bioihbjkbjnl/mcl2 huggingface dataset:
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin glargine; Lispro Low Mix; Lispro Mid Mix; Lispro
Intervention description: Subcutaneous injection daily; Subcutaneous injection twice daily.; Lispro Mid Mix subcutaneous injection 3 times daily.; Lispro subcutaneous injection 3 times daily.
Intervention MeSH terms: Insulin Glargine; Insulin Lispro; Insulin, Isophane; Biphasic Insulins; Isophane insulin, insulin lispro drug combination 50:50
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2091.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: diabetes; type 2

Summary:

      This study will compare insulin lispro low mixture [LM] and insulin glargine both in
      combination with the patient's oral diabetes medicines, for their ability to control blood
      sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with
      regard to the length of time that the overall blood sugar can be controlled.

      This study will also determine whether the safety of insulin lispro LM and any side effects
      that might be associated with it are different from those observed with insulin glargine,
      both in combination with the patient's oral diabetes medications.

      The addendum study (Intensification Addendum) will compare how different insulin treatments
      work to control blood sugar in patients whose diabetes could not be controlled by either
      insulin lispro LM or insulin glargine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have type 2 diabetes.

          -  Must be at least 30 and less than 80 years of age at the time of Visit 1.

          -  Must be on at least two oral antidiabetes medications for at least 90 days.

          -  Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the
             local lab.

        Exclusion Criteria:

          -  Must not have used insulin on a regular basis in the last 12 months.

          -  Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.

          -  Must not have a body mass index (BMI) of greater than 45 (morbid obesity).

          -  Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic,
             or gastrointestinal disease.

          -  Must not be pregnant or intend to get pregnant during course of the study.
Improvement of Fluid Balance in Patients Undergoing Surgery of the Colon and Rectum
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Intervention: Goal-directed fluid optimization; Regimen based on expertise anaesthesist
Intervention description: Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.; Fluid regimen based on expertise anaesthesist
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodynamic optimization; Enhanced recovery after surgery; Goal-directed fluid

Summary:

      58 patients undergoing surgery of the large bowel are divided into two groups. The control
      group will receive standard care. The intervention group will receive standard care plus
      optimization of the blood circulation based on in- or decrease of the output of the heart.
      Between group differences are measured primarily by markers of intestinal damage in plasma
      and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the
      gut).

      The investigators hypothesize that the intervention group will have less intestinal damage,
      improved blood supply to the bowel and improved recovery of the operation compared to the
      control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing elective colorectal surgery with anastomosis;

          -  Minimum age 18 years;

          -  Giving informed consent.

        Exclusion Criteria:

          -  Other causes of intestinal damage: eg. IBD, occlusive disease;

          -  Steroid use;

          -  Esophageal varices and other esophageal disease;

          -  Aortic valve disease.
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
Condition: Infections
MeSH terms: Infections; Pneumonia; Pneumonia, Bacterial
Intervention: Ceftaroline fosamil; Ceftriaxone plus vancomycin
Intervention description: Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days; Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
Intervention MeSH terms: Vancomycin; Ceftriaxone; Ceftaroline fosamil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Infections; Teflaro; cephalosporin; Ceftaroline; antibiotics; pneumonia

Summary:

      The purpose of this study is to determine whether ceftaroline is effective and safe for the
      treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for
      infection due to Methicillin-resistant Staphylococcus aureus (MRSA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are required to meet All of the following inclusion criteria:

               1. Male or female, ≥ 18 years old

               2. Presence of CABP requiring hospitalization

               3. Presence of CABP meeting the following criteria:

        I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days'
        duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory
        tract infection

        MRSA Risk Factors

        • MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a
        history of colonization with MRSA

        Exclusion Criteria:

          -  Subjects must Not meet any of the following exclusion criteria at baseline:

               1. History of any hypersensitivity or allergic reaction to any β-lactam
                  antimicrobial

               2. Suspected or microbiologically-documented infection with a pathogen known to be
                  resistant to any of the study drugs

               3. Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical
                  pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart
                  failure)

               4. More than 24 hours of potentially effective systemic antibacterial therapy for
                  CABP within 96 hours before randomization

