bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: Vancomycin; Vancomycin; Metronidazole; Metronidazole; Vancomycin
Intervention description: Comparison of different doses of drug; Comparison of different doses of drug; Comparison of different doses of drug; Comparison of different doses of drug; Comparison of different drug doses
Intervention MeSH terms: Metronidazole; Vancomycin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and
      beneficial in the treatment of Primary Sclerosing Cholangitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PSC established by alkaline phosphatase >1.5 times and/or two fold
             elevation of liver transaminases (AST and/or ALT) for at least 6 months duration.

          -  Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction,
             beading, or narrowing consistent with PSC.

          -  Both genders.

          -  Age ≥ 18 years old and < than 75 years old.

          -  Patient's informed consent for study participation.

        Exclusion Criteria:

          -  Treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid,
             corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil,
             budesonide, pentoxifylline, tacrolimus, silymarin or prednisone in the preceding three
             months.

          -  Active drug or alcohol use.

          -  Prior history of allergic reactions to the antibiotics which will be used in the
             study.

          -  Any condition that, in the opinion of the investigator, would interfere with the
             patients' ability to complete the study safely or successfully.

          -  Evidence of decompensated liver disease such as recurrent variceal bleeding,
             refractory ascites or spontaneous hepatic encephalopathy.

          -  Anticipated need for transplantation in one year (Mayo survival model <80% one-year
             survival without transplant).

          -  Findings highly suggestive of liver disease of other etiology such as chronic
             alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's
             disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary
             cirrhosis or secondary sclerosing cholangitis.

          -  Pregnancy or current lactation. Subjects becoming pregnant during the study will be
             withdrawn.
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
Condition: Carcinoma, Non-Small-Cell Lung; Colorectal Cancer; Malignant Melanoma; Renal Cancer; Prostate Cancer
MeSH terms: Carcinoma; Prostatic Neoplasms; Colorectal Neoplasms; Melanoma; Neoplasms; Carcinoma, Non-Small-Cell Lung; Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: MDX-1106
Intervention description: patients will receive a single dose of MDX-1106 as a 60 minute infusion.
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: malignancies; cancer; non small cell lung cancer; lung cancer; colorectal cancer; adenocarcinoma; melanoma; malignant melanoma; renal cancer; renal carcinoma; carcinoma; prostate cancer; prostate adenocarcinoma; Recurrent or treatment refractory malignancies

Summary:

      To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when
      administered to patients with advanced non-small cell lung cancer, colorectal cancer,
      malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant
             melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma

          -  Prior treatment must have been completed at least 4 weeks prior to enrollment

          -  No untreated primary or metastatic brain or meningeal tumors

          -  ECOG PS 0 or 1

          -  Meet all screening laboratory values

        Exclusion Criteria:

          -  History of severe hypersensitivity reactions to other monoclonal antibodies

          -  Active autoimmune disease or a documented history of autoimmune disease

          -  Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody

          -  Active infection

          -  Concurrent medical condition requiring the use of immunosuppressive medications
Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function
Condition: Mild and Moderate Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: LCZ696
Intervention description: LCZ696 400 mg once daily
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Renal Impairment,; LCZ696

Summary:

      The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and
      its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety
      of LCZ696 in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male, and female subjects of non-child bearing potential,

          2. Subjects were to weigh at least 50 kg to participate in the study,

          3. and body mass index < 40 kg/m2

          4. Subjects were able to communicate well with the investigator, to understand and comply
             with the requirements of the study;

          5. Subjects were able to understand and sign the written informed consent;

        For renal insufficient subjects:

          1. stable renal disease without evidence of renal progressive

               -  mild renal function: calculated CrCl of 50-≤80 mL/min

               -  moderate renal function: calculated CrCl of 30-<50 mL/min

          2. Vital signs:

               -  oral body temperature between 35.0-37.8 °C

               -  systolic blood pressure, 95-180 mm Hg

               -  diastolic blood pressure, 60-110 mm Hg

               -  pulse rate, 54-95 bpm

        For healthy subjects only

          1. A serum creatinine with a calculated CrCl of >80 mL/min

          2. Vital signs:

               -  oral body temperature between 35.0-37.2 °C

               -  systolic blood pressure, 95-140 mm Hg

               -  diastolic blood pressure, 60-100 mm Hg

               -  pulse rate, 45-90 bpm

        Exclusion Criteria:

