bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: sunitinib; mFOLFOX6; bevacizumab; mFOLFOX6
Intervention description: Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).; FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle; Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.; FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
Intervention MeSH terms: Bevacizumab; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study

Summary:

      This study will compare the safety and efficacy of sunitinib in combination with FOLFOX
      versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic
      colorectal cancer who have not been treated before.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease

          -  Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors
             (RECIST)

          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1

        Exclusion Criteria:

          -  Previous treatment with Sutent, Avastin, or any other systemic therapy for locally
             advanced or metastatic colorectal cancer

          -  Less than 6 months since completion of adjuvant chemotherapy to documentation of
             recurrent disease

          -  History of cardiac disease

          -  Brain mets
Vitamin D and Breast Cancer: Does Weight Make a Difference?
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; Obesity

Summary:

      This is a research study of the effect of Vitamin D on breast cancer. We hope to learn
      whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that
      affect its growth. We believe some of these characteristics may be influenced by body weight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who have undergone a core needle biopsy demonstrating an operable breast cancer
             whom have not yet had any further therapy.

          -  No prior therapy for breast cancer.

          -  Age 18 years or older.

          -  Any menopausal status

          -  Planned surgical resection of breast cancer or repeat core biopsy tissue sampling
             prior to initiation of neoadjuvant systemic chemotherapy.

          -  Availability of tissue blocks from initial core needle biopsy.

          -  Signed informed consent.

          -  Willing to discontinue use of all supplements containing Vitamin D for the duration of
             the study, and take only the Vitamin D provided by the study.

        Exclusion Criteria:

          -  Presence of any Metastatic lesion.

          -  History of parathyroid disease, hypercalcemia, or kidney stones.

          -  History of Selective estrogen receptor modulator (SERM) or aromatase inhibitor
             therapy.

          -  Receiving metformin.

          -  History of renal failure requiring dialysis or kidney transplantation.

          -  Women who are known to be pregnant or who are nursing. (As vitamin D does not have
             toxicity to the fetus, a negative pregnancy test is not a requirement to participate
             in the study.)

          -  Patients planned for surgical therapy of their breast cancer or initiation of systemic
             chemotherapy, that would not allow for at least 7 days of vitamin D intervention

          -  Any condition potentially interfering with subjects ability to comply with taking
             study medication.

          -  Any medical condition that would potentially interfere with vitamin D absorption.

          -  Current participation in another research study that would increase risk to subject,
             in the opinion of the investigators.

          -  Patients currently taking more than 2000 IU of Vitamin D.
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
Condition: Bladder Cancer; Transitional Cell Bladder Cancer; Urethra Cancer; Ureter Cancer; Renal Pelvis Cancer
MeSH terms: Urinary Bladder Neoplasms; Ureteral Neoplasms; Pelvic Neoplasms; Urethral Neoplasms
Intervention: AZD4877
Intervention description: Intravenous (IV)25mg/weekly
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anti-mitotic; Eg5 Inhibitor; Kinesin Spindle Protein Inhibitor; Urothelial Cancer; Bladder Cancer; Renal Pelvis Cancer; Urethra Cancer; Ureter Cancer; Recurrent; Advanced; Stage IV

Summary:

      The purpose of this Phase II study is to determine if AZD4877, an experimental drug that is a
      novel anti-mitotic agent (Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor
      cell division leading to tumor growth), can reduce tumor sizes in patients with bladder
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed urothelial cancer (cancer of the bladder, renal pelvis, ureter, or urethra).

          -  Tumor, Node, Metastasis (TNM) Stage IV urothelial cancer that can not be helped by
             curative surgery and/or curative radiotherapy

          -  Must have had a maximum of 2 prior chemotherapeutic regimens, one for unremovable
             and/or metastasized disease, and the other in the adjuvant or neo-adjuvant setting.

          -  Ambulatory and capable of all selfcare more than 50% of waking hours

        Exclusion Criteria:

          -  Prior treatment with investigational or standard anti-cancer agents, including
             radiotherapy, within 4 weeks prior to first dose of study medication; 6 weeks if prior
             systemic mitomycin, nitrosourea, or suramin.

