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NCT ID: NCT05430854 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus

Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study

RECAST SLE OLE
Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

NCT ID: NCT05430581 Not yet recruiting - Clinical trials for Sports Physical Therapy

Prediction of Knee Injuries Through System Dynamics Modeling

Start date: July 2022
Phase:
Study type: Observational

The large number of studies in the recent decade dealing with knee injury prevention seems not effective enough to cause a decline in knee injury rates. Thus, it has been proposed to use non-linear mathematical models that simulate the operation of complex and dynamic systems. The present study aims to analyze the dynamic relationships of the risk factors for knee injuries through system dynamics modeling to effectively predict and prevent knee injury. The first part of this project includes a qualitative study informing the theoretical non-linear interrelationships among the risk factors. The aim is to examine the initial hypothetical model formulated in the first part of the project through statistical analysis such as factor analysis and structural equation modeling. Pre-season and in-season data from questionnaires and biomechanical measurements for risk factors will be collected from at least 100 athletes who participate in high-risk sports. The athletes will be monitored for injuries during one season, and these data will be used in the next part of the research plan. The next part of the project aims to develop a dynamic simulation model for predicting knee injuries using specific equations. The function of the simulation model will predict the propensity of knee injuries over time. The next step includes the validation and calibration of the model based on the knee injuries that occurred during the season. The validated and calibrated model will then provide implications for effective policy decisions in knee injury prevention.

NCT ID: NCT05430438 Recruiting - Clinical trials for End Stage Kidney Disease

Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Intradialytic hypertension (IDH) is a well-recognized and established complication of hemodialysis that affects an estimated 10-15% of the dialysis population and is associated with an increased risk for cardiovascular adverse events and mortality. The major pathogenic mechanisms include volume and sodium overload, endothelial dysfunction and enhanced vasoconstriction potentially through the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system (SNS) activation. Preliminary uncontrolled studies have demonstrated that in order to achieve proper control of blood pressure (BP) in patients with IDH, volume control with achievement of dry weight, as well as the minimization of sodium load through alteration of dialysate sodium may improve BP. To this day, 3 studies have attempted to evaluate the effect of low dialysate sodium on BP levels in patients with IDH; one study that included 16 patients, compared the effect of low (5 milliequivalent/litre (mEq/L) lower than serum sodium) versus high (5 mEq/L higher than serum sodium) dialysate sodium concentration on BP levels only during the dialysis session; another study examined the effect of low (136 mEq/L) compared to standard (140 mEq/L) sodium dialysate, again, only on peridialytic and intradialytic BP; and only one randomized cross-over study used 24h ABPM to assess the effect of individualized isonatremic vs hyponatremic vs standard dialysate sodium. Hence, the aim of this study is to examine the effect of low (137mEq/L) vs standard (140mEq/L) dialysate sodium on 48h ambulatory blood pressure monitoring (ABPM) in patients with IDH, using appropriate design of randomized crossover study. In addition this is the first study examining the effect of low dialysate sodium on ambulatory central BP, arterial stiffness indices and BP variability in patients with IDH.

NCT ID: NCT05421819 Not yet recruiting - Osteopenia Clinical Trials

Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms

OSTEOME
Start date: June 2022
Phase: N/A
Study type: Interventional

It is well proven that the intestinal microbe regulates bone metabolism by the absorption of calcium and other metallic trace elements. Studies also show that regulation of the intestine and its microbe can affect bone density and resistance to a variety of animal models and humans. At the same time, interest in polyphenol-intestinal microbial interactions and in particular flavonoids and catechins has increased. Indeed, it has been observed that they are transformed via the microbe into bioactive compounds, and polyphenols themselves can modify the synthesis of the intestinal microbe. OSTEOME aspires to design and develop a novel dietary supplement for osteoporosis, activating the intestinal microbiome. At the same time companion biomarkers will be studied related to the efficacy and tolerability of the new supplement. The selection of flavonoids will take place through in vitro and in silico studies focusing on their interaction with pathways that regulate the activity of osteoclasts and osteoblasts. The efficacy and tolerability of the dietary supplement will be evaluated through a randomized clinical intervention.

