bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Combigan Two Times Daily (BID); Simbrinza Three Times Daily (TID)
Intervention MeSH terms: Brimonidine Tartrate, Timolol Maleate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Open-Angle Glaucoma; Ocular Hypertension

Summary:

      To compare Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in subjects
      currently being treated with Latanoprost for Open-Angle Glaucoma or Ocular Hypertension. Both
      of these drugs are currently FDA approved as combination therapy for patients with Open-Angle
      Glaucoma or Ocular Hypertension. The purpose of this clinical trial would be to assess which
      treatment, if either, is superior in lowering intraocular pressure (IOP). A secondary
      objective is to assess the tolerability of each drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open-angle glaucoma or ocular Hypertension

          -  Currently treated with Latanoprost for min of 6 weeks

          -  Male or Female 18 yrs and older

          -  Best Corrected Visual Acuity 20/100 or better in both eyes

          -  Pachymetry >470 and < 640

          -  Women of childbearing potential must have a negative urine pregnancy test at the
             screening/baseline visit

          -  Patient willing and capable of providing informed consent

        Exclusion Criteria:

          -  C/D > 0.8

          -  Visual field loss, which in the opinion of the investigator is functionally
             significant

          -  Current use of ocular steroids

          -  Concurrent significant active ocular disease History (within 3 months prior to
             Screening) of ocular laser, intraocular, filtering or refractive surgery or planned
             ocular surgery of any kind during study participation

          -  Change within prior 30 days or anticipated change in any systemic medication that is
             known to affect IOP

          -  Uncontrolled systemic disease

          -  Significant ocular hyperemia at baseline

          -  Prior glaucoma procedure within 3 months

          -  Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing
             potential and not using a reliable method of contraception

          -  Known allergy or sensitivity to any study medication

          -  Asthma or any other known medical condition that the investigator feels would put
             patient at increased risk from any of the study medications

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days prior to Screening
Reducing Intracranial atheroSclErosis With Repatha
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke; Intracranial Arteriosclerosis; Atherosclerosis
Intervention: Repatha
Intervention description: 140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor
Intervention MeSH terms: Evolocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Intracranial Atherosclerosis

Summary:

      The purpose of this study will be to understand the underlying mechanism by which PCSK9
      inhibition reduces the rate of ischemic stroke seen in the pivotal studies that led to its
      FDA approval for ASCVD such as ischemic stroke. Those trials (FOURIER and ODYSSEY) enrolled
      almost 50,000 patients and showed that PCSK9 inhibition therapy is safe and effective. The
      investigators hypothesize that PCSK9 inhibition lowers the rate of stroke by reducing
      atherosclerotic plaque, which would be particularly beneficial for patients with intracranial
      atherosclerosis, who have the highest rate of recurrent stroke of any stroke mechanism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age

          -  History of ischemic stroke, defined as an episode of neurological dysfunction caused
             by focal cerebral, spinal, or retinal infarction (American Heart Association
             definition).

          -  Large vessel atherosclerosis of an intracranial artery in the circle of Willis with
             50-99% stenosis by WASID criteria (percent stenosis = (1-[diameter stenosis/diameter
             normal]) x 100%) on MRA, CTA or DSA

             ------ Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), tICA,
             ACA (A1)

          -  Current statin use or contraindication to statin

          -  Fasting LDL-C ≥ 70 mg/dL or LDL-C ≥ 60 mg/dL if lipoprotein (a) > 30 mg/ dL

        Exclusion Criteria:

        Gadolinium or PCSK9 inhibitor allergy

          -  Acute or chronic kidney disease with eGFR<30 ml/min/1.73m2

          -  Pacemaker or other MRI contraindications per American College of Radiology guidelines

          -  Inability to return for 78 week follow-up clinic visit and vwMRI
Effect of Simethicone on Screening Colonoscopy
Condition: Adenoma Colon
MeSH terms: Adenoma
Intervention: Simethicone Solution; Polyethylenglycol
Intervention description: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol; Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation
Intervention MeSH terms: Simethicone
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 268.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: screening; adenoma detection rate; simethicone

Summary:

      This study is evaluating the effect of adding a high dose of simethicone to the standard
      polyethylene glycol preparation for screening colonoscopy in the quality of the preparation ,
      adenoma detection rate and withdrawal times.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients between the ages of 30-80 scheduled for screening colonoscopy.

