Decisions

 

Decisions

NREC CodeYearTitleStudy TypeHealth CategoryDecisionView
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-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-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/RCT applicationFavourableVIEW
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, placebo-controlled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation, who progressed oCT applicationFavourableVIEW
21-NREC-CT-1702021A 52-week, randomised, double-blind, double-dummy, parallel group, multicentre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilCT 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 – SASCIACT applicationFavourableVIEW
21-NREC-CT-0842021A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated LiposarcomCT 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 PlatiCT 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’s 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 DEGENECT 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 HeterozygCT 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 (FCT 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 andCT 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 NephCT 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 TreatedCT applicationFavourableVIEW
22-NREC-MD-0062022LANDMARK Trial: A prospective, multinational, multicentre, open-label, randomised, non-inferiority trial to compare safety and effectiveness of Meril’s MyvalMD 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 DCT 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 (MK6482) and Lenvatinib (MK-7902), or MK-1308A in Combination with Lenvatinib, versus Pembrolizumab and Lenvatinib, as FirCT 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 Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line PlatiCT 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-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-0232021TRIO045/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-negatiCT 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 skCT 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 PhCT 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, placebocontrolle 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 (RCT 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 population treated with unrestricted use of Healing-Targeted Supreme stent (HT Supreme) and P2Y12 inhibitor monotherapy afterMD 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/RCT applicationFavourableVIEW

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