bioihbjkbjnl/mcl2 huggingface dataset:
Shiga Microalbuminuria Reduction Trial-2
Condition: Type 2 Diabetes Mellitus; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Intervention: Aliskiren; any angiotensin receptor blockers
Intervention description: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.; The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
Intervention MeSH terms: Angiotensin Receptor Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypertension; Albuminuria; Direct renin inhibitor; Angiotensin receptor blocker; Type 2 diabetes

Summary:

      The purpose of this study is to compare the effects of a direct renin inhibitor (DRI),
      aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes
      under strict blood pressure control with angiotensin receptor blocker (ARB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Segment: outpatients

          -  Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP
             more than130/80 mmHg

          -  Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment

          -  Microalbuminuria: 10 < and < 300 mg/gCr

          -  Informed consent: patients who understand well about this study based on own voluntary
             will and can give a written consent

        Exclusion Criteria:

          -  Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary
             hypertension

          -  Type 1 diabetes

          -  Patients whose investigator regards as difficult to comply with study protocol in
             reference to the package insert of aliskiren

          -  Patients who have history of operation in gastrointestinal tract surgery, and
             anamnestic or concurrent gastrointestinal disorders, which may interfere with drug
             absorption

          -  Serum potassium > 5.6 mEq/L (hyperkalemia)

          -  Urinary microalbumin < 10 or > 300 mg/gCr

          -  Patients who participated in another clinical study within three months
Prophylactic Antimicrobial Catheter Lock
Condition: Bacteremia
MeSH terms: Bacteremia
Intervention: Heparin 1000U/mL; 4% Sodium Citrate with Gentamicin 320 mcg/mL
Intervention description: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis; A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis
Intervention MeSH terms: Gentamicins; Heparin; Citric Acid; Sodium Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 303.0
Sex: All
Healthy volunteers: No
Keywords: Sodium citrate; Gentamicin; Prophylaxis; Hemodialysis; Central venous catheter

Summary:

      This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of
      Heparin versus Gentamicin as a pos-dialysis catheter lock solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requires placement of a central venous catheter or currently has a central venous
             catheter for hemodialysis access.

          -  Must be at least 18 years old

          -  Compliant with a dialysis treatment schedule

          -  Plans to continue hemodialysis treatment and follow-up at the investigational site

          -  Must be able to care for the exit site independently or have someone who is able to
             care for the site for them

          -  Must be able to sign the informed consent document

        Exclusion Criteria:

          -  The subject who has had an infection associated with one or more positive blood
             cultures is not eligible until 14 days after blood cultures have become negative and
             clinical resolution of the episode has occurred

          -  Active exit site or tunnel infection

          -  Systemic or localized infection that is unresponsive to antibiotic therapy and/or is
             life threatening

          -  Known to have antibodies to heparin

          -  Allergy to pork heparin

          -  Allergy to gentamicin

          -  Subject is pregnant

          -  Known intravenous drug abuse
A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Adalimumab; Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Intervention description: Administered every other week by subcutaneous injection for up to 48 weeks, depending on participants' disease activity.; ASAS recommended NSAID doses to treat axial spondyloarthritis.
Intervention MeSH terms: Adalimumab; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Axial Spondyloarthritis; Humira

Summary:

      A study comparing a treat-to-target (T2T) intense treatment approach with routine treatment
      (Standard of Care [SOC]) in reducing disease activity in participants with axial
      spondyloarthritis (axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent before start of study-related assessments or
             procedures

          -  Diagnosis of axSpA (either ankylosing spondylitis or non-radiographic axSpA) and
             fulfilling the Assessment of Spondyloarthritis International Society (ASAS)
             classification criteria for axSpA

          -  Participants aged ≥ 18 years

          -  Disease duration < 5 years

          -  Participants must have a Baseline disease activity as defined by an ASDAS ≥ 2.1 or a
             Bath AS Disease Activity Index (BASDAI) ≥ 4

          -  NSAID-naive or not treated with the maximal recommended NSAID dose during the last 2
             weeks prior to the Baseline visit

          -  Participants must never have failed a NSAID taken at maximal recommended dose for 2
             weeks or more.

