bioihbjkbjnl/mcl2 huggingface dataset:
An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
Condition: Pain, Postoperative; Spine Injuries and Disorders; Narcotic Use
MeSH terms: Pain, Postoperative; Spinal Injuries
Intervention: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone
Intervention description: The study subjects will be assigned to the defined pre-op MMA regimen with standard postop oxycodone based pain control regimen given on an as needed basis. The treatment group outcomes will be compared to patients outside of the study including a historical control group (receiving only post-op pain regimen) prior to the implementation of the new regimen. The studied treatment group will receive within 3 hours before surgery an oral MMA regimen consisting of:
Acetaminophen 975 mg Celecoxib 200 mg Gabapentin 300 mg Oxycodone 10 mg Extended Release
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: A prospective cohort study
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the hypothesis that multimodal pain regimen
      (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered
      pre-operatively before elective spine surgery significantly decreases acute pain
      post-operatively as well as decreasing requirements of post-op opioids for pain control in
      PACU as compared to patients undergoing elective spine surgery without a pre-operative pain
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing elective spine surgery at NYU Winthrop

          -  Age over 18 years

        Exclusion Criteria:

          -  History of neuromuscular disorders

          -  History of inflammatory arthropathies

          -  History of spine metastases or active cancer in spine

          -  Medical History including any of the following: renal dysfunction, gastric ulcers,
             hepatic dysfunction, coagulopathic/bleeding disorders, prior adverse or allergic
             reactions to any of the medications in the study

          -  Age less than 18 years
TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone
Condition: Myofascial Pain
Intervention: Ketorolac; Lidocaine; Dexamethasone
Intervention description: Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.; Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.; Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Intervention MeSH terms: Dexamethasone; Ketorolac; Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trigger Point Injections; steroid; nsaid

Summary:

      Hypothesis

      The main hypothesis of this study is that anti-inflammatory medications (ketorolac or
      dexamethasone) will provide longer-lasting and greater pain relief than just lidocaine in
      trigger point injections where a local twitch response is evoked at the time of the
      injection.

      Purpose/Specific Aims

      The primary objective of this study is to compare the efficacy of three substances used in
      TPIs with a LTR identified at the time of the injection: a CS (dexamethasone), a NSAID
      (ketorolac), or only a local anesthetic (lidocaine).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women age 18 or over

          2. At least one active trigger point

        Exclusion Criteria:

          1. Allergy or contraindication to any NSAID, CS, or local anesthetic

          2. Receiving anticoagulant medication

          3. History of bleeding disorder

          4. Pregnant or breast feeding women

          5. Gastrointestinal ulceration

          6. Pre-existing renal disease

          7. Pre-existing congestive heart failure

          8. Diabetes mellitus

          9. Prior myocardial infarction or stroke

         10. Fibromyalgia
A Comparison of Long-acting Injectable Medications for Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: haloperidol decanoate; paliperidone palmitate
Intervention description: haloperidol decanoate injections, 25-200 mg once a month; Paliperidone palmitate injections, 39 mg - 234 mg once a month
Intervention MeSH terms: Haloperidol; Paliperidone Palmitate; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to compare the "real-world" effectiveness of two
      FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone
      palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective
      disorder who are expected to benefit from the improved medication compliance associated with
      injectable medications. The goal is to evaluate the effects of the medications on outcomes of
      importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy
      makers (all of the above plus costs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR
             criteria

          -  Age 18-65 years

          -  Capacity to provide informed consent

          -  Patients who are likely to benefit from treatment with long-acting injectable
             paliperidone palmitate or haloperidol decanoate

          -  Women of child bearing potential must have a negative serum pregnancy test at the
             Screening Visit.

        Exclusion Criteria:

          -  Patients who are currently stable and doing well on an antipsychotic regimen

          -  Patients not expected to benefit from the study medications due to past experience
             with risperidone, paliperidone or haloperidol

          -  Patients with tardive dyskinesia that is moderate or severe

          -  Patients with any medical condition that, in the judgment of the investigator, might
             preclude safe completion of the study

          -  Women who are pregnant or breastfeeding

          -  Patients with mental retardation
Post-Op Lidocaine Patch
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Lidoderm 5 % Topical Patch; Sham Topical Patch
Intervention description: Lidocaine patch after cesarean section delivery.; Sham patch after cesarean section delivery.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cesarean section; Postoperative pain

Summary:

      Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative
      cesarean incision pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant patients who require a scheduled or non-urgent cesarean birth

          -  Patient able to receive neuraxial analgesia

          -  Patient able to give verbal and written consent for both cesarean birth and study

        Exclusion Criteria:

          -  Patients requiring emergent cesarean birth

          -  Patients allergic to lidocaine or adhesive

          -  Patients who have already received an epidural during this admission or requiring
             general anesthesia for cesarean birth

          -  Patients using chronic oral neuromodulators

          -  Patients with cardiac disease or using anti-arrhythmic agents

          -  Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis,
             osteoarthritis, or lupus.

