bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
Condition: Kidney Transplantation
Intervention: Enteric coated mycophenolate sodium (Myfortic®)
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Keywords: Kidney Transplantation; Mycophenolic Acid; Immunosuppression; Cyclosporine

Summary:

      The study will evaluate kidney graft function in maintenance renal transplant patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female recipients of single or double renal transplant performed since at
             least one year and no more that 5 years

          -  Age > 18 yrs

          -  Adequate and stable renal function

          -  Informed consent.

        Exclusion criteria:

          -  Kidney transplant combined with other organs;

          -  Significant proteinuria

          -  Severe ongoing infections;

          -  Present or historical malignant neoplasia, of any type, with the exception of excised
             non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since
             at least 5 years;

          -  Relapse of the end-stage renal disease on the transplanted kidney;

          -  Leucopenia, thrombocytopenia or severe anemia;

        Other protocol-defined inclusion/exclusion criteria may apply
Niacin, N-3 Fatty Acids and Insulin Resistance
Condition: Metabolic Syndrome; Hypertriglyceridemia
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypertriglyceridemia
Intervention: omega-3 acid ethyl esters; extended release niacin; placebo; omega-3 acid ethyl esters; combined treatment
Intervention description: 4 q qd; 2 g qpm; omacor placebo plus niaspan placebo; 4 g qd; omega-3 acid ethyl esters 4 g qd and extended release niacin, titrate up to 2 g Qpm
Intervention MeSH terms: Niacin; Nicotinic Acids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 40 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: triglycerides; HDL-cholesterol; insulin resistance; omega-3 fatty acids; niacin

Summary:

      This research study is being conducted to test the effects of two drugs on blood lipids
      (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or
      "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products
      are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We
      hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels,
      increase HDL-cholesterol levels and do so without altering glucose levels.
    

Eligibility criteria:

        Inclusion Criteria:

        40 and 69 years of age Male or female (without hormonal cycling as described below) BMI >
        25 Fasting serum triglycerides > 150 mg/dL Ratio of TG/HDL-C > 3.5

        Exclusion Criteria:

        BMIs > 40 kg/m2 TG > 750 mg/dL HDL-C < 10 mg/dL Presence of other secondary causes of
        dyslipidemia or hyperglycemia such as hepatic, renal, thyroid or other endocrine diseases
        History of hypersensitivity to niacin or fish oils History of gout, hepatitis, peptic ulcer
        or cardiovascular disease Presence of diabetes mellitus, whether controlled by diet or
        drugs. (We will eliminate subjects with undiagnosed diabetes by screening for fasting
        glucose > 126 mg/dL) Use of any dietary supplements providing more than 50 mg of niacin or
        100 mg of n-3 FA Use of any herbal preparations or weight-loss products Taking any
        lipid-lowering drugs for at least four weeks prior to screening for the study
        Medically-required treatment with nitrates, calcium channel blockers, or adrenergic
        blocking agents (per the Niaspan package insert) Hemoglobin < 12 g/dL (owing to the
        significant amount of blood being drawn) LDL-C > 145 mg/dL. (This restriction will prevent
        the randomization of any subject whose LDL-C levels, if assigned to an n-3 FA group, might
        rise by 10% and thus exceed 160 mg/dL) Known substance abuse Participation in a clinical
        drug trial anytime during the 30 days prior to screening Anyone whom the investigators
        judge to be a poor candidate
Nicotine Patch as an Analgesic Adjuvant After Surgery
Condition: Pain
Intervention: nicotine patch; nicotine patch; placebo; placebo
Intervention description: nicotine patch (0,5,10 or 15mg/day) applied to smokers; nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers; placebo patch applied to smokers; placebo patch applied to nonsmokers
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: acute pain; nicotine; nausea; sedation

Summary:

      Effect of nicotine patch as an adjutant for acute pain after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult ASA 1-2

        Exclusion Criteria:

          -  Cardiovascular disease

          -  Former smoker

          -  Pregnant

          -  Nursing

          -  Asthma
MEthylene Blue In Patients With Acquired Methemoglobinemia
Condition: Acquired Methaemoglobinaemia
MeSH terms: Methemoglobinemia
Intervention: Methylene Blue
Intervention description: Administration of Methylene Blue to treat acquired methaemoglobinaemia
Intervention MeSH terms: Methylene Blue
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Healthy volunteers: No
Keywords: Acquired Methaemoglobinemia; Methylene Blue

Summary:

      This is an open label, uncontrolled, Phase 4 study including 10 patients who present in
      hospital/urgent care setting with acquired methemoglobinemia. The population may include
      pediatric and adult patients (males and females of all ages are included).

