bioihbjkbjnl/mcl2 huggingface dataset:
Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
Condition: Epistaxis
MeSH terms: Epistaxis; Emergencies
Intervention: Tranexamic Acid; 0.9% Sodium Chloride
Intervention description: TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).; 0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tranexamic acid; epistaxis; emergency medicine; intranasal; TXA

Summary:

      It is estimated that epistaxis results in 4.5 million emergency department visits per year
      throughout the United States. Due to the adverse effects of standard treatment options for
      epistaxis, tranexamic acid (TXA) may be considered an attractive option. In previous studies,
      when used with nasal packing, TXA showed faster time to control of bleeding. The goal of this
      study is to determine the efficacy and safety of topical intranasal TXA applied via atomizer
      for patients with epistaxis who present to the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with anterior epistaxis

        Exclusion Criteria:

          -  Unable to consent, do not have a valid telephone number, pregnant women, prisoners,
             cognitively impaired individuals, diagnosis of posterior epistaxis, major trauma,
             bleeding disorder (such as thrombocytopenia or hemophilia), hemodynamically unstable,
             or had a known hypersensitivity to study medication
Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Medication augmentation; CBT
Intervention MeSH terms: Prazosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 43 Years
Healthy volunteers: No
Keywords: PTSD; Cognitive behavioral therapy (CBT); Medication augmentation; Treatment-resistant PTSD; Cambodian refugees; Culturally sensitive treatment

Summary:

      This project aims to investigate the efficacy of two models to treat Posttraumatic Stress
      Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is
      giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine
      reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those
      patients who still have PTSD, the second step is either another medication or a culturally
      sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients
      will improve in both models, but more so in the the CBT model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PTSD;

          -  PCL great or equal to 44;

          -  Survivor of the Cambodian genocide;

          -  At least 7 years old at the time of the Cambodian genocide

        Exclusion Criteria:

          -  Pregnant;

          -  Active suicidality;

          -  Mental retardation;

          -  Organic mental disorder;

          -  Bipolar disorder;

          -  Alcohol dependence;

          -  Marijuana dependence;

          -  Unable to give conformed consent
A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
Condition: Schizophrenia; Bipolar 1 Disorder; Major Depressive Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Abilify MyCite - Digital Medicine System; Aripiprazole or other oral antipsychotics
Intervention description: The Abilify MyCite system is a drug-device combination product comprised of aripiprazole (an atypical antipsychotic) tablets embedded with a sensor that communicates with a patch (wearable sensor) and a medical software application with collected information (ingestion, mood, activity, rest) tracked and summarized for participants, healthcare providers, and potential caregivers. Abilify MyCite is intended to track drug ingestion and is indicated for the treatment of adults with schizophrenia (SCH), bipolar 1 disorder (BP1) (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with major depressive disorder (MDD).; For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.
Intervention MeSH terms: Aripiprazole; Antipsychotic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 63 Years
Healthy volunteers: No
Keywords: Digital Medicine System

Summary:

      The primary objective of this pragmatic clinical trial (Main Study) was to assess the
      difference between all-cause hospitalizations in participants using Abilify MyCite versus
      virtual matched controls. In addition, secondary and exploratory objectives were to assess
      medication adherence, healthcare utilization and costs, and patient-reported outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are actively enrolled in an Anthem-affiliated commercial, Medicaid, or
             Medicare health plan with medical and pharmacy benefits.

          -  Participants must have a smartphone with data plan.

          -  Participants currently prescribed aripiprazole, or appropriate for aripiprazole
             treatment.

          -  Participants must have a current diagnosis of SCH, BP1, or MDD.

        Exclusion Criteria:

          -  Any participant who participated in another clinical trial within 30 days of
             enrollment into the current study.

          -  Females who are breast-feeding and/or who are pregnant at the time of study
             enrollment, or who plan to become pregnant during the study.

