bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
Condition: Shoulder Pain; Rotator Cuff Tear
MeSH terms: Shoulder Pain; Rotator Cuff Injuries
Intervention: Liposomal bupivacaine; Bupivacaine 0.25%
Intervention description: liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc); 20 cc of bupivacaine 0.25%
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Exparel; Liposomal Bupivacaine; Arthroscopic Shoulder Surgery

Summary:

      The purpose of this study is to compare the quality and duration of pain relief after
      shoulder surgery provided by a single injection of liposomal bupivacaine versus standard
      bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized
      that the liposomal bupivacaine formulation will provide more effective pain relief than
      standard bupivacaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking adults (age >17 years) of American Society of Anesthesiologists (ASA)
             I-III physical class scheduled for elective arthroscopic shoulder surgery will be
             eligible to participate regardless of race/ethnicity.

        Exclusion Criteria:

          -  Subjects will not be eligible for this trial if they report a history of an allergy to
             a local anesthetic, baseline neurological deficit, a medical condition that would make
             it difficult to assess sensory distribution or communicate with the staff, a recent
             history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a
             preexisting coagulation disorder.
Study of Ocular Penetration of Topically Administered Fluoroquinolones
Condition: Cataract Extraction
MeSH terms: Eye Injuries, Penetrating; Cataract
Intervention: Moxifloxacin 0.5% ophthalmic solution; Besifloxacin 0.6% ophthalmic suspension
Intervention description: Administer moxifloxacin study drug prior to cataract surgery.; Administer besifloxacin study drug prior to cataract surgery.
Intervention MeSH terms: Moxifloxacin; Besifloxacin; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5%
      ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after
      pre-operative topical administration in subjects undergoing cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have a visually significant cataract and are planning to have cataract
             surgery.

          -  Subjects who are willing/able and have signed informed consent approved by the
             Institutional Review Board.

        Exclusion Criteria:

          -  Subjects who have a known hypersensitivity, allergy, or contraindication to any
             fluoroquinolone medication, in any form.

          -  Subjects who signs of ocular infection or active inflammation in the study eye.

          -  Subjects who have corneal pathology, including epithelial defect, corneal scarring, or
             severe dry eye syndrome.

          -  Subjects who have used any disallowed medication (including antibiotics) during the
             time period designated as described in the protocol.

          -  Subjects who have any active or chronic/recurrent ocular or systemic disease that is
             uncontrolled and is likely to increase the risk of infection to the patient or
             confound the results of the study.

          -  Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating.

          -  Subjects who have participated in any study of an investigational drug or device
             within 30 days prior to enrollment.
Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics
Condition: Asthma
MeSH terms: Asthma
Intervention: prevenar; pneumovax
Intervention description: 7-valent pneumococcal conjugate vaccine; 23 valent pneumococcal polysaccharide vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: preschool asthma; sequential pneumococcal immunization; immunogenicity; safety

Summary:

      Asthma is a major health problem in preschool children. Infections by pneumococci a the most
      frequent cause of airway infections, which tend to cause worsening of asthma. Vaccination
      against pneumococci is recommended by scientific boards and the medical community, in order
      to reduce the burden of disease. Data on the immunogenicity and safety of pneumococcal
      immunization in preschool asthmatics are scarce.
    

Eligibility criteria:

        Inclusion Criteria:

          -  asthma classified according to the Global Initiative on Asthma (GINA) °1-2

        Exclusion Criteria:

          -  antecedent pneumococcal immunization
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Condition: Pain
MeSH terms: Acute Pain
Intervention: diclofenac potassium oral solution
Intervention description: Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.
Intervention MeSH terms: Diclofenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: pain; moderate pain; mild pain; acute pain; mild acute pain; moderate acute pain; mild or moderate acute pain; NSAID; nonsteroidal anti-inflammatory drug

Summary:

      As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study
      are to characterize the pharmacokinetic (PK) profile and to determine the safety and
      tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to
      moderate acute pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between 2-12 years of age.

          -  Subjects must be post-op, having mild or moderate acute pain.

        Other inclusions apply.

        Exclusion Criteria:

          -  Subject has a known history of allergic reaction, hypersensitivity to diclofenac,
             aspirin, acetaminophen, or reaction to the non-active ingredients of the study
             medication.

          -  Subject has been taking analgesics for 48-72 hours prior to Screening.

          -  Subject has a history of any GI event greater than 6 months before Screening.

