Search results for "clinical trial"
showing 10 items of 1656 documents
MINIMIZING INFLIXIMAB TOXICITY IN THE TREATMENT OF INFLAMMATORY BOWEL DISEASE
2008
Abstract Background Infliximab is a widely used biological agent for the treatment of inflammatory bowel disease, and has a favorable risk/benefit ratio. Aim It is useful to know that patients treated with infliximab are exposed to developing adverse events that could be reduced with a prudent and a rational clinical approach and by optimizing the treatment protocol. Methods PubMed (including Epub) was searched in October 2006 and again in March 2007. Results The high immunogenic potential of infliximab determines the antibodies that inhibit the effect of infliximab and the appearance of subsequent acute and delayed infusion reactions. Infliximab has an immunomodulatory effect, thus increas…
MDS-191: Long-Term Efficacy and Safety of Luspatercept in Lower-Risk Myelodysplastic Syndromes (MDS): Phase 2 PACE-MDS Study
2020
Background: Luspatercept, a first-in-class erythroid maturation agent, has been investigated in patients with LR-MDS and ring sideroblasts (RS) (MEDALIST; Fenaux and Platzbecker NEJM 2020) and in an ongoing Phase 3 trial regardless of RS status (COMMANDS, NCT03682536 ). The previously reported Phase 2 trial of luspatercept (Platzbecker Lanc Onc 2017) includes subtypes of LR-MDS with and without RS, regardless of prior ESA exposure, and various EPO levels. Aims: Evaluate the long-term safety and efficacy of luspatercept in LR-MDS. Methods: Patients were IPSS low/int-1, age ≥ 18 years, Hgb NCT01749514 ; NCT02268383 ). Results: As of 13July2019, 115 patients were enrolled, of whom 108 were tre…
Single-Center-Single-Blinded Clinical Trial to Evaluate the Efficacy of a Nutraceutical Containing Boswellia Serrata, Bromelain, Zinc, Magnesium, Hon…
2022
Some nutraceuticals have been studied as supportive treatment for fighting upper respiratory tract infection and middle ear disease. Our study aims at evaluating the effect of a specific oral supplementation in the treatment of pediatric otits media. The subjects were randomly assigned by the physician (single-blinded study) to one of three groups: Control Group (CG), Treatment Group 1 (TG1), or Treatment Group 2 (TG2). Both TG were treated with Flogostop Duo (for 20 days—TG1 or 30 days—TG2) in combination with the standard treatment, while CG underwent standard treatment only. The standard treatment was nasal aerosol with Fluticasone and Mucolytic, and nasal washing with hypertonic solutio…
Le petit appétit du grand âge
2018
National audience
Antioxidant Therapies and Oxidative Stress in Friedreich´s Ataxia: The Right Path or Just a Diversion?
2020
Friedreich's ataxia is the commonest autosomal recessive ataxia among population of European descent. Despite the huge advances performed in the last decades, a cure still remains elusive. One of the most studied hallmarks of the disease is the increased production of oxidative stress markers in patients and models. This feature has been the motivation to develop treatments that aim to counteract such boost of free radicals and to enhance the production of antioxidant defenses. In this work, we present and critically review those 'antioxidant' drugs that went beyond the disease's models and were approved for its application in clinical trials. The evaluation of these trials highlights some …
Efficacy of “Family Connections”, a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol f…
2020
Abstract Background Patients with borderline personality disorder (BPD) experience significant affect regulation difficulties that cause serious consequences in their work, emotional, and social environments. This dysfunctional pattern also produces great suffering and a heavy burden on their relatives. Fortunately, some studies show that treatment of relatives of people with BPD begins to be important in the patients’ recovery and in improving family dynamics. One of the treatments that has obtained the most empirical support is Family connections (FC). This 12-session program is an adaptation of different Dialectical Behavior Therapy strategies. To test the efficacy of FC, five uncontroll…
Efficacy and safety of photodynamic therapy with RLP068 for diabetic foot ulcers: a review of the literature and clinical experience
2020
This article is the second part of a literature review concerning diabetic foot ulcers (DFUs) and the use of antimicrobial photodynamic therapy (PDT). PDT involves the topical application of a photosensitiser into the tissue, followed by illumination that induces the formation of reactive oxygen species (ROS). PDT provides bacterial inactivation and promotes wound healing, and it can be used to manage the infection and microbial colonisation of DFUs. It has pivotal advantages in comparison with chemotherapeutics, such as no potential to induce resistance, and a wide spectrum of activity. Tetracationic Zn(II) phthalocyanine derivatives have been developed for PDT. Among these, we would like …
Safety and potential interaction of immunosuppressive drugs for the treatment of inflammatory bowel disease in elderly patients
2021
Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, are chronic diseases associated with increased morbidity and reduced quality of life. Age may represent a risk factor for adverse events, due to the multimorbidity and polypharmacy, common in elderly patients. Elderly are often not included in clinical trials evaluating efficacy and safety of study drugs for the treatment of inflammatory bowel diseases. Several drugs, such as aminosalicylates, systemic corticosteroids, immunosuppressant drugs, biological drugs and Janus Kinase inhibitors, are available for the management of inflammatory bowel diseases. With the increasing spectrum of therapeutic options, it is th…
Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b vaccine; Infanrix™ hexa: T…
2014
Infant vaccination using 2-dose priming at 3 and 5 mo of age with a booster at 11–12 mo of age was pioneered in Italy. The 3-5-11 schedule is now used in a growing number of European countries. Infanrix™ hexa (DTPa-HBV-IPV/Hib, GlaxoSmithKline Vaccines) was first licensed for use in 2000 and has been the only pediatric hexavalent vaccine available since 2005. We reviewed available clinical trial data describing the immunogenicity of DTPa-HBV-IPV/Hib when administered at 3, 5, and 11 mo of age, and conducted an analysis of safety using global and Italian post-marketing surveillance data. In Italy, DTPa-HBV-IPV/Hib has a demonstrated safety record extending over a decade of use, it has been a…
Percutaneous Recanalization of Chronic Total Occlusions : 2019 Consensus Document from the EuroCTO Club
2019
Since its inception in December 2006, the EuroCTO Club has strived to provide the framework for state-of-the-art chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in Europe and nearby regions. Among its initiatives, the EuroCTO Club has published a set of recommendations regarding the technical aspects of CTO PCI, whose last edition dates to 2012. The EuroCTO Club consensus document discusses CTO PCI clinical indications, techniques and equipment use, as well as the qualifications of operators/centres. Given the considerable amount of progress made by this subspecialty in recent years, there is a need for an updated document that includes data from recent clinical trial…