bioihbjkbjnl/mcl2 huggingface dataset:
Study of Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: Everolimus; Surgery
Intervention description: Tablets taken once a day with a full glass of water.; Salvage surgical resection
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glioblastoma Multiforme, GBM, RAD001, RAD

Summary:

      This study will define the safety and efficacy of Everolimus (RAD001) administered daily in
      patients with glioblastoma multiforme (GBM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years of age or older

          -  Histologically confirmed Glioblastoma Multiforme (GBM)

          -  Radiographic evidence of disease progression

          -  Patients must have evaluable contrast enhancing tumor

          -  Availability of paraffin blocks or unstained pathology slides for biomarker studies

          -  Karnofsky Performance Status of greater than or equal to 60%

        Exclusion Criteria:

          -  Prior treatment with Mammalian target of rapamycin (mTOR) inhibitor

          -  History of another malignancy within 3 years

          -  Cardiac pacemaker

          -  Ferromagnetic metal implants other than those approves as safe for use in Magnetic
             resonance imaging (MRI) scanners

          -  Claustrophobia

          -  Obesity

          -  Unstable systemic diseases

          -  Elevated cholesterol or triglycerides

          -  Radiation therapy or cytotoxic chemotherapy <=4 weeks prior to study enrollment.
             Patient must have recovered from the toxic effects of a prior chemotherapy.

          -  Patients must be off all enzyme inducing anticonvulsants for at least 2 week before
             study enrollment can occur

          -  Need for increasing dose of steroids. Patients on a stable or tapering dose of
             steroids >=7 days were permitted.
Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Placebo; AIN457
Intervention description: Placebo will be administered at predefined visits over the 6-month treatment phase.; AIN457 will be administered at predefined visits over the 6-month treatment phase.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing Multiple Sclerosis; AIN457; Secukinumab; Magnetic Resonance Imaging; Relapsing Remitting Multiple Sclerosis; Autoimmune Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Diseases

Summary:

      To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing
      multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria

          -  Disease duration of 10 years or less

          -  At least one relapse in the last year

          -  EDSS score 0 to 5.0 at entry

        Exclusion Criteria:

          -  Active chronic disease of the immune system other than multiple sclerosis

          -  History of malignancy within the past 5 years

          -  Active systemic bacterial, viral or fungal infections

          -  Previous treatment with more than one class of multiple sclerosis therapies except for
             previous treatment with glatiramer acetate and interferon-beta(s)

          -  Any medically unstable condition

          -  Unable to undergo MRI scans or repeated blood tests

          -  Pregnant or nursing females

          -  Women of child-bearing potential must use reliable forms of contraception

          -  Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Intervention: S8 Sinus Implant (mometasone furoate, 1350 mcg)
Intervention description: Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the safety and performance of the steroid-releasing
      S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus
      obstruction.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 years of age or older

          -  Diagnosis of chronic sinusitis

          -  Prior bilateral total ethmoidectomy

          -  Recurrent sinus obstruction due to polyps grade 2 or higher

        Key Exclusion Criteria:

          -  Required use of mometasone furoate within 2 weeks prior to implant procedure

          -  Significant scarring or adhesions of the sinus
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
Condition: Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
MeSH terms: Cytomegalovirus Infections
Intervention: ASP0113; Placebo
Intervention description: intramuscular injection; intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASP0113; Cytomegalovirus (CMV); Kidney Transplantation

Summary:

      The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in
      reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects
      receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of
      ASP0113 in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CMV negative subject having received a CMV seropositive kidney (living or deceased)

          -  Participant started valganciclovir or ganciclovir within 10 days of transplant and had
             received it through Randomization.

        Exclusion Criteria:

          -  Participant underwent a course of CMV-specific prophylactic therapy with antiviral
             drugs with a duration of greater than 100 days.

          -  Participant had received from one month prior to transplant or planned to receive CMV
             immunoglobulin.

          -  Participant had CMV viremia or CMV disease from time of transplant until time of
             Randomization.
The Effects of Lycopene on High Risk Prostatic Tissue
Condition: Intraepithelial Prostatic Neoplasia; Prostatic Neoplasms
MeSH terms: Neoplasms; Prostatic Neoplasms; Prostatic Intraepithelial Neoplasia
Intervention: Lycopene 30mg; Placebo
Intervention description: Lycopene 30 mg.; Placebo
Intervention MeSH terms: Lycopene
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 66.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Intraepithelial Prostatic Neoplasia; Prostatic neoplasms; Male urogenital disease; Prostate

Summary:

      The purpose of this research study is to compare the effects of a lycopene supplement made
      from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal
      cells in the prostate, but have not yet had cancer detected. This study will allow us to see
      if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and
      in chemicals measured in the blood that go along with a higher risk of developing cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male

          -  Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior
             to registration. At least 4 weeks must have elapsed between the last biopsy and the
             biopsy used for baseline data.

