bioihbjkbjnl/mcl2 huggingface dataset:
Oral Clofarabine Study in Patients With Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
MeSH terms: Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Intervention: Clofarabine
Intervention description: Starting dose 10 mg (Group 1) or 20 mg (Group 2) as tablets once a day for 5 days in a row and repeated every 4-8 weeks. Each 4-8 week period is a cycle.
Intervention MeSH terms: Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; MDS; Chronic Myelomonocytic Leukemia; CMML; Clofarabine; Clofarex; Clolar; Chemotherapy

Summary:

      The goal of this clinical research study is to learn if clofarabine given by mouth on a
      weekly schedule can help to control MDS. The safety of clofarabine given by mouth will also
      be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with MDS and >/= 5% blasts or IPSS risk intermediate or high; patients with
             Chronic myelomonocytic leukemia (CMML).

          2. No prior intensive chemotherapy or high-dose ara-C (>/= 1g/m2).

          3. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.

          4. Patients must have been off chemotherapy for 2 weeks prior to entering this study and
             recovered from the toxic effects of that therapy, unless there is evidence of rapidly
             progressive disease.

          5. Hydroxyurea is permitted for control of counts prior to treatment.

          6. Procrit, GCSF are allowed before therapy.

          7. Performance 0-2 (ECOG). Adequate organ function including the following:Adequate liver
             function (bilirubin of < 2mg/dl), and renal function (creatinine < 2mg/dl), and SGPT
             (ALT) < 3 X ULN. Adequate cardiac functions (NYHA cardiac III-IV excluded).

          8. Signed informed consent.

        Exclusion Criteria:

          1. Nursing and pregnant females. Patients of childbearing potential should practice
             effective methods of contraception. Child bearing potential defined as not
             post-menopausal for 12 months or no previous surgical sterilization. Should a woman
             become pregnant or suspect she is pregnant while participating in this study, she
             should inform her treating physician immediately.

          2. Active and uncontrolled infections.

          3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.

          4. Prior clofarabine treatment.
Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: BI 10773
Intervention description: Oral once daily
Intervention MeSH terms: Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular
      filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects
      with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the
      safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female subjects 18 years of age or older diagnosed with type 1 diabetes
             mellitus

          2. Glycated hemoglobin (HbA1C) of 6.5% to 11.0% and an estimated glomerular filtration
             rate (eGFR) greater or equal to 60 ml/min/1.73m² at screening

          3. Subjects must be either experienced insulin pump users or be on multiple daily
             injections of any type of insulin

        Exclusion criteria:

          1. Evidence of macroalbuminuria or leukocyte positive urinalysis at screening

          2. Any concomitant medication known to interfere with renin-angiotensin-aldosterone
             system (RAAS) activity or treatment with any other drugs to reduce blood glucose other
             than insulin

          3. History of macrovascular disease or any other disease which would interfere with trial
             participation or any ongoing clinical condition that would jeopardize subject safety
             or study compliance based on investigator judgement
Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ipilimumab
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the safety and effectiveness (how well the drug
      works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with
      metastatic castration resistant prostate cancer.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Prostate cancer with metastases

          -  Prostate cancer should be castration resistant

          -  Progression during hormonal therapy

        Exclusion Criteria:

          -  Visceral metastases (eg liver, lung or brain metastases)

          -  Prior treatment with any immunotherapy for prostate cancer

          -  Prior or ongoing cytotoxic therapy for prostate cancer

          -  Autoimmune disease

          -  Inadequate hematologic, renal, or hepatic function
Oxytocin and Affect Processing in Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Oxytocin; Placebo
Intervention description: See arm/group descriptions for dosage amount and procedure.; See arm/group descriptions for dosage amount and procedure.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators will use multiple methods (including Oxytocin intranasal inhalation,
      neuroimaging, behavioral measures, peripheral hormone measurements) to examine how
      individuals' behavior, cognition, and brain function is impacted by the neuro-hormone
      Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin
      administration on affective processing in non-trauma exposed and trauma-exposed adults (both
      with and without posttraumatic stress disorder, PTSD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults: age 18-55

          -  Be in good medical health

          -  Be cooperative with testing

          -  English is a language spoken in the family

          -  PTSD as diagnosed by a certified clinician or the research team for PTSD group.

