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NCT ID: NCT05314855 Recruiting - Type 2 Diabetes Clinical Trials

Brain Clock and Insulin Resistance

Start date: January 4, 2023
Phase:
Study type: Observational [Patient Registry]

In this observational cohort study the investigators will determine the activity rhythm of the suprachiasmatic nucleus in humans with progressive stages of insulin resistance, using advanced functional brain imaging (7 Tesla functional MRI).

NCT ID: NCT05314517 Active, not recruiting - Clinical trials for Sarcoidosis, Pulmonary

A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis

RESOLVE-Lung
Start date: August 31, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

NCT ID: NCT05314309 Active, not recruiting - CRC Clinical Trials

Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening

mtFIT
Start date: March 25, 2022
Phase:
Study type: Observational

The primary goal of the population-based colorectal (CRC) screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. To improve current CRC screening programs, the investigators have developed and retrospectively validated a test that combines the detection of multiple proteins in stool (the multitarget faecal immunochemical test, mtFIT). mtFIT was found to have a higher accuracy to detect advanced neoplasia (AN), which includes CRC, advanced adenomas and advanced serrated polyps, in comparison to FIT. Thus, this multitarget test has the potential to improve the screening program's efficiency in reducing CRC-related incidence, morbidity and mortality. This new test, in comparison to FIT, shows specifically higher sensitivity in the detection of advanced adenomas, without affecting specificity.

NCT ID: NCT05314283 Completed - Clinical trials for Healthy Volunteers, Medical Device

A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.

Start date: March 28, 2022
Phase: Phase 1
Study type: Interventional

This study investigates how safe the study device DV3395-C1 is when swallowed by healthy men and women. By the use of X-ray the device will be followed from the mouth, through the food pipe to the stomach and then into the gut. It will be checked if the device activates itself in the stomach as planned. Participants will be admitted to the clinic research center on day -1 and will receive the device on day 1 after 6 hours fast. The X-ray session will take up to 5 hours ending with administration of a small amount of contrast agent for better visualisation. The participants will stay at the clinic research center for up to 6 days until the device has been excreted. A follow-up phone call will take place 1 week after the device has been excreted.

NCT ID: NCT05313594 Completed - Glucose Metabolism Clinical Trials

Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses

Start date: March 28, 2022
Phase:
Study type: Observational

Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice. The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations. There are minor risks for the research subjects of this study. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times and Hospital Gelderse Vallei once.

NCT ID: NCT05312879 Recruiting - Clinical trials for Proteinuric Kidney Disease

Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease

AMPLITUDE
Start date: March 30, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.

NCT ID: NCT05312580 Completed - Clinical trials for Peripheral Arterial Disease

PMCF Study for Peripheral Arteries Above the Knee (ATK)

Start date: June 1, 2022
Phase:
Study type: Observational

The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.

NCT ID: NCT05310604 Completed - Clinical trials for Primary Antibody Deficiencies

Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.

GP-PAD II
Start date: May 24, 2022
Phase:
Study type: Observational

Rationale: Primary antibody deficiencies (PAD) encompass a group of rare heterogeneous diseases. The clinical presentation may vary widely, including infectious and autoimmune symptoms and increased risk of malignancy. Due to the rarity of the diseases and this wide array of symptoms there is often a delay in diagnosis, of up to 12 years on average1-4. Timely diagnosis of PAD reduces morbidity, mortality and health care costs as effective therapies are available. The currently available screening systems for the broader group of primary immunodeficiencies (PID) have been shown to have poor diagnostic performance5-10 and are time consuming. We have thus developed an algorithm to screen patient records in a primary care setting for risk factors specifically for PAD. Patients with a high risk may undergo a laboratory assessment and referral if necessary, thus reducing the diagnostic delay of PAD. The aim of the current study is to validate this algorithm. Objective: Main objective: to validate a screening algorithm for PAD in a primary care setting in the Netherlands. Study design: Mono-centre cohort study based on regular care data Study population: Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.

NCT ID: NCT05309720 Recruiting - Burns Clinical Trials

Dermal Substitution in Pediatric Burns

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

The standard treatment of deep dermal to full thickness burns is surgical removal of the burn followed by skin transplantation. Dermal substitutes are increasingly used in the treatment of deep burns to replace lost dermis. Preservation of the collagen and elastin in the acellular human dermal substitute Glyaderm provides a more elastic scar. It is unknown what the effect of Glyaderm on scar quality is in a solely paediatric population. The objective of this case series is to investigate scar maturation and scar quality when applying Glyaderm in deep dermal to full thickness burns in a pediatric population aged ≤15 years old.

NCT ID: NCT05309668 Active, not recruiting - Clinical trials for Neurofibromatosis Type 1

Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN

SPRINKLE
Start date: January 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints. The study will inform the benefit risk profile of the granule formulation in children aged ≥ 1 to < 7 years with NF1 related symptomatic, inoperable PN.