bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacogenomic Evaluation of Antihypertensive Responses 2
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Metoprolol; Chlorthalidone
Intervention description: Metoprolol 50 mg twice daily titrated to 100 mg twice daily
Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily.; Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily
Intervention MeSH terms: Metoprolol; Chlorthalidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 839.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hypertension; antihypertensive drug; pharmacogenetics; genetics; blood pressure; glucose

Summary:

      There are many medications available for the treatment of high blood pressure (hypertension),
      but finding the right one for a specific patient can be challenging. In fact, it is estimated
      that less than 50% of people with hypertension have their blood pressure under control. The
      hypothesis is that genetic differences between individuals influence their response to
      antihypertensive medications. This study is aimed at determining the genetic factors that may
      influence a person's response to either a beta-blocker or a thiazide diuretic. The hope is
      that through this research, the investigators may someday be able to use an individual's
      genetic information to guide the selection of their blood pressure medicine, leading to
      better control of blood pressure, and less need for the current trial and error process.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An average seated home diastolic blood pressure (DBP) > 85 mmHg and < 110 mmHg and
             home systolic blood pressure (SBP) < 180 mmHg.

          -  Subjects must also have an average seated (> 5 minutes) clinic DBP between 90 mmHg and
             110 mmHg and SBP < 180 mmHg

        Exclusion Criteria:

          -  Secondary forms of hypertension (HTN) (including sleep apnea)

          -  Isolated systolic HTN

          -  Other diseases requiring treatment with BP lowering medications

          -  Heart rate < 55 beats/min (for metoprolol only)

          -  Known cardiovascular disease (including history of angina pectoris, heart failure,
             presence of a cardiac pacemaker, history of myocardial infarction or revascularization
             procedure, or cerebrovascular disease, including stroke and TIA)

          -  Diabetes mellitus (Type 1 or 2)

          -  Renal insufficiency (serum creatinine > 1.5 in men or 1.4 in women)

          -  Primary renal disease

          -  Pregnancy or lactation

          -  Liver enzymes > 2.5 upper limits of normal

          -  Current treatment with NSAIDS, cyclooxygenase-2 (COX2) inhibitors, oral contraceptives
             or estrogen.
Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: 13-valent conjugate pneumococcal vaccine
Intervention description: 0.5ml IM for one dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: pneumococcal vaccine; end stage renal disease; dialysis

Summary:

      The purpose of the study is to determine the response of 13-valent conjugate pneumococcal
      vaccine in patients 50 years or older with end stage renal disease on dialysis.

      The study will also try to determine Streptococcus pneumoniae colonization in patients 50
      years or older with end stage renal disease on dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients ≥ 50years of age with End stage renal disease on dialysis (both
             hemodialysis and peritoneal dialysis).

          -  Scheduled to receive pneumococcal vaccine either after 5years of previous vaccination
             or starting vaccination as part of standard care during the study period

        Exclusion Criteria:

          -  History of S. pneumoniae infection within the last 5 years

          -  Vaccinated with an influenza- or diphtheria-containing vaccine within the last 6
             months

          -  History of any severe adverse reaction associated with a vaccine

          -  Received gamma-globulins within the previous 6 months

          -  Known or suspected HIV or on immunosuppressive medications.

          -  Functional or anatomic asplenia

          -  serious chronic medical condition
The Effect of Choice of Intraoperative Opioid on Postoperative Pain
Condition: Pain, Postoperative; Chronic Pain
MeSH terms: Chronic Pain; Pain, Postoperative
Intervention: Methadone; Fentanyl
Intervention description: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.; Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
Intervention MeSH terms: Fentanyl; Analgesics, Opioid; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Fentanyl; Methadone; Thoracic Surgery

Summary:

      The primary aim of this randomized, double-blind study is to examine the effect of a single
      intraoperative dose of methadone on postoperative pain and analgesic requirements in patients
      undergoing cardiac surgery with cardiopulmonary bypass. These patients will be compared to
      subjects receiving a standard dose of the "traditional" intraoperative opioid (fentanyl).
      Secondary outcome measures to be assessed will include standard recovery variables (such as
      length of postoperative intubation, ICU length of stay, incidence of nausea or vomiting,
      level of sedation). In addition, patients will be assessed for the development of chronic
      postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients presenting for elective cardiac surgery with CPB will be eligible for
             enrollment.

