bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin; Teneligliptin + Sulfonylurea
Intervention description: Teneligliptin for 52 weeks; Teneligliptin for 52 weeks in combination with sulfonylurea
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: DPP-IV inhibitor

Summary:

      The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as
      monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type
      2 Diabetes for 52 weeks administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In case of combination therapy with Sulfonylurea, patients who has been receiving a
             stable dose and regimen of sulfonylurea for diabetes over 12 weeks before
             administration of investigational drug

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 12 weeks before administration of investigational drug

          -  HbA1c criteria:

               -  monotherapy: 6.9% - 10.5%

               -  combination therapy with Sulfonylurea: 7.4 - 10.5%

          -  Patients who were not administered diabetes therapeutic drugs prohibited for
             concomitant use within 12 weeks before administration of investigational drug.

        Exclusion Criteria:

          -  Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or
             secondary diabetes (Cushing disease, acromegaly, etc)

          -  Patients who are accepting treatments of arrhythmias

          -  Patients with serious diabetic complications

          -  Patients who are the excessive alcohol addicts

          -  Patients with severe hepatic disorder or severe renal disorder

          -  Patients who are pregnant, lactating, and probably pregnant patients, and patients who
             can not agree to contraception
A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
Condition: Type 2 Diabetes Mellitus, Non Insulin Dependent; Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin; Comparator: glimepiride; open-label metformin
Intervention description: Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks; glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.; open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1035.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Non Insulin Dependent

Summary:

      A study to see if better control of type 2 diabetes can occur in patients taking a stable
      dose of metformin when they are also provided either sitagliptin or glimepiride. This study
      will also see if this treatment is safe and tolerable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Diagnosed with type 2 diabetes

          -  On a stable dose of metformin of at least 1500 mg per day

        Exclusion Criteria:

          -  History of type 1 diabetes

          -  Pregnant

          -  HIV positive

          -  On a weight loss program or medication

          -  Has a history of blood disorder, certain cancers, heart, liver or kidney disease
Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Levomilnacipran ER; Placebo
Intervention description: Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks; Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks; Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 568.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression; Major Depressive Disorder

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-75 years old

          -  Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

          -  The patient's current depressive episode must be at least 6 weeks in duration

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control.

          -  Patients who are considered a suicide risk

          -  Patients with a history of meeting DSM-IV-TR criteria for

          -  a. any manic or hypomanic episode

          -  b. schizophrenia or any other psychotic disorder

          -  c. obsessive-compulsive disorder.
A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)
Condition: Plaque Type Psorisis
MeSH terms: Psoriasis
Intervention: Secukinumab
Intervention description: Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Arms represent stratification of Cw6 positive and Cw6 negative patients
Masking: None (Open Label)
Enrollment: 434.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the differences in the efficacy and safety of secukinumab between
      Cw6-negative and Cw6-positive patients with moderate to severe plaque-type psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must have been able to understand and communicate with the investigator and to
             comply with the requirements of the study and must have given a written, signed and
             dated informed consent before any study related activity was performed.

          2. Men or women at least 18 years of age at time of screening.

          3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months
             (including concomitant psoriatic arthritis as per the Classification Criteria for
             Psoriatic Arthritis criteria [CASPAR]).

          4. Moderate to severe psoriasis as defined at enrollment by:

               -  PASI score ≥ 10 or

               -  PASI score > 5 but < 10 and DLQI ≥10

          5. Patients that are candidates for systemic therapy, whether treatment naïve or after
             failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA)
             or to an anti-TNFα (or is intolerant and/or has a contraindication to these).

        Exclusion criteria

          1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
             guttate psoriasis).

          2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.

          3. Anti-TNFα therapy within timelines depending on drug half-life.

          4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17
             or the IL-17 receptor.

          5. Previous exposure to ustekinumab or any other biologic drug for the treatment of
             psoriasis that was not anti-TNFα therapy.

