Search results for " trials"
showing 10 items of 932 documents
Factors associated with maximal walking speed among older community-living adults.
2011
Background and aims: The relative contribution of different domains on walking speed is largely unknown. This study investigated the central factors associated with maximal walking speed among older people. Methods: Cross-sectional analyses of baseline data from the SCAMOB study (ISRCTN 07330512) involving 605 community-living ambulatory adults aged 75–81 years. Maximal walking speed, leg extensor power, standing balance and body mass index were measured at the research center. Physical activity, smoking, use of alcohol, chronic diseases and depressive symptoms were self-reported by standard questionnaires. Results: The mean maximal walking speed was 1.4 m/s (range 0.3–2.9). In linear regre…
Final report of the efficacy and safety of gemtuzumab ozogamicin (Mylotarg) in patients with CD33-positive acute myeloid leukemia in first recurrence
2005
BACKGROUND In this study, the authors analyzed the efficacy and safety of gemtuzumab ozogamicin (GO) (Mylotarg®), an antibody-targeted chemotherapy for CD33-positive acute myeloid leukemia (AML). METHODS Patients with CD33-positive AML in first recurrence were entered in 3 open-label, single-arm, Phase II studies. Patients received monotherapy with GO 9 mg/m2 as a 2-hour intravenous infusion in 2 doses separated by 2 weeks. Patients were evaluated for remission, survival, and treatment-emergent adverse events. RESULTS Two hundred seventy-seven patients (median age, 61 yrs) were treated with GO, and 71 patients (26%) achieved remission, which was defined as ≤ 5% blasts in the bone marrow wit…
Sublingual administration of captopril in patients with acute myocardial ischemia.
1991
Summary: To investigate the anti-ischemic capability of the angiotensin-converting enzyme inhibitor captopril, 10 patients with acute myocardial ischemia (angina pectoris >1 h, ST-segment depression ±0.1 mV, no rise in creatine phosphokinase) received 25 mg captopril sublingually after being treated with an intravenous infusion of nitroglycerin (3 mg/h) and heparin (1200 IU/h) for 1 hour. A control group of 10 patients received placebo instead of captopril. Results showed a decrease of the initial ST-segment depression from 0.25±0.04 to 0.2±0.03 mV (p>0.01) with nitroglycerin for the captopril group and from 0.26±0.05 to 0.21±0.05 mV (p>0.01) for the control group. An additional decrease to…
Temsirolimus for the treatment of mantle cell lymphoma.
2010
Although recent progress has been made in the treatment of mantle cell lymphoma (MCL) the majority of patients experience relapse and ultimately die of their disease. The translocation t(11;14) is a prerequisite for the diagnosis of MCL and results in overexpression of cyclin D1. Its protein translation is controlled by mTOR, a key element of the PI3K/Akt pathway, and mTOR constitutes an attractive therapeutic target. Temsirolimus, a specific inhibitor of mTOR, has been evaluated in two Phase II trials in patients with relapsed MCL, and promising response rates up to 40% were found. Subsequently, a randomized Phase III trial was initiated, in which superiority in remission induction and pro…
Treatment of Ulcerative Colitis with Olsalazine and Sulphasalazine: Efficacy and Side-Effects
1988
The effects of olsalazine were studied mainly in patients with ulcerative colitis who were intolerant to sulphasalazine, and for relapse prevention. A crossover design with sulphasalazine, 3 g/day, and olsalazine, 1.5 g/day, was applied to compare the side-effects of each drug and to evaluate their therapeutic efficacy. A total of 41 patients with mild or moderately severe left-sided colitis or proctitis were assigned to a randomized treatment schedule. Olsalazine and sulphasalazine were similar in their therapeutic efficacy. Twelve patients complained of adverse effects while on sulphasalazine and 4 patients during olsalazine treatment (p less than 0.05). It is concluded that olsalazine is…
Health benefits of different sport disciplines for adults: systematic review of observational and intervention studies with meta-analysis
2015
The aim was to assess the quality and strength of evidence for the health benefits of specific sport disciplines. Electronic search yielded 2194 records and the selection resulted in 69 eligible studies (47 cross-sectional, 9 cohort, 13 intervention studies). 105 comparisons between participation and non-participation groups in 26 different sport disciplines were reported. Moderately strong evidence showed that both running and football improve aerobic fitness and cardiovascular function at rest, and football reduces adiposity. Conditional evidence showed that running benefits metabolic fitness, adiposity and postural balance, and football improves metabolic fitness, muscular performance, p…
Avelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer patients with microsatellite instability: The SAMCO-PRODI…
2021
Abstract Immune checkpoint inhibitors have failed in treating metastatic colorectal cancer (mCRC) patients except those with dMMR/MSI tumors. However, until very recently we had only non-comparative promising data in this population with anti-programmed cell death 1/ programmed cell death ligand 1 (PD1/PD-L1) antibodies alone or combined with anti- cytotoxic T-lymphocyte-associated protein 4 (CTLA4) antibodies. This comparative phase II trial (NCT 03186326), conducted in more than 100 centers in France, will include dMMR/MSI mCRC patients with progression after a first-line treatment with chemotherapy ± targeted therapies, to evaluate efficacy and safety of the anti-PDL1 Avelumab versus a s…
Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of three randomised trials
2005
Summary Background Chemotherapy is the standard treatment for advanced non-small-cell lung cancer, and myelosuppression is a common side-effect. We aimed to assess whether haematological toxic effects could be a biological measure of drug activity and a marker of efficacy. Methods We analysed data for 1265 patients who received chemotherapy (vinorelbine, gemcitabine, gemcitabine and vinorelbine, cisplatin and vinorelbine, or cisplatin and gemcitabine) within three randomised trials. Primary landmark analyses were restricted to 436 patients who received all six planned chemotherapy cycles and who were alive 180 days after randomisation. Neutropenia was categorised on the basis of worst WHO g…
Quantitative sensory testing: a comprehensive protocol for clinical trials.
2004
We have compiled a comprehensive QST protocol as part of the German Research Network on Neuropathic Pain (DFNS) using well established tests for nearly all aspects of somatosensation. This protocol encompasses thermal as well as mechanical testing procedures. Our rationale was to test for patterns of sensory loss (small and large nerve fiber functions) or gain (hyperalgesia, allodynia, hyperpathia), and to assess both cutaneous and deep pain sensitivity. The practicality of the QST protocol was tested in 18 healthy subjects, 21-58 years, half of them female. All subjects were tested bilaterally over face, hand and foot. We determined thermal detection and pain thresholds including a test fo…
Strategy for Long-Term Surveillance at the German Childhood Cancer Registry - an Update
2011
Background The objective of this paper is to provide information about the quality (e.g. completeness, response) of long-term surveillance in German paediatric oncology and haematology based on the structures implemented by the German Childhood Cancer Registry (GCCR). Methods The GCCR contacts parents or patients to collect and update information on a minimal set of follow-up health status data (e.g. late relapses, subsequent neoplasms, current address) and exchanges this information regularly with the appropriate clinical trials. Results Between 2006 and 2010, GCCR approached a total of about 20,000 patients (contact at the age of 16 years, inquiry concerning the health status) in the cont…