          2. Male and female patients

          3. Ambulatory patients

          4. Signed informed consent form

        Exclusion Criteria:

          1. Previous colonic surgery

          2. Patient with mental/physical condition that impairs oral ingestion of preparation

          3. Allergy or hypersensitivity to simethicone

          4. Patients with limited mobility (bedridden patients)

          5. Patients with gastrointestinal obstruction

          6. Patients with gastroparesis
Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery
Condition: Surgery
Intervention: Dexamethasone; Ropivacaine
Intervention description: IV dexamethasone; Ropivacaine only
Intervention MeSH terms: Dexamethasone; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 8.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Neuraxial; Caudal; Block; Anesthesia; Dexamethasone

Summary:

      Caudal injection of local anesthetic is a neuraxial technique routinely performed on young
      children for postoperative analgesia after lower abdominal and lower extremity surgical
      procedures. One of the major limitations of the use of single shot neuraxial injections for
      this purpose is the limited duration of action of the injected local anesthetic. Adjuvant
      medications, such as clonidine and epinephrine, have been added to the local anesthetic to
      prolong the duration of the neuraxial block, with varying results. Dexamethasone is a
      synthetic glucocorticoid steroid commonly used in the perioperative setting for a multitude
      of indications, including the prolongation of local anesthetic based analgesia. It has been
      shown that the administration of dexamethasone either intravenously or via perineural
      injection can significantly increase the duration of analgesia derived from a local
      anesthesia based peripheral nerve block. Literature also suggests that the effect of
      dexamethasone is equivalent whether given intravenously or perineurally. Interest in
      dexamethasone enhanced caudal analgesia exists and a previous study noted that caudal
      anesthesia can be prolonged by intravenous dexamethasone. The study was criticized for using
      a higher dose of dexamethasone (0.5 mg/kg) than is routinely used in the pediatric population
      outside of airway procedures, which may expose patients to dose related side effects of
      dexamethasone. A large meta-analysis has suggested that 0.1 mg/kg is effective for analgesic
      prolongation, but no direct study of low dose intravenous dexamethasone in combination with
      caudal anesthesia has been performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 2 to 10 years

          -  Scheduled for elective inpatient genitourinary surgical procedure

          -  Caudal anesthesia standard of care for surgical procedure

          -  have provided parental consent and assent in accordance with the institutional review
             board requirements

        Exclusion Criteria:

          -  Abnormal/difficult anatomy

          -  known allergy to ropivacaine or dexamethasone

          -  history of documented chronic pain

          -  existing infection at site of intended injection
Prevention of Persistent Opioid Use in Mothers
Condition: Opioid Use; Postpartum Disorder; Chronic Pain Syndrome
MeSH terms: Puerperal Disorders; Chronic Pain
Intervention: Gabapentin; Placebo
Intervention description: Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.; Placebo to match gabapentin
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A randomization table will be used by the research pharmacy and study drug will be prepared in numbered bottles.
Enrollment: 78.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Our previous work has identified the group of women at risk for prolonged pain, opioid use
      and poor functional recovery after childbirth. The optimal intervention to mitigate this risk
      is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative
      pain compared to placebo to improve post-partum recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Delivery within 5 days, able to provide informed consent, English speaker

        Exclusion Criteria:

          -  Opiate use disorder
Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine
Intervention description: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adductor canal block, nerve block

Summary:

      This is a randomized noninferiority interventional study to determine the equivalence of two
      adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial
      foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during
      their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day
      Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and University of Texas
      Southwestern Outpatient Surgery Center) for eligibility. Eligible individuals may be
      introduced to the study in the orthopedic presurgical clinic or the anesthesia preoperative
      clinic by staff. After consent patients will be randomized (break-seal method) to receive
      either a mid-thigh or distal thigh block using ropivacaine prior to foot, ankle, or leg
      surgery. The following measurements will be obtained to determine the change in sensory
      distribution: pinprick test with Neuropen, maximum voluntary isometric contraction before and
      after block, postoperative pain scores (24 hrs and at discharge) and postoperative opiate
      consumption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 18 years or older

          -  Individuals undergoing surgery of the medial foot, medial ankle, or medial leg for
             which the anesthetic plan includes an adductor canal nerve block

        Exclusion Criteria:

          1. Any known deficit of the ipsilateral lumbar nerve roots, ipsilateral lumbar plexus,
             ipsilateral femoral nerve, obturator nerve or saphenous nerve including diabetic
             peripheral neuropathy

          2. Any local disorder of the skin or otherwise where blockade is to be performed

          3. Body mass index >50

          4. American Society of Anesthesiologists (ASA) classification greater than 3

          5. Allergy to amide local anesthetic medications

          6. Pregnancy

          7. Incarceration

          8. Inability to understand study procedures including inability to understand the English
             language
Efficacy of Losartan in Preventing Progression of COPD
Condition: COPD; Emphysema; Chronic Bronchitis; Smoking
MeSH terms: Bronchitis; Bronchitis, Chronic; Pulmonary Emphysema; Emphysema
Intervention: Losartan; Placebo
Intervention description: Losartan 100 mg daily; Placebo pill daily
Intervention MeSH terms: Losartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; emphysema; angiotensin receptor blocker

