bioihbjkbjnl/mcl2 huggingface dataset:
Low Pain Prediction in Cesarean Section Patients
Condition: Scheduled Cesarean Sections; Postoperative Pain Management; Side Effects
MeSH terms: Pain, Postoperative
Intervention: duramorph; placebo
Intervention description: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.; placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: postoperative pain; narcotic side effects

Summary:

      The investigators are attempting to see if eliminating the amount of long acting spinal
      narcotic during cesarean section delivery will demonstrate pain scores with movement when
      evaluated 24 hours postoperatively as those that receive the standard dosage of spinal
      narcotic when combined with oral acetaminophen or placebo. The investigators also are
      evaluating if there are decreased side effects related to decreased narcotic usage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  anticipated pain level estimated to be in the lowest 20th percentile (calculated <34.3
             utilizing our standard preoperative questionnaire)

          -  age >/= 18

          -  not allergic to any study medications to be utilized in this study

          -  singleton pregnancy

        Exclusion Criteria:

          -  allergies to morphine or acetaminophen

          -  diagnosis of a chronic pain disorder

          -  weight >300 lbs

          -  hepatic disease
A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone; Advair
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate
      comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in
      control of mild persistent asthma?

      The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy
      with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50,
      when measured by this standard methodology (methacholine bronchoprovocation) in subjects with
      mild persistent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects 18 to 65 years of age

          -  a >2 year history of asthma

          -  FEV1 > 80% for subjects currently using Advair®.

        Exclusion Criteria:

          -  severe asthma

          -  current smokers

          -  pregnant or breast-feeding women

          -  other chronic significant illnesses
A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients
Condition: Kidney Transplantation
Intervention: tacrolimus extended release
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Kidney; Immunosuppression; Transplant

Summary:

      Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day
      dosing regimen. This formulation has the potential to improve compliance. Current dosing
      recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day
      administered once daily in the morning. There are no specifications on appropriate dosing in
      obese patients or on whether to use actual, ideal or and adjusted weight. It will be
      advantageous to understand the pharmacokinetics of this medication in the obese to determine
      the appropriate dosing regimen. In this study, obese patients will be randomized to receive
      tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or
      adjusted body weight (aBW).
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is a recipient of a living donor or deceased donor kidney only transplant

          2. Subject is > 18 years of age

          3. BMI≥30 on POD 0

        Exclusion Criteria:

          1. Multi-organ transplant

          2. Subjects taking tacrolimus pre-transplant (i.e. positive crossmatch transplants or
             re-transplants)

          3. Patients undergoing simultaneous sleeve gastrectomy at the time of transplant.
Direct Renin Inhibition Effects on Atherosclerotic Biomarkers
Condition: Coronary Artery Disease; Type 2 Diabetes Mellitus
MeSH terms: Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Aliskiren; Amlodipine
Intervention description: 150 - 300 mg once daily for 6 weeks; 5-10 mg once daily for 6 weeks
Intervention MeSH terms: Amlodipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: diabetes; heart disease; atherosclerosis

Summary:

      The investigators aim to assess if a new blood pressure medication, aliskiren, reduces
      various biomarkers of heart disease found in the blood in patients with a history of both
      heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these
      biomarkers compared to a calcium channel blocker.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes

          -  Diagnosis of coronary artery disease

          -  Currently receiving therapy with an ACE-Inhibitor or Angiotensin Receptor Blocker

          -  Currently receiving antiplatelet therapy and statin therapy

          -  Baseline blood pressure > 100/75 mm Hg

          -  BMI 25-35 kg/m2

        Exclusion Criteria:

          -  Concurrent calcium channel blocker therapy

          -  Documented peripheral edema

          -  Hyperkalemia

          -  Serum creatinine > 2.0

          -  Diagnosed with proteinuria

          -  Diagnosed with liver dysfunction or serious rheumatological disorder
Examining the Effect of Burosumab on Muscle Function
Condition: X-linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Intervention: Burosumab Injection [Crysvita]
Intervention description: Burosumab/Crysvita SC injection monthly
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Crysvita; Burosumab

Summary:

      Patients with X-linked hypophosphatemia (XLH) often report symptoms of fatigue and weakness
      particularly after exertion, in addition to their skeletal complaints. In previous trials
      using KRN23 (same drug as burosumab/Crysvita®), patients report these symptoms improve. The
      investigators wish to test this hypothesis directly by measuring muscle energy when patients
      begin treatment with Crysvita® for the first time.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-65 years of age

          2. Diagnosis of XLH

          3. eGFR ≥ 50 (estimated glomerular filtration rate)

          4. Normal serum calcium

          5. Phosphate ≤ 2.5 mg/dl

          6. Deemed clinically appropriate for starting therapy with Burosumab/Crysvita® (based on
             the treating physician's evaluation)

          7. Deemed appropriate for MR Spectroscopy

        Exclusion Criteria:

          1. Patients with fixed skeletal abnormalities which would prevent them from successfully
             completing study-related functional assessments

          2. Patients unwilling to stop therapy with supplemental phosphate and calcitriol 2 weeks
             prior to enrollment.

