bioihbjkbjnl/mcl2 huggingface dataset:
Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Condition: Suicide, Attempted
MeSH terms: Suicide; Suicide, Attempted
Intervention: Intravenous ketamine; Cognitive training; Sham Training
Intervention description: Single subanesthetic infusion of ketamine (0.5mg/kg); 8 sessions of computer-based cognitive training; 8 sessions of computer-based sham training
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This project seeks to identify the acute and longer-term impact of a single dose of
      intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in
      the medical inpatient setting. The investigators will then test whether ketamine's rapid
      effects can be extended by introducing helpful information delivered by a computer-based
      training protocol. This work could ultimately lead to the ability to treat suicidality more
      efficiently and with broader dissemination by rapidly priming the brain for helpful forms of
      learning.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants will:

          1. be between the ages of 18 and 65 years

          2. be a medical inpatient referred for psychiatric consultation/liaison due to
             suicidality

          3. possess a level of judgment and understanding sufficient to agree to all procedures
             required by the protocol and must sign an informed consent document

          4. be deemed an appropriate and reasonable medical candidate for intravenous ketamine by
             a physician authorized to prescribe medication to the patient during inpatient
             hospitalization

        Exclusion Criteria:

          1. Presence of current psychotic or autism spectrum disorder or current delirium

          2. Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks

          3. Current pregnancy or breastfeeding

          4. Reading level <5th grade as per WRAT-3 reading subtest

          5. Past intolerance or hypersensitivity to ketamine

          6. Patients taking any of the following medications: St John's Wort, theophylline,
             tramadol, metrizamide

          7. Patients who have received ECT in the past 6 months prior to intake

          8. Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate
             withdrawal) or who present with substance-induced psychosis

          9. Patients who, based on expressed preference and/or home geographic location, are
             deemed by the Psychiatric Consultation/Liaison service to be likely to receive
             inpatient psychiatric hospitalization at an alternate location outside of Western
             Psychiatric Institute & Clinic
Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion
Condition: Adenine Phosphoribosyltransferase Deficiency
Intervention: Allopurinol; Febuxostat
Intervention description: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.; This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
Intervention MeSH terms: Allopurinol; Febuxostat
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Xanthine dehydrogenase inhibitor treatment, pharmacotherapy

Summary:

      This exploratory pilot study was an open-label, crossover, single-center and non-randomized
      clinical trial designed to compare the effect of the standardly employed doses of allopurinol
      (400 mg/day) and febuxostat (80 mg/day) on the urinary 2,8-dihydroxyadenine (DHA) excretion
      in patients with adenine phosphoribosyltransferase (APRT) deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients 18 year and older who are enrolled in the APRT Deficiency Registry of The
             Rare Kidney Stone Consortium.

        Exclusion Criteria:

          -  Patients do not want to interrupt drug (allopurinol) treatment for a total of two
             weeks as requested in protocol. No other exclusion criteria if inclusion criteria are
             met.
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
Condition: Hypercholesterolemia With Type2DM
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Intervention: Pitavastatin; Atorvastatin
Intervention description: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks; Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
Intervention MeSH terms: Atorvastatin; Pitavastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: pitavastatin; PWV; ESPRIT; Pitavastatin and Atorvastatin; Adiponectin; fasting insulin; hs-CRP; baPWV

Summary:

      A randomized, open label, dose titration study to evaluate the efficacy and safety of
      Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 25yrs~75yrs

          -  Fasting TG <400mg/dL, LDL-C ≥130mg/dL

          -  3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM,
             6.5%≤HbA1c≤10.0%

        Exclusion Criteria:

          -  Type1 DM, Gestational diabetes

          -  Patient need to treat with Insulin

          -  Patient with operational treatment for severe diabetic complication

          -  Uncontrolled Hypothyroidism

          -  Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within
             3 months (NYHA class4)

          -  Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)

          -  Renal disorder (Serum creatinine ≥ 2.0mg/dL)

          -  Hepatic disorder (AST or ALT ≥ 2.5 X UNL)

