Decisions

 

Decisions

The status of all applications reviewed by NREC-MD can be viewed here:

NREC-MD Decisions log 6 Sept 2024

NREC CodeYearTitleStudy TypeDecisionView
23-NREC-MD-0342023Clinical Investigation Plan (CIP) for: Safety and Performance Study for Arterial Large Hole Vascular Closure Device – ELITE studyMD ApplicationFavourableView
23-NREC-MD-0332023An observational study of the NeuroBell EEG Monitor (a portable and wireless EEG monitor)MD ApplicationFavourableView
23-NREC-MD-0322023Clinical/radiological outcomes associated with the use of conduit™ anterior lumbar interbody fusion (alif) cage system in conjunction with supplemental fixation for the treatment of lumbar degenerative disc disease at one or two contiguous spinal levels from l2-s1MD ApplicationFavourableView
23-NREC-MD-0312023Clinical Performance Study for the Signatera Test Used in Identification of Circulating Tumor-DNA in Muscle-Invasive Bladder Cancer Patients Enrolled Under F. Hoffmann-La Roche Clinical Study Protocol BO42843MD ApplicationFavourableView
23-NREC-MD-0302023Wireless Ultra Long-Term EEG recordings in Epilepsy. A prospective long-term clinical evaluation using the UNEEG EpiSight solutionMD ApplicationFavourableView
23-NREC-MD-0292023A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®MD ApplicationFavourableView
23-NREC-MD-0262023Stellest® Lenses Observational Multi-Centred European Study (SLOMEs)MD ApplicationFavourableView
23-NREC-MD-0252023Collection and Processing of Bone Marrow (BM) Specimens from healthy volunteers for Analytical Performance Evaluation of the BD Reagent Panels and Kits on the BD Flow Cytometer SystemsMD ApplicationFavourableView
23-NREC-MD-0242023Luma Vision’s feasibility study on the VERAFEYE system (LUMINIZE)MD ApplicationFavourableView
23-NREC-MD-0232023Clinical Performance Study Plan for FoundationOne CDX (F1CDx) used as a Clinical Trial Assay (CTA) in the Clinical Trial XPORT-EC-042 for Karyopharm Therapeutics Inc.MD ApplicationFavourableView
23-NREC-MD-0222023Single arm phase 2 trial of neoadjuvant trastuzumab deruxtecan (T-DXd) with response-directed definitive therapy in early stage HER2-positive breast cancer: a standard chemotherapy-sparing approach to curative-intent treatment – SHAMROCK studyMD ApplicationFavourableView
23-NREC-MD-0182023First In Human Clinical Investigation of the FIRE1™ System in Heart Failure PatientsMD ApplicationFavourableView
23-NREC-MD-0172023TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenTwith LuX-Valve Plus System in Patients with Severe or Greater Tricuspid Regurgitation --SafetYand Clinical PerformanceMD ApplicationFavourableView
23-NREC-MD-0162023Ultimaster Nagomi Sirolimus Eluting Coronary Stent System in Complex Percutaneous Coronary Interventions (PCI) Patients (Nagomi Complex study)MD ApplicationFavourableView
23-NREC-MD-0152023Diagnostic Protocol for VENTANA PD-L1 (SP263) CDx Assay in Arcus Biosciences Study ARC-10MD ApplicationFavourableView
23-NREC-MD-0142023A Non-Randomized Clinical Study Evaluating Use of the CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary ArteriesMD ApplicationUnfavourableView
23-NREC-MD-0122023Diagnostic Protocol for VENTANA FGFR2b (FPR2-D) Assay for Amgen Study 20210096 (CTIMP: A Randomized, Multi-Center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab plus Chemotherapy versus Placebo plus Chemotherapy in Subjects with Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression)MD ApplicationFavourableView
23-NREC-MD-0112023BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)MD ApplicationFavourableView
23-NREC-MD-0102023Evolut™ EXPAND TAVR II Pivotal TrialMD ApplicationFavourableView
23-NREC-MD-0072023Repeatability, Reproducibility and Demographic Reference Study in Ocular MicrotremorMD ApplicationFavourableView
23-NREC-MD-0062023An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal CancerMD ApplicationFavourableView
23-NREC-MD-0192023A Non-Randomized Clinical Study Evaluating Use of the CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary ArteriesMD applicationFavourableView
23-NREC-MD-0202023Collection and Processing of Peripheral Blood (PB) Specimens from healthy volunteers for Analytical Performance Evaluation of the BD FACSLyric Flow Cytometer Instrument.MD applicationFavourableView
23-NREC-MD-0132023Children Myopia control Evaluation of Novel Soft Contact LensMD applicationFavourableView
23-NREC-CT-0342023A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients with Amyotrophic Lateral Sclerosis (DAZALS)CT applicationFavourableView
