bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event
Condition: Coronary Arteriosclerosis; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Syndrome
Intervention: prasugrel 10 mg; clopidogrel; prasugrel placebo; prasugrel 60 mg; clopidogrel placebo
Intervention description: 10 mg tablet taken orally; 75 mg tablet taken orally; oral, as blinding mechanism.; 60 mg (six 10-mg tablets) taken orally; oral, as blinding mechanism
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel
      75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of
      study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous
      coronary intervention (PCI) with placement of a stent, performed to treat acute coronary
      syndrome (ACS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with a recent history of an ACS event based on the disease diagnostic criteria
             between 30 and 330 days prior to enrollment, and who state that they are supposed to
             be taking daily aspirin and maintenance dose 75-mg clopidogrel.

          -  Are of a legal age (and at least 18 years of age but less than 75 years of age) and
             competent mental condition to provide written informed consent before entering the
             study.

        Exclusion Criteria:

          -  Left main coronary artery stent or left anterior descending (LAD) bifurcation stent.

          -  Have any form of coronary revascularization (percutaneous coronary intervention [PCI]
             or coronary artery bypass grafting [CABG]) planned to occur during the study (from
             signing consent through the final visit).

          -  Have undergone CABG or PCI within 30 days of entry into the study.

          -  Receiving or will receive oral anticoagulation or other antiplatelet therapy (other
             than aspirin and clopidogrel) that cannot be safely discontinued for the duration of
             the study.

          -  Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that
             cannot be discontinued or are anticipated to require daily treatment with NSAIDs
             during the study.

          -  Have any of the following: history of ischemic or hemorrhagic stroke intracranial
             neoplasm, arteriovenous malformation, or aneurysm history of transient ischemic attack
             (TIA), have a body weight less than 60 kilograms (kg).
S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: arsenic trioxide; gemtuzumab ozogamicin; mercaptopurine; methotrexate; tretinoin
Intervention MeSH terms: Methotrexate; Mercaptopurine; Arsenic Trioxide; Tretinoin; Gemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult acute promyelocytic leukemia (M3); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); untreated adult acute myeloid leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
      such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and
      help kill them or carry cancer-killing substances to them. Others interfere with the ability
      of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic
      leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination
      chemotherapy may be more effective in treating promyelocytic leukemia.

      PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination
      chemotherapy works in treating patients with previously untreated promyelocytic leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow
             examination

               -  APL-RARα-negative by RT-PCR are not eligible

          -  High-risk disease, defined as WBC > 100,000/mm^3

          -  Bone marrow specimens must be made available for cytogenetic studies

        PATIENT CHARACTERISTICS:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prolonged QTc > 0.47 sec

          -  No other malignancy within the past 5 years, except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or stage II cancer from which the patients is currently in complete remission

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic chemotherapy for acute leukemia

               -  At least 3 days since prior tretinoin (ATRA) allowed

          -  Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts
             allowed
Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection
Condition: Liver Fibrosis
MeSH terms: Infections; Hepatitis C; Virus Diseases; Hepatitis; Liver Cirrhosis; Fibrosis
Intervention: Warfarin
Intervention MeSH terms: Warfarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: The study employed a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2.
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 17 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatic fibrosis; anticoagulation; Coumarin; Warfarin; Chronic hepatitis C virus infection

Summary:

      Patients who have been treated for hepatitis C virus (HCV) infection who have failed to
      respond to anti-viral treatment are often concerned about their ongoing liver disease and are
      therefore looking for alternative treatments which might prevent fibrosis progression. This
      view is endorsed by patient representative groups (including Charles Gore at the HepC Trust)
      who have welcomed this trial protocol.

      The study is a single centred, prospective, open labelled design. Practical as well as safety
      concerns dictated that the study could not be conducted in a blinded fashion, since patients
      taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1
      and Phase 2. Phase 1 (observation phase, 0 to 8 weeks) and Phase 2 (treatment phase with
      warfarin anticoagulation, 8 to 16 weeks). Study completed at end of Phase 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged >17 years (male and female)

          -  HCV infection PCR positive

          -  ALT > 40 iu/ml

          -  Ishak fibrosis score (within last 5 years) > 2, < 5

          -  Informed consent

          -  Failed antiviral therapy for HCV in last 5 years

        Exclusion Criteria:

          -  Patients requiring anticoagulation for existing clinical indications

          -  Active peptic ulcer disease

          -  Past history of haemorrhagic stroke

          -  Thrombocytopaenia (platelets count < 100 x 109 /L)

