bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Vaniprevir 600 mg b.i.d.; Vaniprevir 300 mg b.i.d.; Pegylated interferon; Ribavirin
Intervention description: Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks; Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks; Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks; Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (<75 kg or ≥75 kg, respectively), for 48 weeks
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis C

Summary:

      This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated
      interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV)
      infection who did not achieve viral eradication while participating in a prior vaniprevir
      clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184;
      and MK-7009-029, NCT00954993).
    

Eligibility criteria:

        Inclusion criteria:

          -  Participant has participated in a prior vaniprevir clinical trial

          -  Participant agrees to use acceptable birth control method during treatment

        Exclusion criteria:

          -  More than one year has passed since the participant was determined to be eligible for
             enrollment in protocol 028

          -  Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due
             to a safety or tolerability issue

          -  Participant received any investigational therapy for HCV after participating in the
             prior study
A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: bevacizumab [Avastin]; capecitabine [Xeloda]; oxaliplatin
Intervention description: 5mg/kg iv on day 1 of each 2 week cycle.; 1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle; 85mg/m2 iv on day 1 of each 2 week cycle
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the resection rate of liver metastasis, time to disease
      progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin
      and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable
      liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle,
      oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5
      and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and
      the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, <=75 years of age;

          -  chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;

          -  >=1 measurable lesion;

          -  ECOG status 0-2.

        Exclusion Criteria:

          -  prior exposure to Avastin;

          -  clinical or radiological evidence of CNS metastases;

          -  uncontrolled hypertension, or clinically significant cardiovascular disease;

          -  ongoing treatment with aspirin (>325mg/day) or other medications known to predispose
             to gastrointestinal ulceration.
Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI
Condition: Spinal Cord Injury; Sleep Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Spinal Cord Injuries
Intervention: Buspirone; Trazodone; Placebo
Intervention description: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.; 100 mg dose before bed-time; One placebo pill before bed-time
Intervention MeSH terms: Buspirone; Trazodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at the effect of exciting using drugs to target a
      specific pathway in the body, that relies on a natural chemical the body produces called
      'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the
      study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone
      (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of
      time followed by two weeks without drugs (washout period). The drugs will not be taken all at
      the same time, but each will be taken separately for two weeks followed by a night study to
      look at the effect the medication/placebo pill has on the way the body responds during sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with SCI (>6months after spinal cord injury) at the T6 level/above

        Exclusion Criteria:

          -  Pregnant and lactating females

          -  Heart failure, vascular disease, or stroke

          -  Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic
             kidney disease

          -  BMI >38 kg/m2

          -  Mechanical ventilation dependence

          -  The following medications are not allowed (potential interaction with buspirone or
             inhibition of the CYP3A4 system):

               -  cimetidine

               -  ketoconazole

               -  ritonavir

               -  itraconazole

               -  erythromycin

               -  diltiazem

               -  verapamil

               -  Monoamine oxidase (MAO) inhibitors [such as Marplan, Nardil, Parmate, Emsam]

               -  Other prohibited concomitant medications include haloperidol, trazodone, or
                  triazolam
A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Lyophilized S95014
Intervention description: Each patient was administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement.
In total, 9 infusions of lyophilized S95014 were administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients received other backbone chemotherapy agents as per ALL-MB 2015.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia; Phase II; Oncology / Haematology; Continued treatment; Pegaspargase; Lyophilized pegaspargase; Roll-over study / extension study

Summary:

      The purpose of this study is to provide treatment with lyophilized S95014 in pediatric
      patients with ALL who completed the CL2-95014-002 study during the induction phase and who
      are clinically benefitting from S95014 without major toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who completed the CL2-95014-002 study

          -  Patient currently receiving clinical benefit from previous treatment with S95014 as
             per investigator's judgment

          -  Signed informed consent and assent, when appropriate

          -  Highly effective contraception method

        Non-inclusion Criteria:

          -  Unlikely to cooperate in the study

          -  Pregnant and lactating women

          -  Participant already enrolled in the study (informed consent signed)