23-NREC-CT-0272023A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand diseaseCT applicationFavourableView
23-NREC-CT-0262023A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)CT applicationFavourableView
23-NREC-CT-0242023A Phase 1/1b Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants with BRAF and/or NRAS Mutation-positive Solid TumorsCT applicationFavourableView
23-NREC-CT-0232023A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined with Domvanalimab (AB154) Compared to Pembrolizumab in Front-Line, PD-L1- High, Locally Advanced or Metastatic Non-Small Cell Lung CancerCT applicationFavourableView
23-NREC-CT-0122023Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell TransplantationCT applicationFavourableView
23-NREC-CT-0222023A multicentre, single-arm phase II trial of adagrasib in patients with KRASG12C-mutant NSCLC, including the elderly (70 years) or patients with poor performance statusCT applicationFavourableView
23-NREC-CT-0212023The impact of Empagliflozin on Left atrIal Volume and the feasibility of using Fitbit and mHealth to prescribe Exercise in non-diabetic Pre- Heart Failure (ELIVE pre-HF)CT applicationFavourableView
23-NREC-CT-0202023A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II)CT applicationFavourableView
23-NREC-CT-0112023A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing Safety, Tolerability, Pharmacodynamics, Efficacy, and Pharmacokinetics of DYNE-251 Administered to Participants with Duchenne Muscular Dystrophy Amenable to Exon 51 SkippingCT applicationFavourableView
23-NREC-MD-0012023Adagio Medical Pulsed Field Ablation (PFA) & Pulsed Field CryoAblation (PFCA) for Persistent Atrial Fibrillation (PsAF)MD applicationFavourableView
23-NREC-CT-0082023A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis ADOREXT (ALS trial with Daily ORal Edaravone EXTension) studyCT applicationFavourableView
23-NREC-CT-0192023A multicentre, randomized, double-blind, placebo-controlled, parallel- group phase 3 study to evaluate the safety and efficacy of masitinib as add-on therapy in patients with mild to moderate Alzheimer's disease, treated with standard of care: cholinesterase inhibitors, memantine CT applicationFavourableView
23-NREC-CT-0062023ApproaCH: A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial evaluating Efficacy and Safety of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Children with Achondroplasia followed by an Open Label Extension periodCT applicationFavourableView
23-NREC-CT-0032023A Phase 2/3, Randomized, Double-Blinded, PlaceboControlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory MyopathyCT applicationFavourableView
23-NREC-CT-0182023A Phase 2b Randomized, Double-blind, Active- and Placebocontrolled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s DiseaseCT applicationFavourableView
23-NREC-CT-0052023A Phase 3, Randomized, Placebo-Controlled, Double-Blind,Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial CarcinomaCT applicationFavourableView
23-NREC-CT-0092023A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX)CT applicationFavourableView
23-NREC-CT-0022023Phase 2, Open-label Study Evaluating Efficacy and Safety of VX-864 in Subjects With Alpha-1 Antitrypsin Deficiency Who Have the PiZZ Genotype, Over 48 WeeksCT applicationFavourableView
22-NREC-CT-1772022A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients with Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)CT applicationFavourableView
22-NREC-CT-1732022Single arm phase 2 trial of neoadjuvant trastuzumab deruxtecan (T-DXd) with response-directed definitive therapy in early stage HER2-positive breast cancer: a standard chemotherapy-sparing approach to curative-intent treatment – SHAMROCK studyCT applicationFavourableView
22-NREC-CT-1722022A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination with FOLFOX Chemotherapy Patients with Advanced Solid TumoursCT applicationFavourableView
23-NREC-MD-0032023Real world Data collection in subjects treated with the FARAPULSE™ Pulsed Field Ablation system (FARADISE)MD ApplicationFavourableView
23-NREC-MD-0042023Assessment of post-operative pain after a single-visit root canal treatment using VaryFlex Taper files VFNEO and TruNatomy rotary endodontic files: prospective, open-label trial.MD ApplicationUnfavourableView
23-NREC-MD-0022023SECURE - An observational post-marketing study for evaluation of ongoing safety and effectiveness of catheter mapping and ablation using commercially approved BWI medical devices for the treatment of patients with cardiac arrhythmiasMD ApplicationFavourableView
