bioihbjkbjnl/mcl2 huggingface dataset:
Short Course Glucocorticoid Treatment for PTSD
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: prednisone; placebo
Intervention description: 20mg x 2 weeks; placebo
Intervention MeSH terms: Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone
      in addition to standard care will result in reduced PTSD symptoms or symptom severity
      compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for
             PTSD w/ symptom exacerbation (CAPS score ≥ 50)

          -  Stable on other psychotropic meds x1 month

        Exclusion Criteria:

          -  Current or past history of bipolar, schizophrenic, or other psychotic disorder

          -  Organic mental disorder

          -  Alcohol or substance abuse in last 3 months

          -  Clinically significant hepatic or renal disease or other acute or unstable medical
             condition

          -  Chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes,
             rheumatologic diseases
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Condition: Bipolar Depression
MeSH terms: Bipolar Disorder
Intervention: Lurasidone
Intervention description: Participant will have an open label trial of lurasidone for eight weeks.
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The goal of this project is to understand what causes bipolar disorder and how medications
      treat bipolar depression. Particularly, the project focuses on the importance of dopamine
      signaling in the process. Participants will have two different brain scans (MRI and PET
      scan). They will also have treatment for your depression with an FDA approved medication,
      lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to
      improve the treatment of bipolar disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bipolar I disorder, bipolar II disorder or other specified bipolar disorder

          -  Currently in a major depressive episode and moderately depressed

          -  Age 18-50 years old

          -  Patients on psychiatric medications will not be benefitting from those medications

          -  Females of childbearing potential must be willing to use an acceptable form of birth
             control throughout the study

        Exclusion Criteria:

          -  Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance
             use disorder, recent anorexia or bulimia nervosa

          -  Previous failed trial of lurasidone, or had intolerable side effects of lurasidone

          -  Significant active physical illness

          -  Actively suicidal

          -  ECT within the past 6 months

          -  Recent pregnancy, abortion or miscarriage or plans to conceive during the study;
             currently lactating

          -  Metal in the body that is not MRI compatible

          -  Current, past or anticipated exposure to radiation

          -  Currently taking an anticoagulant medication
Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Acetaminophen/Ibuprofen; Acetaminophen/Codeine
Intervention description: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit; After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Intervention MeSH terms: Acetaminophen; Ibuprofen; Codeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain, Postoperative

Summary:

      The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen
      (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after
      hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger,
             under local anesthesia with or without sedation.

        Exclusion Criteria:

          -  ASA> 3;

          -  Coagulopathy;

          -  Renal disease,

          -  Liver disease,

          -  History of recent gastro-intestinal bleeding

          -  Pregnancy.

          -  Diagnosis of chronic pain currently taking opioid pain medication or with a history of
             drug abuse.

          -  Patients with a self-described allergy to ASA, acetaminophen, NSAIDS and codeine.

          -  All patients receiving a brachial plexus block for anesthesia and/or analgesia
Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Intervention: Milk; CCK
Intervention description: Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low.; CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.
Intervention MeSH terms: Cholecystokinin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study aims to combine the use of IV CCK administration followed by oral milk during a
      HIDA scan to further stimulate the gallbladder contractility and decrease the number of false
      abnormal HIDA scans and unnecessary cholecystectomies in some patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients referred to a HIDA scan for evaluation of gallbladder function.

          -  No evidence of gallbladder stones on any prior anatomic imaging studies.

          -  Patients who are able to lie flat on the imaging table for an additional 30 min. of
             imaging after the standard of care 1.5 hour HIDA scan.

        Exclusion Criteria:

          -  Patients who are under 18 years of age.

          -  Patients with evidence of gallbladder stones on other imaging modalities.

          -  Patient allergic to milk or dairy products.

          -  HIDA scan ordered to evaluate for acute cholecystitis.
Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training
Condition: Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Intervention: Vortioxetine 10 mg; Cognitive training program
Intervention description: Online training program, 30 minutes a day, 5 times a week
Intervention MeSH terms: Vortioxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vortioxetine; Elderly; Online cognitive training

Summary:

      The purpose of this research study is to examine the potential benefits of vortioxetine in
      combination with at-home computerized cognitive training program to improve cognition, such
      as memory, attention, and concentration. This study will compare the effectiveness of
      vortioxetine plus cognitive training versus placebo plus cognitive training.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Community-living men and women age 65 and older

          -  Age-related cognitive decline as defined by (a) self-reported cognitive dysfunction
             that is attributed to the aging process (in response to screening questions to the
             participant); (b) ability to complete cognitive battery, but still scoring less than 1
             standard deviation above age-matched norms at both baseline and after the two-week
             cognitive training lead-in.

