bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Ipack; Bupivacaine; Peri Articular Infiltration
Intervention description: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.; 20 cc of bupivacaine(o.25%) injection; Adductor Canal Catheter and Peri Articular Infiltration
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Total knee arthroplasty; Peri articular infiltration; Pack block; Adductor canal catheter

Summary:

      Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced
      osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed
      as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by
      2030.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA (American Society of Anesthesiology) class I-IV

          -  age 18-75.

        Exclusion Criteria:

          -  ASA class V

          -  morbid obesity

          -  patient refusal

          -  patients with chronic pain or on pain medication

          -  allergy to LA

          -  patients receiving any additional regional techniques

          -  coagulopathy

          -  patients receiving systemic anticoagulation

          -  local infection and procedures anticipated to last more than 5 hours.
Belimumab Assessment of Safety in SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo plus standard therapy; Belimumab 10 mg/kg plus standard therapy; Standard therapy
Intervention description: Placebo plus standard therapy; Belimumab 10 mg/kg plus standard therapy; Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.
Intervention MeSH terms: Belimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4019.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies; Lupus; SLE; Systemic Lupus Erythematosus; Autoimmune Disease; Belimumab

Summary:

      The purpose of this study is to further enhance the existing knowledge regarding the side
      effects of belimumab when given with other lupus medicines to adults with active systemic
      lupus erythematosus (SLE). This study mainly focuses on collecting information on serious
      events that are not that common or may only be seen with long-term treatment. These events
      include death, serious infections and other infections of interest, cancers, serious mental
      health problems, including depression and suicide, and serious infusion and hypersensitivity
      reactions. This study is being done to help understand if treatment with belimumab increases
      the risk for these types of events. This study will also see if patients receiving belimumab
      with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.

          -  Active SLE disease.

          -  Autoantibody-positive.

          -  On stable SLE treatment regimen which may include corticosteroids (for example,
             prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants
             (for example, azathioprine, methotrexate, mycophenolate).

        Key Exclusion Criteria:

          -  Pregnant or nursing.

          -  Have received treatment with any of the following: belimumab, either as a marketed
             product or as an investigational agent; any B cell targeted therapy (for example,
             rituximab) in the past year; or any biological agent (for example, adalimumab,
             etanercept, infliximab, or anakinra) in the past 90 days.

          -  Have received a live vaccine within the past 30 days.

          -  Have severe active lupus kidney disease.

          -  Have severe active central nervous system (CNS) lupus.

          -  Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C.
Exploratory Muscle Biopsy Assessment Study in Patients With Late-Onset Pompe Disease Treated With Alglucosidase Alfa
Condition: Pompe Disease (Late-Onset); Glycogen Storage Disease Type II (GSD II); Glycogenesis 2 Acid Maltase Deficiency
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease
Intervention: Alglucosidase Alfa
Intervention description: Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, multicenter study of participants with late-onset Pompe disease naive
      to treatment with enzyme replacement therapy (ERT). The primary objective of this study is to
      evaluate glycogen clearance in muscle tissue samples collected pre and post alglucosidase
      alfa treatment in participants with Late-Onset Pompe disease.

      The secondary objectives are to characterize the disease burden in participants with
      late-onset Pompe disease and explore imaging, histologic, and functional assessments in these
      participants and to explore potential plasma or urine biomarkers relative to late-onset Pompe
      disease and participant's response to treatment with alglucosidase alfa
      (Myozyme®/Lumizyme®/GZ419829).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has confirmed acid alpha-glucosidase (GAA) enzyme deficiency from any
             tissue source and/or confirmed GAA gene mutations and without known cardiac
             hypertrophy

          -  The participant is able to ambulate a distance without stopping and without an
             assistive device. Use of assistive device for community ambulation is appropriate

          -  The participant has a certain forced vital capacity (FVC) in upright position

          -  The participant, if female and of childbearing potential, must have a negative
             pregnancy test (urine beta-human chorionic gonadotropin [beta-hCG]) at baseline

        Exclusion Criteria:

          -  The participant has had previous treatment with ERT

          -  The participant is wheelchair dependent

          -  The participant requires invasive-ventilation (non-invasive ventilation is allowed)

          -  The participant is participating in another clinical study using investigational
             treatment

          -  The participant cannot submit to magnetic resonance imaging (MRI) examination because
             of a formal contraindication such as a pacemaker, implanted ferromagnetic metals, etc

          -  The participant, in the opinion of the Investigator, is unable to adhere to the
             requirements of the study
Effect of Pulse Width With Spinal Cord Stimulation
Condition: Pain; Chronic Pain; Back Pain
MeSH terms: Back Pain; Chronic Pain
Intervention: Precision
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Neurostimulation; Back pain; Chronic Pain

Summary:

      The primary objective of this study is to assess the effects of varying pulse width in
      suprathreshold dorsal column stimulation in patients with low back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome),
             which is primarily located in the low back, with minimal lower extremity pain.

          -  Have been permanently implanted with a Precision spinal cord stimulation (SCS) system
             within 6 months, or be an appropriate candidate for SCS and for the surgical
             procedures required for SCS as determined by the physician and have independently
             selected SCS with Precision for treatment.

          -  Be 18 years of age or older.

          -  Be willing and able to comply with all study related procedures and visits.

          -  Be capable of reading and understanding patient information materials and giving
             written informed consent.

        Exclusion Criteria:

          -  Have any significant medical condition that is likely to interfere with study
             procedures or likely to confound evaluation of study endpoints.

          -  Have any other chronic pain condition likely to confound evaluation of study
             endpoints.
Effect of Epinephrine on Post-polypectomy Pain
Condition: Colonic Polyp
MeSH terms: Colonic Polyps
Intervention: Epinephrine
Intervention description: Epinephrine in the submucosal injection fluid
Intervention MeSH terms: Epinephrine
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: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Epinephrine is widely used in endoscopic mucosal resection of large polyps to prevent
      post-polypectomy bleeding. No previous studies looked at increase in immediate
      post-polypectomy pain with the use of epinephrine.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients aged 18 years and over

          2. Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps

          3. Able to sign informed consent

        Exclusion Criteria

          1. Patients previously enrolled in the study

          2. Pedunculated polyps

          3. Polyps not amenable to endoscopic resection

          4. Patients allergic or sensitive to epinephrine

          5. Patients with coronary artery disease who have had a myocardial infarction in the past
             year, or had coronary stenting in the past year, or had angina in the past year.

          6. Patients electing anesthesia other than monitored anesthesia care with propofol (MAC)
             for colonoscopy
Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab 300 mg; Secukinumab 150 mg; Placebo
Intervention description: 150 mg x 2 s.c. injection; 150 mg s.c. injection; Placebo
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study design displays results combined as two or more Arms/Groups. Patients assigned to Placebo arm in Treatment Period 1 (TP1) may have switched to Secukinumab 300mg in Treatment Period 2 (TP2). Summaries by group were performed cumulatively by actual treatment received (as follows) for every visit until Week 16 groups in Treatment Period 1: · Secukinumab 300mg (Group 1) · Secukinumab 150mg (Group 2) · Placebo (Group 3) For entire treatment period, summaries by treatment group were performed cumulatively by the actual treatment received (as follows) for every visit til Week 52, including patients who switched at Weeks 16, 28, 40. For safety variables · Any Secukinumab 150 mg (Group 2) · Any Secukinumab 300mg (Group 1) · Any Secukinumab (Group 3) Hence, participants who received "Placebo" in TP1 were combined with participants who received "Any Secukinumab" in "Group 3" and "Any Secukinumab 300mg" in "Group 1" in TP2. Safety is presented for the ENTIRE period, including TP1 and TP2
Masking: Double (Participant, Investigator)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PsA; ACR; CASPAR; inflammatory arthritis; spondylitis

Summary:

      To demonstrate that the efficacy of secukinumab 300 mg at Week 16 was superior to placebo in
      adult patients with active PsA based on the proportion of patients achieving an American
      College of Rheumatology 20 (ACR20) response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female patients at least 18 years of age

