 18 and 88 at the time of admission to Oakwood Hospital and
             Medical Center during January 1, 2014 or date of Institutional Review Board (IRB)
             approval to December 1, 2015

          -  Diagnosed with end stage renal disease and requires hemodialysis three times a week

          -  No allergy to β lactam medications

          -  Existing IV access for parenteral ertapenem infusion

          -  Willing for blood draws, at predose, 0.5, 1, 2, 6, 12 hours post-hemodialysis and
             pre-hemodialysis for the following hemodialysis and immediately post hemodialysis
             session and 1 hour post.

          -  No evidence of hepatic disease

          -  No history of alcoholism or drug abuse within pervious 2 years

          -  Not pregnant

        Exclusion Criteria:

          -  History of any form of epilepsy, seizure or convulsion

          -  Currently taking any forms of valproic acid or divalproex sodium for treatment of any
             disease states

          -  Currently taking probenecid

          -  Current Clostridium difficile (C. diff.) infection, defined as 30 days prior to day-1
             of receiving ertapenem for this study

          -  Currently receiving any antimicrobial agents for prophylaxis or treatment
Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas
Condition: Recurrent Glioblastoma
MeSH terms: Glioblastoma; Glioma; Recurrence
Intervention: enzastaurin; bevacizumab; Enzyme-inducing antiepileptic drugs (EIAED); Non-enzyme inducing antiepileptic drugs (NEIAED)
Intervention description: 1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).; 10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).; Administered orally; Administered orally
Intervention MeSH terms: Bevacizumab; Anticonvulsants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of
      recurrent malignant gliomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be at least 18 years old

          -  Participant must have been diagnosed with a recurrent brain tumor by magnetic
             resonance imaging (MRI) scan

          -  Participant must be willing to practice adequate contraception

          -  Participant must be able to swallow the enzastaurin tablets whole and receive
             bevacizumab intravenously

          -  Participant must agree to use the study drug only as instructed by your study doctor
             and staff.

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Participants who have significant heart, liver, kidney, or psychiatric disease

          -  Participants who have an active infection

          -  Participants who have any recent bleeding in the brain

          -  Participants who are taking any anti-coagulation or anti-platelet medication
             [including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2)
             inhibitors]
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Condition: Nerve Pain
MeSH terms: Neuralgia
Intervention: AZD2423; AZD2423; Placebo
Intervention description: 20 mg tablet; 50 mg tablet; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Analgesic effect

Summary:

      A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days
      treatment in patients with posttraumatic neuralgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent form

          -  Males and female patients aged 18 to 80 years

          -  Patients with neuropathic pain due to peripheral nerve injury caused by trauma or
             surgery

        Exclusion Criteria:

          -  Other paint that may confound assessment of neuropathic pain

          -  History of treatment failure with more than three adequate trials of treatment for
             neuropathic pain

          -  Central neuropathic pain conditions (caused by Central Nervous System injury/disease,
             eg. Stroke)
Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing
Condition: Wounds
Intervention: COPA AMD (note: name is not an acronym); COPA (note: name is not an acronym)
Intervention description: Foam dressing impregnated with Polyhexamethylene Biguanide; Regular foam dressing without PHMB
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a multi-center, prospective, randomized, double blind, pilot clinical trial of
      subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA
      AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic
      wounds.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subject is 18 to 85 years of age inclusive

          -  subject has a foot ulcer

          -  subject has a leg ulcer

          -  subject has an open wound of at 1.0 cm (2)

          -  subject has one of the following: Palpable pulse, ABI > 0.56 or toe pressure > 50 mmHg

          -  subject or legally authorized rep is able to understand and willing to give written
             informed consent

        Exclusion Criteria:

          -  subject has an allergy to Chlorhexidine Gluconate (CHG)

          -  subject has open wounds that in the opinion of the Principal Investigator do not have
             the ability to heal

          -  subject has current malignant disease or history of malignant disease in past 5 years