        Exclusion Criteria:

          -  Known dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease,
             cerebrovascular disease) per self-report, informant report, medical records, or
             neuropsychological testing

          -  Any current psychiatric disorder

          -  Medical conditions that suggest shortened lifespan, such as metastatic cancer; or
             would prohibit safe participation in the interventions, including cardiovascular
             disease or musculoskeletal conditions; or with the assessments.

          -  Sensory impairment that would prevent participation

          -  IQ < 70 as estimated by the Wechsler Test of Adult Reading

          -  Alcohol or substance abuse within 6 months

          -  Concurrent cognitive training, such as brain-training software, or other interventions
             expected to affect neuroplasticity

          -  Psychotropic medications or those with likely CNS effects (none within 4 weeks prior
             to study entry)
A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism; Emergencies
Intervention: Rivaroxaban; Standard-of-care
Intervention description: Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally.; Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rivaroxaban; JNJ39039039; Pulmonary embolism

Summary:

      The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants
      who are discharged from the Emergency Department (ED) to the home environment and treated
      with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or
      venous thromboembolism (VTE) events through Day 30 compared to participants who are treated
      with initial hospitalization and standard-of-care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have confirmed acute symptomatic Pulmonary Embolism (PE) with or without symptomatic
             deep vein thrombosis (DVT)

          -  A PE participant diagnosed in the Emergency Department (ED) who is deemed to be at low
             risk of clinical deterioration as determined by the Hestia criteria

          -  Have no contraindications to and be able to complete randomized treatment and all
             study assessments

          -  Have a life expectancy of at least 6 months

          -  Must be willing and able to adhere to the prohibitions and restrictions specified in
             this protocol

        Exclusion Criteria:

          -  Having received any Combined P-gp (P-glycoprotein) and strong CYP3A4 (Cytochrome P450)
             inhibitors (such as but not limited to ketoconazole, telithromycin or protease
             inhibitors) use within 4 days before randomization, or planned use during the study.
             Itraconazole use within 7 days before randomization or planned use during the study

          -  Having received any Combined P-gp and strong CYP3A4 inducers (such as but not limited
             to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital,
             carbamazepine, or St. John's Wort) use within 2 weeks before randomization or planned
             use during the study

          -  Who Has contraindications to the use of any anticoagulant therapy (example, bleeding
             diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy
             documented at Screening)

          -  Who Has known allergies, hypersensitivity, or intolerance to rivaroxaban or its
             excipients

          -  Woman who is pregnant, or breast-feeding, or planning to become pregnant
Understanding Disparities in Quitting in African American and White Smokers
Condition: Smoking Cessation
Intervention: Varenicline
Intervention description: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to describe the differences in quitting smoking between African
      Americans (AA) and White smokers treated with varenicline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-Hispanic African American or non-Hispanic White

          -  ≥ 18 years of age

          -  Smoked 3-20 cigarettes per day

          -  Smoked on >25 days of the past 30 days

          -  Functioning telephone

          -  Interested in quitting smoking

          -  Interested in taking 3 months of varenicline

          -  Willing to complete all study visits

        Exclusion Criteria:

          -  Renal impairment

          -  Evidence or history of clinically significant allergic reactions to varenicline

          -  A cardiovascular event in the past month Hospitalization in the past 2 months for any
             cardiovascular disease, including but not limited to:

               -  Angina

               -  Myocardial infarction

               -  Peripheral vascular disease

               -  Stroke

          -  New onset of chest pain or arrhythmia in the past 2 months

          -  History of alcohol or drug dependency in the past year

          -  Major depressive disorder in the last year requiring treatment

          -  History of panic disorder, psychosis, bipolar disorder, or eating disorders

          -  Use of tobacco products other than cigarettes in past 30 days

          -  Use of pharmacotherapy in the month prior to enrollment, including prior use of
             varenicline

