bioihbjkbjnl/mcl2 huggingface dataset:
Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
Condition: Hypertension; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Carvedilol; Metoprolol
Intervention description: 25 mg twice daily for five months.; 200 mg twice daily for five months.
Intervention MeSH terms: Metoprolol; Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: beta-blockers; endothelial function

Summary:

      The purpose of this study is to compare the vascular effects of two commonly used blood
      pressure medications, carvedilol and metoprolol in hypertensive patients with type 2
      diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 30-80 years old

          -  Documented history of type 2 diabetes

          -  Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30
             days before and throughout the study period

          -  Stable anti-diabetic regimen throughout the study period

          -  Body mass index (BMI) between 22-45 kg/m2

          -  HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between
             6-8% for patients who are being controlled by diet alone

          -  Screening blood pressure (BP) > 130/80 (average of 3 sitting measurements), with
             current medications

        Exclusion Criteria:

          -  Uncontrollable or symptomatic arrhythmias

          -  Unstable angina

          -  Sick sinus syndrome or second or third degree heart block

          -  Decompensated heart failure

          -  Myocardial infarction (MI) or stroke within 3 months of screening

          -  Bradycardia

          -  Chronic obstructive pulmonary disease (COPD) with required inhaled or oral
             bronchodilators or corticosteroids

          -  Bronchial asthma or related bronchospastic conditions

          -  New onset/diagnosed type 2 diabetes (<3 months)

          -  Clinically significant renal or liver disease (creatinine >2.5 mg/dL)

          -  Endocrine disorders

          -  Use of anorectic or other diet drugs inconsistent with recommendations for type 2
             diabetics

          -  Use of beta-blockers within 3 months of screening

          -  Use of corticosteroids

          -  Systemic disease, including cancer, with reduced life expectancy (<12 months)

          -  Psychological illness/condition that interferes with comprehension of study
             requirements

          -  Use of an investigational drug within 30 days of entry into study
Open Label Use Of RiaStap During Aortic Reconstruction
Condition: Coagulopathic Bleeding
Intervention: RiaSTAP
Intervention description: One time dose of 70 mg/kg will be administered intravenously.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL
      Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving
      hemostasis thereby reducing overall blood product transfusion after separation from
      cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size
      this is a pilot study and in effect will determine the fibrinogen level response to
      fibrinogen concentrate administered during aortic reconstructive surgery. It will be
      underpowered to detect reduction in bleeding but comparison to historical controls will be
      included as a secondary outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective, adult aortic reconstruction involving a hemi-arch replacement at DUMC.

        Exclusion Criteria:

          -  Concomitant procedures such as CABG , stents (within the last 3 years), refusal of
             blood transfusion, recent MI (within the last 3 months), pregnancy, INR > 1.1,
             platelet inhibitor drugs within 5 days of surgery (aspirin 325 mg within 48 hours of
             surgery), platelet count < 150,000, age <18 years, inability to obtain written
             informed consent, known coagulopathy including a history of recent coumadin therapy.
Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Intervention: Protocol for rocuronium neuromuscular block
Intervention description: The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neostigmine; sugammadex; rocuronium; neuromuscular blocking agents

Summary:

      This is an estimation study, prospectively evaluating the incidence of postoperative residual
      neuromuscular blockade (PRNB) when a best practice protocol is implemented for a cohort of
      abdominal surgery and orthopedic surgery patients. The protocol is developed within the
      constraint of subjective monitoring, quantitative monitoring is not used, and use of
      rocuronium for paralysis and either neostigmine or sugammadex for reversal. The primary
      outcome is the incidence of PRNB on arrival to the post-anesthesia care unit, defined as a
      train-of-four ration <0.9.
    

Eligibility criteria:

        Inclusion Criteria: Adult 18 years old or older, Will undergo open or laparoscopic
        abdominal surgery or orthopedic surgery expected to last <6 hours at Harborview or Univ of
        Wash Med Ctr, Have American Society of Anesthesiologists physical status I-III, scheduled
        to have general anesthesia with at least 1 dose of nondepolarizing neuromuscular blocking
        drug for endotracheal intubation or intraoperative neuromuscular blockade.

        -

        Exclusion Criteria: Allergy to neuromuscular blocking drugs, patients with neuromuscular
        disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-English
        speaking.

        -
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone; Flumist; Physiologic saline
Intervention description: single dose licensed trivalent inactivated influenza vaccine (2007-08); single dose licensed live-attenuated influenza vaccine Flumist (2007-08); single dose placebo administered as an intranasal spray or intramuscular injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1952.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Live attenuated influenza vaccine; Inactivated influenza vaccine; Vaccine Efficacy

Summary:

      The purpose of this study is to evaluate the absolute (versus placebo) and relative (one
      vaccine compared to the other) efficacies of the live attenuated and inactivated influenza
      vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating
      strains whether similar or dissimilar to strains included in the vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult men and women

          -  Age 18-49 years

          -  Who reside geographically close to one of the four study sites in Michigan

        Exclusion Criteria:

          -  Persons with any of the health conditions for which the inactivated vaccine is
             recommended