          -  Clinical evidence of portal hypertension

          -  Known cerebrovascular abnormalities;

          -  HIV antibody positive;

          -  Alcohol abuse (>40 unites/week)

          -  Menhorragia

          -  Pregnancy
Bethanechol for Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Bethanechol
Intervention description: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover.
Intervention MeSH terms: Bethanechol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary goals of this study are to ease the symptoms of patients with Eosinophilic
      Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those
      symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  Age 18-75

          -  Symptoms associated with EoE such as dysphagia, heartburn, vomiting, abdominal pain,
             food impaction

          -  Subject has signed informed consent for the administration of bethanechol that informs
             the patient of potential adverse events

          -  Clinically or pathologically proven EoE

        Exclusion Criteria:

          -  Known allergy to bethanechol

          -  Asthma

          -  Pregnant or breast-feeding women

          -  Severe neurological problems

          -  Severe diabetes

          -  Achalasia

          -  Known allergy to lidocaine or other local anesthetic

          -  Hypothyroidism

          -  Peptic ulcer

          -  Pronounced bradycardia or hypotension

          -  Vasomotor instability

          -  Coronary artery disease

          -  Epilepsy

          -  Parkinsonism

          -  Weakened gastrointestinal or bladder wall

          -  Mechanical obstruction of the gastrointestinal tract or bladder neck

          -  Urinary bladder surgery in the 6 months prior to the study

          -  Gastrointestinal resection and anastomosis

          -  Spastic gastrointestinal disturbances

          -  Acute inflammatory lesions of the gastrointestinal tract

          -  Peritonitis

          -  Marked vagotonia
Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients
Condition: Atrial Fibrillation; Lung Transplant; Complications
MeSH terms: Atrial Fibrillation
Intervention: Amiodarone with CoSeal; CO2 driver
Intervention description: CoSeal Surgical Sealant (Baxter Healthcare) consist of 2 formulations of synthetic polyethylene glycols, a dilute hydrogen chloride solution along with a sodium phosphate/sodium carbonate solution. These separate solutions are mixed at the time of application to form a hydrogel. Amiodarone hydrochloride powder (1mg/kg) will be mixed with CoSeal at the time of application to form an amiodarone containing hydrogel. The dosing of amiodarone is based on previous study using amiodarone hydrogel in post-operative coronary artery bypass patients [8]. This hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.; The amiodarone hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.
Intervention MeSH terms: Amiodarone
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: 18 Years
Healthy volunteers: No

Summary:

      This study will prospectively evaluate the use of an amiodarone releasing hydrogel applied to
      the pulmonary veins and atria at the time of lung transplantation. This study will include
      patients undergoing lung transplantation at Jewish Hospital, Louisville KY. The prospective
      group will be compared to historical controls from the same institution. Investigators will
      access medical records and database entries for those patients undergoing lung
      transplantation after January 1st 2005 in order to obtain matched controls for analysis.
      Informed consent will be obtained from the prospective cohort prior to patient enrollment.
      This pilot study will be used to obtain preliminary data in order to proceed with a larger
      randomized control trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject or legal representative has signed Informed Consent Form (ICF)

          -  Undergoing lung transplant at the Jewish Hospital

          -  Age ≥ 18 years

          -  Subjects willing and able to comply with the follow up requirements of the study

        Exclusion Criteria:

          -  Patients with previous history of atrial fibrillation.

          -  Patients with previously documented allergy or adverse reaction to amiodarone.

          -  Patients with previous ablation for atrial fibrillation

          -  Patients with an implantable pacemaker.
The Fibrin Patch Soft Tissue Study
Condition: Hemostasis
Intervention: Fibrin Pad; SURGICEL™
Intervention description: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).; Absorbable hemostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to
      SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft
      tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects >= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal,
             pelvic or thoracic (non-cardiac) surgical procedures

          -  Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified
             intraoperatively by the surgeon

          -  Subjects must be willing to participate in the study, and provide written informed
             consent

        Exclusion Criteria:

          -  Subjects with any intra-operative findings identified by the surgeon that may preclude
             conduct of the study procedure

          -  Subject with TBS within an actively infected field

          -  Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony
             confine

          -  Subjects with known intolerance to blood products or to one of the components of the
             study product

          -  Subjects unwilling to receive blood products

          -  Subjects with immunodeficiency diseases (including known HIV)

          -  Subjects who are known, current alcohol and / or drug abusers

          -  Subjects who have participated in another investigational drug or device research
             study within 30 days of enrollment