          3. Patients who have undergone an orthopaedic procedure within the previous 6 months
             involving implantation of metal hardware
Evaluation of Skin Affix in the Emergency Room
Condition: Wounds
MeSH terms: Emergencies
Intervention: Skin Affix
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: SkinAffix

Summary:

      Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than 5 years of age

          -  Requires the use of a surgical skin adhesive

          -  Informed consent signed

        Exclusion Criteria:

          -  Sensitivity to topical adhesive products or formaldehyde

          -  Hx keloid formation, hypotension, diabetes, blood clotting disorders

          -  Wound infections

          -  mucosal surfaces or skin exposed to body fluids
A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Condition: Prevention of New Onset Diabetes Among Kidney Transplant Patients
MeSH terms: Diabetes Mellitus
Intervention: Insulin treatment for hyperglycemia
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney transplant; New onset diabetes; Prevention; Insulin

Summary:

      Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in
      decreasing the incidence of NODAT among de novo kidney transplant patients with manifested
      post-transplant hyperglycemia during the first week after transplantation.

      Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress
      related to the surgery and use of higher doses of immunosuppressive medications, and leads to
      lower incidence of NODAT at 1 and 2 years.

      Specific Aim 2: To determine the improvement in overall glycemic control with the early
      initiation of insulin therapy.

      Hypothesis 2: Early initiation of insulin therapy results in greater overall control of
      glycemia compared to standard care of dietary counseling, life-style modification, oral
      hypoglycemic agents and/or insulin as needed at 1 year.

      Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to
      the early initiation of insulin therapy at one year post-transplantation.

      Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of
      post-transplant hyperglycemia and preserves better beta-cell function at 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients (> 18 years) with end stage renal disease (ESRD) undergoing kidney
             transplantation;

          2. Standard triple immunosuppressive medications following kidney transplantation
             including tacrolimus, mycophenolate mofetil and corticosteroids;

          3. Capable to understand the study protocol and to give informed consent;

        Exclusion Criteria:

        1. Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study
Condition: Vitamin D Deficiency; Nutritional Deficiency
MeSH terms: Vitamin D Deficiency; Malnutrition
Intervention: High dose Cholecalciferol; Cholecalciferol
Intervention description: Mothers in experimental group will receive 6,000 IU of vitamin D in addition to their prenatal vitamin, daily for 3 months. Infants in this group will receive placebo vitamin D drops; Mothers in placebo control group will receive 600 IU of vitamin D in the form of their prenatal vitamin along with placebo vitamin D. Infants of the mothers in this group will receive standard 400 IU of vitamin D
Intervention MeSH terms: Cholecalciferol; Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 0 Days
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Vitamin D

Summary:

      The overall goal of this study is to assess maternal vitamin D status along with diet, and
      milk composition, and in turn, to evaluate if infant vitamin D status can be improved with
      increased maternal supplementation and diet education. The central hypothesis is that by
      maximizing maternal vitamin D status in breastfed, preterm infants (<35 weeks), there will be
      an increase infant 25(OH)D status at 1,2, and 3 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with documentation of fully breastfeeding who present within one month of
             delivery, who are 18-45 years old and in good general health will be eligible for
             participation.

          -  Infants <35 weeks corrected gestational age at birth

        Exclusion Criteria:

          -  NO DMI/DMII, HTN, or parathyroid disease IF thyroid issues, currently euthyroid

          -  Multiple gestations

          -  No liver disease

          -  No major congenital abnormalities

          -  No kidney disease

          -  No inborn errors of metabolism

          -  No parathyroid disease

          -  No disorders of calcium metabolism

          -  No antiepileptics

          -  No steroids

          -  No congenital heart disease

          -  No severe illness at birth deemed incompatible with survival
Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rivastigmine 5 and 10 cm^2 patch
Intervention MeSH terms: Rivastigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Rivastigmine; Patch

Summary:

      This study evaluated the safety and efficacy of 10 cm^2 rivastigmine patch in patients with
      Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who
      stayed on the target size of 10 cm^2 for at least 8 weeks. This proportion was then compared
      to historical data of the percentage of patients who could reach a rivastigmine capsule
      target dose of 12 mg and stay on it at least 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males, and females not of child-bearing potential (surgically sterile or at least one
             year postmenopausal), of at least 50 years of age