          -  Prior surgery or bone marrow transplant related to the studied disease

          -  History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs

          -  Psychiatric illness/social situation that would limit compliance with study
             requirements

          -  Group "E" and "T-HR" patients according to ALL-MB 2015 protocol classification

          -  Major safety issue due to previous S95014 administration (e.g. non recovery of safety
             parameters, serious hypersensitivity, serious pancreatitis, serious haemorrhage,
             serious thromboembolic event)

          -  Significant laboratory abnormality or uncontrolled intercurrent illness (e.g.
             life-threatening acute tumor lysis syndrome, symptomatic congestive heart failure,
             cardiac arrhythmia, severe or uncontrolled active acute infection) likely to
             jeopardize the patients' safety or to interfere with the conduct of the study, in the
             investigator's opinion
The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
Condition: Bladder Pain Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Somatoform Disorders
Intervention: Gefapixant; Placebo
Intervention description: 50 or 300 mg tablets for a total daily dose of 50, 100, 150, 200, 250 or 300 mg BID, orally with food for 4 weeks; Dose matched placebo tablets, BID, orally, with food for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 107.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of gefapixant (AF-219/MK-7264) in female
      participants with moderate to severe pain associated with interstitial cystitis/bladder pain
      syndrome (IC/BPS) after 4 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women

          -  Women of child bearing potential must not be pregnant during the study and must use
             two forms of birth control

          -  Clinical evidence of Interstitial Cystitis /Bladder Pain Syndrome (IC/BPS)

          -  Have provided written informed consent

        Exclusion Criteria:

          -  History of diseases that can be confused for IC/BPS

          -  Unable to void spontaneously

          -  Immunosuppressant, intravesicular, nerve stimulator or opioid treatment for certain
             periods prior to start of the study

          -  Changes to doses of Elmiron®, antidepressant, alpha-adrenergic antagonist, H1
             antagonist, or anti-muscarinic treatment within a certain period prior to the start of
             the study
A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-06882961
Intervention description: 4 matching placebo tablets taken twice a day (BID); Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 412.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, double-blind, placebo controlled, parallel group study is being
      conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of
      multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM)
      inadequately controlled on metformin and/or diet and exercise. In addition, the study is
      intended to enable selection of efficacious doses for future clinical development of
      PF-06882961.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM who are treated with metformin and/or diet and exercise

          -  HbA1c greater than or equal to 7% and less than or equal to 10.5%

          -  Total body weight >50 kg (110 lb) with BMI 24.5 to 45.4 kg/m^2

        Exclusion Criteria:

          -  Any condition possibly affecting drug absorption

          -  Diagnosis of Type 1 diabetes

          -  History of myocardial infarction, unstable angina, arterial revascularization, stroke,
             heart failure, or transient ischemic attack within 6 months of screening

          -  Any malignancy not considered cured

          -  Personal or family history of MTC or MEN2, or participants with suspected MTC

          -  Acute pancreatitis or history of chronic pancreatitis

          -  Symptomatic gallbladder disease

          -  Known medical history of active proliferative retinopathy and/or macular edema

          -  Known medical history of active liver disease, including chronic active hepatitis B or
             C, or primary biliary cirrhosis

          -  Known history of HIV

          -  Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or
             equal to 100 mmHg (diastolic)

          -  Clinically relevant ECG abnormalities

          -  Positive urine drug test
Anakinra to Prevent Adverse Post-infarction Remodeling (2)
Condition: Acute Myocardial Infarction; Heart Failure
MeSH terms: Heart Failure; Myocardial Infarction; Infarction
Intervention: Anakinra; Placebo
Intervention description: Anakinra 100 mg s.c. daily for 14 days; 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 110 Years
Healthy volunteers: No
Keywords: Acute myocardial infarction; Heart Failure; Cardiac Remodeling

Summary:

      Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many
      patients die early during the course, and those who survive are at risk for dying late from
      adverse cardiac remodeling and heart failure.

