bioihbjkbjnl/mcl2 huggingface dataset:
Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin; Pramlintide + Insulin
Intervention description: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.; 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pramlintide; Islet Amyloid Polypeptide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: pediatric; juvenile; diabetes mellitus; Pediatric type 1 diabetes mellitus

Summary:

      The primary objective of this study is to examine the effect of pramlintide given pre-meal
      and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial
      glucose excursions.

      The secondary objective is to examine the effect of pramlintide and insulin on glucagon
      suppression in type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes only

          -  Diagnosed with T1DM for at least 1 year

          -  HbA1C less than or equal to 8.5%

          -  Currently treated using insulin glargine with or without Humalog/ Novolog or on the
             insulin pump

          -  Hemoglobin equal to or greater than 12mg/dL

          -  Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism

          -  Negative pregnancy test, in the case of females

        Exclusion Criteria:

          -  Lack of supportive family

          -  Evidence or history of chemical abuse

          -  BMI (body mass index) greater than the 90th percentile OR less than the 10th
             percentile for age

          -  Patient who is poorly compliant with current insulin management and/or Prescribed self
             blood glucose monitoring

          -  Patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/
             hospitalizations) in the past 6 months

          -  Have hypoglycemia unawareness

          -  Have a confirmed diagnosis of gastroparesis, and/ or require medications that
             stimulate gastrointestinal motility

          -  Pregnant or lactating patients, or patients planning on becoming pregnant
Veteran Stress and Learning Study
Condition: Stress Disorders, Posttraumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Hydrocortisone; D-Cycloserine; Placebo
Intervention description: 25 mg/oral one hour prior to extinction task; 50 mg/oral one hour prior to extinction task; One hour prior to extinction task
Intervention MeSH terms: Cycloserine; Hydrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Stress Disorders, Posttraumatic; Hydrocortisone; Cycloserine; Extinction, Psychological; PTSD; San Francisco

Summary:

      This is a research study examining the use of two medications, Hydrocortisone and
      D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear
      responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder
      (PTSD). These responses will be tested using a fear learning and memory task administered by
      computer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans and civilians with an age range of 18 to 65 years

          -  Participants must be physically healthy volunteers

        Exclusion Criteria:

          -  Individuals who fall outside the age range

          -  Individuals with medical conditions that would interfere with participation

          -  Other criteria
A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM/IVA; Placebo
Intervention MeSH terms: Ivacaftor
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in
      subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.
      This study is designed to evaluate the effect of LUM/IVA on exercise tolerance in subjects
      with CF, homozygous for the F508del-CFTR mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del-CFTR mutation

          -  Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative
             pilocarpine iontophoresis

          -  Stable CF disease as judged by the investigator

          -  Forced expiratory volume in 1 second (FEV1) at least 40% and not greater than 90% of
             predicted

        Exclusion Criteria:

          -  History of any comorbidity that might confound the results of the study, interfere
             with the use of cardiopulmonary exercise tests (CPETs) as an assessment, or pose an
             additional risk in administering study drug to the subject

          -  Any previous exposure to LUM or IVA

          -  History of cardiac arrhythmia, ischemic heart disease, congestive heart failure, or
             other clinically significant cardiac condition, or medical condition requiring chronic
             use of a beta blocker, non-dihydropyridine calcium channel blocker, or other cardiac
             medication known to affect exercise tolerance

          -  History of solid organ or hematological transplantation

          -  For subjects under 18 years of age at Screening, except those who have had bilateral
             lens removal, selected findings on a screening ophthalmologic examination will be
             exclusionary

          -  Using or expected to require any concomitant medication that is prohibited in this
             study

          -  History of alcohol or drug abuse, as deemed by the investigator, in the past year,
             including but not limited to cannabis, cocaine, and opiates

          -  Participation in an investigational drug study within 30 days before the Screening
             Visit

          -  Pregnant or nursing females; males with a female partner who is pregnant or nursing

          -  Colonization with organisms associated with a more rapid decline in pulmonary status
Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty
Condition: Pain
Intervention: Peripheral Nerve Blockade; 10 meter walk test on post-operative day 1; In person and over the phone questionnaire; Force transduction of quadriceps strength
Intervention description: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization; Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist; Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores; Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: 10 meter walk test; Opioid consumption

Summary:

      Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on
      physical therapy measures and pain scores as well as opiate consumption.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is scheduled for elective unilateral TKA;

          2. The subject is ≥ 18 years and ≤ 80 years;

          3. The subject's weight is between 65-130 kg;

          4. The subject's primary anesthesia care team has planned for a neuraxial anesthetic
             (i.e. spinal, epidural or combined-spinal epidural);

          5. The patient agrees to receive an adductor canal block;

          6. American Society of Anesthesiologists class 1-3.

        Exclusion Criteria:

          1. Subject is < 18 years of age or >80 years of age;

          2. Subject is non-English speaking;

          3. Subject is known or believed to be pregnant;

          4. Subject is a prisoner;

          5. Subject has impaired decision-making capacity per discretion of the Investigator;

          6. Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative
             aspiration;

          7. Any condition for which the primary anesthesia care team deems neuraxial anesthesia
             inappropriate;

          8. Significant pre-existing neuropathy on the operative limb;

          9. Significant renal, cardiac or hepatic disease per discretion of the investigator;

         10. American Society of Anesthesiologists class 4-5;

         11. Known hypersensitivity and/or allergies to local anesthetics;

         12. Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).
Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Lumason
Intervention description: 2.4 mL per lesion
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out if a different type of imaging study called
      contrast enhanced ultrasound (CEUS) is as good as, or better than CT or MRI in patients
      diagnosed with hepatocellular carcinoma (HCC) after receiving TACE treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥18 years of age) patients with diagnosed HCC (via imaging, biopsy, or
             combination of imaging and biochemical markers), who are treated with their first
             round of TACE.

          -  Sex: male or female

          -  BMI ≤ 40

        Exclusion Criteria:

          -  Children (<18), pregnant patients

          -  Patients who do not speak English

          -  Patients with a history of hypersensitivity reactions to sulfur hexafluoride lipid
             microsphere components or to any of the inactive ingredients in Lumason.

          -  Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute
             coronary artery syndromes, worsening or unstable congestive heart failure, or serious
             ventricular arrhythmias)

          -  Patients who have a prior non-contrast ultrasound, within last 3 months (at time of
             consent), where the tumor could not be seen - most commonly due to severe steatosis or
             obesity.

          -  Pregnant or nursing woman

          -  Patients who do not plan to get their follow-up CT/MRI at Hershey Medical Center.
ADA Linagliptin in Long Term Care
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: linagliptin; insulin glargine
Intervention description: 5mg linagliptin tablets
Intervention MeSH terms: Insulin Glargine; Linagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nursing home facility; long-term care facility; older patients; elderly patients; hyperglycemia; type 2 diabetes

Summary:

      This is a study to determine whether glycemic control, as measured by change in HbA1c and
      frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and
      basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with
      poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with
      linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that
      treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement
      in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC
      residents with T2D. We will also determine differences in clinical outcome, resource
      utilization, and hospitalization costs between LTC residents with T2D treated with
      linagliptin and basal and correction insulin. We will compare differences in complications
      (infectious and non-infectious, neurological and cardiovascular events), emergency room
      visits and hospitalizations between groups during the 6 months of intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females with known history of type 2 diabetes, treated with diet, OADs as
             monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale
             insulin.

          2. Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

        Exclusion Criteria:

          1. Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis

          2. Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.

          3. Recurrent severe hypoglycemia or hypoglycemic unawareness.

          4. Subjects with history of gastrointestinal obstruction or gastroparesis.

          5. Patients with acute or chronic pancreatitis or pancreatic cancer.

          6. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage
             liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of
             normal, or significantly impaired renal function (GFR < 45 ml/min).

          7. Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.

          8. Mental condition rendering the subject unable to understand the nature and scope of
             the study.
Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV
Condition: Chronic Inflammation
MeSH terms: Inflammation
Intervention: CBD oil
Intervention description: Each participant will be provided two 30mL(Milliliters) bottles (2000mg CBD per bottle) with a syringe dropper during their initial (baseline) visit with instructions to administer the solution under the tongue (0.5 cc ~1/2 dropper) twice per day (BID) 8-12 hours apart (morning and evening) at the prescribed daily dosage (63mg/day).
The investigators plan to collect samples from five patients over three time points: baseline (no CBD), and after one and two months of CBD-administration
Intervention MeSH terms: Cannabidiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related
      to chronic inflammation, a condition characterizing PLWH.

