bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of RTH258 Versus Aflibercept - Study 1
Condition: Neovascular Age-Related Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Wet Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Brolucizumab ophthalmic solution; Aflibercept ophthalmic solution
Intervention description: Ophthalmic solution for IVT injection; Ophthalmic solution for IVT injection
Intervention MeSH terms: Aflibercept; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1775.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; CNV; IVT

Summary:

      The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for
      intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic
      solution for IVT injection (2 mg) in subjects with untreated active choroidal
      neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study
      eye.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provide written informed consent

          -  Active choroidal neovascularization (CNV) lesions secondary to age-related macular
             degeneration (AMD) that affected the central subfield in the study eye at Screening;

          -  Total area of CNV comprising >50% of the total lesion area in the study eye at
             Screening;

          -  Intraretinal and/or subretinal fluid affecting the central subfield of the study eye
             at Screening;

          -  Best Corrected Visual Acuity (BCVA) between 78 and 23 letters, inclusive, in the study
             eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS)
             testing.

        Key Exclusion Criteria:

          -  Any active intraocular or periocular infection or active intraocular inflammation in
             either eye at Baseline;

          -  Central subfield of the study eye affected by fibrosis or geographic atrophy or total
             area of fibrosis >50% of the total lesion in the study eye at Screening;

          -  Subretinal blood affecting the foveal center point and/or >50% of the lesion of the
             study eye at Screening;

          -  Any approved or investigational treatment for neovascular age-related macular
             degeneration (nAMD) in the study eye at any time;

          -  Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or
             current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within
             4 weeks prior to Baseline;

          -  Pregnant or nursing women; women of child-bearing potential;

          -  Stroke or myocardial infarction in the 90-day period prior to Baseline.
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
Condition: Gastrointestinal Hemorrhage
MeSH terms: Peptic Ulcer; Gastrointestinal Hemorrhage; Peptic Ulcer Hemorrhage; Hemorrhage
Intervention: Esomeprazole
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being carried out to see if constant 3 days infusion of Nexium is effective in
      preventing rebleeding after an endoscopic treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signs of a bleeding in the stomach

          -  One endoscopically confirmed bleeding ulcer in the stomach or duodenum

        Exclusion Criteria:

          -  Malignancy or other advanced disease.

          -  Major cardiovascular event.

          -  Severe hepatic disease
Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Hemoglobinuria, Nocturnal
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transfusion dependent; paroxysmal nocturnal hemoglobinuria; hemolytic

Summary:

      The purpose of this study is to evaluate the long-term safety of eculizumab in patients with
      transfusion dependent hemolytic PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have fully completed the TRIUMPH, SHEPHERD, or X03-001 studies

          -  TRIUMPH patients who have discontinued receiving investigational drug prior to the
             last visit of the study due to lack of efficacy or exacerbation of symptoms of PNH and
             have completed all monthly safety and efficacy procedures

          -  Patient must be willing and able to give written informed consent

          -  Patient must avoid conception during the trial

        Exclusion Criteria:

          -  Patients who have terminated early from the SHEPHERD or X03-001 studies

          -  Patients who have terminated early from the TRIUMPH study due to an adverse event

          -  Female who is pregnant, breast feeding, or intending to conceive during the course of
             the study

          -  Any condition that could increase the patient's risk by participating in the study or
             could confound the outcome of the study
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Intervention: Placebo; Relamorelin
Intervention description: Placebo injected twice daily; Relamorelin 10 μg injected twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetic gastroparesis; vomiting

Summary:

      A 46-week study to compare the efficacy of relamorelin with that of placebo in participants
      with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants
      will either continue on relamorelin or placebo for 6 additional weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are eligible to be included in the study only if all the following
             criteria apply:

          -  Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01
             (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study

          -  Able to provide written informed consent (IC) prior to any study procedures and
             willing and able to comply with study procedures

          -  In the opinion of the investigator, the participant demonstrated adequate compliance
             with the study procedures in Study RLM-MD-01 or RLM-MD-02

