Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
Depressive DisorderMajor1 moreAs the role of (neuro)inflammation in depression is emerging, augmentation of antidepressant treatments with anti-inflammatory drugs such as celecoxib has shown encouraging preliminary results. However, inflammation is not present in all depressed patients. Depression is heterogeneous: patients express diverse and sometimes opposing symptoms and biological profiles. The investigators of the present trial recently introduced the concept of ImmunoMetabolic Depression (IMD), characterized by the clustering of inflammatory/metabolic dysregulations and atypical, energy-related symptoms (hyperphagia, weight gain, hypersomnia, fatigue and leaden paralysis), and present in approximately 30% of cases. Converging evidence suggests that in this subgroup of depression cases, inflammation may exert a crucial pathobiological mechanism, representing therefore an actionable therapeutic target. In this trial IMD will be applied as a tool to personalize treatment, by matching depressed subjects with IMD with a targeted anti-inflammatory add-on treatment. In this study, 140 persons with IMD will be selected. In this specific group of patients, the investigators will test whether celecoxib add-on (400 mg/d) is more effective than placebo in the treatment of depression through a 12-week double-blind, randomized (1:1), placebo-controlled trial. By selecting specifically depressed patients with IMD, the proposed treatment selectively targets key inflammatory pathophysiological pathways to enhance clinical outcome for depression. This personalized approach is expected to lead to large health gains for a sizable proportion of patients. The main hypothesis is that the group of patients with IMD receiving TAU + celecoxib, as compared to the TAU + placebo, will show a better symptom course over the 12-week follow-up.
Emotion Regulation Training to Reduce Cardiovascular Disease Risk Among Depressed Young Adults in...
Major Depressive DisorderCardiovascular Diseases3 moreThe proposed study will investigate the utility of a single-session emotion regulation training to reduce CVD risk among young adults diagnosed with MDD living in Southern MS. Using an single-arm, non-randomized design, young adults aged 18-29 will undergo a single-session emotion regulation skills training. Before and immediately after the skills training session, participants will supply several biological metrics tied to CVD risk: resting HRV, inflammation (measured via c-reactive protein [CRP]), and blood pressure. Participants will provide the same biological metrics at a one-week follow-up visit to assess short-term sustained gains following the single-session intervention and complete a 7-day ecological momentary assessment (EMA) of their daily emotion regulation skills use and depressive symptoms between these two visits.
Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery...
Neuromuscular BlockadeInnate Inflammatory Response2 moreMonocenter randomized controlled trial to compare the effect of deep neuromuscular blockade (NMB) versus moderate NMB during total hip replacement surgery on postoperative quality of recovery and innate immune function.
Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation...
Renal Failure AcuteMultiple Organ Failure1 moreThe purpose of this study is to assess the effectiveness and the safety of extracorporeal methods for removing mediators of systemic inflammation in patients with multiple organ dysfunction syndrome after heart and aorta surgery.
Anakinra for Preterm Infants Pilot
Prematurity; ExtremeInflammationPhase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood...
InfectionsVector Borne Diseases10 moreThis is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP). Up to 18 participants will be enrolled in cohorts of up to 6 participants each. The study will proceed as follows for all participants: Screening period of up to 28 days to recruit healthy adult participants. Day 0: Intravenous inoculation with approximately 2,800 viable P. falciparum-infected red blood cells. Days 1-3: Daily follow up via phone call or text message. Days 4-7: Daily site visits for clinical evaluation and blood sampling to monitor malaria parasite numbers via quantitative polymerase chain reaction (qPCR). Day 7 PM: Start of confinement within the clinical trial unit. Day 8: Administration of a single oral dose of the IMP (MMV367). Different doses of MMV367 will be administered across and within cohorts in order to effectively characterise the PK/PD relationship. Days 8-11: Regular clinical evaluation and blood sampling while confined to monitor malaria parasite numbers and measure MMV367 plasma concentration. Day 11 AM: End of confinement within clinical trial unit. Days 12-23: Outpatient follow-up for clinical evaluation and blood sampling. Day 24: Initiation of compulsory definitive antimalarial treatment with Riamet® (artemether/lumefantrine) and/or other registered antimalarials if required. Treatment will be initiated earlier than Day 24 in the event of: Insufficient parasite clearance following IMP dosing Parasite regrowth following IMP dosing Characterising the pharmacokinetic/pharmacodynamic relationship of MMV367 Participant discontinuation/withdrawal, Investigator's discretion in the interest of participant safety. Day 27: End of study visit for final clinical evaluation and to ensure complete clearance of malaria parasites.
Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1)
Gaucher Disease Type 1The purpose of this study is to measure levels of blood and brain chemicals related to oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher disease (GD1) to see if these levels are altered by GD1.
Paricalcitol Improves Anemia of Inflammation
AnemiaAnemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is a selective vitamin D receptor activator with potential benefits on anti-inflammatory cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.
Impact of NMES and HPRO on Recovery After SAH- Pilot Study
Subarachnoid HemorrhageMuscle Atrophy2 moreThe study purpose is to investigate the hypothesis that in adults with SAH, early neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls receiving standard of care interventions for nutrition and mobilization. The investigators will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH. This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as compared to age and severity-matched SAH patients undergoing standard of care interventions for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and NMES interventions have upon inflammatory cytokines and markers of energy balance. Results of this study will establish evidence for precision nutrition plus early exercise to mitigate the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health recovery outcomes.
ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular...
Cardiovascular RiskChronic Kidney Disease1 moreThis study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.