        Exclusion Criteria:

          -  Contraindications for NSAIDs or tumor necrosis factor (TNF) blocker according to local
             labeling

          -  If entering the study on concomitant NSAIDs, participants taking the maximal
             recommended dose during the last 2 weeks prior to the Baseline Visit or have failed or
             developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more
             at any time

          -  Prior exposure to any anti-TNF therapy; any biologic therapy with a potential
             therapeutic impact on SpA, or participant has been treated with any investigational
             drug of chemical or biologic nature within a minimum of 30 days or five half-lives
             (whichever is longer) of the drug prior to the Baseline visit.
Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Aromasin (exemestane)
Intervention description: the dosage, frequency and duration base on the LPD approved by SFDA.
Intervention MeSH terms: Exemestane
Phase: Phase 4
Study type: Interventional
Masking: None (Open Label)
Enrollment: 564.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; Aromasin; adjuvant chemotherapy; endocrine therapy

Summary:

      Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women
      with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years
      of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of
      adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial
      waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since
      then, there is currently lack of systematic collection and analysis for the efficacy and
      safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Interventional
      Study is being proposed to collect data systematically and to assess the efficacy and safety
      of Aromasin® adjuvant setting in Chinese population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.

          -  ER positive.

          -  The patient must be postmenopausal woman.

          -  The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will
             switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will
             necessarily precede and will be independent of the decision to enroll patients in the
             study).

        Exclusion Criteria:

          -  Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving
             Aromasin® treatment, there is evidence of a local relapse or distant metastasis of
             breast cancer, or a second primary cancer.

          -  Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase
             inhibitors (not Aromasin®).
Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food
Condition: Transfusional Hemosiderosis
MeSH terms: Hemochromatosis; Hemosiderosis
Intervention: deferasirox:
Intervention description: Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.
Intervention MeSH terms: Deferasirox
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Exjade; deferasirox; palatability; tolerability; food; iron overload; Serum Iron overload due to transfusions

Summary:

      This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20
      centers. All patients who met the study criteria and were taking, beginning or resuming
      treatment with Deferasirox were allowed. The study will began with a one month run-in phase,
      where all patients were instructed to take Deferasirox according to their physician's
      prescribing information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with thalassemia major, sickle cell disease (SCD), low or
             intermediate 1 (INT 1) risk myelodysplastic syndrome (MDS) or other anemias and
             transfusional hemosiderosis.

          -  Patients who were on, starting, or resuming treatment with Exjade.

          -  Patients who were >2 years (i.e., 2 years of age or older).

        Exclusion criteria:

          -  Serum creatinine above the upper limit of normal (ULN) for age.

          -  Alanine aminotransferase (ALT) >2.5 times the ULN.-High risk intermediate-2 or high
             risk MDS or acute leukemia.
TAP-patients With Robotic Assisted Lap Prostatectomy
Condition: Postsurgical Pain; Analgesia; Prostatectomy
MeSH terms: Pain, Postoperative
Intervention: EXPAREL 20 mL; EXPAREL 40 mL
Intervention description: EXPAREL 266 mg (undiluted); EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: TAP, robot-assisted prostatectomy

Summary:

      The purpose of the study is to assess the safety and efficacy of EXPAREL when administered
      via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical
      analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male subjects, aged 18-75.

          -  American Society of Anesthesiology (ASA) physical status 1-3.

          -  Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon
             (Ingolf Tuerk, MD).

          -  Subjects must be physically and mentally able to participate in the study and complete
             all study assessments.

          -  Subjects must be able to give fully informed consent to participate in this study
             after demonstrating a good understanding of the risks and benefits of the TAP
             infiltration.

        Exclusion Criteria:

          -  Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local
             anesthetics.

          -  Inability to tolerate oxycodone with acetaminophen (e.g. Percocet).

          -  Any subject whose anatomy or surgical procedure in the opinion of the Investigator
             might preclude the potential successful performance of a TAP.

          -  Any subject who in the opinion of the Investigator might be harmed or be a poor
             candidate for participation in the study.