          -  subject has inability to comply with the study protocol and procedures

          -  subjects who require use of topical agents other than the impregnated or regular foam
             dressings dressings
Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840
Intervention description: Individualized oral doses of ALXN1840.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of the study was to evaluate the efficacy of ALXN1840 (formerly WTX101) for
      24 weeks on non-ceruloplasmin-bound copper (NCC) concentrations adjusted for molybdenum
      plasma concentration in participants newly diagnosed with Wilson Disease (WD) who were aged
      18 and older and who had NCC concentrations within or above the reference range at the time
      of enrollment in the study. The study consisted of a 24-week Treatment Period, followed by a
      planned 36-month Extension Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to understand and willing to comply with study procedures, restrictions, and
             requirements, as judged by the Investigator.

          -  Newly established diagnosis of WD by Leipzig-Score ≥ 4 documented by testing as
             outlined in 2012 European Association for the Study of the Liver Wilson Disease
             Clinical Practice Guidelines.

          -  NCC levels within or above the normal reference range (0.8 to 2.3 micromole).

          -  Willing to undergo 48 hour washout from current WD treatment

        Exclusion Criteria:

          -  Treatment for greater than 24 months for WD with chelation therapy (for example,
             penicillamine, trientine hydrochloride) or zinc therapy.

          -  Decompensated hepatic cirrhosis.

          -  Model for End-Stage Liver Disease score > 11.

          -  Modified Nazer score > 6.

          -  Gastrointestinal bleed within past 6 months.

          -  Alanine aminotransferase > 5 x upper limit of normal.

          -  Marked neurological disease requiring either nasogastric feeding or intensive
             in-patient medical care.

          -  Severe anemia with a hemoglobin < 9 grams/deciliter.
Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia; Lymphoplasmacytic Lymphoma
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: Thalidomide; Rituximab
Intervention description: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.; Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
Intervention MeSH terms: Thalidomide; Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: thalidomide; rituximab; Waldenstrom's

Summary:

      The purpose of this study is to determine the percentage of people who can attain remission
      and the length of time such responses to therapy are sustained, as well as the side effects
      that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinicopathological diagnosis of Waldenstrom's macroglobulinemia requiring therapy

          -  Baseline staging requirements

          -  Absolute Neutrophil Count > 500/microliter (uL)

          -  Platelet Count > 25,000/uL

          -  Serum creatinine < 2.5mg/dL

          -  Total bilirubin and transaminase (SGOT) < 2.5 X Upper Limit of Normal (ULN)

          -  Greater than 18 years of age

          -  Life expectancy of 3 months or greater

          -  Eastern Cooperative Oncology Group (ECOG) status performance of 0-2

        Exclusion Criteria:

          -  Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry

          -  Pregnant or lactating women

          -  Serious co-morbid disease

          -  Uncontrolled bacterial, fungal or viral infection

          -  Active second malignancy
A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nilotinib; DTIC
Intervention description: Nilotinib was provided as 200 mg hard gelatin capsules for oral use.; DTIC was supplied locally as sterile powder for i.v. infusion.
Intervention MeSH terms: Dacarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; AMN107; c-Kit; c-Kit mutated metastatic and/or inoperable melanoma

Summary:

      The purpose of this study is to determine whether nilotinib is efficacious in the treatment
      of metastatic and/or inoperable melanoma harboring a c-Kit mutation.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11
        or 13, or mutations Y822D and mutations D820Y, Y823D of exon 17, as confirmed by the
        central laboratory 3. Stage III unresectable or stage IV disease 4. The presence of one or
        more measurable lesions as detected by radiological or photographic methods and assessed
        according to RECIST 1.0. Lesions must have a size of at least 10mm at longest diameter
        (using a slice thickness of 5 mm)or double the slice thickness to be considered a target
        lesion. Target lesions should not be selected in previously irradiated fields unless there
        is clear evidence of progression 5. WHO performance status 0 - 2

