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Inflammatory Response clinical trials

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NCT ID: NCT06008223 Completed - Sepsis Clinical Trials

Clinical Analysis of Vitamin B6 in Sepsis

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Methodology Patients A total of 128 patients with sepsis and AKI who were admitted to several centers including Huzhou first people's Hospital combined with Wuxing People's Hospital, Linghu people's Hospital and Nanxun people's Hospital from November 1, 2021 to October 31, 2022 were included in the study. And all patients were diagnosed by clinical examination, Diagnostic criteria sepsis was diagnosed according to the international Sepsis-3 for patients with suspected infection using the quickly Sepsis related organ failure assessment (qSOFA). The qSOFA score consists of only three criteria: Glasgow Coma Scale (GCS) <15, systolic blood pressure ≤ 100 mmHg, and respiratory rate ≥22/min. A qSOFA score of 2 or more points indicates suspected sepsis. Criteria for AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO), by the presence of one of the following: ①Increase in SCr by ≥ 0.3mg/dl (≥26.5 μ mol/L) within 48h;② Renal impairment is known or increase in SCr by ≥50% within 7days; ③ Oliguria for ≥4 hours. All patients were authorized by their families to sign informed consent, and the study was approved by the ethics committee of the hospital. Inclusion criteria: ①18-65 years old; ② The hospital survival time was more than 48 hours, and the medical records were complete; ③There is no history of vitamin B6 use in the recent period of admission (within 2 weeks before admission). Exclusion criteria: ①Patients with chronic renal insufficiency or renal failure in the past; ②Related renal injury caused by reasons other than sepsis; ③At the time of admission to ICU, there was cardiac failure or cardiogenic shock in combination with sepsis; ④Patients who use nephrotoxic drugs or contrast agents; ⑤Previous kidney transplantation; ⑥Patients with restrictive use of positive inotropic drugs (such as left ventricular outflow tract stenosis); ⑦Age<18 or>65; ⑧pregnant woman. Treatment 128 patients were divided into experimental and control group by random number table method, 64 patients in each group. Both groups were given routine treatment of sepsis and corresponding treatment of primary disease. The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection, the course of treatment is one week or until the patient dies. That in control group were injected with 0.9% sodium chloride solution 6 ml intravenously. Assessment The general clinical data of the two groups were recorded, including age, sex, acute physiology and chronic health status scoring system II (APACHE II), qSOFA, and the constituent ratio of primary disease before treatment. The inflammatory reaction indexes of the two groups were detected before and on the 7th day of treatment, including Interleukin 6 (IL-6), interleukin 8 (IL-8), tumor necrosis factor (TNF-α) and endothelin-1 (ET-1). After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA). ELISA kits for IL-6 (ab178013), IL-8 (ab214030), and TNF-a(ab181241) were purchased from abcam company. ELISA kit for ET-1 (K7429-100) was purchased from BioVision. All ELISA experiments were performed according to the kit instructions. The oxidative stress response indexs of the two groups were detected before and on the 7th day of treatment, including superoxide dismutase (SOD), glutathione (GSH), malondialdehyde (MDA). The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA. The renal function indexs before and after treatment were detected before and on the 7th day of treatment, including the blood urea nitrogen (BUN) and serum creatinine (sCr) and renal resistance index (RRI). RRI was detected by ultrasound. And the clinical data, including the rate of renal replacement therapy, ICU length of stay, total hospitalization expenses, and 28-d mortality, were recorded. Statistical analysis All measurements were expressed as mean ± standard deviation (x ± s). And the counting datas were expressed in the form of percentage [n (%)]. The statistical SPSS 23.0 software were performed using the two samples t-test and adjusted chi-square test for the two groups. P-value,0.05 was considered to be statistically significant.

NCT ID: NCT06003972 Completed - Heart Failure Clinical Trials

Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure

Copaxone
Start date: January 4, 2021
Phase: Phase 2
Study type: Interventional

Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure. Trial Design - An open-label, randomized, prospective trial of patients hospitalized due to acute decompensation of heart failure with reduced ejection fraction. - Patients will be enrolled within 24 hours from hospital admission. - Randomization and intervention will begin within 24 hours of enrollment (and at least 24 hours after admission). - Patients will be randomized in a 1:1 ratio either to receive guideline directed medical therapy (GDMT) or GDMT plus Copaxone. - Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14 days. - Patients will be assessed during 4 time points(screening/randomization, visit 3 day, visit 14 day, visit 30 day) as elaborated in article "monitoring". - Changes in inflammatory cytokines will be compared between control and intervention group throughout 3 time points. - The trial will be approved by the institutional view board and conducted in accordance with the principles or Good Clinical Practice guidelines and the Declaration of Helsinki.

NCT ID: NCT05907135 Completed - Clinical trials for Inflammatory Response

Beet Supplementation, Exercise, Inflammation

Start date: July 15, 2023
Phase: N/A
Study type: Interventional

This study will determine if ingesting a beet-based supplement with nitrates for 2 weeks moderates exercise-induced inflammation.

NCT ID: NCT05743855 Completed - Chronic Pain Clinical Trials

The Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.

Start date: March 28, 2019
Phase: N/A
Study type: Interventional

Evaluating the effect of a combined therapy of chiropractic sessions plus nutritional supplement containing hemp, omega-3 fatty acids, and broccoli extract oil in patients experiencing chronic pain and inflammation.

