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Oxidative Stress clinical trials

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NCT ID: NCT03612453 Completed - Smoking Cessation Clinical Trials

ESTxENDS Trial- Substudy on Oxidative Stress Induced by Electronic Nicotine Delivery Systems (ENDS) Measured in EBC

ESTxENDS
Start date: April 3, 2019
Phase: N/A
Study type: Interventional

--> This is a substudy of the main ESTxENDS trial (NCT03589989). Oxidative stress outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. Smoking induces inflammation leading to acute and chronic oxidative stress, both evidenced in in vitro and in vivo studies. Tobacco-smoke contains free reactive radicals that generate reactive oxygen species (ROS). Afterwards ROS in turn induce oxidative stress, which likely plays a key role in causing airways and related pathologies linked to tobacco-smoke exposure. Acute and chronic oxidative stress can be measured by quantifying two biomarkers in exhaled breath condensates: 8-iso-prostaglandin F2α (8-isoprostane) and 8-Oxo-2'-deoxyguanosine (8-OHdG). 8-isoprostane, a marker of lipoperoxidation, results mainly from the non-enzymatic action of free radical attack on arachidonic fatty acids. 8-OHdG is a marker of DNA oxidation caused by ROS, and a predictor of lung cancer. Oxidative stress between smokers who quit (with or without ENDS) and those who use ENDS for a long time have not yet been assessed in the setting of a randomized controlled trial (RCT). This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events, the exposure to inhaled chemicals and the effect of ENDS on health-related outcomes, in particular by measuring oxidative stress in exhaled breath condensates (EBC). For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 6-month period. Measures of oxidative stress by means of exhaled breath condensates and urine samples will be assessed at baseline and at 6- months' follow-up by asking to breathe for 20 minutes in a vial kept frozen at -10°C to collect around 2 mL of EBC.

NCT ID: NCT03612375 Completed - Smoking Cessation Clinical Trials

ESTxENDS Trial-Substudy on Oxidative Stress Induced by Electronic Nicotine Delivery Systems (ENDS) Measured in Urine

ESTxENDS
Start date: July 16, 2018
Phase: N/A
Study type: Interventional

--> This is a substudy of the main ESTxENDS trial (NCT03589989). Oxidative stress outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. Smoking induces inflammation leading to acute and chronic oxidative stress, both evidenced in in vitro and in vivo studies. Tobacco-smoke contains free reactive radicals that generate reactive oxygen species (ROS). Afterwards ROS in turn induce oxidative stress, which likely plays a key role in causing airways and related pathologies linked to tobacco-smoke exposure. Acute and chronic oxidative stress can be measured by quantifying two biomarkers in urine samples: 8-iso-prostaglandin F2α (8-isoprostane) and 8-Oxo-2'-deoxyguanosine (8-OHdG). 8-isoprostane, a marker of lipoperoxidation, results mainly from the non-enzymatic action of free radical attack on arachidonic fatty acids. 8-OHdG is a marker of DNA oxidation caused by ROS, and a predictor of lung cancer. Oxidative stress between smokers who quit (with or without ENDS) and those who use ENDS for a long time have not yet been assessed in the setting of a randomized controlled trial (RCT). This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events, the exposure to inhaled chemicals and the effect of ENDS on health-related outcomes, in particular by measuring oxidative stress in urine samples. For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Measures of oxidative stress by means of exhaled breath condensates and urine samples will be assessed at baseline and at 6-, 12- and 24- months' follow-up.