      The initial ischemic damage to the myocardium initiates an intense inflammatory response in
      promoting further cardiac dysfunction and heart failure. The investigators propose that an
      antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory
      response and lead to a more favorable cardiac remodeling process.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with STEMI will be asked to enroll according to the following inclusion
             criteria:

               -  age > 18 years,

               -  acute (<12 h) onset of chest pain associated with ST segment elevation (>2 mm) in
                  2 or more anatomically contiguous leads at ECG,

               -  and successful primary percutaneous coronary intervention.

        Exclusion criteria:

          -  inability to give informed consent,

          -  late presentation (>12 h),

          -  unsuccessful revascularization procedure,

          -  hemodynamic instability including hypotension,

          -  prior Q-wave AMI,

          -  end-stage congestive heart failure (American Heart Association [AHA]/American College
             of Cardiology [ACC] class C-D, New York Heart Association IV), severe left ventricular
             dysfunction (EF<20%),

          -  severe valvular heart disease,

          -  pregnancy, dye allergy or contraindications to cardiac angiography and/or magnetic
             resonance imaging, coagulopathy (INR>1.5 or platelet count<50000/mm3),

          -  recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs),

          -  chronic inflammatory disease (including but not limited to rheumatoid arthritis,
             systemic lupus erythematosus), and malignancy or any comorbidity limiting survival or
             conditions predicting inability to complete the study.
A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Parsaclisib
Intervention description: Parsaclisib once daily for 8 weeks followed by once weekly
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diffuse large B-cell lymphoma; relapsed; refractory; non-Hodgkin lymphoma; phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor; Bruton's tyrosine kinase (BTK)

Summary:

      The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects
      with relapsed or refractory diffuse large B-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible 19 years and older in South Korea

          -  Relapsed or refractory DLBCL, which has been histologically documented, defined as
             having received at least 2 but no more than 5 prior treatment regimens and ineligible
             for high-dose chemotherapy supported by autologous stem cell transplant.

          -  Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable
             extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or
             magnetic resonance imaging (MRI).

          -  Subjects must be willing to undergo an incisional or excisional lymph node biopsy of
             accessible adenopathy or provide the most recent, available archived tumor biopsy.

          -  Eastern Cooperative Oncology Group performance status 0 to 2.

        Exclusion Criteria:

          -  Primary mediastinal (thymic) large B-cell lymphoma.

          -  Known brain or central nervous system metastases or history of uncontrolled seizures.

          -  Allogeneic stem cell transplant within the last 6 months, or active graft versus host
             disease following allogeneic transplant, or autologous stem cell transplant within the
             last 3 months.

          -  Use or expected use during the study of any prohibited medications, including potent
             cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever
             is longer) before the first dose of study drug.

          -  Prior treatment with the following:

               -  Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ
                  inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg,
                  ibrutinib).

               -  Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a
                  pan PI3K inhibitor.
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: MEDI6012; Placebo SC; Placebo IV
Intervention description: Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1.; Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.; Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Coronary Artery Disease; CAD

Summary:

      This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune
      unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and
      immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women 40 - 75 years old

          -  History of Stable CAD

          -  Currently receiving statin as standard of care

        Exclusion Criteria:

          -  Severe angina pectoris symptoms

          -  High-risk coronary or carotid artery disease that will likely require surgical or
             percutaneous intervention during the study period

          -  Hospitalization for heart failure within 12 months prior to screening

          -  Uncontrolled Hypertension

          -  Within 6 months prior to screening, a history of ACS or hospitalization for heart
             failure

          -  Clinically significant abnormalities in rhythm, conduction or morphology of ECG

          -  Subjects with transplanted heart, left ventricular assist device, implanted pacemaker,
             implantable cardioverter defibrillator, or cardiac resynchronization therapy

          -  Untreated life-threatening ventricular arrhythmias

          -  History, within 12 months prior to screening, of myocarditis or restrictive
             pericarditis, or hemodynamically significant valvular hear disease or aortic disease

          -  Undergone major surgery with in 3 months prior to screening or has planned major
             surgery during the study period