      The study will run in both the EU and the US. The aim of the study is to confirm safety and
      efficacy of ProvayBlueTM for the treatment of acquired methemoglobinemia and has been
      requested by the US-FDA as a Post-Marketing requirements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric or adult patients (males and females of all ages are included) diagnosed
             with acquired methemoglobinemia and receiving treatment with ProvayBlue™ as per the
             treating physician's diagnosis and hospital standard of care.

        Acquired methemoglobinemia is defined as a level of methemoglobinemia >30% or ≤30% in case
        of clinical symptoms (e.g. sleepiness, cyanosis, dizziness, etc.).

          -  Written informed consent obtained prior to any data collection (retrospective and
             prospective) for this study and study specific assessments.

        Exclusion Criteria:

          -  Known severe hypersensitivity reactions to methylene blue or any other thiazine dye;

          -  Known deficiency in glucose-6-phosphate dehydrogenase (G6PD) due to the risk of
             hemolytic anemia as well as lack of therapeutic effect;

          -  Known deficiency in Nicotinamide Adenine Dinucleotide Phosphate Hydrogen (NADPH)
             reductase.

          -  Known use of selective serotonin reuptake inhibitors (SSRIs), serotonin and
             norepinephrine reuptake inhibitors (SNRIs), MonoAmine Oxidase (MAO) inhibitors or
             drugs metabolised via CYP isoenzymes anticipated during the treatment phase of the
             study.

          -  Women who refuse to stop breastfeeding for up to 8 days after receiving the last dose
             of ProvayBlueTM.
Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy
Condition: Morbid Obesity; High BMI
MeSH terms: Obesity, Morbid
Intervention: Bupivacaine
Intervention description: Bupivacaine Hcl 0.25% Inj
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Sleeve gastrectomy; Quadratus lumborum block; Bariatric surgery

Summary:

      The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in
      which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus
      lumborum muscle. This results in posterior spread of local anesthetic through the middle
      layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral
      space resulting in potentially longer-lasting and denser analgesia than wound infiltration.
      The QL 2 block derives from the TAP block, which is also a fascial plane block that is
      commonly used to treat pain following surgery involving the anterior abdominal wall. However,
      the QL block's more posterior location has recently been shown to provide a longer lasting
      and more profound analgesic effect than the TAP block, possibly by communicating with the
      paravertebral space. Although the TAP has been shown to be effective in a variety of surgical
      procedures involving an anterior abdominal wall incision including laparoscopic bariatric
      surgery the QL 2 block has until now, not been studied in the context of bariatric surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy

          -  18-65 years of age

          -  BMI> 35 kg/m2.

        Exclusion Criteria:

          -  Contraindications to administration of local anesthesia (e.g. local anesthetic
             allergy)

          -  Contraindication/allergy to acetaminophen or ketorolac

          -  History of substance abuse or chronic opioid use

          -  Coagulopathy

          -  Patients receiving systemic anticoagulation

          -  Local infection

          -  ASA 4
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Condition: Intervertebral Disc Degeneration
MeSH terms: Intervertebral Disc Degeneration
Intervention: Duloxetine; Placebo
Intervention description: duloxetine 60 mg; placebo
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation
      with fentanyl demand controlled by the patient. The primary objective is to evaluate the
      efficacy of duloxetine in fentanyl consumption during the postoperative period of patients
      undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints
      were pain scores and the presence or absence of adverse effects such as headache, nausea,
      vomiting, itching, dizziness and drowsiness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients were included, of both genders, aged between 18 and 70 years and American
             Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study

        Exclusion Criteria:

          -  Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use
             of illegal substances or alcohol in an abusive manner and abnormal kidney or liver
             function tests.
Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; biphasic insulin aspart 30
Intervention description: Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms; Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control
      when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified
      treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic
      drugs) alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1

          -  HbA1c at least 7.0 % - maximum 11 % at screening

          -  Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)

          -  An antidiabetic regimen that has been stable for at least 3 months prior to screening

          -  An antidiabetic regimen that includes a minimum of 2 OADs

          -  OADs dosed at least 50% of the maximum recommended dose

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to trial product(s) or related products

          -  Females of childbearing potential who are pregnant, breast-feeding or intend to become
             pregnant or are not using adequate contraceptive methods (adequate contraceptive
             measures as required by local law or practice)

          -  The receipt of any investigational medicinal product within one month prior to this
             trial

          -  Suffer from a life threatening disease (cancer)

          -  Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and
             or any myocardial infarction (treated or untreated) within 6 months prior to screening

          -  Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase
             (AST) above 2 times the central laboratory's upper reference limit)

