bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: topical desonide hydrogel 0.05%
Intervention description: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions
Intervention MeSH terms: Desonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: No

Summary:

      The purpose of this research study is to better understand how this study drug works when
      people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug
      Administration (FDA) for atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 3 months or greater.

          -  Subjects must have diagnosis of mild to moderate atopic dermatitis by an investigator
             (a 2 or 3 on the IGA scale).

          -  Subjects must have >2% BSA involvement to be enrolled.

          -  Informed consent of participation must be given by parent or guardian if he or she is
             <7 years old. Children who are 7 to 18 years old will be given an assent form to sign.

          -  Moisturizers will be allowed during the study as long as the use remains stable from
             screening/baseline throughout the study.

        Exclusion Criteria:

          -  Known allergy or sensitivity to topical desonide hydrogel in the subject.

          -  Inability to complete all study-related visits.

          -  Introduction of any other prescription medication, topical or systemic, for atopic
             dermatitis while participating in the study. Other than stable use of over the counter
             non-medicated moisturizers, all other topical treatments for AD must be stopped prior
             to study drug initiation. There will be no required washout for any topical therapies.
             Stable use of systemic therapies may be continued throughout the study.

          -  Requiring >130 gm of cream in a 4 week period.

          -  Pregnant women and women who are breastfeeding are to be excluded. Women of
             childbearing potential will be allowed to participate in the study, and these subjects
             will be required to use at least one form of birth control. Use of desonide in
             pregnant subjects is controversial and is only to be used when benefits outweigh the
             risks.
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; Insulin Lispro Premix (mid-mixture and low-mixture)
Intervention description: patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks; patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 344.0
Sex: All
Minimum age: 30 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This study is designed to look at how best to start and then gradually intensify (as needed)
      the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus, Type 2

          -  have been receiving metformin plus at least one other oral antihyperglycemic
             medication (OAM) (sulfonylurea or Thiazolidinedione [TZD]) without insulin, for at
             least 90 days prior to Visit 1

          -  glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%

          -  regularly consume a light breakfast (less than 15% of total daily calorie intake)

          -  capable and willing to follow the protocol

          -  give written consent

        Exclusion Criteria:

          -  are taking a TZD whose country label does not allow in combination with insulin

          -  are taking any glucose-lowering agents (other than specified in the inclusion criteria
             above)

          -  have a body mass index greater than 40 kg/m^2

          -  have a history of severe hypoglycemia in past 24 weeks

          -  are pregnant or may become pregnant

          -  women who are breastfeeding

          -  have significant cardiac disease

          -  have significant renal or liver disease

          -  undergoing therapy for a malignancy

          -  contraindications to study medications

          -  have an irregular sleep/wake cycle
Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneli (Teneligliptin); Placebo; Insulin
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in
      combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to
      evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an
      extension treatment for up to 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who has been receiving a stable dose and regimen of insulin over 12 weeks
             before administration of investigational drug

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 12 weeks before administration of investigational drug

          -  Patients whose HbA1c is between 7.5% and 10.5%

          -  Patients who were not administered diabetes therapeutic drugs prohibited for
             concomitant use within 12 weeks before administration of investigational drug.

        Exclusion Criteria:

          -  Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or
             secondary diabetes (Cushing disease, acromegaly, etc)

          -  Patients who are accepting treatments of arrhythmias

          -  Patients with serious diabetic complications

          -  Patients who are the excessive alcohol addicts

          -  Patients with severe hepatic disorder or severe renal disorder.

