scholarly journals Hydrogen: A Novel Treatment Strategy in Kidney Disease

2022 ◽  
pp. 1-11
Author(s):  
Bo Wang ◽  
Zhuoshu Li ◽  
Longfei Mao ◽  
Mingyi Zhao ◽  
Bingchang Yang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Kidney Disease ◽  
Large Scale ◽  
Animal Experiments ◽  
Signal Transduction Pathway ◽  
Reactive Oxygen ◽  
Chemical Substance ◽  
Signal Molecules ◽  
Simple Diffusion ◽  
Randomized Controlled Clinical Trials

<b><i>Background:</i></b> Hydrogen is a chemical substance that has yet to be widely used in medicine. However, recent evidence indicates that hydrogen has multi-faceted pharmacological effects such as antioxidant, anti-inflammatory, and antiapoptotic properties. An increased number of studies are being conducted on the application of hydrogen in various diseases, especially those affecting the renal system. <b><i>Summary:</i></b> Hydrogen can be inhaled, as a gas or liquid, and can be administered orally, intravenously, or locally. Hydrogen can rapidly enter suborganelles such as mitochondria and nucleus by simple diffusion, producing reactive oxygen species (ROS) and triggering DNA damage. Hydrogen can selectively scavenge hydroxyl radical (•OH) and peroxynitrite (ONOO<sup>−</sup>), but not other reactive oxygen radicals with physiological functions, such as peroxyanion (O<sub>2</sub><sup>−</sup>) and hydrogen peroxide (H<sub>2</sub>O<sub>2</sub>). Although the regulatory effect of hydrogen on the signal transduction pathway has been confirmed, the specific mechanism of its influence on signal molecules remains unknown. Although many studies have investigated the therapeutic and preventive effects of H<sub>2</sub> in cellular and animal experiments, clinical trials are few and still far behind. As a result, more clinical trials are required to investigate the role of hydrogen in kidney disease, as well as the effect of its dose, timing, and form on the overall efficacy. Large-scale randomized controlled clinical trials will be required before hydrogen can be used to treat renal illnesses. <b><i>Key Messages:</i></b> This article reviews the mechanisms of hydrogen in the treatment of renal disease and explores the possibilities of its use in clinical practice.

scholarly journals Assessing the legal duty to use or disclose interim data for ongoing clinical trials

2019 ◽  
Vol 6 (1) ◽  
pp. 51-84
Author(s):  
Lisa Eckstein
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Large Scale ◽  
Clinical Trial Data ◽  
New Drugs ◽  
Therapeutic Interventions ◽  
Scientific Integrity ◽  
Randomized Controlled Clinical Trials ◽  
Legal Obligations ◽  
Legal Duty

Abstract Randomized controlled clinical trials, leading to large-scale meta-analyses, are considered the gold standard for research evaluating new drugs and other therapeutic interventions. To promote scientific integrity and prevent the adoption of potentially fallacious early trends, emerging information is commonly shielded from sponsors, investigators, and other clinical trial actors, including through the use of independent Data and Safety Monitoring Boards (DSMBs). Once established, a DSMB is usually the only body to have access to unblinded information until trial completion or the crossing of pre-specified, and often highly stringent, stopping boundaries. Yet, in certain circumstances, clinical trial actors have legal obligations to trial participants and others to use or disclose emerging information. This paper canvasses potential legal obligations to use or disclose emerging clinical trial data, including through tort law and securities laws. The analysis is supplemented by a comprehensive search of US cases in which courts have adjudicated upon such allegations. Notably, available cases demonstrate widespread judicial deference to clinical trial practices designed to shield clinical trial actors from emerging information. As a result, despite a theoretical possibility of legal obligations of use or disclosure, it appears that these will rarely be enforceable.

scholarly journals Understanding COVID-19 in Wuhan From the Perspective of Cold-Dampness: Clinical Evidences and Mechanisms

2021 ◽  
Vol 8 ◽  
Author(s):  
Yujiao Zheng ◽  
De Jin ◽  
Jiaran Lin ◽  
Yuehong Zhang ◽  
Jiaxing Tian ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Immune Responses ◽  
Retrospective Cohort ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Close Association ◽  
Animal Experiments ◽  
Wuhan City ◽  
Retrospective Cohort Studies

