scholarly journals Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Daniel Glinatsi ◽  
Marte S. Heiberg ◽  
Anna Rudin ◽  
Dan Nordström ◽  
Espen A. Haavardsholm ◽  
...  
Keyword(s):  
Study Protocol ◽  
Conventional Therapy ◽  
Open Label ◽  
Biological Treatments ◽  
Blinded Assessor

scholarly journals Oral Nutritional Supplementation for the Dietary Management of Malnutrition in Cancer: Study Protocol of A Randomized, Open-Label, Multicentre Clinical Trial

2019 ◽  
Vol 4 (07) ◽  
Author(s):  
Edit Nadasi ◽  
Gellert Cseh
Keyword(s):  
Clinical Trial ◽  
Cancer Patients ◽  
Study Protocol ◽  
Negative Energy ◽  
Malignant Diseases ◽  
Open Label ◽  
Multicentre Clinical Trial ◽  
Patients With Cancer ◽  
Extra Energy ◽  
Oral Nutritional Supplements

In cancer, more than 30% of patients die due to cachexia and more than 50% of patients with cancer die with cachexia being present. Patients with cancer cachexia frequently develop a chronic negative energy and protein balance driven by a combination of reduced food intake and metabolic change. Several studies have already demonstrated the usefulness of oral nutritional supplements (ONS) in managing malnutrition of cancer patients. Though increased energy intake is very important in managing cancer-related malnutrition, the source of this extra energy and the presence of anti-inflammatory and immunonutritional components may also play an important role. Here we present the study protocol of a randomized, open-label, multicentre clinical trial aimed to determine whether an ONS composed according to the needs of patients with malignant diseases an ONS composed according to the needs of patients with malignant diseases is more effective than a general product in improving the nutritional status in cancer patients.

AB0510 INFLIXIMAB IS AN EFFECTIVE GLUCOCORTICOID-SPARING TREATMENT FOR TAKAYASU ARTERITIS: RESULTS OF A MULTICENTER OPEN-LABEL PROSPECTIVE STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1552.1-1553
Author(s):  
P. Mertz ◽  
J. F. Kleinmann ◽  
M. Lambert ◽  
X. Puéchal ◽  
T. Martin ◽  
...  
Keyword(s):  
Cohort Study ◽  
Takayasu Arteritis ◽  
Conventional Therapy ◽  
Clinical Laboratory ◽  
Immunosuppressive Treatment ◽  
Median Dose ◽  
Open Label ◽  
National Drug ◽  
Sparing Effect

Background:Approximately half of patients with Takayasu Arteritis (TA) have glucocorticoid (GC)-dependency and require the addition of a second-line immunosuppressive treatment.Objectives:Here, we conducted a multicenter open-label prospective cohort study to assess the efficacy and safety of infliximab originator as a GC-sparing agent in TA.Methods:A temporary recommendation for use for infliximab in refractory TA was approved by the French National Drug Authorities (April 2014). Infliximab was administered to patients in case of disease activity with a NIH score ≥2 despite conventional therapy. Data regarding patient’s clinical, laboratory, imaging and treatments were obtained at baseline, and at each following visit until last visit (October 2017). TA activity was evaluated according to NIH criteria and GC requirement throughout the study.Results:Twenty-three patients were enrolled, including 19 female. The median age at inclusion was 33 years (Interquartile range, IQR: 23-44 years). At baseline, 17 (74%) patients were treated with GCs, at a median dose of 10 mg/day (IQR: 0-21) of prednisone-equivalent. After a median follow-up of 36.9 months (IQR: 10-58.7), improvement of ≥1 NIH criterion of TA activity was achieved for 14/22 (64%) patients. The median GC dose was 8 mg/day (IQR: 7-10) at 6 months; 5 mg/day (IQR: 0-8) at 12 months and 0 mg/day (IQR: 0-5) at 36 months of follow-up. Overall, infliximab originator had a significant GC-sparing effect between baseline and last follow-up (p=0.009).Conclusion:This multicenter open-label cohort study suggests that infliximab originator is an effective GC-sparing treatment for TA refractory to conventional therapy.Disclosure of Interests:None declared

scholarly journals SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029808 ◽  
Author(s):  
Leon de Wit ◽  
Doortje Rademaker ◽  
Daphne N Voormolen ◽  
Bettina M C Akerboom ◽  
Rosalie M Kiewiet-Kemper ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Glycaemic Control ◽  
Study Protocol ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Large For Gestational Age ◽  
Secondary Outcome ◽  
Oral Glucose ◽  
Open Label ◽  
Randomised Controlled

IntroductionIn women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.MethodsThe SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.Trial registration numberNTR6134; Pre-results.

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