bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: capecitabine (Xeloda®); docetaxel (Taxotere®)
Intervention description: 825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.; 75 mg/m^2 intravenous on day 1 of each 3 week cycle
Intervention MeSH terms: Docetaxel; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 470.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to
      that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced
      or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients
      were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on
      days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on
      day 1 of each 3 week cycle. The anticipated time on study treatment was until disease
      progression and the target sample size was 440 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women >=18 years of age;

          -  >=1 target lesion;

          -  locally advanced or metastatic breast cancer;

          -  demonstrated resistance to anthracycline;

          -  >=2 regimens of chemotherapy for advanced/metastatic disease.

        Exclusion Criteria:

          -  previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral
             fluoropyrimidines;

          -  previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: LDV/SOF; SOF; RBV; Peg-IFN; GS-9669; VEL
Intervention description: Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily; SOF 400 mg tablet administered orally once daily; Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly; GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily; Velpatasvir (VEL) tablet(s) administered orally once daily
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 359.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of
      combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic
      hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic genotype 1, 2, 3, or 6 HCV infection

          -  Cirrhosis determination; a liver biopsy may be required

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
             skin cancers)

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment or compliance with the protocol
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Condition: Non Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
Intervention: Tropifexor; Licogliflozin; Placebo
Intervention description: 100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day; 30mg tablet of licoglifozin taken orally every day; licogliflozin placebo + tropifexor placebo
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NASH; Non alcoholic steatohepatitis; Tropifexor; LJN452; Licogliflozin; LIK066; Placebo

Summary:

      Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and
      tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy,
      compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis
      (NASH) and liver fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy
        obtained no more than 6 months before randomization as demonstrated by the following:

          1. NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation
             and ballooning and

          2. Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at
             screening

          -  HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or
             sulfonylureas

          -  Clinical evidence of liver impairment as defined by the presence of any of the
             following abnormalities:

               -  Platelet count < LLN (see Central laboratory manual).

               -  Serum albumin < LLN (see Central laboratory manual).

               -  International Normalized Ratio (INR) > ULN (see Central laboratory manual).

               -  ALT or AST > 5× ULN (confirmed by 2 values during screening).

               -  Total bilirubin > ULN (see Central laboratory manual) (confirmed by 2 values
                  during screening), including Gilbert's syndrome.

               -  Alkaline phosphatase > 300 IU/L (confirmed by 2 values during screening).

               -  History of esophageal varices, ascites or hepatic encephalopathy

               -  Splenomegaly

               -  MELD score >12
TEAM: Testosterone Supplementation and Exercise in Elderly Men
Condition: Healthy
Intervention: LowT; Resistance Training; Placebo; HighT
Intervention description: Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.; Weight training 45-60 minutes 3 times per week; 2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.; High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: Male
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: andropause; hypogonadism; AndroGel; exercise; PRT; Testosterone; T supplementation

Summary:

      The purpose of this study is to evaluate the effects of testosterone supplementation
      (AndroGel) on body composition, strength, endurance, cognition, and function in older men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy, untrained men 60 years or older with low-normal testosterone levels
             (200-350ng/dL)

          -  Must reside in the Denver metro area

        Exclusion Criteria:

          -  Prostate/breast cancer

          -  Unable to exercise safely

          -  severe obesity (>34 body mass index [BMI])

          -  Polycythemia

          -  Diabetes

          -  Use of drugs that could affect T levels

          -  Cognitive dysfunction (MMSE less than 24)

          -  PSA above the age-adjusted normal level or AUA greater than 19

          -  Unable to pass stress test due to active CAD
Safety and Efficacy of L-NAME and Midodrine to Increase MAP
Condition: Orthostatic Hypotension; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Hypotension, Orthostatic; Hypotension
Intervention: L-NAME; Midodrine; Placebo
Intervention description: A non-selective inhibitor of nitric oxide synthase and placebo. It has been used experimentally to induce hypertension.; To treat low blood pressure.; A pill with an inactive substance that looks like the study drug.
Intervention MeSH terms: Midodrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Spinal Cord Injury; Orthostatic Hypotension; Blood Pressure; Midodrine Hydrochloride; L-NAME

