bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
Condition: Partial Epilepsies; Partial Onset Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: lacosamide; lacosamide; lacosamide
Intervention description: Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days; Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days; Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 16 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: epilepsy; seizures; Lacosamide; Vimpat; intravenous

Summary:

      The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered
      in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with
      partial-onset seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures

          -  Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days
             prior to screening and duration of trial

          -  Acceptable candidate for venipuncture and intravenous (iv) infusion

          -  At least 1 partial seizure with motor component per 90 days

          -  Maximum allowed seizure frequency during 28 days prior to screening is 40 partial
             seizures of any type

        Exclusion Criteria:

          -  Previous use of lacosamide

          -  History of primary generalized seizures

          -  History of status epilepticus within last 12 months

          -  History of cluster seizures during 8 week period prior to screening

          -  Non-epileptic events, including psychogenic seizures that could be confused with
             seizures

          -  Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic
             analgesics within 28 days prior to screening

          -  Received any rescue benzodiazepines more than once during the 28 days prior to
             screening

          -  Concomitant treatment of felbamate or previous felbamate therapy within last 6 months

          -  Prior or concomitant vigabatrin use
A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Intervention: Lanabecestat
Intervention description: Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 421.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Dementia; Brain Diseases; Neurodegenerative Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Delirium, Dementia, Amnestic, Cognitive Disorders; Tauopathies; Memory; Amyloid

Summary:

      This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The
      purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in
      participants with early Alzheimer's disease dementia at the time of entry into study
      I8D-MC-AZES.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility
             criteria for delayed-start I8D-MC-AZFD.

        Exclusion Criteria:

          -  Participants who participate in AMARANTH (NCT02245737) who develop new conditions
             precluding them from enrolling into I8D-MC-AZFD.
Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Condition: Acute Coronary Syndrome; Percutaneous Coronary Intervention
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Ticagrelor; Clopidogrel; Acetylsalicylic acid ASA
Intervention description: 90 mg, oral dose twice daily; 75 mg, oral dose once daily; Low Dose ASA
Intervention MeSH terms: Aspirin; Clopidogrel; Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 801.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: acute coronary syndrome; coronary disease; coronary artery disease

Summary:

      The purpose of the study is to assess the efficacy (prevention of vascular events) and safety
      (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top
      of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned
      percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent

          -  Index event of non-ST or ST segment elevation ACS

        Exclusion Criteria:

          -  Index event is an acute complication of percutaneous coronary intervention

          -  Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event
             before the first dose of study treatment

          -  Oral anticoagulation therapy that cannot be stopped

          -  The conditions associated with increased risk of bradycardiac events
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders; Hemorrhage
Intervention: nonacog beta pegol
Intervention description: For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Male
Minimum age: 0 Years
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate the safety and
      efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  Male, age below 6 years at the time of signing informed consent

          -  Patients with the diagnosis of haemophilia B (FIX (coagulation factor IX) activity
             level below or equal to 2%) based on medical records or central laboratory results

          -  Previously untreated or exposed to FIX containing products less than or equal to 3
             exposure days (5 previous exposures to blood components is acceptable)

        Exclusion Criteria:

          -  Any history of FIX inhibitors (defined by medical records)

          -  Known or suspected hypersensitivity to trial product or related products

          -  Previous participation in this trial. Participation is defined as first dose
             administered of trial product

          -  Receipt of any investigational medicinal product within 30 days before screening

          -  Congenital or acquired coagulation disorder other than haemophilia B

          -  Any chronic disorder or severe disease which, in the opinion of the Investigator,
             might jeopardise the patient's safety or compliance with the protocol

          -  Patient's parent(s)/LAR(s) (legally acceptable representative) mental incapacity,
             unwillingness to cooperate, or a language barrier precluding adequate understanding
             and cooperation
CU Programme of Idarucizumab for Japanese Patients
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: idarucizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The objective is to collect the safety data of idarucizumab for patients treated with
      dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of
      uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are
      required.
    

Eligibility criteria:

        Inclusion criteria:

          -  Currently taking dabigatran etexilate.

          -  Age >= 20 years at entry.

          -  Written Informed consent

          -  Group A:

             -- Uncontrolled or life-threatening judged by the physician to require a reversal
             agent.

          -  Group B:

               -  A condition requiring emergency surgery or invasive procedure where adequate
                  hemostasis is required. Emergency is defined as within the following 8 hours.

        Exclusion criteria:

          -  Contraindications to study medication including known hypersensitivity to the drug or
             its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

          -  Group A:

               -  Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with
                  standard supportive care.

               -  Patients with no clinical signs of bleeding.