23-NREC-CT-0042023A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFYCT ApplicationFavourableView
22-NREC-CT-1862023The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular diseaseCT ApplicationFavourableView
22-NREC-CT-1812022ORACLE: A long-term follow-up study to evaluate the safety and durability of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study.CT ApplicationFavourableView
22-NREC-CT-1802022NEoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (NEEDS Trial)CT ApplicationFavourableView
22-NREC-CT-1792023A Pilot Study to Assess the Use of Methylone in the Treatment of Post-PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])CT ApplicationUnfavourableView
22-NREC-CT-1782022IMPAHCT-FUL: A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002CT ApplicationFavourableView
22-NREC-CT-1742022A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic MalignanciesCT ApplicationFavourableView
22-NREC-CT-1692022A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cCT ApplicationFavourableView
22-NREC-CT-1672022A Phase 3, Randomized, International Multicenter Trial Of DAY101 Monotherapy Versus Standard Of Care Chemotherapy In Patients With Pediatric Low-Grade Glioma Harboring An Activating RAF Alteration Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)CT ApplicationFavourableView
22-NREC-CT-1642022A Phase 3, Two-Stage, Randomized, Multicenter, Open Label Study Comparing CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM)CT ApplicationFavourableView
22-NREC-CT-1612022A Phase 2b, Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary FibrosisCT ApplicationFavourableView
22-NREC-CT-1582022A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF)NREC CTFavourableView
22-NREC-CT-1562022A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients with CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic MalignanciesNREC CTFavourableView
22-NREC-CT-1552022A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisNREC CTFavourableView
22-NREC-CT-1532022RANDOMISED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 3 TRIAL OF TRIUMEQ IN AMYOTROPHIC LATERAL SCLEROSISNREC CTFavourableView
22-NREC-CT-1512022A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal HyperplasiaNREC CTFavourableView
22-NREC-CT-1502022A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal HyperplasiaNREC CTFavourableView
22-NREC-CT-1432022A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks in women with, or at high risk for developing hormone-receptor positive breast cancerNREC CTFavourableView
22-NREC-CT-1362022A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants with Aggressive and Indolent B-cell MalignanciesNREC CTFavourableView
22-NREC-CT-1172022A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell LymphomaCT ApplicationFavourableView
22-NREC-MD-0382022Comparison of Departmental Echocardiogram vs Caption Ai-driven Acquisition (CODEC-AI)MD applicationFavourableView
22-NREC-MD-0392022Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction with or without Combined Iliofemoral ObstructionMD applicationFavourableView
22-NREC-MD-0372022A single-centre, investigator-led, observational clinical investigation to evaluate the performance of ECG gathered from a single arm for the detection of heart rhythmMD applicationFavourableView
22-NREC-MD-0362022A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (PROACTIVE-HF Trial)MD applicationFavourableView
22-NREC-CT-1682022A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolismCT applicationFavourableView
22-NREC-CT-1592022A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)CT applicationFavourableView
22-NREC-CT-1572022A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-CT applicationFavourableView
22-NREC-MD-0352022Product Surveillance Registry (PSR) CoronaryMD applicationFavourableView
22-NREC-MD-0342022Wound Assessment Using Spectral Imaging (WAUSI)MD applicationFavourableView
22-NREC-CT-1552022A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisCT applicationFavourableView
22-NREC-CT-1542022IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24- Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH)CT applicationFavourableView
22-NREC-CT-1492022Brightline-1: A Phase II/III, randomized, open-label, multi-center study of BI 907828 compared to doxorubicin as first line treatment of patients with advancedCT applicationFavourableView
22-NREC-CT-1312022Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy -IronWomanCT applicationFavourableView
