bioihbjkbjnl/mcl2 huggingface dataset:
Pectoralis and Serratus Muscle Blocks
Condition: Post Operative Pain Control
MeSH terms: Pain, Postoperative
Intervention: Exparel 266 MG Per 20 ML Injection; Placebo
Intervention description: The local anesthetic (LA) used for the PECS II or serratus plane blocks will be a 0.5% bupivacaine HCL, not to exceed 2.5mg/kg or up to 150mg. The LA solution can be diluted with preservative free normal saline for smaller patients to allow for appropriate volume of injection. Treatment patients will also be given liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc. San Diego, CA) in a dose of 266 mg in 20 ml can be safely combined with bupivacaine HCL at a ratio not exceeding 2:1, but cannot be combined with other local anesthetics due to the concern of rapid release of encapsulated bupivacaine and subsequent local anesthetic toxicity.; Patients randomized to standard analgesia technique will be given pain medications.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The overall research plan is PECS/SAP blocks with liposomal bupivacaine improve the Overall
      Benefit Analgesia Score averaged over the postoperative days 1, 2, and 3. A 20% reduction on
      geometric means (i.e., true ratio of geometric means of 0.80) in OBAS will be considered the
      minimal clinically important benefit.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-85 years old;

          2. Elective minimally invasive robotically-assisted mitral valve repair via anterolateral
             thoracotomy

        Exclusion Criteria:

          1. Weight less than 50 kg;

          2. Pregnancy or lactation;

          3. Emergency surgery and patients transferred from the ICU to the operating room;

          4. Redo cardiothoracic surgery or post-operative reoperation within 72 hours of index
             procedure (including minor chest wall procedures including tube thoracostomy,
             thoracentesis or percutaneous drain placement);

          5. Anticipated endotracheal intubation > 24 hours;

          6. Anticipated non-study nerve block that provides analgesia to the intercostal nerves;

          7. Active systemic or cardiopulmonary infection;

          8. Mechanical circulatory support;

          9. Allergy or contraindication to study local anesthetics;

         10. Current chronic pain or routine opioid use (patients on chronic enteral opioids like
             Percocet or Vicodin) in a dose of > 30 mg of morphine-milligram-equivalents for at
             least 10 days in last 30 days;

         11. Poorly controlled psychiatric disorders;

         12. Clinically important current neurologic deficit;

         13. Active liver disease or cirrhosis;

         14. Pacemaker generator or breast implants ipsilateral to surgery;

         15. Previous participation in this study.
The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation
Condition: Nasal Obstruction
MeSH terms: Nasal Obstruction
Intervention: Triamcinolone Acetonide; Ayr saline nasal mist
Intervention description: 2 sprays sprayed to both nostrils daily for 42 days.; 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this project is to determine if intranasal corticosteroids have an effect on
      nasal obstruction in patients with nasal septal deviation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18

          -  NOSE score greater than 55

          -  Nasal septal deviation on exam

        Exclusion Criteria:

          -  Intranasal steroid use within the last three months

          -  Current systemic steroid use

          -  Prior septal surgery

          -  Individuals who are pregnant or actively breastfeeding
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Naproxen Sodium (Aleve, BAY117031); Ibuprofen (Advil); Placebo
Intervention description: 220 mg x 2 tablets, oral, single dose; 200 mg x 2 tablets, oral, single dose; Matching placebo, 2 tablets, oral, single dose
Intervention MeSH terms: Ibuprofen; Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 387.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Postsurgical pain

Summary:

      To compare the duration of analgesic efficacy as determined by the time to rescue medication
      of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen
      400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to
      severe post-impaction surgery dental pain.

      To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440
      mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

      To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440
      mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, ambulatory, male or female volunteers 16-40 years of age;

          -  Body mass index 18.0 to 30.0 kg/m^2 inclusive;

          -  Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony
             impacted third molars. Up to two maxillary third molars may be removed regardless of
             impaction level. Supernumerary teeth present may also be removed at the discretion of
             the oral surgeon;

          -  Mandibular molars must demonstrate modified Demirjian root classification stage D, E,
             F, G or H;

        Exclusion Criteria:

          -  History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal
             anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local
             anesthetics, rescue medication or components of the investigational products;

          -  Evidence or history of clinically significant (in the judgment of the investigator)
             hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
             psychiatric, neurologic diseases, or malignancies within the last 5 years;

          -  Relevant concomitant disease such as asthma (exercise induced asthma is permitted)
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
Condition: Post-operative Craniotomy Patients; Carotid Endarterectomy and Carotid Artery Stenosis Patients; Post-op Spine Patients Admitted to the NCCU; Endovascular Patients Undergoing Intracranial Intervention; Traumatic Brain Injuries NPO for at Least 12 Hours
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Carotid Stenosis
Intervention: Intravenous acetaminophen; Placebo for IV acetaminophen
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Craniotomy

Summary:

      To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient
      pain.