NCT ID: NCT03601364 Completed - Oxidative Stress Clinical Trials

The Effects of Peep and Tidal Volume on Oxidative Stress in Cardiopulmonary Bypass Surgery

Start date: August 1, 2018
Phase:
Study type: Observational

Although cardio-pulmonary bypass surgery (CPBS) is a routine procedure worldwide, patient morbidity and mortality are still high due to postoperative negative complications.Inflammatory response and systemic oxidative stress have been reported to be directly related to this practice.Mechanisms explaining this condition have been described as being related to several events that occur during the cardiopulmonary bypass (CPBS), where blood is exposed to non-physiological surfaces, surgical trauma, ischemia-reperfusion, and changes in body temperature.In addition, CPB induces atelectasis and affects the structure of the bronchoalveolar tree.Prolongation of atelectasis may facilitate proinflammatory cytokine production by macrophages.One of the most damaging consequences of all these events is the formation of reactive oxygen species (ROS) and radicals originating from various cellular and enzymatic sources such as myocardial cells, activated neutrophils.ROS has toxic effects on cellular structures including lipids, proteins and nucleic acids.Oxidative reaction damages cellular function and may increase perioperative or postoperative complications after CPBS.Total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) reflect the redox balance between oxidation and antioxidation.TAS measurement is an indication of the activity of all antioxidants and TOS is an indicator of ROS.OSI is a measure of the ratio of TOS to TAS and the level of Oxidative Stress (OS).The contribution of various mechanisms to oxidant-antioxidant balance during on-pump coronary artery bypass grafting (ONCABG) has not yet been fully evaluated. The investigator's aim in this study is to investigate the effect of lung protective mechanism (Tidal Volum, PEEP) on oxidative stress parameters such as TAS, TOS, Thiol / Disulphide, Catalase, Glutathione Peroxidase, MDA (Melanil Dialdehyde) in cardio pulmonary bypass surgery

NCT ID: NCT03593733 Completed - Fatigue Clinical Trials

Comparison Between Photobiomodulation Therapy (PBMT) and a Cold-Water Immersion (CWI) in Recovery Soccer Player: Analysis of Biochemical Markers of Recovery and Muscular Oxidative Stress.

Start date: January 2017
Phase: N/A
Study type: Interventional

Competitive soccer engages many of the body's systems to a major extent. The musculoskeletal, nervous, immune and metabolic systems are stressed to a point where recovery strategies post-exercise become influential in preparing for the next match. Recovery from exercise can be an important factor in performance during repeated bouts of exercise. In a tournament situation, where athletes may compete numerous times over a few days, enhancing recovery may provide a competitive advantage. Recent work has highlighted that the aim of most recovery interventions is to return psychological, physiological, and performance variables to the 'pre-exercise' level or to baseline conditions identified in the absence of fatigue. The post-exercise cold water immersion (CWI) through its primary ability to decrease tissue temperature and blood flow, is purported to facilitate recovery by ameliorating hyperthermia and subsequent alterations to the central nervous system (CNS), reducing cardiovascular strain, removing accumulated muscle metabolic by-products, attenuating exercise-induced muscle damage (EIMD) and improving autonomic nervous system function. All these alterations provoke important physiological changes for the recovery of the athlete. Scientific evidence for other strategies reviewed in their ability to accelerate the return to the initial level of performance is still lacking. These include active recovery, stretching, compression garments, massage and electrical stimulation. While this does not mean that these strategies do not aid the recovery process, the protocols implemented up until now do not significantly accelerate the return to initial levels of performance in comparison with a control condition. Among these new strategies, Photobimodulation therapy - PBMT using low-level laser therapy (LLLT) and light-emitting diode therapy (LEDT) has been the focus of important research insights science in recent years. The PBMT has been used to increase muscle performance and reduces muscle fatigue signals. The mechanism proposed for the use of PBMT in sports and exercise is the increase in cytochrome c-oxidase in skeletal muscle fibers that lead to upregulation of mitochondrial activity, which increases ATP production promoting more energy for the muscle and decreases oxidative stress and reactive oxygen species production. Considering that the consented CWI is already used with good results in soccer athletes, however it has some drawbacks such as the time of application and the inconvenience caused by the application of cold and the new possibilities presented in the literature of the use of PBMT we propose to carry out this study. To address these issues, the present study aims to investigate and analyze biological markers on oxidative stress and muscle damage in soccer athletes after a match submitted to recovery strategies through CWI and PBMT

