Search results for "Adverse effect"

Pharmacological Management of Cancer Pain in the Elderly

2007

Existing studies indicate a high prevalence rate and poor management of cancer pain in the elderly. Pain is often considered an expected concomitant of aging, and older patients are considered more sensitive to opioids. Despite the well known pharmacokinetic changes in the elderly, the complex network of factors involved in the opioid response make the evaluation of a single element, such as age, more difficult. Notwithstanding such difficulties, appropriate analgesic treatment is able to control cancer pain in the elderly in most cases. Skills necessary to optimise pain control in older cancer patients include the ability to objectively assess functional age (not necessarily related to chr…

Opioid less perioperative care.

2017

Opioids are the most frequently administered analgesics in the perioperative period. The analgesic potency of opioids is without question. While the opioid- free or opioid-less perioperative care concept is not a reality in most surgical centers of the United States and other developed countries, there is a significant number of healthcare problems (i.e. adverse events, opioid-induced hyperalgesia and opioid diversion) related to the indiscriminate use of opioids that warrants the implementation of multimodal analgesia strategies. Although it has been suggested an association between the use of opioids and cancer progression, there is a need of well-designed studies to confirm that associat…

Evaluation of Safety, Tolerability and Efficacy of Temsirolimus in Patients with Relapsed or Refractory Mantle Cell Lymphoma (Rel/Refr Mcl) in Routin…

2014

ABSTRACT Aim: Temsirolimus (TEMS), an mTOR-inhibitor, is approved in the EU for the treatment of patients (pts) with relapsed or refractory (rel/refr) MCL. A pivotal study demonstrated significantly longer progression free survival with TEMS (175 mg weekly for 3 weeks followed by 75 mg weekly) in rel/refr MCL pts compared to investigatoŕs choice therapy (4.8 mo vs 1.9 mo; P = .0009). To evaluate safety and efficacy of TEMS in an unselected patient population during clinical routine, a prospective non-interventional study with TEMS in rel/refr MCL pts is useful. Here we report on interim results of the study. Methods: A German multicenter registry for rel/refr MCL pts treated with TEMS was s…

Luspatercept Increases Hemoglobin and Reduces Transfusion Burden in Patients with Low-Intermediate Risk Myelodysplastic Syndromes (MDS): Long-Term Re…

2016

Abstract Background: Management of anemia is a common therapeutic challenge in patients with MDS. Luspatercept (ACE-536), a fusion protein containing modified activin receptor type IIB, is being developed for treatment of anemia in lower-risk MDS. Luspatercept binds GDF11 and other TGF-β superfamily ligands to promote late-stage erythroid differentiation and increase hemoglobin (Hgb) levels (Suragani R, Nat Med, 2014 and Attie K, Am J Hematol, 2014). Aims: This is an ongoing, phase 2, multicenter, open-label, long-term extension study to evaluate the effects of luspatercept in patients (pts) with low-intermediate risk MDS. Endpoints include long-term safety and tolerability, erythroid respo…

Cardiac arrhythmia induced by hypothermia in a cardiac model in vitro

2013

The neurological damage after cardiac arrest (CA) constitutes a big challenge of hospital discharge since years. The therapeutic hypothermia therapy (34°C-32°C) has shown its benefit to reduce cerebral oxygen demand and improve neurological outcomes after the cardiac arrest. Despite the fact that induced hypothermia after CA has been shown to increase the hospital survival rate, it can have many adverse effects, among which the cardiac arrhythmia generation represents an important part (up to 34%, according different clinical studies). Compared to studies in vivo, cardiac culture in vitro provides a better spatial resolution at cellular level, which could bring some insights of the mechanis…

Possible Adverse Effects of Hyperventilation on rCBF during the Acute Phase of Total Proximal Occlusion of a Main Cerebral Artery

1969

Recent studies seem to favor a beneficial effect of hyperventilation (HV) in cases of cerebrovascular occlusion [1, 4] and brain trauma [2, 5]. On the other hand, it seems that, at least under certain circumstances, HV may exert an adverse effect upon cerebral blood flow and metabolism [3]. Since this question is not settled yet, it seems worthwhile to report briefly the present case of reversible total occlusion of the middle cerebral artery closely followed by successive rCBF studies (133Xe-gamma-clearance method), in which, during the acute phase, HV caused a latent ischemia to become manifest.

<tocheading>Original Article</tocheading>

1999

In this double-blind clinical trial 429 patients (217 terbinafine and 212 clotrimazole) were randomized to receive twice daily terbinafine 1% topical solution for 1 week followed by a vehicle application for 3 weeks, or 1% clotrimazole solution for 4 weeks. Patients were evaluated clinically and mycologically at baseline and then at weeks one, two, four (end of treatment), and eight (end of follow-up). To be evaluable the patient needed to have a positive culture for a dermatophyte and positive KOH microscopy and a clinical diagnosis of tinea pedis (interdigital type) at baseline. Effective treatment of tinea pedis was recorded in 181 of 217 (83%) of patients treated for 1 week with terbina…

Evaluation of Safe and Effectiveness of an Injectable Solution Acid Deoxycholic Based for Reduction of Localized Adiposities

2018

Background:. The use of deoxycholic acid to reduce localized fat deposits is a procedure that has been in use for about 30 years. Its effectiveness as treatment is due to emulsification of phospholipids and therefore, solubilization of the biological membranes with resulting fat necrosis. The purpose of the study was to assess the effectiveness and the safety of an injectable solution containing sodium deoxycholtate 1.25% (DB125), used as intralipotherapy. Methods:. The effectiveness and safety of DB125 solution have been assessed with a multicentre observational prospective study carried out between February and October 2017. The 221 selected patients presented with various forms and degre…

Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regime…

2013

Abstract Background:  Interleukin-17A has major proinflammatory activity in psoriatic lesional skin. Objectives:  Assess the efficacy and safety of secukinumab, a fully human IgG1κ monoclonal anti-interleukin-17A antibody, in moderate-to-severe plaque psoriasis in a phase II regimen-finding study. Methods:  404 patients were randomised to subcutaneous placebo (67 patients) or one of three secukinumab 150 mg induction regimens: Single (week 0; 66 patients), Early (weeks 0, 1, 2, 4; 133 patients), and Monthly (weeks 0, 4, 8; 138 patients). The primary outcome was ≥75% improvement from baseline Psoriasis Area and Severity Index (PASI) score at week 12. PASI 75 responders from active treatment …

2021

Abstract Strong evidence suggests that endoplasmic reticulum stress plays a critical role in the pathogenesis of amyotrophic lateral sclerosis (ALS) through altered regulation of proteostasis. Robust preclinical findings demonstrated that guanabenz selectively inhibits endoplasmic reticulum stress-induced eIF2α-phosphatase, allowing misfolded protein clearance, reduces neuronal death and prolongs survival in in vitro and in vivo models. However, its safety and efficacy in patients with ALS are unknown. To address these issues, we conducted a multicentre, randomized, double-blind trial with a futility design. Patients with ALS who had displayed an onset of symptoms within the previous 18 mon…