bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Intervention: Nesiritide; Nitroglycerin
Intervention description: Bolus 2 mcg/kg followed by 0.01 mcg/kg/min; 5-10 mcg/min titrating per protocol based on blood pressure
Intervention MeSH terms: Natriuretic Peptide, Brain; Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Natriuretic peptides; BNP; Heart Failure; Nitoglycerin; Biomarkers

Summary:

      The purpose of this study is to determine whether Nesiritide is more effective than
      nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity
      when proper infusion duration is administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age.

          -  Subject must be able to understand the potential risks and benefits associated with
             the study.

          -  Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment.

          -  Clinical symptoms of dyspnea and laboratory admission BNP levels > 500 pg/mL.

          -  Neither pregnant or breastfeeding at the time of enrollment.

          -  Authorization of patient's enrollment by patient's medical provider.

        Exclusion Criteria:

          -  <18 years of age

          -  Denies written informed consent

          -  Pregnant or lactating.

          -  Baseline systolic BP < 90 mmHg or cardiogenic shock

          -  No symptoms of congestion or admission BNP < 500 pg/mL

          -  Known allergy to E.coli-derived products, or any history of anaphylactic reactions to
             nesiritide.

          -  Receiving dialysis at the time of enrollment.

          -  Serum creatinine > 2.5 mg/dL at the time of enrollment.
Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)
Condition: Bleeding
MeSH terms: Hemorrhage
Intervention: FloSeal Matrix
Intervention description: 10 ml of FloSeal Matrix will be applied to the endoscopic wound bed.
Intervention MeSH terms: Hemostatics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Endoscopic; saphenous; vein; harvest

Summary:

      This is a prospective, randomized trial to see in patients undergoing coronary artery bypass
      grafting and endoscopically-harvested greater saphenous vein, if using FloSeal Matrix in the
      endoscopically-harvested saphenous vein wound bed decreases bleeding and complications.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sign a consent form that has been approved by the Institutional Review Board.

          2. Be at least 18 years of age.

          3. Scheduled to undergo coronary artery bypass grafting with EVH.

          4. Be able to return to Duke University Medical Center for post-operative visit.

        Exclusion Criteria:

          1. Be participating concurrently in another clinical trial that involves an
             investigational drug or device that would interfere with this study.

          2. Reported allergy to FloSeal Matrix™
PRET: Patients Prone to Recurrence After Endovascular Treatment
Condition: Intracranial Aneurysm; Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Intracranial Aneurysm; Aneurysm; Hemorrhage; Recurrence
Intervention: endovascular coil embolization
Intervention description: standard endovascular coil embolization with or without adjunct techniques
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 447.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: large aneurysm; recurrence; hydrocoil

Summary:

      The PRET study aims at comparing two types of coils used in the endovascular treatment of
      intracranial aneurysms. The first type made of platinum has been used for more than 15 years.
      The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that
      expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET
      study is that the newer hydrocoil will be more effective and yet as safe as the older
      platinum coil.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients presenting at least one aneurysm 'prone to recurrence after endovascular
             treatment' (PRET), defined for the sake of this study as:

               -  PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension
                  ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms);
                  for ruptured lesions, patients should be in WFNS grade I, II or III.

               -  PRET-2: an Aneurysm presenting a major recurrence after previous coiling; and
                  judged by the neurovascular team to require elective treatment.

          -  The anatomy of the lesion is such that endovascular treatment is possible with both
             types of coils (not necessarily certain or probable)

          -  The endovascular physician is content to use either type of coils (platinum or
             hydrogel-coated coils) but no other type of coils

          -  Patient is 18 or older

          -  Life expectancy is more than 2 years

        Exclusion Criteria:

          -  Presence of other aneurysms requiring treatment during the same session

          -  Patients with associated cerebral arteriovenous malformations

          -  When parent vessel occlusion, without simultaneous endosaccular coiling of the
             aneurysm, is the primary intent of the procedure

          -  Any absolute contraindication to endovascular treatment, angiography, or anaesthesia
             such as severe allergies to contrast or medications
Plegridy Satisfaction Study in Participants
Condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: peginterferon beta-1a
Intervention description: 125 mcg administered subcutaneously (SC) every 2 weeks.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the
      satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with
      injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction
      Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are
      to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants'
      satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants'
      adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN
      beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on
      participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on
      participants' injection-system satisfaction; Evaluate the relationship between participants'
      satisfaction and adherence; Evaluate the relationship between participants' satisfaction and
      social-demographic factors (age, sex, employment working, level of education, etc) and
      clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate
      the treatment safety and tolerability.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects diagnosed with Relapsing Remitting MS according to 2010 McDonald criteria.