          -  Pregnant, contemplating getting pregnant, or breastfeeding

          -  Plans to move from Kansas City during the treatment and follow-up phase

          -  Another household member enrolled in the study
Adult Growth Hormone Deficiency and Cardiovascular Risk
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Intervention: Blood draws; growth hormone releasing hormone (GHRH) & arginine; Carotid ultrasound; MRI; Endothelial cell biopsy
Intervention description: Subjects will have serum cardiovascular markers assessed; Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.; Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.; Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.; Subjects will undergo endothelial cell biopsies to harvest endothelial cells to study. It will occur once and takes approximately 20 minutes. Patients will have an iv placed and then a sterile wire is passed back and forth in the iv a couple of times. Three wires are passed.
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Growth hormone

Summary:

      This protocol will assess the cardiovascular risk associated with growth hormone deficiency
      in adults. We will use multiple modalities to assess risk for heart attacks or strokes
      including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are
      growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize
      that adults with growth hormone deficiency will have results suggestive of an increased risk
      for cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 19 years or older who have undergone transsphenoidal surgery for a clinically
             non-secreting pituitary adenoma

        Exclusion Criteria:

          -  Currently taking growth hormone, radiation therapy in the past 5 years, changes in
             dose of other pituitary hormone replacement therapy in past 3 months, taking
             hydrocortisone (or its equivalent) at a dose of > 30 mg/day, pregnant or nursing women
Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding
Condition: Esophageal and Gastric Varices
MeSH terms: Esophageal and Gastric Varices
Intervention: carvedilol; cyanoacrylate
Intervention description: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.; The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
Intervention MeSH terms: Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Gastric varices; cyanoacrylate; carvedilol

Summary:

      Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal
      bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective
      β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is
      not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to
      gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of 20 to 80 years

          -  Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within
             24 h of bleeding

          -  Stable hemodynamic condition for at least 3 days after cyanoacrylate injection

        Exclusion Criteria:

          -  Previous treatment of gastric varices, including endoscopic therapy, transjugular
             intrahepatic porto-systemic shunt, or surgery

          -  Contraindications to non-selective beta-blockers or cyanoacrylate injection

          -  Serum total bilirubin >10 mg/dL

          -  Grade III/IV hepatic encephalopathy

          -  Hepato-renal syndrome

          -  Severe heart failure (NYHA Fc III/IV)

          -  Chronic kidney disease under renal replacement therapy

          -  Refractory ascites

          -  Malignancy other than hepatocellular carcinoma

          -  Pregnancy

          -  Pacemaker use

          -  Refusal to participate
Carbohydrate Consumption as a Factor in Aspart Dosing
Condition: Diabetes
Intervention: aspart; aspart- Insulin
Intervention description: Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate); 0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray
Intervention MeSH terms: Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; prandial; insulin; aspart; carbohydrate; inpatient; novolog

Summary:

      Good sugar control in postoperative hospitalized patient has been shown to improve wound
      healing and infection rates. However, sugar control is difficult to achieve and suboptimal
      use of insulin is thought to be a contributory factor. Though it is known that generally the
      consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing
      meal-time insulin is based on the fraction of the total meal-tray eaten which includes
      proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a
      patient who consumes a portion of mainly proteins and fats on their trays or an
      underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high
      blood sugars can follow respectively.

      Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of
      carbohydrates consumed will result in better sugar control compared to the usual practice of
      dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged > or = to 18 admitted to general surgical floors, excluding the ICU, at
             Rush University Medical Center, regardless of race, ethnicity, gender

          -  Clinical diagnoses of type 2 diabetes for more than 6 months prior to admission

          -  Treated with insulin and/or 2 or more oral diabetic agents

          -  Estimated length of stay 3 days or more

          -  Postoperative point of care blood glucose of > 180 mg/dL

        Exclusion Criteria:

          -  Glomerular Filtration Rate < 60 based on MDRD equation

          -  Pregnant patients

          -  Receiving parenteral or enteral nutrition

          -  Patients with an admitting diagnosis of hypoglycemia

          -  Outpatient insulin < 0.5 units/kg/day

          -  Inability to give consent

          -  Severe liver disease

          -  Known hypopituitarism or adrenal insufficiency

          -  Treatment with Prednisone at dose > 5 mg daily or its equivalent