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NCT ID: NCT06018831 Recruiting - Kidney Diseases Clinical Trials

Urine and Ultrasound Screening for Kidney Disease in Children

Start date: April 12, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to early detect kidney disease in the natural population cohort of children by urine and ultrasound screening, to assist in the precise prevention and treatment of children's kidney disease, and to establish a risk prediction system for children's kidney disease. About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Through the project, child who is found with abnormal urine or ultrasound result will be referred to Children's Hospital of Fudan University to get further examination and treatment.

NCT ID: NCT06178107 Recruiting - Celiac Disease Clinical Trials

Efficacy of Cholesterol-lowering L. Plantarum on Cardiometabolic Health Biomarkers in Coeliac Disease Patients

ProCoChoL
Start date: April 12, 2022
Phase: N/A
Study type: Interventional

Recent studies have also shown that 30% of the world's population carries the susceptibility genes for coeliac disease and that only 2-5% of these individuals are really affected, however, studies suggest the existence of other factors capable of contributing to the onset of the disease, such as intestinal dysbiosis. We have also seen how each of us has a specific microbiota, defined as an individual human enterotype, which depends on our background and can be modified by the diet. Recently, much interest has been directed to a strain of lactobacilli, called Lactobacillus plantarum (LP-LDL®) capable of reducing cholesterol and preventing the reabsorption of bile salts in the liver. The efficacy of this bacterial strain has been confirmed in 3 different human studies demonstrating the efficacy of LP-LDL® in patients with high baseline cholesterol (TC> 6mmol / L). This is a food supplement that has been commercially available in multiple formulations in Europe for over 3 years. LP-LDP is a probiotic strain, safe to use, selected for its high bile salt hydrolase in vitro, and in vivo cholesterol reduction activity. The intake of 2 Å~ 109 CFU encapsulated LP-LDL twice daily, significantly reduced LDL-C (13.9%), total cholesterol (TC) (37.6%), TG (53.9%), and significantly increased HDL-C (14.7%; in subjects >60 years of age; 6-12 weeks) in normal to mildly hypercholesterolaemic subjects. In a recent double-blind placebo-controlled human study published by the Journal of Functional Foods (2022) and carried out by the University of Roehampton (UK), LPLDL showcased statistically significant reductions in multiple cardiovascular risk biomarkers, including total cholesterol, LDL cholesterol, non-HDL cholesterol and apoB. No adverse effects were noted throughout the study. We are here proposing a pilot human intervention study to evaluate the effectiveness of the LP-LDL® probiotic in reducing cardiovascular risk factors inclusive of cholesterol in the blood in people with coeliac disease.

NCT ID: NCT04478734 Recruiting - Huntington Disease Clinical Trials

Trial of the Combined Use of Thiamine and Biotin in Patients With Huntington's Disease

HUNTIAM
Start date: April 12, 2023
Phase: Phase 2
Study type: Interventional

Evaluate the safety and tolerability of combined oral thiamine with biotin therapy in patients with Huntington´s disease in mild to moderate stages and it is intended to evaluate the biological effect of the treatment in the central nervous system of these patients using as the main biomarker the increase in the level of thiamine monophosphate (TMP) in cerebrospinal fluid (CSF) of these patients with Huntington Disease (HD) during a follow-up period of one year. Our main hypothesis is that combined thiamine-biotin oral therapy is a secure and well-tolerated treatment, potentially capable of modifying the disease course or avoiding the progression of symptoms in early-stages HD patients

NCT ID: NCT05012033 Recruiting - Asthma Clinical Trials

Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting

EHD-Pred PK
Start date: April 12, 2023
Phase:
Study type: Observational

This is a pilot study to investigate serum prednisolone profiles in: - Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting. - Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone. The study will comprise 3 groups, including those started on high doses of prednisolone acutely in an inpatient or outpatient setting, participants on chronically high doses, and those receiving a several week course of high dose methylprednisolone or dexamethasone. The study aims to measure prednisolone levels at a number of time points to investigate serum profile differences in those receiving prednisolone acutely compared with longer term steroid use. Further samples will be taken to characterise additional metabolic changes.