          -  Persons for whom either vaccine is contraindicated
Prevention of Relapse & Recurrence of Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Recurrence; Depression; Bipolar Disorder
Intervention: Lithium / Fluoxetine; Lithium / Placebo
Intervention description: Individualized Daily Dosage; Individualized Daily Dosage
Intervention MeSH terms: Lithium Carbonate; Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Manic Depression; Major Depressive Episode; Mania; Hypomania; Long Term Treatment

Summary:

      The purpose of this study is to determine whether the long-term use of combined
      antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in
      preventing the relapse and recurrence of bipolar depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men/women (all races and ethnicity)

          -  Age at least 18 years old

          -  Bipolar Type I Disorder

          -  Current Major Depressive Episode

          -  Able to understand and provide signed informed consent

        Exclusion Criteria:

          -  Current alcohol or drug abuse

          -  Alcohol or drug dependence within 3 months

          -  Allergic to Fluoxetine or Lithium

          -  Unstable medical condition (e.g., uncontrolled thyroid, renal, cardiovascular disease)

          -  Pregnant or nursing women

          -  Women of child-bearing potential unwilling to use a medically acceptable form of
             contraception

          -  Actively suicidal

          -  Requiring hospitalization

          -  Use of medication contraindicated with lithium or fluoxetine

          -  Unable to participate in a year-long trial
Postpartum HPV Vaccination
Condition: HPV-Related Malignancy
MeSH terms: Neoplasms
Intervention: Gardasil9
Intervention description: Gardasil 9
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 195.0
Sex: Female
Minimum age: 16 Years
Maximum age: 26 Years
Healthy volunteers: No

Summary:

      Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore,
      greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer
      disproportionately affects women of color in both incidence and mortality. Due to low HPV
      vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are
      necessary in order to maximize the cancer prevention potential of this vaccine. The
      puerperium is a time period when women are engaged in the healthcare system and have almost
      universal access to affordable health care. Two prior studies have shown that postpartum HPV
      vaccination is acceptable to patients, and high rates of vaccination were achieved in these
      primarily Hispanic populations. However, data show that the immune response in young women is
      less robust than in adolescents, and no studies have examined immunogenicity in postpartum
      women specifically. We propose an HPV vaccination pilot study in women who receive postpartum
      care at University of Alabama at Birmingham (UAB) hospital. We will examine the
      acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital

        Exclusion criteria

          -  Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid
             use, preeclampsia, non-English speaking
Preoperative Steroids in Autoimmune Thyroid Disease
Condition: Thyroid Diseases
MeSH terms: Thyroid Diseases
Intervention: Prednisone
Intervention description: used to reduce inflammation
Intervention MeSH terms: Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled pilot study
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Autoimmune disease; Graves' Disease; Hashimoto's Thyroiditis

Summary:

      This pilot project will randomize a small sample of patients about to undergo surgery for
      their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone
      alters the inflammation of the gland and makes surgery less difficult. It will enroll 30
      participants who will each be on study for up to 7 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Graves' disease or Hashimoto's disease with positive thyroid autoantibodies
             (Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating
             Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]).

          -  Participants will be invited to join the study after the decision has been made to
             proceed with thyroidectomy as the clinical treatment of their autoimmune thyroid
             disease.

        Exclusion Criteria:

          -  Pediatric patients < 18

          -  Prior treatment with radioactive iodine (RAI)

          -  Known diagnosis of thyroid cancer

          -  Diabetic patients.

          -  Patients on any immunosuppressive regiment (such as organ transplant patients or
             patients treated for other autoimmune condition)

          -  Pregnant patients.

          -  Patients being treated for active infection.

          -  Any patient for whom the surgeon feels steroids would provide a clear benefit (ie.
             Extremely high auto-antibody levels with a very large, inflamed thyroid gland) will be
             treated according to the clinical judgement of the surgeon. If a surgeon feels
             steroids are indicated and prescribes them, the patient will not be eligible for the
             trial.
Fluoxetine vs Aripiprazole Comparative Trial (FACT)
Condition: Attenuated Psychosis Syndrome
MeSH terms: Psychotic Disorders; Mental Disorders
Intervention: Aripiprazole; Fluoxetine
Intervention description: see arm description; see arm description
Intervention MeSH terms: Aripiprazole; Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 12 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with
      aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate
      severity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  consent obtained from patients and their parents (assent for patients under 18);

          -  age 12-25 years (inclusive);

          -  English-speaking;

          -  at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe
             or severe.

