bioihbjkbjnl/mcl2 huggingface dataset:
Cancer Venous Thromboembolism (VTE)
Condition: Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Cancer
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Edoxaban; Dalteparin; Low molecular weight heparin
Intervention description: After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.; Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.; Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.
Intervention MeSH terms: Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1046.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Active Cancer with Metastasis

Summary:

      The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short
      course of LMWH) compared with dalteparin for the prevention of the combined outcome of
      recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with
      cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will
      be compared with dalteparin for superiority.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects with age ≥ 18 years or the otherwise legal lower age according
             to the country of residence;

          -  Confirmed acute lower extremity proximal DVT or PE for which long term treatment with
             low molecular weight heparin (LMWH) is indicated;

          -  Cancer, other than basal-cell or squamous-cell carcinoma of the skin;

          -  Able to provide written informed consent.

        Exclusion Criteria:

          -  Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
             current (index) episode of DVT and/or PE;

          -  Treatment with therapeutic doses of an anticoagulant other than that used for
             pretreatment of the current (index) VTE episode prior to randomization;

          -  Active bleeding or high risk for bleeding contraindicating treatment with LMWH or
             edoxaban;

          -  Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or
             edoxaban;
A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: MK-0518; Comparator: efavirenz; Comparator: Truvada; Comparator: Placebo to MK-0518; Comparator: Placebo to efavirenz
Intervention description: 400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks; 600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks; One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir); Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks; Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks
Intervention MeSH terms: Tenofovir; Emtricitabine; Efavirenz; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 566.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in
      combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected
      patients not previously treated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a male or female at least 18 years of age

          -  Participant is HIV positive

          -  Participant is naïve to antiretroviral therapy (ART) and has not received any ART

        Exclusion Criteria:

          -  Participant has received approved or experimental antiretroviral agents in the past

          -  Participant has been treated for a viral infection other than HIV such as hepatitis B
             virus infection with an agent that is active against HIV including but not limited to
             adefovir or lamivudine (= 7 days total)

          -  Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz

          -  Participant has used another experimental HIV-integrase inhibitor

          -  Participant has a current (active) diagnosis of acute hepatitis due to any cause

          -  Participants with chronic hepatitis including chronic hepatitis B and/or C may enter
             the study as long as they have stable liver function tests
Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers
Condition: Healthy
Intervention: NPC-01
Intervention description: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norinyl; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: NPC-01; Pharmacokinetics; Healthy female volunteer; Norethisterone; Ethinyl Estradiol

Summary:

      The purpose of this study is to assess the pharmacokinetic profiles of norethisterone and
      ethinyl estradiol after single oral administration of NPC-01 in healthy female volunteers.

      Pharmacokinetics of norethisterone and ethinyl estradiol will be evaluated on the basis of
      AUC, Cmax, tmax, t1/2, MRT, kel and AUC∞.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female aged between 20 to 35 years

          -  BMI:18.0-26.0

        Exclusion Criteria:

          -  Females who are pregnant

          -  Drug use affecting sex hormone secretion
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: rLP2086 vaccine; control
Intervention description: 120 mcg, 3 doses, at month 0, 2, and 6.; HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5715.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: phase 3 safety study; 5700 healthy subjects; 3 vaccine doses at month 0; 2; and 6; control HAV/saline/HAV

Summary:

      A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to
      receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will
      receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

      All subjects will be followed for 6 months after the last vaccination to assess safety and
      tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects aged 10 to 25 years.

        Exclusion Criteria:

          -  Previous vaccination with Hepatitis A virus vaccine

          -  Previous vaccination with investigational meningococcal B vaccine

          -  History of culture-proven N. meningitidis serogroup B disease

          -  Any neuroinflammatory or autoimmune condition

          -  Any immune defect that would prevent an effective response to the study vaccine
Pediatric Tonsillectomy Pain Reduction Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: lidocaine (1%) + bupivacaine (0.5%); Normal saline; Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
Intervention description: Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
B - lidocaine (1%) + bupivacaine (0.5%); Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
A - normal saline; Submucosal injection of 1.5 mL into each tonsillar fossa prior to performing tonsillectomy.
C - lidocaine (1%) + bupivacaine (0.5%) + clonidine (25mcg)
Intervention MeSH terms: Lidocaine; Clonidine; 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: 120.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tonsillectomy; Postoperative Pain; Clonidine; Anesthetics, Local

Summary:

      Tonsillectomy is associated with a significant decrease quality of life in children secondary
      to pain, which is worsened with swallowing. The objective of the current study is to conduct
      a prospective, double-blind, placebo-controlled, randomized clinical trial using a
      pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in
      reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline
      injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) +
      clonidine (25 µg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3 - 17 years old

          -  BMI < 35

          -  Negative pregnancy test in female patients age 10 and older

          -  Diagnosed with adenotonsillar hypertrophy, recurrent adenotonsillitis or upper airway
             obstruction and will be undergoing tonsillectomy alone or adenotonsillectomy

        Exclusion Criteria:

          -  Diagnosis of obstructive sleep apnea

          -  Patient with peritonsillar abscess

          -  Allergy to study medication

          -  Any major systemic illness, genetic disorder or diagnosed syndrome

          -  Bleeding disorder
A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Interleukin 28B testing
Intervention description: Blood sampling for IL28B genotyping
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with
      HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the
      predecessor ML18253 study. The study consists of a single visit where eligible patients will
      undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Chronic hepatitis B