        Exclusion Criteria:

          1. C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon
             not allowed by the inclusion criteria

          2. Patients with c-Kit amplifications only and no mutation

          3. Patients with any history of brain metastases

          4. Patients who have had any prior treatment with TKIs

          5. Patients receiving medications or herbal extracts which interfere with nilotinib
             metabolism which are not discontinued by the time of the baseline visit

          6. Acute or chronic liver or renal disease considered unrelated to melanoma

        Other protocol-defined inclusion/exclusion criteria may have applied.
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: AVP-786; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Negative Symptoms; Schizophrenia; AVP-786

Summary:

      The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability
      of AVP-786 as an adjunctive treatment compared with placebo in patients with residual
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I.
             version 6.0.

          -  Patients must meet PANSS criteria

          -  Patients currently receiving atypical antipsychotics are eligible provided they are on
             a stable dose

        Exclusion Criteria:

          -  Patients with current major depressive disorder (MDD)

          -  Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic
             medication

          -  Patients currently using anticholinergic medications

          -  Recent in-patient hospitalization
5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: 5-azacytidine
Intervention description: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; 5-azacytidine; allogeneic stem cell transplantation

Summary:

      The purpose of this study is to examine the feasibility and efficacy of using the
      demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients
      with high risk myelodysplastic syndrome (MDS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients fulfilling the following criteria will be eligible for study entry:

               1. Diagnosis of MDS according to WHO criteria

               2. Intermediate-2 or high risk by IPSS score

               3. Clinically able to receive 5-Azacytidine

               4. Serum bilirubin levels </=1.5 times the upper limit of the normal range for the
                  laboratory (ULN). Higher levels are acceptable if these can be attributed to
                  active hemolysis or ineffective erythropoiesis

               5. Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic
                  transaminase (SGPT) levels </=2 x ULN

               6. Serum creatinine levels </=1.5 x ULN

               7. Negative serum pregnancy test prior to 5-Azacytidine treatment for women of
                  childbearing potential

               8. Women and men of childbearing potential agree to use contraception while
                  receiving treatment with 5-Azacytidine

               9. Potentially eligible for allogeneic transplantation

              10. No prior allogeneic transplant

              11. Age 18 to 70, inclusive.

        Exclusion Criteria:

          1. Known or suspected hypersensitivity to 5-azacytidine or mannitol

          2. Patients previously treated with 5-azacytidine or deoxyazacytidine

          3. Pregnant or breast feeding

          4. Patients with advanced malignant hepatic tumors
A Multi-Center Trial of Nepicastat for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Nepicastat; Placebo
Intervention description: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 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: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving
      the number of subjects that achieve abstinence from cocaine and reducing cocaine use in
      subjects with cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age

          -  Is seeking treatment for cocaine dependence

          -  Is able to understand and provide written informed consent

          -  Has completed all psychological assessments and procedures required during the 7 - 14
             day screening period

          -  If female, agrees to use an acceptable method of birth control

          -  Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase
             of the study

        Exclusion Criteria:

          -  Please contact the study site for more information
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Tarceva (Trademark) (erlotinib HCl, OSI-774); Combination carboplatin and paclitaxel
Intervention description: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy; Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tarceva; NSCLC; EGFR; ECOG Performance Status 2; erlotinib; Non-Small Cell Lung Cancer; OSI-774

Summary:

      The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy
      of erlotinib and standard chemotherapy in patients with advanced, previously untreated
      nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG)
      performance status (PS) of 2. The study will also evaluate the safety of single-agent
      erlotinib in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)

          -  No prior chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 2

          -  Clinically or radiologically measurable disease per RECIST criteria

        Exclusion Criteria:

          -  Gastro-intestinal abnormalities

          -  Any concurrent anticancer therapy

          -  Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind

          -  Other active malignancies

          -  Uncontrolled brain metastases

          -  Severe abnormalities of the cornea

          -  Significant cardiac disease