bioihbjkbjnl/mcl2 huggingface dataset:
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
Condition: Agitation,Psychomotor; Haloperidol Causing Adverse Effects in Therapeutic Use; Lorazepam Causing Adverse Effects in Therapeutic Use; Loxapine Causing Adverse Effects in Therapeutic Use
MeSH terms: Psychomotor Agitation
Intervention: Haloperidol + lorazepam; Loxapine
Intervention description: Haloperidol + lorazepam + placebo; loxapine + placebo
Intervention MeSH terms: Lorazepam; Haloperidol; Haloperidol decanoate; Loxapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to determine the noninferiority of inhaled loxapine
      compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Requires treatment for agitation in the judgment of a physician

          2. Patient either pre-consented, has surrogate consent, or able to consent (in cases of
             mild agitation).

          3. The patient is at least 18 years of age and less than 65 years of age.

          4. Patients with known or presumed schizophrenia or bipolar 1 disorder.

        Exclusion Criteria:

          1. Patients with acute respiratory signs/symptoms (eg, wheezing).

          2. Known diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma or taking
             meds for asthma or COPD.

          3. Female patients who are obviously pregnant or breast-feeding.

          4. Medically unstable patients.

          5. Patients or surrogates who object to being in the study (even if previously
             pre-consented).

          6. Physician objection to patient enrollment in the study.

          7. Prisoners or incarcerated.
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
Condition: Sars-CoV2
MeSH terms: COVID-19
Intervention: Octagam
Intervention description: Standard of Care plus Octagam infusion for 3 days.
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus; IVIG; COVID-19

Summary:

      The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce
      respiratory complications (respiratory failure and need for a ventilator) caused by
      coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized
      IVIG for patients infected with the influenza virus. The investigator wants to find out if
      IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune
      system some help to clear the infection naturally.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed COVID-19 positive test result (including presumptive positive).

          -  Hospitalization

          -  Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not
             mechanically ventilated

          -  Age ≥18 years old.

          -  Access to a phone in the hospital room or an electronic device that is capable of
             receiving phone calls and/or video calls and/or e-mail.

          -  Able to read/write/speak English or Spanish fluently.

          -  Subjects must have the capacity to provide consent or an appropriate Legally
             Authorized Representative (LAR) to provide informed consent.

        provide informed consent, and provide authorization of use and disclosure of personal
        health information.

          -  Negative pregnancy test for women of childbearing potential.

        Exclusion Criteria:

          -  Severe allergy to any IVIG product formulation

          -  History of DVT, PE, thromboembolic stroke or other thrombotic events

          -  Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from
             corn.

          -  Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)

          -  Active participant in another research treatment study

          -  Mechanically ventilated patient

          -  Code status is Do Not Resuscitate or Do Not Intubate
Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
Condition: Ankle Sprain
MeSH terms: Arthralgia; Ankle Injuries
Intervention: diclofenac potassium 25 mg tablet; placebo
Intervention description: diclofenac potassium 25 mg tablet; placebo
Intervention MeSH terms: Diclofenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Joint Pain

Summary:

      The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet
      compared with placebo taken three times a day in subjects with acute ankle sprains under
      'in-use' conditions, in particular with regard to pain relief.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 years and over.

          -  Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.

          -  Injury within past 12 hours.

        Exclusion Criteria:

          -  Pain medication was taken within the 6 hours that precede randomization.

          -  During the past 3 months: Grade I-III sprain of the same ankle.

          -  During the past 6 months: Grade II-III sprain, any other significant injury (such as
             fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or
             foot.

          -  Pain or instability in the same ankle attributable to previous ankle sprain or any
             other trauma.

