bioihbjkbjnl/mcl2 huggingface dataset:
Phase IIIB Subcutaneous Missed Dose Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Placebo
Intervention description: Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term); Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis (RA)

Summary:

      The purpose of the study is to determine whether subcutaneous abatacept administered to
      patients with rheumatoid arthritis is associated with increased immunogenicity or increased
      safety events upon withdrawal and reintroduction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Rheumatoid Arthritis

          -  Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1

          -  On background methotrexate at least 3 months (≥10mg weekly)

          -  Must be able to self injection or allow a care giver to do it for them

          -  Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except
             for methotrexate

        Exclusion Criteria:

          -  Participants who had prior exposure to abatacept or CTLA-4 Ig

          -  Received treatment with rituximab.

          -  Participants who have received treatment with leflunomide within 1 year of screening

          -  Participants who have received treatment with immunoadsorption columns (such as
             Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other
             calcineurin inhibitors, or D-Penicillamine.
A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab [Avastin]; capecitabine [Xeloda]
Intervention description: 15 mg/kg iv on day 1 of each 3 week cycle (maintenance phase); 1000 mg/m2 po bid on days 1-14 of each 3 week cycle (maintenance phase)
Intervention MeSH terms: Bevacizumab; Capecitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 287.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda
      (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer
      who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients
      will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each
      cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not
      progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of
      each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone.
      Study treatment will continue until disease progression, unacceptable toxicity, patient
      request for withdrawal or end of study, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  HER2-negative metastatic breast cancer

          -  candidates for taxane-based chemotherapy;

          -  ECOG performance status of 0 or 1.

        Exclusion Criteria:

          -  previous chemotherapy for metastatic breast cancer;

          -  prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;

          -  prior radiotherapy for treatment of metastatic disease;

          -  chronic daily treatment with aspirin (325 mg/day) or clopidogrel(>75mg/day).
Periodontal Infection and Endothelial Dysfunction
Condition: Periodontitis
MeSH terms: Periodontitis
Intervention: One-Stage Full-Mouth Disinfection; Periodontal care
Intervention description: Scaling and root planing, four quadrants in one session
Tongue brushing with a 1% chlorhexidine gel (1 minute)
Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
Subgingival chlorhexidine (1%) irrigation in all pockets
Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
Basic oral hygiene instructions
Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved); Basic oral hygiene instructions
Supragingival plaque removal
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Periodontitis; Oral health; Cardiovascular disease

Summary:

      The purpose of this study is to determine the effect of periodontal therapy on endothelial
      function and other biomarkers of cardiovascular disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be 25 years of age or older

          -  Three or more periodontal pockets with a probing depth (PD) > 5mm

          -  Have at least 20 natural teeth

          -  Provide informed consent and willingness to cooperate with the study protocol

        Exclusion Criteria:

          -  History of antibiotic use in the previous three months

          -  Pregnant or lactating females

          -  Treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular
             drugs

          -  Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure,
             tuberculosis, and autoimmune diseases

          -  Previous history of cardiovascular disease: Acute myocardial infarct, stable angina,
             unstable angina, heart failure, atrial fibrillation, atrioventricular block,
             peripheral vascular disease, cerebrovascular accident

          -  Patients who received periodontal treatment within the last 3 months

          -  Patients who require antibiotic prophylaxis before examination or treatment

          -  Patients with mental retardation and dementia
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and
      the need of a booster dose
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Written informed consent obtained prior to study entry

          -  Subjects correctly included in and having completed study IC51-304 according to the
             protocol.

        Exclusion Criteria:

          -  Use of any other investigational or non-registered drug or vaccine in addition to the
             study vaccine during the study period

          -  Immunodeficiency including post-organ-transplantation or immunosuppressive therapy

          -  Pregnancy, lactation or unreliable contraception in female subjects
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine
Intervention description: Vortioxetine tablets
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1075.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No
Keywords: Depression; Melancholia; Paraphrenia; Drug Therapy

Summary:

      The purpose of this study is to determine the long-term safety and tolerability of
      vortioxetine, once daily (QD), in participants with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed either study LuAA21004_315 ( NCT01153009), LuAA21004_316 (NCT01163266),
             or LuAA21004_317 (NCT01179516) immediately prior to enrollment in the extension study
             (ie, the baseline visit is the same visit as the Week 8 [Lu AA21004_317] or Week 10
             [Lu AA21004_315 or Lu AA21004_316] assessment of the preceding protocol).

          -  Suffers from a recurrent major depressive episode) as the primary diagnosis according
             to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
             Revision (DSM-IV-TR) criteria (classification code 296.3x) at entry into the prior
             study.

          -  Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of
             this participant according to the opinion of the investigator.

          -  Females of childbearing potential who are sexually active with a nonsterilized male
             partner agree to routinely use adequate contraception throughout the duration of the
             study.

        Exclusion Criteria:

          -  Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar
             disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the
             prior study.

          -  In the investigator's clinical judgment, has a significant risk of suicide and/or a
             score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression
             Rating Scale (MADRS).

          -  In the opinion of the investigator, is unlikely to comply with the clinical study
             protocol or is unsuitable for any reason.

          -  Has a clinically significant moderate or severe ongoing adverse event related to study
             medication from the prior study.

