bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: LCZ696
Intervention description: LCZ696 50 mg/100 mg/200 mg bid
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 498.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart failure, reduced ejection fraction, LCZ696, titration, safety, tolerability

Summary:

      The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in
      heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching
      target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration
      regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular
             ejection fraction ≤ 35%; on beta blockers

        Exclusion Criteria:

          -  Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2;
             systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended
             target doses of angiotensin converting enzyme inhibitors or angiotensin receptor
             blockers

        Other protocol-defined inclusion/exclusion criteria may apply.
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
Condition: Pain; Needle Phobia
Intervention: EMLA Cream; Synera Patch
Intervention description: 60 minutes x1; 20 minutes x1
Intervention MeSH terms: Lidocaine; Tetracaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: EMLA; venipuncture; children; Synera patch; pediatric; Lidocaine/prilocaine

Summary:

      This study compares the efficacy of the Synera patch with Eutectic Mixture of Local
      Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children in outpatient clinics requiring venipuncture for medical care

          -  Ages 4-12 years old

          -  The ability to demonstrate proper understanding of the Wong-Baker FACES Pain Ranking
             Scale

          -  Parents of enrolled children need to be present during the procedure and be willing to
             rate their child's pain

        Exclusion Criteria:

          -  Damaged or inflamed skin at the designated application site

          -  Known sensitivity to components of Synera or EMLA (lidocaine, tetracaine, or local
             anesthetics of the amide or ester type, Para Aminobenzoic (PABA) derivatives)

          -  Contraindications to SYnera or EMLA use (Severe hepatic disease, history of
             drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)

          -  Use of analgesics during the past 24 hours
A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Metronidazole Actavis; Non-active Moisturizing Cream
Intervention description: Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.; Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.; Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Intervention MeSH terms: Metronidazole; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%)
      topical cream in the prevention and treatment of rash associated with Tarceva treatment, in
      participants with non-small cell lung cancer. The first cohort of participants enrolled in
      the study will be treated twice daily with metronidazole cream on the right side of the face
      and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily).
      The corresponding body parts on the left side will be treated according to local standard
      procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated
      participants will only receive twice daily treatment with metronidazole cream if and when
      they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The
      anticipated time on metronidazole treatment is less than (<) 3 months, and the target sample
      size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-small cell lung cancer

          -  eligible to start treatment with erlotinib

        Exclusion Criteria:

          -  hypersensitivity to metronidazole
High Dose Vitamin C in the Critically Ill Patient
Condition: Shock
MeSH terms: Critical Illness
Intervention: Ascorbic Acid; Ringers Lactate or Normal Saline
Intervention description: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams; Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypovolemic or septic

Summary:

      The purpose of this study is to determine the effectiveness of high doses of Vitamin C in
      critically ill patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Activation of the Mass Transfusion Protocol following surgery or trauma.

          -  Diagnosis of septic shock. Septic shock will be defined as sepsis induced hypotension
             (i.e. systolic blood pressure <90mmHg or drop of systolic blood pressure >40mmHg in
             the presence of infection) that does not respond to a 2 liter fluid bolus.

        Exclusion Criteria:

          -  Age less than 18 years.

          -  Pregnant women.

          -  Creatinine of greater than 2.2 g/dl at time of enrollment, history of chronic kidney
             or end stage renal disease, rise in creatinine > 1 g/dl within 24 hours prior to
             enrollment.

          -  Brain death diagnosed within 4 hours of presentation to the trauma bay or intensive
             care unit

          -  Patients with history of hemolytic blood disease, e.g. glucose-6-phosphate
             dehydrogenase deficiency, Sickle Cell Disease and Thalassemia.

          -  Patients in isolated cardiogenic shock.