          -  Ankle sprain attributable to a known disease affecting the ligaments, such as ligament
             hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's
             syndrome, Ehlers-Danlos syndrome).
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Condition: Post-Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: ibandronate [Bonviva/Boniva]; ibandronate [Bonviva/Boniva]
Intervention description: 3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).; 2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 781.0
Sex: Female
Healthy volunteers: No

Summary:

      This 2-arm study was designed to assess the long-term safety and tolerability of intravenous
      (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had
      previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received
      Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received
      daily supplementation with vitamin D and calcium. The anticipated time on study treatment was
      2+ years, and the target sample size was 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75%
             compliance

          -  Ambulatory

        Exclusion Criteria:

          -  Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the
             planned start date for this study

          -  Malignant disease diagnosed since inclusion into previous study

          -  Treatment with drugs affecting bone metabolism since inclusion into previous study
Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Condition: Colorectal Disorders
Intervention: Exparel; IV Lidocaine
Intervention description: 2. Liposomal bupivacaine TAP block (experimental arm)
Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
Adhesive tapes will be applied at the level of the TAP block puncture sites.; 1. Intravenous Lidocaine infusion (control arm, current standard of care)
100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare the analgesic impact of intravenous perioperative lidocaine infusion with
      preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated
      into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary
      endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative
      morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include
      date of ambulation, return of bowel function (first flatus), tolerance of goal diet,
      incidence of post-operative nausea and vomiting during hospital stay, length of stay
      (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and
      surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and
      quality of life on follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years

          -  Elective laparoscopic colorectal surgery

          -  ASA I-III

        Exclusion Criteria:

          -  Contraindication to Na Channel Blocker

          -  Chronic Opioid use

          -  Liver dysfunction

          -  Renal insufficiency

          -  Epilepsy

          -  Psychomotor retardation

          -  BMI >40

          -  Sleep Apnea

          -  Cardiac Rhythm Disorders

          -  Planned open or concomitant procedure
PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)
Condition: Liver Cirrhosis; Hypertension, Portal
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Fibrosis
Intervention: Proton Pump Inhibitors; Placebo
Intervention description: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.; Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Intervention MeSH terms: Proton Pump Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal varices; Hemorrhage

Summary:

      This study is aimed at investigating the effect of PPIs on gastroesophageal varices in liver
      cirrhosis. Half of participants will receive PPI, while the other half will receive a
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of cirrhosis

          -  GEVs was diagnosed by endoscopy

        Exclusion Criteria:

          -  Acute gastrointestinal bleeding need emergency surgery

          -  Acid-related disease, such as peptic ulcer disease or gastroesophageal reflux diseases
             (GERD)

          -  Hepatocellular carcinoma (HCC) or other malignant tumor

          -  History of esophagus, stomach or liver surgery

          -  Child-Pugh C and can't be improved to Child-Pugh A or B

          -  Preparing to be pregnant, pregnant or breast feeding

          -  Allergic to PPIs(proton pump inhibitors) or intolerable

          -  Cannot provide informed consent
Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Condition: Diabetic Ketoacidosis; Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Ketosis; Acidosis; Diabetic Ketoacidosis
Intervention: Early Glargine; Late Glargine; IV insulin infusion; IV fluid and electrolytes replacement
Intervention description: A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion; A historical retrospective control group for the adult patients admitted to the same ICU with a diagnosis of DKA and received insulin glargine after anion gap closure.; Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol; The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years old

          -  Meet DKA definition (BG ≥ 250 mg/dl, Anion Gap > 12 mEq/L, and positive Ketones in
             serum or urine)

          -  Having the capacity to sign Informed consent

        Exclusion Criteria:

          -  IV insulin infusion was initiated for more than 4 hours.

          -  Persistent hypotension (SBP<80 mmHg despite receiving 1000cc normal saline).

          -  Require Vasopressor

          -  Acute Coronary Syndrome

          -  Pregnant

          -  End-stage renal disease

          -  Unwilling to consent to participate in the trial

          -  Currently under police custody

          -  Transferred from another hospital

          -  Require emergent surgery
Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Gabapentin 250mg/5mL NDC:59762-5025-01; Simple Syrup
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 10 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: gabapentin; Analgesic Drugs; Analgesics, Nonopioid

Summary:

      The purpose of this study is to evaluate the patient experience when using gabapentin with
      other pain control medications after posterior spinal fusion surgery for scoliosis in
      adolescents. These results will be compared to patients who underwent the same procedure
      during the study period and received the same standardized pain control regimen excluding
      gabapentin. Effects on pain level, opioid use, and satisfaction will be measured. Opioid side
      effects including nausea, sedation and urinary retention (inability to empty one's bladder)
      will also be recorded.The null hypotheses are as follows:

        1. There is no significant difference in pain control when adding gabapentin to a
           multimodal pain management protocol in pediatric post-operative posterior spinal fusion
           patients.

