bioihbjkbjnl/mcl2 huggingface dataset:
Continuous Glucose Sensor Profiles in Non-Diabetic Subjects
Condition: Healthy Subjects Without Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Continuous glucose monitor
Intervention description: Daily use of a continuous glucose monitor for 3-7 days
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a
      large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use
      of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma
      glucose testing. Although the primary outcome in the >= 7.0% cohort is differences in HbA1c
      levels, important secondary outcomes are differences in the percent of glucose sensor values
      either above or below the target glucose range of 70-180 mg/dl and differences in glucose
      variability. Prevention of biochemical hypoglycemia is a particularly important outcome in
      the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and
      CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely
      useful for comparative purposes to establish a reference range of sensor values in healthy,
      non-diabetic control subjects for this study and other future investigations. The objective
      of this protocol is to establish such reference sensor glucose ranges in each of the 3
      devices being utilized in the JDRF study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 8 years

          -  Body mass index (BMI) between the 10th to 90th percentile for age and sex (based on
             CDC, 2000 nomogram) and < 28 kg body weight/meter in adult subjects

          -  No significant chronic illness or taking any acute or chronic medications that might
             affect glucose metabolism.

        Exclusion Criteria:

          -  History of diabetes or positive islet cell antibody testing
Reversing Ticagrelor's Effects With Fresh Platelets
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Ticagrelor loading dose; Aspirin loading dose; Ticagrelor maintenance dose; Aspirin maintenance dose
Intervention description: Single loading dose of Ticagrelor 180 mg; Single loading dose of Aspirin 325 mg; Ticagrelor 90 mg twice daily x 7 days; Aspirin 81 mg once daily x 7 days
Intervention MeSH terms: Aspirin; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Antiplatelet; Ticagrelor; Platelets; Thrombosis; Coronary artery disease

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteer between 18 and 75 years old.

          -  History of stable (i.e. non-acute) cardiovascular disease or the presence of risk
             factors for cardiovascular disease (i.e. hypertension, diabetes, hyperlipidemia, high
             calcium score and abnormal findings on angiography or stress test).

        Exclusion Criteria:

          -  Conditions associated with hemorrhagic risk, e.g., frequent epistaxis,
             gastrointestinal ulcer, hemorrhagic vascular lesions, recent surgery.

          -  Allergy or hypersensitivity to aspirin or ticagrelor.

          -  Loss of >400 mL blood or blood donation within past 3 months.

          -  Positive serology for hepatitis B (HBs Ag) or hepatitis C.

          -  History of drug abuse or alcohol abuse.

          -  Positive pregnancy test.

          -  Evidence of unstable or acute cardiovascular disease (e.g., unstable angina, recent
             myocardial infarction, congestive heart failure).

          -  History of clinically relevant pulmonary, hepatic, gastrointestinal, renal, metabolic,
             hematologic, neurologic, respiratory or psychiatric disease, bleeding, acute
             infectious disease or signs of acute illness.
Comparative Effectiveness Study for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium; Quetiapine
Intervention description: 600-900mg per day over 6 months; 100-800mg a day over 6 months
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Bipolar disorder; Comparative effectiveness trial; Lithium; Quetiapine

Summary:

      The purpose of this study is to compare the effectiveness of lithium and quetiapine for the
      treatment of individuals with bipolar disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meets DSM-IV criteria for BD I or II, which is the primary focus of treatment

          2. Able to give written informed consent

          3. Age > to 18 years and < 68 years

          4. Women of child bearing potential must agree to use adequate contraception (e.g. oral
             contraceptives, intrauterine device, barrier methods, or total abstinence from
             intercourse; Depo Provera is acceptable if it is started 3 months prior to
             enrollment), inform their doctor at the earliest possible time of their plans to
             conceive, and to understand the risks of lithium and other study treatments to the
             fetus and infant

          5. Currently symptomatic, as defined as a Clinical Global Impression - Bipolar Disorder
             Overall Severity (CGI-BP-S) score of at least 3 (mild)

          6. If currently taking an SGA, participants would be required to be willing to either
             discontinue or switch to QTP

          7. Willing to be randomized to either QTP+APT or Li+APT.

        Exclusion Criteria:

          1. Unwilling or unable to comply with study requirements

          2. If maintained on thyroid medication must be euthyroid for at least 1 month before
             Visit 1

          3. Patients who have had intolerable side effects with QTP or Li

          4. Patients whose clinical status requires inpatient care

          5. Drug/alcohol dependence within the past 30 days

          6. Pregnancy as determined by urine pregnancy test or breastfeeding

          7. History of nonresponse to Li at a serum level of ≥ 1.0 mEq/L ≥ 8 weeks

          8. History of nonresponse to QTP at doses of at least 600 mg ≥ 8 weeks.
A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis
Condition: Relapsing Forms of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fingolimod; Standard MS DMTs
Intervention description: 0.5 mg/day oral capsule
Intervention MeSH terms: Fingolimod Hydrochloride; Interferon beta-1b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1053.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Relapsing Forms of Multiple Sclerosis; Disease Modifying Therapy; fingolimod; Patient Reported Outcomes

