Search results for " trial"
showing 10 items of 3715 documents
Follow Up On CD8-Depleted Donor-Lymphocyte Infusions After T-Cell Depleted Allogeneic Hemopoietic Stem Cell Transplantation
2013
We applied prophylactic CD8-depleted (CD8depl) donor lymphocyte infusions (DLI) in the setting of T-cell depleted reduced-intensity allogeneic hematopoietic stem cell transplantation (HSCT) in a phase I/II trial. T-cell depletion was carried out by the use of high-dose Alemtuzumab (100 mg or 60 mg for unrelated or sibling donor transplantation, respectively). We have demonstrated the feasibility of this approach after having treated 23 patients in this protocol (Meyer et al. Blood 2007). From 2004 to 2011, 134 patients with different hematologic diseases were included and followed for a median observation time of 1.5 years after transplantation (range, 1.5-9 years). Median age was 56 years …
Clinical research focused in European adult women with minority diseases: Do we try hard enough?
2021
We analyzed the European countries participation in clinical trials addressing to new drug development focused on rare diseases in women comparing to more prevalent diseases as breast cancer. Participation was not associated with type of healthcare system neither socio-economic features, but it was associated with population size. Protocol ratios focused on breast cancer vs. orphan drugs and rare diseases was 15:1 and 9:1, respectively, mainly focused on ovarian cancer. Protocol number was insufficient to evaluate the success of Regulation (EC) 141/2000, it is necessary to increase the scientific quality and the number of really new molecules.
Efficacy and safety of micafungin for treatment of serious Candida infections in patients with or without malignant disease
2011
The aim of this study was to evaluate micafungin efficacy for treatment of invasive candidiasis/candidaemia in patients with cancer. Modified intent-to-treat populations were analysed from two trials: one, in adults and children with confirmed Candida infection, compared micafungin (adults 100 mg day(-1); children 2 mg kg(-1) day(-1)) with liposomal amphotericin B (L-AmB 3 mg kg(-1) day(-1)); and the other, in adults only, compared micafungin (100 or 150 mg day(-1)) with caspofungin (50 mg day(-1); 70 mg loading dose). Primary efficacy endpoint in both trials was treatment success, defined as both clinical and mycological response at end of therapy. In the micafungin/L-AmB trial, 183/489 pa…
Chronic total coronary occlusions and the Occluded Artery Trial. A critical appraisal.
2008
The OAT trial and its angiographic substudy TOSCA-2, along with a number of published commentaries, represents examples of over-interpretation of clinical study results. A study that achieved no statistically significant result for any of the study endpoints can only claim to have proven that their null hypothesis cannot be rejected. The lack of power due to a reduction of patient numbers by one third, and an unexpected low event rate, makes it not unlikely that another trial would be able to disprove the null hypothesis. These statistical facts should be accepted by the authors and commentators. Instead, the inconclusive results were interpreted in such a way that they might apply to patie…
Multizentrische Phase II — Studie der Arbeitsgruppe Lebermetastasen zur wöchentlichen intraarteriellen 24 h Hochdosistherapie mit 5-FU und Folinsäure…
1998
This prospective multicenter trial was performed to determine the response rate, toxicity and applicability of continuous 24 h hepatic arterial infusion of high-dose 5-FU and folinic acid. An improved response rate (60.5% in non-pretreated patients) was however associated with many systemic side-effects (340/509), mainly nausea and diarrhea. Therefore this treatment should be applied only in selected patients in specialized centers.
The use of a questionnaire for improvement of postoperative analgesia after transurethral resection of the prostate
2003
Abstract Background : Postoperative analgesic studies with methods like i.v. patient controlled analgesia (i.v. PCA) or epidural analgesia have reported effective pain relief after major surgery, also after urologic cancer surgery. In contrast, systematic results after minor urologic surgery are widely unknown, although the pain intensities may be high for a short time. The aim of the study was to evaluate the usefulness of a pain questionnaire as a measurement tool of postoperative analgesic quality after transurethral resection of the prostate (TUR-P). Methods : A questionnaire of the American Pain Society (APS) for quality assurance of postoperative pain therapy was adapted to estimate t…
Summary of the Effects of Exercise Therapy in Non-Communicable Diseases: Clinically Relevant Evidence from Meta-Analyses of Randomized Controlled Tri…
2021
There is strong evidence that exercise therapy leads to better measured and self-reported physical fitness and function in patients with chronic diseases, along with improvements in body composition. The evidence for other health benefits has not been summarized as systematically across different chronic diseases. Given the volume of research that has appeared in the past decade, this review of meta-analyses of randomized controlled trials (RCTs) in patients with specific chronic diseases summarizes the evidence regarding exercise therapy for various outcomes to help practitioners in prescribing exercise therapy for their patients. Meta-analyses published before Jan 1, 2021, based on at lea…
Late Breaking Abstract - Predictive value of FeNO in patients with non-specific respiratory symptoms: a randomised controlled trial
2017
Background: Fractional exhaled nitric oxide (FeNO) can predict treatment response in asthma, but little is known of its utility in patients with non-specific respiratory symptoms (NSRS). Aims and objectives: To evaluate the association between baseline FeNO and response to treatment with inhaled corticosteroids (ICS) in patients with NSRS. Methods: This was a multi-centre randomised, placebo-controlled trial, carried out in UK and Singapore. It consisted of a 2-week assessment period to establish baseline measurements and a 4-week treatment period with either extrafine ICS (200 µ beclomethasone bid) or placebo. NIOX VERO (Circassia) was used to measure baseline FeNO. The primary endpoint wa…
Metacognitive group training for forensic and dangerous non-forensic patients with schizophrenia: A randomised controlled feasibility trial
2014
BACKGROUND: In schizophrenia, the presence of certain cognitive biases has been established. Informed by this, metacognitive training (MCT) has been developed for schizophrenia. There is increasing evidence of its effectiveness with some patients, but its applicability to dangerous patients has not yet been demonstrated. AIMS: Our aim was to test the feasibility of a randomised controlled trial (RCT) of MCT for patients in a high-security hospital setting. METHODS: Twenty of 33 eligible and selected male in-patients with schizophrenia and a history of violence were randomised pairwise to eight sessions of MCT or treatment as usual. Symptom severity and reasoning, according to the jumping to…
Editorial commentary: Sleep disordered breathing and cardiovascular outcomes: is it time to change our thinking?
2017
no abstract