bioihbjkbjnl/mcl2 huggingface dataset:
Role of Pepsin Assay in Wheezy Infants
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Intervention: Omeprazole and domperidone
Intervention description: wheezy infants with abnormal MII-pH or reflux esophagitis will be given omeprazol(10mg/once/day) and domperidone (0.2mg/kg/day t.d.s)
Intervention MeSH terms: Domperidone; Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 6 Months
Maximum age: 2 Years
Healthy volunteers: No

Summary:

      Wheezy infants were tested for gastro-esophageal reflux disease (GERD) using combined
      multiple channel intraluminal impedance-pH (MII-pH), esophagogastroduodenoscope (EGD), lipid
      laden macrophage index and BAL pepsin. Wheezy infants with abnormal MII-pH or reflux
      esophagitis were given domperidone and omeprazole then re-evaluated for symptoms control and
      exacerbations recurrence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants with physician documented 3 attacks of wheezing episodes over the last 6
             months or persistent wheeze over the last one month

        Exclusion Criteria:

          -  Wheezy infants with atopy (allergic rhino-conjunctivitis or eczema), prematurity (less
             than 34 weeks), abnormal neurological examination, congenital heart diseases, airspace
             opacity on chest radiography, tracheal-bronchial malformations, immune deficiency and
             anatomical esophageal or gastric malformations
Glargine U300 Hospital Trial
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Glargine U300; Glargine U100; Glulisine Insulin
Intervention description: Glargine U300 is a new generation long-acting insulin.; Glargine U100 is a long-acting insulin.; Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Intervention MeSH terms: Insulin Glargine; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blood glucose

Summary:

      The purpose of this study is to find out if treatment with Glargine U300 when compared to
      Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D),
      who are admitted to the hospital and then transition at home, after discharge from the
      hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females between > 18 years admitted to a general medicine or surgical
             service.

          -  Known histories of T2D treated with either diet alone, oral monotherapy, any
             combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide)
             or insulin therapy with the exception of degludec and glargine U300.

          -  Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without
             laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or
             positive serum or urinary ketones).

        Exclusion Criteria:

          -  Subjects with increased BG concentration, but without a known history of diabetes.

          -  Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA
             (weekly exenatide, dulaglutide or albiglutide).

          -  Patients with acute critical or surgical illness admitted to the ICU or expected to
             require admission to the ICU.

          -  Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and
             portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30
             ml/min).

          -  Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study.

          -  Female subjects who are pregnant or breast feeding at time of enrollment into the
             study.
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Farxiga; Placebo; Metformin; Insulin
Intervention description: Farxiga 10mg/day; Placebo; Metformin background therapy >/= 1500mg/day; Insulin >/= 30 units
Intervention MeSH terms: Metformin; Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately
      Controlled With Either Metformin Or Insulin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (T2DM)

          -  Treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose
             of insulin > or = to 30 units/day and up to 2 OAD medications for at least 8 weeks

          -  Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening

          -  Body mass index (BMI) < or = to 45 kg/m2

        Exclusion Criteria:

          -  For patients who enter the study taking a stable dose of metformin, history of taking
             OAD medications other than metformin during the 8 weeks prior to screening or have
             been on insulin therapy within 1 year of screening

          -  For patients who enter the study taking insulin, history of taking any other therapy
             outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to
             screening.

          -  Use of sulfonylureas during the 8 weeks prior to screening

          -  Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2)
             inhibitor

          -  Ingestion of any medication know to affect glucose metabolism for >7 consecutive days
             during the 3 months prior to screening

          -  Ingestion of prescription or over the counter weight loss medication during 3 months
             prior to screening
Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Condition: Lipid Metabolism Disorders
MeSH terms: Hypercholesterolemia; Dyslipidemias; Metabolic Diseases; Lipid Metabolism Disorders
Intervention: Fluvastatin sodium
Intervention description: Fluvastatin sodium Extended Release Tablets 80mg
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 436.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dyslipidemias; Fluvastatin sodium; Chinese

Summary:

      This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release
      Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C
      lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or
      mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when
      treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high
             CV risk according to Chinese Dyslipidemia Guideline (2007).

          -  Not having achieved lipid treatment goals despite following a cholesterol restrictive
             diet and/or lipid lowering monotherapy improperly prior to Visit 1 (inclusion in the
             6-week open-label study phase).

          -  Not having achieved lipid treatment goals on a stable dose of Fluvastatin sodium
             Immediate Release Capsule 40 mg QD during the 6 week open-label study phase (inclusion
             in the 12-week double-blind study phase).

