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Immune Suppression clinical trials

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NCT ID: NCT04805216 Completed - Covid19 Clinical Trials

Covid-19 Vaccine Response in Immunocompromised Haematology Patients

COVAC-IC
Start date: March 15, 2021
Phase:
Study type: Observational

The UK Medicine and Healthcare products Regulatory Agency (MHRA) granted temporary authorisation to three Covid-19 vaccines in December 2020 and January 2021. These vaccinations include: - Covid-19 mRNA BNT162b2 vaccine (Pfizer-BioNtech vaccine); - ChAdOx1-S vaccine (Astra Zeneca vaccine); - Covid-19 mRNA vaccine (Moderna vaccine). Any other Covid-19 vaccines approved for use by the MHRA in immunocompromised and immunocompetent patients are to be included in this study. The above vaccines have received temporary authorisation after placebo-controlled phase 3 studies confirmed their safety and efficacy in over 100,000 volunteers. People who were immunocompromised or were receiving chemotherapy, radiotherapy or immunoglobulin treatment were excluded from these studies. Safety, efficacy, and durability of antibody response in these studies has been assessed for up to 14 weeks only. These vaccines are being rolled out in the UK and have been recommended for use for immunosuppressed individuals including patients undergoing chemotherapy, immunotherapy, radiotherapy, and those who have undergone stem cell transplantation. Though the MHRA has approved vaccination for immunocompromised patients there is no published evidence to confirm safety and efficacy in these patients. The durability of antibody response and whether this is affected by concurrent chemotherapy, immunotherapy, radiotherapy treatment is also unknown. This observational study aims to evaluate the immune response to Covid-19 vaccines in haematology patients who have immune suppression either due to disease, treatment, or both. The investigators plan to measure Anti-SARS-COV2 IgG antibody levels at 3-5 time points 30 days apart after patients have received their 2nd dose of Covid-19 vaccine. The investigators will also collect any adverse events reported by patient including Covid-19 infection or disease after vaccination. The study plans to recruit 50 haematology patients who are clinically assessed by a haematologist as immunosuppressed due to their disease, treatment, or both. The study also plans to recruit 30 healthy (immunocompetent) volunteers who would be the control group for comparison of antibody response and durability.

NCT ID: NCT04526977 Recruiting - Covid19 Clinical Trials

Differences in Immune Response Among HIV-1-infected Individuals With Previous or Current COVID-19 (CoVIHDis).

CoVIHDis
Start date: January 10, 2021
Phase:
Study type: Observational

People living with HIV could have different susceptibility and outcome to the SARS CoV-2 infection. The risk of SARS CoV-2 infection in this population could be no related to HIV infection, immunodepression or antiretroviral therapy, but to the different susceptibility as measured by ACE2 or CD26 receptors. Also, patients with HIV-1 infection could have different cytokine profile and cellular immune response after SARS-CoV-2 infection, leading to a differential outcome,

NCT ID: NCT04382508 Enrolling by invitation - Infection Clinical Trials

Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

ImmunoCOVID
Start date: March 22, 2020
Phase:
Study type: Observational

A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.

NCT ID: NCT04345978 Active, not recruiting - Colorectal Cancer Clinical Trials

Effects of Fasting Strategies on Postoperative Recovery and Long-term Prognosis in Patients With Colorectal Cancer

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

In 2018, colorectal cancer is the third most common malignant tumor in terms of morbidity and second mortality in the world. Surgical resection is still the main treatment for colorectal cancer.With the introduction of the ERAS, the latest international and domestic guidelines for fasting before surgery all advocate shortening the fasting time. For example, 2 hours before surgery, oral take cleared fluids, including water, sugar water, fruit juice, tea and black coffee (without milk) is allowed.Solid food can be consumed 4 hours before surgery, and oral diet should be resumed as soon as possible after surgery. Changes in diet, nutritional status, and physical activity are closely related to the incidence of colorectal cancer. Therefore, we believe that the intestine may be very sensitive to different fasting times during the perioperative period. Prolonging the fasting time may improve the prognosis by improving postoperative insulin resistance, reducing inflammation and protecting anti-tumor immune function in patients with colorectal cancer.Prolonged fasting time seems to be contrary to the results of some studies, and whether it is applicable to patients with tumor surgery is unclear. Therefore, there is an urgent need to conduct large-scale, prospective, randomized controlled clinical studies to clarify the most suitable perioperative fasting strategy (including composition, interval, and amount) for cancer patients, which can not only reduce surgical stress and speed up postoperative rehabilitation,reduce postoperative metastasis and recurrence and improve mid- and long-term prognosis.

NCT ID: NCT04315077 Completed - Oxidative Stress Clinical Trials

The Short Term Effects of Oceanix Supplementation on Recovery

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Subjects will be stratified into quartiles based on peak force achieved in the isometric mid-thigh pull assessment during screen and prior to baseline testing. Subjects from each quartile will be randomly divided by into treatment and or placebo conditions. Following randomization, subjects will be baseline tested on isometric mid-thigh pull and salivary immunoglobulin A. Following baseline testing, subject will be given their respective supplement conditions and will be instructed to consume one serving (25mg) a day for 21 consecutive days. For days 1 through 14 subjects will be asked to refrain from resistance training. Subjects will undergo a five day intense resistance training protocol will on day 15 to day 19. Subjects will complete follow-up testing in a manner identical to baseline on day 20 and 21 (24- and 48-hours post completion of the training protocol).