          -  Have an AUA symptom score <=25 at time of registration.

          -  Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements
             within 1 month of randomization. Participants must agree to refrain from taking
             non-study dietary supplements while on study

          -  Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or
             specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the
             prostate within 1 month of registration. Patients must also agree to refrain from
             taking the non-prescription substances while on study

          -  Be willing to limit intake of lycopene-containing foods while on study

          -  Have no prior cancer (except basal cell or squamous cell skin cancer) or complete
             remission for at least 5 years

          -  Be ambulatory, capable of self-care and able to carry out light or sedentary work

          -  Have a dietary fat intake of 23-48% of calories

          -  Participant's physician recommends repeat biopsy 4-6 months after randomization

        Exclusion Criteria:

          -  No repeat biopsy planned

          -  Not willing to change diet

          -  Have a diagnosis of prostate cancer
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CNTO 1959 (5 mg); CNTO 1959 (15 mg); CNTO 1959 (50 mg); CNTO 1959 (100 mg); CNTO 1959 (200 mg); Adalimumab; Placebo
Intervention description: Subcutaneous (SC) injections; SC injections; SC injections; SC injections; SC injections; SC injections; SC injections
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Moderate to Severe Plaque-Type Psoriasis; Psoriasis; Plaque-type psoriasis; CNTO 1959; adalimumab

Summary:

      The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the
      treatment of patients with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6
             months prior to first administration of any study agent

          -  Must be a candidate for phototherapy or systemic treatment for psoriasis (either new
             to treatment or having had previous treatment)

          -  Must be considered, in the opinion of the investigator, suitable candidates for
             adalimumab therapy

          -  If a woman, she must be postmenopausal, or if premenopausal, she must be either
             surgically sterile, practicing a highly effective method of birth control, or not
             heterosexually active during the study and for 5 months after receiving the last dose
             of study drug

          -  If a man, he must agree to use a double-barrier method of birth control (or must have
             been surgically sterilized) and to not donate sperm during the study and for 5 months
             after receiving the last dose of study drug.

        Exclusion Criteria:

          -  History of or current signs or symptoms of severe, progressive, or uncontrolled renal,
             hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic,
             cerebral, or psychiatric disease

          -  Has a contra-indication to anti-TNF therapy

          -  Has a history of chronic or recurrent infectious disease

          -  Has a nonplaque form of psoriasis or has drug-induced psoriasis

          -  Has been previously treated with adalimumab

          -  Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23,
             (including but not limited to ustekinumab, briakinumab [ABT-874], AIN457, and
             SCH900222) within 6 months of the first administration of study agent.
Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Dyslipidemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Dyslipidemias
Intervention: Simvastatin; Ezetimibe/Simvastatin
Intervention description: simvastatin 20 mg daily; Ezetimibe (10mg)/Simvastatin (20mg)
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Type 1 Diabetes Mellitus; dyslipidemia; adolescents

Summary:

      The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin
      in adolescents with Type 1 Diabetes and to determine the amount of decrease in
      LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be
      safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12-18 years of age with Type 1 Diabetes and seen at the Barbara Davis Center for
             Childhood Diabetes

          -  Positive diabetes auto-antibodies or provider diagnosed Type 1 Diabetes

          -  LDL > 130 mg/dl.

        Exclusion Criteria:

          -  Familial hypercholesterolemia, Triglycerides (TG) > 400mg/dl

          -  Type 1 Diabetes of less than three-month duration

          -  HbA1c>9.5%

          -  Abnormal thyroid function

          -  Abnormal Creatine Kinase (CK) values (defined as > 10 times the upper limit of normal)

          -  Abnormal liver function tests (ALT/AST) (defined as >3 times the upper limit of
             normal)

          -  Pregnancy, and patients on oral contraceptives

          -  All resources are in English. Spanish speakers will not be available for the follow-up
             calls.
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients
Condition: Ewing's Sarcoma
MeSH terms: Sarcoma; Sarcoma, Ewing
Intervention: Vincristine; Doxorubicin; Cyclophosphamide; Dexrazoxane; ImmTher
Intervention description: 2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.; 90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6.; 2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6.; 900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.; 900 mcg/m^2 IV over 1 hour every week x 50-52 weeks.
Intervention MeSH terms: Cyclophosphamide; Doxorubicin; Vincristine; Dexrazoxane; Razoxane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 3 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Ewing's Sarcoma; Vincristine; Doxorubicin; Adriamycin; Rubex; Cyclophosphamide; Dexrazoxane; Zinecard; VACdxr; ImmTher

Summary:

      Objectives:

        1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and
           Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free
           survival seen with standard VAC therapy.

