bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a; Ribavirin; peginterferon alfa-2a; Ribavirin
Intervention description: 180 µg sc weekly for 48 weeks; 1200 mg po daily for 48 weeks; 360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks; 1400-1600 mg po daily for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance
      dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety
      of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with
      chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight
      ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS
      180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg
      sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed
      by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc
      weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po
      daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free
      follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size
      is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥18 years of age

          -  CHC infection, genotype 1

          -  Hepatitis C virus (HCV) RNA ≥400,000 IU/mL

          -  Baseline body weight ≥85 kg

          -  Liver biopsy (within 24 months of first dose) with results consistent with CHC

        Exclusion Criteria:

          -  Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase
             or protease inhibitors

          -  Other forms of liver disease, including liver cancer

          -  Human immunodeficiency virus infection
Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients
Condition: Head and Neck Cancer; Acute Pain; Postoperative Pain
MeSH terms: Acute Pain
Intervention: Gabapentin; Placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oral cavity; oropharynx; hypopharynx and larynx

Summary:

      Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect
      provider and hospital quality of care. Furthermore, at the core of a healthcare team and
      healthcare system is the desire to provide patients with the best possible care in order to
      achieve the best possible outcomes. Providers have the duty to identify areas of needed
      improvement within the domains of treatment. An area of need that is ubiquitous within
      medicine is pain control; in this case acute postoperative pain control is the targeted
      condition. Studies have already shown that better control of acute postoperative pain leads
      to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient
      satisfaction and a reduced likelihood of developing chronic pain. Research within the field
      of pain management has definitively revealed that a combination of different medication
      regimens can control acute postoperative pain better than narcotics alone. In particular, the
      medication gabapentin has been shown to improve acute postop pain in many kinds of surgical
      settings, and it is a safe medication with arguably fewer side effects than narcotics. The
      investigators know that certain groups of post surgical otolaryngology patients can be at
      risk for high levels of postoperative pain. Given all of this information, physicians have a
      responsibility to utilize medications such as gabapentin to do a better job of controlling
      patient's pain. This investigation is a quality improvement project designed to elucidate the
      benefits of gabapentin in pain management in patients undergoing surgery of the head and neck
      mucosal surfaces. It will provide much needed data in an understudied population and
      ultimately will improve the practice of pain management, patient satisfaction and quality of
      care delivered in the Barnes otolaryngology department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects undergoing definitive mucosal head and neck resection including oral cavity,
             oropharynx, larynx, and hypopharynx

          -  At least one night of planned inpatient stay

        Exclusion Criteria:

          -  Incapable of giving informed consent

          -  Age less than 18

          -  Glomerular Filtration Rate (GFR) less than 30

          -  Allergy to gabapentin

          -  Baseline gabapentin or lyrica use

          -  Chronic opioid use for over six months
Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48; Placebo s.c. at randomization, Weeks 1, 2, 3, 4, and 8; secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: scalp psoriasis; plaque psoriasis; secukinumab; AIN457; biologic; monoclonal antibod; psoriasis; AIN457A

Summary:

      This study provided a comparison of secukinumab to placebo with respect to skin inflammation
      as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample
      analyses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to
             randomization

          -  Moderate to severe plaque psoriasis as defined at baseline by:

               -  ≥10% Body Surface Area (BSA) involvement and

               -  PASI total score of ≥12 and

               -  IGA mod 2011 score of ≥3 (based on a scale of 0-4)

        Exclusion Criteria:

          -  Forms of diagnosed psoriasis other than chronic plaque psoriasis

          -  Medication-induced or medication exacerbated psoriasis

          -  Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A
             or IL-17RA receptors

          -  Ongoing use of prohibited treatments

          -  Pregnant or nursing (lactating) women

        Other protocol-defined inclusion/exclusion criteria may apply
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair
Condition: Hernia
MeSH terms: Hernia; Hernia, Abdominal; Internal Hernia
Intervention: EXPAREL
Intervention description: single dose 266 mg of undiluted EXPAREL
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: analgesia; hernia repair

Summary:

      Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the
      Transversus Abdominis Plane (TAP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.