          -  Has used/uses disallowed concomitant medication.
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Tofacitinib 5 mg BID; Tofacitinib 10 mg BID; Adalimumab; Placebo; Placebo
Intervention description: Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months; Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months; Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months; Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months; Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months
Intervention MeSH terms: Adalimumab; Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 422.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriatic arthritis; radiographic changes; active comparator; tofacitinib

Summary:

      This is a 12-month study investigating the effectiveness and safety of tofactinib in treating
      the signs and symptoms of active psoriatic arthritis and improving physical function and
      preserving bone structure in patients with an inadequate response to a traditional,
      nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, aged >= 18 years at time of consent.

          -  Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months

          -  Meet the Classification Criteria of PsA (CASPAR) at time of screening

          -  Must not have been adequately treated with a a traditional non-biologic disease
             modifying anti-rheumatic drug (DMARD).

          -  Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and
             required

          -  Must not have taken a biologic Tumour Necrosis Factor Inhibitor

          -  Must have 3 or more swollen joints AND 3 or more tender joints

          -  Must have active psoriasis skin lesions

        Exclusion Criteria:

          -  Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the
             exception of nail psoriasis which is allowed

          -  Pregnant or breast feeding, females of child-bearing potential not using highly
             effective contraception

          -  New York Heart Association Class III and IV congestive heart failure

          -  History of hypersensitivity or infusion reaction to biologic agents

          -  Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: Metformin 500 mg bid; Metformin 1000 mg bid; Empagliflozin low dose qd; Empagliflozin high dose qd; Empagliflozin low dose bid; Metformin 500 mg bid; Empagliflozin high dose bid; Empagliflozin low dose bid; Metformin 1000 mg bid; Metformin 500 mg bid; Metformin 1000 mg bid; Empagliflozin high dose bid; Metformin 1000 mg bid; Empagliflozin high dose bid
Intervention description: Metformin 500 mg twice daily; Metformin 1000 mg twice daily; Empagliflozin low dose once daily; Empagliflozin high dose once daily; Empagliflozin low dose split twice daily; Metformin 500 mg twice daily; Empagliflozin high dose split twice daily; Empagliflozin low dose split twice daily; Metformin 1000 mg twice daily; Metformin 500 mg twice daily; Metformin 1000 mg twice daily; Empagliflozin high dose split twice daily; Metformin 1000 mg twice daily; Empagliflozin high dose split twice daily
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy and safety of two doses (high and low) of
      empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in
      patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of
      empagliflozin + metformin versus each individual component after 24 weeks of treatment.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of type 2 diabetes mellitus prior to informed consent

          2. Male and female patients on diet and exercise regimen who are drug-naive, defined as
             absence of any oral antidiabetic therapy for 12 weeks prior to randomization

          3. HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)

          4. Body Mass Index (BMI) <= 45 kg/m2 at screening

        Exclusion criteria:

          1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an
             overnight fast during placebo run-in and confirmed by a second laboratory measurement
             (not on the same day)

          2. Any antidiabetic drug within 12 weeks prior to randomization

          3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60
             ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period

          4. Contraindications to metformin according to the local label
A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
Condition: Postoperative Dental Pain
MeSH terms: Toothache
Intervention: Comparator: etoricoxib; Comparator: ibuprofen; Comparator: acetaminophen + codeine; Comparator: placebo
Intervention description: etoricoxib 90 mg; 120 mg (once daily) over three days.; ibuprofen 2400 mg (600 mg Q6h) over three Days; acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days; matching placebo over three Days
Intervention MeSH terms: Acetaminophen; Ibuprofen; Etoricoxib; Codeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 588.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative Dental Pain

Summary:

      The purpose of this study is to compare the pain relieving effect of different doses of
      MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental
      pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and
      patient evaluation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be scheduled to have 2 or more third molars removed, at least 1 of which
             is partially embedded in bone and is impacted in the lower jaw

          -  Patients must be experiencing moderate to severe pain following the dental procedure

        Exclusion Criteria:

          -  Previous molar extraction within the past 45 days

          -  Personal or family history of an inherited bleeding disorder

          -  Uncontrolled high blood pressure
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
Condition: Acquired Bleeding Disorder; Trauma
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
Intervention: eptacog alfa (activated); placebo
Intervention description: Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection.
Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours.; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 554.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The purpose of the trial is to evaluate that activated
      recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely
      injured trauma patients by assessing mortality and morbidity.

      Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso
             and/or proximal lower extremity) refractory to blood component therapy and surgical
             haemostatic procedures at the time of randomisation
Travoprost 3-Month Safety and Efficacy Study
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost ophthalmic solution, 0.003%; Travoprost ophthalmic solution, 0.004%
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1099.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-Angle Glaucoma; Ocular Hypertension

Summary:

      The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy
      of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or
      ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation
             or pigment dispersion) or ocular hypertension.

          -  Qualifying intraocular pressure at both eligibility visits.

          -  Understand and sign an informed consent form.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth
             control.

          -  Severe central visual field loss in either eye.

          -  Chronic, recurrent or severe inflammatory eye disease.

          -  Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to
             20/80 Snellen).

          -  Any abnormality preventing reliable applanation tonometry.

          -  Hypersensitivity to prostaglandin analogs or to any component of the study
             medications.

          -  Therapy with another investigational agent within 30 days prior to the Screening
             Visit.

          -  Other protocol-defined exclusion criteria may apply.