      To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels
      in neurocritically ill patients.

      To assess the effect of an intravenous nonnarcotic pain medication on common side effects
      seen in patients taking other intravenous narcotic pain medication in the neurocritical care
      unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 45 kg (amenable to adult dosing)

          -  all traumatic brain injuries NPO for at least 12 hours

          -  all post-operative craniotomy patients

          -  all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke
             patients

          -  all carotid endarterectomy and carotid artery stenosis patients

          -  all endovascular patients undergoing intracranial intervention

          -  all post-op spine patients admitted to the NCCU

        Exclusion Criteria:

          -  documented allergy to acetaminophen

          -  documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease
             (hepatitis)

          -  documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed
             prior to study procedures that will ensure patients do not have renal impairment.

          -  patients who are pregnant or breast feeding
A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic
Condition: Schizophrenia; Schizoaffective Disorder; First Episode Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Intervention: Digital Medicine System; Aripiprazole; Olanzapine; Quetiapine; Risperidone
Intervention description: DMS components: a CoE product consisting of an approved antipsychotic medicinal product co-encapsulated with Conformité Européenne (CE)-marked miniature ingestible event marker in tablet; a CE-marked compatible medical device (a Proteus Patch [Disposable Wearable Sensor Version 5]); proprietary medical software (a local and remote computing application).; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Digital Medicine System

Summary:

      Digital medicine systems (DMS) have been designed to assist individuals with the management
      of their daily health, wellness, and medication use. The DMS is being developed as a
      healthcare management tool to precisely measure medication adherence and to potentially
      enhance adherence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant was prescribed aripiprazole, olanzapine, quetiapine, or risperidone.

          -  Participant possessed a smartphone, or a smartphone provided by the Sponsor, and was
             willing to download and interact with the DMS app.

          -  Skin on the anterior chest just above the lower edge of the rib cage was free of any
             dermatological problems (for example, open wounds, warts, rashes, atopic dermatitis).

        Exclusion Criteria:

          -  Participant with a known allergy to adhesive tape or any pertinent components of the
             patch or CoE product.

          -  Prisoners could not be enrolled into this trial.

          -  Participant who was hospitalized due to mental or physical illness (inpatient) at the
             time of screening/baseline.

          -  Any participant who, through religious or lifestyle choices, would not take gelatin
             capsules.

          -  Female of childbearing potential who was breast-feeding and/or who had a positive
             pregnancy test result prior to receiving trial enrollment, or who planned to become
             pregnancy during the trial.
Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
Condition: Heart Transplant Surgery; Lung Transplant Surgery
MeSH terms: Heart Failure
Intervention: iNO; iEPO
Intervention description: Subject will receive inhaled Nitric Oxide in this intervention; Subject will receive inhaled Epoprostrenol in this intervention
Intervention MeSH terms: Nitric Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 519.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart and Lung transplantation surgery; Pulmonary vasodilation therapy

Summary:

      1. to conduct a clinical investigation to determine if inhaled epoprostenol (Veletri®, iEPO)
      and inhaled nitric oxide (iNO) will have similar impact on outcomes in adult patients
      undergoing durable LVAD placement, heart transplantation, or lung transplantation 2. to
      conduct a cost-capture analysis on the expense each drug incurs per patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart transplantation

          -  LVAD placement

          -  Lung Transplantation

        Exclusion Criteria:

          -  Combined Organ Transplantation

          -  Age < 18 years old

          -  Pregnancy

          -  Known allergy to prostaglandin (rare)

          -  Refusal of blood products due to personal or religious preference

          -  Subject is enrolled in another study protocol, which does not allow randomization of
             PVD therapy

          -  Heart transplant or durable LVAD recipients with adult congenital heart disease (CHD)

             o Caveat: Does NOT meet exclusion criteria if the scheduled heart transplant or LVAD
             implantation is due to heart failure from a previous heart transplantation related to
             CHD, performed more than 90 days previous to the date of trial enrollment

          -  Heart transplant recipients diagnosed with Arrythmogenic Right Ventricular
             Cardiomyopathy

          -  Heart transplant recipients diagnosed with Acute Cardiac Allograft Rejection after a
             previous heart transplantation.

