bioihbjkbjnl/mcl2 huggingface dataset:
Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study
Condition: Hypercholesterolemia, Familial
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Evolocumab; Placebo
Intervention description: Administered by subcutaneous injection; d by subcutaneous injection
Intervention MeSH terms: Evolocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Heterozygous Familial Hypercholesterolemia; Proprotein convertase subtilisin/kexin type 9 (PCSK9)

Summary:

      The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous
      evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in
      adults with heterozygous familial hypercholesterolemia (HeFH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 75 years of age

          -  Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic
             criteria outlined by the Simon Broome Register Group (Scientific Steering Committee
             1991)

          -  On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4
             weeks

          -  Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL

          -  Fasting triglycerides ≤ 400 mg/dL

        Exclusion Criteria:

          -  Homozygous familial hypercholesterolemia

          -  Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to
             randomization

          -  New York Heart Association (NYHA) III or IV heart failure, or known left ventricular
             ejection fraction < 30%

          -  Uncontrolled cardiac arrhythmia

          -  Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
             coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization

          -  Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c > 8.5%)

          -  Uncontrolled hypertension
A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: 8 mg/kg infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multi-center, randomized, parallel-group, active-controlled, open-label study will
      evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time
      compared to the normal infusion time. Patients will be randomized to 8 mg/kg
      RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg
      infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, at least 18 years of age, inclusive

          -  Diagnosis of rheumatoid arthritis of at least 6 months duration

          -  Moderate to severe active rheumatoid arthritis (DAS28 >/=3.2)

          -  Patients received at least 1 disease-modifying anti-rheumatic drug (DMARD) and/or 1 or
             more TNFalfa-inhibitors over a period of at least 8 weeks

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             surgery within 6 months following randomization

          -  Rheumatic autoimmune disease other than rheumatoid arthritis

          -  Prior history of or current inflammatory joint disease other than rheumatoid arthritis

          -  Functional class IV (ACR criteria)

          -  History of severe allergic reaction to human, humanized or murine monoclonal
             antibodies

          -  Known active current or history of recurrent infection (including tuberculosis)

          -  Primary or secondary immunodeficiency (history of or currently active)

          -  Body weight >150 kg

          -  Previous treatment with any cell-depleting therapies

          -  Previous treatment with tocilizumab
Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery
Condition: CABG
Intervention: Placebo; GLP-1 (7-36) amide
Intervention description: 1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours.; 1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.
Intervention MeSH terms: Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: CABG; Cardiac Surgical Patient

Summary:

      This research is being done to see if giving a hormone called GLP-1 can improve heart
      function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in
      people who have non-emergent coronary artery bypass graft (CABG) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females age > 18 years of age

          -  Able to consent

          -  Scheduled for non-emergent coronary artery bypass graft (CABG)

          -  Have an ejection fraction < 35%

          -  Ischemic patients with Left Ventricular Dysfunction (LVD) who need a valve procedure
             with their CABG

        Exclusion Criteria:

          -  Emergency coronary artery bypass graft surgery

          -  Patients with an ejection fraction > 35%

          -  Repeat or redo CABG patients

          -  Patients with a history of pancreatitis

          -  Pregnant or lactating females
Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
Condition: Eastern Equine Encephalitis
MeSH terms: Encephalomyelitis, Equine; Encephalomyelitis, Eastern Equine; Encephalitis
Intervention: Inactivated, Dried, TSI-GSD 104, EEE
Intervention description: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: EEE

Summary:

      This study is designed to determine the safety and immunogenicity of Eastern Equine
      Encephalitis (EEE) Vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old.

          -  EEE PRNT80 ≤ 1:20.

          -  EEE PRNT80 ≤ 1:40 for booster series

          -  (females) Negative pregnancy test on the same day before vaccination.

          -  Not planning pregnancy for 3 months.

          -  At risk for exposure to virulent EEE virus (with up-to-date risk assessment).

          -  Up-to-date (within 1 year) physical examination/tests.

          -  Sign and date the approved informed consent.

          -  Willing to return for all follow-up visits.

          -  Agree to report adverse events (AE) up to 28 days after each vaccination.

        Exclusion Criteria:

          -  Over 65 years of age (for Primary Immunization).

          -  Clinically significant abnormal lab results including evidence of Hepatitis C,
             Hepatitis B carrier state, or elevated (2X normal) liver function tests.

          -  History of immunodeficiency or current treatment with immunosuppressive medication.

          -  (females) Currently breastfeeding.

          -  Confirmed human immunodeficiency virus (HIV) titer.

          -  Any known allergies to components of the vaccine.

          -  A medical condition that, in the judgment of the Principal Investigator (PI), would
             impact subject safety (i.e.-vaccination or exposure to another Alphavirus).

          -  Administration of any IND product or live vaccine within 28 days of EEE.

          -  Any unresolved AEs resulting from a previous immunization.
Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Placebo for Nasulin; Nasulin
Intervention description: Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.; Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Phase 2 Study for novel insulin delivery of type 2 diabetes

Summary:

      The purpose of this study is:

        -  To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia,
           assessed by continuous glucose monitoring data and serum fructosamine levels in patient
           volunteers with Type 2 Diabetes.

        -  To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient
           volunteers with Type 2 Diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with Type 2 diabetes (18 years of age or older)

          -  Currently treated with basal insulin and OAD(s)

          -  HbA1c range of 6.5 - 10.

          -  BMI less than 41

        Exclusion Criteria:

          -  Multiple daily injections of mealtime insulin

          -  Regular use of nasal sprays

          -  Significant nasal pathology

          -  Employed in a job which required irregular shift or night work
AZD7268 Safety and Tolerability Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: AZD7268; Escitalopram; Placebo capsules; Placebo tablets
Intervention description: 15 mg, oral, twice daily (BID); 20 mg, oral, once daily (QD); Placebo capsules to match AZD7268; Placebo tablets to match encapsulated escitalopram
Intervention MeSH terms: Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      The purpose of this study is to prove the principle that treatment with AZD7268 reduces
      depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed, written, and dated Informed Consent prior to any study specific
             procedures

          -  Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision
             (APA 2000) for any of the following:

          -  296.2x Major Depressive Disorder, Single Episode, or

          -  296.3x Major Depressive Disorder, Recurrent

        Exclusion Criteria:

          -  Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety
             disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis
             should have been made at least 6 months before enrollment

          -  Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the
             patient's current psychiatric status

          -  Patients whose current episode of depression started less than 4 weeks before
             enrollment
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
Condition: Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Intervention: ADX-N05; Placebo
Intervention description: 150 mg once a day for seven days followed by 300 mg once a day for seven days; Placebo to match ADX-N05 once a day for 2 consecutive weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in
      the treatment of excessive daytime sleepiness in adults with narcolepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of narcolepsy

          -  Good general health

          -  Willing and able to comply with the study design and schedule and other requirements

        Exclusion Criteria:

          -  If female, pregnant or lactating

          -  Customary bedtime later than midnight

          -  History of significant medical condition, behavioral or psychiatric disorder
             (including suicidal ideation), or surgical history

          -  Any other clinically relevant medical, behavioral or psychiatric disorder other than
             narcolepsy that is associated with excessive sleepiness

          -  History of significant cardiovascular disease

          -  Body mass index >34

          -  Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day

          -  History of alcohol or drug abuse within the past two years

          -  Nicotine dependence that has an affect on sleep
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Bexsero; Saline Placebo; Havrix; MenABCWY
Intervention description: Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB_0_2 Group.; One dose administered intramusculary in the deltoid muscle at Month 1 in ABCWY_ 0_2 Group and rMenB_0_2 Group, Month 2 in ABCWY_0_6 Group and ABCWY_0_11 Group and Month 6 in ABCWY_0_1 Group.; Two doses administered in the deltoid muscle at Month 2 and 12 in ABCWY_0_1 Group, Month 1 and 12 in Group ABCWY_0_6 Group and ABCWY_0_2_6 Group , Month 0 and 6 in ABCWY_0_11 Group and Month 6 and 12 in ABCWY_ 0_2 Group and rMenB_0_2 Group.; Two to three doses administered in the deltoid muscle at Month 0 and 1 in ABCWY_0_1 Group, Month 0 and 6 in ABCWY_0_6 Group, Month 1 and 12 in ABCWY_0_11 Group, Month 0, 2 and 6 in ABCWY_0_2_6 Group, Month 0 and 2 in ABCWY_ 0_2 Group and rMenB_0_2 Group.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1063.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purposes for conducting the study are firstly to assess immunological
      non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to
      healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine
      (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give
      the flexibility for the national vaccination program by showing the safety and immunogenicity
      of MenABCWY administrated according to four different vaccination schedules and additionally
      to evaluate a potential benefit of the 3-dose vaccination series.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adolecents from 10-18 yearsof age, generally in good health, and available for all
             study visits, and who/whose legally acceptable representative has given written
             informed consent at the time of enrollment.