Traditional Chinese medicine (TCM) has played a significant role in the treatment of coronavirus disease 2019 (COVID-19) in Wuhan City. During the epidemic, Academician Tong Xiaolin suggested a close association of COVID-19 with cold-dampness, an etiological factor in TCM, by summarizing the characteristics of the COVID-19 patients in Wuhan. and the theory of Cold-dampness Plague was proposed. Based on the Cold-dampness Plague theory, a series of TCM drugs, such as Huoxiang Zhengqi Dropping Pills, Lianhua Qingwen Granules Hanshiyi Formula, and Tongzhi Granule were developed for the different stages, namely mild, moderate, severe, recovery, of the COVID-19. In addition, clinical evidences were obtained through randomized clinical trials or retrospective cohort studies. The Anti-SARS-CoV-2 mechanism of the TCM prescriptions were then summarized from the four aspects: targeting the ACE2 and 3CLPro, targeting cytokines, targeting acute immune responses to SARS-CoV-2, and targeting pulmonary fibrosis. Despite the clinical efficacy and therapeutic pharmacology speculation, more studies such as large-scale randomized clinical trials, cell and animal experiments are needed to further verify the theory of the Cold-dampness Plague in COVID-19 patients.

scholarly journals Palm Oil Tocotrienols in Cancer Chemoprevention and Treatment

2021 ◽  
Author(s):  
Azman Abdullah ◽  
Ahmed Atia ◽  
Nadia Salem Alrawaiq ◽  
Mohd Kamil Md Yusof ◽  
Muhammad Fadzli Rusli
Keyword(s):  
Clinical Trials ◽  
Palm Oil ◽  
Large Scale ◽  
Animal Experiments ◽  
Radical Scavenging ◽  
Anticancer Activities ◽  
Treatment And Prevention ◽  
Radical Scavenging Properties

Cancer remains a worrying cause of fatality worldwide despite the advancement in medicine. Among the dietary phytonutrients, tocotrienols have been extensively studied for their bioactivity against cancer. Palm oil is a rich source of tocotrienols. The most common formulation of tocotrienols is the tocotrienol-rich fraction of palm oil (TRF). The anticancer activities of tocotrienols were once presumed due to their antioxidant and free radical scavenging properties. However, recent evidence suggested that tocotrienols are capable of demonstrating cancer-fighting properties through their influence in various signalling pathways. The selectivity of tocotrienols in killing cancer cells without affecting normal cells is indicative of their potential role in cancer treatment and prevention. Tocotrienols had proven to be particularly effective in the chemoprevention and treatment of breast, colorectal, pancreatic, prostate and liver cancers in many in vitro and in vivo animal experiments. However, the efficacy of tocotrienols in the management of human cancers are still questionable due to their poor bioavailability and lack of well-designed clinical trials. Nevertheless, due to their superb safety profiles, palm oil tocotrienols are still considered ideal candidates for future large scale clinical trials to prove their efficacy to treat or prevent cancers in humans.

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.

Effect of coronavirus disease in patients with kidney disease in India

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 1255-1259
Author(s):  
Shashi Prabha Singh ◽  
Preeti Sharma ◽  
Durgesh singh ◽  
Pradeep kumar ◽  
Rakesh Sharma ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Meta Analysis ◽  
Tertiary Care ◽  
Type Ii Diabetes Mellitus ◽  
Asymptomatic Infection ◽  
Type Ii ◽  
Cardiorespiratory Failure ◽  
Inflammatory State

Coronavirus disease 19 is a global pandemic which infects over millions of people worldwide in a limited time and changes the lifestyle, clinical spectrum lies from asymptomatic infection to pneumonitis with cardiorespiratory failure and finally death. Higher mortality occurs in senior and who are suffering from co-morbidities like chronic kidney disease, (HTN) hypertension, (DM TYPE II) diabetes mellitus or (CVD) cardiovascular diseases. However, rather than normal individuals, patients with chronic kidney disease (CKD) are under higher risk for infections. The chronic systemic inflammatory state is a significant cause for morbidity and mortality in CKD patients. The objective of this review is to discuss the pathogenesis of COVID-19 in CKD, changes observed in the immune system of CKD patients, COVID-19 infections risk in CKD and therapeutic approach of COVID-19 in CKD patients. From the standpoint of frequent renal co-morbidities in covid19 patients, renal complications were explored in covid19 patients received at level 2 tertiary care Santosh Hospital, Ghaziabad, U.P. Delhi-NCR India during March to August 2020 as per the protocol of Nephrology Society of India. Relevant clinical trials were reviewed in support. Meta-analysis and clinical trials are covered in this review study. Duplicate studies are not taken into account. The outcome of the studies shows that CKD patients are more prone to COVID-19. CKD patients are more likely infected with COVID-19 virus. Whereas in intensive care, CKD occurs more frequent than DM type II and CVD. So,COVID-19 pathogenesis in CKD patients, risk of COVID-19, immunologic changes and therapy COVID-19 in CKD can add support in the effective management of COVID-19.

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