        2. There is no significant difference in the amount of opioid medication required for pain
           control in pediatric post-operative posterior spinal fusion patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of age 10-19 with an American Society of Anesthesiologists patient
             classification of I to III undergoing surgery to correct idiopathic or neurogenic
             scoliosis.

        Exclusion Criteria:

          -  Patients who require a surgical approach or technique differing from posterior spinal
             fusion and/or have allergies to any of the standardized or experimental study
             medications: acetaminophen, gabapentin, hydromorphone, ketorolac or oxycodone.
Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%; timolol maleate 0.5%; latanoprost 0.005%
Intervention description: 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.; 1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.; 1 drop of latanoprost 0.005% once nightly.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Latanoprost; Maleic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive
      therapy to Xalatan in subjects with glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age

          -  Give written informed consent

          -  Be in good general health as determined by your doctor

          -  Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension

          -  If you are a female of child bearing potential, you must be willing to practice
             effective contraception for the duration of the study (i.e., abstinence, spermicide,
             condoms, or birth control pills)

          -  Understand the study instructions, and be able to follow the study instructions; and

          -  Be likely to complete the entire study period (12 weeks), including all regularly
             scheduled study visits

        Exclusion Criteria:

          -  Have any active ocular disease other than glaucoma or ocular hypertension that would
             interfere with study interpretation

          -  History of severe renal or hepatic impairment

          -  Subjects with severe cardiovascular disease should not be enrolled unless their
             disease is controlled and clearance has been obtained from the subject's primary care
             physician and/or cardiologist

          -  Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive
             pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree
             atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled
             congestive heart failure

          -  Any systemic disease or clinical evidence of any condition which would make the
             subject, in the opinion of the investigator, unsuitable for the study or could
             potentially confound the study results; and

          -  Concurrent participation or prior participation in any investigational drug or device
             study within the last 30 days prior to the screening visit
Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: LCZ696
Intervention description: LCZ696 film-coated tables were supplied to the investigators. Tablets were taken with a glass of water, and were administered with or without food.
The target dose of LCZ696 was 200 mg twice daily. Starting dose of LCZ696 was either 50 or 100 mg, twice daily. The dose of LCZ696 should be doubled every 2-4 weeks to achieve the target dose of 200 mg twice daily, as tolerated by the patient.
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1002.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute decompensated heart failure; Reduced ejection fraction; Pre-discharge treatment; Post-discharge treatment; Angiotensin receptor neprilysine inhibitor; HFrEF

Summary:

      To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with
      LCZ696 in HFrEF patients following stabilization after an ADHF episode.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients hospitalized due to acute decompensated HF episode (ADHF) as primary
             diagnosis) and consistent Signs & Symptoms

          2. Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection
             fraction: Left ventricular ejection fraction ≤ 40% at Screening

          3. Patients did not receive any IV vasodilators (except nitrates), and/or any IV
             inotropic therapy from the time of presentation for ADHF to Randomization

          4. Stabilized (while in the hospital) for at least 24 hours leading to Randomization.

          5. Meeting one of the following criteria:

               -  Patients on any dose of ACEI or ARB at screening

               -  ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks
                  before screening.

        Exclusion Criteria:

          1. History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors
             or to any of the LCZ696 excipients.

          2. Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to
             randomization

          3. End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as
             measured by MDRD formula at Randomization.

          4. Serum potassium above 5.4 mmol/L at Randomization.

          5. Known history of hereditary or idiopathic angioedema or angioedema related to previous
             ACE inhibitor or ARB therapy

          6. Severe hepatic impairment, biliary cirrhosis and cholestasis