Search results for "Phase"
showing 10 items of 6344 documents
Is there a role for recombinant tumor necrosis factor alpha in the intravesical treatment of superficial bladder tumors?--a phase II study
1995
Clinical use of recombinant tumor necrosis factor-alpha is strongly limited by its severe toxicity, mainly cardiovascular, when systemically administered. Recent studies suggest that topical (intrapleural, intraperitoneal, intratumoral) administration is free of significant toxicity. Human recombinant tumor necrosis factor-alpha was administered intravesically, at a dose of 500 mg dissolved in 30 ml of phosphate buffer (pH7.6-7.8) plus 0.25% human albumin, weekly for two months to 18 patients with papillary transitional cell carcinoma of the bladder. Of the 15 evaluable patients, four (26%) achieved a complete response. Systemic and local tolerability were excellent. Int J Urol 1995;2:100-1…
Luspatercept Response in ESA-NaïVe/RS+ Patients and RS- Patients with Low-Intermediate Risk Myelodysplastic Syndromes (MDS)
2016
Abstract Background: Management of anemia is a common therapeutic challenge in patients with myelodysplastic syndromes (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 study to evaluate the effects of luspatercept in patient (pts) with low-intermediate risk MDS. Endpoints included erythroid response (IWG HI-E), RBC transfus…
Clinical Efficacy of Laquinimod for the Treatment of Multiple Sclerosis; Pooled Analyses from the ALLEGRO and BRAVO Phase III Trials (S01.007)
2012
Objective: The current report provides detail on pooled analyses assessing the effect of laquinimod on relapse, disability, and brain atrophy measures from the recently completed phase III trials ALLEGRO and BRAVO. Background Laquinimod is an oral, CNS acting immunomodulator in development for the treatment of multiple sclerosis. Its impact on disability progression and brain atrophy, two indices of longterm outcome for patients with multiple sclerosis (MS) are being studied in its phase III trials. Design/Methods: MS patients (N=2437) were randomized to laquinimod (n=984) or placebo (n = 1006). In both trials, patients underwent neurological examinations including the Expanded Disability S…
A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic ha…
2021
BACKGROUND: Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. METHODS: In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who re…
PAP/HIP Protein Is an Obesogenic Factor
2013
In this article we report the obesogenic role of the acute phase protein PAP/HIP. We found that the transgenic TgPAP/HIP mice develop spontaneous obesity under standard nutritional conditions, with high levels of glucose, leptin, and LDL and low levels of triglycerides and HDL in blood. Accordingly, PAP/HIP-deficient mice are skinny under standard nutritional conditions. We also found that expression of PAP/HIP is induced in intestinal epithelial cells in response to gavage with olive oil and this induction is AG490 sensitive. We demonstrated that incubation of 3T3-L1 preadipocytes with a low concentration as 1 ng/ml of recombinant PAP/HIP results in accelerated BrdU incorporation in vitro.…
Turpentine-induced fever during stimulation and inhibition of hepatic protein synthesis
2003
Abstract 1. Male Wistar rats pretreated with d -galactosamine (500 mg/kg, i.p.), a specific inhibitor of hepatic protein synthesis, developed attenuated and prolonged fever in response to turpentine (0.5 ml/rat, s.c.). 2. Hepatic protein synthesis stimulator epinephrine (1.8 mg/kg, s.c.) did not affect body temperature response of Wistar rats to turpentine. 3. Both d -galactosamine (500 mg/kg) and epinephrine (1.8 mg/kg) failed to affect body temperature in non-febrile rats. 4. These data support the hypothesis that liver-synthesised acute phase proteins might be involved in mechanisms of fever, probably, as modulators of activated cytokine network, mediating febrile response.
Behavioural treatment of improper eating by an institutionalised woman with profound intellectual disability—description of a successful intervention
2002
Intensive 11-day behavioural training of an institutionalised woman with profound intellectual disability was used to teach proper eating by reducing her eating errors. The methods used included an increased number of learning opportunities, graduated guidance, the use of social reinforcement, and mild punishment through simple correction of eating errors. The treatment was faded into a maintenance phase. After the intensive training phase, the participant ceased to eat with her fingers from a plate, and her eating changed to a more tidy habit. She was also released from having her hand tied during the meals. The results were maintained during an informal follow-up 4 years later.
Anteil des frühen systolischen Flussanstiegs am antegrad fließenden Gesamtvolumen bei Phasenkontrast-Flussmessungen in Atemanhaltetechnik
2005
Purpose To evaluate the contribution of early systole for the assessment of antegrade aortic flow volume by breath-hold velocity-encoded magnetic resonance (MR) flow measurements. Materials and methods Expiratory breath-hold fast low-angle shot (FLASH) phase-contrast flow measurements (temporal resolution tRes 61 msec, shared phases) perpendicular to the proximal ascending aorta and short axis true fast imaging with steady-state precession (TrueFISP) cine MR ventriculometry (tRes 34.5 msec) were performed in ten healthy male volunteers on a 1.5 T MR system (Sonata, Siemens Medical Solutions). Antegrade aortic flow volume (AFV) and left ventricular stroke volume (LV-SV) were evaluated using …
The Italian paediatric society raccomandations on children and adolescents extra-domestic activities during the SARS COV-2 emergency phase 2
2020
Abstract Background Due to novel coronavirus infection emergency, restricting measures have been imposed in Italy. As well as adults, also children are limited in their daily routine. Main text As the lockdown period is expected to end on 3rd May 2020, we discuss the opportunity for children to practice safely recreational or physical activity outdoor. Conclusion The Italian Paediatric Society recommends specific recreational and physical activities according to the age of the children and respecting social distancing.
OneShot-M: A New Device for Close Laparoscopy Pneumoperitoneum
2018
Introduction. The induction of pneumoperitoneum is the first and most critical phase of laparoscopy, due to the significant risk of serious vascular and visceral complications. The closed technique for the creation of pneumoperitoneum could lead to several surgical complications. The present study aimed to overcome the complications associated with the insertion of Veress needle, improving its use, and facilitating the rapid creation of pneumoperitoneum. Methods. Thirty large white female pigs were enrolled in our study. A common plunger was modified in order to allow the passage of a 15-cm long Veress needle. This method was applied to 26 laparoscopic procedures (26 pigs) of several speci…