bioihbjkbjnl/mcl2 huggingface dataset:
Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Condition: Prophylaxis of Acute Mountain Sickness
MeSH terms: Altitude Sickness
Intervention: Low Dose Acetazolamide; Normal Dose Acetazolamide
Intervention description: Administration of low dose acetazolamide; Administration of normal dose acetazolamide
Intervention MeSH terms: Acetazolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 4, randomized, double-blinded interventional trial comparing alternative
      doses of Acetazolamide for the prevention of High Altitude Illness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  English or Indian speaking

          -  Mountaineers or trekkers who plan to climb Mt. McKinley or trek to Base Camp on Mt.
             Everest

        Exclusion Criteria:

          -  Low sodium and/potassium blood serum levels

          -  Kidney disease or dysfunction

          -  Liver disease, dysfunction, or cirrhosis

          -  Suprarenal gland failure or dysfunction

          -  Hyperchloremic acidosis

          -  Angle-closure glaucoma

          -  Taking high dose aspirin (over 325 mg/day)

          -  Any reaction to sulfa drugs or acetazolamide

          -  Pregnant or lactating women
Reversing Ticagrelor's Effects With Fresh Platelets
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Ticagrelor loading dose; Aspirin loading dose; Ticagrelor maintenance dose; Aspirin maintenance dose
Intervention description: Single loading dose of Ticagrelor 180 mg; Single loading dose of Aspirin 325 mg; Ticagrelor 90 mg twice daily x 7 days; Aspirin 81 mg once daily x 7 days
Intervention MeSH terms: Aspirin; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Antiplatelet; Ticagrelor; Platelets; Thrombosis; Coronary artery disease

Summary:

      Acute coronary syndrome (ACS) patients treated with antiplatelet drugs who require coronary
      artery bypass grafting (CABG) surgery have to wait 5-7 days for the effects of the drugs to
      wean off. This treatment-devoid period leaves the patient vulnerable, therefore any means to
      shorten this period could be useful. The present study aims to investigate the possibility of
      reversing the antiplatelet effects of ticagrelor with the help of fresh donor platelets.
      Fresh platelets will be added to blood samples of treated patients in varying concentrations
      at specific timepoints to determine the time and amount of fresh platelets needed to
      normalize platelet reactivity in the treated samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteer between 18 and 75 years old.

          -  History of stable (i.e. non-acute) cardiovascular disease or the presence of risk
             factors for cardiovascular disease (i.e. hypertension, diabetes, hyperlipidemia, high
             calcium score and abnormal findings on angiography or stress test).

        Exclusion Criteria:

          -  Conditions associated with hemorrhagic risk, e.g., frequent epistaxis,
             gastrointestinal ulcer, hemorrhagic vascular lesions, recent surgery.

          -  Allergy or hypersensitivity to aspirin or ticagrelor.

          -  Loss of >400 mL blood or blood donation within past 3 months.

          -  Positive serology for hepatitis B (HBs Ag) or hepatitis C.

          -  History of drug abuse or alcohol abuse.

          -  Positive pregnancy test.

          -  Evidence of unstable or acute cardiovascular disease (e.g., unstable angina, recent
             myocardial infarction, congestive heart failure).

          -  History of clinically relevant pulmonary, hepatic, gastrointestinal, renal, metabolic,
             hematologic, neurologic, respiratory or psychiatric disease, bleeding, acute
             infectious disease or signs of acute illness.
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
Surgical Conditions During Laparoscopic Bariatric Surgery
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Intervention: Rocuronium; Insufflation pressure
Intervention description: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment; The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: morbid obesity; laparoscopic surgery; neuromuscular blockade

Summary:

      Obesity affects more than 78 million adults in the United States and it is estimated that 35%
      of the US population is obese. Currently, more than 179,000 bariatric procedures are
      performed in the US each year with the majority of these surgeries using laparoscopic
      techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but
      there is no evidence that a deep NMB improves surgical conditions and that the surgeons can
      discriminate between a moderate and deep NMB. There is also evidence that maintaining low
      insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal
      of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis
      that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in
      the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize
      lower insufflation pressure and decreases postoperative pain requirements after laparoscopic
      bariatric surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  ASA I-III

          -  BMI ≥ 35

        Exclusion Criteria:

          -  Inability to obtain written informed consent

          -  Pregnancy or breastfeeding

          -  Allergy to rocuronium, sugammadex, or any anesthetic agents used in the protocol

          -  Known or suspected neuromuscular disorders

          -  Significant renal disease with a serum creatinine ≥ 2 mg/dl f. Significant liver
             disease g. A family history of malignant hyperthermia
Adult Oral Ibuprofen Study for ED Pain Patients
Condition: Pain, Acute
MeSH terms: Acute Pain
Intervention: Oral Ibuprofen
Intervention description: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Emergency Medicine; Acute Pain; Oral Ibuprofen

Summary:

      Ibuprofen is one of the most widely used non-steroidal anti-inflammatory drug (NSAID) for
      management of mild -to moderate pain in the ED (acute musculo-skeletal pain, headache, dental
      pain). Ibuprofen as a representative of NSAID's as a class follows the analgesic ceiling
      concept that postulates that there is a dose of a drug beyond which any further dosage
      increase results in no additional analgesic effect. Despite this fact, Ibuprofen may commonly
      be used at doses above its analgesic ceiling, although this may not offer an incremental
      analgesic advantage and potentially adds risk of harm. The analgesic ceiling dose for
      ibuprofen is only 200-400mg/dose, and about 1200 mg/day. Thus, we hypothesize that
      administration of Ibuprofen in a dose of 400 mg in the ED is as effective in treating
      mild-to-moderate acute pain in patients presenting to the ED as 600 mg and 800 mg
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult ED patients aged 18 and older

          -  Chief complaint of mild to moderate musculoskeletal pain, headache, or dental pain
             intensity of less than 4 on a standard 0 to 10 numeric rating scale.

          -  Acute pain (within 30 days of onset)

          -  Patients who would routinely be treated with oral ibuprofen

        Exclusion Criteria:

          -  pregnancy or breastfeeding,

          -  active peptic ulcer disease,

          -  acute gastrointestinal hemorrhage,

          -  known history of severe renal or hepatic insufficiency, allergy to nonsteroidal
             anti-inflammatory drugs,

          -  patients having already received analgesic medication.
Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Condition: Pituitary Tumor; Pain
MeSH terms: Pituitary Neoplasms; Pituitary Diseases
Intervention: IV Caldolor; IV Placebo
Intervention description: IV Caldolor (IV ibuprofen) intraoperatively and postoperatively; IV Placebo intraoperatively and postoperatively
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo-controlled intervention trial involving 100 treated
      subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects
      will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in
      the standard post-operative medication arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient undergoing ENTS surgery for resection of pituitary tumor.

          -  Adults >18 years and <80 years of age.

          -  English speaking and literate or able to understand the use of a pain scale.

          -  Body Mass Index >19 and <40 kg/m2

        Exclusion Criteria:

          -  Renal failure (acute or chronic) or creatinine >2.0

          -  Allergy or intolerance to acetaminophen, ibuprofen, or opioids

          -  Pre-operative opioid tolerance, dependence, or abuse

          -  Anaphylaxis to opioids

          -  History of peptic ulcer disease or recent gastrointestinal bleed requiring surgery

          -  Cirrhosis, hepatitis, liver transplant, or liver function studies out of normal range,
             defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin>
             3x upper limit of normal range

          -  Subject unwilling or unable to sign informed consent for the study

          -  Pregnancy

          -  Incarcerated patients
Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Oxcarbazepine
Intervention description: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).
Intervention MeSH terms: Oxcarbazepine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oxcarbazepine; Brain Derived Neurotrophic Factor; Bipolar disorder; Neuroprotection

Summary:

      The present study has been designed to evaluate the change in serum BDNF level with
      oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its
      neuroprotective effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with the diagnosis of bipolar affective disorder (by ICD-10 DCR) current
             episode mania without psychotic symptoms

          -  Patients aged 18-45 years, of either sex.

          -  Patients with baseline score > 20 on the Young Mania Rating Scale (YMRS).

          -  Patients who had not taken any treatment for at least 4 weeks before inclusion.

        Exclusion Criteria:

          -  Patients with bipolar disorder (by ICD-10 DCR) presenting during
             depressive/euthymic/mixed episode.

          -  Patients who are already under treatment for the presenting conditions.

          -  Rapid cycling in the past 12 months.