          -  Participants who are currently being treated with a long-acting injectable
             antipsychotic.
Buprenorphine to Improve HIV Care Engagement and Outcomes
Condition: HIV; Substance Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: Buprenorphine/naloxone; Methadone Maintenance Therapy
Intervention description: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.; Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
Intervention MeSH terms: Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare two models of substance abuse treatment in Vietnam,
      and how they each affect HIV care. In Vietnam, the current model for treating people with HIV
      who are also dependent on opioids is to refer them to methadone maintenance treatment
      centers. The new model the protocol will study is treatment of HIV and opioid dependence with
      buprenorphine/naloxone and counseling in the HIV clinic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV positive

          -  Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use
             disorder

          -  Urine drug screen positive for opioids

          -  Interested in receiving treatment for opioid dependence

          -  Age at least 18 years old

          -  Willing to practice an effective method of birth control, if female

        Exclusion Criteria:

          -  Known hypersensitivity to buprenorphine or naloxone

          -  aspartate aminotransferase (AST) & alanine aminotransferase (ALT) > 5x upper limit

          -  Currently pregnant or breastfeeding

          -  Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection,
             psychosis) that precludes safe participation in the opinion of study physician

          -  Methadone maintenance treatment within 30 days of consent
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Condition: Pain, Postoperative; Mammaplasty
MeSH terms: Pain, Postoperative
Intervention: Depofoam bupivacaine; Bupivacaine hydrochloride (HCl)
Intervention description: The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.; The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients undergoing breast reconstruction with tissue expanders will be treated with a local
      anesthetic during their procedure and monitor their post-operative pain level and amount of
      oral pain medication taken. This information will be used to determine if liposomal
      bupivacaine provides better and longer pain control vs. bupivacaine HCl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing breast reconstruction with tissue expander

        Exclusion Criteria:

          -  history of adverse reaction to local anesthesia

          -  chronic liver disease

          -  history of chronic preoperative consumption of narcotics or opioids

          -  history of alcohol and/or illicit drug dependence

          -  undergoing combined procedures

          -  diagnosed with neuromuscular/neurosensory disorder

          -  positive pregnancy test

          -  previous breast conservation therapy (lumpectomy with radiation treatment

          -  previous surgeries or trauma in the breast or chest region (denervation may bias pain
             perception)

          -  axillary node dissection

          -  psychosis.
Esophageal Food Impaction
Condition: Esophageal Food Bolus Obstruction
Intervention: Nitrostat 0.4Mg Sublingual Tablet
Intervention description: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure > 100 mmHg.
Intervention MeSH terms: Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to obtain data on the safety and efficacy of oral nitroglycerin
      solution for the treatment of esophageal food impaction in patients presenting to the
      Emergency Department with presumed esophageal food impaction. The main hypothesis is to
      determine the success rate of oral nitroglycerin solution in relieving the food impaction by
      assessing the resolution of symptoms and the ability of the patient to swallow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over the age of 18 years

          -  Presentation consistent with esophageal food impaction

          -  Ability to swallow a small volume of liquid.

        Exclusion Criteria:

          -  Intractable vomiting

          -  Hemodynamic instability or SBP <100 mmHg

          -  Concern for or evidence of significant airway compromise

          -  Concern for or evidence of esophageal perforation,

          -  Concern for or evidence of coronary ischemia

          -  Presentation > 12 hours since onset.
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Praluent (Alirocumab); Placebo
Intervention MeSH terms: Alirocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2176.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Summary:

      The main purpose of this study is to evaluate the effect on mental state (known as
      "neurocognitive function") with use of Praluent.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men and women ≥ age 40 years and ≤ age 85 years

          -  Patients with heterozygous familial hypercholesterolemia (heFH) or with non-familial
             hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk

          -  Patients with history of coronary heart disease (CHD) not having adequate control of
             their hypercholesterolemia with LDL-C ≥70 mg/dL, or all other patients with LDL-C ≥100
             mg/dL and be on maximally-tolerated dose of statin (unless they are statin-intolerant)

          -  Patients must have successfully completed the Motor Screening Task

          -  Patients must be willing and able to comply with clinic visits and study related
             procedures

          -  Patients must provide signed informed consent

        Key Exclusion Criteria:

          -  Patients with known Alzheimer's disease or other dementia, schizophrenia, bipolar
             disorder, severe depression, cognitive impairment, or patients with a sleep disorder
             requiring daily pharmacological treatment

          -  Recent (within 3 months prior to the screening visit) myocardial infarction, unstable
             angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous
             coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting,
             stroke, transient ischemic attack, carotid revascularization, endovascular procedure
             or surgical intervention for peripheral vascular disease

