bioihbjkbjnl/mcl2 huggingface dataset:
Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients
Condition: Head and Neck Cancer; Acute Pain; Postoperative Pain
MeSH terms: Acute Pain
Intervention: Gabapentin; Placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oral cavity; oropharynx; hypopharynx and larynx

Summary:

      Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect
      provider and hospital quality of care. Furthermore, at the core of a healthcare team and
      healthcare system is the desire to provide patients with the best possible care in order to
      achieve the best possible outcomes. Providers have the duty to identify areas of needed
      improvement within the domains of treatment. An area of need that is ubiquitous within
      medicine is pain control; in this case acute postoperative pain control is the targeted
      condition. Studies have already shown that better control of acute postoperative pain leads
      to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient
      satisfaction and a reduced likelihood of developing chronic pain. Research within the field
      of pain management has definitively revealed that a combination of different medication
      regimens can control acute postoperative pain better than narcotics alone. In particular, the
      medication gabapentin has been shown to improve acute postop pain in many kinds of surgical
      settings, and it is a safe medication with arguably fewer side effects than narcotics. The
      investigators know that certain groups of post surgical otolaryngology patients can be at
      risk for high levels of postoperative pain. Given all of this information, physicians have a
      responsibility to utilize medications such as gabapentin to do a better job of controlling
      patient's pain. This investigation is a quality improvement project designed to elucidate the
      benefits of gabapentin in pain management in patients undergoing surgery of the head and neck
      mucosal surfaces. It will provide much needed data in an understudied population and
      ultimately will improve the practice of pain management, patient satisfaction and quality of
      care delivered in the Barnes otolaryngology department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects undergoing definitive mucosal head and neck resection including oral cavity,
             oropharynx, larynx, and hypopharynx

          -  At least one night of planned inpatient stay

        Exclusion Criteria:

          -  Incapable of giving informed consent

          -  Age less than 18

          -  Glomerular Filtration Rate (GFR) less than 30

          -  Allergy to gabapentin

          -  Baseline gabapentin or lyrica use

          -  Chronic opioid use for over six months
Guanfacine in Children With Tic Disorders
Condition: Tourette Disorder; Tourette Syndrome
MeSH terms: Tourette Syndrome; Tic Disorders; Tics
Intervention: placebo; extended-release guanfacine (Intuniv)
Intervention description: Administered up to 8 weeks.; 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
Intervention MeSH terms: Guanfacine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tourette Syndrome; Tourette Disorder; Tics; Motor tics; Vocal tics; Intuniv; Guanfacine; Medication; Drug; Placebo; Child; Children; Adolescent

Summary:

      The goal of this pilot study is to obtain preliminary information on the tolerability and
      efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette
      Disorder (TD, also called Tourette syndrome).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.

          -  Between ages 6 yrs 0 mos and 17 years 0 months.

          -  Weight >/= 15 kg (33 lbs).

          -  Ability to swallow pills whole.

        Exclusion Criteria:

          -  IQ < 80.

          -  Positive pregnancy test.

          -  Positive drug test.

          -  Low blood pressure.

          -  Prior history of hypersensitivity to guanfacine.

          -  Prior failed treatment with an adequate trial of guanfacine in last 2 years.

          -  Concurrent treatment with another psychoactive medication for tics, stimulant
             medication, or Habit Reversal therapy.

          -  Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks
             with no planned changes; SSRIs are allowed.
Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Pain, Postoperative
Intervention: Ropivacaine; Ketorolac; Clonidine; Epinephrine; 0.9% sodium chloride
Intervention description: Ropivacaine (5mg/ml)-50ml; ketorolac (30mg/ml)- 1 ml; clonidine (0.1mg/ml)- 0.8ml; epinephrine (1mg/ml)-1ml; Sodium chloride 0.9%- 47.7 ml
Intervention MeSH terms: Ketorolac; Clonidine; Epinephrine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the use of a local injection around the knee (periarticular) during
      total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The
      injection is a combination of various medications which are thought to reduce pain levels.

      Approximately 128 patients will participate in this study, half of the patients will receive
      this injection during surgery and the other half will receive a saline (salt water)
      injection. Pain scores after the surgery will be compared between the two groups.

      All patients will also receive a long-acting (24 hours) morphine injection during surgery.