NCT ID: NCT05421286 Not yet recruiting - Inflammation Clinical Trials

The MISTRAL Study: Gut Microbiome Correlates of Serious AIDS and Non-AIDS Events

MISTRAL
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

MISTRAL (Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination) is a 5-year EU Horizon 2020 project, running from 1/1/2020 - 31/12/2024. The project is led by Fundacio Privada Institut de Recerca de la Sida-Caixa CAIXA in Barcelona and aims to explore the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies. If successful, MISTRAL will benefit millions of human beings living with, or at risk of acquiring HIV-1 infection, and will produce novel concepts and technical innovations applicable to other human diseases. By doing that, MISTRAL will help to unlock the full clinical potential of the human microbiome to stratify patient outcomes and will irreversibly bring microbiome science closer to clinical practice

NCT ID: NCT05418491 Enrolling by invitation - Clinical trials for Post-intervention, Allergic Manifestations

To Investigate the Prolonged Effect of the Consumption of a Partially Hydrolyzed Infant Formula During the First 6 Months of Life on the Development of Allergic Manifestations at 5 Years of Age, Compared to a Standard Infant Formula and Exclusive Breastfeeding.

Start date: July 15, 2022
Phase:
Study type: Observational

The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T. 5-year follow-up study, aims to investigate the prolonged effect of each feeding regimen [formula-fed (exclusively or partially) with the partially hydrolyzed formula (pHF) or the standard formula (SF), or exclusively breastfed] within the first 6 months of life on the development of any allergic manifestations up to the age of 5 years. Allergic manifestations within this time period will include the presence of any of the following: atopic dermatitis, food allergies, respiratory allergies, urticaria, drug allergy and insect venom allergy. In addition, differences on growth (weight, height, BMI) will be examined.

NCT ID: NCT05417191 Completed - Clinical trials for Cardiometabolic Health

Effect of Differently Fed Farmed Gilthead Sea Bream Consumption

Start date: December 1, 2012
Phase: N/A
Study type: Interventional

The trial was a double-blind randomized dietary intervention study with a 1:1 allocation ratio, conducted in accordance with the Declaration of Helsinki. This study compared two treatments, i.e., farmed fish fed with olive pomace enriched diet (enriched fish; EF) versus farmed fish fed with fish oil diet (conventional fish; CF), using a crossover design. The study lasted 22 weeks; treatment period one (8 weeks, mid-January-end of March), washout period (6 weeks), and treatment period two (8 weeks, mid-May-end of July). The participants were equally distributed to the two treatments along treatment periods. Eligible subjects were all adults aged between 30 and 65 years old with a body mass index (BMI) between 24.0 and 31.0 kg/m2 who met the eligibility criteria for habitual fish consumption (<150 g of cooked fish per week). Exclusion criteria were pregnancy, current or recent weight loss effort, use of dietary supplements and being under treatment for any medical disorder. Subjects were allowed to use medical treatment for thyroid gland disorders, iron or folic acid supplements, contraceptives or hormone replacement therapy (HRT) for women, provided they would continue receiving their medication throughout the study. The aim of the study was to evaluate the effects of consumption of fillets from differently fed farmed gilthead sea bream on markers of cardiometabolic health such as platelet aggregation, circulating haemostatic markers, markers of inflammation and oxidative stress.

NCT ID: NCT05412511 Recruiting - Body Composition Clinical Trials

Metabolic Cost of Medicine Ball Training

M?T-UTH
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

In this study, the investigators will be able to estimate the metabolic cost of several foundational medicine ball training exercises.

NCT ID: NCT05412498 Recruiting - Body Composition Clinical Trials

Metabolic Cost of Battle Rope Training

BRT-UTH
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

In this study, the investigators will be able to estimate the metabolic cost of several foundational battle rope training exercises.

NCT ID: NCT05411341 Not yet recruiting - Cataract Clinical Trials

Comparison of Two Different Optical Biometric Systems

Start date: June 2022
Phase:
Study type: Observational [Patient Registry]

Primary objective of this study is to evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (IOL-PC).