          2. Individuals of who the investigator believes can and will comply with the requirements
             of the protocol (e.g. use of an eDiary, return for follow-up visits, available for
             phone contacts).

          3. Female subjects of childbearing potential must have a negative urine preganancy test.

        Exclusion Criteria:

          1. Serious, acute, or chronic illness. Previous or suspected disease caused by N.
             meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.

          2. Exposure to individuals with clicically proven meningococcal disease or clinical
             bacterial meningitis without further microbiologic characteriszation.
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
Condition: HIV-1
Intervention: Etravirine (TMC125); Optimized background regimen (OBR)
Intervention description: Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks.; An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir [LPV], darunavir [DRV], atazanavir [ATV] or saquinavir [SQV]) in combination with nucleos(t)ide reverse transcriptase inhibitor(s) (N[t]RTIs) to be dosed according to the drugs individual package inserts for 48 weeks.
Intervention MeSH terms: Etravirine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: HIV-1; TMC125-TiDP35-C213; TMC125-C213

Summary:

      The purpose of this study is to determine the safety and antiviral activity of etravirine in
      treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected

          -  Body weight according to age within the 10-90th percentile of CDC growth chart

          -  On steady antiretroviral therapy regimen for at least 8 weeks at screening and willing
             to remain on that regimen until baseline

          -  HIV viral load of 1,000 copies/ml or greater at study entry

          -  Parent or legal guardian willing to provide informed consent, if necessary

        Exclusion Criteria:

          -  The Key Exclusion Criteria are: Evidence of resistance to etravirinel Any grade 3 or 4
             toxicity (More information available in the protocol)

          -  Use of disallowed concomitant therapy (specified in the protocol)

          -  Currently active AIDS defining illness (category C)

          -  Active hepatitis A, B or C virus infection

          -  Any clinically significant diseases or findings that, in the opinion of the
             investigator, would interfere with the study

          -  Receipt of any ARV or non-ARV investigational medication or investigational vaccine
             within 30 days prior to screening

          -  History of clinically significant allergy or hypersensitivity to any of the excipients
             of the investigational medication (TMC125)
Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset CRPS After TKA
Condition: CRPS
Intervention: pregabalin; Placebo
Intervention description: PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.; Placebo for Given 2 hours prior to surgery, and twice a day for 14 postoperative days.
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The Department of Anesthesiology is conducting a clinical trial to evaluate if pregabalin
      given prior to and for several days after Total Knee Arthroplasty (TKA) will reduce the
      prevalence of Complex Regional Pain Syndrome (CRPS) at late postoperative times. The
      prevalence of complex regional pain syndrome (CRPS) following total knee arthroplasty (TKA)
      is 13% at 6 months post-surgery. CRPS is a painful debilitating condition, with 4 main
      classes of symptoms : sensory, including burning, allodynia, and hyperalgesia in the affected
      limb; vasomotor, including temperature asymmetry and skin color changes; edema and sudomotor,
      including sweating; and movement disorders and dystrophy, including decreased range of
      motion, motor dysfunction (weakness, tremor, dystonia) and changes in hair, nails or skin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of osteoarthritis

          2. Subjects who can understand and communicate in English.

        Exclusion Criteria:

          1. Younger than 21 years or older than 80 years.

          2. American Society of Anesthesiologists physical status IV.

          3. Prior usage of gabapentin (or pregabalin) will not be an exclusionary criterion;
             however, patients will have been withdrawn from these medications for at least 7 days
             before surgery.

          4. Patients with a history of neuropathic pain conditions.

          5. Patients who are currently enrolled in another investigational study.

          6. Pre-existing heart conditions

          7. Patients on thiazolidinedione class of anti-diabetic medications (eg. rosiglitazone,
             pioglitazone).

             -