bioihbjkbjnl/mcl2 huggingface dataset:
Buffered Lidocaine in Paracervical Blocks
Condition: Pain
Intervention: Lidocaine; Lidocaine-Sodium Bicarbonate
Intervention description: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain; Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
Intervention MeSH terms: Lidocaine; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A statistician not involved with the conduct of the study will use a computer random number generator to generate random permuted blocks. This statistician will place allocation assignment cards in sequentially numbered, sealed, opaque envelopes. A different randomization scheme will be used for each location, one at the Kapi'olani office and one at the Queen's office.
A clinic staff member not involved with the conduct of the study will be trained specifically in the opening of the allocation envelopes. The staff member will be trained to open the envelope and remove the study card to read the allocation group: buffered lidocaine or plain lidocaine. The clinic staff member will then prepare the buffered lidocaine or plain lidocaine in an unlabeled syringe, and place it on the surgical tray.
Enrollment: 98.0
Sex: Female
Minimum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      For pain relief during a first trimester surgical aspiration, most providers use the
      paracervical block, either alone or in combination with other pain control techniques. Some
      providers use buffered lidocaine due to a belief that it decreases pain. Others use plain
      lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain
      lidocaine in a two site injection. Few studies have compared buffered versus unbuffered
      lidocaine for paracervical blocks during first trimester uterine aspirations. This study
      seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for
      paracervical blocks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women 14 years and older

          -  Desiring uterine aspiration for pregnancy or surgical management of a miscarriage

          -  Gestational age up to 13 weeks and 6 days to be established by best dating (i.e. last
             menstrual period or earliest ultrasound)

          -  Treatment plan involves outpatient uterine aspiration

          -  Participant able to provide informed consent in English and willing to participate in
             the study

        Exclusion Criteria:

          -  Unable to read, speak, or understand English

          -  Unable to provide informed consent

          -  Currently incarcerated

          -  Under the age of 14 years

          -  Contraindications to receiving lidocaine or buffered lidocaine
Hypoxic Pulmonary Vasoconstriction Pilot Study
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Intervention: Sildenafil study group
Intervention description: One dose of 20 mg Sildenafil will be given one hour before CT imaging.
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if the events leading to smoking-associated
      centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent
      mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced
      inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between the ages of 30 and 60.

          -  Must be currently smoking at least 1/2 pack/day (confirmed with cotinine level).

          -  Must have pulmonary function test (PFT) results that meet the following:

          -  Forced Expiratory Volume at one second (FEV1)/Forced Vital Capacity (FVC) > 70%

          -  Forced Expiratory Flow at 25-75% (FEF25-75) > 79% of predicted

          -  FVC greater than 80% of predicted

          -  Must be able to give informed consent for self.

        Exclusion Criteria:

          -  Pregnant or breastfeeding females.

          -  Body Mass Index (BMI) greater than 32.

          -  Weight of greater than 220 pounds (100 kg).

          -  Allergies to shell fish, seafood, eggs or iodine.

          -  Heart disease, kidney disease or diabetes.

          -  Diagnosis of asthma.

          -  Usage of any medications that are known to affect the heart or lungs (contraceptives,
             anti-depressants, analgesics EXCEPT aspirin, antihypertensives, and medications for
             osteoporosis and gastrointestinal diseases will be allowed).

          -  Any metal in or on the body between the nose and the abdomen.

          -  Any major organ system disease (by judgment of study medical team).

        For the subjects that will receive Sildenafil as part of the study, additional exclusion
        criteria are as follows:

          -  Nitroglycerin usage.

          -  Prior history of hypersensitivity to Sildenafil.
Low Dose Peri-operative IV Ketamine for Chronic Post-surgery Pain Prevention
Condition: Chronic Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ketamine
Intervention description: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ketamine; Thoracotomy; VATS; Pain

Summary:

      This study will test the null hypothesis that low-dose ketamine given peri-operatively will
      have no effect on the development of chronic post-surgical pain, in patients undergoing
      thoracotomy or video assisted thoracic surgery (VATS) procedures

      A double-blind, randomised placebo-controlled trial will be used to test the null hypothesis.
      Potential participants due to undergo either thoracotomy or video assisted thoracic surgery
      (VATS) will be identified by the collaborating thoracic surgeons in the out-patient
      department. Patients will be sent information about the study by post, prior to admission for
      surgery. If they are willing to participate, written consent will be sought on the ward
      preoperatively, where they will complete baseline measures of pain.

      Patients will be randomised to receive an intravenous infusion of placebo (saline) or
      ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and
      continuing for the first three postoperative days (96 hours in total). Prior to starting the
      infusion a loading dose of ketamine (0.1 mg per kg) will be administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult patients (18 years and above) who are undergoing either thoracotomy or video
             assisted thoracic surgery (VATS).

          -  Participants must be able to understand English.

        Exclusion Criteria:

          -  Patient refusal

          -  History of previous chronic thoracic pain

          -  Neuropathic pain (whatever the site), existing at time of recruitment

          -  Pre-operative analgesic treatments which include the following medications: strong
             opioids (step 3 analgesics), tricyclic antidepressants, venlafaxine, gabapentin,
             pregabalin, duloxetine, clonazepam or carbamazepine.

