bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
Condition: Liver Transplantation
Intervention: tacrolimus modified release (MR); tacrolimus
Intervention description: Oral; Oral
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pharmacokinetics; Therapy; Immunosuppression; Drugs, Investigational; Adult

Summary:

      A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable
      liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression
      regimen to a modified release tacrolimus based immunosuppression regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is currently receiving Prograf ® based immunosuppressive therapy for liver
             transplantation.

          -  Patient has stable whole blood trough level concentrations of Prograf® and is
             clinically stable

        Exclusion Criteria:

          -  Patient has previously received an organ transplant other than a liver

          -  Patient is currently receiving sirolimus immunosuppression therapy.
PF-04191834 Single Dose Bronchodilatory Study In Asthma.
Condition: Asthma
MeSH terms: Asthma
Intervention: PF-04191834; PF-04191834; PF-04191834; zileuton; Placebo
Intervention description: 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.; 100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.; 2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose; 1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.; 2 x placebo tablets + placebo oral dispersion, single dose.
Intervention MeSH terms: Zileuton
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Bronchodilator

Summary:

      Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in
      patients with asthma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistent mild/moderate asthma for at least 6 months.

          -  Reduced lung function

          -  Reversible airway obstruction

        Exclusion Criteria:

          -  Pregnant/nursing females.

          -  Liver function tests greater than upper limit of normal (ULN)
Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
Condition: Endocarditis; Bacteremia
MeSH terms: Bacteremia; Endocarditis, Bacterial; Endocarditis
Intervention: Dalbavancin; Standard of Care
Intervention description: Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.; Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Intervention MeSH terms: Dalbavancin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the
      completion of therapy in patients with complicated bacteremia or infective endocarditis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of complicated bacteremia or infective endocarditis

          -  Gram-positive bacteremia at screening with methicillin-susceptible Staphylococcus
             aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) or Streptococci

          -  Treatment with standard of care antibiotics for 72 hours (h) - 10 days

          -  Defervescence for at least 24h and clearance of bacteremia from screening pathogen.

        Exclusion Criteria:

          -  Embolic events

          -  History of prosthetic valve surgery, cardiac device or prosthetic joint

          -  Left-sided endocarditis due to Staphylococcus aureus (S. aureus)

          -  Large mobile vegetations (>10 mm) on mitral valves

          -  Perivalvular abscess

          -  Uncomplicated bacteremia due to S. aureus

          -  Gram-negative bacteria or fungi in blood cultures

          -  Heart failure associated with infective endocarditis [Left Ventricular Ejection
             Fraction (LVEF) <40%]

          -  Intravascular material or removable infection source not intended to be removed within
             4 days postrandomization

          -  Planned valve replacement surgery within 3 days of randomization

          -  Refractory shock, significant hepatic insufficiency or severe leukopenia [Absolute
             Neutrophil Count (ANC) < 500 cells/mm^3]

          -  Known osteomyelitis

          -  Hypersensitivity to dalbavancin or other drugs in glycopeptide class

          -  Infection with enterococci, coagulase-negative staphylococci, or with organism not
             susceptible to dalbavancin or vancomycin

          -  Immunosuppression/immune deficiency

          -  Concomitant systemic antibacterial therapy for gram-positive infection other than that
             allowed in protocol

          -  Pregnant or nursing females.
Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer
Condition: Head and Neck Cancer; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms
Intervention: Cisplatin; Standard Fractionation Radiotherapy; Panitumumab
Intervention description: Administered intravenously (IV; in a vein); 70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions); Administered intravenously
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; panitumumab

Summary:

      The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for
      patients with locally advanced squamous cell carcinoma of the head and neck but additional
      improvements to treatment regimens are needed. The study is investigating if the addition of
      a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding
      unmanageable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral
             cavity, oropharynx, hypopharynx or larynx

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (you must be
             well enough to receive chemoradiation therapy)

          -  You must be at least 18 years of age

          -  Your test results must show that your kidneys, liver and blood cells are working
             adequately and that, if you are female, you are not pregnant

          -  You must have measurable disease

        Exclusion Criteria:

          -  Cancer of the nasopharynx, sinus, salivary gland or skin

          -  History of another cancer (other than head and neck) unless treated with curative
             intent and with no evidence of disease for more than 3 years, with the exception of
             non-melanoma skin cancer or in situ cervical cancer

          -  Previous treatment with anti-endothelial growth factor receptor (EGFr) antibody
             therapy or EGFr inhibitors

          -  Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal
             sampling or biopsy) or radiotherapy

          -  Clinically significant cardiovascular disease (including myocardial infarction,
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
             arrhythmia) within one year before you join the study

          -  Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation)
             resulting in hospitalization within 6 months of study screening

          -  History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary
             fibrosis)

          -  Major surgery within 28 days of screening
A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Bevacizumab; Carboplatin; Gemcitabine
Intervention description: 15 mg/kg iv every 3 weeks; to an AUC = 2, on days 1 and 8 of each 3-week cycle; 1000 mg/m2 iv on days 1 and 8 of each 3-week cycle
Intervention MeSH terms: Bevacizumab; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter study will assess the efficacy and safety of bevacizumab in combination with
      gemcitabine and cisplatin as first line treatment in participants with triple negative
      metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg
      intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an
      area under curve [AUC]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study
      treatment is until disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants, >/= 18 years of age

          -  Metastatic breast cancer

          -  Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2
             (HER2)-negative disease

          -  Treatment-naïve for metastatic breast cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Adequate hematological, renal and liver function

          -  Patients should have received Anthracyclines and Taxanes in the adjuvant setting

          -  Women of childbearing potential must agree to use adequate contraception (per
             institutional standard of care) during treatment and until 6 months after the last
             administration of investigational products

        Exclusion Criteria:

          -  Prior first line treatment for metastatic breast cancer

          -  Central nervous system (CNS) metastasis

          -  Uncontrolled hypertension (> 170/95 mmHg)

          -  Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline

          -  Other malignancy within the last 5 years, except for adequately treated carcinoma in
             situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited
             basal cell skin cancer.

          -  Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants
             having received gemcitabine or carboplatin as part of adjuvant therapy are eligible,
             if recurrence was first documented >6 months after the last exposure to the drug(s)

          -  Requirement of chronic use of immunosuppressive agents

          -  HIV, hepatitis B or hepatitis C infection
Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Condition: Kidney Transplantation
Intervention: Cyclosporine; CP-690,550; CP-690,550
Intervention description: Standard of care; CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12; CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12
Intervention MeSH terms: Cyclosporine; Cyclosporins; Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 338.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Immunosuppression; JAK3 inhibitor; kidney transplantation.

Summary:

      A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune
      system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this
      research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant
      patients for 12 months. Patients will be assigned to one of three treatment groups after
      receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing
      regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be
      a standard-of-care control arm. Patients will continue to take the assigned study medication
      for 12 months as well as other standard transplant medications such as prednisone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of a first-time kidney transplant

          -  Between the ages of 18 and 70 years, inclusive

        Exclusion Criteria:

          -  Recipient of any non-kidney transplant
A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Eteplirsen
Intervention description: Eteplirsen IV infusion once weekly.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: DMD; Duchenne; Eteplirsen; Dystrophy; Dystrophin; Exon Skipping; Exon 51; Ambulatory; Pediatric

Summary:

      The purpose of this extension study is to evaluate the ongoing safety and tolerability of
      additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in
      male participants with DMD who have successfully completed the 96-week eteplirsen Study
      4658-102.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant successfully completes 96 weeks of treatment in Study 4658-102.

        Exclusion Criteria:

          -  Participant has a prior or ongoing medical condition that, in the Investigator's
             opinion, could adversely affect the safety of the participant, or make it unlikely
             that the course of treatment or follow-up would be completed, or impair the assessment
             of study results.

        Other inclusion/exclusion criteria apply.
Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
Condition: Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Sarcoma; Thromboembolism; Vaginal Cancer; Vulvar Cancer
MeSH terms: Sarcoma; Uterine Cervical Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Thromboembolism
Intervention: fondaparinux sodium
Intervention description: Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: thromboembolism; cervical cancer; endometrial cancer; ovarian epithelial cancer; ovarian germ cell tumor; borderline ovarian surface epithelial-stromal tumor; ovarian sarcoma; ovarian stromal cancer; uterine sarcoma; vaginal cancer; vulvar cancer; fallopian tube cancer

Summary:

      RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are
      undergoing surgery for gynecologic cancer.

      PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood
      clots in patients undergoing surgery for gynecologic cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  Scheduled to undergo major, open abdominal-pelvic surgery for known or presumed
             gynecologic malignancy

          -  Age 18 years or older at the time of signing the consent

          -  Gynecologic Oncology Group (GOG) performance status of ≤ 2

          -  Life expectancy of > 3 months

          -  Patient's weight must be ≥ 50 kg

          -  Adequate organ function within 28 days of study entry defined as:

               -  Hemoglobin ≥ 9.0 g/dL

               -  Platelet ≥ 100,000 x 109/L

               -  Blood urea nitrogen (BUN) ≤ 30 mg/dL

               -  Serum creatinine ≤ 1.5 mg/dL

          -  Not pregnant as determined by a negative urine or serum pregnancy test within 14 days
             of study enrollment

          -  Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

        Exclusion Criteria

          -  Current treatment with anticoagulants

          -  Thromboembolism within the previous 6 months

          -  Bleeding/blood disorders (e.g., thrombocytopenia), gastrointestinal bleeding (e.g.,
             active ulcers), history of stroke within past 3 years, or severe and currently
             uncontrolled high blood pressure

          -  Bacterial endocarditis

          -  Known hypersensitivity to fondaparinux sodium
Computer-Assisted Intervention for Smoking During Pregnancy
Condition: Smoking
Intervention: Computer-delivered brief intervention (5As); Contingency Management
Intervention description: After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.; Participants randomized by the computer into this condition will view a 20-minute music and tv videos after completing the brief assessment. The research assistant will then briefly describe the CM process, with a period for questions to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cigarette smoking; pregnancy; intervention; efficacy; Motivational Interviewing; Contingency Management

Summary:

      This study will develop:

        1. Develop the computer-based brief intervention and Contingency Management (CM)
           components, with repeated feedback from experts, prenatal clinic staff, and
           participants.

        2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women
           to Brief Intervention, CM, combined, or control conditions.

        3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported
           smoking, breath carbon monoxide (CO), and urinary cotinine levels.

        4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of
           post-partum follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 18 years

          -  pregnant, gestation <= 27 weeks

          -  cigarette smoking in the past week (even if only one puff)

        Exclusion Criteria:

          -  inability to speak or understand spoken English

          -  do not intend to carry pregnancy to full term

          -  frank psychosis
Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease
Condition: Graft Versus Host Disease; Ophthalmologic Complications
MeSH terms: Graft vs Host Disease
Intervention: graft versus host disease prophylaxis/therapy; questionnaire administration; optical coherence tomography
Intervention description: Wear bandage lenses; Ancillary studies; Optional ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Chronic graft-versus-host disease; eye

Summary:

      This phase II clinical trial studies how well bandage lenses work in treating patients with
      ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and
      damage caused by eye graft versus host disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic graft versus host disease (GVHD) as defined by the National
             Institutes of Health (NIH) criteria

          -  Ocular symptoms of NIH eye score 2 or greater:

               -  Score 2: Moderate dry eye symptoms partially affecting activities of daily living
                  (ADL) (requiring drops > 3 x per day or punctal plugs), WITHOUT vision impairment

               -  Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to
                  relieve pain) OR unable to work because of ocular symptoms OR loss of vision
                  caused by keratoconjunctivitis

          -  No new systemic immunosuppressive medications within 1 month prior to enrollment

          -  Subject has the ability to understand and willingness to sign a written informed
             consent document

        Exclusion Criteria:

          -  Absolute neutrophil count < 1000/ul

          -  Known hypersensitivity or allergy to contact lenses

          -  Evidence of any active viral, bacterial, or fungal infection in the eyes that is
             progressive despite appropriate treatment

          -  Treatment with contact lenses within the previous 3 months for any indication

          -  Active psychiatric disorder, substance abuse or any other reason that would interfere
             with compliance with the study protocol