NCT ID: NCT03591536 Completed - Inflammation Clinical Trials

Effects of Pentoxifylline After Cardiac Surgery

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Acute Kidney Injury (AKI) is a common and serious post operative complication and may occur in up to 50% of all patients undergoing cardiac surgery and is associated with 8% mortality rate compared with 0.9% in non-affected patients and remains a major factor for post surgery adverse outcomes. Early interventions to prevent postoperative AKI can help decreasing morbidity and mortality in these patients. Using cardiopulmonary bypass during cardiac surgery triggers systemic inflammatory response and recruits pro-inflammatory cytokines such as tumor necrosis factor, interleukin -10 (IL-10) and Interleukin-6 (IL-6) accompanying with production of free oxygen radicals which provokes oxidative stress in the milieu of ischemic reperfusion injury. Pentoxifylline as a non-specific phosphodiesterase inhibitor, can suppress the production of some factors of inflammatory response and oxidative stress, probably prevent post surgery AKI with these mechanisms.

NCT ID: NCT03563833 Recruiting - Oxidative Stress Clinical Trials

Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and StO2 in Hypotensive Anesthesia Applications

Start date: May 4, 2018
Phase: N/A
Study type: Interventional

The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.

NCT ID: NCT03563456 Completed - Clinical trials for Type 2 Diabetes Mellitus

Development of Structured Exercise Program for T2DM Management

Start date: June 5, 2017
Phase: N/A
Study type: Interventional

The study started by the process of designing a structured exercise that will manage the T2DM with regards to the effectiveness in glycemic control, the benefit for physical fitness, and safe. Subjects consist of 18 - 65 years old T2DM patients are allocated into 2 groups; EXP group and KTR group. The EXP group follow the protocol of 12-week structured exercise, combination of 3 times per week high intensity interval training with 2 times per week resistance exercises. The pre- and post- measure are physical fitness consists of VO2max, grip strength, sit and reach, push ups, back extension, BMI and body fat percentage; HbA1c; plasma MDA and SOD. The KTR group follow the once a week continuous exercise program. The structured exercise is hypothesized to lower HbA1c, lower plasma MDA, increase SOD.

NCT ID: NCT03557476 Completed - Oxidative Stress Clinical Trials

Effects of Octacosanol During Taekwondo Training

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Taekwondo players undergo rapid reductions of body weight prior to their competition in order to gain a size advantage over the opponent. However, these large weight changes with concomitant high intensity exercise training induce poor lipid profiles and high levels of oxidative stress, which can be detrimental to health and sports performance. Therefore, the purpose of this study was to investigate the ability of the nutritional supplement octacosanol to combat the physiological detriments that can occur from these rapid weight changes paired with high intensity exercise training.

NCT ID: NCT03557229 Active, not recruiting - Septic Shock Clinical Trials

Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

Start date: July 23, 2018
Phase: Phase 3
Study type: Interventional

Sepsis and septic shock are public health problems worldwide that represents an excessive cost for health systems. Despite the great technological and research advances, mortality can reach up to 80% in patients with multiple organ failure (FOM). Therapeutic studies focused on evaluating the usefulness of the use of antioxidants have shown different outcomes and results. This randomized clinical trial in patients with septic shock at two general intensive care units try to evaluate the usefulness of four different antioxidant therapies added to the conventional treatment, which includes: n-acetyl cysteine, vitamin C, vitamin E and melatonin. Measurement of parameters before and after treatment of oxidative stress includes nitrates and nitrites, lipid peroxidation, glutathione peroxidase, glutathione s transferase, extracellular activity of SOD, GSH concentration and evaluation of total antioxidant capacity. The investigators will also evaluate the clinical impact of antioxidant therapy with the SOFA score.

NCT ID: NCT03544411 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM

Start date: July 2, 2018
Phase: Phase 1
Study type: Interventional

This study determines the effect of olive oil and bran oil on antioxidant levels, and glycemic control in patients with type 2 diabetes mellitus (DM) Intervention: Patient type 2 DM will receive olive oil and bran oil with cross over study