“DanGer Shock” study, which is an international, open-label, randomized trial examining the impact of a Microaxial Flow Pump (Impella CP) plus standard care versus standard care alone in infarct-related cardiogenic shock. Objective: To compare the safety and efficacy of Impella … Read More
Author Archives: admin
MANDARA: Benralizumab vs. Mepolizumab for EGPA
“MANDARA” study, a phase 3, double-blind, randomized, active-controlled trial, comparing Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis (EGPA). Objective: To assess the efficacy and safety of benralizumab as compared with mepolizumab in adults with relapsing or refractory EGPA who … Read More
PAPILLON Trial: Amivantamab in Lung Cancer
Year: 2023 Title: PAPILLON Subtitle: Amivantamab plus Chemotherapy in NSCLC with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Type of Trial: A Randomized, Open-label Phase 3 trial Objective: To compare the efficacy, as demonstrated by progression-free survival (PFS), in … Read More
ONWARDS-1 Trial: Icodec in T2DM
Year: 2023 Title: ONWARDS 1 Subtitle: Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin Type of Trial: Randomized, open-label, treat-to-target phase 3a trial Objective: To investigate the efficacy and long-term safety of once-weekly insulin icodec … Read More
ENRICH Trial: Minimally Invasive Removal of ICH
Year: 2024 Title: ENRICH TRIAL Subtitle: Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage Type of Trial: A multicenter, randomized, adaptive clinical trial Objective: To compare standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive … Read More
NADIM II Trial: Nivolumab in Lung Cancer
Objective: To examine the pathological Complete Response defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone. Inclusion Criteria: Exclusion Criteria: Participants: 86 Patients Treatment Groups: Primary Outcome: Secondary Outcomes: … Read More
MAESTRO-NASH Trial: Resmetirom for NASH
Objective: To determine if 80 or 100 mg of Resmetirom compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease. Inclusion Criteria: Exclusion Criteria: Participants: 966 Patients Treatment Groups: Primary … Read More
LIBRETTO-531 Trial: Selpercatinib in Medullay Thyroid Cancer
Objective: To determine if the study drug selpercatinib is safer and more effective compared to standard treatment in participants with RET-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. … Read More
LIBRETTO-431 Trial: Selpercatinib in NSCLC
Objective: To determine if the study drug selpercatinib, compared to a standard treatment, is effective and safe in participants with RET fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Inclusion Criteria: Participants: … Read More
LIXIPARK Trial: Lixisenatide in Early Parkinson’s Disease
Objective: To evaluate the effect of lixisenatide, versus placebo, administered as add-on therapy with the usual antiparkinsonian treatment, on the progression of motor disability in patients with early Parkinson’s Disease (PD) to assess its potential “disease-modifying” effect. Inclusion Criteria: Exclusion … Read More