Decisions

 

Decisions

NREC CodeYearTitleStudy TypeDecisionView
22-NREC-CT-0122022A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional ChondrosarcomaCT applicationFavourableVIEW
22-NREC-CT-0872022A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigators Choice Chemotherapy in Second or Third-Line Recurrent or Metastatic Cervical CancerCT applicationUnfavourableVIEW
22-NREC-CT-0862022An open-label, randomized, Phase 3 clinical trial of IO102- IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanomaCT applicationFavourableVIEW
22-NREC-CT-0842022A Phase 3 open-label, multicenter study of the long-term safety and efficacy of intravenous recombinant coagulation factor VIII Fc-von willebrand factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; BIVV001) in previously treated patients with severe hemophiliaCT applicationFavourableVIEW
22-NREC-CT-0712022A Phase 3, open-label, parallel group, multicenter, extension study evaluating the long-term treatment of bimekizumab in study participants with moderate to severe hidradenitis suppurativaCT applicationFavourableVIEW
22-NREC-CT-0202022A Phase IIIb, Multicenter, Randomized, Visual Assessor-Masked Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration (DIAGRID)CT applicationFavourableVIEW
22-NREC-CT-0192022A MULTICENTER, OPEN-LABEL PHASE IV STUDY TO EVALUATE OVERALL HEALTH, PHYSICAL ACTIVITY, AND JOINT OUTCOMES, IN PARTICIPANTS AGED 13 AND < 70 YEARS WITH SEVERE OR MODERATE HEMOPHILIA A WITHOUT FVIII INHIBITORS ON EMICIZUMABCT applicationFavourableVIEW
22-NREC-CT-0182022A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung CancerCT applicationFavourableVIEW
22-NREC-CT-0172022A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Familial Chylomicronemia SyndromeCT applicationFavourableVIEW
22-NREC-CT-0282022CONNected Electronic Inhalers Asthma Control Trial 3 (“CONNECT 3”), a 24-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison Study of Standard of Care Treatment Versus the Budesonide/Formoterol Digihaler Digital System, to Optimize Outcomes in Adult Patients with AsthmaCT applicationUnfavourableVIEW
22-NREC-MD-0122022DermAssist Ireland StudyMD applicationUnfavourableVIEW
22-NREC-CT-0872022A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator’s Choice Chemotherapy in Secondor Third-Line Recurrent or Metastatic Cervical CancerCT ApplicationUnfavourableVIEW
22-NREC-MD-010202121-NREC-MD-010 - 'LANDMARK Trial'MD applicationUnfavourableVIEW
22-NREC-MD-004202222-NREC-MD-004 The ProVIDE Clinical StudyMD applicationUnfavourableVIEW
21-NREC-CT-1742022A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)CT applicationFavourableVIEW
21-NREC-CT-1722022EPIK-B5: A Phase III, randomized, double-blind, placebocontrolled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HRpositive, HER2-negative advanced breast cancer with a PIK3CA mutation, who progressed on or after aromatase inhibitor and a CDK4/6 inhibitor.CT applicationFavourableVIEW
21-NREC-CT-1702021A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab.CT applicationFavourableVIEW
21-NREC-CT-1472021The use of Sildenafil in Neonates with Down Syndrome to Reduce Pulmonary Vascular Resistance.CT applicationFavourableVIEW
21-NREC-CT-038-NPC2021Phase III postneoadjuvant study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment – SASCIA.CT applicationFavourableVIEW
21-NREC-CT-0842021A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated LiposarcomaCT applicationFavourableVIEW
21-NREC-CT-046-NCP2021A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma (iNHL) – The COASTAL StudyCT applicationFavourableVIEW
21-NREC-CT-1342021A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96 / ENGOT-ov65)CT applicationFavourableVIEW
21-NREC-CT-1312021A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn DiseaseCT applicationFavourableVIEW
21-NREC-CT-1282021EXPLORE: A PHASE 2, OUTCOMES ASSESSOR-MASKED, MULTICENTRE, RANDOMISED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO DOSES OF GT005 ADMINISTERED AS A SINGLE SUBRETINAL INJECTION IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.CT applicationFavourableVIEW
21-NREC-CT-1302021Phase II, randomized, open-label, international, multicenter study to compare efficacy of standard chemotherapy vs. letrozole plus abemaciclib as neoadjuvant therapy in HR-positive/HER2-negative high/intermediate risk breast cancer patients. CARABELACT applicationFavourableVIEW