      The hypothesis is that those participants receiving intrathecal Duramorph and local
      periarticular injections will have improved pain scores and reduced narcotic use when
      compared with intrathecal Duramorph alone at 48 hours postoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Written informed consent

        Exclusion Criteria:

          -  Pregnant women

          -  Creatinine clearance less than 60 ml/min

          -  BMI greater than 40

          -  Currently use greater than 80mg morphine-equivalents daily (pre-operatively)

          -  Receive a unicondylar knee replacement
Loteprednol vs. Prednisolone and Fluorometholone
Condition: Intraocular Pressure; Corneal Opacity
MeSH terms: Corneal Opacity
Intervention: Loteprednol Etabonate 0.5% Oph Gel; Prednisolone Acetate 1% Oph Susp
Intervention MeSH terms: Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Examiners are masked to the treatment arm when obtaining measurements of intraocular pressure (IOP) and grading corneal haze.
Enrollment: 131.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Photorefractive keratectomy

Summary:

      Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially
      vision-threatening postoperative complication of photorefractive keratectomy (PRK). Topical
      ophthalmic corticosteroids are routinely prescribed by most surgeons postoperatively to help
      prevent this complication.

      Goals of topical steroids use after PRK include effective modulation of the healing response
      to prevent corneal haze while at the same time minimizing side effects, such as intraocular
      pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that
      exerts its therapeutic effects and is then quickly changed into inactive metabolites. This
      relatively fast metabolism of loteprednol gives it a lower side effect profile than other
      steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature,
      there is currently no consensus on a standard regimen or which type of corticosteroid should
      be used after PRK.

      Investigators are conducting a prospective, randomized trial to compare the incidence of
      intraocular pressure rise and visually significant postoperative corneal haze after PRK with
      the use of loteprednol 0.5% gel compared to the use of earlier generation steroids,
      prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects who are deemed suitable candidates for PRK after routine refractive
             surgery screening will be considered eligible for participation in this study.

          -  Subjects must be at least 21 years of age and not pregnant or nursing (due to
             fluctuations in visual parameters during pregnancy).

        Exclusion Criteria:

          -  Selection will be consistent with the current standard of care for PRK. Any patient
             that is not a suitable candidate for PRK will not be included.
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Condition: Spinal Fusion Acquired; Spinal Stenosis; Lesions of Lumbosacral Intervertebral Disc; Spinal Diseases
MeSH terms: Spinal Stenosis; Spinal Diseases
Intervention: Dexmedetomidine; 0.9% Saline
Intervention description: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.; Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Lumbar Fusion; Inflammation; Dexmedetomidine; Length of Hospital Stay; General Anesthesia; Anti-inflammatory; GPCR; Cytokine; Immune Response

Summary:

      Major lumbar spine surgery causes inflammation, soreness and swelling that can delay
      discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory
      effects. This study will evaluate whether DEX can help get patients out of the hospital
      faster after major spine surgery by reducing the inflammation associated with the procedure
      itself. A separate part of the study will evaluate the blood levels of some specific
      indicators of inflammation called cytokines. Measuring cytokines before and after surgery
      will aid in determining if DEX has altered the inflammatory response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Classification I - III

          -  Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels

        Exclusion Criteria:

          -  Allergy to dexmedetomidine

          -  Cardiac disease with reduced ejection fraction < 30%

          -  History of cirrhosis, active hepatitis or attenuated hepatic function

          -  Chronic use of steroids, COX-2 inhibitors, alpha-2 agonists, or statins

          -  Current anticoagulant therapy

          -  Patients requiring motor evoked potential (MEP) monitoring

          -  Positive pregnancy test
Magnesium Sulfate in Obese Preeclamptics
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Intervention: Magnesium sulfate 4g loading dose, 1g/hr infusion; Magnesium sulfate 6g loading dose, 2g/hr infusion
Intervention MeSH terms: Magnesium Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to learn how medications participant will receive in the course
      of their delivery are metabolized (broken down by the body). The investigators hope to learn
      more about the way drugs are metabolized by pregnant women, and how those drugs are
      distributed in the blood and body compartments and cleared in the urine, and how maternal
      body weight affects the metabolism. With this information the investigators will be able to
      develop a treatment regimen considering factors in the body that affect magnesium levels so
      that the investigators can improve treatment of pregnant women. The goal of the study is to
      understand how different dosing of magnesium sulfate affects blood levels of the magnesium in
      larger women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women who are ages 18-45

          -  32-42 weeks' pregnant

          -  Prescribed magnesium sulfate for preeclampsia

          -  BMI ≥35 kg/m2

        Exclusion Criteria:

          -  Pregnant women < 32 weeks' pregnant

          -  Women who are on dialysis
Study With Aminophylline to Attenuate of the Side Effects of Regadenoson
Condition: Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
Intervention: Aminophylline; Placebo
Intervention description: 75 mg of intravenous aminophylline; Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Intervention MeSH terms: Aminophylline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 248.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: regadenoson; lexiscan; aminophylline; SPECT; Myocardial Perfusion Imaging; pharmacologic stress test

Summary:

      The routine administration of 75 mg of intravenous aminophylline following regadenoson
      (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce
      the gastrointestinal (diarrhea and stomach upset) and other side effects related to
      regadenoson.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients referred to undergo a clinically-indicated regadenoson-stress
             myocardial perfusion imaging at Rush University Medical Center

        Exclusion Criteria:

          -  Patient refusal to participate

          -  Known allergic reaction to aminophylline.