        Exclusion Criteria:

          -  Moderate or severe acute or chronic medical illnesses (e.g.cardiac disease, diabetes,
             epilepsy, influenza).

          -  History of hypertension with baseline blood pressure above 160 mm Hg (systolic) over
             100 mm Hg (diastolic).

          -  history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).

          -  weight >300lb

          -  The use of some psychotropic medications will not be allowed. Females taking
             contraceptive hormones will not be able to participate in the study.

          -  Currently breast feeding or pregnant

          -  For MRI ONLY: Any metal or electromagnetic implants

          -  For MRI ONLY: Significant hearing loss or other severe sensory impairment

          -  A fragile health status.

          -  For MRI ONLY: A history of seizures or current use of anticonvulsants

          -  Healthy adult controls (HC):

          -  Be free of both neurological and psychiatric disorders (current and past) on the basis
             of self-report

          -  Be free of psychiatric disorders
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Methylnaltrexone bromide; Placebo
Intervention description: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.; Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
Intervention MeSH terms: Bromides; Methylnaltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the safety and activity of MNTX in relieving
      opioid-induced constipation following orthopedic procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants greater than or equal to (>=) 18 years of age.

          2. Participants must have undergone an orthopedic procedure (that is, total knee or hip
             replacement, spinal fusion, or reduction of fracture(s) with or without surgical
             fixation post trauma).

          3. Participants must be receiving opioid analgesics (a mu agonist only-not to include
             agents with mixed mechanisms of action such as tramadol or buprenorphine) after the
             procedures and be expected to require daily opioid analgesics for at least 7 days post
             randomization.

          4. Participants must be acutely constipated following their orthopedic procedure.

          5. Participants must receive all doses of study drug in either hospitals or
             rehabilitation facilities.

          6. Participants must sign an informed consent form.

          7. Females of childbearing potential must have a negative pregnancy test and use
             appropriate birth control throughout the study.

          8. Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds [lbs]).

        Exclusion Criteria:

          1. Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.

          2. Participants who received any investigational new drug (experimental) in the previous
             30 days.

          3. Participants who have received a laxative (for example, lactulose) or an enema within
             48 hours prior to the first dose.

          4. Participants with constipation not attributed to post procedure opioids.

          5. Participants with a history of alcohol or prescription or non-prescription drug abuse
             within the past 2 years.

          6. Female participants who are pregnant or lactating.

          7. Participants with a known history of chronic active hepatitis B or hepatitis C virus
             or human immunodeficiency virus (HIV) infection.
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: BI 207127 NA; peginterferon; Ribavirin; Ribavirin; BI 207127 NA; BI 201335 NA; BI 201335 NA; peginterferon
Intervention description: one fix dose; per package insert; per weight BID; per weight BID; one fix dose; high dose; low dose; per package insert
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to investigate tolerability, safety, pharmacokinetics and
      antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks
      in Japanese treatment-naive patients with chronic GT-1 HCV infection.
    

Eligibility criteria:

        Inclusion criteria:

          -  Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and
             detected HCV ribonucleic acid(RNA) at screening in addition to:

               1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to
                  screening; or,

               2. liver biopsy consistent with chronic HCV infection.

          -  HCV infection of genotype 1 confirmed by genotypic testing at screening

          -  Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral /
             immunomodulatory drug for acute or chronic HCV infection.