          -  Previous history of refractoriness to carbazepine or oxcarbazepine.

          -  Patients with comorbid substance abuse or history of organicity

          -  Pregnant and nursing women, patients with history of major medical or neurological
             illness.
Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds
Condition: Diabetic Wound
MeSH terms: Wounds and Injuries
Intervention: NPWT and lyopreserved Stravix; NPWT and cryopreserved Stravix
Intervention description: Subjects will be treated with NPWT and lyopreserved Stravix; Subjects will be treated with NPWT and lyopreserved Stravix
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, 2-arm parallel assignment, randomized clinical trial. Stravix will be applied at initial visit with NPWT and will only be reapplied after 4 weeks if wound is not ready for grafting unless debridement is indicated.
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare
      lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a diabetes mellitus

          -  Men/women ≥21 years old

          -  Post-operative foot or ankle wounds sized >4cm2 that have presented for <1 year

          -  ABI ≥0.5 or toe pressures >30 mmHg

          -  Wounds indicated for treatment with NPWT

        Exclusion Criteria:

          -  Active Charcot arthropy

          -  Unable to use NPWT at home

          -  Untreated bone or soft tissue infection

          -  Is pregnant or plans to become pregnant

          -  Is nursing or actively lactating

          -  Developmental disability/significant psychological disorder that in the opinion of the
             investigator could impair the subject's ability to provide informed consent,
             participate in the study protocol or record study measures, including untreated
             schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2
             years.

          -  Active alcohol or substance abuse in the opinion of the investigator that could impair
             the subject's ability to provide informed consent, participate in the study protocol
             or record study materials
Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)
Condition: Human Immunodeficiency Virus; Smoking
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Bupropion; Varenicline; Cognitive Behavioral Therapy; Nicotine Replacement Therapy; Relapse Prevention Text Messaging
Intervention description: Smoking cessation pharmacotherapy prescribed in accordance with package insert.; Smoking cessation pharmacotherapy prescribed in accordance with package insert.; Behavioral intervention; modules include identifying reasons for quitting, setting a quit date, breathing relaxation technique, identifying smoking triggers, identifying social support, and education about relapse prevention; Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).; Participants will be invited to utilize SmokefreeVET, a mobile text messaging service for military Veterans trying to quit smoking. The 6- to 8-week program provides 24/7 encouragement, advice, and tips to help smokers quit smoking and stay quit.
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus; Smoking; Veterans

Summary:

      Smoking is a significant cause of damage to health and quality of life specifically for
      Veterans with human immunodeficiency virus (HIV). Smoking cessation interventions for this
      population are lacking. The primary aim of this project is to explore smoking cessation
      treatment preferences among Veteran smokers living with HIV. The study team will refine the
      design and content of a smoking cessation treatment for Veteran smokers living with HIV. The
      intervention uses mobile health and telehealth technology to personalize smoking cessation
      counseling and medications and provide relapse prevention text messaging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  VHA patient

          -  HIV positive serostatus

          -  currently smoking 7 cigarettes per week

          -  willing to complete study procedures. Exclusion criteria are:

        Exclusion Criteria:

          -  current hospitalization

          -  acute risk for suicide documented in the medical record

          -  inability to complete study procedures.
Simplified Insulin Regimen for the Elderly
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; Insulin Glargine; Insulin Aspart; Insulin Lispro
Intervention description: 0.40 units/kg body weight; 0.20 units/kg body weight; 0.20 units/kg body weight; 0.20 units/kg body weight
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Diabetes; Elderly; Insulin treatment; Quality of life

Summary:

      Basal-bolus insulin therapy, which includes one injection of long acting insulin and three
      injections of short acting insulin is the most commonly used insulin treatment. However, many
      older patients find the basal-bolus insulin regimen hard to manage because it involves 4
      injections and 4 blood glucose tests each day. It is possible that a simplified treatment
      that involves one injection of long acting insulin daily and two blood glucose tests daily
      might be equally effective. This simplified regimen, if effective, would be easier to use and
      might result in less errors. Therefore, the investigators want to conduct this study to
      compare using a single daily injection of basal insulin with the usual basal-bolus insulin
      regimen in elderly patients (age >65 years) with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

        -Age >65 years

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  Enrollment in another research study

          -  History of hypoglycemia unawareness

          -  Pregnant women

          -  Prisoners