          -  Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea,
             abdominal discomfort, nausea or vomiting.

          -  Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and
             acute coronary symptoms.

          -  Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12
             months or any seizure in the past week.

          -  Pregnant or breast-feeding women.

          -  Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).
Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Placebo; Montelukast; Levocetirizine
Intervention description: Pharmaceutical form: Over-encapsulated tablet
Route of administration: Oral use; Pharmaceutical form: Over-encapsulated tablet
Concentration: 10 mg
Route of administration: Oral use; Pharmaceutical form: Over-encapsulated tablet
Concentration: 5 mg
Route of administration: Oral use
Intervention MeSH terms: Montelukast; Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Levocetirizine; Xyzal; Rhinitis; Allergic; Seasonal; Ragweed

Summary:

      To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of
      seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an
      environmental exposure unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years

          -  Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR)
             related symptoms (mean value), as defined by the protocol

        Exclusion Criteria:

          -  Any clinically significant condition that might interfere with the treatment
             evaluation, both for efficacy and safety

          -  Have used forbidden concomitant medications as defined by the protocol
A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
Condition: Total Hip and Knee Arthroplasty
Intervention: Liposomal Bupivacaine; Ropivacaine; Bupivacaine; Clonidine; Ketorolac; Epinephrine
Intervention description: Periarticular injection; Periarticular injection; Included as an element of the Liposomal bupivacaine intervention periarticular injection; Included as an element of both interventions as a standard of care periarticular injection; Included as an element of both interventions as a standard of care periarticular injection; Included as an element of both interventions as a standard of care periarticular injection
Intervention MeSH terms: Ketorolac; Clonidine; Epinephrine; Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study evaluates two routinely used drug combinations for periarticular injection
      following total hip and knee arthroplasty for pain control. One group will receive liposomal
      bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive
      ropivacaine, clonidine, epinephrine and ketorolac.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)

        Exclusion Criteria:

          -  Current use of opioid drugs

          -  Revision surgery

          -  Surgical complication (femoral fracture with implant insertion)

          -  Inability to provide Informed Consent
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer; Ulcer
Intervention: TheraHoney HD; SkinTegrity
Intervention description: Honey; Hydrogel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No
Keywords: skin ulcers

Summary:

      Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer
      wounds
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects of any age

          -  Sacral wounds with necrotic tissue

        Exclusion Criteria:

          -  3rd degree burns

          -  know hypersensitivity to products
Studying the Effects of Sibutramine on Eating Behavior
Condition: Obesity
MeSH terms: Obesity
Intervention: Sibutramine; Placebo
Intervention description: 1 week of active sibutramine (15mg); 2 weeks of placebo
Intervention MeSH terms: Sibutramine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Obesity; sibutramine; eating behavior

Summary:

      Obesity is a major public health concern, and the search for useful pharmacologic
      interventions is ongoing. This study aims to develop a comprehensive series of assessments to
      directly assess eating behavior, cognitive functioning, and psychological functioning under
      sibutramine and placebo conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  moderately obese

          -  stable weight for a minimum of 3 months

          -  systolic blood pressure less than or equal to 140 mm Hg

          -  diastolic blood pressure less than or equal to 90 mm Hg

          -  pulse less than or equal to 95 beats per minute

          -  English language proficiency

        Exclusion Criteria:

          -  on medications known to affect appetite, weight, or metabolism

          -  current or past history of: binge eating disorder, anorexia nervosa or bulimia
             nervosa, major depression

          -  current or past evidence of psychosis, bipolar illness

          -  current or past history of alcohol or drug abuse or dependence

          -  known history of learning disorder or developmental disability

          -  current or past attention deficit hyperactivity disorders

          -  low platelet count

          -  current diabetes mellitus

          -  uncontrolled asthma, or controlled only with oral steroids

          -  hypothyroidism not adequately treated

          -  pregnancy, planning to become pregnant, or lactation within the previous 6 months

          -  history of neurological disorder or injury

          -  history of moderate or severe head injury

          -  waist circumference greater than 188 cm

          -  indwelling metallic object, non-removable metal jewelery, medicinal patch or recent
             metallic ink tattoo

          -  pacemaker

          -  metallic implants

          -  medication patches

          -  significant claustrophobia

          -  color blindness