          -  Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the
             study.
Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Intervention: Lansoprazole
Intervention description: Lansoprazole capsules
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GERD; Gastroesophageal Reflux Disease; Drug Therapy

Summary:

      The purpose of this study is to measure the safety, efficacy and quality of life of
      lansoprazole in patients with reflux disease over a five year period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had Gastro Esophageal Reflux disease with or without oesophagitis.

          -  Had a history of heartburn at least for 5 days per week during the past 6 months or
             was receiving long-term treatment with a proton pump inhibitor and during two weeks
             (without proton pump inhibitor treatment) prior to enrolment.

        Exclusion Criteria:

          -  History of surgery of stomach or oesophagus.

          -  Gastric ulcer (can be included after healing of gastric ulcer).

          -  Duodenal ulcer (can be included after healing of duodenal ulcer).

          -  Bleeding (melena, hematemesis).

          -  Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).

          -  Barrett oesophagus with dysplasia.

          -  Complicated esophagitis (oesophageal strictures or ulcers).

          -  Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within
             the previous two weeks.

          -  Pregnancy, wish to become pregnant, breast feeding.

          -  Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic
             acid (aspirin) > 100 mg/day.
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension; Timolol Maleate 0.5%
Intervention description: Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.; Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-Angle Glaucoma; Ocular Hypertension; Simbrinza™; Intraocular Pressure

Summary:

      The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period
      using Simbrinza™ topical ophthalmic suspension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.

          -  Willing and able to attend all study-related visits and be housed overnight at
             clinical site for the study assessments.

          -  Must sign an Informed Consent form.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential if pregnant, breastfeeding, or not using adequate
             birth control.

          -  Severe central visual field loss in either eye.

          -  Chronic, recurrent or severe inflammatory eye disease.

          -  Ocular trauma or ocular surgery within the past 6 months.

          -  Ocular infection or ocular inflammation within the past 3 months.

          -  Clinically significant or progressive retinal disease.

          -  Other ocular pathology, including severe dry eye, that may in the opinion of the
             investigator preclude the administration of study medication.

          -  Any other conditions including severe illness which would make the patient, in the
             opinion of the Investigator, unsuitable for the study.

          -  Any medical condition that would preclude the safe administration of a topical
             beta-blocker.

          -  Cannot safely discontinue all glucocorticoids administered by any route.

          -  Other protocol-specified exclusion criteria may apply.
Sodium Supplementation and Growth in Very Low Birth Weight Infants
Condition: Extreme Immaturity
MeSH terms: Birth Weight
Intervention: Sodium chloride; Placebo
Intervention description: sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 53.0
Sex: All
Minimum age: 7 Days
Maximum age: 8 Days
Healthy volunteers: No
Keywords: anthropometrics; weight; nutrition

Summary:

      Adequate growth during the neonatal period is critical for optimal long term outcomes.
      Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to
      thrive suggesting that factors other than total calorie intake are important in ensuring
      consistent weight gain. Several reports have indicated a positive sodium balance is critical
      in ensuring good weight gain in very low birth weight infants, however these infants are
      susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to
      diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but
      there is no evidence for this practice in preterm neonates. Our central hypothesis is that
      early supplementation with sodium will ensure positive sodium balance in very low birth
      weight infants and will result in optimal weight gain and enhanced long term outcomes.
      Secondarily we hypothesize that low sodium concentrations in the urine will not correlate
      with low serum sodium values.
    

Eligibility criteria:

        Inclusion Criteria:

          -  infants born at less than 32 weeks postmenstrual age

        Exclusion Criteria:

          -  infants with major malformations deemed incompatible with life disease states
             characterized by edema renal failure, defined as an increase in serum creatinine by
             0.5 mg/dl/day or urine output less than 0.5 ml/kg/hour
Functional Effects of Botox on the Brain Using MRS and fMRI
Condition: Healthy
Intervention: onabotulinumtoxinA
Intervention description: This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA .
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 30 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in
      a growing number of indications including disorders involving skeletal muscle (e.g.,
      strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g.,
      bladder), glands (axillary hyperhidrosis) and nociceptive pain (e.g. migraine) (Brin. 2014).
      Recently, several studies have suggested that peripheral BOTOX injections in the region of
      the glabellar lines (muscles around the eyes) may be effective in treating major depression
      and chronic migraine. However, the mechanism underlying the effect of peripheral BOTOX
      injections on the brain is not well understood. Therefore, the Investigators propose to
      further explore the functional effects of BOTOX injections on brain in healthy controls. The
      approach will involve the measurement of brain metabolites in the brainstem using MRS as well
      as an investigation of the functioning and connectivity between regions of the brain using
      resting state MRI and high resolution fMRI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females