               5. End-stage renal disease [Creatinine Clearance (CrCl) < 15], including
                  hemodialysis

               6. Evidence of significant hepatic, hematological, or immunocompromising condition
A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)
Condition: Hemophilia A With Inhibitors
MeSH terms: Hemophilia A
Intervention: rFVIIIFc
Intervention description: rFVIIIFc 200 IU/kg/day in ITI Period, 50 or 100 IU/kg (adjusted according to Investigator judgement) in tapering Period, and prophylactic regimen in Follow-Up period as powder for injection administered intravenously.
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Healthy volunteers: No

Summary:

      The primary purpose of this study was to describe the time to tolerization (i.e., ITI
      success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability of the participant or his legally authorized representative (e.g., parent or
             legal guardian) to understand the purpose and risks of the study and provide signed
             and dated informed consent and authorization to use protected health information in
             accordance with national and local participant privacy regulations

          -  Male participants of any age diagnosed with severe hemophilia A (as confirmed from the
             medical record)

          -  Currently diagnosed with high titer inhibitors (historical peak greater than or equal
             to (>=) 5 Bethesda units per milliliter (BU/mL), according to medical records)

          -  Previously treated with any plasma-derived or recombinant conventional or Extended
             Half-Life FVIII

        Exclusion Criteria:

          -  Other coagulation disorder(s) in addition to hemophilia A

          -  Previous immune tolerance induction (ITI)

          -  History of hypersensitivity or anaphylaxis associated with any factor VIII (FVIII)
             administration

          -  Planned major surgery scheduled during the study unless deferred until after study
             completion (minor surgery such as tooth extraction or insertion/replacement of central
             venous access device is allowed)

          -  Abnormal renal function (serum creatinine >1.5 milligram per deciliter (mg/dL) or 2 ×
             upper limit of normal (ULN) for participant age based on local laboratory range) as
             assessed by local laboratory

          -  Serum alanine aminotransferase or aspartate aminotransferase > 5 × upper limit of
             normal (ULN) as assessed by local laboratory
Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients
Condition: Hypertension; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Intervention: Aliskiren
Intervention description: 150mg/day for all as initial dose, 300mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months
Intervention MeSH terms: Renin Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Elderly chronic kidney disease; Hypertension; Aliskiren

Summary:

      The purpose of this study is to determine whether aliskiren is effective in the treatment of
      blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease
      (CKD) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Chronic kidney disease

          -  Clinical diagnosis of Hypertension (Blood pressure >=140/90mmHg)

          -  Elderly people(>=65 years old)

        Exclusion Criteria:

          -  The patients who are already taking aliskiren

          -  The patients who are receiving hemodialysis or peritoneal dialysis

          -  The patients who are taking cyclosporin

          -  The patients who have hyperkalemia(>=5.5mEq/ml)

          -  Severe heart failure (>=NYHA class III)

          -  Insulin dependent diabetic mellitus or poor controlled insulin independent diabetic
             mellitus (>=HbA1c 9.0&)

          -  Severe liver dysfunction (five folds increased AST or ALT than standard values)
Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Intervention: IANB Articaine; SUP Articaine; SUP Lidocaine
Intervention description: IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.; After unsuccessful IANB with articaine, proceed to give 1.7cc of 4% articaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).; After unsuccessful IANB with articaine, proceed to give 1.7cc of 2% lidocaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).
Intervention MeSH terms: Lidocaine; Carticaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Articaine; Lidocaine; Anesthesia, Local; Endodontics; Molar; Dental Pulp Diseases

Summary:

      The purpose of this trial is to study the ability of a frequently used dental anesthetic
      (articaine) to achieve complete numbness of a diseased tooth with the most commonly used
      injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique
      fails, a commonly used supplemental (SUP) technique with one of two possible dental
      anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of
      complete numbness between the two anesthetics.

      Standardized administration of anesthesia is provided by controlled delivery using Midwest
      Comfort Control Syringe.

      The investigators hypothesize that supplemental infiltration anesthesia with articaine will
      give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular
      molars with irreversible pulpits.

      This study consisted of two periods of patient enrollment, treatment and data collection:
      Part I: 101 subjects; Part II: 100 subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients

          -  irreversible pulpitis in mandibular molar

        Exclusion Criteria:

          -  below 18 years
Evaluation of 3 Intraocular Lenses Following Lens Extraction
Condition: Cataract
MeSH terms: Cataract
Intervention: Crystalens AO; ReSTOR; Tecnis Multifocal IOL
Intervention description: Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.; ReSTOR surgically implanted bilaterally. Study observation up to 180 days.; Tecnis surgically implanted bilaterally. Study observation up to 180 days.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Intra Ocular Lens; Ocular surgery; Phacoemulsification

Summary:

      The objective of this study is to evaluate the efficacy and subject satisfaction with three
      different FDA approved lenses for adults over 40 years of age who desire a reduction in
      spectacle dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a clinically documented diagnosis of age-related bilateral
             cataracts that are considered amenable to treatment with standard phacoemulsification
             cataract extraction.