          -  Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of
             Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related
             Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental
             Disorders) criteria

          -  MMSE (Mini-Mental State Examination) score of > 10 and < 26

          -  Patients initiating therapy for the first time with a cholinesterase inhibitor
             (patients prescribed both rivastigmine and memantine are allowed)

          -  Patients who failed to benefit from previous cholinesterase inhibitor treatment

        Exclusion Criteria:

          -  Patients not treated according to the product monograph for rivastigmine capsules

          -  patients involved in a clinical trial

          -  Current diagnosis of an active skin lesion/disorder that would prevent accurate
             assessment of the adhesion and potential skin irritation of the patch (e.g., atopic
             dermatitis, wounded or scratched skin in the area of the patch application)

        Other protocol-defined exclusion criteria applied to the study.
Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center
Condition: Pain; Pain, Acute; Anesthesia
MeSH terms: Acute Pain
Intervention: Sublingual Sufentanil; IV Fentanyl
Intervention description: 30 mcg of sublingual sufentanil; 50 mcg of IV fentanyl
Intervention MeSH terms: Fentanyl; Sufentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a single dose of sublingual sufentanil is as or
      more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing outpatient ambulatory surgery

          -  recipient of general anesthesia

          -  pain score of 4 or greater in the PACU

        Exclusion Criteria:

          -  non-english speaking patients

          -  cancer surgeries

          -  patients who have allergy or intolerance to the study drugs or derivatives

          -  patients on chronic opioids (defined as daily opioids for 3 months or longer)
Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation
Condition: Neuritis; Radiofrequency Ablation
MeSH terms: Neuritis
Intervention: Dexamethasone 4 mg/ml; Normal saline
Intervention description: dexamethasone 4 milligram given post-ablation at each lesion site; Placebo, normal saline administered post-ablation at each lesion site
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each patient serves as his or her own control. Investigators are recruiting patients who are undergoing bilateral procedures. Each patient will receive dexamethasone at each lesion site post-ablation on one side, and placebo (saline) on the other.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The patient, care providers, and principle investigator will be blinded.
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Chronic neck and back pain has become one of the leading causes of disability and loss of
      productivity. For many patients with facet or sacroiliac joint mediated pain who have
      responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the
      joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe
      procedure with minimal risk of adverse events. However, with any procedure involving damage
      to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The
      investigators will test the hypothesis that dexamethasone injection delivered at the time of
      lesion effectively prevents the development of post-ablation neuritis through a
      placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic,
      lumbar, and sacroiliac joint radiofrequency denervations
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac
             joint pain who have responded to medial branch blocks and are already scheduled for
             bilateral radiofrequency ablations

          -  age greater than 18 years old

          -  English speaking

        Exclusion Criteria:

          -  patient not previously scheduled for radiofrequency ablation of the cervical,
             thoracic, or lumbar facets, or sacroiliac joints

          -  on anticoagulation

          -  have a pacemaker

          -  age less than 18 years old

          -  non-English speaking
Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
Condition: Pain
Intervention: Fentanyl; saline
Intervention description: 100 mcg in 1 mL intranasal spray; Sodium Chloride 0.9% intranasal spray
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intranasal fentanyl; Cystoscopy

Summary:

      The purpose of this study is to assess the efficacy of intranasally-administrated fentanyl
      spray to decrease the pain during cystoscopy (the passage of a telescopic instrument into the
      bladder for purpose of diagnosing the cause of blood in the urine, urinary complaints or any
      other problems with the urinary bladder). The current standard practice is to use Lidocaine
      jelly (a local anesthetic) given through the urethra to lubricate and decrease pain. In this
      study, an additional medicine (fentanyl) is used to reduce pain that occurs during and after
      the above procedure.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Urological indications for cystoscopic procedure.

        Exclusion Criteria:

          1. History of analgesia abuse or former opioid addiction.

          2. Allergy to fentanyl.

          3. Acute/chronic nasal problems such as rhinitis or sinusitis.

          4. Positive urine pregnancy test / lactation.

          5. Acute bronchial asthma / upper airway obstruction.

          6. Presence of bradycardia or a history of seizures.

          7. Concomitant use of drugs that inhibit CYP3A4 (e.g., ritonavir, ketoconazole,
             itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amprenavir,
             aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, MAO inhibitors and
             verapamil)

          8. 0-10 NRS pain score more than 3 on baseline.

          9. Any situation or condition which, in the investigator's opinion, puts the subject at
             significant risk, or could confound the study results.