Search results for "Randomized controlled"

A randomized trial of quilizumab in adults with refractory chronic spontaneous urticaria

2016

Clofarabine Significantly Increases Eradication of Minimal Residual Disease of B-Precursor ALL Compared to High-Dose Cytarabine in Randomized Trial C…

2020

Background Since the FDA approval of clofarabine for the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL) at childhood, several studies have been launched which put clofarabine under scrutiny in combination with other cytostatic drugs as second or third line therapy. As a novel treatment-strategy we introduced the combination of clofarabine with pegylated asparaginase (PEG-ASP) in a randomized fashion in comparison to the standard consolidation course with high dose cytarabine (Hidac) combined with PEG-ASP into the frontline management of ALL within the CoALL 08-09 protocol. The primary objective of the study was to compare the MRD based assessment of the cytotoxic eff…

Cardiovascular consequences of sleep disordered breathing: the role of CPAP treatment

2020

CPAP treatment decreases BP in OSA patients, especially in severe OSA, and in patients with poorly controlled BP. OSA adversely affects heart function and remodelling, but its role in the pathogenesis of HF remains unclear. Similarly, the impact of CPAP is uncertain, and results of the ongoing ADVENT-HF trial will provide more information. Several experimental studies in animals and humans indicate a central role of intermittent hypoxia in atherogenesis through multiple mechanisms. However, randomised controlled trials (RCTs) in patients with CAD and OSA found no difference in outcomes between CPAP-treated and untreated patients. The negative results of secondary prevention RCTs may be the …

A Dose-Dependent Improvement in Exercise Tolerance in Patients With Stable Angina Treated With Mildronate: A Clinical Trial “MILSS I”

2011

Objective. To assess the efficacy of various doses of Mildronate in combination with standard therapy for the exercise tolerance of patients with stable angina pectoris. The primary efficacy variable was the change in exercise time in bicycle ergometry from the baseline to 12 weeks of treatment. The secondary endpoints were the changes in maximum achieved load and time to the onset of angina from the baseline to week 12. Material and Methods. A total of 512 patients with chronic coronary heart disease who had ischemia as the limiting factor in the exercise test from 72 study centers in 4 countries were enrolled in this prospective, randomized, double-blind, placebo controlled phase 2 study.…

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 …

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…

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…