          -  Patients who are pregnant, lactating, and probably pregnant patients, and patients who
             can not agree to contraception
Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
Condition: Osteoarthritis; Arthroplasty
MeSH terms: Osteoarthritis
Intervention: Ropivacaine with NaCl; Epinephrine; Morphine; Ketorolac Tromethamine; Ropivacaine
Intervention description: 50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment; 0.15 mg Epinephrine are injected as part of the drug "cocktail"; 4 mg Morphine are injected as part of the drug "cocktail"; 30 mg morphine are injected as part of the drug "cocktail"; 30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Epinephrine; Morphine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to examine whether there is a difference in the level
      of resting pain following total hip arthroplasty with an anterior approach with use of a
      psoas compartment block versus a local periarticular anesthetic infiltration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at
             Beaumont Hospital Royal Oak

          -  Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease)

          -  Surgical approach is anterior

        Exclusion Criteria:

          -  Minors (age less than 18 years)

          -  Pregnant (surgically sterile, post-menopausal, or negative blood test)

          -  Previous ipsilateral hip surgery

          -  Lumbar instrumentation

          -  Acute trauma

          -  Rheumatoid arthritis

          -  Avascular necrosis

          -  Hip dysplasia

          -  Known sensitivity, allergy, or contraindication to anesthetics being used in the study

          -  Narcotic sensitivity

          -  History of over 6 months of opioid dependency prior to surgery (excluding tramadol)

          -  Peripheral neuropathy

          -  Mental/cognitive impairment that would interfere with the patient's self-assessments
             of function, pain, or quality of life
The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
Condition: HIV
Intervention: Raltegravir; Tenofovir; Emtricitabine
Intervention description: 400 mg twice daily; 245 mg once daily; 200mg once daily
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: HIV affected over 60 years old
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: HIV; Pharmatokinetic; 60 years old; Raltegravir

Summary:

      This is a phase IV, open label, prospective, one phase pharmacokinetic and observational
      study.

      Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy
      to:

        -  tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus

        -  raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24
           hour pharmacokinetic visit.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV-1 infected males or females

          2. 60 years of age or greater*

          3. signed informed consent

          4. willing to switch therapy as per study protocol

          5. no previous exposure to raltegravir or HIV-1 integrase inhibitors

          6. plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the
             last 3 months

          7. currently receiving a stable antiretroviral regimen with no antiretroviral drug
             switches for at least 3 months

          8. no previous clinically-significant resistance documented on HIV-1 genotypic resistance

          9. subjects in good health upon medical history, physical exam, and laboratory testing

         10. BMI above or equal to 18 and below 32

         11. Male subjects who are heterosexually active must use two forms of barrier
             contraception (e.g., condom with spermicide) during heterosexual intercourse, from
             screening through completion of the study.

         12. Have local screening laboratory results (haematology and chemistry that fall within
             the normal range of the central laboratory's reference ranges unless the results have
             been determined by the Investigator to have no clinical significance * 50% of total
             enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged
             between 60 and 64 recruited, only subjects aged 65 or over will be eligible.

        Exclusion Criteria:

          1. current alcohol abuse or drug dependence

          2. positive urine drug of abuse screening

          3. active opportunistic infection or significant co-morbidities

          4. current disallowed concomitant medication
A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta
Intervention description: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene
      glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for
      correction and/or maintenance of hemoglobin levels in participants with chronic kidney
      disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA)
      or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy
      polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram
      (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size
      was 200 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >=18 years of age;

          -  Chronic renal anemia;

          -  No ESA therapy during previous 3 months.

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 2 months;

          -  Poorly controlled hypertension requiring hospitalization in previous 6 months;

          -  Significant acute or chronic bleeding.
Fibrinogen Concentrate vs Cryoprecipitate
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Intervention: Fibrinogen Concentrate; Cryoprecipitate
Intervention description: Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group; Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 60.0
Sex: All
Minimum age: 1 Day
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      One of the most common hemostatic derangements in pediatric open- heart surgery is an acute
      acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet
      aggregation, resulting in increased bleeding and allogenic blood transfusions.

      Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in
      pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen
      concentrate will be as effective in treating post-CPB bleeding and will decrease total blood
      product exposure when used as part of a blood transfusion algorithm.

      We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a
      fibrinogen level <250mg/dL while on bypass.