22-NREC-MD-0152022Remote photoplethysmography for monitoring vital signs: useability and acceptance within a specialist palliative care unitMD applicationUnfavourableView
22-NREC-CT-0962022A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess safety, tolerability, pharmacokinetic and pharmacodynamics of BI 764198CT applicationFavourableView
22-NREC-CT-0952022Efficacy and safety of COMP360 psilocybin therapy in anorexia nervosa: a proof-of-concept studyCT applicationFavourableView
22-NREC-CT-0092022TENecteplase in Central Retinal Artery Occlusion Study: TEN-CRAOS. A randomized placebo-controlled trial of tenecteplase in patients with central retinal arteryCT applicationFavourableView
22-NREC-CT-0132022A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive UnresectableCT applicationFavourableView
22-NREC-MD-0322022ProVee Urethral Expander System IDE StudyMD applicationFavourableView
22-NREC-MD-0312022An open-label, single site, pilot clinical investigation to assess the detectability and sizing of invasive breast cancers, the detectability of benign breast lesions, as well as the differentiation between malignant and benign breast lesions using the Wavelia #2 Microwave Breast Imaging system (Wavelia #2 Pilot #1 StudyMD applicationFavourableView
22-NREC-MD-0302022A randomized trial of ultrasound-facilitated, catheter-directed, thrombolysis versus anticoagulation for acute intermediate-high risk pulmonary embolism: The higher-risk pulmonary embolism thrombolysis studyMD applicationFavourableView
22-NREC-MD-0262022Effectiveness of the SpaceOAR Vue System in Subjects with Prostate Cancer being Treated with Stereotactic Body RadiothErapy (SABRE)MD applicationFavourableView
22-NREC-CT-1482022A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)CT applicationFavourableView
22-NREC-CT-1442022A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Examine the Efficacy and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder Followed by an Open-Label ExtensionCT applicationFavourableView
22-NREC-CT-1332022CONNected 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 applicationFavourableView
22-NREC-CT-1282022A multi-centre, single arm, open-label extension study to evaluate the long-term safety of GSK3511294 (Depemokimab) in adult and adolescent participants with severe asthma with an eosinophilic phenotype from studies 206713 or 213744CT applicationFavourableView
22-NREC-MD-0092022Real-World Outcomes Study on Subjects Treated with Radiofrequency AblationMD applicationFavourableView
22-NREC-CT-0982022A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ≥2 to <18 years with Pulmonary Arterial HypertensionCT applicationFavourableView
22-NREC-CT-0882022Multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarctionCT applicationFavourableView
22-NREC-CT-0852022A Phase 2, Open-Label, Multi-Center Study of PDS0101 (R-DOTAP [Versamune®] + HPVmix) and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects with Recurrent and/or Metastatic Head and Neck Cancer and High-Risk Human Papillomavirus-16 (HPV16) InfectionCT applicationFavourableView
22-NREC-MD-0272022CONNected 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 OptimMD applicationFavourableView
22-NREC-MD-0252022A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordellaâ„¢ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (PROACTIVE- HF Trial)MD applicationUnfavourableView
22-NREC-MD-0242022Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction with or without Combined Iliofemoral ObstructionMD applicationUnfavourableView
22-NREC-MD-0232022Multi-Centre Prospective Observational Cohort Study: To assess the performance of single use duodenoscopeMD applicationFavourableView
22-NREC-MD-0212022LiquID Guide Catheter Extension Safety StudyMD applicationFavourableView
22-NREC-MD-0202022A single-centre, investigator-led, observational clinical investigation to evaluate the performance of ECG gathered from a single arm for the detection of heart rhythm abnormalities, as compared to hospital telemetry ECGMD applicationUnfavourableView
22-NREC-CT-0142022Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR geneCT applicationFavourableView
22-NREC-MD-0082022Fissure Closure with the AeriSeal System for CONVERTing Ventilation Status in Patients with Severe Emphysema: a MultiCenter, Prospective Trial (CONVERT Trial)MD applicationFavourableView
22-NREC-CT-0722022A PHASE III, MULTI-CENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GANTENERUMAB IN PARTICIPANTS AT RISK FOR OR AT THE EARLIEST STAGES OF ALZHEIMERS'S DISEASECT applicationFavourableView
