A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer
Diabetic Foot UlcerFoot Ulcer2 moreThis Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (<16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing/observation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.
Assess the Safety and Efficacy of CT0594CP Cells in Relapsed/Refractory Multiple Myeloma or Plasma...
Relapsed and/or Refractory Multiple MyelomaPlasma Cell Leukemia in RelapseThis is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
De-escalating Antiplatelet Therapy to Assess Platelet Reactivity and Outcomes in High Bleeding Risk...
Dual Antiplatelet TherapyAcute Coronary Syndrome1 moreHigh bleeding risk (HBR) patients, comprising up to 50% of those presenting with acute coronary syndrome (ACS), are a high-risk group that is increasing in size due to an aging population. The optimal selection of the potency and duration of antiplatelet therapy to reduce the risk of recurrent ischemic and bleeding events in HBR patients is still a matter of debate. Multiple strategies to reduce bleeding during secondary prevention, such as reducing the duration of dual antiplatelet therapy, using single antiplatelet therapy with a P2Y12 inhibitor, or de-escalating to a lower potency or lower-dose P2Y12 inhibitor, have been proposed. De-escalation to a lower potency or lower-dose P2Y12 inhibitor is particularly attractive because it maintains efficient pharmacological inhibition of multiple platelet pathways while potentially reducing bleeding through less aggressive activity. Yet, there has been no study comparing the effects of different de-escalation strategies with the standard potent P2Y12 inhibitors in HBR patients. The aim of the DESC-HBR study is to assess the impact of de-escalating P2Y12 inhibitor to clopidogrel 75mg, prasugrel 5mg or ticagrelor 60mg bid in HBR patients, in comparison with full-dose potent P2Y12 inhibitors, on the proportion of patients with optimal platelet reactivity (OPR). Secondary objectives involve exploring the effect of de-escalation on clinical events and patients' quality of life.
The PIFPAF-PFA Study
Persistent Atrial FibrillationPulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.
Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia...
Waldenstrom MacroglobulinemiaWaldenstrom's Macroglobulinemia Recurrent1 moreThis study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
pBFS-guided Dual-target cTBS for Aphasia After Stroke
StrokeAphasiaThe objective of this trial is to evaluate the effectiveness and safeness of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) for language function recovery in post-stroke aphasic patients.
pBFS-guided Multi-target cTBS for Aphasia After Stroke
StrokeAphasiaIn this study, a randomized, double-blind, parallel-controlled trial was employed to evaluate the effectiveness and safety of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) and the superior frontal gyrus (SFG) for language function recovery in post-stroke aphasic patients.
Short and Intermediate Term Effect of Dapagliflozin on Left Ventricular Remodeling in Anterior STEMI...
STEMIMethodology This study will enroll (120) patients presenting with acute anterior STEMI who will undergo early reperfusion presenting at Helwan University Hospitals and Ain Shams University Hospitals. Diagnosis of STEMI will be based on: Sustained ST-segment elevation of at least 1 mm in at least 2 contiguous leads or new/presumably new left bundle branch block, plus >Typical anginal pain, or > diagnostic levels of serum cardiac biomarkers, or > imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. They will be subdivided into two (2) groups according to Dapagliflozin intake into: - Group A: Patients with diabetes mellitus (DM) (60) patients, they will be further subdivided into 2 subgroups: Group A1: 30 patients will receive Dapagliflozin in addition to standard anti-ischemic and anti-diabetic treatment. Group A2: 30 patients will receive standard anti-ischemic and antidiabetic treatment (Dapagliflozin not included). - Group B: Patients without DM (60) patients, subdivided to 2 subgroups: Group B1: 30 patients will receive standard anti-ischemic treatment. Group B2: 30 patients will receiv up e standard anti-ischemic treatment and Dapagliflozin. Methodology in details: The study patients will undergo early reperfusion according to the recent practice guidelines and the local hospital policy in managing ST elevation MI patients. Echocardiography will be performed twice: within 48 hours of admission and 3 months following the index event. Management: Twelve-lead electrocardiogram will be recorded at baseline and 30-min post-procedure. The ST-segment changes will be evaluated in the single lead with the most prominent ST-segment elevation before intervention. The ST-segment elevation will be measured to the nearest 0.5 mm at 60 ms after the J point. Significant ST segment resolution (STR) is defined as a reduction in ST-segment elevation of 50% after 30 min of infarct artery recanalization. Immediately before the procedure, patients will receive aspirin (300 mg), ticagrelor (180 mg) or clopidogrel (600 mg) depending on availability. Adjunctive pharmacological treatment during the procedure will include: Unfractionated heparin as an initial bolus of 70 U/kg and additional boluses during the procedure to achieve an activated clotting time of 250 to 350 s (200 to 250 s if Glycoprotein IIb/IIIa (GPIIb/IIIa) antagonist is used). Heparin will be discontinued at the end of percutaneous coronary intervention. The use of a GPIIb/IIIa antagonist during the procedure, primary PCI technique, indications, and methods of thrombectomy if indicated will be done under the regulations of the local hospital policy and the most recent practice guidelines.
The Effects of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy
Inflammatory CardiomyopathyMyocarditisEvaluating the long-term therapeutic effects of hydroxychloroquine(compared to glucocorticoid therapy alone) in patients with inflammatory cardiomyopathy--a multicenter randomized controlled study
A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor...
Intracerebral HemorrhageThe purpose of the study is to provide a first assessment of safety, tolerability and efficacy of Ir-CPI, administered on top of standard-of-care, on secondary brain injury in patients with spontaneous intracerebral haemorrhage.