          6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during
             screening.

          7. Ongoing use of corticosteroid topical treatments or UV therapy.
A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain
Condition: Pain; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Tramadol Hydrochloride; Acetaminophen; Placebo; Tramadol plus Acetaminophen
Intervention description: Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).; Acetaminophen two oral capsules will be administered once as 650 mg.; Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.; Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively.
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 328.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Pain; Tooth extraction; Oral surgery; Postoperative pain; JNS013; Tramadol hydrochloride; Acetaminophen

Summary:

      The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral
      dose administration in participants with pain after tooth-extraction of mandibular impacted
      wisdom tooth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants planned to receive a tooth extraction of one mandibular impacted wisdom
             tooth

          -  Participants who require bone removal and separation of the crown at tooth extraction

          -  Participants whose intensity of pain associated with tooth extraction within 2 hours
             after tooth extraction is greater than or equal to 50.0 millimeter on the visual
             analog scale (VAS)

          -  Participants who did not undergo general anesthesia or sedation at tooth extraction

          -  Participants without an abnormality (including laboratory test values) corresponding
             to Grade 3 in the "Criteria for severity classification of adverse drug reactions"
             during the pretreatment observation period

        Exclusion Criteria:

          -  Participants with conditions for which tramadol is contraindicated

          -  Participants with conditions for which acetaminophen is contraindicated

          -  Participants with history of convulsions or the possibility of convulsive seizures

          -  Pregnant participants or those who may be pregnant, lactating mothers, and those who
             wish pregnancy during the study period

          -  Participants with concurrent, previous, or possible alcohol dependence, drug
             dependence or narcotic addiction
Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)
Condition: Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
MeSH terms: Schizophrenia; Schizophrenia, Paranoid; Schizophrenia, Disorganized
Intervention: asenapine
Intervention description: asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate whether asenapine, which is approved by the United States
      Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is
      generally safe and well tolerated in adolescents with schizophrenia. This is an extension of
      base study P05896 (NCT01190254), which means participants must have completed participation
      in the 8-week base study in order to qualify for this extension study P05897. Participants in
      this extension study will receive open-label asenapine for 26 weeks. Throughout the study,
      observations will be made on each participant at various times to assess the long-term
      safety, tolerability and efficacy of the study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Each participant must be between 12 and 17 years of age at the time of entry on this
             study, however, participants in the 8-week base study (P05896 [NCT01190254]) who reach
             18 years of age while on P05896 may be enrolled in this extension study provided all
             other inclusion/exclusion criteria are met.

          -  Must have completed the 8-week efficacy and safety trial (P05896 [NCT01190254]) and,
             according to the investigator's judgment, would benefit from long-term treatment.

          -  Must have demonstrated an acceptable degree of compliance with trial medication,
             visits, and other requirements in the 8-week trial (P05896 [NCT01190254]), in the
             opinion of the investigator.

        Exclusion Criteria:

          -  A female participant must not be pregnant and must not have the intention to become
             pregnant during the trial.

          -  A participant must not be at imminent risk of self-harm or harm to others.

          -  A participant must not currently be under involuntary inpatient commitment.
Mobile - Bearing Knee Study
Condition: Inflammatory Tissue Disorder; Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis; Secondary Arthritis
MeSH terms: Arthritis; Necrosis
Intervention: Encore Mobile-Bearing Knee
Intervention description: Used for primary total knee replacement
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 419.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skeletal maturity

          -  Less than 70 on preoperative Knee Society Score (Rating Score)

          -  Sufficient bone stock, as judged by radiographs, to support primary knee implant

          -  Patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis,
             secondary arthritis, or avascular necrosis of the femoral condyles

          -  Patient is not pregnant

          -  Primary total knee replacement

          -  Sufficient collateral ligaments to support device, as judged by physician during
             stability testing (varus/valgus and flexion/extension)