          -  Previous participation in study ML18253

          -  Administration of at least one dose of the study drug during ML18253 study

        Exclusion Criteria:

          -  Patients not satisfying the above inclusion criteria will not be enrolled in the study
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: montelukast sodium; Comparator: Placebo
Intervention description: one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years; one placebo chewable tablet daily at bed time for 2 weeks
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 413.0
Sex: All
Minimum age: 2 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of montelukast compared to placebo in children during the
      spring allergic rhinitis season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of allergic rhinitis symptoms which flare up during the study
             season

          -  Patient is a non-smoker

          -  Patient is in otherwise good health

          -  Patient is able to chew a tablet

        Exclusion Criteria:

          -  Patient is hospitalized

          -  Patient is pregnant or nursing mother, or <8 weeks post partum

          -  Patient and/or parent intend to move or vacation away from home during the trial

          -  Patient has had a major surgical procedure within 4 weeks of the prestudy visit

          -  Patient has been treated in an emergency room or hospitalized for asthma within 3
             months prior to study

          -  Patient has an upper respiratory, eye, or sinus infection, or a history of any of
             these within 3 weeks prior to study

          -  Patient has a recent history of a psychiatric disorder or attention deficit
             hyperactivity disorder
A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Condition: Breast Cancer; Neoplasm Metastasis
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Intervention: Standard supportive care (packed RBC transfusion); epoetin alfa + packed RBC transfusion
Intervention description: Per doctor prescription; 40,000 IU SC once a week.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2098.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: anemia; metastatic breast cancer; Hemoglobin; progression-free survival (PFS); erythropoiesis-stimulating agents (ESA)

Summary:

      The purpose of this study is to assess the impact on tumor progression as evaluated by
      progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared
      with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating
      anemia according to label guidance in patients with metastatic breast cancer receiving
      standard chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed (e.g., slide of tissue) breast cancer

          -  HER2/NEU positive or negative

          -  Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic
             (M1) lesion prior to starting the current chemotherapy

          -  Received 1st and 2nd line chemotherapy

          -  Hemoglobin (Hb) <= 11g/dL at the time of randomization

          -  planned to receive at least 2 more cycles of chemotherapy

          -  Life expectancy > 6 months

          -  Eastern Cooperative Oncology Group score 0 or 1

          -  At least 18 years old using effective birth control or surgically sterile or
             postmenopausal for 1 year

        Exclusion Criteria:

          -  Active second cancer

          -  no recent history of clinically relevant thrombovascular event

          -  Current treatment with anticoagulants

          -  Brain metastasis or CNS involvement

          -  Anemia secondary to another cause

          -  Recent (within prior 1 months) use of an ESA

          -  Patient pregnant or breast feeding

          -  Progressive disease during adjuvant/neoadjuvant chemotherapy

          -  Rapidly progressive or life-threatening metastatic disease

          -  Concomitant endocrine therapy

          -  Patient in whom the only site of metastasis was local and was successfully treated
             surgically.
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Condition: Cataract Extraction
MeSH terms: Cataract
Intervention: ketorolac eye drops
Intervention description: 1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day
Placebo
Intervention MeSH terms: Ketorolac; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the
      treatment of inflammation and pain associated with cataract surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing cataract surgery

        Exclusion Criteria:

          -  Uncontrolled ocular disease in cataract surgery eye
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide
Intervention description: 50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 322.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial-onset Seizures; Lacosamide; Monotherapy; Vimpat

Summary:

      This open-label extension trial will assess the long-term use of Lacosamide monotherapy and
      safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset
      seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has
             taken at least 1 dose of SP902 Maintenance Phase trial medication) and either
             completed SP902 or met an exit criterion in SP902; subject is allowed up to 2
             concomitant Antiepileptic Drugs (AEDs)

        Exclusion Criteria:

          -  Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial,
             or is experiencing an ongoing Serious Adverse Event (SAE)
Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: BI 695502; Avastin
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to evaluate the safety and tolerability of BI 695502 in
      combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy
      (when applicable). As well as to evaluate the following efficacy parameters: Progression-free
      survival (PFS), objective response rate (proportion of patients with complete response [CR]
      plus partial response [PR]), overall survival (OS), duration of response (DOR), time to
      progression (TTP).
    

Eligibility criteria:

        Inclusion criteria:

          -  Males and females aged >=18 years (for Japan only: Age >=20 years at time of signing
             Informed Consent Form) with histologically confirmed metastatic colorectal cancer
             (mCRC).

          -  Metastatic disease not amenable to surgical curative treatment and eligible to receive
             therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.

          -  At least one measurable lesion according to Response Evaluation Criteria in Solid
             Tumors (RECIST) 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

          -  Adequate hepatic, renal and bone marrow function.

          -  Further inclusion criteria apply.

        Exclusion criteria:

          -  Prior systemic therapy for metastatic disease

          -  Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular
             endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin®
             biosimilar

          -  Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for
             basal cell cancer of the skin or pre-invasive cancer of the cervix

          -  Spinal cord compression or brain metastases unless asymptomatic, stable and not
             requiring steroids for at least 6 weeks prior to start of study treatment

          -  Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from
             previous anticancer therapy (including radiotherapy)

          -  History or evidence of inherited bleeding diathesis or coagulopathy with the risk of
             bleeding

          -  A thrombotic or hemorrhagic event <=6 months prior to screening (includes hemoptysis,
             Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage,
             epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks,
             myocardial infarction, angina, and coronary artery disease)

          -  Further exclusion criteria apply