          -  History of liver cirrhosis

          -  Transplant patients (liver, kidney, heart)
The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TCM-700C; Peginterferon alfa-2a; Ribavirin; Placebo
Intervention description: An add-on drug to conventional treatment of Hepatitis C; conventional treatment of Hepatitis C; conventional treatment of Hepatitis C; Placebo, without acting ingredient.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: add-on treatment; botanical drug; HCV genotype 1; TCM-700C; genotype I

Summary:

      The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on
      treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients
      with genotype 1 chronic hepatitis C infections. This will be demonstrated by a higher
      sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks
      after the termination of combinational drug treatment, compared with the placebo add-on.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV strain confirmed as genotype I;

          -  Elevated ALT (≥1.5 x upper limit of normal)during last 6 months

          -  Females of childbearing potential with a negative serum pregnancy test

          -  Subject must be willing to sign a written informed consent

          -  Subject must be willing and able to adhere to dose and visit schedule.

        Exclusion Criteria:

          -  Serum AFP levels > 400 ng/ml

          -  Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR
             system fibrosis score of 3-4, or hepatocellular carcinoma (HCC);

          -  Co-infection with hepatitis B virus (HBV);

          -  Anti-HIV positive;
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: FTY720; Placebo
Intervention description: Administered orally once daily for 6 months; Administered orally once daily for 6 months
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: FTY720,; MS

Summary:

      To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese
      patients with relapsing multiple sclerosis (MS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients aged 18-60

          -  Patients with a diagnosis of multiple sclerosis

        Exclusion Criteria:

          -  Patients with a history or presence of chronic disease of the immune system other than
             MS

          -  Patients with a history or presence of malignancy, pulmonary or heart disease, etc.

          -  Pregnant or nursing (lactating) women

        Other protocol-defined inclusion/exclusion criteria may apply
"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
Condition: Renal Transplant
Intervention: Campath-1H
Intervention MeSH terms: Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: prevent kidney rejection

Summary:

      The purpose of the study is to see if campath-1H can be used in first time renal transplant
      subjects to prevent rejection and reduce the overall amount of anti-rejection medications
      that patients take on a daily basis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary renal transplant (not HLA identical)

          -  ages 18-60 years

        Exclusion Criteria:

          -  recipient panel reactive antibody level >10%

          -  recipient of a DCD kidney

          -  no prior organ transplant

          -  no multi-organ transplant recipient

          -  no subject who is currently receiving systemic corticosteroids

          -  no pregnant or lactating subjects

          -  no history of Hepatitis B, C or HIV positivity

          -  no recipient of a kidney with cold ischemia time >36 hours
Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis; Psoriasis; Skin Diseases
MeSH terms: Psoriasis; Skin Diseases
Intervention: JTE-451 Tablets; Placebo Tablets
Intervention description: Active drug tablets containing JTE-451; Placebo tablets matching in appearance to the active drug tablets
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: Double-blind
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: JTE-451; Psoriasis; Plaque psoriasis; IMPACT-PS

Summary:

      Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects
      with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a history of moderate to severe plaque psoriasis for at least 6 months prior
             to Visit 1;

          -  Subjects with moderate to severe plaque psoriasis covering ≥10% body surface area
             (BSA), with a psoriasis area and severity index (PASI) ≥12 and static Physician's
             Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2

        Exclusion Criteria:

          -  History of discontinuation of biologic therapies (including marketed and
             investigational drugs) directly targeting Interleukin (IL)-17A, IL-17A/F, IL-17
             receptor A, IL-12/IL-23p40 or IL-23p19 due to lack of efficacy, according to the
             Investigator's judgment;

          -  Prior exposure to retinoid-related orphan receptor (ROR)-γ inhibitors;

          -  Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication-induced psoriasis or other skin conditions (e.g., clinically-significant
             eczema or severe acne) at Visit 1;

          -  History or presence of itch due to underlying conditions other than plaque psoriasis
             which cause or influence pruritus of the skin within 12 months prior to Visit 1.
Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer
Condition: Bladder Cancer; High Risk Superficial
MeSH terms: Urinary Bladder Neoplasms
Intervention: Bacillus Calmette-Guérin (BCG)
Intervention MeSH terms: BCG Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bacillus Calmette-Guérin (BCG); 14-174

Summary:

      This is a phase II study. This means that BCG therapy has already been found to be safe in
      humans. The investigators just want to see if using more treatments works better.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis,
             TaHG, or T1) that is pathologically confirmed by the Memorial Sloan Kettering
             Department of Pathology or a documented history of TaHG or T1 non-muscle invasive
             urothelial bladder tumors.