        Exclusion Criteria:

          -  lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform
             disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major
             depression with psychotic features;

          -  current psychosis (any positive symptom SOPS score of 6, i.e., extreme);

          -  current diagnosis of Major Depressive Disorder, single episode or recurrent, severe
             without psychotic features;

          -  current stimulant treatment;

          -  history of neurological, neuroendocrine or other medical condition known to affect the
             brain;

          -  any significant medical condition that contra-indicates treatment with either
             aripiprazole or fluoxetine;

          -  past or current substance dependence; sunstance abuse within the last 4 weeks;

          -  IQ < 70.
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Condition: Acne Rosacea
MeSH terms: Rosacea
Intervention: Azelaic acid 15%; Brimonidine 0.33%
Intervention description: Applied to the face each AM and PM; Applied to the face each AM 30 minutes after the application of Azelaic acid 15%
Intervention MeSH terms: Azelaic acid; Brimonidine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The pilot study will investigate whether combination treatment of Finacea 15% Gel and
      Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in
      treating both the papules/pustules and erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  18 years of age and older

          -  Female subjects of childbearing potential must have a negative urine pregnancy test at
             Baseline

          -  Female subjects of childbearing potential must practice a reliable method of
             contraception throughout the study

          -  Moderate or severe rosacea with an Investigator Global Assessment (IGA) score of 3 or
             4

          -  Able to understand and comply with the requirements of the study and sign Informed
             Consent/Health Insurance Portability and Accountability Authorization forms

        Exclusion Criteria:

          -  Female subjects who are pregnant, breast feeding or who are of childbearing potential
             and not practicing a reliable method of birthcontrol

          -  History of hypersensitivity or idiosyncratic reaction to any component of the test
             medications

          -  Subjects who have not completed the proper wash-out periods for prohibited medications
             and/or procedures

          -  Medical condition that contraindicates the subject's participation in the study

          -  Alcohol or drug abuse is evident within the past 5 years

          -  History of poor cooperation, non-compliance with medical treatment, unreliability

          -  Participation in an investigational drug study within 30 days of the Baseline visit
Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole
Condition: Dyspepsia; Emergency; Pain
MeSH terms: Emergencies; Dyspepsia
Intervention: Normal saline; Pantoprazole; Oral antacid; Hyoscine butylbromide
Intervention description: 10 ml of 0.9% sodium chloride solution; 80 mg of intravenous pantoprazole; 30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide); 20 mg of intravenous hyoscine butylbromide
Intervention MeSH terms: Scopolamine; Pantoprazole; Anti-Ulcer Agents; Antacids; Butylscopolammonium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 15 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Dyspepsia; Emergency treatment; Pantoprazole; Antacid; Pain measurement

Summary:

      The purpose of this study is to evaluate the immediate synergistic effect on the relief of
      severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of
      oral antacid and antispasmodic agent (the conventional treatment).
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of acid-related dyspepsia

          -  age 15 to 50 years

        Exclusion Criteria:

          -  pre-treatment 100-millimeter linear Visual Analog Scale (100-mm VAS) pain scores less
             than 5.0

          -  known cases of malignancies or terminal illnesses

          -  known cases of major medical problems

          -  allergic to studied drugs

          -  contraindicated to hyoscine butylbromide (glaucoma, myasthenia gravis, paralytic
             ileus, pyloric stenosis, prostatic enlargement, porphyria)

          -  received acid antisecretory agents (proton pump inhibitors or histamine-2 receptor
             antagonists), antispasmodic agents, alcoholic consumption, nonsteroidal
             anti-inflammatory drugs, aspirin and steroids within 5 days or oral antacids within 4
             hours prior to the visit

          -  receiving clopidogrel, statins, iron therapies, warfarins, antiretroviral agents,
             which may have serious drug interaction with the proton pump inhibitors

          -  receiving drugs that have strong anticholinergic activities (e.g. acetylcholinesterase
             inhibitors for Parkinson's or Alzheimer diseases, antihistamines, antispasmodic
             agents, antipsychotics, skeletal muscle relaxants, tricyclic antidepressants) or
             decongestants, which may have serious drug interaction with hyoscine butylbromide

          -  suspected other alternative diagnoses (e.g. gut obstruction, biliary colic,
             pancreatitis, hepatitis or localized hepatobiliary infections, etc.)

          -  pregnancy or breast-feeding participants

          -  did not comprehend the Visual Analog Scale (VAS) evaluation
Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Condition: Mycoses; Fungemia; Central Nervous System Fungal Infections; Lung Diseases, Fungal
MeSH terms: Infections; Communicable Diseases; Mycoses; Fungemia; Lung Diseases, Fungal; Central Nervous System Fungal Infections; Lung Diseases
Intervention: Anidulafungin; Fluconazole
Intervention description: 200 mg IV loading dose followed by 100 mg qd for 21 days; 400 mg IV for 21 days
Intervention MeSH terms: Fluconazole; Anidulafungin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for
      the prevention of fungal diseases in liver transplant recipients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver transplant recipient at increased risk for infection increased risk include any
             of the following:

          -  retransplantation

          -  renal replacement therapy (dialysis),

          -  post transplant abdominal surgery (within 21days)

          -  receipt of corticosteroids for greater than 14 days within the 4 weeks -preceding
             transplant

          -  ICU care for greater than 48 hours at the time of transplantation

          -  colonization with Candida sps within 4 weeks of transplantation

          -  requirement of 15 units or greater of packed red cell transfusions

          -  Intraoperative time exceeding 6 hours

        Exclusion Criteria:

          -  Hypersensitivity to azole or echinocandin antifungal agents

          -  receipt of systemic antifungal therapy within 4 weeks prior to transplantation