          -  Inadequate bone marrow reserve

          -  Inadequate liver function in the presence of liver metastases

          -  Impaired renal function
Herpes Simplex Type 1 Suppression in Hepatitis C
Condition: Chronic Hepatitis C Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Valacyclovir; Placebo
Intervention description: Valacyclovir 500 mg po bid; Placebo tablet twice daily
Intervention MeSH terms: Valacyclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic hepatitis C infection

Summary:

      The purpose of this study is to examine the effects of valacyclovir in patients who have
      chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies
      to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold
      sores or fever blisters, also known as herpes labialis, but most persons do not have any
      symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug
      administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic
      hepatitis C infection.

      The study will take 16 weeks. Participants will be assigned to take either the study drug,
      valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and
      patients will not know which medication they are receiving. Study visits will occur every two
      weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V.
      Sonny Montgomery VA Medical Center in Jackson, Mississippi.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C infection with a detectable HCV RNA in the serum on two occasions,
             6 months apart

          -  Focus HSV-2 IgG negative and Focus HSV-1 IgG positive, using manufacturer's cut-offs

        Exclusion Criteria:

          -  Antiherpes or immunomodulatory therapy during the past 30 days,

          -  HIV or chronic hepatitis B infection,

          -  Decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy,
             jaundice/icterus),

          -  Creatinine clearance <50 ml/min.,

          -  Female subject who is pregnant or nursing,

          -  Gastrointestinal disorder which might result in malabsorption of valacyclovir,

          -  History of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic
             uremic syndrome,

          -  Allergy to valacyclovir or related drug.
Study Evaluating Vabicaserin in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: vabicaserin; risperidone; placebo
Intervention description: This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
Intervention MeSH terms: Risperidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary purpose of this protocol is to establish the efficacy, safety, and tolerability
      of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy, men and women, aged 18 to 65.

          -  Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of
             schizophrenia established greater than 1 year.

          -  Ability to remain hospitalized for the duration of the screening period and for 4
             weeks of double-blind treatment.

        Exclusion Criteria:

          -  Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR
             criteria).

          -  Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria),
             including alcohol (except for nicotine), within 3 months before baseline (day -1).

          -  Subjects taking high or chronic doses of benzodiazepine at the screening evaluation
             who, in the investigator's judgment, would be likely to have severe withdrawal
             symptoms upon discontinuation.
Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Recurrence
Intervention: Electrochemotherapy
Intervention description: Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz. Drug used is Bleomycin.
Intervention MeSH terms: Bleomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Recurrence

Summary:

      By applying short electric pulses to cells, the cell membranes can become permeabilised
      (electroporation). This can be used augment the effect of chemotherapy, by providing direct
      access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several
      hundred fold, enabling once-only treatment. We wish to offer electrochemotherapy to breast
      cancer patients suffering from chest wall recurrences that are ulcerated or painful and where
      other treatments have failed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18

          -  Histological proven cancer of the breast.

          -  Progressive and/or metastatic disease.

          -  No further standard treatment for the patient available or the patient does not wish
             to receive the offered standard treatment.

          -  If Endocrine therapy: Progression in cutaneous lesions.

          -  If treatment with trastuzumab (Herceptin)can continue this treatment if there is no
             regression in cutaneous lesions.

          -  At least 2 weeks since last chemotherapy, patients treated with Navelbine
             (Vinorelbine), Capecitabin (Xeloda) or weekly Paclitaxel (Taxol)can continue this
             treatment if there is no regression in cutaneous metastases.

          -  Malignant cutaneous or subcutaneous lesion to be treated ≥ 3 cm.

          -  WHO performance ≤ 2.

          -  Life expectancy of at least 3 months.

          -  Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is allowed.

          -  Sexual active men and women must use safe anticonceptive during and up to 6 month
             after last treatment.

          -  Written informed consent must be obtained according to the local Ethics committee
             requirements.

        Exclusion Criteria:

          -  Acute lung infection

          -  Previous bleomycin treatment exceeding 200.000 Units/m2.

          -  Known hypersensitivity to any of the components of the treatment.

          -  Known hypersensitivity to any of the components used in the planned anesthesia.

          -  Pregnant or lactating women. In fertile women this is ensured by measuring HCG in
             blood.