      The investigators propose to study the effects of CBD on inflammation in PLWH, and establish
      the molecular role of different immune cells in this process. The investigators plan to use
      single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five
      persons with HIV who will provide blood samples before and after taking CBD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willingness to take CBD and to participate in follow up for two months

          -  Older than 21 and younger than 60

          -  Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count
             <350cells/ml)

        Exclusion Criteria:

          -  Conditions/medications that may impair the immune response, e.g., rheumatoid
             arthritis, cancer, diabetes, chronic infections, CAD (Cold agglutinin disease),
             cellulitis, autoimmune diseases such as lupus, sarcoidosis

          -  All medications that may affect inflammation such as aspirin, steroids, statins; CD4
             count <350cells/ml), pregnancy, and current marijuana or CBD use (urine drug screen)

          -  UF(University of Florida)/Shands staff and students will not be considered for
             enrollment
A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation
Condition: Anesthesia
Intervention: Dexmedetomidine and Midazolam; Propofol, Midazolam, and Fentanyl
Intervention description: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.; Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oral Surgery; Third Molars; Intravenous Sedation; Dexmedetomidine

Summary:

      Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar
      surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and
      3) no significant hemodynamic or respiratory changes when compared to a sedation combination
      of midazolam, fentanyl and propofol for sedation during third molar surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have 3-4 partial or full bony impacted third molars requiring surgical
             extraction

          -  ASA Class I or II

          -  English-speaking and Spanish-speaking subjects

        Exclusion Criteria:

          -  ASA Class III or higher

          -  Patients taking alpha-2 agonists or benzodiazepines

          -  Allergy or drug reaction to any of the drugs used in this study (benzodiazepines,
             opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)

          -  BMI greater than 30

          -  History of or current substance abuse or alcoholism

          -  History of mood-altering medications, tranquilizers, or antidepressants.

          -  Pregnant females
Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast
Intervention MeSH terms: Apremilast
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:

      Sixteen week open label study of apremilast in combination with topical steroids with a four
      week safety follow up visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be in general good health as judged by investigator

          -  Female of childbearing potential (FCBP) must have a negative pregnancy test at
             screening and Baseline.

          -  FCBP must use an approved method of contraception as outlined in the protocol.

          -  Male subjects who engage in activity in which conception is possible must use barrier
             contraception as defined in the protocol.

          -  18 years of age or older

          -  Understand and voluntarily sign the Informed Consent

          -  Able to adhere to study visit schedule

          -  Moderate plaque type psoriasis as define by a a PGA of 3

          -  BSA 0f 5-10% or a DLQI score of 7 or more

          -  History of uncontrolled plaque psoriasis after either stable dose of high potency
             topical steroids for 2 weeks or mid-potency steroids for 4 weeks within the last 6
             months

        Exclusion Criteria:

          -  Any clinically significant disease as determined by the investigator or major disease
             that is currently uncontrolled

          -  Any condition, including the presence of laboratory abnormalities, which would place
             the subject at unacceptable risk

          -  Prior history of suicide attempt at any time in the subject's lifetime prior to
             screening or randomization, or major psychiatric illness requiring hospitalization
             within the last 3 years

          -  Pregnant or breastfeeding, FCBP who are not willing to use acceptable birth control
             methods.

          -  Active substance abuse or a history of substance abuse within 6 months prior to
             screening.

          -  Malignancy or history of malignancy except fo treated (cured) basal cell or or
             squamous cell in situ skin carcinomas, treated (cured) cervical intraepithelial
             neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the
             previous 5 years

          -  Has not completed the prescribed washout for restricted treatments

          -  Known or suspected allergy to investigational product

          -  Other types of psoriasis

          -  Prior history of depression

          -  Prior use of apremilast
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment 2%
Intervention description: Applied BID
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 3 Months
Maximum age: 23 Months
Healthy volunteers: No

Summary:

      This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of
      crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than
      24 months of age with mild-to-moderate AD.
    

Eligibility criteria:

        Inclusion Criteria:

        Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD

        Exclusion Criteria:

        Subjects with any clinically significant dermatological condition or disease (including
        active or potentially recurrent non-AD dermatological conditions that overlap with AD such
        as Netherton Syndrome)