          -  Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females

          -  Recurrent hypoglycaemia or hypoglycaemic unawareness

          -  Anemia (haemoglobin below 10 mg/dl)
Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis
Condition: Hypersensitivity
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Hypersensitivity
Intervention: Artificial Tear Supplement; Cold compress; Anti-allergic Medication
Intervention description: artificial tear supplement (Hypromellose); Cold compress bag fill with temperature retention gel placed over closed eyes Sold by http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue; 1 drop on single occasion after exposure to grass pollen
Intervention MeSH terms: Anti-Allergic Agents; Ophthalmic Solutions; Lubricant Eye Drops; Epinastine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular allergy; Tear supplement; Cold compress

Summary:

      Seasonal allergic conjunctivitis (SAC) is an irritating eye condition that affects many
      people, caused by hypersensitivity to normally harmless substances such as pollen, and often
      accompanies seasonal hay fever. Treatments that can be used before initiating medical therapy
      include artificial tear supplements (ATS) and cold compresses (CC). However, there is no
      evidence in the scientific literature that demonstrates their efficacy compared to no
      treatment or their combined effect with anti-allergic medication. Therefore the investigators
      aim to examine the efficacy of ATS and CC alone, in comparison to anti-allergic medication,
      and CC in combination with anti-allergic medication. In addition, the investigators also aim
      to determine the time course of ocular allergic reactions. At the end of the study the
      investigators will be able to see whether or not ATS and CC are effective in treating SAC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of seasonal allergic conjunctivitis or seasonal allergic rhinoconjunctivitis
             (seasonal hay fever) that is not currently active.

        Exclusion Criteria:

          -  eye surgery in the last 3 months

          -  active eye condition

          -  adverse reaction to ocular drugs or dyes

          -  history of anaphylaxis (severe systemic allergic reaction)

          -  use any ocular medication or systemic medications (antihistamines, mast cell
             stabilisers, non-steroidal anti-inflammatory drugs or steroids) at least 14 days prior
             to the start and for the duration of the study
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
Condition: Tendinopathy; Hip Pain
MeSH terms: Tendinopathy
Intervention: PRP; Whole Blood; Ultrasound
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Gluteus Medius Tendinosis

Summary:

      Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain
      Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by
      side lying, stair climbing, and walking. Treatment is currently limited to lifestyle
      modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical
      repair. Platelet rich plasma (PRP) injections contain important growth factors that are
      essential in the healing and tissue formation processes. However, the extent to which PRP is
      more efficacious than whole blood in tendinopathy remains unclear. In this double-blind
      randomized trial, patients will be allocated to receive either a PRP or whole-blood
      injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months,
      and 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe lateral hip pain for greater than 3 months

          -  Symptoms are refractory to conservative treatment, including at least 8 weeks of
             traditional physical therapy for this condition

          -  Moderate to severe gluteus medius tendinosis with or without partial tear <1 cm

          -  Normal neurologic exam except for hip abductor weakness on the affected side

        Exclusion Criteria:

          -  Severe (Tonnis grade >1) hip osteoarthritis with active synovitis or bone edema

          -  Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal
             distribution

          -  No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on
             MRI

          -  Any condition that requires anti-platelet or anti-coagulation therapy, including
             aspirin therapy for cardiac conditions

          -  Non-English speaking
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®
Condition: Paget's Disease of the Bone; Hypocalcemia
MeSH terms: Bone Diseases; Osteitis Deformans; Hypocalcemia
Intervention: Reclast (ZOL446, zoledronic acid); Calcium; Vitamin D
Intervention description: 5 mg i.v. annually ("real-life, physician prescribed"); 1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation); 800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Healthy volunteers: No
Keywords: Paget's; hypocalcemia; zoledronic acid; serum calcium

Summary:

      This study will evaluate the impact of investigator and patient education and educational
      materials to foster calcium and vitamin D supplementation to mitigate the potential for
      hypocalcemia post Reclast® administration in patients with Paget's disease of bone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  As per currently approved Reclast® Package Insert:

        Exclusion Criteria:

        - As per currently approved Reclast® Package Insert:
A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
Condition: Uncomplicated Bacterial Cystitis
MeSH terms: Cystitis
Intervention: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days; ciprofloxacin 250 mg BID x 3 days
Intervention MeSH terms: Ciprofloxacin; Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of
      nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  pre-menopausal females

          -  ages 18-45 years old

          -  symptoms of a UTI (dysuria, frequency, urgency)

        Exclusion Criteria:

          -  Onset of symptoms >7 days prior to the ED visit

          -  Non-English speaking

          -  Symptoms of pyelonephritis

          -  Diabetic

          -  Indications of sepsis

          -  Immunocompromised

          -  Currently using prophylactic antimicrobials

          -  Medications that could interfere with study drug

          -  Pregnant

          -  Lactating

          -  History of kidney or liver disease

          -  Vaginal symptoms

          -  Presence of a urinary catheter

          -  Treatment for UBC <2 weeks prior to ED visit

          -  Known allergy to study drug

          -  Unavailable for follow-up