          -  Ages 30-40 years of age

          -  Right-handed

          -  Normal or corrected-to-normal vision

          -  No history of psychiatric, neurological, or medical co-morbidities that might
             interfere with normal brain functioning

          -  Fluent in English

          -  Moderate to severe glabellar lines

        Exclusion Criteria:

          -  Pregnancy

          -  Ferrous metal, a pacemaker, or other battery-operated device implanted in the body

          -  Claustrophobia

          -  Known hypersensitivity to Botulinum Toxin

          -  Infection on the forehead or between the eyes

          -  Urinary tract infection
Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen
Condition: Pain
Intervention: Oral Acetaminophen; IV Acetaminophen; IV Morphine; Placebo Tablets; Saline
Intervention description: Acetaminophen for oral administration (2 tablets, 500 mg/tablet); Acetaminophen for intravenous (IV) administration (1,000 mg/100 mL); Morphine for IV administration (0.125 mg/kg); Placebo tablets matching oral acetaminophen; Saline placebo matching IV acetaminophen
Intervention MeSH terms: Acetaminophen; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post-surgical pain; Pharmacokinetics

Summary:

      Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can
      reduce the amount of opioids needed for this.

      The problem is that morphine slows down digestion. That can delay pain relief from APAP
      pills. It can even change what the body does to the drug [pharmacokinetics (PK)].

      Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills.

      This study will measure the PK of APAP pills and IV when used with morphine in healthy
      volunteers.

      IV APAP will likely be more effective and cause fewer side effects when used with morphine to
      treat pain after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must have a health status of "healthy" assessed by the investigator and
             defined as no clinically significant deviation from normal medical history, physical
             examination, vital signs, and clinical laboratory determinations.

          2. Subject must have a body mass index ≥ 19.0 and ≤ 32.0 kg/m² with a minimum weight of
             110 pounds (50 kg) at Screening.

        Exclusion Criteria:

          1. Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B
             (surface antigen), or hepatitis C virus antibody at screening.

          2. Subject has a history of any drug allergy, hypersensitivity, or intolerance to
             acetaminophen or morphine/opioids or to any of the excipients in the IV or oral
             formulations used.

          3. Subject has an oxygen saturation of less than 95% while awake at screening and
             check-in.

          4. Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates,
             cannabinoids, benzodiazepines, cocaine, amphetamine) or alcohol at the screening and
             check-in.

          5. Subject has donated or had significant loss of whole blood (480 mL or more) within 30
             days, or plasma within 14 days prior to dosing.

          6. Subject has any other medical, psychiatric and/or social reason for exclusion as
             determined by the investigator.
Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity
Condition: Metabolic Syndrome X
MeSH terms: Obesity; Metabolic Syndrome
Intervention: Eplerenone; Ramipril
Intervention description: 5 mg x 1 week followed by 10 mg x 9 weeks.; Ramipril 5mg qd x 1 week f/b Ramipril qd x 9 weeks.
Intervention MeSH terms: Ramipril; Eplerenone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fibrolytic Dysfunction; Obesity; PAI-1

Summary:

      The combination of high blood pressure and having central obesity is an increasing important
      factor for heart disease in men and women. It can also lead to the early development of
      hardening of the arteries and increased risk of a stroke. This study will analyze patients'
      genetic make up to identify who may be at greater risk for heart disease and strokes in
      relationship to high blood pressure and central obesity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or females between the ages of 18 to 65 years of age.

          -  Documented diagnosis for the metabolic syndrome:

          -  Subjects with hypertension (SP>130mmHg)

          -  Subjects with central obesity (females waist >35"; males waist >40")

          -  Subjects with dyslipidemia (HDL <40mg/dl, triglycerides > 150 mg/dl)

          -  Subjects who are insulin resistance (fasting glucose >100mg/dl)

        Exclusion Criteria:

          -  Subjects who smoke

          -  Women who are pregnant (confirmed by urine beta-HCG).

          -  Women who are breast feeding

          -  Subjects with documentation of the following health risk:

               -  Subjects with serum creatinine >2.0 mg/dl (males), >1.8 mg/dl (females)

               -  Subjects whose creatinine clearance < 50 mls/min

               -  Subjects with serum potassium >5.5mEql

               -  Subjects with Type 2 diabetes with microalbuminuria (spot urine
                  protein/creatinine ration >0.2)

          -  Subjects who are currently taking the following medications:

          -  Warfarin