bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Pemetrexed in Children With Recurrent Cancer
Condition: Osteosarcoma; Medulloblastoma; Sarcoma, Ewing's; Neuroblastoma (Measurable Disease); Neuroblastoma (Metaiodobenzylguanidine; Positive Evaluable); Rhabdomyosarcoma; Ependymoma; Non-brainstem High-grade Glioma
MeSH terms: Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Ependymoma; Medulloblastoma; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral
Intervention: pemetrexed
Intervention description: 1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Maximum age: 22 Years
Healthy volunteers: No

Summary:

      To determine the response rate of pemetrexed given every 21 days for the treatment of
      children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive
      neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma,
      medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma,
             rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma

          -  Measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance 0,1,2

          -  Adequate renal, liver and bone marrow function

          -  Patient's current disease state must be one with no known curative therapy or therapy
             proven to prolong survival with an acceptable quality of life

        Exclusion Criteria:

          -  Growth factors that support platelet or white cell number or function must not have
             been administered within the last 7 days prior to enrollment (14 days if Neulasta)

          -  Patients with central nervous system (CNS) tumors who have not been on a stable or
             decreasing dose of dexamethasone or other corticosteroid for 7 days prior to
             enrollment

          -  Patients with uncontrolled infection

          -  Patients who have received pemetrexed previously

          -  Patients with pleural effusions or ascites
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Condition: Postmenopausal Osteoporosis; Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: synthetic hPTH 1-34
Intervention description: Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34
Intervention MeSH terms: Parathyroid Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 46 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoporosis; Parathyroid hormone; Teriparatide; Bone formation; Bone resorption

Summary:

      Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone
      strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment
      increases bone formation less and less over time. This study will test whether increasing the
      daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies
      will test several potential reasons why PTH's effects on bone formation decline over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Three or more years after menopause

          -  Bone mineral density T-score < or = -2.0 by dual-energy x-ray absorptiometry (DXA) of
             vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of
             vertebral body trabeculae

        Exclusion Criteria:

          -  Cannot walk without assistance

          -  Significant heart, kidney, liver, or malignant disease

          -  Current alcohol abuse

          -  Major psychiatric disorders

          -  Other current or past disorders known to affect bone

          -  Use of medications known to affect bone for > 7 days in the past 12 months

          -  Use of bisphosphonates or fluoride

          -  Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests,
             or complete blood count

          -  Elevated calcium levels in 24-hour urine collection
A Study for Patients With Non-Squamous Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; Folic acid; Folic Acid; Vitamin B12; dexamethasone; dexamethasone
Intervention description: 500 mg/m^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles.; 350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed.; 350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed.; 1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.; 4 mg taken orally [or equivalent] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed.; 4 mg taken orally [or equivalent] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.
Intervention MeSH terms: Folic Acid; Vitamin B 12; Vitamin B Complex; Dexamethasone; Dexamethasone acetate; Pemetrexed; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given
      folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side
      effects associated with pemetrexed. The aim is whether it is possible to simplify the folic
      acid and steroid schedule without increasing toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) with locally
             advanced or metastatic disease (Stage IIIA, IIIB or IV)that is of non-squamous
             histology

          -  Patients must have failed only one prior chemotherapy regime and must be considered
             eligible for further chemotherapy following progression of their disease.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

          -  Adequate organ function

        Exclusion Criteria:

          -  Concurrent administration of any other anti-tumor therapy

          -  Other co-existing malignancies

          -  Pregnancy or breast feeding

          -  Serious concomitant disorders

          -  Inability or unwillingness to take folic acid or vitamin B12 supplementation
Selegiline for Smoking Cessation - 1
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Selegiline Transdermal Patch; Placebo; Smoking Cessation Counseling
Intervention description: Selegiline cm(2) via transdermal system; Matching placebo via transdermal system; Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Intervention MeSH terms: Selegiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is designed to examine the effects of Selegiline Transdermal System
      and behavioral intervention in smoking cessation as compared to behavioral intervention
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age

          -  Be in good general health

          -  Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for
             nicotine dependence

          -  Be currently smoking > 15 cigarettes/day, and have smoked cigarettes for the past 5
             years

          -  Subjects must be motivated to quite smoking

          -  If female and of child bearing potential, agrees to use birth control and subject

          -  Subject must be able to understand and provide written informed consent.

        Exclusion

        Criteria:

          -  Please contact site for more information
Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma
Condition: Recurrent Melanoma; Stage IV Skin Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Laboratory Biomarker Analysis; Pharmacological Study; Stereotactic Body Radiation Therapy
Intervention description: Given IV; Correlative studies; Correlative studies; Undergo SBRT
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in
      treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able
      to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal
      antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor
      cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of melanoma

          -  Previously treated or previously untreated stage IV melanoma by American Joint
             Committee on Cancer (AJCC) staging criteria

          -  Presence of an index lesion between 1 and 5 cm

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

          -  Signed informed consent document

          -  Adequate renal, hepatic, and hematologic indices for ipilimumab therapy

          -  Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold
             position for treatment)

        Exclusion Criteria:

          -  Prior systemic therapy within 14 days of study enrollment; patients must be adequately
             recovered from prior systemic therapy side effects as deemed by the treating
             investigator

          -  Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic
             sclerosis, active inflammatory bowel disease if bowel is within target field, etc)

          -  Presence of central nervous system metastasis (including active brain metastasis);
             active brain metastasis would be defined as untreated brain metastases; if the brain
             metastases have received prior treatment (usually either with surgery or radiation),
             they are no longer active