          -  Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months
             with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and
             ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)

          -  Rheumatoid factor and/or anti-CCP antibodies negative at screening

          -  A target skin psoriatic lesion and a PASI score of 1 or greater

        Exclusion Criteria:

          -  Chest X-ray with evidence of ongoing infectious or malignant process

          -  Patients who ever received biologic immunomodulating agents including those targeting
             TNFα, IL-6 and IL-12/23 investigational or approved
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
Condition: Retinopathy of Prematurity; Retinal Detachment; Blindness
MeSH terms: Blindness; Retinal Diseases; Retinal Detachment; Retinopathy of Prematurity; Premature Birth
Intervention: ACULAR; REFRESH TEARS; placebo
Intervention description: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.; infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours.
Intervention MeSH terms: Ketorolac Tromethamine; Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 10 Days
Maximum age: 15 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Retinopathy of Prematurity; Premature Infants; ACULAR; Refresh Tears

Summary:

      The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye
      drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or
      decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear).

      The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to
      severe ROP (grade II and above)by 50%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All preterm infants of gestational age less or equal to 28 weeks completed gestational
             age and 10 to 15 days of postnatal age admitted to our regional NICU
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Intervention: Atorvastatin
Intervention description: Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To evaluate the percentage of Korean dyslipidemic subjects in the total group and each
      cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at
      starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a Korean , dyslipidemic outpatient

          2. Is eligible for LDL-lowering drug therapy at screening and baseline as determined by
             the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C
             ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for
             subjects with 2 or more CHD risk factors and 10 year risk < 10 % 2. 3 LDL-C ≥ 130
             mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C
             ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk >
             20 %)

          3. Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline

        Exclusion Criteria:

          1. Is pregnant or lactating

          2. Has present myopathy or history of myopathy or has personal or familial history of
             hereditary muscular disorders or any history of rhabdomyolysis

          3. Has history of intolerance or hypersensitivity to atorvastatin or other statins

          4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg
             and/or diastolic BP ≥ 100mmHg)

          5. Has HbAlc > 10%

          6. Has any severe disease of has had any major problem or surgical procedure within the 3
             months prior to screening that is likely to jeopardize the planned termination of the
             study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft,
             cardiac infarct, severe or unstable angina pectoris)
Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production
Condition: Obstetric Pain
MeSH terms: Labor Pain
Intervention: Preemptive epidural analgesia; Standard of care
Intervention description: Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions.; Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Epidural; analgesia; labor; cytokines

Summary:

      During labor there is an increased production of inflammatory mediators called cytokines.
      Higher concentration of certain cytokines has been linked to adverse neonatal and maternal
      outcomes.

      Epidural analgesia is commonly performed after the parturient feels labor pain.

      We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can
      influence the production of cytokines.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age>18

          2. Singleton pregnancy with no known fetal malformations

          3. Above or equal to 38 weeks of pregnancy

        Exclusion Criteria:

          1. Systemic medical illnesses

          2. Chronic medications except for iron and vitamins

          3. Women developing fever > 380C

          4. Women with history of delivery of children with cerebral palsy

          5. History of infertility

          6. Premature contractions
Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Ocular Hypertension
Intervention: bimatoprost 0.03% eye drops; travoprost 0.004% eye drops
Intervention description: bimatoprost 0.03% 1 drop nightly for 3 months; travoprost 0.004% 1 drop nightly for 3 months
Intervention MeSH terms: Bimatoprost; Travoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with glaucoma or ocular hypertension currently being treated with latanoprost
      0.005%, and in need of additional IOP lowering, will be randomized to receive either
      bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%
    

Eligibility criteria:

        Inclusion Criteria:

          -  Glaucoma or ocular hypertension in both eyes

          -  Currently being treated with latanoprost 0.005% daily and in need of additional
             IOP-lowering

          -  Best-corrected visual acuity of 20/100 or better in each eye

          -  Visual field within 6 months of study entry

        Exclusion Criteria:

          -  Secondary glaucoma

          -  Active intraocular inflammation or macular edema

          -  Intraocular surgery or laser surgery within the past 3 months