Summary:

      Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage
      due to smoking. The goal of this study is to determine whether this drug which is also used
      to treat hypertension can stabilize or improve lung function in people who have from chronic
      obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with COPD who are either active or former smokers

        Exclusion Criteria:

          -  Clinical requirement or history of intolerance of angiotensin receptor blockers,
             serious heart, liver, kidney, neurological disease.
Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
Condition: Surgery; Breast Reconstruction
Intervention: Serrato; Control
Intervention description: Serratus plane block.; Standard anesthesia
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group parallel arm. With study group receiving regional anesthestic block with levobupivacaine and control group receiving standard care with intravenous analgesia only
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oncological; Surgery; Breast; Reconstruction

Summary:

      The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia
      technique ( interfascial block at the serratus muscle) performed in patient undergoing breast
      surgery and the effect of this technique on postoperative analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients older than 18 years, undergoing oncological surgery and/or breast
             reconstruction surgery whose pathology and surgical intervention supose at least a 24
             hours hospital admission

        Exclusion Criteria:

          -  ASA Physical Status Classification System- IV.- Morbid obesity (Body mass index >40).
             -Impossibility of anatomical structures ultrasound identification in a satisfactory
             way (there can be no distinction in the interfascial plane between serratus and
             pectoral muscle). -Opioids treatment before surgery. Sepsis and/or infection at the
             puncture site.

          -  Haemostasis disorders. - Allergy to any of the drugs used in the study.
Inpatient Diabetes on Corticosteroids
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: NPH; Correction Factor
Intervention description: NPH given per study table based on steroid dose and patient weight in kg.; Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: corticosteroid; diabetes; insulin

Summary:

      Despite a significant problem with out-of-control glucose levels in patients with diabetes
      receiving corticosteroids for a variety of illnesses, there are no published protocols
      addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators
      propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin
      for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed
      to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's
      usual insulin regimen and timed to correspond to the corticosteroid dosing regimen.
      Investigators will prospectively enroll eligible consented patients with diabetes who are
      receiving corticosteroids as part of their treatment in a large county hospital, will
      randomize them to intervention or control groups, and will monitor their glucose levels
      during their inpatient stay. The protocol will demonstrate improved control of glucose levels
      with minimal risk of hypoglycemia, and will provide a practical and readily implementable
      protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior history of diabetes

          -  Able to provide informed consent

          -  Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the
             equivalent of dexamethasone or methylprednisolone

          -  Expect to be hospitalized for 48 hours

        Exclusion Criteria:

          -  Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2

          -  ALT (alanine aminotransferase) > 2 times upper normal for laboratory
Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus
Condition: Chronic Kidney Disease (CKD); Type 2 Diabetes Mellitus (T2DM); Coronary Artery Disease (CAD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Clopidogrel; Clopidogrel active metabolite
Intervention description: Both CKD and Non-CKD patients will be administered a 600-mg LD of clopidogrel followed by a single 75-mg MD administered after 24 hours.; In both CKD and Non-CKD patients, blood samples collected at baseline only (before clopidogrel LD administration) will be incubated with escalating concentrations of clopidogrel active metabolite (1, 3 and 10 μM)
Intervention MeSH terms: Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pharmacodynamics (PD); pharmacokinetic (PK); clopidogrel

Summary:

      Patients with diabetes mellitus (DM) and chronic kidney disease (CKD) are at increased risk
      of atherothrombotic events. Clopidogrel is the most widely used platelet P2Y12 receptor
      inhibitor in patients with coronary artery disease (CAD). However, despite its benefits, many
      patients still experience recurrent atherothrombotic events. The proposed study will test the
      central hypothesis that in DM patients the presence of CKD reduces clopidogrel-mediated P2Y12
      inhibitory effects through synergistic mechanisms, which include upregulation of the P2Y12
      signaling pathway and impaired clopidogrel metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 DM, defined according to ADA definition, on treatment with oral hypoglycemic
             agents and/or insulin

          -  Angiographically documented CAD

          -  On treatment with low-dose aspirin (81mg/day) for ≥30 days as part of standard of
             care.

        Exclusion Criteria:

          -  Use of any antiplatelet therapy (except aspirin) in prior 30 days

          -  Use of parenteral or oral anticoagulation

          -  Active bleeding

          -  High risk of bleeding

          -  Clinical indication to be on a P2Y12 receptor inhibitor

          -  End-stage renal disease on hemodialysis

          -  Any active malignancy

          -  Platelet count < 100x106/µl

          -  Hemoglobin <9 g/dl

          -  Severe known liver disease

          -  Hemodynamic instability

          -  Known allergy to clopidogrel

          -  Pregnant / lactating females (women of childbearing age must use reliable birth
             control).