21-NREC-CT-1272021Protocol IM026024: A Phase 2, Multicenter, Randomized, Double-blind, PlaceboControlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus ErythematosusCT applicationFavourableVIEW
21-NREC-CT-1012021A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508deland a Minimal Function Mutation (F/MF)CT applicationFavourableVIEW
21-NREC-CT-1002021A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationCT applicationFavourableVIEW
21-NREC-CT-1262021A double-blind randomised phase III trial evaluating the efficacy of ADT +/- darolutamide in de novo metastatic prostate cancer patients with vulnerable functional ability and not elected for docetaxel or androgen receptor targeted agentsCT applicationFavourableVIEW
22-NREC-CT-0292022A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)CT applicationFavourableVIEW
22-NREC-CT-0092022TENECTEPLASE IN CENTRAL RETINAL ARTERY OCCLUSION STUDY (TenCRAOS): A Prospective, randomised-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomisation)CT applicationFavourableVIEW
22-NREC-CT-0112022PaTcH Trial: A phase 2 study to explore primary and emerging resistance mechanisms in patients with metastatic refractory Pancreatic cancer treated with Trametinib and HydroxychloroquineCT applicationFavourableVIEW
22-NREC-CT-0102022A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)CT applicationFavourableVIEW
21-NREC-CT-1562021A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome - RECONNECTCT applicationFavourableVIEW
21-NREC-CT-1712021A 52-week, randomised, double-blind, placebo-controlled, parallel group, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilic phenotypeCT applicationFavourableVIEW
21-NREC-CT-1732022A phase IIb, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free dietCT applicationFavourableVIEW
22-NREC-MD-0032022Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE) is referred to as the GSR DEFINE study, Including Irish Country Addendum (IMPROVE)MD applicationFavourableVIEW
22-NREC-MD-0022022Tinnitus Patient Registry at Ótologie Tinnitus Care (Ótologie)MD applicationFavourableVIEW
22-NREC-MD-0052022Treatment Evaluation of Neuromodulation for Tinnitus Stage A3 (TENT-A3)MD applicationFavourableVIEW
22-NREC-CT-0262022A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-322)CT applicationFavourableVIEW
22-NREC-MD-0062022LANDMARK Trial: A prospective, multinational, multicentre, open-label, randomized, noninferiority trial to compare safety and effectiveness of Meril’s Myval Transcatheter Heart Valve (THV) series vs. Contemporary Valves (Edwards’ Sapien THV series and Medtronic’s Evolut THV series) in patients with severe symptomatic native aortic valve stenosis.MD applicationFavourableVIEW
22-NREC-MD-0092022Real-World Outcomes Study on Subjects Treated with Radiofrequency AblationMD applicationFavourableVIEW
21-NREC-CT-1322021A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Bendamustine plus Rituximab in Untreated Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-313)CT applicationFavourableVIEW
21-NREC-CT-1292021HORIZON: A PHASE II, OPEN-LABEL, OUTCOMES-ASSESSOR MASKED, MULTICENTRE, RANDOMISED, CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO DOSES OF GT005 ADMINISTERED AS A SINGLE SUBRETINAL INJECTION IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO DRY AGE-RELATED MACULAR DEGENERATIONCT applicationFavourableVIEW
21-NREC-MD-0152021Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR guided revascularizationMD applicationFavourableVIEW
21-NREC-CT-1202021A phase II study to evaluate the long-term safety and efficacy of alpelisib in patients with PIK3CA-Related Overgrowth Spectrum (PROS) who previously participated in Study CBYL719F12002 (EPIK-P1)CT applicationFavourableVIEW
21-NREC-CT-1332021An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination with Lenvatinib, versus Pembrolizumab and Lenvatinib, as First-line Treatment in Participants with Advanced Clear Cell Renal Cell Carcinoma (ccRCC)CT applicationFavourableVIEW
21-NREC-MD-0042021MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy InvestigationMD applicationFavourableVIEW
21-NREC-MD-0012021PORSAV (Protecting OR Staff from Aerosolized Virus)MD applicationFavourableVIEW
21-NREC-CT-0472021A comparison of reduced dose total body irradiation (TBI) and cyclophosphamide with fludarabine and melphalan reduced intensity conditioning in adults with acute lymphoblastic leukaemia (ALL) in complete remissionCT applicationFavourableVIEW