        Exclusion Criteria:

          -  Patients with known hypersensitivity to fluvastatin or any of the excipients.

          -  Dyslipidemia secondary to other causes.

          -  Known muscle disease or history of muscle disease and/or serum CPK levels greater than
             2 x upper limit of normal (ULN).

          -  A history or evidence of Acute Myocardial infarction (AMI), unstable angina (UA) or
             Coronary artery bypass surgery or Percutaneous Coronary Intervention (PCI) within the
             previous 8 weeks.

          -  Active liver disease and/or serum transaminase levels (ALT, AST) greater than 1.5 x
             ULN.

          -  Patients on a proper lipid lowering monotherapy (defined as at least 12 weeks
             continuous monotherapy with a recommended dose and administration in the label) within
             the previous 3 months prior to visit 1.

        Other protocol-defined inclusion/exclusion criteria may apply.
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
Condition: Osteoporosis; Atypical Femoral Fracture
MeSH terms: Osteoporosis; Fractures, Bone; Femoral Fractures
Intervention: teriparatide
Intervention description: 20 microgram once-daily subcutaneous injection
Intervention MeSH terms: Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Healthy volunteers: No
Keywords: osteoporosis; atypical femoral fractures; prior bisphosphonate treatment; postmenopausal women; bone loss

Summary:

      This open label comparison study examines the hypothesis that teriparatide given immediately
      following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will
      enhance healing and improve bone mineral density compared to delayed treatment (after six
      months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or
      for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition
      will have greater quality of life measures and less pain compared to those with delayed or no
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal women

          -  with osteoporosis who have been on bisphosphonate therapy for one year or more (all
             bisphosphonates will be included such as alendronate, risdedronate, ibandronate, or
             zoledronic acid).

          -  Patients will also be included if they are on glucocorticoids or other medications
             known to affect bone mineral metabolism as these are often found in patients with
             these types of fractures.

          -  sustain an atypical subtrochanteric or diaphyseal femoral shaft fracture as defined by
             the the 2010 ASBMR task force. An atypical fracture must include all of the following:
             (1) a location in the femur distal to lesser trochanter; (2) no trauma or minimal
             trauma as a fall; (3) transverse or short oblique configuration; (4) noncomminuted;
             and (5) complete fracture extends through both cortices and may be associated with a
             medial spike; incomplete fractures involve only the lateral cortex. Patients who have
             an incomplete fracture can be included if they fall into the 2010 ASBMR task force
             definition.

        Exclusion Criteria:

          -  men

          -  children

          -  those who have had radiation therapy

          -  Paget's disease

          -  treatment with teriparatide for two year in the past

          -  metastatic bone disease

          -  active cancer

          -  hypercalcemia

          -  hyperparathyroidism

          -  metabolic disease other than osteoporosis
Pediatric Ketamine Study for Pain Management
Condition: Pain
Intervention: Ketamine; Fentanyl
Intervention description: intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.; intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Intervention MeSH terms: Fentanyl; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Analgesia; pediatrics; pain management

Summary:

      Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for
      the treatment of moderate to severe pain in pediatric patients in the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 3-17,

          -  weighing less than 50kg

          -  present to the pediatric ED with moderate-severe acute pain (defined as pain greater
             than or equal to 6/10).

          -  Treating physician determines the patient to require opioid analgesia.

        Exclusion Criteria:

          -  Children with facial trauma or any abnormal nasal anatomy;

          -  developmentally delayed children;

          -  children with head trauma/increased intracranial pressure (ICP);

          -  children with known allergy to fentanyl or ketamine;

          -  children who are unable to provide pain scale assessment;

          -  children with chronic pain of greater than 4 weeks;

          -  Pregnant females;

          -  and children with a Glasgow Coma Scale (GCS)<15.
Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
Condition: Pain, Intractable; Breakthrough Pain; Chronic Pain
MeSH terms: Chronic Pain; Breakthrough Pain; Pain, Intractable
Intervention: Bupivacaine; Opioid
Intervention description: Patient-activated intrathecal bolus for incident pain; Patient-activated intrathecal bolus for incident pain
Intervention MeSH terms: Fentanyl; Morphine; Hydromorphone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 31 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the local anesthetic bupivacaine delivered
      intrathecally in small doses via PTM self-administered boluses significantly improves the
      breakthrough pain and functional status of patients with chronic intractable pain who are
      managed with an intrathecal drug delivery system.
    

Eligibility criteria:

        Inclusion Criteria

          -  Age more than 30 years implanted with an intrathecal drug delivery device.