          1. Current use of ACE inhibitors, valsartan, and drugs that were known as CYP2C9
             substrates, potassium-sparing diuretics;

          2. Smokers;

          3. History of renal transplant at any time in the past and on immunosuppressant therapy;

          4. Dialysis patients;

          5. Medical history of clinically significant ECG abnormalities or a family history of a
             prolonged QT-interval syndrome;

          6. Any surgical or medical condition which may significantly alter the absorption,
             distribution, metabolism or excretion of any drug substance; Other protocol defined
             inclusion/exclusion criteria may apply
A Tasisulam and Midazolam Drug Interaction Study in Cancer Patients
Condition: Advanced Cancer
Intervention: Tasisulam; Midazolam
Intervention description: Patient specific dose, administered intravenously, on Day 1 of a 28-day cycle. Minimum of one (1) 28-day cycle. Patients may continue to receive tasisulam until disease progression or until discontinuation criteria are met.; 1.2 milligrams (mg), administered orally once prior to the initiation of tasisulam therapy and once on Day 8 after initiation of tasisulam therapy
Intervention MeSH terms: Midazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Tumors; Lymphoma

Summary:

      The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using
      midazolam as a sensitive and specific probe substrate of CYP3A.

      The study will also assess the safety and tolerability of tasisulam and midazolam given in
      combination and document any antitumor activity with tasisulam.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed solid malignancy or lymphoma that is
             advanced and/or metastatic disease which has not responded to standard therapy or for
             which no standard therapy exists.

          -  Have a performance status of less than or equal to 2 on the Eastern Cooperative
             Oncology Group (ECOG) scale

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at
             least 30 days (45 days for mitomycin-C or nitrosoureas) prior to study enrollment and
             recovered from the acute effects of therapy. Limited field radiotherapy is permitted
             (in consultation with the investigator)

          -  Have an estimated life expectancy, in the judgment of the investigator, of greater
             than or equal to 12 weeks

        Exclusion Criteria:

          -  Have received treatment within 30 days of the initial dose of study drug with an
             experimental agent for non-cancer indications that has not received regulatory
             approval for any indication

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not
             required). Patients with active brain metastasis are excluded

          -  Have current acute or chronic leukemia

          -  Patients who have clinically significant chronic obstructive pulmonary disease (COPD)
             or other respiratory diseases that may be at risk during periods of conscious sedation
             under midazolam

          -  Patients with a known history of obstructive sleep apnea, difficult intubation, or
             syndromes associated with airway abnormalities.
A Study to Investigate the Safety and Effect of the Study Drug (FE 204205) in Patients With Cirrhotic Portal Hypertension
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Intervention: FE 204205; Placebo
Intervention description: In Part 1 of the trial, each subject will receive increasing IV doses of FE 204205, given once daily as 2 hour infusion, on three consecutive days.
In Part 2 of the trial, each subject will receive a 2 hour IV infusion of the maximum tolerated dose of FE 204205 as defined in Part 1 of the trial.; In Part 2 of the trial, each subject will receive a 2 hour IV infusion of placebo.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to investigate safety, tolerability, pharmacodynamics (PD), and
      pharmacokinetics (PK) after intravenous (IV) administration of FE 204205 in patients with
      cirrhotic portal hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed evidence of cirrhosis

          -  From medical history anticipated hepatic venous pressure gradient greater than equal
             to (≥)12 mmHg

        Exclusion Criteria:

          -  Co-existing disease e.g. significant organ failure and decompensated cirrhosis

          -  Type 1 hepatorenal syndrome

          -  Acute-on-chronic liver failure

          -  Hepatic encephalopathy ≥grade 2

          -  Hepatocellular carcinoma

          -  History of underlying chronic heart disease

          -  Use of vasopressin or terlipressin within 7 days prior to dosing
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Betrixaban
Intervention description: 80 mg betrixaban qd for 8 days
Intervention MeSH terms: Betrixaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Betrixaban; Renal impairment; Healthy; Kidney dysfunction

Summary:

      The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and
      tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to
      healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to understand and sign the written informed consent.

          -  Subjects should have either normal renal function or have stable renal disease

        Exclusion Criteria:

          -  Subjects require dialysis

          -  Evidence of active bleeding or bleeding disorder

          -  Unstable or clinically significant other disorders such as respiratory, hepatic,
             metabolic, psychiatric or gastrointestinal disorder