NCT ID: NCT04207177 Active, not recruiting - Clinical trials for Kidney Transplant; Complications

Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects

MicrobioTac
Start date: October 30, 2019
Phase: Phase 4
Study type: Interventional

Kidney transplant recipients of living- and deceased donor grafts and treated with both mycophenolate mofetil (MMF) and tacrolimus (Tac) will be included. A 12-hour pharmacokinetic (PK) investigation of both mycophenolate (MPA) and Tac will be performed in pharmacokinetic steady state conditions between 3 to 8 weeks and one year after transplantation. Feces samples will be collected before (if possible), 1 week after transplantation and at the day of the 12-hour PK investigations. Data on dietary intake and physical activity will be obtained in association with the feces sampling in all patients. Patients will be invited to a follow-up visit one year after transplantation where the 12-hour PK investigation, feces sampling, dietary and activity data collection is repeated. Standard follow-up data after renal transplantations, such as acute rejection episodes, infections, renal function, post transplant diabetes mellitus (PTDM), protocol biopsies, adherence to immunosuppressive drugs, graft loss and death will be collected for all patients up to 5 years after transplantation according to standard schedule at the transplant center. A subgroup of kidney transplant recipients scheduled for living donor transplantation will be included before transplantation for pre-transplant investigations in addition to the investigations after transplantation. These patients will be randomized to either receive one week of treatment with MMF or Tac before transplantation. Feces samples and a 12-hour PK investigation will be performed after one week of treatment (before transplantation).

NCT ID: NCT03937323 Completed - Pancreatitis Clinical Trials

Immun Status at Pancreatitis Patients

Start date: June 1, 2019
Phase:
Study type: Observational [Patient Registry]

Pancreatitis is a common complication especially in patients with gallbladder stones, most patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20% of patients, the disease is severe and mortality rates of up to 30% are detected in these patients. In the evaluation of acute biliary pancreatitis, many scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity and mortality of the disease. In this study, the investigators aimed to evaluate the correlation between morbidity and mortality of acute biliary pancreatitis and serum proinflammatory cytokines with ELISA and lymphocyte subtypes with Flow-cytometry.

NCT ID: NCT03806764 Enrolling by invitation - Clinical trials for Cytomegalovirus Infections

Cytomegalovirus (CMV) Reactivation in Allogeneic HSCT Recipient

CReSCT
Start date: April 17, 2018
Phase: N/A
Study type: Interventional

This study consists of two parts: 1) Part 1, a retrospective part on 250 consecutive patients following allogeneic haematopoietic stem cell transplant (allo-HSCT) at the Royal Melbourne Hospital from 2012 to 2017, inclusive, and 2) Part 2, a prospective part on 120 allo-HSCT patients from 4 sites in Australia: the Royal Melbourne Hospital, Peter MacCallum Cancer Centre, Austin Hospital, and Westmead Hospital. In Part 1, medical records of allo-HSCT recipients will be evaluated to determine the incidence and clinical outcomes of CMV viremia post HSCT, including both the direct (CMV disease) and indirect (such as invasive fungal infection, other viral infections, bacterial infection) effects on clinical outcomes. In Part 2, allo-HSCT participants at risk of CMV disease will be assessed to determine the association of host CMV-specific immunity with clinical management and outcomes over one year post allo-HSCT. The overall aims of the study are to establish if CMV infection in allo-HSCT patients are associated with poor clinical outcomes; and whether measurement of immunological functions could provide an early indicator to identify patients at risk and appropriate timing for initiation of CMV treatment.

NCT ID: NCT03572413 Completed - Surgery Clinical Trials

The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis.

RECOVER-PLUS
Start date: October 24, 2018
Phase: Phase 4
Study type: Interventional

Substudy of the RECOVER trial (a randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery) investigating innate immune homeostasis after laparoscopic colorectal surgery.

NCT ID: NCT03445234 Completed - Clinical trials for Inflammatory Response

Blueberries, Bananas, Exercise Recovery

Start date: September 11, 2017
Phase: N/A
Study type: Interventional

The PURPOSE of this study is to investigate the combined influence of 2-weeks blueberry ingestion and banana ingestion (during exercise) on performance and in mitigating metabolic perturbation, immune dysfunction, and increase in inflammation following a 75-km cycling time trial. We hypothesize that the combination of 2-weeks ingestion of blueberries (versus placebo) and acute ingestion of bananas (versus water alone) during 75-km cycling will: 1. Enhance performance. 2. Attenuate the magnitude of metabolic perturbation due to exercise (using a targeted panel of metabolites) which may be associated with increased plasma levels of beneficial gut-derived phenolics. 3. Attenuate post-exercise inflammation (as measured with cytokines, muscle damage markers, regulatory lipid mediators, ex-vivo monocyte cell cultures, and targeted immune proteins including S100A8 and S100A12). 4. Counter post-exercise downturns in innate immune function (natural killer cell lytic activity), and viral defense (using an ex-vivo cell culture with Hela cells).