Search results for "Randomized Controlled Trials as Topic"
showing 10 items of 435 documents
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…
Improvement in quality of life with omalizumab in patients with severe allergic asthma.
2006
Patients with severe persistent asthma experience daily symptoms and frequent serious exacerbations that contribute to a significant impairment of health-related quality of life (QoL).A pooled analysis was completed of six controlled clinical trials that evaluated the effect of add-on omalizumab on asthma-related QoL in patients with severe persistent allergic (IgE-mediated) asthma. Asthma-related QoL was assessed at baseline and treatment endpoint using the well-validated Juniper Asthma Quality of Life Questionnaire (AQLQ). Change from baseline in AQLQ total score was compared between treatments using analysis of covariance methods. The percentage of patients who achieved a clinically mean…
Tobacco smoking and nicotine dependence in first episode and established psychosis
2019
Aim\ud People with psychotic disorders have increased premature mortality in comparison with the general population, with high rates of cigarette use a contributing factor. We aimed to describe the prevalence of cigarette use and nicotine dependence (ND) in first episode psychosis (FEP), and established psychosis; and to investigate associations between clinical symptoms and ND.\ud \ud Methodology\ud Smoking and clinical data were collected from two cohorts: 181 people with FEP recruited as part of the Physical Health and Substance Use Measures in First Onset Psychosis (PUMP) study and from 432 people with established psychosis recruited as part of the Improving\ud physical health and reduc…
Benchmarking of cognitive-behavioral therapy for depression in efficacy and effectiveness studies--how do exclusion criteria affect treatment outcome?
2011
Abstract Objective: Little is known about how exclusion criteria applied in randomized controlled trials (RCTs) affect the transfer of psychotherapy outcome research to naturalistic settings. This study evaluated the effects of naturalistic depression therapies and benchmarked them with published RCTs. Method: Commonly used exclusion criteria were applied to n=338 depressive patients receiving cognitive-behavioral therapy. Outcomes of the resulting subsample eligible for RCTs were compared to those reported in RCTs. Results: Treatment outcomes of the total sample (d=1.16) and the subsample eligible for RCTs (d=1.15) were highly similar. Therapy outcome was worse than in high-quality RCTs (d…
Psychological interventions to foster resilience in healthcare students
2020
Background Resilience can be defined as maintaining or regaining mental health during or after significant adversities such as a potentially traumatising event, challenging life circumstances, a critical life transition or physical illness. Healthcare students, such as medical, nursing, psychology and social work students, are exposed to various study- and work-related stressors, the latter particularly during later phases of health professional education. They are at increased risk of developing symptoms of burnout or mental disorders. This population may benefit from resilience-promoting training programmes. Objectives To assess the effects of interventions to foster resilience in healthc…
Influence of Thymopentin on Antibody Response, and Monocyte and T Cell Function in Hemodialysis Patients Who Fail to Respond to Hepatitis B Vaccinati…
1990
We investigated the influence of thymopentin as an adjuvant for hepatitis B vaccination on in vitro monocyte and T cell function and in vivo antibody response in a prospective, placebo-controlled double-blind trial in 20 low- and nonresponders to hepatitis B vaccination on chronic hemodialysis. 50 mg thymopentin was given subcutaneously twice per week for 3 weeks, followed by 1 intramuscular injection of 40 micrograms HB-Vax and 3 subsequent injections of thymopentin. After 1 month, the patients were boostered with 40 micrograms HB-Vax. There was no significant difference in T cell and monocyte function after administration of thymopentin, as determined in vitro. After 3 months, 3 patients …
Prevalence and management of pain in Italian patients with advanced non-small-cell lung cancer
2004
Pain is a highly distressing symptom for patients with advanced cancer. WHO analgesic ladder is widely accepted as a guideline for its treatment. Our aim was to describe pain prevalence among patients diagnosed with advanced non-small-cell lung cancer (NSCLC), impact of pain on quality of life (QoL) and adequacy of pain management. Data of 1021 Italian patients enrolled in three randomised trials of chemotherapy for NSCLC were pooled. QoL was assessed by EORTC QLQ-C30 and LC-13. Analgesic consumption during the 3 weeks following QoL assessment was recorded. Adequacy of pain management was evaluated by the Pain Management Index (PMI). Some pain was reported by 74% of patients (42% mild, 24% …
Enhancing the efficacy of integrative improvisational music therapy in the treatment of depression : study protocol for a randomised controlled trial
2019
Abstract Background Depression is among the leading causes of disability worldwide. Not all people with depression respond adequately to standard treatments. An innovative therapy that has shown promising results in controlled trials is music therapy. Based on a previous trial that suggested beneficial effects of integrative improvisational music therapy (IIMT) on short and medium-term depression symptoms as well as anxiety and functioning, this trial aims to determine potential mechanisms of and improvements in its effects by examining specific variations of IIMT. Methods/design A 2 × 2 factorial randomised controlled trial will be carried out at a single centre in Finland involving 68 adu…
Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care:Study protocol for a randomis…
2018
Background: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TA…