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Pilot And Phase 2 Study Of The Efficacy Of A Treatment Protocol With Dexamethasone Implant Loading Dose In Patients With Diabetic Macular Edema (LOADEX) PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Pilot And Phase 2 Study Of The Efficacy Of A Treatment Protocol With Dexamethasone Implant Loading Dose In Patients With Diabetic Macular Edema (LOADEX) articles that have been published worldwide.
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Oprozomib is an oral proteasome inhibitor with activity in multiple myeloma (MM). Our phase 1b/2 study examined the safety and efficacy of oprozomib with dexamethasone in patients with relapsed and refractory MM. Oprozomib was administered with a 5/14 or 2/7 schedule with dexamethasone. Phase 1b primary objectives were to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of oprozomib; phase 2 primary objectives were to determine overall response rate (ORR) and safety/tolerabilit...
Treatment for AL amyloidosis aims to eradicate clonal plasma cells, thereby disrupting the amyloid deposition causing organ damage. Risk-adapted high-dose melphalan plus autologous stem cell transplantation (RA-ASCT) is an effective therapy. We conducted a prospective pilot analysis of a comprehensive approach using bortezomib and dexamethasone (BD) pre- and post-RA-ASCT in 19 patients. BD induction (up to 3 cycles of bortezomib 1.3 mg/m intravenously [IV] and dexamethasone 40 mg orally [PO] or IV, days 1, ...
GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy-study protocol.
Prostate cancer is the third most important cancer in terms of mortality in men. No standard local treatment exists for patients with an intraprostatic recurrence after radiotherapy. Stereotatic body radiotherapy (SBRT) could be a curative treatment for local recurrence. The phase I/II primary objective is the selection of the recommended dose for salvage-SBRT and to estimate the efficacy.
OTX-101 (CEQUA™) is approved in the United States for treatment of keratoconjunctivitis sicca (KCS). This pooled analysis of 2 studies (phase 2b/3 and phase 3) evaluates the efficacy and safety of OTX-101 0.09% in the intent-to-treat (ITT) population and the subgroup of patients with a baseline Schirmer score less than 10 mm.
Dexamethasone is a synthetic steroid that has been used for many years in the clinical routine due to its anti-inflammatory, anti-allergic and immunosuppressive properties. Furthermore, dexamethasone has been used for a long time for prophylaxis and treatment of chemotherapy-induced nausea and vomiting. In the meantime dexamethasone has been approved as standard for the prophylaxis and treatment of postoperative nausea and vomiting (PONV). This review article outlines the indications and side effects of t...
To assess the efficacy and safety of prenatal dexamethasone treatment in offspring at risk for congenital adrenal hyperplasia.
Recently, phase III trials assessed a new combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) in induction therapy in transplantation-eligible Multiple Myeloma (MM) patients, before consolidation with RVD and Lenalidomide maintenance. We present a retrospective study evaluating this approach with patients from the real life.
The aim of this study was to develop dexamethasone loaded nanoparticles for the local treatment of oral precancerous lesions. Dexamethasone loaded nanoparticles were prepared using the emulsification/solvent evaporation method. The prepared nanoparticles were characterised for pH, particle size, polydispersity index, zeta potential, morphology, encapsulation efficiency and drug loading. Furthermore, drug release, stability, drug diffusion and cell culture studies were undertaken. The particle size, polydi...
Hematopoietic stem cell transplant (HSCT) is an intensive treatment associated with distressing treatment and disease-related symptoms that affect patient outcomes such as functional status and quality of life. Self-efficacy for symptom management (SESM) is a person's belief in their ability to perform behaviors to prevent and relieve symptoms. Presence of SESM can impact symptom distress and functional status. This study describes the changes over time and relationships among SESM, symptom distress, and ph...
Microsurgery is a treatment option for dural arteriovenous fistula (DAF), but its efficacy is still unclear. This study aims to assess the efficacy and safety of microsurgery for the treatment of patients with DAF.