          -  Long-term use of systemic corticosteroids; patients with replacement steroids and not
             immunosuppressive steroids may enroll in the study

          -  Prior radiation therapy (RT) that precludes the delivery of SBRT
Use of Fenofibrate for Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Intervention: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
Intervention description: 160 mg per day for 1 year
Intervention MeSH terms: Fenofibrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PBC; Primary Biliary Cirrhosis; Fenofibrate; Triglide

Summary:

      This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with
      primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of PBC by serological (positive antimitochondrial antibodies)
             and/or histological evidence (diagnostic liver biopsy)

          -  Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year

          -  Persistent elevation of serum alkaline phosphatase ≥ 2 times the upper limit of normal
             on two separate measurements

          -  Female patients of childbearing age should have a pregnancy test done within -days of
             the beginning of this trial, and should agree to be on adequate contraception
             throughout the study period

          -  Signed informed consent after careful review of the information and study details by
             one of the investigators

        Exclusion Criteria

          -  Hypersensitivity to fenofibrate

          -  Prisoners and institutionalized subjects

          -  Pregnant or nursing women

          -  Anticipated need for liver transplantation in one year (estimated one year survival <
             80%) as determined by the Mayo risk score. The Mayo risk score takes into account the
             patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or
             absence of peripheral edema.

          -  Recipients of liver transplantation

          -  Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites

          -  Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic
             hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis,
             cholangiocarcinoma

          -  Acute or chronic renal failure

          -  Known history of cholecystitis with intact gallbladder

          -  Current use of statins, as the concomitant use of fibrates and statins would increase
             the risk of toxicity
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: TMC435; Ribavirin (R); PegIFNα-2a (P); Placebo
Intervention description: TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.; Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.; PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.; Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.
Intervention MeSH terms: Ribavirin; Simeprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 386.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; TMC435; Peginterferon alpha-2a; PegIFNalpha-2a; RBV; Ribavirin; Placebo

Summary:

      The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in
      combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the
      proportion of patients with sustained virologic response at Week 72 (patients with
      undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and
      at Week 72), compared to the control group receiving PegIFN and RBV in combination with
      TMC435-matched placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with documented chronic genotype-1 hepatitis C infection and with plasma HCV
             RNA of > 100,000 IU/mL at screening

          -  Patients that have not been treated before for HCV

          -  Patients that are of childbearing potential or have a partner of childbearing
             potential should agree to use 2 effective methods of contraception

        Exclusion Criteria:

          -  Patients with cirrhosis or evidence of hepatic decompensation

          -  Co-infection with the human immunodeficiency virus (HIV)

          -  Any contraindication to Pegasys or Copegus therapy

          -  History of, or any current medical condition which could impact the safety of the
             patient in the study
A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
Condition: Dementia With Lewy Bodies (DLB)
MeSH terms: Dementia; Lewy Body Disease
Intervention: E2020
Intervention description: Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Lewy Body Disease; Dementia; Clinical Trial; Phase II; E2020; donepezil hydrochloride

Summary:

      The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with
      Dementia with Lewy Bodies (DLB).
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the
             diagnostic criteria for DLB.

          2. Patients who have completed Phase II double-blind study (E2020-J081-431).

          3. Patients having caregivers who submit written consent for cooperative involvement in
             this study, can routinely stay with patients 3 days a week (at least 4 hours a day),
             provide patients' information necessary for this study, assist treatment compliance
             and escort their patients on required visits to study institution.

        Exclusion criteria:

          1. Patients with a complication of serious neuropsychiatric disease(s) such as stroke,
             brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental
             retardation, brain trauma with unconsciousness, and/or who underwent brain surgery
             causing unsolved deficiency.

          2. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or
             other diseases unable to secure the safety.

          3. Pregnant or lactating women, or women who are willing to become pregnant no later than
             1 month after the scheduled study completion.

          4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater
             than IV).

          5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than
             50 beats/min.
Gabapentin Treatment of Cannabis Dependence
Condition: Cannabis Dependence; Cannabis Withdrawal; Cognitive Deficits
MeSH terms: Marijuana Abuse; Cognition Disorders; Cognitive Dysfunction
Intervention: gabapentin 1200mg/day; Placebo; Manual-guided behavioral counseling
Intervention description: gabapentin 1200mg/day for 12 weeks; 1200mg/day of placebo for 12 weeks; Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cannabis Treatment; Cannabis Use; Cannabis Dependence; Executive Functioning; Cognitive Deficits

Summary:

      This is a clinical study to evaluate the efficacy of the medication gabapentin in treating
      persons with cannabis dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females from 18-65 years of age

          -  Meets DSM IV criteria for current cannabis dependence

          -  Seeking research-based outpatient treatment for cannabis dependence that involves
             daily medication

          -  Smoked MJ daily at least 25 days per month during the 90 days prior to randomization

          -  At least a 2-year history of regular MJ use

        Exclusion Criteria:

          -  Abstinent from cannabis more than 2 days at the time of randomization

          -  Active suicidal ideation

          -  Currently meets DSM IV criteria for abuse or dependence on other substances, or has
             urine drug screen positive for substances, other than cannabis or nicotine

          -  Significant medical disorders that will increase potential risk or interfere with
             study participation,

          -  Sexually active female participants with childbearing potential who are pregnant,
             nursing or refuse to use a reliable method of birth control

          -  Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine
             dependence,

          -  Inability to understand and/or comply with the provisions of the protocol and consent
             form

          -  Treatment with an investigational drug during the previous month

          -  Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or
             its ingredients

          -  Ongoing treatment with medications that may affect study outcomes