bioihbjkbjnl/mcl2 huggingface dataset:
12 Versus 20 mL PCB for D&E Cervical Prep
Condition: Pain
Intervention: 12 mL paracervical block; 20 mL paracervical block
Intervention description: Injection of 12 mL of lidocaine; Injection of 20 mL of lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
Masking: Single (Participant)
Masking description: The provider and staff will be aware of arm allocation, but participants will remain blinded.
Enrollment: 96.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: paracervical block; abortion; dilation and evacuation; cervical preparation

Summary:

      More research is needed to investigate methods of pain control for cervical preparation for
      abortion procedures. Women report pain with paracervical block injection as well as with
      osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine
      paracervical block for pain control during cervical preparation (osmotic dilator insertion)
      for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18 and older

          -  Intrauterine pregnancy ≥16 weeks gestation

          -  English speaking competency

          -  Willing and able to sign consent forms

          -  Agree to comply with study procedures

        Exclusion Criteria:

          -  Women less than 18 years of age

          -  IV conscious sedation

          -  Known allergy to study medication (lidocaine)

          -  Any women not meeting inclusion criteria above will be excluded from participation
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
Brilinta Taiwan Post Approval Safety Study
Condition: Non ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Infarction
Intervention: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Intervention description: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: NSTEMI

Summary:

      A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the
      cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with
      non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles
      are depolarized) elevation myocardial infarction
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures

          2. Female or male aged at least 20 years

          3. Patient who is considered as ethnic Taiwanese

          4. Index event of non-ST elevation myocardial infarction

        Exclusion Criteria:

          1. Contraindication or other reason that ticagrelor should not be administered

          2. Index event is an acute complication of Percutaneous coronary intervention (PCI)

          3. Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days
             from the enrolment

          4. Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped

          5. Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic
             treatment following enrolment
L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer
Condition: Breast Cancer; Chemotherapeutic Agent Toxicity; Neurotoxicity
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: L-carnitine L-tartrate; placebo
Intervention description: Given orally; Given orally
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: neurotoxicity; chemotherapeutic agent toxicity; stage IV breast cancer; recurrent breast cancer

Summary:

      RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.

      PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in
      preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of breast cancer

               -  Metastatic disease

          -  Scheduled to receive ≥ 1 of the following chemotherapy drugs:

               -  Paclitaxel

               -  Docetaxel

               -  Capecitabine

               -  Gemcitabine hydrochloride

                    -  Concurrent enrollment in the University of Minnesota study "Population
                       Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with
                       Solid Tumors" (Human Subjects Code 0508M72989) required

               -  Albumin-bound paclitaxel (Abraxane)

               -  Doxorubicin hydrochloride

        PATIENT CHARACTERISTICS:

          -  Life expectancy ≥ 6 months

          -  Serum creatinine < 2.0 mg/dL

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No history of seizures

          -  No uncontrolled hypertension

          -  No history of stroke

          -  No malabsorption syndrome

          -  No cognitive impairment

          -  No history of psychiatric disability affecting informed consent or compliance with
             drug intake

          -  Able to take oral medication

          -  Able to complete questionnaire(s) alone or with assistance

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No concurrent warfarin

          -  No concurrent radiotherapy
Impact of Propofol Reduction in Anesthesia Induction
Condition: Propofol Adverse Reaction; Anesthesia
Intervention: Propofol Injection
Intervention description: 1, 1.5 or 2 mg/kg of propofol according to the subgroup
Intervention MeSH terms: Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 time groups, divided into 3 dose groups
Masking: Single (Participant)
Masking description: aleatory assignation, time measured by nurses, drugs administrated by principal investigator
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: propofol synergy; fentanyl; anesthesia induction

Summary:

      Objective: Determine if, by reducing the dose of propofol and increasing the time elapsed
      between fentanyl and propofol administration, hemodynamic response is improved.

      Methods: Patients were randomized into time groups (2 and 1 minute) and each subdivided into
      dose groups (1, 1.5 and 2 mg kg-1) obtaining six time-dose groups. After receiving 2 μg kg-1
      of fentanyl, propofol was administered after the predetermined time. Time to hypnosis
      (BIS<60) and hemodynamic parameters at pre-induction, pre-intubation and postintubation were
      registered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults who required general anesthesia

          -  General anesthesia with endotracheal intubation (no supraglottic devices)

          -  Signed informed consent

          -  Non-cardiac surgery

          -  Same anesthesiologist

        Exclusion Criteria:

          -  Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac
             output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60%
             with normal arterial saturation or lactate >3 mmol/l)

          -  Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal
             obstruction, pregnancy, etc.)