          -  Heart transplant or durable LVAD recipients with preoperative RVAD for right heart
             failure

          -  Patient is scheduled to undergo lung transplantation but has undergone heart
             transplantation in the previous 90 days

          -  Patient is scheduled to undergo durable LVAD implantation but has undergone heart
             transplantation in the previous 90 days

          -  Patient is scheduled to undergo heart transplantation but has undergone lung
             transplantation in the previous 90 days

          -  Patients with preoperative Venovenous ECMO as a bridge to lung transplantation

          -  Heart transplant or durable LVAD recipients with preoperative RVAD for right heart
             failure
Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
Condition: Neuromuscular Block; Renal Transplant Donor of Left Kidney; Renal Transplant Donor of Right Kidney; Surgery
Intervention: Rocuronium; No additional Rocuronium
Intervention description: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.; No additional rocuronium is administered after tracheal intubation.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Laparoscopic donor nephrectomy; Early quality of recovery

Summary:

      Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the
      consequences of postoperative pain and analgesia consumptions. The investigators' goal is to
      establish the relationship between the use of deep neuromuscular blockade (NMB) during
      laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the
      investigators designed a trial in which patients scheduled for living donor nephrectomy are
      randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will
      be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.
    

Eligibility criteria:

        All adult individuals, who are scheduled for living kidney donation.

        Inclusion Criteria:

          -  obtained informed consent

          -  age over 18 years

        Exclusion Criteria:

          -  insufficient control of the Dutch language to read the patient information and to fill
             out the questionnaires

          -  chronic use of analgesics or psychotropic drugs

          -  use of NSAIDs shorter than 5 days before surgery

          -  known or suspect allergy to rocuronium of sugammadex

          -  neuromuscular disease

          -  indication for rapid sequence induction

          -  deficiency of vitamin K-dependent clotting factors, coagulopathy or active use of
             coumarin derivates.

          -  Peri-operative use of fusidic acid or flucloxacillin

          -  Severe renal impairment (creatinine clearance <30ml/min)

          -  Morbid obesity (BMI>35 kg/m2)
Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
Condition: Diabetes Mellitus
Intervention: Saxagliptin
Intervention description: 2.5-5 mg daily
Intervention MeSH terms: Saxagliptin; Dipeptidyl-Peptidase IV Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 110 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety and efficacy of a drug called
      saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized
      patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c
      ≤7.0% on ≤ 2 non-insulin agents at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0%
             on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical
             illness.

          -  Written informed consent.

        Exclusion Criteria:

          -  Admitted to or expected to require admission to ICU

          -  Patients with a history of diabetic ketoacidosis or hyperosmolar state

          -  HbA1c >7.5% at the time of admission or within 3 months before admission

          -  Insulin requiring before admission

          -  Unable to take oral food or medications

          -  Systemic steroid use

          -  Pregnancy or breastfeeding

          -  Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an
             acceptable method to avoid pregnancy for the entire study period and up to 4 weeks
             after the last dose of study drug.

          -  History of pancreatitis or active gallbladder disease

          -  End stage renal disease on dialysis

          -  Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors

          -  Subject unable to give informed consent
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
Condition: Opioid Use; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ibuprofen; Acetaminophen; Norco
Intervention description: NSAID; analgesic; acetaminophen plus opioid
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
Masking: None (Open Label)
Enrollment: 170.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postpartum

Summary:

      Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus
      opioid
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaker women who had a cesarean section

        Exclusion Criteria:

          -  Inability or refusal to provide informed consent.

          -  Reported current or prior opioid or benzodiazepine use disorder, including urine drug
             screen positive for a non prescribed opioid or benzodiazepine upon admission or during
             prenatal care.

          -  Current treatment with methadone, buprenorphine or buprenorphine plus naloxone.

          -  Known alcoholism disorder.

          -  Severe renal or hepatic impairment.

          -  Known creatinine > 1.5 at the time of delivery or severe proteinuria leading to
             diagnosis of renal disease prior to delivery.

          -  Severe peptic ulcer disease

          -  Severe asthma (if patient has asthma but has previously tolerated NSAIDS, she will be
             allowed to participate)

          -  Known CYP450/CY92D6 mutation conferring opioid ultra-rapid metabolizer status.

          -  Allergy to any of the study drugs (anaphylaxis).

          -  Incarcerated or institutionalized patients.

          -  Inability to follow up as outpatient in our outpatient clinic.

          -  wound dehiscence or infection diagnosed prior to discharge from the hospital

          -  wound vac placed prior to discharge from the hospital