          -  Subjects must require a spherical lens power from 10.00 D to 33.00 D

          -  Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32
             or better in both eyes, as documented by a Potential Acuity Meter

        Exclusion Criteria:

          -  Subjects with conditions with increased risk of zonular rupture, such as
             pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect
             postoperative centration, tilt, and stability of the lens.

          -  Subjects who have any active inflammation or edema (swelling) of the cornea, including
             but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.

          -  Subjects with visually significant diabetic retinopathy (proliferative or
             non-proliferative) which reduces potential acuity to 20/32 or worse.
Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Transepicardial with Transseptal CD 133+ Implantation
Intervention description: Transepicardial with Transseptal CD 133+ Implantation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: CD 133+; Transepicardial with Transseptal Implantation; CABG

Summary:

      Heart Failure has several etiologies and one of them is coronary artery disease. Coronary
      artery bypass grafting (CABG) is one of revascularizations method which has been used for
      decades in coronary artery disease theraphy. However, data about coronary artery bypass
      grafting shows that post-CABG patients still have low ejection fraction. For the last decade,
      there have been a lot of studies about the using of stem cells to increase heart
      contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone
      marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells
      is given during CABG by injection transepicardial and transseptal. The purpose of this study
      is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem
      cells can improve myocardial perfusion in patient with low ejection fraction following CABG
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with coronary artery disease 3 vessels disease indicated for CABG

          -  LVEF < 35% which has been confirmed by MRI

          -  Patients with akinetic or hypokineic segment, and left ventricle myocardial
             hypoperfusion confirmed in MRI

          -  has signed informed consent

        Exclusion Criteria:

        Emergency CABG Ungraftable coronary artery Acute myocardial Infarct (<14 days) Valve
        disease which need surgery repair Contraindicated for MRI High degree ventricular arrhytmia
        Coagulation disorder HIV positive patient, Hepatitis B + patients, HCV + patients AST/ALT >
        1,5 upper normal value Creatinine > 2 g/dl. Malignancy

        Drop out criteria :

        Aortic cross clamp >120 minutes and CABG total time >180
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine Extended Release; Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
Intervention description: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.; SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioid dependence; Buprenorphine; primary care treatment; extended-release buprenorphine

Summary:

      This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded,
      examining the feasibility and acceptability of Buprenorphine extended-release vs. daily
      sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at
      community re-entry.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults >18yo incarcerated in NYC jails with known release dates.

          -  DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).

          -  Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid
             treatment program.

        Exclusion Criteria:

          -  Individual not interested in XRB treatment. Current SLB patients are otherwise by
             definition appropriate for XRB.

          -  Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be
             administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine
             with a sensitivity/specificity of: 25 mIU hCG/ml, >99%. Time to result is four
             minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter
             to ensure that a participant is not pregnant

          -  No severe or acute medical or psychiatric disability preventing safe study
             participation or making follow-up unlikely.
12 Versus 20 mL PCB for D&E Cervical Prep
Condition: Pain
Intervention: 12 mL paracervical block; 20 mL paracervical block
Intervention description: Injection of 12 mL of lidocaine; Injection of 20 mL of lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
Masking: Single (Participant)
Masking description: The provider and staff will be aware of arm allocation, but participants will remain blinded.
Enrollment: 96.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: paracervical block; abortion; dilation and evacuation; cervical preparation

Summary:

      More research is needed to investigate methods of pain control for cervical preparation for
      abortion procedures. Women report pain with paracervical block injection as well as with
      osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine
      paracervical block for pain control during cervical preparation (osmotic dilator insertion)
      for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18 and older

          -  Intrauterine pregnancy ≥16 weeks gestation

          -  English speaking competency

          -  Willing and able to sign consent forms

          -  Agree to comply with study procedures

        Exclusion Criteria:

          -  Women less than 18 years of age

          -  IV conscious sedation

          -  Known allergy to study medication (lidocaine)

          -  Any women not meeting inclusion criteria above will be excluded from participation