        Exclusion Criteria:

          1. Preoperative renal failure requiring dialysis

          2. Significant hepatic dysfunction (liver function tests > 2 times upper normal limit)

          3. Preoperative ejection fraction < 30%

          4. Pulmonary disease necessitating home oxygen therapy

          5. Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain
             hemodynamic stability

          6. Allergy to methadone or fentanyl

          7. Preoperative pain, use of preoperative opioids, or recent history of opioid abuse
Testing the Anesthetic Effectiveness of Three Different Dental Local Anesthetics Injected Next to a Lower First Molar
Condition: Anesthetic Effectiveness
Intervention: Mandibular buccal Infiltration injection
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: degree of pulpal anesthesia obtained; primary infiltration in the lower first molar

Summary:

      Infiltration (injecting next to the tooth) injections are common in dentistry and a number of
      studies have shown that articaine anesthetic, when injected next to the tooth as a
      supplemental injection, works very well following a typical inferior alveolar (lower jaw)
      nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine
      with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower
      jaw) infiltration injections of the first molar. The purpose of this prospective, randomized,
      double-blind, crossover study is to compare the degree of anesthesia obtained from the three
      solutions as a primary infiltration injection next to the mandibular first molar. The
      investigators also will record the pain of injection and postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between the ages of 18 and 65 years.

          -  in good health (ASA classification II or lower).

          -  able to provide informed consent.

        Exclusion Criteria:

          -  allergy to articaine, lidocaine or prilocaine.

          -  history of significant medical problems (ASA classification III or greater).

          -  depression (taking tri-cyclic antidepressant medications to control).

          -  have taken CNS depressants (including alcohol or any analgesic medications) within the
             last 48 hours prior to testing.

          -  lactating or pregnant.

          -  inability to give informed consent.
Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Beta-blocker monotherapy; Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
Intervention description: Per participant's current prescribed therapy
Intervention MeSH terms: Timolol; Travoprost; Ophthalmic Solutions; Adrenergic beta-Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open Angle Glaucoma; Ocular Hypertension; Intraocular Pressure

Summary:

      The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with
      travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with
      open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.

          -  Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion
             of the investigator, from further intraocular pressure (lOP) reduction.

          -  Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.

          -  Must be able to understand and sign an Informed Consent form.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Use of medication excluded by the protocol.

          -  Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.

          -  Ocular surgeries or procedures excluded by the protocol.

          -  Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to
             20/80 Snellen, 0.60 logMAR or 0.25 decimal).

          -  Hypersensitivity to prostaglandin analogues or any component of the study medications
             in the opinion of the investigator.

          -  Women of childbearing potential if pregnant, test positive for pregnancy at Screening
             visit, breastfeeding, or not in agreement to use adequate birth control methods to
             prevent pregnancy throughout the study.

          -  Other protocol-specified exclusion criteria may apply.
A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure
Condition: Photodamaged Skin
Intervention: Imedeen; Placebo
Intervention description: Two tablets per day for 6 months; Two tablets per day for 6 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 194.0
Sex: Female
Minimum age: 35 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.

Summary:

      The study hypothesis is that Imedeen will show effects on skin health, when compared to
      placebo over a 6 month intervention period with respect to changes in skin appearance, skin
      density, moisture, and in fine lines and wrinkles.
    

Eligibility criteria:

        Inclusion Criteria:

        In general good health and have no contraindications to the study product; Have Fitzpatrick
        Skin Type I-IV as determined by a trained evaluator. Have Glogau Classification of
        Photoaging of II or III as determined by the investigator.

        Exclusion Criteria:

        Use of any dietary supplement, over-the-counter or prescription product with the indication
        of improving the appearance or condition of the skin within one month of baseline.