          -  Intrathecal pump patients on stable dose for the last 3 months.

          -  Using on average more than 2 and less than 10 PTM doses per day

          -  Intrathecal medication admixture consisting of bupivacaine and another opioid
             (fentanyl or hydromorphone or morphine)

        Exclusion Criteria

          -  Using 10 or more PTM bolus doses per day or 2 or less PTM bolus doses per day

          -  Pending litigation or worker compensation claim

          -  Any recent (less than 3 month) procedures in spine (surgeries) or catheter
             adjustments.

          -  Recent pump dose adjustment within the past 3 months

          -  Pumps with medications other than bupivacaine/opioid combination.

          -  Pregnant or breast feeding
Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst
Condition: Pilonidal Cysts
MeSH terms: Cysts; Pilonidal Sinus
Intervention: Melectis G
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 890.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pilonidal cysts; Cavity wound; long healing; honey

Summary:

      The management of pilonidal cysts is a skin excision and under deep skin. Scarring requires
      regular dressings (daily for 15 days and then every 48 hours) until complete healing. This
      healing is obtained on average in 68 days. Some patients have difficulties in healing with a
      final healing achieved on average in 95 days. Some teams use honey to promote wound cavitary
      wounds (wound infection, pressure ulcers, varicose wound). The acceleration of wound healing
      is due to antibacterial properties and hyperosmolarity to reduce secretions. ) The use of
      honey in pilonidal cysts is not evaluated and may accelerate healing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cavity Wound to 6 weeks of a pilonidal cyst excision

          -  Bloodless wound

          -  Pilonidal cyst not recurred

          -  Age : 18 years and older

          -  Signature of informed consent

          -  In the capacity to understand the study

        Exclusion Criteria:

          -  Bleeding wound

          -  Refused to participate in Protocol

          -  Patient immunocompromised

          -  Recurrent pilonidal cyst

          -  Patients on long-term corticosteroid

          -  Patient deprived of liberty, under guardianship

          -  Patient unable to understand the study

          -  Allergy or hypersensitivity to honey

          -  Allergy Or hypersensitivity to hyaluronic acid

          -  Allergy or hypersensitivity to guar gum

          -  Allergy or hypersensitivity to pectin

          -  Known allergy to propolis (potentially present in honey)

          -  Sensitivity to zinc oxide

          -  Sensitivity known dressings used in this trial or any component

          -  Diabetes Non-insulin or insulin
Study Evaluating the Effects of Avanafil on Semen Parameters
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: avanafil; Placebo
Intervention description: 100 mg
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy male

Summary:

      The purpose of this study is to determine whether avanafil will affect different aspects of
      sperm production.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent

          -  Able to produce semen samples without requiring therapy (PDE5 inhibitors,
             over-the-counter (OTC) medication, and/or herbal supplements) for erectile dysfunction

          -  Be medically healthy (no clinically significant screening results for medical history,
             electrocardiogram (ECG), laboratory studies, physical examination, etc.) in the
             opinion of the investigator

          -  Be willing and able to comply with all study requirements

        Exclusion Criteria:

          -  An International Index of Erectile Function (IIEF) erectile function domain score of
             less than 17;

          -  History of infertility, vasectomy, testicular mass, testicular trauma, testicular
             abnormality (including size), radiation to the testis, previous pelvic surgery,
             cryotherapy of the prostate, known sperm defect, or retrograde ejaculation, or
             cryptorchidism;

          -  Resting heart rate <45 or >90 beats per minute at screening (3 rechecks permitted);

          -  Screening systolic blood pressure <90 or >140 mmHg and/or diastolic blood pressure <50
             or >90 mmHg (3 rechecks permitted);

          -  High serum FSH (>18.0 mIU/mL), high serum LH (>18 mIU/mL), or low serum testosterone
             (< 270 ng/dL, early morning collection) on screening;

          -  AST or ALT >2.0 x ULN or other evidence of significant hepatic impairment;

          -  Prostate specific antigen (PSA) level ≥4 ng/mL at screening;

          -  Individuals who perform rotating shift work during the course of the study.
A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy, safety and tolerability of once monthly
      administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients
      with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose
      of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA
      previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels
      within the target range. The anticipated time on study treatment is 3-12 months, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia;

          -  continuous maintenance ESA therapy with the same dosing interval during the previous
             month, and no change in totally weekly dose.

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months;

          -  poorly controlled hypertension;

          -  significant acute or chronic bleeding;

          -  active malignant disease (except non-melanoma skin cancer).