Summary:

      After a spinal cord injury the brain is no longer completely in control of the body below the
      level of injury. This affects many organs and systems in the body, we are interested in
      understanding how a spinal cord injury affects blood pressure and blood flow to the brain. We
      are going to study blood pressure while the person is seated in a wheelchair before and after
      we give the subject medications which should increase blood pressure in a laboratory setting
      and over the course of a normal day in persons with spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

        Spinal Cord Injured Subjects:

          -  chronic spinal cord injury (1 year post injury) with a seated MAP of 65mmHg (almost
             all individuals with tetraplegia demonstrate this)

          -  Male or female with an age of 18 - 65 years

        Control Subjects:

          -  Male or female with an age of 18 - 65 years

        Exclusion Criteria:

        Spinal Cord Injured Subjects:

          -  acute illness

          -  cardiovascular disease

          -  renal disease

          -  medications that affect the cardiovascular system

        Control Subjects:

          -  acute illness

          -  cardiovascular disease

          -  renal disease

          -  medications that affect the cardiovascular system
Harm Reduction With Pharmacotherapy (HaRP)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: XR-NTX; Placebo; HRC
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: Masking of the double-blind portion of the study was quadruple until after all data had been collected, when they were unblinded.
Enrollment: 308.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: harm reduction, naltrexone, alcohol use disorder, homelessness

Summary:

      The goal of this study is to test the efficacy of extended-release naltrexone and harm
      reduction counseling in reducing alcohol-related harm among homeless people with alcohol
      dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  being a registered client at one of the named partnering sites

          -  being at least 21 years of age (for legal reasons)

          -  agreeing to use an adequate form of birth control (if female and in childbearing
             years) fulfilling criteria for current alcohol dependence according to DSM-IV-TR
             criteria as determined by the SCID-I/P

        Exclusion Criteria:

          -  refusal or inability to consent to participation in research

          -  constituting a risk to safety and security of other clients or staff

          -  known sensitivity or allergy to naltrexone/XR-NTX

          -  current treatment with naltrexone/XR-NTX

          -  being pregnant or nursing

          -  suicide attempts within the past year

          -  renal insufficiency/serum creatinine level > 1.5

          -  current opioid dependence according to the DSM-IV-TR criteria

          -  liver transaminases (AST, ALT) > 5 times the upper limit of normal (ULN)

          -  clinical diagnosis of decompensated liver disease
Treatment of Oral Warts in HIV+ Patients
Condition: Papillomatosis; HIV Infections
MeSH terms: Papilloma
Intervention: Interferon-alpha; placebo
Intervention description: 500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks; 200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks
Intervention MeSH terms: Interferons; Interferon-alpha
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: human immunodeficiency virus; human papilloma virus; warts, oral; papillomatosis; treatment experienced

Summary:

      This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a
      treatment of oral warts in HIV-positive adults.

      The hypothesis of this study is that interferon-alpha will be safe and that a higher
      percentage of subjects given interferon-alpha will experience a complete or nearly complete
      remission of their oral warts compared to subjects given placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have tested positive for HIV.

          -  Must have two or more warts inside the mouth.

          -  Must be receiving a standard course of anti-retroviral therapy (HAART).

        Exclusion Criteria:

          -  Must not be receiving oral or injected steroids.

          -  Must not be taking other drugs for treatment of oral warts.