          -  18 years and older

          -  All visible papillary lesions must be macroscopically resected within 60 days of
             treatment initiation.

          -  Absence of urothelial carcinoma involving the upper urinary tract (documented by
             radiological imaging or biopsy) preferably within 12 months from the start of
             treatment. Should the imaging or biopsy be performed outside this window it will be up
             to the physicians discretion to re-scan/biopsy.

          -  Patients who have received a single dose of mitomycin C following staging TUR.

        Exclusion Criteria:

          -  Currently being treated or scheduled to have radiation treatment for bladder cancer
             during the study.

          -  Treatment with intravesical BCG or chemotherapy for a patient's current <T2 tumor
             during the 12 months prior to the current diagnosis.

          -  Currently being treated or scheduled to have treatment with any systemic or
             intravesical chemotherapeutic agent during the study.

          -  Currently being treated with or having been treated in the last 12 months with any
             investigational drug for high risk superficial bladder cancer.

          -  Previous muscle-invasive (i.e., stage T2 or higher) transitional cell carcinoma of the
             bladder.

          -  Currently being treated for metastatic transitional cell carcinoma.

          -  Scheduled to have surgery for bladder cancer during the study.

          -  Presence of clinically significant infections or congenital or acquired
             immunodeficiency.
Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma
Condition: Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Tumor, Recurrent
MeSH terms: Glioblastoma; Brain Neoplasms; Astrocytoma; Oligodendroglioma
Intervention: Temozolomide
Intervention description: 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Temozolomide; Brain Tumor, Recurrent; Chemotherapy

Summary:

      The purpose of this study is to evaluate the efficacy of temozolomide on a protracted
      schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive
      high grade glioma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient age >18 years old

          -  Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic
             oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)

          -  Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or
             adjuvant treatment approved in Magnetic Resonance imaging

          -  Karnofsky Performance Status scale >/=50 (due to brain pathology)

          -  Adequate hematological, renal and hepatic function

          -  Patients willing to participate in the study and signing the informed consent

        Exclusion Criteria:

          -  Karnofsky Performance Status scale <50

          -  Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility
             will be warned for appropriate contraception during the study

          -  Patients not suitable for follow-up
Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
Condition: Breast Cancer; Cancer Survivor; Hot Flashes; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Hot Flashes
Intervention: magnesium oxide; questionnaire administration; quality-of-life assessment
Intervention description: Given PO; Ancillary studies; Ancillary studies
Intervention MeSH terms: Magnesium Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer survivor; hot flashes; breast cancer; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.

      PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot
      flashes in menopausal women with cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Meets 1 of the following criteria:

               -  History of breast cancer (currently without malignant disease)

               -  No history of breast cancer but wishes to avoid estrogen due to a perceived
                  increased risk of breast cancer

          -  Must have bothersome hot flashes (defined by their occurrence of ≥ 14 times per week
             and of sufficient severity to make the patient desire therapeutic intervention) for ≥
             1 month before study entry

          -  Has undergone treatment for cancer (patients other than breast cancer survivors are
             eligible)

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Creatinine clearance ≥ 30 mL/min

          -  No hypersensitivity to magnesium oxide

          -  No medical or other condition(s) that, in the opinion of the
             investigator/sub-investigator, may compromise the objectives of the study

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 4 weeks since prior and no concurrent antineoplastic chemotherapy,
             androgens, estrogens, progestational agents, or gabapentin

          -  More than 28 days since prior and no other concurrent investigational drugs

          -  Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed provided patient has
             been on a constant dose for > 4 weeks AND is not expected to stop the medication
             during the study period