Summary:

      The purpose of this study is to evaluate the change in patient-reported outcomes, physician
      assessment of a change as well as safety and tolerability in patients with Relapsing Forms of
      Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of
      two treatment arms: fingolimod vs. standard of care DMT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsing forms of MS

          -  Expanded Disability Status Scale (EDSS) 0-5.5

          -  Continuous treatment with MS DMT for a minimum of 6 months

          -  Fingolimod naive

        Exclusion Criteria:

          -  Immune system diseases other than MS

          -  Active macular edema

          -  History of selected prior infections and criteria for immunizations

          -  History of selected immune system treatments and/or medications

          -  Selected cardiovascular, pulmonary, or hepatic conditions

          -  Selected abnormal laboratory values

          -  Pregnant or nursing women

        Other protocol-defined inclusion/exclusion criteria applied
Switching to Iloperidone From Other Antipsychotics in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: iloperidone
Intervention description: Iloperidone tablets supplied at doses of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to achieve a target dose of 12-24 mg/day for 12 weeks.
Intervention MeSH terms: Iloperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 501.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Schizophrenia; iloperidone; switch; gradual switch; immediate switch

Summary:

      Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult
      subjects with schizophrenia who require a change in their current antipsychotic treatment of
      risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or
      safety/tolerability reasons.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, 18 to 64 years of age, inclusive

          -  DSM-IV diagnosis of schizophrenia

          -  Patients currently on an optimal in-label dose of one of the following permitted
             antipsychotic treatments for at least 30 days: risperidone, olanzapine, or
             aripiprazole

          -  Efficacy Clinical Global Impression of Severity (E-CGI-S) of 4 or 5 or

          -  Not tolerating one of the permitted treatments and exhibits one of the allowable
             side-effects

        Exclusion Criteria:

          -  Any other current Axis I disorder other than schizophrenia which is the focus of
             treatment;

          -  Acutely psychotic or patient's symptom severity requires hospitalization

          -  Patient with significant cardiovascular illness (myocardial infarction, cardiac
             arrhythmia)

        Other protocol-defined inclusion/exclusion criteria may apply
BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Intervention: Cefepime, Meropenem, or Piperacillin/Tazobactam; Cefepime, Meropenem, or Piperacillin/Tazobactam
Intervention description: A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam); A 1:1 randomization scheme based on the infusion duration (continuous over 24 hours or intermittent over 30 minutes) with stratification based on the beta-lactam prescribed (cefepime, meropenem, or piperacillin/tazobactam)
Intervention MeSH terms: Meropenem; Tazobactam; Piperacillin; Cefepime; Piperacillin, Tazobactam Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The study plans to randomize a total of 240 patients infected with Gram-negative bacterial
      pneumonia to receive beta-lactam (meropenem, cefepime, or piperacillin/tazobactam) continuous
      or intermittent infusion and collect baseline and regular follow-up respiratory cultures to
      assess the development of new resistance. The investigators will measure beta-lactam
      concentration to assess the impact of drug exposure on the bacterial resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to the ICU with severe pneumonia (IDSA/ATS 2016/2019): presence of signs,
             symptoms and confirmatory chest imaging consistent with pneumonia (e.g. fever, cough
             and pulmonary infiltrate by chest radiograph)

          -  Age ≥18 years

          -  Positive respiratory culture (with or without an initial positive rapid identification
             test and/or Gram stain) for Gram-negative bacteria including, but not limited to, P.
             aeruginosa, K. pneumoniae, E. coli, S. marcescens, H. influenzae, Enterobacter spp.,
             M. catarrhalis, A. baumannii, Achromobacter spp., P. mirabilis, and/or B. cepacia

          -  Received within the last 72 hours or will receive meropenem, cefepime, or
             piperacillin/tazobactam therapy

        Exclusion Criteria:

          -  Pregnancy

          -  Prisoners

          -  Allergy to the beta-lactams to be administered in this study

          -  On renal replacement therapy at the time of randomization

          -  Baseline culture resistant to the beta-lactams in the study

          -  COVID patients enrolled in other trials
Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
Condition: Obesity; Complications; Caesarean Section, Wound
MeSH terms: Wounds and Injuries
Intervention: Silverlon; Standard Dressing
Intervention description: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.; Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 37.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Cesarean Section; Wound care

Summary:

      Obese patients undergoing cesarean section are at high risk for wound complications, which
      occur in approximately 20% of patients. This is a randomized controlled trial designed to
      determine whether the risk for wound-related complications can be reduced by covering the
      incision with a silver-impregnated dressing in the postoperative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing cesarean section (with or without concurrent tubal ligation)

          -  Body mass index (based on most recent weight) >=30

        Exclusion Criteria:

          -  Known allergy to silver

          -  Less than 18 years of age

          -  Preoperative evidence of current abdominal wall infection

          -  Contraindication to closure of the skin at time of surgery

          -  Plan to perform procedures in addition to cesarean section (with or without tubal
             ligation)

          -  Patients with previously placed abdominal wall mesh at site of planned surgery

          -  Inability to participate in medical decision making

          -  Inability to follow up with the Michigan Visiting Nurses or are unable to return to
             the University of Michigan Medical Center for staple removal
Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
Condition: Bradycardia; Arrhythmias
MeSH terms: Bradycardia
Intervention: Atropine
Intervention description: intravenous atropine affect on heart rate
Intervention MeSH terms: Atropine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: This is a single arm study where a dose of atropine was administered and the ECG recorded.
Masking: None (Open Label)
Masking description: Observer of ECG rhythm strips was unaware of the study hypothesis, the study drug administered, the dose given and the arrhythmias sought. Your statement that masking a single outcome implies a multi-arm study precludes a panoramic perspective of clinical research study designs and scenarios in which assessors may be effectively blinded.
Enrollment: 60.0
Sex: All
Minimum age: 1 Day
Maximum age: 2 Years
Healthy volunteers: No
Keywords: Atropine; bradycardia; tachycardia

Summary:

      An infants heart rate is very important because it ensures that blood is pumped to all organs
      in the body. Heart rate may decrease during anesthesia and surgery, and this is why the
      anesthesiologist will often give a medication to prevent this from happening. The most common
      drug for this purpose is called atropine. The dose of most drugs given to babies is based
      upon the baby's weight, but some believe that the dose of atropine should not be less than
      0.1mg. However there is no evidence to support this minimum dose. A larger dose of atropine
      may cause a very fast heart rate instead. Anesthesiologists routinely dose the atropine based
      upon the baby's weight without regard for a minimum dose.

      The purpose of the present study is to measure the heart rate after doses of atropine in
      neonates and infants who receive less than 0.1 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age : 0-2 years old

          2. Weight : less than the 95th percentile for age and height ( no more than 15kg )

          3. ASA classification : I-II

          4. Meets the hospital and department of anesthesiology guidelines with respect to
             peri-operative care

        Exclusion Criteria:

          1. History of heart disease

          2. Any condition predisposing to arrhythmia

          3. Any medication known to influence the heart rate

          4. Child taking anti-cholinergic medication routinely

          5. The use of succinylcholine anticipated (will cause bradycardia)

          6. Rapid sequence intubation is required (due to aspiration risk)

          7. Known difficult airway (may be difficult to bag mask ventilate)
Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome
Condition: Gout
MeSH terms: Metabolic Syndrome; Hyperuricemia
Intervention: Febuxostat
Intervention description: One 40 mg tablet once a day for 6 months
Intervention MeSH terms: Febuxostat
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This study is being done to evaluate whether the medication, febuxostat, can improve the
      degree of insulin resistance and other features of the metabolic syndrome (high blood
      pressure, elevated insulin levels, excess body fat around the waist, and/or high cholesterol)
      by lowering uric acid levels in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 21 years

          -  Gout

          -  Hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women).

        Exclusion Criteria:

          -  Current treatment with insulin, azathioprine, mercaptopurine, or theophylline.

          -  Treatment with febuxostat, allopurinol or other uricosuric agents (including losartan,
             probenecid) within the past year

          -  Uncontrolled hypertension (clinic systolic blood pressure > 160 mmHg or diastolic
             blood pressure > 90 mmHg within the past 6 months)

          -  Uncontrolled diabetes mellitus (HbA1c > 7%)

          -  estimated GFR < 60 ml/min by MDRD

          -  Elevated liver function tests (AST or ALT greater than 3 times the upper limit of
             normal)

          -  Pregnancy
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Condition: Pain; Pain, Acute; Anesthesia
MeSH terms: Acute Pain
Intervention: Sublingual Sufentanil
Intervention description: 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.
Intervention MeSH terms: Sufentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a single dose of sublingual sufentanil given
      15-30 minutes prior to wake up is efficacious at reducing recovery room time.
    

Eligibility criteria:

        Inclusion Criteria:

        - Adult patients undergoing outpatient ambulatory surgery undergoing general anesthesia for
        orthopedic surgery

        Exclusion Criteria:

          -  non-english speaking patients

          -  patients who have allergy or intolerance to the study drugs or derivatives