          -  Subject is currently receiving any medication that is contraindicated for use
             concomitantly with diclofenac or acetaminophen.

          -  Subject is requiring treatment for pre-existing hypertension.

        Other exclusions apply.
Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir and truvada; Atazanavir, Norvir and Truvada
Intervention description: Raltegravir 400 mg po bid, truvada 1 tab q daily; Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Atazanavir Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Raltegravir; Integrase inhibitor; Protease inhibitor; Naive patients; HIV disease; Lipids; Treatment Naïve

Summary:

      This is a pilot that will evaluate two regimens for treating HIV infected patients that
      haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial
      infarction and antiretroviral therapy used may contribute to this. We will evaluate
      virological, immunological and cardiovascular effects of two HIV treatment regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be HIV-1 positive and naïve to HIV therapy.

          -  Patients must plan to participate and be available for the trial for the 96-week study
             period.

          -  Patients followed at Thomas Street Clinic.

          -  Patients must be over 18 years old.

        Exclusion Criteria:

          -  Patients must not be pregnant or plan to become pregnant over the 96-week study
             period.

          -  Patients cannot be on a proton pump inhibitor.

          -  Patients cannot be undergoing treatment for active tuberculosis.

          -  Renal Insufficiency with a creatinine clearance < 50 ml/min/1.73 m2 by the MDRD GFR
             calculation.
Sustiva Levels With Use of a Gel Capsule
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Intervention: Efavirenz; Over-encapsulated efavirenz
Intervention description: Subject will take efavirenz for 5 days.; Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.
Intervention MeSH terms: Efavirenz
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: efavirenz; Sustiva; pharmacokinetics

Summary:

      We are studying if putting a gel capsule over a standard HIV drug changes the ability of the
      body to absorb the drug. This is important because we want to be able to study new HIV drugs
      against the most common drugs used today and the most common is Sustiva, which is also called
      efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is
      absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will
      draw blood to see how much is absorbed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-negative, proven by ELISA

          -  Age: ≥ 18 years old

        Exclusion Criteria:

          -  Psychiatric or psychological illness that would make adherence to protocol procedures
             unlikely.
Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
Condition: Hyperglycemia
MeSH terms: Hyperglycemia; Emergencies
Intervention: Insulin
Intervention description: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperglycemia; Glycemic control

Summary:

      Glycemic control can be safely achieved in surgical and medical intensive care unit settings
      and has been shown to improve short and long-term clinical outcomes. As such, insulin
      infusion protocols are routinely used in the ICU setting. The investigators plan to establish
      the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED
      setting. The investigators propose to study the aspects of implementing a strict glycemic
      control protocol in the ED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with blood glucose ≥130 mg% considered to be critically ill as defined by:

        APACHE II score ≥9 (See Appendix 1) OR >2 SIRS criteria with lactate ≥ 4 or BP < 90mmHg
        despite one liter of fluid OR Evidence of Organ Dysfunction (see Appendix 1)

        Exclusion Criteria:

          -  Patients requiring urgent interventional procedure (e.g. cardiac catheterization,
             dialysis) or surgery performed outside of the ED.
Glycemia in Diabetic Elders Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Standard Treatment; Incretin-Based Treatment
Intervention description: traditional drugs only; incretin-based drugs
Intervention MeSH terms: Metformin; Dipeptidyl-Peptidase IV Inhibitors; Incretins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients
      conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology
      Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen
      base solely on traditional drugs, a regimen including newer drugs will achieve glycemic
      target faster and induce less hypoglycemia, weight gain, and other side effects, over the
      short run.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetics diagnosed for at least 6 months

          -  Patients ages ≥ 65 years and older

          -  Active patients in the Bay West Endocrinology practice

          -  Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0%
             and 12%

          -  Eligible for randomization to either treatment group

          -  Patients willing to follow either treatment arm including regimen using one or more
             injectables

          -  Patients to have an English Reading Level of Grade 6 or above

          -  Patients residing at home

        Exclusion Criteria:

          -  Unwilling to use a regimen that may contain using one or more injections

          -  Using short acting insulin prior to the study

          -  Using GLP-1 in past 10 weeks

          -  History of hypoglycemia unawareness or episodes needing emergency intervention