21-NREC-MD-0052021Conduction System Pacing Optimized Therapy (CSPOT)MD applicationFavourableVIEW
21-NREC-CT-0492021A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line TherapyCT applicationFavourableVIEW
21-NREC-MD-0092021A prospective, multicenter post-marketing clinical investigation of the Tsert SITM System, model NG SI IMT 3X in patients with central vision impairment associated with end-stage age-related macular degenerationMD applicationFavourableVIEW
21-NREC-CT-0702021A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab.CT applicationFavourableVIEW
21-NREC-MD-0112021An observational study of ocular microtremor in mild head injuryMD applicationFavourableVIEW
21-NREC-CT-0862021A Phase 1/2 Trial of the Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight LossCT applicationFavourableVIEW
21-NREC-CT-0952021Multi-center, double-blind, randomized, placebo[1]controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s DiseaseCT applicationFavourableVIEW
21-NREC-CT-0462021A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) – The COASTAL StudyCT applicationFavourableVIEW
21-NREC-CT-0712021A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction.CT applicationFavourableVIEW
21-NREC-CT-0202021A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis ADORE (ALS Deceleration with ORal Edaravone) studyCT applicationFavourableVIEW
21-NREC-CT-0212021A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis who are Naïve to Biologic Disease-modifying Anti-rheumatic DrugsCT applicationFavourableVIEW
21-NREC-CT-0222021A phase III, randomized, double-blind, placebo-controlled, multicenter trial to evaluate the safety and efficacy of AMX0035 versus placebo for 48-week treatment of adult patients with Amyotrophic Lateral Sclerosis (ALS)CT applicationFavourableVIEW
21-NREC-CT-0232021TTRIO045/LidERA : A phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant compared with physician’s choice of adjuvant endocrine monotherapy in patients with estrogen receptor-positive, HER2-negative, early breast cancer.CT applicationFavourableVIEW
21-NREC-CT-0482021A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C MutationCT applicationFavourableVIEW
21-NREC-CT-0692021A Phase 1/2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR- 707) combined with cemiplimab for the treatment of participants with advanced unresectable or metastatic skin cancersCT applicationFavourableVIEW
21-NREC-CT-0022021A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS)CT applicationFavourableVIEW
21-NREC-CT-0032021An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension PhaseCT applicationFavourableVIEW
21-NREC-CT-0042021DEXTERITY-AFP: Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation after Thrombus Removal to Yield Benefit in Acute Femorpopliteal DVT (CIP0217) after Thrombus Removal to Yield Benefit in Acute Femorpopliteal DVT (CIP0217)CT applicationFavourableVIEW
21-NREC-CT-0052021DEXTERITY-SCI: Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation after Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT (CIP0218)CT applicationFavourableVIEW
21-NREC-CT-0012021Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)CT applicationFavourableVIEW
21-NREC-CT-0112021A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)CT applicationFavourableVIEW
21-NREC-CT-0132021A Phase 3, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM)CT applicationFavourableVIEW
21-NREC-CT-0072021A phase III, randomized, double-masked, placebo controlled, parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine 0.01%) in treating the progression of myopia in pediatric subjectsCT applicationFavourableVIEW
21-NREC-CT-0142021An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line or Third-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 TherapyCT applicationFavourableVIEW
21-NREC-MD-0032021PIONEER IV trial: Non-inferiority of angiography-derived physiology guidance versus usual care in an All-comers PCI population treated with unrestricted use of the Healing-Targeted Supreme (HT SupremeTM) drug- eluting stent and P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy: the PIONEER IV trialMD applicationFavourableVIEW
21-NREC-CT-0122021A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone LymphomaCT applicationFavourableVIEW

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