Decisions

 

Decisions

NREC CodeYearTitleStudy TypeHealth CategoryDecisionView
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) ResubmissionMD 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
21-NREC-CT-0012021Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)FavourableVIEW

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