        2. To evaluate the feasibility and describe the toxicity associated with VACdxr.

        3. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a
           weekly basis for 50- 52 weeks.

        4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High risk Ewing's Family of tumors (metastatic disease at diagnosis, humerus, femur or
             trunk primary, bulky primary (greater than 8 cm)), or LDH greater or equal to 900
             IU/ml prior to biopsy.

          -  No prior chemotherapy.

          -  Written informed consent

          -  Normal cardiac function (ejection fraction greater or equal to 50%).

          -  Males and non pregnant females.

          -  Biologic age 3-60 years old.

          -  Adequate bone marrow function (defined as an absolute peripheral granulocyte count
             of>500/mm3, platelet count of >75,000/mm3, and hemoglobin >8g/dl with transfusion if
             required).

          -  Adequate renal function defined as blood urea nitrogen (BUN) <30mg% and serum
             creatinine <1.5 x normal for age or creatinine clearance >70.

          -  Patients of child bearing potential must agree to use an effective method of
             contraception.

          -  Normal hepatic function (bilirubin <1.5mg/dl, serum glutamate oxaloacetate
             transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) <3x normal).

        Exclusion Criteria: N/A
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
Condition: Lung Cancer; Non-Small-Cell Lung Carcinoma
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Capecitabine; Docetaxel
Intervention description: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.; 36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Intervention MeSH terms: Docetaxel; Capecitabine
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
Keywords: Previously Untreated; Advanced

Summary:

      This study will determine the objective response rate in chemotherapy naive non-small cell
      lung cancer patients with advanced disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have advanced NSCLC

          -  No prior chemotherapy

          -  Eastern Cooperative Oncology Group(ECOG)Performance Status:0 or 1

          -  Must have measurable disease (RECIST criteria)

          -  life expectancy of at least 12 weeks

          -  adequate organ function including

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Psychiatric disorders that would interfere w/consent or follow-up

          -  Patients with uncontrolled diabetes mellitus, defined as random blood sugar >
             250mg/dL.
Darbepoetin Alfa and Anemia of Cancer
Condition: Anemia; Anemia of Cancer; Cancer; Carcinoma; Neoplasms; Non-Myeloid Malignancies
MeSH terms: Neoplasms; Anemia
Intervention: darbepoetin alfa
Intervention description: Administered subcutaneously.
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia of cancer; darbepoetin alfa; Aranesp

Summary:

      This phase 2, multicenter, randomized, open-label, comparative study was designed to
      determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health
      related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not
      receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to
      receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of
      observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).
    

Eligibility criteria:

        Inclusion Criteria:

          -  nonmyeloid malignancies (including lymphocytic leukemias)

          -  anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or
             previous chemotherapy or radiotherapy

          -  Eastern Cooperative Oncology Group performance status of 0 to 2

          -  adequate liver and renal functions

          -  18 years or older

        Exclusion Criteria:

          -  history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more
             than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening

          -  acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome

          -  known hematologic disorders that could cause anemia

          -  inflammatory or cardiac disorders

          -  previous positive antibody response to any erythropoietic agent

          -  history of pure red cell aplasia
Vitamin C & Thiamine to Treat Sepsis and Septic Shock
Condition: Sepsis; Septic Shock
MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock
Intervention: Vitamin C; Vitamin B1
Intervention description: Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum).; Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
Intervention MeSH terms: Vitamins; Ascorbic Acid; Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All parties involved, except for pharmacy personnel will be blinded.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Sepsis; Septic Shock; Vitamin C; Thiamine

Summary:

      Investigators propose to investigate the use of IV vitamins B1 and C in a randomized,
      double-blinded, prospective trial to determine if these medications decrease mortality rates
      in patients with severe sepsis or septic shock.
    

Eligibility criteria:

        Patients must meet all inclusion criteria:

          1. Between the ages of 18 and 90 years old

          2. Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by
             the Surviving Sepsis 2012 guidelines.

          3. Weight more than 30 kg

          4. Full code

        Exclusion Criteria:

          1. Not diagnosed with severe sepsis or septic shock

          2. Younger than 18 or older than 90 years old

          3. With a history of nephrolithiasis

          4. Who are pregnant

          5. Weigh less than 30 kg

          6. Not located in the ICU

          7. Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort
             measures only (CMO)

          8. Currently on dialysis