NCT ID: NCT05674708 Completed - Inflammation Clinical Trials

Fat Quality and Postprandial Inflammation

PI:fat
Start date: February 7, 2023
Phase: N/A
Study type: Interventional

This aim of this randomized controlled postprandial study is to compare the effects of four different far sources (butter, coconut, corn oil and flax seed oil) on postprandial inflammation and metabolic response. The main questions it aims to answer are: 1. What is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation? 2. Is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation mediated by glucose or blood lipids? 3. Can postprandial inflammatory or metabolic response be predicted by individual factors at baseline? Participants will consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours.

NCT ID: NCT05666622 Completed - Periodontitis Clinical Trials

DNI Values After Periodontal Treatment

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The study included 70 systemically healthy individuals, as a test group of 35 patients with Stage 3, Grade A periodontitis and a control group of 35 individuals with no periodontal disease. Blood samples were taken for the examination of DNI, white blood cells (WBC), immature granulocytes (IG), procalcitonin, C-reactive protein (CRP), lymphocyte count and neutrophil count. For the patients with periodontitis, blood sample assays were repeated 3 months after NSPT.

NCT ID: NCT05596500 Completed - Clinical trials for Inflammatory Response

Blueberry-protein Supplementation and Exercise

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

This study is the human clinical trial component of an SBIR grant with Sinnovatek (funded). Cyclists (n=20) will consume a blueberry-protein, blueberry, or placebo supplement for 2 weeks prior to cycling for 2.5 h at high intensity. Washout periods (2 weeks) will separate the 3 trials, and the cyclists will crossover (randomized) to one of the two others supplements for 2 weeks, and then engage in additional 2.5 h cycling bouts. Blood and urine samples will be collected pre- and post-supplementation for each of the 3 trials. Blood samples will also be collected immediately after and 1.5h- and 24h-post-exercise. Blood samples will be analyzed for inflammation and oxidative stress outcomes. Urine samples will be analyzed for blueberry gut-derived phenolics.

NCT ID: NCT05594329 Completed - Cognitive Change Clinical Trials

Neurological, Inflammatory and Metabolic Effects of Acute Mushroom Intervention in Older Adults

OYSACO
Start date: August 15, 2022
Phase: N/A
Study type: Interventional

This randomized crossover trial (RCT) investigates the acute effect (over a 6-hour period) of a meal containing varying serving sizes (doses) of freeze-dried oyster mushroom powder, on the cognitive behaviour and markers of metabolism and inflammation related to neuronal health in healthy adults aged 60-80 years old. The study will involve a screening visit and four testing visits, with a week interval between each. During the four testing visits, cognitive-mood battery tests will be taken at baseline and then at 2-, 4- and 6-hour intervals following the consumption of the intervention meal. Also, a blood draw will be taken at the end of each testing visit day to allow the determination of inflammatory, metabolic and neuronal markers.

NCT ID: NCT05573438 Completed - Clinical trials for Inflammatory Response

Acute Inflammatory and Metabolic Effect of High Fructose Intake

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

Fructose consumption is associated with the development of metabolic diseases and low-grade inflammation. However, the acute effect of a single meal rich in fructose on the metabolic and inflammatory response is not fully understood. This study will to evaluate the acute metabolic and inflammatory effect caused by a meal containing fructose overload. This will be a three-arm crossover, randomized, double-blind clinical trial. Participants will undergo the three interventions for random order: (i) standardized meal plus sucrose overload; (ii) standardized meal plus glucose overload; (iii) standardized meal plus fructose overload. During the washout period (7 to 21 days), the subjects will instructed to maintain their usual eating behavior and physical activity. On the day of each intervention, participants will to the outpatient clinic in the morning after an overnight fast. Anthropometric data (weight, height, and waist circumference) will collected. Body composition will evaluated using bioimpedance (Quantum® apparatus, RJM Systems, Michigan) and blood pressure and heart rate (digital monitor, model HEM705CP®, Omron) will measured after 30 minutes of rest. A catheter with a three-way stopcock will inserted into the arm of the volunteers. Blood samples (5mL) will collected after overnight fasting (baseline) and 30, 60, 120, and 240 minutes after the standardized meal containing sucrose or glucose or fructose overload. Participants will remain seated throughout the evaluation period. Participants will receive a standardized meal of bread, ham, and margarine plus a sweetened drink (200mL) with similar amounts of different carbohydrates (sucrose, glucose, or fructose) in each intervention. The meals will provide 25% of the energy requirements, calculated from the resting energy expenditure measured by indirect calorimetry (KORR®, MetaCheck) multiplied by the activity factor plus 10% referring to the thermal effect of food. The meal will consiste of 15% of protein, 30% of fat, and 55% of carbohydrate (30% of complex carbohydrates and 25% of sucrose or glucose or fructose). Serum levels of glucose, triglycerides, total cholesterol, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured by colorimetric enzymatic test. Serum levels of adiponectin, leptin, resistin and TNF will be measured by Enzyme Linked ImmuneSorbent Assay (ELISA). Serum levels of IL-2, IL-4, IL-5, IL-6, IL-10, IL-17, IFN-γ and eotaxin will be obtained by the Cytometric Bead Array (CBA).

NCT ID: NCT05530564 Completed - Pain Clinical Trials

Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.