          -  Certain laboratory findings obtained during the screening visit as defined in the
             protocol

          -  Any condition or situation, including other significant mental or neurological
             disorders that, in the investigator's opinion, may confound the study results, or may
             interfere significantly with the patient's participation in the study

          -  Pregnant or breastfeeding women

          -  A positive human immunodeficiency virus (HIV) test

        NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose
Condition: Magnetic Resonance Imaging
Intervention: Gadoterate (Dotarem/Clariscan); Gadobutrol (Gadavist/Gadovist, BAY86-4875)
Intervention description: Patients received a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.; Patients received a single dose of 1.0 molar BAY86-4875 (0.075 mmol per kg body weight) intravenously.
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gadolinium; Contrast enhancement; Central nervous system lesion

Summary:

      The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used
      for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system
      (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions.
      Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is
      applied to improve the analysability of MRI-images.

      The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the
      gadolinium-based contrast agent gadobutrol delivers images of similar quality to those
      obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known or highly suspected central nervous system (CNS) pathology referred for
             contrast-enhanced MRI of the CNS.

          -  Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum
             creatinine result within four weeks prior to the first study MRI.

          -  Women with negative urine pregnancy test within 1 hour prior to the administration of
             gadoterate (the first MRI).

        Exclusion Criteria:

          -  No enhancing lesion visible on the gadoterate-enhanced MRI scan.

          -  Pregnancy or breastfeeding.

          -  Severe cardiovascular disease
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Fluticasone furoate and fexofenadine
Intervention description: Fluticasone furoate and fexofenadine
Intervention MeSH terms: Fluticasone; Xhance; Fexofenadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 1000.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: once daily; mountain cedar; fexofenadine; allergic rhinitis; fluticasone furoate

Summary:

      The primary objective of this study is to compare the nighttime symptom relief of fluticasone
      furoate nasal spray and oral fexofenadine
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed consent.

          -  Outpatient.

          -  Females of child-bearing potential must use appropriate contraception.

          -  Diagnosis of seasonal allergic rhinitis to mountain cedar.

          -  Adequate exposure to allergen.

          -  Able to comply with study procedures.

          -  Literate.

        Exclusion criteria:

          -  Significant concomitant medical condition.

          -  Use of corticosteroids, allergy medications, or other medication that affect allergic
             rhinitis

          -  Positive pregnancy test.

          -  Allergy to any component of the investigational product.

          -  Tobacco use

          -  Contact lens use

          -  Has chickenpox or measles or recent exposure

          -  Other clinical trial drug exposure in last 30 days

          -  Affiliation with clinic site
Effects of Linagliptin on Endothelial Function
Condition: Type 2 Diabetes; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Linagliptin; Placebo
Intervention description: The subject will receive Linagliptin 5mg orally once daily for 12 weeks.; The subject will receive placebo orally once daily for 12 weeks.
Intervention MeSH terms: Linagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is planned to evaluate if linagliptin can improve endothelial function in patients
      with type 2 diabetes mellitus. In addition, the effect of linagliptin on arginine
      bioavailability ratios and postchallenge glycaemic control will be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 40 to 80 years

          -  Early diabetes (postchallenge diabetes (2h glucose >200 mg/dl or type 2 diabetes
             treated with diet only or on a stable dose of metformin monotherapy)

          -  Coronary atherosclerosis (diagnosed via coronary angiography or coronary computer
             tomography)

        Exclusion Criteria:

          -  Acute coronary syndrome or cerebrovascular event within the previous 4 weeks

          -  Body Mass Index (BMI) > 35 kg/m2

          -  HbA1c <6.0% (42 mmol/mol)

          -  Serum creatinine > 2.5 mg/dl

          -  Aspartate Transaminase (AST)/Alanine Transaminase (ALT)>3x upper limit of normal

          -  HbA1c >9.0% (>75 mmol/mol)

          -  Heart failure > New York Heart Association (NYHA) class II

          -  Uncontrolled hypertension (blood pressure > 165 / 100 mmHg)

          -  Treatment with orally administered steroids

          -  New onset statin or Angiotensin Converting Enzym- (ACE-) inhibitor within the previous
             6 weeks

          -  Known Malignancy

          -  Pregnancy or breast feeding women.