        Exclusion Criteria:

          -  Participants are excluded from the study if any of the following criteria apply:

          -  Participant is not willing or able to abide by the restrictions regarding concomitant
             medicine use

          -  Participant is planning to receive an investigational drug (other than study
             treatment) or investigational device at any time during Study RLM-MD-03

          -  Participant has an unresolved adverse event (AE) or a clinically significant finding
             on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG)
             that, in the investigator's opinion, would limit the participant's ability to
             participate in or complete the study

          -  Any other reason that, in the investigator's opinion, would confound proper
             interpretation of the study or expose a participant to unacceptable risk, including
             renal, hepatic or cardiopulmonary disease
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
Condition: Neuralgia, Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: Placebo; Pregabalin; Pregabalin; Pregabalin
Intervention description: placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).; Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).; Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).; Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 372.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment
      of postherpetic neuralgia in a dose-ranging manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Visual Analogue Scale (VAS) of pain is higher than 40 mm.

          -  Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

        Exclusion Criteria:

          -  Malignancy within the past 2 years.

          -  Patients who have undergone neurolytic or neurosurgical therapy for postherpetic
             neuralgia.

          -  Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age,
             and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).

          -  Patients having other severe pain which may impair the self assessment of the pain due
             to postherpetic neuralgia.

          -  Skin conditions in the affected dermatome that could alter sensation.
Treatment of Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: botulinum toxin; Placebo
Intervention description: neuromodulator to be injected in the GL region; Placebo to be injected in the GL area
Intervention MeSH terms: Botulinum Toxins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to evaluate the efficacy and safety of a single dose of
      QM1114-DP compared to placebo for the treatment of moderate to severe GL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years of age or older.

          2. Moderate to severe GL at maximum frown as assessed by the Investigator.

          3. Moderate to severe GL at maximum frown as assessed by the subject.

        Exclusion Criteria:

          1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study
             treatment.

          2. Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          3. Known allergy or hypersensitivity to any component of the investigational product
             (QM1114-DP) or any botulinum toxin serotype.
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
Condition: Small Cell Lung Carcinoma
MeSH terms: Small Cell Lung Carcinoma
Intervention: Ipilimumab; Placebo matching Ipilimumab; Etoposide; Cisplatin; Carboplatin
Intervention MeSH terms: Carboplatin; Etoposide; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1351.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and
      Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell
      Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

          -  Eastern Cooperative Oncology Group (ECOG) of 0 or 1

        Exclusion Criteria:

          -  Prior systemic therapy for lung cancer

          -  Symptomatic Central Nervous System (CNS) metastases

          -  History of autoimmune disease
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: APL-2
Intervention description: Complement (C3) Inhibitor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluation of the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal
      Hemoglobinuria .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years old (inclusive).

          -  Have LDH ≥1.5 x ULN at the screening visit.

          -  Have PNH diagnosis, confirmed by high sensitivity flow cytometry (granulocyte or
             monocyte clone >10%).

          -  Have Hb less than the lower limit of normal (LLN) at the screening visit.

          -  Have ferritin greater than/equal to the LLN, or total iron binding capacity (TIBC)
             less than/equal to ULN at the screening visit, based on central laboratory reference
             ranges. If a subject is receiving iron supplements at screening, the Investigator must
             ensure that the subject's dose has been stable for 4 weeks prior to screening, and it
             must be maintained throughout the study. Subjects not receiving iron at screening must
             not start iron supplementation during the course of the study.

          -  Body mass index (BMI) ≤ 35 kg/m2 at the screening visit.

          -  Have a platelet count of >50,000/mm3 at the screening visit.

          -  Have an absolute neutrophil count >500/mm3 at the screening visit.

        Exclusion Criteria:

          -  Treatment with any complement inhibitor (eg, eculizumab) within 3 months prior to
             screening.

          -  Hereditary complement deficiency.

          -  History of bone marrow transplantation.