          -  Varus deformity <45 or valgus deformity <45 or fixed flexion deformity <90

          -  Patient is likely to be available for evaluation for the duration of the study

          -  Able and willing to sign the informed consent and follow study procedures

        Exclusion Criteria:

          -  Skeletal immaturity

          -  Greater than or equal to 70 on preoperative Knee Society Score (Rating Scale)

          -  Previous knee surgery that has adversely affected bone stock or prior total knee
             replacement

          -  Post patellectomy

          -  Patient is pregnant

          -  Insufficient collateral ligaments, as judged by the physician

          -  Neurological conditions that might hinder patient's ability to follow study procedures
             (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple
             Sclerosis, previous stroke which affects lower extremity).

          -  Varus deformity >45 or valgus deformity >45 or fixed flexion deformity >90.

          -  Mental conditions that may interfere with ability to give an informed consent or
             willingness to fulfill the study requirements (i.e., severe mental retardation such
             that the patient cannot understand the informed consent process, global dementia,
             prior strokes that interfere the with patient's cognitive abilities, senile dementia,
             and Alzheimer's Disease).

          -  Prisoners

          -  Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle
             deficiencies, refusal to modify postoperative physical activities, skeletal
             immaturity).
Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: linagliptin; placebo
Intervention description: patients receive linagliptin 5 mg tablets once daily; patients receive placebo matching linagliptin 5 mg once daily
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 241.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and tolerability of
      linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to
      stable treatment in elderly patients with T2DM with insufficient glycaemic control
    

Eligibility criteria:

        Inclusion criteria:

          1. Type 2 diabetes mellitus

          2. HbA1c >= 7.0%

          3. Age >= 70 years

          4. Signed and dated written informed consent

        Exclusion criteria:

          1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent

          2. Impaired hepatic function

          3. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or
             pre-mixed insulins

          4. Treatment with anti-obesity drugs
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
Condition: Bacterial Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Ceftaroline fosamil for Injection; Ceftriaxone; Placebo
Intervention description: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days; 1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days; Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind
Intervention MeSH terms: Ceftriaxone; Ceftaroline fosamil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 622.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ceftaroline; Community-acquired pneumonia; CAP; Streptococcus pneumoniae; Haemophilus influenzae; Mycoplasma pneumoniae; Chlamydophila spp; Legionella ssp; multi-drug resistant Streptococcus pneumoniae (MDRSP); antimicrobial resistance; pneumococci; beta-lactam; ceftaroline fosamil; ceftriaxone; antibiotic

Summary:

      The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective
      in the treatment of community-acquired pneumonia in adults.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with community-acquired pneumonia requiring:

          -  initial hospitalization or treatment in an emergency room or urgent care setting

          -  infection requiring initial treatment with IV antimicrobial

        Exclusion Criteria:

          -  Community-acquired pneumonia suitable for outpatient therapy with an oral
             antimicrobial agent

          -  Respiratory tract infections not due to community-acquired bacterial pathogens

          -  Infections resistant to ceftriaxone

          -  Any condition requiring concomitant systemic corticosteroids

          -  History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Intervention: nonacog beta pegol
Intervention description: The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Minimum age: 13 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

      The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog
      beta pegol) during surgical procedures in patients with haemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with haemophilia B with a FIX activity below or equal to 2%

          -  Male patients with moderately severe or severe congenital haemophilia B with a FIX
             activity below or equal to 2% according to medical records

          -  History of at least 150 exposure days to other FIX products

          -  Scheduled major surgery

        Exclusion Criteria:

          -  Known history of FIX (coagulation factor nine) inhibitors based on existing medical
             records, laboratory report reviews and patient and LAR (legal acceptable
             representative) interviews

          -  Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units
             (central laboratory)

          -  Previous arterial thrombotic events (e.g. myocardial infarction and intracranial
             thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by
             available medical records)

          -  ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at
             screening (central laboratory)

          -  Immune modulating or chemotherapeutic medication