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NCT ID: NCT06392178 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

SugarVita: a Digital Board Game

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The serious digital game, SugarVita, is a collaborative effort between the Máxima Medical Centre (MMC) and Eindhoven University of Technology (TUe), intending to enhance self-management for individuals with diabetes. As a mobile application available on smartphones and tablets, SugarVita emerged from cooperative design sessions involving patients diagnosed with diabetes. The average age of type 2 diabetes patients in the Netherlands exceeds 50 years. Following extensive discussions with these patients, the decision was made to model SugarVita after a digital board game, reminiscent of the classic board game 'ganzenbord' (Game of the Goose). In SugarVita, players experience a day in the life of an individual with diabetes, making choices regarding dietary habits, physical activity, and medication intake. Throughout this simulated day, the blood glucose level serves as a central theme. Players earn points by effectively managing their blood glucose levels. SugarVita can be played together with relatives or friends. The game aims to give people with diabetes more control over their chronic condition. Self-care is now seen as the primary approach to diabetes, which is a complex multi-faceted task where training and education are crucial. Importantly, SugarVita recognizes that a conventional 'dry' explanation may not resonate with everyone.

NCT ID: NCT06392074 Recruiting - Healthy Volunteers Clinical Trials

A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders

MB04-A-01-23
Start date: March 7, 2024
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, three-part, two-sequence per part, two-period, single-dose, cross-over study in healthy male volunteers to compare the PK, safety, and immunogenicity of MB04 and EU /US Enbrel®. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

NCT ID: NCT06391424 Recruiting - Critical Illness Clinical Trials

Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU)

EXTUBATE
Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. The rapid shallow breathing index (RSBI) is an important parameter used in an SBT. Because the high incidence of extubation failure (re-intubation within 48 hours) a search for a better parameter than the RSBI is warranted. Using the measured end-tidal oxygen (etO2) of mechanically ventilated patients it is possible to calculate the VO2, which is a measure of patient effort. The VO2 is a parameter with the potential to predict weaning success or failure, together with other parameters of patient effort like the work of breathing (WOB), pressure time product (PTP) and esophageal pressure swings, reflecting muscle strength of the diaphragm. Therefore, the investigators want to investigate if these parameters are associated with an SBT success or failure.

NCT ID: NCT06391359 Recruiting - Clinical trials for Idiopathic Acute Pancreatitis

Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)

PICUS-2
Start date: July 30, 2023
Phase: N/A
Study type: Interventional

Rationale: Annually, acute pancreatitis is diagnosed in 6,500 patients in the Netherlands. In up to 25% of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis (IAP). IAP is known for its high recurrence rate. It is hypothesized that microlithiasis, a type of biliary pancreatitis, is the most common cause of IAP. Laparoscopic cholecystectomy (LC) is highly effective in preventing recurrence of biliary pancreatitis. Currently no randomized trial has compared LC with conservative treatment in patients with IAP after adequate work-up including endoscopic ultrasound. Objective: To assess the effectiveness of LC as compared to conservative treatment in patients after a first episode of 'EUS-negative' IAP. Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization. Study population: Adults with a first episode of 'EUS-negative' IAP. Intervention (if applicable): Laparoscopic cholecystectomy versus conservative treatment. Main study parameters/endpoints: The primary endpoint is pancreatitis recurrence. Secondary endpoints include occurrence of biliary events, complications of LC, number and severity of recurrent episodes of pancreatitis, quality of life (QALY), costs (hospital and societal) and cost-effectiveness.

NCT ID: NCT06390475 Recruiting - Clinical trials for Splanchnic Vein Thrombosis

Optimizing Diagnosis of Splanchic Vein Thrombosis With MRDTI (Rhea)

Start date: March 22, 2019
Phase:
Study type: Observational

The Rhea-study is a multicenter prospective diagnostic proof-of-concept study There is an unquestionable need for improved diagnostic approaches for (incidental) SVT. The researchers plan to evaluate the MRDTI technique, that has been shown to be accurate in other settings of difficult-to-diagnosis venous thrombosis, for the notoriously challenging diagnosis of incidental SVT. This study targets an important unmet need and will provide the basis for precision medicine for patients with SVT in the near future, i.e. the possibility of assessment of the age of the thrombus in patients with incidental SVT, which is of utmost importance for determination of the indication for anticoagulant therapy. If this hypothesis is proven true, i.e. sensitivity of MRDTI for SVT is indeed >90%, the investigators will proceed with performing a randomized controlled outcome study in which patients with possible/probable chronic SVT with normal MRDTI test results and no other indications for anticoagulant therapy. These patients will be randomized between active therapeutically dosed anticoagulation versus no anticoagulation, to compare clinical outcome with regard to the occurrence of venous thromboembolism and/or Progressive symptomatic SVT as well as major bleeding.

NCT ID: NCT06390020 Recruiting - Clinical trials for Sensory Processing Sensitivity

Mindfulness-Based Stress Reduction (MBSR) for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study

MindSens
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

This study investigates the efficacy of MBSR training in alleviating stress-related symptoms among individuals with high sensory processing sensitivity. Participants will be randomly allocated to either the MBSR group or the control group. The primary hypothesis is that participants in the MBSR group, relative to control group, will have lower depression-anxiety-stress scores post-intervention, after controlling for baseline scores. The secondary hypothesis is that in the MBSR group, relative to control group, other mental health, physical health and well-being outcomes, as well as potential mindfulness mechanisms will also improve, after controlling for baseline scores.

NCT ID: NCT06388642 Recruiting - Clinical trials for Erythropoietic Protoporphyria

Pharmacokinetics of Afamelanotide in EPP Patients

Start date: March 7, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.

NCT ID: NCT06386341 Recruiting - Quality of Life Clinical Trials

QoL in OSA patiënts Treated With MMA Surgery.

QOMAS
Start date: August 2, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea. The main question it aims to answer is: Does MMA surgery in OSA patiënts improve their quality of life? Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure.

NCT ID: NCT06379347 Recruiting - Volume Status Clinical Trials

HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound

HOCUS-POCUS
Start date: February 28, 2024
Phase:
Study type: Observational

Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward.

NCT ID: NCT06376240 Recruiting - Type 2 Diabetes Clinical Trials

The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes

PYRAMID
Start date: March 21, 2024
Phase: N/A
Study type: Interventional

Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation.