bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Herceptin
Intervention description: Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
Intervention MeSH terms: Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2577.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and
      tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in
      participants with early HER2-positive breast cancer following tumor excision. Participants
      will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an
      assisted administration using a conventional syringe and needle/vial formulation (Cohort A)
      or with assisted and self-administration using a single-use injection device (SID) in
      selected participants (Cohort B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed early invasive HER2-positive carcinoma of the breast with no
             evidence of residual, locally recurrent, or metastatic disease and defined as clinical
             Stage I to IIIC that is eligible for treatment with Herceptin

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%

        Exclusion Criteria:

          -  Previous neoadjuvant or adjuvant breast cancer treatment with an approved or
             investigational anti-HER2 agent

          -  History of other malignancy except for curatively treated carcinoma in situ of the
             cervix, basal cell carcinoma, or curatively treated malignancies (other than breast
             cancer) where the participant has been disease-free for at least 5 years

          -  Past history of ductal carcinoma in situ treated with any systemic therapy or with
             radiation therapy to the ipsilateral breast where invasive cancer subsequently
             developed

          -  Metastatic disease

          -  Inadequate bone marrow, hepatic, or renal function

          -  Serious cardiac or cardiovascular disease including uncontrolled hypertension or
             history of hypertensive crisis or hypertensive encephalopathy

          -  History of severe allergic or immunological reactions, such as difficult-to-control
             asthma

          -  Pregnant or lactating women
Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Tanezumab; Tanezumab; Tanezumab
Intervention description: Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections; Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections; Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
Intervention MeSH terms: Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases

Summary:

      An evaluation of the long term safety of tanezumab when administered by subcutaneous
      injection every 8 weeks for up to 64 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have participated in specific Phase 3 parent study

        Exclusion Criteria:

          -  Failed screening for parent study, pregnant women, lactating mothers
A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit/ Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: prolonged release (PR) OROS methylphenidate 54 mg; prolonged release (PR) OROS methylphenidate 72 mg; Placebo
Intervention description: 18+36mg once daily for 13 weeks; 2x36mg once daily for 13 weeks; 2xplacebo once daily for 13 weeks
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 279.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Adult; ADHD; Concerta

Summary:

      The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release
      (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with
      attention deficit/hyperactivity disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental
             Diseases, Fourth Edition (DSM-IV) and confirmed by the Conners' Adult ADHD Diagnostic
             Interview for DSM IV

          -  Described chronic course of ADHD symptomatology from childhood to adulthood, with some
             symptoms present before age 7 years and continue to meet DSM-IV criteria at the time
             of assessment

          -  CAARS score of at least or equal to 24 as determined by investigator at screening
             visit

          -  Patient agrees to take only the supplied study drug as treatment for ADHD during the
             study

          -  Patient agrees not to initiate a new behavioral modification program during the study
             or if currently using a behavioral modification program agrees not to change this
             program during the study.

        Exclusion Criteria:

          -  Known to be a non-responder to methylphenidate, or patient has a child known to be a
             non-responder to methylphenidate

          -  Has been treated with any methylphenidate-containing medication within 1 month of
             screening visit

          -  Participation in and premature withdrawal from 42603ATT3002, CR002479 or 42603ATT3004,
             CR011068 study

          -  Known allergy or hypersensitivity to methylphenidate, or components of PR OROS
             methylphenidate

          -  Any clinically unstable psychiatric condition including, but not limited to the
             following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder
             (OCD), anti-social personality disorder, borderline personality disorder.
Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
Condition: Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
MeSH terms: Influenza, Human; Tetanus; Epiglottitis; Meningitis
Intervention: Hib-CRM197; Hib-TT
Intervention description: No vaccine administered in V37_07E2 study; No vaccine administered in V37_07E2 study
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 426.0
Sex: All
Minimum age: 5 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Haemophilus influenzae type b; persistency; children; CRM197; anti-PRP antibody

Summary:

      Evaluate the persistency of immune response against Haemophilus influenzae type b by
      assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT
      booster vaccine approximately 4 years before.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children previously enrolled in V37_07E1 study and who received the appropriate
             vaccination.

          2. Children whose parent(s) or legal guardian(s) had given written consent after the
             nature of the study was explained according to local regulatory requirements.

        Exclusion Criteria:

          1. Any confirmed or suspected current immunosuppressive or immunodeficient condition
             since the end of V37_07E1 study, based on medical history and physical examination (no
             laboratory testing required).

          2. Treatment with corticosteroids or other immunosuppressive/immunostimulant drugs as
             defined below:

             i) chronic use of oral and parenteral immunosuppressants (>= 15 days of use) or other
             immune-modifying drugs within 60 days prior to the blood sampling (short term usage of
             topical, inhaled and/or intranasal corticosteroids were allowed) ii) receipt of
             immunostimulants within 60 days prior to Visit 1

          3. Administration of immunoglobulins and/or any blood products up to 3 months before
             enrollment.

          4. Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the blood sampling.

          5. Any condition, which, in the opinion of the investigator, might be a contraindication
             to the execution of the blood draw.
Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Vandetanib; Erlotinib
Intervention description: once daily oral tablet; oral dose
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1574.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non Small Cell Lung Cancer; NSCLC

Summary:

      To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung
      Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy,
      Erlotinib
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed locally advanced or metastatic NSCLC

          -  Failure of at least one but not more than two prior chemotherapy regimens

        Exclusion Criteria:

          -  Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent),
             sorafenib (Nexavar)

          -  Chemotherapy or other type of anti cancer therapy within 4 weeks of study start
Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Intervention: Triamcinolone; Bupivicaine alone
Intervention description: Injection of bupivacaine and triamcinolone; Injection of bupivacaine
Intervention MeSH terms: Triamcinolone; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of
      triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain.
      The treatment group will undergo EUS-CPB with bupivicaine plus triamcinolone ("therapeutic
      block"). There control group will undergo EUS-CPB with bupivicaine alone ("diagnostic
      block").
    

Eligibility criteria:

        Inclusion criteria include:

          -  Age >18 yrs

          -  Ability for informed consent

          -  Chronic pancreatic-type abdominal pain (type B) (11).

        Exclusion criteria include:

          -  Pregnancy

          -  Malignancy

          -  Recent acute pancreatitis (within 2 months)

          -  Elevated INR (>1.5) or low platelet count (<75 cells/mm3)

          -  Allergy to eggs or "caine" anesthetics or corticosteroids; AND

          -  Becks depression score>20.
An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
Condition: Pain
MeSH terms: Chronic Pain
Intervention: Tramadol Hydrochloride Plus Acetaminophen (Open-Label); Tramadol Hydrochloride Plus Acetaminophen (Double-Blind); Placebo (Double-Blind)
Intervention description: Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets).; Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks.; Matching placebo will be given up to 4 weeks.
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 321.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Chronic pain; Acetoaminophen; Tramadol; Osteoarthritis of the knee; Low back pain

Summary:

      The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride
      plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis
      (a progressive and degenerative joint disease, in which the joints become painful and stiff)
      of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which
      cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with sustention of chronic pain associated with OA or LBP for at least 3
             months

          -  Participants whose pain cannot be controlled sufficiently with at least 14-day
             continuous treatment with identical oral NSAIDs at a usual maximum dose during 3
             months prior to this study

          -  Outpatients

          -  Ambulatory participants without need for any supportive device or assistance during
             daily life

        Exclusion Criteria:

          -  Participants with conditions for which opioids are contraindicated

          -  Participants with conditions for which acetaminophen is contraindicated

          -  Participants with history of convulsion or the possibility of convulsive seizure

          -  Participants with concurrent, previous, or possible alcohol dependence, drug
             dependence, or narcotic addiction

          -  Pregnant participants or those who may be pregnant, lactating mothers, and
             participants who wish pregnancy during the study period
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Filgotinib; Placebo to match filgotinib; csDMARDs
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effects of filgotinib versus placebo
      for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the
      percentage of participants achieving an American College of Rheumatology 20% improvement
      response (ACR20) at Week 12.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League
             Against Rheumatism [EULAR] criteria for RA), and are ACR functional class I-III.

          -  Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints [SJC66]) and ≥6
             tender joints (from a tender joint count based on 68 joints [TJC68]) at screening and
             Day 1

          -  Ongoing treatment with a stable prescription of 1 or 2 csDMARDs

          -  Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for
             the treatment of RA to which they have had an inadequate response or intolerance

        Key Exclusion Criteria:

          -  Previous treatment with any janus kinase (JAK) inhibitor

        NOTE: Other protocol Inclusion/ Exclusion criteria may apply.
Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia
Condition: Hypertension,; Hyperlipidemia
MeSH terms: Hypertension; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Valsartan 160mg; Rosuvastatin 20mg; Valsartan 160mg placebo; Rosuvastatin 20mg placebo
Intervention MeSH terms: Valsartan; Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 168.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the efficacy and safety of the coadministration of valsartan
      (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered
      alone in patients with hypertension and hyperlipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient aged 20-80 years who has hypertension and hyperlipidemia

          2. Patient who has a Hypertension

          3. Patient who has a Hyperlipidemia according to NCEP-ATP III guideline(2004)

          4. Patient who signed the Informed Consent Form after receiving an explanation on the
             purpose, methods, and effect of the study

        Exclusion Criteria:

          1. If blood pressure and fasting serum lipid level measured at screening and Visit 2 (0
             week) satisfy the following criteria 1) sitSBP≥180mmHg or sitDBP≥110mmHg (For high
             risk group, sitSBP≥ 160mmHg or sitDBP ≥100mmHg ) 2) LDL-C>250mg/dL , or TG≥ 400mg/dL

          2. If sitSBP difference between the right and left arms >20mmHg or sitDBP difference
             between the right and left arms > 10mmHg at screening

          3. When blood pressure is repeatedly measured from the selected arm at screening, if
             sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg

          4. Patient with orthostatic hypotension accompanying symptoms at screening (decrease in
             sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Lanreotide Autogel®; Lanreotide Acetate
Intervention description: Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate).; Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection (provided as a sterile injectable lyophilisate of lanreotide acetate).
Intervention MeSH terms: Lanreotide; Somatostatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg
      with lanreotide 40mg PR in subjects with active acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has active acromegaly defined as elevated GH and IGF-1 levels (measured at a
             central laboratory) as outlined below:

               -  A serum level for IGF-1 ≥1.3 x upper limit of normal range (ULN) during the
                  screening period (applicable to both treatment naïve subjects and subjects who
                  have stopped treatment and undergone a washout period prior to Visit 1(Week -4).

               -  Subjects must have mean serum GH concentration ≥2.5 μg/L in a GH cycle (5 samples
                  taken at 0, 30, 60, 90 and 120 minutes) during the screening period.

          -  The subject has undergone surgical removal of an adenoma for acromegaly at least 3
             months prior to Screening, or is likely to require pituitary surgery in the future but
             not before completing at least 32 weeks of study treatment plus an additional follow
             up of 8 weeks for subjects taking part in the pharmacokinetics (PK) extension, or for
             whom pituitary surgery is not an option (due to contraindications, refusal etc.) and
             is therefore never likely to undergo pituitary surgery.

        Exclusion Criteria:

          -  The subject has been treated with radiotherapy within 10 years prior to Screening.

          -  The subject has been treated with lanreotide Autogel, lanreotide PR, pegvisomant,
             cabergoline or octreotide LAR within 3 months of Screening or octreotide immediate
             release (IR) or bromocriptin within 2 weeks of Screening.

          -  The subject has a history of or currently presents with clinically significant
             ventricular or atrial dysrhythmias ≥Grade 2, using the National Cancer Institute
             Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.

          -  The subject has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) >8.5%).