NCT ID: NCT05364970 Recruiting - Knee Injuries Clinical Trials

IVR in Motor Rehabilitation

IVR_MOT
Start date: April 12, 2023
Phase: Early Phase 1
Study type: Interventional

The present project on sport rehabilitation aims at validating a rehabilitation protocol in immersive virtual reality (IVR) for restoring motor functions following peripheral injuries of the lower limbs. Sport injuries are related to direct and indirect costs and, in many cases, cause an interruption of motor activity for prolonged periods. Sport physiotherapy aims at recovering the motor functionality in order to guarantee the fastest possible return to sport. It employs plasticity and compensatory mechanisms within the injured motor system. However, being primarily based on the execution of movements that can be largely compromised, the treatment might be intrinsically complicated. It has been suggested that the motor system can be activated by observing one's own body perform the movements, without any actual movement execution. By using multisensory integration and sense of presence in IVR, it is possible to create an illusory experience that a moving virtual body (avatar) temporarily becomes one's own moving body. Moreover, this experience activates the motor system similarly to the activation from one's own actual movements. Based on these considerations, the present study hypothesizes that observation of one's own virtual body, without any movement execution, might activate the motor system to the extent of significantly improving functional recovery. The randomized clinical trial will recruit participants that underwent knee surgery and are in the first phase of the rehabilitation period (starting within two weeks after the surgery). Together with the traditional training protocol (4-6 weeks) participants will be administered a training in IVR that will include a virtual avatar performing a series of standard lower limb rehabilitation exercises. Participants will be randomly assigned to the experimental group (avatar observed from the first-person perspective, i.e., perceived as one's own body), the active control group (avatar observed from the third-person perspective, i.e., perceived as another person's body) and the group with no intervention. Before, at midpoint and after intervention, a standard battery of tests will be administered to evaluate the state of the motor system), as well as measures of embodiment for controlling the efficacy of the virtual scenario. The hypothesis is that the experimental group will show greater improvement of the motor functionality compared to the two control groups.

NCT ID: NCT05420935 Recruiting - Clinical trials for Hypersensitivity, Immediate

Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room

MEDIREP
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

Acute per-anesthetic hypersensitivity reaction (HSA-PA) is a rapidly occurring systemic reaction following injection of a drug during anesthesia (mortality between 3 and 9%). The substances responsible for these reactions in France are curare in 60% of cases, followed by antibiotics. The main mechanism mentioned is an immediate systemic hypersensitivity immune reaction mediated by IgE antibodies (anaphylaxis). NeuroMuscular Blocking Agents (NMBA; curare) relax skeletal muscles to facilitate surgeries and permit intubation, but lead to adverse reactions: (a) severe hypersensitivity reactions (anaphylaxis) thought to rely on pre-existing anti-NMBA antibodies; (b) complications due to postoperative residual curarization. Identification of patients at risk remains suboptimal due to the lack of adequate tools to detect anti-NMBA antibodies. A capturing agent exists for only one out of the four most used NMBAs, allowing reversal of profound curarization. Case reports suggested that it might also ameliorate an ongoing anaphylaxis due to that NMBA. Based on strong preliminary results, our study proposes to characterize anti-drugs antibody repertoires in patients with various NMBA or antibiotics-anaphylaxis, describe activation pathways leading to anaphylaxis, develop and validate diagnostic and therapeutic molecules to ameliorate patient screening, NMBA-anaphylaxis and reverse profound neuromuscular block.

NCT ID: NCT05443074 Recruiting - Clinical trials for Urinary Incontinence

Efficacy of a Face to Face Versus a Remote Physiotherapy Instruction Session About Pelvic Floor in Women With Urinary Incontinence

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess and to compare the efficacy of a face to face versus a remote physiotherapy instruction session about pelvic floor muscle (PFM) function, including teaching women how to contract their PFM and how to perceive a correct PFM contraction. Study participants will be randomly assigned to participate in one of the three study groups: Group 1 will receive face to face instructions, Group 2 will receive real time remote instructions and Group 3 will not receive any instruction. The primary outcome measure is PFM function assessed using the modified Oxford Scale.

NCT ID: NCT05482789 Recruiting - Clinical trials for Gestational Diabetes

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

Start date: April 12, 2023
Phase: Phase 4
Study type: Interventional

This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, the investigators will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps the participants' pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.

NCT ID: NCT05483907 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF

Start date: April 12, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).

NCT ID: NCT05511246 Recruiting - Clinical trials for Ventricular Tachycardia

Venous Ethanol for Ventricular Tachycardia

VELVET
Start date: April 12, 2023
Phase: Phase 2
Study type: Interventional

Comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -Venous Ethanol for Left Ventricular Ischemic Ventricular Tachycardia -VELVET clinical trial