          -  Female subjects who are pregnant or nursing
JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: JKB-121: 5 mg twice daily; JKB-121: 10 mg twice daily; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily
      and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in
      patients with biopsy-proven nonalcoholic steatohepatitis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years

          2. Provision of written informed consent

          3. Biopsy-proven NASH within 12 months or at screening

          4. ALT > 40 U/L for women and > 60 U/L for men at screening and at least once in the
             previous 12 months.

          5. HBA1C of ≤ 9.0

        Exclusion Criteria:

          1. Any chronic liver disease other than NASH

          2. Cirrhosis, as assessed clinically or histologically

          3. Presence of vascular liver disease

          4. BMI ≤ 25 kg/m2

          5. Excessive alcohol use (> 20 g/day) within the past 2 years

          6. AST or ALT > 250 U/L.

          7. Type 1 diabetes mellitus

          8. Bariatric surgery in the past 5 years.

          9. Weight gain of > 5% in past 6 months or > 10% change in past 12 months.

         10. Contraindication to MRI

         11. Inadequate venous access

         12. HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or Hepatitis C
             virus (HCV) RNA positive.

         13. Receiving an elemental diet or parenteral nutrition

         14. Chronic pancreatitis or pancreatic insufficiency

         15. Any history of complications of cirrhosis

         16. Concurrent conditions:

               -  Inflammatory bowel disease

               -  Significant cardiac disease

               -  chronic infection or immune mediated disease

               -  Any malignant disease

               -  Prior solid organ transplant

               -  Any other concurrent condition which, in the opinion of the investigator, could
                  impact adversely on the subject participating or the interpretation of the study
                  data.

         17. Concurrent medications which may treat NASH

         18. HbA1C > 9.0%

         19. Pregnancy or breastfeeding.
Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma
Condition: Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Panobinostat with Rituximab
Intervention description: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
Intervention MeSH terms: Rituximab; Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DLBCL (Diffuse Large B Cell Lymphoma); Panobinostat; LBH589 (Panobinostat); LBH-589 (Panobinostat); HDAC inhibitor (Histone deacetylase inhibitor); DAC inhibitor (deacetylase inhibitor); deacetylase inhibitor; lymphoma

Summary:

      Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by
      blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory
      studies. However, it is not known if it will show the same activity in humans. Panobinostat
      has been given to participants with various types of cancers, including DLBCL, in previous
      research studies. In this study panobinostat will be given with the the antibody rituximab,
      which is FDA approved to be given with chemotherapy in DLBCL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed or refractory DLBCL

          -  More than 1 line of prior chemotherapy

        Exclusion Criteria:

          -  Currently receiving anticancer therapy or investigational agents

          -  Major surgery within last 4 weeks

          -  Known leptomeningeal or brain metastases

          -  Known HIV infection

          -  Uncontrolled fungal, bacterial, viral or other infection

          -  History of another malignancy (except for non-melanoma skin cancer or in situ cervical
             or breast cancer) unless disease free for at least 3 years

          -  Hepatitis B or C positive

          -  GI disease

          -  Pregnant or breastfeeding

          -  Prior treatment with an HDAC inhibitor including valproic acid
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Intervention: Active comparator: Modafinil + placebo; THN102 300/3; THN102 300/27
Intervention MeSH terms: Flecainide; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way
      cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102
      (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).
    

Eligibility criteria:

        Main inclusion Criteria:

          -  Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2
             (without cataplexy) according to the International Classification of Sleep Disorders
             (ICSD-3) criteria.

          -  Body mass index >18 kg/m2 and <35 kg/m2.

          -  Patients treated with modafinil at stable dosage for at least 2 months and still
             complaining of excessive daily somnolence (EDS) despite the treatment

          -  Epworth Sleepiness Scale (ESS) score should be ≥ 14/24 during the baseline period.

        Main exclusion Criteria:

          -  Patients with an untreated sleep apnea syndrome (respiratory disorder index > 30/h) or
             who have any other cause of daytime sleepiness as assessed on patient history.

          -  Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as
             Parkinson's disease, Alzheimer's disease, Huntington's Chorea, multiple sclerosis,
             moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical
             anxiety or depression, Beck Depression Inventory ≥ 21 or with suicidal risk (if item >
             0), or other problem that in the investigator's opinion would preclude the patient's
             participation and completion of this trial or comprise reliable representation of
             subjective symptoms.

          -  Contraindication to flecainide