          -  Subjects with EDSS score between 0.0 and 5.0 at baseline.

        Key Exclusion Criteria:

          -  Pregnancy or breast-feeding.

          -  Have any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary
             of Product Characteristics.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons
Condition: HSV Infection; HIV Infection
MeSH terms: Infections; Communicable Diseases
Intervention: acyclovir; valacyclovir
Intervention description: acyclovir 400 mg orally, twice daily for 12 weeks; valacyclovir 1.5 g orally, twice daily, for 12 weeks
Intervention MeSH terms: Valacyclovir; Acyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HSV; HIV

Summary:

      The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or
      acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with
      HIV-1 and HSV-2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 seropositive

          -  Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy
             during the study period

          -  CD4 cell count >250 cell/µL

          -  Not otherwise eligible for antiretroviral therapy according to Uganda national
             guidelines

          -  Detectable HIV-1 plasma viral load

          -  HSV-2 seropositive

          -  Not intending to move out of the area for the duration of study participation.

          -  Able to participate in the study at the Partners in Prevention site in Thika, Kenya

        Exclusion Criteria:

          -  Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.

          -  Planned use of acyclovir, valacyclovir, or famciclovir

          -  Use of ganciclovir, foscarnet, or cidofovir

          -  Known medical history of seizures

          -  Serum creatinine >1.5 mg/dL

          -  AST or ALT >3 times upper limit of normal

          -  Hematocrit <30 %

          -  Absolute neutrophil count <1000

          -  Platelet count <75,000

          -  History of thrombotic microangiopathy

          -  Any other condition which, in the opinion of the principal investigator, may
             compromise the ability to follow study procedures and complete the study

          -  Participation in another HIV therapeutics trial

          -  For women, pregnancy as confirmed by a urine pregnancy test
Impact of LDL-cholesterol Lowering on Platelet Activation
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Evolocumab
Intervention description: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
Intervention MeSH terms: Evolocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperlipidemia, Hypercholesterolemia, atherothrombosis

Summary:

      The primary goal is to assess the impact of Evolocumab therapy on platelet function of
      familial hypercholesterolemia (FH) patients in a randomized, double blind study. Evolocumab
      is a humanized monoclonal antibody that targets circulating PCSK9, increases hepatic LDL
      receptor, decreases plasma LDL cholesterol and reduces risk of cardiovascular events.
      Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally
      tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel problems,
      who need additional lowering of LDL cholesterol.

      The secondary goal is to determine if platelet activation or the response to Evolocumab
      therapy is modified by rs3184504 polymorphism. The investigators believe that these
      investigations will complement ongoing studies to demonstrate that Evolocumab reduces
      athero-thrombotic risk and aid the decision-making as to whether Evolocumab can reduce the
      atherothrombotic risk in acute coronary syndrome (ACS) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have a clinical diagnosis of familial hypercholesterolemia (FH)

          -  Subjects who are referred to Dr. Ginsberg's Lipid Practice for treatment with PCSK9
             inhibitor

          -  Subjects with LDL cholesterol levels >100 mg/dl on baseline treatment with statins
             and/or ezetimibe

        Exclusion Criteria:

          -  Children under 18 years of age
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Ribavirin; Ribavirin; peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]
Intervention description: 1000/1200mg po daily for 72 weeks; 1000/1200mg po daily for 48 weeks; 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks; 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.; 180 micrograms sc weekly for 72 weeks; 180 micrograms sc weekly for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 948.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 4 arm study is designed for patients with CHC who have not responded to peginterferon
      alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening
      the duration of treatment, as well as including an initial 12-week period of high-dose
      PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS
      (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment
      is 1-2 years and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  CHC infection;

          -  liver biopsy (in <24 calendar months of first dose), with results consistent with CHC
             infection;

          -  use of 2 forms of contraception during study and 6 months after the study in both men
             and women;

          -  Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin
             combination therapy given for >=12 weeks.

