bioihbjkbjnl/mcl2 huggingface dataset:
Once-A-Day Pregabalin For Partial Seizures
Condition: Partial Seizures; Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: pregabalin; pregabalin; pregabalin; pregabalin; pregabalin; pregabalin; placebo
Intervention description: Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days; Controlled Release Tablets, 165 mg, once per day (QD) for 11 days; Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks); Controlled Release Tablets, 165 mg, once per day (QD) for 7 days; Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days; Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks); matched to the active drug
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Partial epilepsy; partial seizures; epilepsy; seizures; adjunctive therapy; intervention; controlled-release; placebo-controlled; seizure

Summary:

      Approximately 30% percent of subjects with partial seizures are refractory to treatment with
      single or combination antiepileptic drugs. The present study will compare the efficacy of two
      different dosages of pregabalin CR dosed once daily as compared to placebo, when used as
      adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using
      a randomized, parallel group design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex,
             with or without evolution into a bilateral, convulsive seizure)

          -  Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have
             taken at least 2 prior (or ongoing) AEDs

        Exclusion Criteria:

          -  Primary generalized seizures (for example, absence, myoclonic seizures or
             Lennox-Gastaut Syndrome)

          -  Status epilepticus within one year prior to screening
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Condition: Helicobacter Infections
MeSH terms: Helicobacter Infections
Intervention: Omeprazole, amoxicillin, clarithromycin; Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
Intervention description: Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID; Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules QID, with omeprazole 20 mg BID.
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Tetracycline; Bismuth tripotassium dicitrate; Omeprazole; Bismuth
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: H. Pylori; Quadruple therapy; Eradication rate; Multinational trial; Resistance to antibiotics; Subjects with confirmed Helicobacter Pylori infection

Summary:

      This study aims at evaluating efficacy and safety of quadruple therapy (bismuth,
      metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin,
      clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that
      quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed
      H. pylori positive status will be randomized to one of the treatments described above. At
      week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm
      eradication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive H. Pylori status;

          -  Presence of upper gastro-intestinal symptoms;

          -  Mental and legal ability to sign informed consent.

        Exclusion Criteria:

          -  Previous surgery of the GI tract;

          -  Clinically significant impairment of renal or hepatic function;

          -  Severe unstable cardiovascular, pulmonary or endocrine disease;

          -  Barrett's oesophagus or high-grade dysplasia;

          -  Dysphagia or vomiting as major symptoms.
Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Intervention: Keppra XR (Levetiracetam XR)
Intervention description: 500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Keppra XR; Levetiracetam XR; long term; partial seizures

Summary:

      To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term
      safety of Keppra XR in subjects with partial onset seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week
             up titration period

        Exclusion Criteria:

          -  Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]

          -  Subjects who were discontinued prior to the end of titration period
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Intervention: Lubiprostone
Intervention description: 12 or 24 mcg soft capsules for oral administration.
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years
      diagnosed with functional constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic
             Criteria for Childhood Functional Constipation

          -  At least 6 years of age but less than 18 years of age at the time of randomisation

          -  Only stable dose of selective serotonin re-uptake inhibitors (SSRIs),
             serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO)
             inhibitors are allowed if participant is taking antidepressants

        Exclusion Criteria:

          -  Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or
             defecation

          -  Untreated faecal impaction at the time of screening

          -  Medical/surgical condition that might interfere with the absorption, distribution,
             metabolism, or excretion of the study medication
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: teneligliptin; glinide; biguanide; alpha-glucosidase inhibitor
Intervention MeSH terms: Biguanides; Glycoside Hydrolase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 462.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic
             agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) 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

          -  Patients whose HbA1c is between 6.5% - 10.0%

          -  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 habitual excessive alcohol consumption.

          -  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
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
Condition: Contraception
Intervention: CDB-2914; Levonorgestrel
Intervention description: Single dose; Single dose
Intervention MeSH terms: Levonorgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2221.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to
      levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern
             Ireland (UK) and 18 years or more in Ireland and US

          -  present within 120 hours of unprotected intercourse

          -  regular menstrual cycles

          -  No current use of hormonal contraception

          -  Willing to not use hormonal methods of contraception until study completion

          -  At least one complete menstrual cycle (2 menses) post miscarriage, delivery or
             abortion

          -  For women who present more than 72 hours after intercourse, decline the insertion of
             an Intra Uterine Device for emergency contraception

          -  Able to provide informed consent

          -  Willing to abstain from further acts of unprotected intercourse until study completion

        Exclusion Criteria:

          -  One or more acts of unprotected intercourse more than 120 hours

          -  current or recent use of hormonal methods of contraception

          -  currently pregnant or breastfeeding

          -  tubal ligation or current use of IUD

          -  Use of hormonal emergency contraception since last menstrual period

          -  Current use of IUD

          -  Tubal ligation

          -  Partner with a vasectomy

          -  Unsure about the date of the last menstrual period

          -  Severe asthma insufficiently controlled by oral glucocorticoid

          -  Hypersensitivity to the active substance levonorgestrel or any of the excipients of
             the drug products used in the study
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Epoprostenol
Intervention description: Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit
Intervention MeSH terms: Epoprostenol; Tezosentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Healthy volunteers: No

Summary:

      This is an open-label, nonrandomized extension to study AC-066A301. The study will assess
      safety and tolerability of ACT-385781A while providing a means for continuing treatment after
      ending participation in study AC-066A301.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent prior to initiation of any study-mandated procedure

          2. Patients who completed participation in study AC-066A301

          3. Patients who have not obtained access for commercial EFI at the time of ending
             participation in study AC-066A301

        Exclusion Criteria:

          1. Patients who prematurely discontinued study drug in study AC-066A301

          2. Patients for whom continued treatment with EFI is no longer considered appropriate
A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Bevacizumab; Placebo; Capecitabine; Cisplatin
Intervention description: 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle; Placebo matched to bevacizumab on Day 1 of every 3-week cycle; 1000 mg/m^2 orally twice daily on Days 1-14 of every 3-week cycle; 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles
Intervention MeSH terms: Bevacizumab; Capecitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of bevacizumab in combination with
      capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in
      participants who have not received prior chemotherapy for advanced or metastatic gastric
      cancer. Participants will be randomized to one of two treatment groups Bevacizumab +
      Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction
             with inoperable, locally advanced or metastatic disease, not amenable to curative
             therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2

          -  Measurable disease or non-measurable but evaluable disease, according to the Response
             Evaluation Criteria in Solid Tumors (RECIST)

        Exclusion Criteria:

          -  Previous chemotherapy for locally advanced or metastatic gastric cancer

          -  Previous platinum or anti-angiogenic therapy

          -  Radiotherapy within 28 days of randomization

          -  Evidence of Central Nervous System (CNS) metastasis at baseline
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Mircera; Darbepoetin alfa
Intervention description: Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.; As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the
      treatment of anemia in patients with chronic kidney disease who are not on dialysis and who
      are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized
      either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly
      subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the
      weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic kidney disease, not requiring dialysis;

          -  receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and
             during screening/baseline period.

        Exclusion Criteria:

          -  overt gastrointestinal bleeding within 8 weeks before screening, or during
             screening/baseline period;

          -  transfusion of red blood cells within 8 weeks before screening, or during
             screening/baseline period;

          -  active malignant disease;

          -  previous treatment with Mircera.
DE-117 Spectrum 5 Study
Condition: Primary Open-angle Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-117 Ophthalmic Solution
Intervention description: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117
      ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or
      OHT
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.

          -  Provide signed written informed consent.

          -  Diagnosis of POAG or OHT in both eyes.

          -  Qualifying corrected visual acuity in each eye.

          -  Qualifying central corneal thickness in each eye.

          -  Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost
             Run-in Period.

          -  Qualifying Anterior chamber angle.

          -  Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

        Exclusion Criteria:

          -  Patients who cannot safely discontinue use of Ocular Hypotensive Medications during
             Washout.

          -  Patients with prior exposure to DE-117.

          -  History of ocular surgery specifically intended to lower IOP

          -  Advanced glaucoma in either eye.

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             Goldmann applanation tonometry.

          -  Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1
             (Screening) and throughout the study in either eye.

          -  Females who are pregnant, nursing, or planning a pregnancy.
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: certolizumab pegol 400 mg; Placebo
Intervention description: Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.; Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: certolizumab pegol; Cimzia; Crohn's Disease; Inflammatory Bowel Disease

Summary:

      The current study is designed to measure the corticosteroid-sparing effect of certolizumab
      pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe
      Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at
      a dose no higher than 30 mg/day prednisone or equivalent during the week prior to
      randomization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women

          -  Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease
             Activity Index (CDAI) score of ≥ 220 ≤450)

        Exclusion Criteria:

          -  Active or draining fistula present at screening

          -  Lactating and/or pregnant female subjects

          -  A history of any health condition that could potentially interfere with the disease
             and/or the treatment

          -  A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal
             product

          -  Any other condition which in the Investigator's judgment would make the patient
             unsuitable for inclusion in the study

          -  History of drug or alcohol abuse in the prior year

          -  Receipt of any experimental therapy within or outside a clinical trial in the 3 months
             prior to Visit 0