          -  End-stage renal disease

          -  Dementia

          -  Blindness

          -  Terminal illness
Synthetic vs Natural Estrogen in Combined Oral Contraception
Condition: Contraception
Intervention: Ethinyl estradiol / dienogest; Estradiol valerate / dienogest; Dienogest
Intervention description: One tablet orally for 9 weeks, continuous use; One tablet orally for 9 weeks, continuous use; One tablet orally for 9 weeks, continuous use
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate; Nandrolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception, oral; Ethinyl Estradiol; Estradiol Valerate; Dienogest; Insulin resistance; Chronic inflammation; Coagulation

Summary:

      The main objective of the study is to compare the metabolic effects of natural estradiol and
      synthetic ethinylestradiol used in combined oral contraception in healthy women. A
      progestin-only preparation will be used in comparison. The main goal is to study the effects
      on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP).
      Our hypothesis is that the natural estradiol preparation will influence blood glucose levels,
      markers of coagulation and chronic inflammation less than the ethinylestradiol preparation.
      The progestin-only preparation will not effect these parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI 19-24.9, regular menstrual cycles (21-35 days), a minimum of 2 months without any
             hormonal contraceptives, no contraindications for use of hormonal contraception

        Exclusion Criteria:

          -  Polycystic ovaries, hypertension, smoking, alcohol abuse, pregnancy, lactation,
             abnormal result in pre-screening 2h oral glucose tolerance test, regular medications
Aralast alpha1-proteinase Inhibitor Surveillance Study
Condition: Alpha1-antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: ARALAST Alpha1-Proteinase Inhibitor
Intervention description: Weekly ARALAST infusions for 2 years, dose and mode of administration as prescribed by the physician
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are
      to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are
      initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related
      quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory
      analyses to evaluate the safety of long-term administration of ARALAST.

      Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every
      6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw
      portion of the study, which will also include assessments of antibodies to ARALAST, and
      chemistry panel. Subjects will be treated according to the prescribing (attending)
      physician's instructions based on the prescribing information given in the ARALAST package
      insert.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 years of age or older

          -  Diagnosis of AAT deficiency associated emphysema

          -  Active prescription for augmentation therapy with ARALAST

          -  On service with Coram (a speciality pharmacy provider)

          -  Signed and dated informed consent

        Exclusion Criteria:

          -  Clinically significant medical (other than COPD), psychiatric, or cognitive illness
             that, in the opinion of Coram or the sponsor or the investigator, may compromise
             subject safety or compliance (such as end stage renal or hepatic or heart disease, or
             metastatic cancer or any difficulty in communicating over the telephone lines)

          -  Previous treatment with ARALAST (i.e. subjects who had previously received and then
             discontinued ARALAST augmentation therapy and are now restarting ARALAST will be
             excluded from the study)
Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Condition: Type 2 Diabetes Mellitus; Inadequate Glycaemic Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Saxagliptin; Glimepiride; Placebo for dapagliflozin; Placebo for saxagliptin; Placebo for glimepiride
Intervention description: 10 mg, orally Green, plain, diamond-shaped, film-coated tablet; 5 mg, orally Plain, yellow, biconvex, round, film-coated tablet; 1, 2, or 4 mg, orally Opaque gray capsule; Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet; Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet; Does not contain active ingredient, orally. Opaque gray capsule
Intervention MeSH terms: Dapagliflozin; Glimepiride; Saxagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 939.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus Type 2,; metformin,; saxagliptin,; dapagliflozin,; glimepiride,; inadequate glycaemic control

Summary:

      This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as
      an addition to metformin is effective and safe in treating patients with type 2 diabetes when
      compared to glimepiride (sulphonylurea) as an addition to metformin treatment.
    

Eligibility criteria:

        Inclusion Criteria: Main Inclusion Criteria:

          1. Is male or female and ≥18 and <75 years old at time of informed consent.

          2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with
             individual need for therapy escalation.

          3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of
             metformin therapy for at least 8 weeks prior to Enrolment visit.

          4. Has a BMI of ≤45 kg/m2 at Enrolment visit.

          5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on
             central laboratory results from Visit 1.

        Main, Exclusion Criteria:

          1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes
             of the young (MODY), or secondary diabetes mellitus or known presence of glutamate
             decarboxylase 65 (GAD65) antibodies.

          2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or
             volume depletion that may affect the patient's safety and/or the interpretation of
             efficacy or safety data.

          3. Clinically significant cardiovascular disease or procedure within 3 months prior to
             Enrolment or expected to require coronary revascularization procedure during the
             course of the study.

          4. Concomitant treatment with loop diuretics