          -  Undergoing open repair of a unilateral abdominal hernia below the level of the
             umbilicus.

          -  Abdominal incision length of 3-12 cm.

          -  Subjects must be physically and mentally able to participate in the study and complete
             all study assessments.

          -  Subjects must be able to give fully informed consent to participate in this study
             after demonstrating a good understanding of the risks and benefits of the proposed
             components of the TAP infiltration.

        Exclusion Criteria:

          -  History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics

          -  Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator,
             might preclude the potential successful performance of a TAP infiltration.

          -  Any subject who in the opinion of the Investigator, might be harmed or be a poor
             candidate for participation in the study.

          -  Any subject, who in the opinion of the Investigator, is on chronic pain medicine.

          -  Any female subject who is currently pregnant.

          -  Subjects who have received any investigational drug within 30 days prior to study drug
             administration, or planned administration of another investigational product or
             procedure during their participation in this study.
Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.
Condition: Disorders of Gallbladder, Biliary Tract and Pancrease
MeSH terms: Gallbladder Diseases
Intervention: Propofol; Midazolam; Meperidine
Intervention description: Propofol is the sedative drug used as an additional sedation to one of the study arm.; Midazolam is one of the two conventional sedative drugs included in both arms.; Meperidine is one of the two conventional sedative drugs included in both arms.
Intervention MeSH terms: Midazolam; Meperidine; Propofol
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Propofol; Midazolam; Meperidine

Summary:

      The purpose of this study is to compare efficacy and safety of combination of propofol and
      midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP
    

Eligibility criteria:

        Inclusion Criteria:

        . All outpatients aged more than 18 years who were schedule for ERCP -

        Exclusion Criteria:

          -  pregnant woman

          -  emergency situation ( i.e. concomitant upper gastrointestinal bleeding, acute
             cholangitis )

          -  American Society of Anesthesiologist ( ASA )Class IV or V

          -  respiratory disease,

          -  sleep apnea

          -  allergy to egg or soybean

          -  drug abuse( benzodiazepine, opioid agonist )

          -  previous history of failure sedation
Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Golimumab
Intervention description: Golimumab 50mg/0.5 mL in a single-use, ready-to-use autoinjector. Golimumab is a fully human anti-TNF (tumor necrosis factor) alpha monoclonal antibody that will be administered SC.
Intervention MeSH terms: Golimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for
      Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor
      superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic
      response to golimumab treatment in participants with moderate to severe UC who have failed on
      prior conventional therapies. The primary endpoints of this study are to correlate serum
      soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and
      histological activity (Geboes index) of disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inadequate response to conventional therapy including corticosteroids or are
             intolerant to, or have medical contraindications for conventional therapies

          -  UC diagnosed prior to screening, based on a biopsy collected at endoscopy

          -  Moderate to severe active UC with total Mayo score of 6 to 12, inclusive at baseline,
             and endoscopic Mayo sub-score, greater than or equal to 2

          -  Adenomatous polyps removed within last 5 years or at the screening visit prior to the
             first drug treatment

          -  Extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for
             ≥10 years should have a colonoscopy to exclude the presence of dysplasia within 1 year
             prior to study inclusion or a colonoscopy to exclude the presence of malignancy at the
             screening visit

          -  No history of untreated latent or active Tuberculosis (TB) prior to screening

          -  Negative stool results for enteric pathogens

        Exclusion Criteria:

          -  History of asthma

          -  History of autoimmune diseases

          -  History of hypertension
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Condition: Cataract
MeSH terms: Cataract
Intervention: ReSTOR
Intervention description: Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ReSTOR Aspheric +3 IOL

Summary:

      A prospective evaluation of the visual parameters in a series of patients bilaterally
      implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with cataracts

        Exclusion Criteria:

          -  Pre-existing conditions that could skew the results or are contraindications for the
             ReSTOR intraocular lens;

          -  <1 diopter astigmatism by keratometry readings.
Armodafinil for Patients Starting Hepatitis C Virus Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Armodafinil; Sugar Pill
Intervention description: 50mg - 250mg pills, taken each morning, for 14 weeks; Inactive pill, matched to look like active medication
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HCV+; HCV treatment; Fatigue; patients starting alpha interferon/ribavirin treatment

Summary:

      Fatigue is one of the most common side effects of the treatment of hepatitis C infection with
      pegylated interferon and ribavirin, and is a major cause of treatment discontinuation.
      Armodafinil is an FDA approved stimulant medication for the treatment of narcolepsy and
      shift-work sleep disorder. This is a randomized placebo controlled study to determine whether
      patients assigned to armodafinil have fewer missed doses, dose reductions or treatment
      discontinuation due to side effects in the first 12 weeks of treatment for hepatitis C
      infection than do placebo patients. Placebo patients are offered 14 weeks of open label
      armodafinil after Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV+ patients medically cleared for IFN/RBV treatment -HIV+ or HIV-

          -  Speaks English

          -  Able and willing to give informed consent

          -  Fecund women: use barrier method of contraception

        Exclusion Criteria:

          -  Untreated and uncontrolled hypertension

          -  Left ventricular hypertrophy

          -  Currently taking stimulant medication

          -  Uncontrolled mental health problems including: MDD, suicidal or homicidal ideation,
             bipolar disorder, or schizophrenia
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Intervention: PNEUMOVAX™ 23
Intervention description: PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 70 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if revaccination with pneumococcal vaccine
      (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese
      adults. The primary hypothesis being tested is that the geometric mean concentration of
      antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after
      revaccination will be superior to that before revaccination in Japanese adults who received a
      primary vaccination at least 5 years before revaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese participant

          -  Good health or any underlying chronic illness is documented to be in stable condition

          -  Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5
             years before enrollment in the study

          -  Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination Exclusion
             Criteria:

          -  Known allergy or sensitivity to any of the components of the study vaccine

          -  History of pneumococcal conjugate vaccination

          -  Known or suspected immune dysfunction, immunosuppression, or autoimmune disease.
             Participants with a history of cancer who are not actively treated and not
             immunosuppressed will be eligible

          -  Functional or anatomic asplenia

          -  Received immunoglobulin within 6 months before study vaccine or is planned during the
             study

          -  Received any investigational drugs or vaccines within 2 months before study
             vaccination

          -  History of pneumococcal disease (positive culture from blood or other normally sterile
             site)

          -  Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular
             injection

          -  History of convulsion

          -  Previously diagnosed with immunodeficiency or has a close relative with congenital
             immune deficiency

          -  Participating in any other clinical trial
Modafinil for Treatment of Fatigue in ALS Patients
Condition: Fatigue
MeSH terms: Fatigue
Intervention: Modafinil; Placebo
Intervention description: Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.; Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Fatigue; low energy; ALS; treatment

Summary:

      The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating
      fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic
      lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of ALS

          -  Ages 18-80

          -  Clinically significant fatigue (4.5+ on Fatigue Severity Scale with duration 3+ months
             plus impairment in 1+ categories of role function)

          -  Speaks English

          -  Able and willing to give informed consent

          -  Can communicate verbally or with assistive device

          -  Can swallow capsules

          -  Forced vital capacity 50+%

        Exclusion Criteria:

          -  Untreated hypothyroidism (TSH > 4.25 UIU/ML)

          -  Untreated and uncontrolled hypertension

          -  Clinically significant anemia (HCT < 33%)

          -  Untreated or under-treated major depressive disorder

          -  Current clinically significant suicidal ideation

          -  Started antidepressant medication for treatment of depression during past 6 weeks

          -  Currently taking psychostimulant medication

          -  History or current psychosis or bipolar disorder

          -  Fecund women not currently using barrier methods of contraception