        Exclusion Criteria:

          -  women who are pregnant or breastfeeding;

          -  male partners of women who are pregnant;

          -  conditions associated with decompensated liver disease;

          -  other forms of liver disease, including liver cancer;

          -  human immunodeficiency virus infection.
Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder; Suicidal Ideation; Nightmares
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Suicidal Ideation
Intervention: Prazosin; Placebo
Intervention MeSH terms: Prazosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are
      already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine
      Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators
      hypothesize that patients receiving prazosin will have a greater reduction in suicidal
      ideation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PTSD

          -  Frequent nightmares

          -  Suicidality

        Exclusion Criteria:

          -  Schizophrenia

          -  Bipolar

          -  Substance abuse
Foot and Ankle Clinic Application for Liposomal Related Anesthetic
Condition: Ankle Arthrodesis; Hindfoot Arthrodesis; Tibitalocalceal Arthrodesis
Intervention: Exparel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to review the use of surgeon applied liposomal release
      anesthetic (Exparel) for post operative analgesia.

      Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post
      operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by
      the use of this modality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis,
             hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular
             arthrodesis

          -  Patients over the age of 18

          -  The subject is psychosocially, mentally, and physically able to understand and comply
             with the requirements of the study

        Exclusion Criteria:

          -  < 18 years of age

          -  Patients with a history of infection

          -  Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the
             arms or legs due to damaged nerves

          -  Patients having surgery on both feet at the same time

          -  Patients having any other different type of foot and ankle surgery
Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Intervention: Bisoprolol
Intervention description: Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.
Intervention MeSH terms: Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Bisoprolol; Chronic Heart failure

Summary:

      At present, there is some clinical data for different functional response to beta-blockers
      associated with beta-adrenergic receptor polymorphisms. But there has been no data reported,
      about the incidence of beta-adrenergic receptor polymorphism and association with
      beta-adrenergic receptor polymorphism and response to beta-blocker therapy in Korean heart
      failure (HF) subjects. This single-arm, open-label, multicentric study is designed with the
      purpose of analyzing the association between genetic polymorphism of beta-adrenergic receptor
      and the effects of beta-blocker (bisoprolol) in Korean HF subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years of age and <80 years of age

          -  Chronic heart failure subjects with stable clinical condition

          -  New York Heart Association (NYHA) functional classification II-III

          -  Left ventricular ejection fraction (LVEF) ≤45%

        Exclusion Criteria:

          -  NYHA functional classification IV

          -  Acute myocardial infarction, Unstable Angina Pectoris, Coronary artery bypass graft,
             Percutaneous coronary intervention (PCI), Valve surgery in the preceding 3 months

          -  Hypersensitivity to bisoprolol or any of the Concor excipients

          -  Subjects with over mild valvular stenosis and severe(Grade III/IV) pulmonary
             insufficiency

          -  Systolic Blood Pressure <90 millimeters of mercury (mmHg) at screening

          -  Resting Heart Rate <55 beats per minute (bpm) confirmed by electrocardiogram (ECG) at
             screening

          -  Subjects who are taking concomitant drug which can have drug-drug interaction (DDI)
             with bisoprolol

          -  Woman of childbearing age without effective contraception measures, or who are
             pregnant or lactating
Treatment of Insomnia in Migraineurs
Condition: Insomnia; Migraine
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: eszopiclone; placebo
Intervention description: 3 mg tablet every night at bedtime; 1 tablet every night at bedtime
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; migraine; eszopiclone; insomnia in migraineurs

Summary:

      It is hypothesized that treating insomnia in migraineurs, many of whom also have tension
      headaches, prolongs total sleep time to the extent that it decreases overall headache
      frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly
      affecting daytime functioning, which is hypothesized to improve as well with prolonged total
      sleep time.
    

Eligibility criteria:

        Inclusion criteria:

          1. Men and women, 18 to 64 years of age (inclusive) with International Headache Society
             (IHS)-II migraine with/without aura and Diagnostic and Statistical Manual (DSM)-IV
             primary insomnia (sleep onset/sleep maintenance).

          2. Migraine frequency is 4-12 times per month, with a maximum of 20 days with headache
             per month, for 1 month or longer prior to screening.

          3. A usual, estimated total sleep time of 6½ hours per night or less, for 1 month or
             longer prior to screening, due to problems falling asleep, waking up during the night,
             or waking up early.

        Exclusion criteria:

          1. Abortive migraine treatment with schedule II-III opioids.

          2. Use of caffeine-containing medications, prescription and non-prescription, not
             exceeding 10 days per month.

          3. Preventive migraine treatment with tricyclics or anticonvulsants.

          4. Treatment of insomnia with non-prescription medications, such as diphenhydramine,
             melatonin, or valerian, and prescription medications, such as hypnotics, barbiturates,
             benzodiazepines, sedating antihistamines, antidepressants, and antipsychotics.