          -  Creatinine Kinase > 2.5 X UNL

          -  Gravida or lactation phase

          -  Administration of Atorvastatin, Rosuvastatin, Pitavastatin
Clinical, Pharmacological and Molecular Effects of IV and Oral Acetaminophen in Adults With aSAH
Condition: Subarachnoid Hemorrhage; Stroke
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Intervention: IV acetaminophen; Oral acetaminophen; Oral placebo; IV placebo
Intervention description: Patients in this group will receive IV acetaminophen and an oral placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.; Patients in this group will receive oral acetaminophen and an IV saline solution placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.; Patients who receive IV acetaminophen will also receive an oral placebo with their IV treatments (every 6 hours for a 14 day period).; Patients who receive oral acetaminophen will also receive a saline solution placebo at the same time that they receive the oral acetaminophen treatment (every 6 hours for 14 days).
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acetaminophen; interleukin-6; interleukin-1; thromboxane A2

Summary:

      This study compares the bioavailability of IV and PO acetaminophen in both blood and the
      cerebrospinal fluid (CSF) of patients following subarachnoid hemorrhage. The study will also
      compare the temperature and levels of inflammatory cytokines in both blood and CSF of
      patients treated with IV and PO acetaminophen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of subarachnoid hemorrhage (must be confirmed by CT, CT angiography, lumbar
             puncture, or MRI).

          -  Fisher Grade between 1-3 (subarachnoid blood without signs of intraventricular
             hemorrhage or parenchymal extension).

          -  Placement of an external ventricular drain.

          -  Adults aged 18-100 years.

        Exclusion Criteria:

          -  Anyone under the age of 18 or over the age of 100.

          -  Adult patients with subarachnoid hemorrhage with interventricular hemorrhage or
             parenchymal extension (Fisher Grade 4).

          -  Contraindication to acetaminophen such as a known hypersensitivity, severe hepatic
             impairment, or severe active liver disease.

          -  Severe renal impairment (creatinine clearance ≤ 30 mL/min).
A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Analog Mid Mixture; Basal Insulin Analog
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 814.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: mid mixture insulin analog; basal insulin analog

Summary:

      The purpose of this study is to compare the effectiveness of basal insulin analog and insulin
      analog mid mixture in Chinese participants with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  have type 2 diabetes as defined by World Health Organization (WHO) criteria

          -  are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by
             the investigator

          -  most recent HbA1c value ≥7.5% within 12 weeks of study entry

          -  in the opinion of the investigator, require to initiate premix analog or basal insulin
             analog treatment

          -  willing to start with insulin treatment

        Exclusion Criteria:

          -  have a diagnosis of type 1 diabetes

          -  have received any type of insulin within 24 months of study entry (except for
             intermittent use of insulin of less than 1 month each time)

          -  have serious preexisting medical or other conditions that, in the judgment of the
             investigator, would preclude participation in this study

          -  are pregnant or breastfeeding, or intend to become pregnant during the course of the
             study

          -  are currently enrolled or have participated, within the last 30 days in any other
             clinical trial involving an investigational product or any other type of medical
             research judged not to be scientifically or medically compatible
Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Intervention: Endotracheal intubation; Laryngeal mask airway; remifentanil
Intervention description: additional premedication in the endotracheal intubation/INSURE arm
Intervention MeSH terms: Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 2 Hours
Maximum age: 48 Hours
Healthy volunteers: No
Keywords: surfactant

Summary:

      In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via
      nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be
      randomized to standard delivery of surfactant via and endotracheal tube airway (inserted
      after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via
      laryngeal mask airway (LMA). The intent is to remove the airways and return babies to
      non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate
      of failure of initial surfactant therapy. Standardized failure criteria are reached: a)
      early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal
      intubation and mechanical ventilation) or, b) late, if the baby requires ventilation,
      retreatment with surfactant within 8 hours or more than 2 doses of surfactant.

      The objective of this protocol is to reduce the need for endotracheal intubation and
      mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by
      instilling surfactant though an LMA, while achieving comparable efficacy of surfactant
      treatment.

