bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
Condition: Anemia; Dialysis-Dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: vadadustat; epoetin alfa
Intervention description: vadadustat; epoetin alfa
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; kidney; dialysis-dependent chronic kidney disease; CKD; DD-CKD; renal; vadadustat; AKB-6548; hypoxia-inducible factor; HIF; hypoxia-inducible factor prolyl-hydroxylase inhibitor; HIF-PHI; hyporesponder; hyporesponsive; epoetin alfa; hemoglobin; erythropoiesis stimulating agent; ESA

Summary:

      This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa
      for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease
      (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ≥18 years of age

          -  Receiving chronic maintenance hemodialysis for end-stage kidney disease

          -  Currently receiving epoetin alfa for anemia

          -  Hb between 8.5 and 10.0 g/dL during screening

        Exclusion Criteria:

          -  Anemia due to a cause other than CKD or presence of active bleeding or recent blood
             loss

          -  Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic
             malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia

          -  Red blood cell transfusion within 4 weeks prior to or during screening

          -  Anticipated to recover adequate kidney function to no longer require hemodialysis
             during study participation
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Docetaxel; Gemcitabine; Carboplatin; Radiation
Intervention description: 30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles; 1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles; AUC = 1.5 weekly x 7; To 63 Gy
Intervention MeSH terms: Carboplatin; Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively
      non-toxic combination in advanced NSCLC. This study will help to better define optimal
      preoperative regimens for patients with resectable NSCLC. Since both of these drugs are
      potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may
      produce not only radio-sensitization, but also considerable antitumor efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Histologically confirmed non-small cell lung cancer

          -  Must be operable candidate

          -  Clinical stage IB, II, and select III non-small cell lung cancer are eligible

          -  Measurable or evaluable disease

          -  Able to perform activities of daily living with minimal assistance

          -  Must be > 18 years of age

          -  Adequate bone marrow, liver or kidney

          -  No previous chemotherapy or radiation therapy for non-small cell lung cancer

          -  Moderate to severe peripheral neuropathy

          -  Understand the nature of this study and give written informed consent.

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Stage IV disease

          -  History of prior malignancy within five years

          -  Women who are pregnant or breast-feeding

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.
Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
Condition: Cataract
MeSH terms: Cataract
Intervention: OMS302 Solution; OMS302 Mydriatic Solution; OMS302 Anti-inflammatory Solution; Balanced Salt Solution (BSS) Solution
Intervention MeSH terms: Anti-Inflammatory Agents; Pharmaceutical Solutions; Mydriatics
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the use of OMS302 (the study drug) in
      individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and
      effective at maintaining an adequately dilated pupil during surgery and reducing
      post-operative symptoms of discomfort (such as eye pain and irritation).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Competent and willing to voluntarily provide informed consent

          -  18 years of age or older

          -  In good general health needing to undergo cataract extraction with lens replacement
             surgery in one eye, under topical anesthesia

          -  Other inclusion criteria to be evaluated by the investigator

        Exclusion Criteria:

          -  No allergies to the medications and/or the active ingredients of any of the study
             medications

          -  No medications with the same activities as the of the active ingredients in OMS302 for
             defined time intervals prior to and after surgery

          -  No other significant eye injuries, eye conditions or general medical conditions likely
             to interfere with the evaluation of the study medication

          -  Other exclusion criteria to be evaluated by the investigator
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo
Intervention description: Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.; Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peritoneal Neoplasma

Summary:

      Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced
      Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen
      of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO)
             stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at
             presentation. Patients must have achieved a clinical complete response (disappearance
             of all clinical and radiological evidence of tumor) after only one regimen (4-6
             cycles) of platinum and taxane-based standard chemotherapy received after tumor
             debulkment.

          -  Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose
             of sorafenib.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  All scans used to document complete response must be done within 30 days prior to
             randomization.

          -  Patients must be able to swallow and retain oral medication.

        Exclusion Criteria:

          -  Patients with any residual cancer tissue after the completion of chemotherapy
             detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).

          -  Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.

          -  Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma,
             germ cell).

          -  Major surgery, open biopsy, or significant traumatic injury within 30 days prior to
             randomization.
Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Intervention: Triheptanoin 1g/kg/day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this project is to study the efficacy of an anaplerotic treatment on brain
      energy profile evolution at an early stage of the Huntington disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  5 < UHDRS < 50

          -  Age > 18 years

          -  Ability to undergo MR scanning

          -  Covered by french social security

        Exclusion Criteria:

          -  Evidence of psychiatric disorder

          -  Attendant neurological disorder

          -  Contraindications to MRI (claustrophobia, metallic or material implants)

          -  Severe head injury

          -  Unable to understand the protocol

          -  Pregnancy

          -  Failure to give informed consent

          -  Subjects with exclusion criteria required by french law (e.g. subjects who require a
             legally authorized representative to obtain consent)

          -  Unwillingness to be informed in case of abnormal MRI
Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
Condition: Grade IV Glioma; Grade IV Astrocytoma; Glioblastoma Multiforme
MeSH terms: Glioblastoma; Glioma; Astrocytoma
Intervention: TVI-Brain-1
Intervention description: Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Intervention MeSH terms: Adjuvants, Immunologic
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brain Neoplasms; Central Nervous System Neoplasms; Brain Diseases; Neoplasms; Nervous System Neoplasms; Glioblastoma; Astrocytoma; Nervous System Diseases; Central Nervous System Diseases; Glioma; Recurrent astrocytoma; Recurrent glioma; Cancer vaccine; Immunotherapy; Killer T cells; Activated T cells; GM-CSF; Activated lymphocytes

Summary:

      TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can
      produce immune cells, called 'killer' white blood cells that have the ability to kill large
      numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to
      generate large numbers of those 'killer' white blood cells and to deliver those cells into
      your body so that they can kill your cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18

          -  Informed consent

          -  Diagnosis of grade IV glioma with progression following standard treatment.