          -  Treatment with granulocyte colony stimulating factor (G-CSF) or other cytokines.
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
Condition: Hypercholesterolemia; Statin-Associated Myopathy
MeSH terms: Hypercholesterolemia
Intervention: Red Yeast Rice; Pravastatin; Lifestyle modification program
Intervention description: Four 600mg capsules twice daily for 12 weeks; One 20mg capsule twice daily for 12 weeks; Weekly sessions each lasting 3 1/2 hours for 12 weeks
Intervention MeSH terms: Pravastatin; Red yeast rice
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Statin related myalgia; Hyperlipidemia; Red yeast rice; Cardiovascular Diseases; Nutritional and Metabolic Diseases

Summary:

      This study will examine the effect of red yeast rice extract compared to pravastatin on
      muscle related complaints in individuals with high cholesterol who have previously been
      unable to tolerate statin medications due to muscle pain. The study will determine whether
      red yeast is associated with a lower level of muscle related complaints compared to
      pravastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject reports stopping at least one statin drug due to complaints of muscle pain or
             weakness which his/her physician thinks was attributable to the drug.

          -  Subject has never taken pravastatin.

          -  Subject willing to remain off the dietary supplements CoQ10, L-carnitine, fish oil,
             policosanol, and guggulipid, garlic, and phytosterols in margarines (e.g. Benecol,
             Promise activ), milk or cereal products, for one month prior to the trial and for the
             duration of the trial.

        Exclusion Criteria:

          -  A history of muscle damage (CK>1000 IU) on statin therapy.

          -  A history of generalized chronic pain such as fibromyalgia, or generalized arthritis.

          -  Any active cardiac problem including chest pain, angina, heart attack, bypass surgery,
             angioplasty/stent or unstable angina/acute coronary syndrome within the past 6 months.

          -  Taking other lipid lowering drugs including: ezetimibe, gemfibrozil, niacin, fibrates
             or bile acid sequestrants.

          -  Triglyceride level more than 400 mg/dl.

          -  Taking weight loss medication including orlistat, sibutramine, diethylpropion,
             phendimetrazine, phentermine.

          -  Taking pain medication or systemic steroids on a chronic basis.
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
Condition: Candidiasis, Invasive
MeSH terms: Candidiasis; Candidiasis, Invasive
Intervention: Caspofungin; Amphotericin B Deoxycholate
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Caspofungin; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Maximum age: 3 Months
Healthy volunteers: No

Summary:

      The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared
      with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and
      infants. The primary hypothesis to be tested in the study is that caspofungin will be
      superior to amphotericin B deoxycholate with regard to the proportion of participants with
      fungal-free survival at the 2-week post-therapy follow-up visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Culture-confirmed invasive Candida infection

        Exclusion Criteria:

          -  Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial
             skin surfaces

          -  Positive culture for Candida only from sputum, broncho-alveolar lavage, catheter tip,
             or previously placed indwelling non-vascular catheters or drains

          -  Prosthetic device as the suspected site of Candida infection

          -  Active co-infection with a non-Candida fungal organism

          -  Received >48 hours of systemic antifungal treatment since the positive Candida index
             culture was collected as therapy for the present episode of invasive candidiasis

          -  Failed prior systemic antifungal therapy for the present episode of invasive
             candidiasis

          -  Diagnosis of acute hepatitis or cirrhosis

          -  Scheduled or anticipated to receive rifampin or other systemic antifungal therapy
             while on study therapy

          -  History (including participant's mother) of allergy, hypersensitivity, or any serious
             reaction to caspofungin or other member of the echinocandin class, or to amphotericin
             B deoxycholate or other member of the polyene class

          -  Severe congenital disorder known to lower immune response
CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: rituximab [MabThera/Rituxan]; fludarabine; cyclophosphamide
Intervention description: Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8; Every 4 weeks, 6 cycles; Every 4 weeks, 3 cycles
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of intense combination treatment including
      MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients
      with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  B-cell CLL

          -  No previous chemotherapy, radiotherapy, or immunotherapy

        Exclusion Criteria:

          -  Reduced organ function, or bone marrow dysfunction not due to CLL

          -  Patients with a history of other malignancies within 2 years prior to study entry,
             except for adequately treated cancer in situ of the cervix, or basal or squamous cell
             skin cancer

          -  Patients with a history of severe cardiac disease.