SIRT is an established treatment option for liver malignancies. Metabolic information can provide additional knowledge about tumoral characteristics and treatment response. FDG-PET/CT was shown to be advantageous for pre-/post-SIRT evaluation. However, whole-body PET/CT is an elaborate procedure. The aim of the study was to optimize clinical efficacy assessment after SIRT with a low-dose, low-cost protocol for focused diagnostic work-up.
Bezlotoxumab is a fully human monoclonal antibody that binds and neutralizes Clostridium difficile toxin B. This analysis investigated the potential of bezlotoxumab to induce immunogenicity in healthy phase 1 trial participants and in phase 2/3 trial participants receiving oral antibacterial therapy for primary or recurrent C difficile infection. Immunogenicity to bezlotoxumab was evaluated following a single intravenous dose (≤20 mg/kg) or 2 consecutive doses (10 mg/kg) given 84 days apart in healthy p...
To compare the efficacy and safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection versus dexamethasone implant (Ozurdex) for the treatment of center-involved DME (CiDME).
Phase II study to evaluate the efficacy of Trastuzumab in combination with Capecitabine.
The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.
ObjectiveTo study the effectiveness and safety of the intravitreal dexamethasone implant 0.7mg (Ozurdex®) in vitrectomy surgery for epiretinal membrane.MethodsThis is a prospective, multicenter, pilot study. Inclusion criteria included visually significant (
To continue the assessment of the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults (NCT02670538).
Phase II study of neoadjuvant treatment of sequential S-1-based concurrent chemoradiotherapy followed by systemic chemotherapy with gemcitabine for borderline resectable pancreatic adenocarcinoma (HOPS-BR 01).
Preoperative treatment is recommended for borderline resectable pancreatic ductal adenocarcinoma (BR-PC). However, the standard treatment has not yet been determined. We conducted a multicenter phase II study to investigate the efficacy of neoadjuvant treatment of sequential chemoradiation followed by chemotherapy.
Selective dorsal rhizotomy (SDR) is a surgical procedure used to treat spasticity in children with spastic cerebral palsy. Currently, there is a lack of work examining the efficacy of optimizing pain management protocols after single-level laminectomy for SDR. This pilot study aimed to compare the clinical outcomes of SDR completed with a traditional pain management protocol versus one designed for opioid dosage reduction.
Combinations of bortezomib (Velcade), cyclophosphamide and dexamethasone have shown significant efficacy and safety for patients of newly diagnosed multiple myeloma (NDMM). In this study, we compared the efficacy and safety of modified VCD regimens with novel changes in bortezomib dose and schedule for NDMM.
This study will aim to systematically explore the efficacy of resveratrol for the treatment of patients with ulcerative colitis (UC).
Insomnia is a significant problem for many adolescents and often is associated with detrimental effects on physical and mental health. Drawing on emerging models of intervention in the adult literature, this pilot study investigated the efficacy, safety, and acceptability of a novel, brief (3-week) behavioral intervention among adolescents with unresolved chronic insomnia.
The increasing incidence of nonmelanoma skin cancer (NMSC) poses a serious public health concern. Standard care for basal cell carcinoma (BCC) requires patients to attend multiple visits for diagnosis and treatment. This pilot study describes a model of care that aims to alleviate some of the demand placed both on the specialty and on patients by utilizing a novel same-day approach to BCC management with noninvasive diagnosis, same-day treatment, and noninvasive imaging follow-up. This study evaluates the e...
Secondary lymphedema is a serious and debilitating condition, which may cause a range of cutaneous, infectious and joint complications with major psychological and social consequences. There is no curative treatment available. Initial symptomatic treatment includes Intensive Decongestive Treatment (IDT), which involves the use of multi-layered compression bandages, along with manual lymph drainage, physical exercise and skin care. IDT leads to an average decrease in limb volume of 20-40%, when compared to t...
Chronic inflammatory diseases such as psoriasis require treatment options that maintain efficacy and tolerability during extended treatment.