          -  Concomitant use of any of the following medications is prohibited if not on a stable
             regimen for the time period indicated below prior to screening:

               -  Erythropoietin or immunosuppressants for at least 8 weeks

               -  Systemic corticosteroids for at least 4 weeks

               -  Vitamin K antagonists (eg, warfarin) with a stable international normalized ratio
                  (INR) for at least 4 weeks

               -  Iron supplements, vitamin B12, or folic acid for at least 4 weeks

               -  Low-molecular-weight heparin for at least 4 weeks
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
Condition: Ocular Inflammation and Pain After Cataract Surgery
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: APP13007, 0.05%; Matching Vehicle Placebo for APP13007, 0.05%
Intervention description: APP13007 eye drop, 0.05%; Matching vehicle placebo eye drop
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 370.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a
      randomized, parallel-group, double-masked fashion. The subjects will have undergone routine
      cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day;
      POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The
      study comprises the Main Study and the Endothelial Cell Sub-study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age or older expected to undergo unilateral uncomplicated
             cataract extraction via phacoemulsification and posterior chamber intraocular lens
             implantation in one eye.

          -  Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of
             the minimum angle of resolution (logMAR) in the study eye to be operated and
             contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study
             (ETDRS) chart at Visit 1.

          -  Willing and able to comply with study requirements and visit schedule.

          -  Provide signed and dated informed consent.

        Exclusion Criteria:

          -  Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any
             of the study medication's components including benzalkonium chloride and soybean
             lecithin or any routine medication required during cataract surgery or for the conduct
             of study procedures

          -  Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in
             either eye at the Screening visit

          -  Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit

        Note: Other inclusion/exclusion criteria apply.
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: montelukast sodium; Comparator: cetirizine; Comparator: placebo
Intervention description: montelukast 10 mg tablet orally once daily at bedtime for 6 weeks; cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks; placebo tablet orally once daily at bedtime for 6 weeks
Intervention MeSH terms: Cetirizine; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1365.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will assess the ability of montelukast to improve the signs and symptoms of
      perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an
      active control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a documented clinical history of perennial allergic rhinitis

          -  Patient is a nonsmoker

          -  Patient is in good general health

        Exclusion Criteria:

          -  Patient is hospitalized

          -  Patient is a woman who is <8 weeks postpartum or is breast-feeding

          -  Patient is a current or past abuser of alcohol or illicit drugs
Sitagliptin Added-on to Insulin Study (0431-051)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator : placebo (unspecified)
Intervention description: sitagliptin 100 mg tablet qd for a 24-wk treatment period.; sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 641.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2
      Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin
      combination therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Patient is poorly controlled while on insulin or insulin and metformin

        Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

          -  Patient is taking oral antidiabetic agents other than metformin during the past 3
             months

          -  Patient is currently on treatment with daily use of pre-prandial short-acting or
             rapid-acting insulin
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL255; Placebo
Intervention MeSH terms: Topiramate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Epilepsy; partial onset seizure; adjunctive therapy

Summary:

      The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive
      therapy in patients with refractory partial onset-seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a confirmed diagnosis of partial-onset seizures with or without secondary
             generalization for at least 12 months prior to Visit 1.

          -  Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to
             Visit 1 (12 weeks for phenobarbital and primidone).

          -  Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure
             free days, during the 8-week baseline.

        Exclusion Criteria:

          -  Have a history of seizure episodes lasting less than 30 minutes in which several
             seizures occur with such frequency that the initiation and completion of each
             individual seizure cannot be distinguished, within 3 months prior to Visit 1.

          -  Have a history of pseudoseizures, or status epilepticus, within 3 months prior to
             Visit 1.

          -  Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow
             angle glaucoma.

          -  Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric
             illness within 2 years of Visit 1.

          -  Currently taking, or have taken felbamate within the past 18 months, or have taken
             vigabatrin in the past.

          -  Have taken topiramate within the past 6 months.