Ethical issues in adult oncology randomized clinical trials

2011 ◽  
Vol 1 (5) ◽  
pp. 629-636 ◽  
Author(s):  
Erika P Hamilton ◽  
Jeffrey M Peppercorn
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Ethical Issues

scholarly journals Historical Perspective on Clinical Trials of Carnitine in Children and Adults

2016 ◽  
Vol 68 (Suppl. 3) ◽  
pp. 1-4 ◽  
Author(s):  
Neil R.M. Buist
Keyword(s):  
Clinical Trials ◽  
Inborn Errors Of Metabolism ◽  
Randomized Clinical Trials ◽  
Ethical Issues ◽  
Carnitine Deficiency ◽  
Nutritional Deficiencies ◽  
Inborn Errors ◽  
Treatment Protocols ◽  
The Us ◽  
Primary Carnitine Deficiency

The metabolic roles of carnitine have been greatly clarified over the past 50 years, and it is now well established that carnitine is a key player in mitochondrial generation of energy and metabolism of acetyl coenzyme A. A therapeutic role for carnitine in treatment of nutritional deficiencies in infants and children was first demonstrated in 1958, and since that time it has been used to treat a number of inborn errors of metabolism. Carnitine was approved by the US Food and Drug Administration in 1985 for treatment of ‘primary carnitine deficiency', and later in 1992 for treatment of ‘secondary carnitine deficiency', a definition that included the majority of relevant metabolic disorders associated with low or abnormal plasma carnitine levels. Today, carnitine treatment of inborn errors of metabolism is a safe and integral part of many treatment protocols, and a growing interest in carnitine has resulted in greater recognition of many causes of carnitine depletion. Notwithstanding, there is still a lack of data from randomized clinical trials, even on the use of carnitine in inborn errors of metabolism, although ethical issues may be a contributing factor in this regard.

Ethical Issues in the Case of Surgical Repair of Cleft Palate

1995 ◽  
Vol 32 (4) ◽  
pp. 271-281 ◽  
Author(s):  
Samuel Berkowitz
Keyword(s):  
Clinical Trials ◽  
Cleft Palate ◽  
Randomized Clinical Trials ◽  
Surgical Repair ◽  
Ethical Issues ◽  
Relative Size ◽  
Theoretical Aspect ◽  
Ethical Considerations ◽  
Treatment Plans ◽  
Clinical Problems

There are some advantages to prospective randomized clinical trials (PRCT) to resolve some limited clinical problems. But, when this method is used to determine the best surgical procedure to close the palatal cleft space, there are strong ethical considerations that cannot be overcome. There are two basic problems. The first is having the surgeon perform surgical procedures which he/she does not believe is the treatment of choice or that can be performed as skillfully as others, even after demonstrations. Secondly, this method does not consider the theoretical aspect that many clefts within the same cleft type are different in the relative size of cleft space to size of soft tissue available for closing the cleft space, thereby creating different degrees of scarring. Different outcomes to the same surgery must, therefore, result irrespective of the surgeons’ skills or treatment plans. Retrospective research studies, whether they involve one or more institutions, have been and are still very valuable in improving the knowledge base of all areas of cleft palate habilitation.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

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