          -  Suspected difficult airway

          -  Known allergy to anesthetic drugs
Ciprofloxacin for Prevention of BK Infection
Condition: BK Virus Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Ciprofloxacin; placebo
Intervention description: Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator.; Patients will be randomized 2:1 placebo comparator to active comparator, Cipro.
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BK infection; BK viremia; BK nephropathy; polyomavirus; fluoroquinolone; ciprofloxacin

Summary:

      BK infection is an important cause of graft dysfunction and graft loss after renal
      transplantation. It has been widely accepted that emergence of BK virus correlates with the
      more potent immunosuppressive agents used to lower acute rejection rates. In contrast to
      other opportunistic infections after transplantation, for which routine prophylactic agents
      are administered, there is no effective agent for the prevention of BK infection. Some data,
      however, suggests that quinolone antibiotics such as ciprofloxacin may have activity against
      BK virus. This has led us to investigate whether routine, short-term ciprofloxacin
      administration post-transplant can lower the incidence of BK infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects over the age of 18 years

          -  Recipients of a primary or repeat renal allograft either alone (from a deceased or
             living donor) or as a dual-kidney transplant

          -  Signed informed consent form prior to any research assessment

        Exclusion Criteria:

          -  Patients with known severe allergy to ciprofloxacin

          -  History of tendon rupture or tendinitis

          -  Use of antiarrythmic drugs known to prolong the QT interval such as class IA
             antiarrhythmic drugs (e.g. quinidine, procainamide, disopyramide), class III
             antiarrhythmic drugs (e.g. amiodarone, sotalol)

          -  Patients with history of previous non-renal transplantation

          -  Recipients administered rituximab within one year prior to transplantation, or
             recipients expected to receive rituximab as part of desensitization strategy or for
             the presence of historical donor specific antibodies

          -  QTc interval interval of greater than 500 msec on admission or post-operative EKG

          -  BK nephropathy with previous transplant

          -  BK viremia on admission

          -  Any condition present during the initial transplant hospitalization that in the
             investigator's judgment would increase the risk associated with participation in the
             study
Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Clonidine; Placebo
Intervention description: clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine; Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 36 Weeks
Maximum age: 45 Weeks
Healthy volunteers: No

Summary:

      This is a prospective randomized double blinded study comparing the effect on duration of
      pharmacologic treatment and duration of hospital stay when using clonidine at 12
      µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the
      management of term and near term infants with neonatal abstinence syndrome (NAS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requiring neonatal intensive care unit (NICU) admission for management of neonatal
             abstinence syndrome

          -  Gestational age greater than or equal to 36 weeks

          -  Less than or equal to 48 hours of treatment with morphine for NAS

        Exclusion Criteria:

          -  Presence of seizures

          -  Congenital malformations, genetic syndromes or the presence of TORCH infections

          -  Major medical problems

          -  Heart rate and/or blood pressure instability
Glucagon Use in Colonoscopies
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Intervention: Glucagon
Intervention description: glucagon (hormone produced by the body)
Intervention MeSH terms: Glucagon
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: glucagon, screening colonoscopy

Summary:

      The investigators believe that glucagon therapy will have a positive impact on key parameters
      of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma
      detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort,
      and patient's willingness to undergo a repeat colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any subject who has already been already cleared for and scheduled to undergo
             colonoscopy at SFGH endoscopy center.

        Exclusion Criteria:

          1. Refusal to give informed consent.

          2. Age <18 or >70.

          3. Prior intra-abdominal surgery

          4. Diabetes

          5. Pheochromocytoma

          6. Insulinoma

          7. Liver disease (Child-Pugh Score >6)

          8. Pregnancy
Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)
Condition: Knee Arthropathy
MeSH terms: Joint Diseases
Intervention: Bupivacaine with epinephrine; Methylprednisolone; Cefazolin; 8 MHz. Chiba needle; Bupivacaine with Dexamethasone; Bupivacaine 25cc; Bupivacaine 20cc; Dexamethasone
Intervention description: bupivacaine 0.5% with epinephrine 30cc; 40 mg/ml, 1 ml; 500 mg in 10 ml; 22G/ 4 inches; 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone; 25 cc 0.25% bupivacaine; 20cc 0.25% bupivacaine; 2 mg IV dexamethasone.
Intervention MeSH terms: Cefazolin; Cephalosporins; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: IPACK; PAI

Summary:

      A comparison of two pain control methods - the combination of Adductor Canal Block
      (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal
      artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)
      - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with
      ambulation on postoperative day one (24 hours post-block administration).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with osteoarthritis scheduled for a primary either partial or total knee
             arthroplasty with a participating surgeon

          -  Age 18 to 80 years

          -  Planned use of regional anesthesia

          -  Ability to follow study protocol

          -  English speaking (secondary outcomes include questionnaires validated in English only)

          -  Patients of participating surgeons

        Exclusion Criteria:

          -  Hepatic or renal insufficiency

          -  Younger than 18 years old and older than 80

          -  Patients undergoing general anesthesia

          -  Allergy or intolerance to one of the study medications

          -  BMI > 40

          -  Diabetes

          -  ASA of IV

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine
             equivalent of >5mg/day for one month)

          -  Patients with severe valgus deformity and flexion contracture
Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: placebo; Pregabalin
Intervention description: Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.; Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pregabalin; postoperative pain; abdominal hysterectomy

Summary:

      This study aims to compare the effect of pre-operative oral pregabalin on post operative
      morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ASA classification 1-2 undergoing abdominal hysterectomy with/without
             salpingo-oophorectomy under spinal anesthesia with intrathecal morphine

          2. Patient can use patient-controlled analgesia (IV PCA)

        Exclusion Criteria:

          1. History of drug allergy to gabapentinoid and related drug

          2. History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol
             addiction or chronic pain patient

          3. Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and
             Psychiatric disorder