          -  Allergy to bupivacaine, morphine, paracetamol, tramadol, dihydrocodeine or ketamine.
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: oral cromolyn sodium; Placebo
Intervention description: Oral cromolyn sodium; Saline
Intervention MeSH terms: Cromolyn Sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when
      made into a viscous preparation for the treatment of eosinophilic esophagitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of eosinophilic esophagitis

        Exclusion Criteria:

          -  Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed
             corticosteroids will require a 4 week washout period.

          -  Pregnancy (all females of child bearing potential will have urine pregnancy test done
             at baseline).

          -  Evidence of pathologic eosinophilia in other locations in the GI tract.

          -  Participation in another research protocol

          -  Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and
             liver function panel drawn)
Control of Pain in Intravitreal Injections Using Topical NSAIDs
Condition: Intravitreal Injections; IVI
Intervention: Bromfenac; Artificial tears
Intervention description: An NSAID used to treat eye pain and swelling; eye drops to lubricate the eye and maintain moisture
Intervention MeSH terms: Bromfenac; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain

Summary:

      Intravitreal injections (IVI) are a common form of treatment for multiple retinal
      pathologies. The investigators hypothesize that an intervention with a topical NSAID will
      alleviate pain experienced at intravitreal injection (IVI) and post-IVI. 46 participants will
      be recruited, randomized into 1 of 3 treatment arms, and can expect to be on study for a day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eyes with retinal pathology requiring anti-VEGF therapy

          -  Previously had an IVI

        Exclusion Criteria:

          -  History of previous eye surgery other than cataract extraction

          -  Herpetic eye disease

          -  Uncontrolled glaucoma

          -  Uveitis

          -  Acute conjunctivitis

          -  Pregnancy

          -  Known previous adverse response or contraindication to intravitreal injection,
             Bromfenac, or other NSAIDs.

          -  Keratitis including povidone-induced keratitis

          -  Bullous keratopathy

          -  Diagnosis of dry eye syndrome

          -  Uncontrolled diabetes

          -  NSAID use 3 days prior to IVI
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
Condition: Breast Reconstruction; Anesthesia; Transverse Abdominis Plane Block
Intervention: Liposomal bupivacaine; Regular bupivacaine
Intervention description: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.; 20mL of 0.25% bupivacaine injected on each side.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking description: Participants and plastic surgeons will be blinded to the study treatment arm
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will compare the efficiency of transversus abominus plane (TAP) block using
      liposomal bupivacaine versus plain bupivacaine that is administered in the operating room
      under ultrasound guidance prior to the in patients undergoing abdominally-based free flap
      breast reconstruction at Vanderbilt University Medical Center.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age between 18-85 years

          2. males or females

          3. plastic surgery for abdominally-based free flap breast reconstruction.

        Exclusion Criteria:

          1. those not candidates for TAP blocks due to allergies to the medications (e.g.,
             bupivacaine)

          2. those with anatomic contra-indications to performing a TAP block

          3. those unwilling to participate in follow-up assessments

          4. vulnerable populations

          5. chronic pain or associated diagnosis
The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
Condition: Adenotonsillar Hypertrophy; Obstructive Sleep Apnea; Tonsillitis; Adenoiditis
MeSH terms: Tonsillitis; Sleep Apnea, Obstructive; Hypertrophy
Intervention: Normal Saline; Dexmedetomidine
Intervention description: to arms 2,4. Serves as the placebo.; to arms 1,3
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: 92.0
Sex: All
Minimum age: 3 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The investigators aim to investigate the effect of dexmedetomidine on the perioperative
      respiratory complications in this patient population undergoing both awake and deep tracheal
      extubation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without
             myringotomy or myringoplasty

          -  ASA 1 & 2

        Exclusion Criteria:

          -  Known allergy or hypersensitivity reaction to dexmedetomidine

          -  Organ dysfunction (renal/hepatic failure or leukemia)

          -  Cardiac disease (congenital or acquired)

          -  Airway or thoracic malformation

          -  Cerebral palsy

          -  Hypotonia

          -  Need for premedication

          -  Current/recent upper respiratory infection (within four weeks prior to the surgery)

          -  Asthma

          -  Allergy or intolerance to clonidine

          -  Non-English speaking parents/patients.
Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence
Condition: Medication Adherence
Intervention: Varenicline; Placebo
Intervention description: Participants will be provided varenicline medication; Participants will be provided placebo medication
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Balanced placebo design
Masking: Double (Participant, Investigator)
Masking description: double-blind
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The current study will use the double-blind balanced placebo design to examine differences
      between expectancies versus the pharmacological effects of varenicline medication
      administered for two weeks to cigarette smokers. The double-blind balanced placebo design
      includes medication administration (active medication v. placebo) and medication information
      (told truth v. deception) resulting in four groups of smokers: (1) told therapeutic dose (TD)
      medication + received TD medication; (2) told TD medication + received placebo; (3) told low
      dose (LD) medication+ received TD dose medication; (4) told LD medication + received placebo.
      Ecological momentary assessments (EMA) in the form of Daily Dairies delivered via smartphone
      will assess real-time side effects, withdrawal symptoms, cigarettes smoked, medication use,
      and reasons for medication non-adherence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Smoking at least 5 cigarettes per day (cpd) for the past year

          -  A carbon monoxide (CO) >10ppm

          -  English speaking

          -  Must own a cellphone with SMS text capacity with Internet access OR daily use of email

          -  Must be varenicline naïve

          -  Express a desire to quit smoking

        Exclusion Criteria:

          -  Living in a restricted environment (e.g., prison or jail facility, etc.)