          -  Plasma HCV RNA = 100,000 IU/mL at screening

        Exclusion criteria:

          -  Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic
             testing at screening

          -  Human immunodeficiency virus (HIV) co-infection

          -  Decompensated liver disease, or history of decompensated liver disease

          -  Body weight < 40 or > 125 kg at screening

          -  Hemoglobin <12.0g/dL for women and <13.0g/dL for men at screening

          -  White blood cell count <3000 cells/mm3 at screening

          -  Absolute neutrophil count < 1,500 cells/mm3 at screening

          -  Platelet count < 90,000 /mm3 at screening

          -  Serum creatinine > 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50
             mL/min at screening
Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Condition: Relapsed and/or Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elotuzumab; Thalidomide; Dexamethasone; Cyclophosphamide
Intervention description: Powder for solution, 400-mg vials, for infusion; 50-mg capsules administered orally; 2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration; 50-mg tablets administered orally
Intervention MeSH terms: Thalidomide; Dexamethasone; Dexamethasone acetate; Cyclophosphamide; Elotuzumab; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and tolerability of elotuzumab
      administered in combination with thalidomide and dexamethasone in the treatment of relapsed
      and/or refractory multiple myeloma.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Key Inclusion Criteria:

          -  Confirmed diagnosis of previously treated multiple myeloma with progression documented
             by criteria of the International Myeloma Working Group after or during the most recent
             therapy

          -  Patient received 5 or fewer prior lines of therapy

          -  Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in
             cohort) or 0 to 2 (additional patients)

          -  Measurable disease as defined by at least 1 of the following:

               -  Serum immunoglobulin (Ig)G, IgA, IgM, or monoclonal (M) protein level ≥0.5 g/dL
                  or serum IgD M protein level ≥0.05 g/dL; or

               -  Urine M protein level ≥200 mg excreted in a 24-hour collection sample; or

               -  Involved serum free light chain level ≥10 mg/dL, provided the free light chain
                  ratio is abnormal

        Key Exclusion Criteria:

          -  Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
             cell dyscrasia

          -  Monoclonal gammopathy of undetermined significance, smoldering myeloma, or
             Waldenström's macroglobulinemia

          -  Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition ≤50%

          -  Electrocardiogram finding of QTc ≥450 msec

          -  Active plasma cell leukemia (defined as either 20% of peripheral white blood cells,
             composed of plasma/CD138+ cells or an absolute plasma cell count of 2*10^9/L)

          -  Diagnosis of nonsecretory myeloma

          -  Active hepatitis A, B, or C virus infection

          -  Grade ≥2 neuropathy
A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)
Condition: Cesarean Section
Intervention: Insorb absorbable staples; Insorb
Intervention description: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples; Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: metallic staples; absorbable staples; Cesarean Delivery

Summary:

      The purpose of the study is to compare post operative pain, cost effectiveness, speed of
      closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples
      versus absorbable staples (Insorb) after Cesarean Delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obstetric service patients (receiving prenatal care from the Faculty Medical Center)

          -  Women greater than 18 years old

          -  Singleton gestation

          -  Cesarean Section performed by Pfannenstiel skin incision

        Exclusion Criteria:

          -  History of drug or alcohol abuse

          -  Contraindication to post operative NSAID's or Narcotics

          -  Emergent Cesarean Deliveries

          -  Less then 18 years of age
Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Intervention: caspofungin
Intervention description: i.v.
Intervention MeSH terms: Caspofungin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: aspergillosis; caspofungin; maximum tolerated dose

Summary:

      This study investigates the safety and tolerability as well as the efficacy and
      pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic
      malignancies and proven or probable invasive aspergillosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Immunocompromised due to hematologic malignancies, bone marrow failure syndromes,
             hematopoietic stem cell transplantation, solid organ transplantation, other conditions
             resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy,
             treatment with other immunosuppressive medications, or other immunocompromising
             conditions that place patients at risk for invasive fungal infections.

          -  Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria

        Exclusion Criteria:

          -  Concomitant other systemic antifungal agents are not permitted on study.

          -  Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal
             infection present for > 4 weeks preceding entry into study

          -  Prior systemic therapy of ≥ 4 days with any polyene anti-fungal agent within 14 days
             of study enrollment

          -  Prior systemic therapy of ≥ 4 days with non-polyenes for the current, documented IFI.