22-NREC-MD-0112022Feasibility study of the HighLife 28mm trans-septal transcatheter mitral valve in patients with moderate-severe or severe mitral regurgitation and at high surgical riskMD applicationFavourableView
22-NREC-CT-0902022A Randomized, Double-Blind, Placebo controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients with Uncontrolled Moderate to Severe AsthmaCT applicationFavourableView
22-NREC-CT-0912022A MULTINATIONAL, PHASE 2, RANDOMISED, ADAPTIVE PROTOCOL TO EVALUATE IMMUNOGENICITY AND REACTOGENICITY OF DIFFERENT COVID-19 VACCINES ADMINISTRATION IN OLDER ADULTS ALREADY VACCINATED AGAINST SARS-COV-2 (EU-COVAT-1_AGED)CT applicationFavourableView
22-NREC-CT-0922022A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG- 3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMACT applicationFavourableView
22-NREC-CT-0942022A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design in children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short stature.CT applicationFavourableView
22-NREC-MD-0142022Transcatheter Repair of Tricuspid Regurgitation with Edwards PASCAL Transcatheter Valve Repair System: A European prospective, multicenter Post Market Clinical Follow upMD applicationUnfavourableView
22-NREC-CT-1012022A multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE)CT applicationFavourableView
22-NREC-CT-1092022A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients with Relapsed Refractory Multiple MyelomaCT applicationFavourableView
22-NREC-CT-1022022A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRCT applicationFavourableView
22-NREC-CT-1032022An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)CT applicationFavourableView
22-NREC-CT-1042022A 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-MD-0172022Real world evidence observational study to evaluate performance and safety of intravesical sodium hyaluronate (Cystistat®) in the treatment of patients with interstitial cystitis (IC)/bladder pain syndrome (BPS)MD applicationFavourableView
22-NREC-MD-0182022A wearable in-phase chest wall vibration device for relief of dyspnoea in COPD: a first-in-human exploratory studyMD applicationFavourableView
22-NREC-MD-0192022Coronary PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASEMD applicationUnfavourableView
22-NREC-CT-1162022An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal CancerCT applicationFavourableView
22-NREC-MD-0222022A Prospective Open label single arm Post Market Clinical Follow-up trial of the FARAPULSE pulsed field ablation system in patients with paroxysmal Atrial fibrillation.MD applicationFavourableView
22-NREC-CT-1292022A Phase 3, Randomized, Multicentre, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Participants with Light Chain (AL) AmyloidosisCT applicationFavourableView
22-NREC-MD-0292022Remote photoplethysmography for measuring vital signs: use ability and acceptance within a specialist palliative care unitMD applicationFavourableView
22-NREC-MD-0282022Preliminary testing of the Safety, Usability and Functionality of an innovative and smart medical device: Compression Therapy System Prototype for Venous Leg Ulcer treatment in healthy volunteersMD applicationFavourableView
22-NREC-CT-0622022A Phase 2 Trial of MRTX849 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C MutationCT applicationFavourableView
22-NREC-CT-0272022A Phase 2, Randomized, Parallel, Open-Label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-Agent Belantamab Mafodotin (GSK2857916) in Participants with Relapsed or Refractory Multiple Myeloma (DREAMM-1CT applicationFavourableView
22-NREC-CT-1302022Phase 2, randomized, parallel-group, double-blind, placebocontrolled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativaCT applicationFavourableView
22-NREC-CT-1352022A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigators Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical CancerCT applicationFavourableView
22-NREC-CT-0122022A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional ChondrosarcomaCT applicationFavourableView
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 hemophilia ACT 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 Second or Third-Line Recurrent or Metastatic Cervical CancerCT ApplicationUnfavourableView
22-NREC-MD-0102021LANDMARK TrialMD applicationUnfavourableView
22-NREC-MD-0042022The 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
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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