          -  Must be able to tolerate surgery to provide tumor tissue for vaccine.

          -  Must be able to produce viable vaccine from tumor tissue.

          -  Karnofsky Performance Status must be 70 or greater.

          -  Negative HIV test.

          -  Negative for hepatitis B and C virus.

          -  Respiratory reserve must be reasonable.

          -  Sufficient renal function.

          -  Satisfactory blood counts.

          -  Negative pregnancy test for women of childbearing potential.

        Exclusion Criteria:

          -  Surgically removed cancer reveals that it is not grade IV glioma.

          -  Concomitant life-threatening disease.

          -  Active autoimmune disease.

          -  Currently receiving chemotherapy or biological therapy for the treatment of cancer.

          -  Currently receiving immunosuppressive drugs for any reason.

          -  Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months.

          -  Prior treatment with Gliadel wafers.

          -  Corticosteroids beyond peri-operative period.

          -  Psychological, familial, sociological or geographical conditions that do not permit
             adequate medical follow-up and compliance with the study protocol.
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Condition: Preterm Infants
MeSH terms: Premature Birth
Intervention: three times weekly Epo; weekly Epo
Intervention description: Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks; Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 7 Days
Maximum age: 100 Days
Healthy volunteers: No
Keywords: anemia; transfusions; erythropoiesis; neonate; preterm

Summary:

      Preterm infants are a risk for multiple transfusions, and the administration of human
      recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing
      usually occurs three times a week, but extended dosing schedules have been successful in
      adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard
      three times weekly dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  < or = 1,500 grams

          -  < or = 32 weeks gestation

          -  > or = 7 days of age

          -  informed consent obtained

        Exclusion Criteria:

          -  hemolytic disease

          -  hypertension

          -  seizures

          -  thromboses

          -  major malformation
A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: LY2157299; Sorafenib; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transforming growth factor beta (TGF-β)

Summary:

      The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as LY2157299 in participants with hepatocellular carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological evidence of a diagnosis of HCC not amenable to curative surgery.

          -  Have Child-Pugh Class A.

          -  Have the presence of measurable disease.

          -  Have adequate organ function.

          -  Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG)
             scale.

          -  If male or female with reproductive potential, must agree to use medically approved
             contraceptive precautions during the trial and for 3 months following the last dose of
             study drug.

          -  If females with childbearing potential, must have had a negative serum pregnancy test
             7 days prior to the first dose of study drug.

          -  Are able to swallow capsules or tablets.

          -  Have available diagnostic or biopsy tumor tissue.

        Exclusion Criteria:

          -  Have received previous systemic treatment for advanced disease.

          -  Have known HCC with fibro-lamellar or mixed histology.

          -  Have presence of clinically relevant ascites.

          -  Have had a liver transplant.

          -  Have moderate or severe cardiac disease.

          -  Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C virus
             infection.

          -  Have experienced Grade 3 or 4 gastrointestinal bleeding or any variceal bleeding
             episode in the 3 months prior to enrollment requiring transfusion or endoscopic or
             operative intervention.

          -  Have esophageal or gastric varices that require immediate intervention or represent a
             high bleeding risk.

          -  Had major surgery within 4 weeks prior to the study randomization.
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Condition: Urinary Tract Infections; Catheter Infection; Catheter-Related Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Catheter-Related Infections
Intervention: Catheter insertion with Povidone Iodine; Standard of care catheter insertion
Intervention description: The catheter will be treated with Povidone Iodine prior to insertion.; Catheter inserted right out of package.
Intervention MeSH terms: Iodine; Povidone-Iodine; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery:
Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or
Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Masking: None (Open Label)
Enrollment: 99.0
Sex: Female
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      Urinary Tract Infection (UTI) complications following catheter use in surgical patients
      remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by
      50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use
      associated with this complication and improve cost-effectiveness of care. The investigators
      hypothesize that they can reduce the incidence of UTIs after catheter placement with the
      implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the
      environment exposure of the catheter before, during and after insertion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. women 18-89 years of age

          2. admitted for surgery lasting >1 hour and requiring urinary catheter,

          3. have normal urine analysis within 24 hours pre-surgery, and

          4. able to provide informed consent.

        Exclusion Criteria:

          1. currently on dialysis,

          2. chronic urinary infection,

          3. hyperthyroidism,

          4. current infection,

          5. a history of allergy or sensitivity to iodine.

          6. women who are pregnant or breast feeding

          7. men due to their lower incidence of UTIs compared to the female population.
VELCADE,Rituximab,Cyclophosphamide and Decadron
Condition: Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: VELCADE®; Rituximab; Cyclophosphamide; Decadron
Intervention description: 1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.; 375 mg/m^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.; 400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.; 40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Rituximab; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: NHL

Summary:

      Overall response rate and Time to disease progression using this regimen in patients with
      low-grade B-Cell Non-Hodgkin's Lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Small Lymphocytic Lymphoma

          -  Follicular Cell Lymphoma (grades I and II)

          -  Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy
             and stem cell transplant

          -  Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia

          -  Marginal Zone Lymphoma

          -  MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation.

          -  Adequate bone marrow function, renal function, and hepatic function as outlined in
             details below.

          -  ECOG performance status of 0, 1, or 2

          -  Able to read, understand, and sign an IRB approved informed consent

        Exclusion Criteria:

          -  Known HIV positive status

          -  Known CNS involvement

          -  Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.