        History of or current disease or condition of the skin that the investigator deems
        inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other
        scaly inflammatory diseases).

        Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or
        invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments
        by a physician or skin care professional within the last 6 to 9 months from baseline
        (pending procedure type) or plan to have a treatment during the study.
Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy
Condition: Coughing
MeSH terms: Cough
Intervention: Dexmedetomidine; Saline
Intervention description: We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.; We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Coughing during emergence from general anaesthesia may lead to dangerous effects including
      laryngospasm, detrimental haemodynamic changes. Post-thyroidectomy bleeding occurs in 1-4% of
      patients, and severe coughing may cause bleeding. Dexmedetomidine, a potent α adrenoreceptor
      agonist, is theoretically appropriate for reducing airway and haemodynamic reflexes during
      emergence from anaesthesia.

      In this study, we investigated whether intravenous single-dose dexmedetomidine at the end of
      surgery reduces coughing during extubation after thyroidectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA physical status 1 or 2 patients patients scheduled for thyroidectomy

        Exclusion Criteria:

          -  Severe cardiovascular disease history of motion sickness active status of upper
             respiratory infection allergy to dexmedetomidine patients who cannot understand Korean
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: HeartMate II (HMII); Warfarin; acetylsalicylic acid (ASA) therapy
Intervention description: Left Ventricular Assist Device; (INR Target 2.0-2.5, median 2.25, per standard of patient care); (81mg/day)
Intervention MeSH terms: Aspirin; Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: HeartMate II (HMII); Left Ventricular Assist Device (LVAD)

Summary:

      This study is a prospective, multi-center, randomized, double-blind placebo-controlled study
      of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA
             approved indications for use

          -  Subject is ≥ 50 years of age

          -  Subject is receiving the HM II as their first LVAD

          -  Subject or legally authorized representative (LAR) has signed an informed consent form
             (ICF).

        Exclusion Criteria

          -  Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic
             balloon pump or Impella® devices

          -  Participation in any other clinical investigation(s) involving an MCS device, or an
             investigation(s) that is likely to confound study results or affect study outcome

          -  Antiplatelet therapy is mandated for other conditions, in particular: a) recent
             coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other
             conditions where the investigator is not comfortable leaving subjects off-ASA or
             starting ASA post LVAD implantation. In situations where the investigator is
             uncertain, the Steering Committee can provide recommendation to the investigator as
             needed.

          -  Subjects in whom heart transplantation is expected in ≤ 6 months

          -  Subjects with a known ASA allergy
Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin
Condition: Infection
Intervention: Vancomycin CI; Vancomycin II
Intervention description: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin; Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin; Antibiotics, Antitubercular
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: infusion therapy; continuous infusions; nephrotoxicity; outpatient parenteral antibiotic therapy; vancomycin

Summary:

      Evaluate the safety and outcomes associated between the two treatment modalities
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients at least 18 years of age

          -  Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy
             (OPAT) services

          -  Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home
             Infusion Pharmacy

          -  Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in
             duration

          -  Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours
             dosing at the time of enrollment

        Exclusion Criteria:

          -  Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin:
             Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg

          -  Pre-existing leukopenia: White Blood Cell (WBC) < 4,000 x 103 cells/µL
Octylseal Surgical Adhesive in General Surgery
Condition: Wounds
Intervention: Cyanoacrylate (Octylseal )
Intervention description: surgical adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: wounds

Summary:

      The purpose of this study is to evaluate how surgical adhesive is used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Candidate for use of a topical surgical skin adhesive

        Exclusion Criteria:

          -  Subjects with know sensitivity to topical surgical tissue adhesive products or
             degrading products (cyanoacrylates or formaldehyde)

          -  Subjects with a history of keloid formation, hypotension, insulin dependent diabetes
             mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy
             history

          -  Subjects who present with a contraindications for product usage as per labeling

          -  A wound with evidence of active infection or gangrene or wounds of decubitus etiology

          -  Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to
             bodily fluids or with dense natural hair

          -  Subjects with known hypersensitivity to cyanoacrylate or formaldehyde