          -  Pregnant or nursing

          -  Currently enrolled in a smoking cessation treatment program, using NRT products, or
             prescribed bupropion or varenicline

          -  Known allergy to varenicline

          -  History of kidney disease, dialysis or known kidney impairment

          -  Cognitive impairment or unstable psychiatric condition that interferes with the
             informed consent process (individuals stable on psychiatric medications will be
             included)

          -  Daily or exclusive use of other tobacco products

          -  Current suicidal or homicidal ideation or a suicidal attempt within the past 12 months

          -  History of stroke, heart attack, or seizures
Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes
Condition: Type 1 Diabetes; Diabetic Nephropathy; Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 1
Intervention: sodium bicarbonate
Intervention description: All participants will receive 2 doses of 1950mg sodium bicarbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether alkalinization of urine uric acid by 2
      doses of sodium bicarbonate (1950mg) over 24-hours reduces precipitation and crystallization
      of urine uric acid over in adults with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (aged 18-45 years) with type 1 diabetes

          -  Participants must be able to be fasting prior to study visit and give informed
             consent.

        Exclusion Criteria:

          -  Non-type 1 diabetes

          -  History of eGFR <60 ml/min/1.73m2 or microalbuminuria or greater

          -  History of hypocalcemia or at risk of hypocalcemia

          -  Taking allopurinol or uric acid altering medications

          -  Ketogenic diet

          -  Ketonuria

          -  Taking phosphorus binders (e.g. sevelamer)

          -  Pregnant or breastfeeding

          -  Taking the following medications which may interact with sodium bicarbonate (e.g.
             phentermine, pseudoephedrine, antifungal medication, cephalosporin antibiotics [e.g.
             Keflex], tetracycline antibiotics [e.g. doxycycline], steroids or lithium)

          -  Taking SGLT-2 inhibitors

          -  Taking blood pressure medications
Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic Acid
Intervention description: Intravenous infusion of 5 mg zoledronic acid
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Denosumab; Bone turnover markers; Bone mineral density

Summary:

      Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that
      prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease
      bone resorption and fracture risk, and many patients will reach osteopenic bone mineral
      density (BMD) levels on treatment with denosumab. The treatment effect on bone turnover and
      BMD has, however, been demonstrated to be reversible. This study will show if the bone mass
      can be maintained by administrating zoledronic acid and if timing of the first dose of
      zoledronic acid after last dose of denosumab matters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (postmenopausal for at least two years)

          -  Men above 50 years

          -  Treatment for at least two years with denosumab

          -  Last denosumab injection less than five months ago

        Exclusion Criteria:

          -  Low-energy vertebral fracture at any time

          -  Low-energy hip fracture within the last 12 months

          -  BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)

          -  Alendronate treatment for more than three years prior to denosumab treatment

          -  Ongoing treatment with glucocorticoids

          -  Metabolic bone disease

          -  Hormone replacement therapy

          -  Cancer

          -  Estimated glomerular filtration rate (eGFR) < 35 mL/min

          -  Allergy to zoledronic acid

          -  Hypocalcaemia

          -  Contraindications for zoledronic acid according to the SPC
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid; Necrosis
Intervention: tofacitinib; tofacitinib; adalimumab; etanercept
Intervention description: Oral tablet, 5 mg BID; Oral tablet, 10 mg BID; Pre-filled syringe, 40 mg subcutaneous injection, every other week; Pre-filled syringe, 50 mg subcutaneous injection, every week
Intervention MeSH terms: Adalimumab; Etanercept; Tofacitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4372.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Post-marketing; Phase 4; Open-label; Safety Surveillance; CP690550; Xeljanz; oral treatment

Summary:

      This post-marketing study is designed to compare the safety of tofacitinib versus TNF
      inhibitor with respect to major cardiovascular adverse events and malignancies, excluding
      non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety
      events, including non-melanoma skin cancers, hepatic events, infections, and efficacy
      parameters will be collected and evaluated in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe rheumatoid arthritis

          -  Taking methotrexate without adequate control of symptoms

          -  Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure,
             high cholesterol levels, diabetes mellitus, history of heart attack, family history of
             coronary heart disease, extra-articular RA disease)

        Exclusion Criteria:

          -  Current or recent infection

          -  Clinically significant laboratory abnormalities

          -  Pregnancy