          -  Group B:

               -  surgery or procedure which is elective or where the risk of uncontrolled or
                  unmanageable bleeding is low.
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: LEO 43204 gel; Vehicle gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 373.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to compare the short term efficacy of LEO 43204 gel with
      vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive
      days as field treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment
             area of sun-damaged skin on the full balding scalp (the balding part of the scalp
             should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)

          -  Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking
             area of 50 cm2 (8 In2). The tracking area must be within the treatment area

        Exclusion Criteria:

          -  Location of the treatment area (full balding scalp) within 5 cm of an incompletely
             healed wound or within 5 cm of a suspected BCC or SCC

          -  Treatment with ingenol mebutate gel in the treatment area within the last 12 months

          -  Lesions in the treatment area that have: atypical clinical appearance (e.g.
             hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g.
             did not respond to cryotherapy on two previous occasions)

          -  History or evidence of skin conditions other than the trial indication that would
             interfere with the evaluation of the trial medication (e.g. eczema, unstable
             psoriasis, xeroderma pigmentosum)
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
Condition: Urologic Diseases; Hypospadias; Undescended Testes; Chordee; Hydrocele; Orchiectomy
MeSH terms: Hypospadias; Urologic Diseases; Cryptorchidism
Intervention: Exparel 133 miligrams per 10 milliliter injection; Bupivacaine Hydrochloride
Intervention description: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection; Local wound infiltration with 0.25% bupivacaine.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 104.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in
      improving pain scores and reducing narcotic pain requirements in pediatric patients following
      minor urologic procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric patients 6 years and older undergoing minor pediatric urologic surgery

          -  Patients who are otherwise eligible to receive routine care following minor urologic
             surgery

        Exclusion Criteria:

          -  Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal,
             hepatic dysfunction)

          -  Pediatric patients younger than 6 years of age

          -  Pediatric patients with a history of pain syndromes or are unable to tolerate opiate
             medication

          -  Unwilling to participate in 48 hours and 10-14 day follow-up phone calls
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL/VOX
Intervention description: 400/100/100 mg FDC tablet administered orally once daily with food
Intervention MeSH terms: Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to determine the efficacy, safety, and tolerability
      of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination
      (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or
      without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior
      treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral
      (DAA)-containing regimens.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or
             older who did not achieve sustained virologic response (SVR) in a prior
             Gilead-sponsored HCV treatment study

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Condition: Kidney Neoplasms
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: Axitinib (AG-013736); Sorafenib
Intervention description: axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing; sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing
Intervention MeSH terms: Sorafenib; Axitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 723.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Axitinib in Second Line Treatment of Patients With Metastatic Renal Cell Cancer

Summary:

      The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in
      delaying tumor progression in patients with metastatic renal cell cancer after failure of one
      first line regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed renal cell cancer with a component of clear
             cell subtype, with metastasis

          -  Evidence of measurable disease

          -  Must have failed one prior systemic first-line regimen for metastatic renal cell
             cancer

        Exclusion Criteria:

          -  Prior treatment for metastatic renal cell cancer with more that one systemic first
             line therapy

          -  Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Macular Laser Photocoagulation
Intervention description: Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).; Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).; Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema; DME; VEGF Trap-Eye; best-corrected visual acuity (BCVA)

Summary:

      To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the
      best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy
      study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 years with type 1 or 2 diabetes mellitus

          -  Subjects with diabetic macular edema (DME) secondary to diabetes mellitus involving
             the center of the macula in the study eye

          -  Decrease in vision determined to be primarily the result of DME in the study eye

          -  Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS)
             letter score of 73 to 24 (20/40 to 20/320) in the study eye

        Exclusion Criteria:

          -  Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day
             1

          -  More than 2 previous macular laser treatments in the study eye

          -  Previous use of intraocular or periocular corticosteroids in the study eye within 120
             days of Day 1

          -  Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium,
             bevacizumab, ranibizumab etc.) within 90 days of Day 1

          -  Active proliferative diabetic retinopathy (PDR) in the study eye

          -  Uncontrolled diabetes mellitus, as defined by HbA1c >12%

          -  Only 1 functional eye even if that eye is otherwise eligible for the study
Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria
Condition: Arthritis, Reactive; Reiter Disease
MeSH terms: Chlamydia Infections; Arthritis, Reactive; Arthritis
Intervention: Doxycycline and Rifampin; Azithromycin and Rifampin; Placebo
Intervention description: doxycycline 100mg daily; rifampin 300mg daily (both for 6 months); Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months); Methylcellulose
Intervention MeSH terms: Azithromycin; Doxycycline; Rifampin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chlamydia

Summary:

      Reactive arthritis, also known as Reiter's syndrome, is a form of arthritis that occurs as a
      reaction to an infection elsewhere in the body. It is characterized by inflammation of the
      joints, tendons, urogenital tract, and eyes. Pain and swelling in the knees, ankles, and feet
      are common. This study will determine the effectiveness of antibiotic therapy in treating
      people with chlamydia-induced reactive arthritis that has lasted for more than 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet the following European Spondyloarthropathy Study Group Criteria:

               1. inflammatory spinal pain OR

               2. synovitis AND

               3. one or more of the following:

                    1. positive family history

                    2. urethritis or cervicitis within 1 month prior to onset of arthritis

                    3. buttock pain

                    4. enthesopathy

                    5. sacroiliitis

          -  Disease duration of at least 6 months

          -  Negative pregnancy test at study baseline and willing to use an effective method of
             contraception other than combined oral contraceptives for the duration of the study
             (for women of childbearing age)

        Exclusion Criteria:

          -  Sensitivity or history of allergic reaction to rifampin, doxycycline, or azithromycin

          -  Currently taking any medications that may interact with the study medications,
             specifically rifampin

          -  Liver transaminases greater than or equal to two times the normal level

          -  Significant abnormalities in the complete blood count (CBC)

          -  Pregnant

          -  Current psoriasis

          -  Diagnosis of inflammatory bowel disease

          -  Diagnosis of ankylosing spondylitis

          -  Previous prolonged exposure to antibiotics (more than 2 weeks) as a potential
             treatment for reactive arthritis