          -  Subjects who have received any investigational drug within 30 days prior to study drug
             administration or planned administration of another investigational product or
             procedure during their participation in this study.
Sedation Methods During Cataract Surgery
Condition: Phacoemulsification; Cataract
MeSH terms: Cataract
Intervention: Midazolam + Ketamine 10 MG/ML: 0.5 ML; Midazolam + Ketamine 10 MG/ML: 1 ML; Midazolam + Normal saline
Intervention description: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.; 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.; Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, double-masked, three-armed clinical comparison
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Surgical conditions and patient response not aware of medication given.
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ketamine; midazolam; sedation

Summary:

      Background: Phacoemulsification is the most common surgical procedure performed in the United
      States and European Union and sedation is commonly used during phacoemulsification to help
      alleviate patient anxiety and prevent the patient from interfering with the procedure. The
      investigators have administered ketamine in addition to midazolam in this regard. To study
      the effectiveness of this technique, The investigators proposed a study to determine if
      adding low-dose ketamine to midazolam has any beneficial (or negative) effects on operating
      conditions, patient satisfaction, and recovery during and after unilateral
      phacoemulsification procedures performed using topical anesthesia and intravenous (IV)
      conscious sedation.

      Methods: In a free-standing Outpatient Surgery Center, the investigators conducted a
      randomized, double-masked, 3-arm, prospective comparison of IV midazolam only vs. midazolam
      with ketamine 5 mg IV vs. midazolam with ketamine 10 mg IV. The investigators then measured a
      single surgeon's assessment of surgical conditions, self-reported patient satisfaction,
      postoperative pain score, and duration of postoperative stay. The investigators also analyzed
      the dose of midazolam required to meet subjective anxiolysis in each group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients met inclusion criteria if they were between 18- and 80-years-old and
             undergoing elective cataract surgery performed by a single ophthalmologist (KW).

        Exclusion Criteria:

          -  Patients younger than 18, older than 80, those with a serum creatinine >3 mg/dl,
             advanced liver disease (liver enzymes twice the normal range or higher), and those
             with an allergy to any of the study medications were excluded from the study.
Eszopiclone Treatment & Cortisol Responsivity
Condition: Insomnia
Intervention: eszopiclone
Intervention description: 6 weeks standard oral therapy
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study was designed to use a sensitive neuroendocrine probe, the
      Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults
      with insomnia. The primary aim was to assess cortisol reactivity before and after long-term
      (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone
      would result in a significant reduction in plasma cortisol response to the DEX/CRH test
      following treatment of insomnia with standard dose of eszopiclone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to Moderate Insomnia

        Exclusion Criteria:

          -  Any acute or chronic medical condition involving function of HPA axis (e.g., Cushing's
             or Addison's Disease, adrenal or pituitary gland disorders)

          -  Currently taking, or unable to be free of, antidepressant, neuroleptic, anxiolytic, or
             thymoleptic drugs for at least 2 weeks preceding the DEX/CRH test (free of fluoxetine
             for at least 6 weeks)

          -  Current use of psychotropic medication or medication (prescribed or over the counter)
             thought to affect HPA axis function or glucocorticoid synthesis/release (e.g.,
             prednisone, anabolic steroids, DHEA, ketoconazole, metyrapone)

          -  History of a significant adverse reaction to eszopiclone

          -  Meets DSM-IV criteria for any Axis I psychiatric disorder, including substance abuse
             presently, or substance dependence within the past 6 months

          -  Pregnancy, lactation, or unable/unwilling to use reliable methods of contraception
             during the study procedures

          -  Limited mental competency and the inability to give informed, voluntary, written
             consent to participate.
ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Shared Decision Making
Intervention description: This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1400.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus Type 2

Summary:

      The purpose of this study is to evaluate whether a combination of pharmacist-delivered
      patient engagement techniques improves disease control and medication adherence among
      patients with poorly-controlled diabetes compared with usual care. These engagement
      techniques include shared decision-making and brief negotiated interviewing and are delivered
      telephonically.
    

Eligibility criteria:

        Inclusion:

          -  Commercially-insured beneficiaries

          -  Receive all medical/prescription drug benefits through Horizon

          -  On ≥1 one oral hypoglycemic agent

          -  Latest HbA1c measurement ≥ 8% (within previous 6 months)

          -  Provided phone number to Horizon

        Exclusion:

        - Currently using any insulin