      We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard
      of care in the management of peri- operative bleeding in neonatal patients undergoing
      cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as
      effective as the standard of care, then we would plan a multi-center trial to demonstrate the
      safety and efficacy of this medication. If we are able to demonstrate that fibrinogen
      concentrate is effective, fibrinogen concentrate could replace allogenic products and
      potentially decrease transfusion related morbidity in mortality in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonates of at least 32 weeks of gestational age and infants up to 12 months of age
             with the diagnosis of congenital heart disease, requiring open heart surgery with
             cardiopulmonary bypass

        Exclusion Criteria:

          -  Pre-existing coagulopathy, including unexplained bleeding or history of clotting
Ultrasound Guided Pain Control Versus Standard Treatment in Emergency Department HIP Fracture Patients
Condition: Hip Fracture
MeSH terms: Emergencies; Fractures, Bone; Hip Fractures
Intervention: UFNB (Ultrasound guided femoral nerve block); UFIB (Ultrasound Guided Fascia Iliaca Compartment Block); IVMS (IV Morphine)
Intervention description: Ultrasound Guided Femoral Nerve Block; Intravenous Morphine
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hip Fracture; Ultrasound; Nerve Block

Summary:

      Hip Fracture (HFx) is a painful injury that is often treated in the Emergency Department (ED)
      with intravenous opiates. However, this class of medications may cause deleterious side
      effects. An alternative analgesic approach involves regional anesthesia. The investigators
      attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNBs) could be
      safely performed in an ED setting, (2) whether UPNBs would be more effective than standard
      treatment in controlling pain from HFx and (3) which of two UPNBs was superior for pain
      relief.

      A convenience sample of patients with an isolated HFx and a pain score > 5/10 were enrolled
      and randomized to one of three arms: (1) Ultrasound guided 3-in-1 femoral nerve block (UFNB),
      (2) Ultrasound guided fascia iliaca compartment block (UFIB), or (3) IVMS. Patients indicated
      their pain from 0 (no pain) to 10 (extreme pain).
    

Eligibility criteria:

        Inclusion Criteria:

          1. English speaking patients

          2. ≥18 years of age

          3. radiographic evidence of hip fracture

          4. Patients must be awake, alert and oriented to time, place and person.

          5. pain score of ≥ 5 in 10 point scale.

        Exclusion Criteria:

          1. cognitive deficits

          2. allergic to amide-type local anesthetic or morphine

          3. more injuries than just hip fracture.
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
Condition: Nail Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: etanercept
Intervention description: Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.
Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nail Psoriasis; Plaque Psoriasis

Summary:

      The purpose of this study is to evaluate if Etanercept administered at a higher initial dose
      provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower
      initial dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Active, stable plaque psoriasis defined by the following criteria:

               -  Body surface area (BSA) ≥ 10 % at screening and baseline

               -  Or, PASI >10 at screening and baseline

               -  Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at
                  screening and baseline

               -  Or, DLQI > 10 at baseline

          -  Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI >
             14 - Target nail is defined as the nail with the highest nail score (matrix+bed
             scores) at baseline. Should more than one fingernail have the same score, the target
             fingernail will be chosen by the investigator.

          -  Failure of at least one systemic psoriasis therapy for nail psoriasis

          -  Eligible to receive biologic therapy for psoriasis in accordance to local guidelines

        Exclusion Criteria:

          -  Evidence of Skin conditions other than psoriasis

          -  Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate,
             acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug
             initiation

          -  Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
Condition: Ethmoid Sinusitis; Rhinosinusitis
MeSH terms: Sinusitis; Ethmoid Sinusitis
Intervention: AdvaCoat sinus gel; Merogel Injectable
Intervention description: A sterile,viscoelastic, bioresorbable gel composed of highly purified hyaluronan, a naturally occurring constituent of tissues in the body; Bioresorbable hyaluronic acid product
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: rhinosinusitis, ethmoid

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel,
      a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery.
      Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus
      tissues and Merogel applied to the middle meatus tissues on the opposite side.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who:

          1. Have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history,
             and prior radiography

          2. Have bilateral ethmoid sinus disease

          3. Are scheduled for bilateral anterior or total ethmoidectomy

        Exclusion Criteria:

          1. Unilateral ethmoid sinus disease

          2. Partial resection of middle turbinates, unilateral or bilateral