          -  Must not have other active HIV-related opportunistic infections.
Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
Condition: Mixed Mullerian Tumors of the Uterus
MeSH terms: Mixed Tumor, Mullerian; Carcinosarcoma; Uterine Neoplasms
Intervention: Gemcitabine; Oxaliplatin; Radiation
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oxaliplatin; gemcitabine; MMMT

Summary:

      The purpose of this research study is to determine the feasibility and safety of giving the
      combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether
      or not this drug combined with radiation therapy works in treating women with Mullerian
      tumors of the uterus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Surgically staged and histologically confirmed diagnosis of MMMT

          -  18 years of age or older

          -  ECOG Performance Score of 0-2

          -  Adequate bone marrow function

          -  Adequate renal function

          -  Adequate hepatic function

          -  Patients must be recovered from both the acute and late effects of any prior surgery

        Exclusion Criteria:

          -  Patients with an active infection

          -  Patients with CNS metastases

          -  History of prior malignancy within the past 5 years except curatively treated basal
             cell carcinoma of the skin, or cervical intraepithelial neoplasia

          -  Known hypersensitivity to any of the components of oxaliplatin or gemcitabine

          -  Prior radiation to the pelvis

          -  Patients who are receiving concurrent investigational therapy or who have received
             investigational therapy within 30 days

          -  Peripheral neuropathy greater or equal to Grade 2

          -  Stage IV visceral disease (lung and liver metastases at presentation)

          -  Any other medical condition, including mental illness or substance abuse, deemed by
             the investigator to be likely to interfere with a patient's ability to sign informed
             consent

          -  Known HIV or Hepatitis B or C (active, previously treated or both)

          -  Pregnant or breast feeding
A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550 + methotrexate; Placebo + Methotrexate
Intervention description: CP-690,550 dose is 10 mg twice daily, oral tablets, for 4 weeks Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week; Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week
Intervention MeSH terms: Methotrexate; Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid
      arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have a diagnosis of rheumatoid arthritis based on the American College of
             Rheumatology Association

          -  The subject has active disease at both Screening and Baseline, as defined:

               -  ≥4 joints tender or painful on motion, AND

               -  ≥4 joints swollen;

          -  The subject must have at least one knee, one elbow, one wrist or two
             metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver
             technique

        Exclusion Criteria:

          -  No arthroscopy should have been performed in the past 3 months in the same joint that
             is to be biopsied in this study.

          -  No intra-articular steroids should have been injected in the joint to be biopsied in
             this study in the previous 3 months.

          -  Subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels <
             9.0 gm/dL or hematocrit < 30 % at screening visit or within the 3 months prior to
             baseline synovial biopsy.

          -  An absolute white blood cell (WBC) count of < 3.0 x 109/L (<3000/mm3) or absolute
             neutrophil count of <1.2 X 109/L (<1200/mm3) at screening visit or within the 3 months
             prior to baseline synovial biopsy.

          -  Thrombocytopenia, as defined by a platelet count <100 x 109/L (< 100,000/mm3) at
             screening visit or within the 3 months prior to baseline synovial biopsy.

          -  Estimated GFR less than 40 ml/min based on Cockcroft Gault calculation .
Ahmed Glaucoma Valve Surgery With Mitomycin-C
Condition: Glaucoma; Primary Open Angle Glaucoma; Secondary Glaucoma; Neovascular Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular
Intervention: Mitomycin-C; Balanced Salt Solution; Ahmed Glaucoma Valve Implant
Intervention description: Intraoperative and postoperative injections of mitomycin-c/Mitosol; Intraoperative and postoperative injections of BSS; Implantation of Ahmed Valve in study eye
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed
      valve implantation. Approximately 100 patients will be enrolled, with half receiving the
      Mitomycin-C treatment and the other half receiving placebo treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular
             pressure (IOP) greater than or equal to 18 mm Hg.

          -  Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.

          -  For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye
             to be implanted is enrolled.

        Exclusion Criteria:

          -  Unwilling or unable to give consent, unwilling to accept randomization, or unable to
             return for scheduled protocol visits.

          -  Pregnant or nursing women.

          -  Previous cyclodestruction or glaucoma drainage device (GDD) surgery.

          -  Patients with nanophthalmos.

          -  Patients with Sturge-Weber syndrome or other conditions associated with elevated
             episcleral venous pressure.

          -  No light perception vision.

          -  VA <20/200 in non-study eye.

          -  Need for glaucoma surgery combined with other ocular procedures (i.e. cataract
             extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for
             additional ocular surgery.

          -  Previous scleral buckling procedure or silicone oil present.

          -  Uveitic glaucoma.