      The hypothesis is that surfactant treatment through an LMA will decrease the proportion of
      babies with RDS who require mechanical ventilation or subsequent intubation, when compared to
      standard surfactant treatment following endotracheal intubation with sedation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild-to-moderate RDS;

          -  Postnatal age 2 to 48 hours;

          -  Gestational age 27 0/7 to 36 6/7 weeks;

          -  Treated with nasal CPAP modalities ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at
             least 2 hours to maintain SpO2 90-95%;

          -  Informed consent

        Exclusion Criteria:

          -  Weight < 800 g;

          -  Airway anomalies;

          -  Pulmonary air leaks;

          -  Craniofacial or cardiothoracic malformations
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fingolimod
Intervention description: Commercially available 0.5mg hard capsules, taken orally once per day
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-cohort, non-randomized, open-label multicenter
Masking: None (Open Label)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsing Multiple Sclerosis; RMS; Relapsing Multiple Sclerosis (RMS); Multiple Sclerosis; MS; Multiple Sclerosis (MS); Fingolimod; FLUENT; Immune Phenotype; adult; FTY720

Summary:

      A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS)
      after treatment with 0.5mg fingolimod
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing forms of Multiple Sclerosis

          -  Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR
             patients already on commercially prescribed fingolimod 0.5mg per day continuously for
             ≥ 2 years

        Exclusion Criteria (per USPI):

          -  Patients who in the last 6 months experienced myocardial infarction, unstable angina,
             stroke, transient ischemic stroke, decompensated heart failure requiring
             hospitalization or Class III/IV heart failure

          -  History or presence of Mobitz Type II second-degree or third-degree atrioventricular
             block or sick sinus syndrome, unless patient had a functioning pacemaker

          -  Baseline QTc interval ≥ 500 msec

          -  Treatment with Class Ia or Class III anti-arrhythmic drugs

          -  Patients who had a hypersensitivity reaction to fingolimod or any of the excipients
Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: letrozole
Intervention description: 2.5 mg daily by mouth for 6 months
Intervention MeSH terms: Letrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: breast cancer; adjuvant treatment in post menopausal women; letrozole; arthralgia-myalgia

Summary:

      This study will evaluate whether patients who are intolerant and discontinue anastrozole due
      to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking
      letrozole
    

Eligibility criteria:

        Inclusion Criteria:

          1. Postmenopausal women with HR+ early stage breast cancer at the time of initial
             diagnosis. For study purposes, postmenopausal is defined as:

               -  Age ≥ 50 y and amenorrheic for 12 or more months.

               -  Age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant
                  chemotherapy.

               -  Age < 50 y and amenorrheic for 12 or more months.

               -  Prior bilateral oophorectomy.

               -  Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per
                  local institutional standards.

               -  Age > 55 y and prior hysterectomy.

          2. Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry
             when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3
             (NCI-CTCAE V3) arthralgia-myalgia.

          3. Hormone receptor-positive tumors as defined by institutional standards.

          4. ECOG performance status of 0, 1, or 2

          5. Consent to participate in the trial. -

        Exclusion Criteria:

          1. Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding
             chest wall recurrence with no evidence of systemic disease.

          2. Recent history of pain associated with non-traumatic bone fracture.

          3. Pain requiring chronic use of analgesics (due to any reason).

          4. History of rheumatological disease except osteoarthritis.

          5. Prior hormonal therapy with AIs other than anastrozole.

          6. Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other
             than Estring®, Vagifem® or low dose estrogen vaginal cream.

          7. Concomitant disease which significantly affects quality of life.

          8. Patient unable to complete self administered questionnaire.

          9. Patients unable to sign consent form.

        Other protocol-defined inclusion/exclusion criteria may apply
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Intervention: IM epinephrine 1:1000; No intervention
Intervention description: IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.; A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
Intervention MeSH terms: Epinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Status asthmaticus; Asthma exacerbation; Epinephrine; Adjunctive therapy

Summary:

      Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled
      bronchodilators (β2 agonists) for children with severe asthma exacerbation.

      Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists)
      for children with severe asthma exacerbation.

      Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose
      of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects
      20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by
      an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23
      gauge one inch needle.

      In addition to the study intervention, the standardized treatment pathway based on the
      current asthma guidelines in use at the investigator's center will be utilized. This pathway
      includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration
      and dosages of these other interventions will be administered at the discretion of the
      treating provider.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than 6 years and less than 18 years

          2. Pre-existing diagnosis of asthma

          3. Presenting to the ED with an asthma exacerbation

        Exclusion Criteria:

          1. History of chronic lung or upper airway disease other than asthma

          2. History significant, uncorrected congenital heart disease or cardiac arrhythmia

          3. History of thyroid disease

          4. Impending respiratory failure

          5. Allergy to epinephrine

          6. Pregnancy

          7. PEFR>60% of predicted and clinical asthma score less than 8