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NCT ID: NCT05977205 Completed - Type 2 Diabetes Clinical Trials

COVID-19 Glycemic Control Study

Start date: May 2, 2020
Phase:
Study type: Observational

Diabetes mellitus is a chronic disease characterized by the inability of the body to maintain normoglycemia. Treatment of diabetes relies mostly on diabetes self-management, requiring a large investment of time and energy on a daily basis. Psychological wellbeing, behavioral patterns and social context play a major role in diabetes self-management and glycemic control. Social isolation behavior (self-quarantining) may impact glycemic control by influencing daily routines, therapy adherence, physical activity, and self-measurement and eating behaviors. Therefore, a period of nationwide self-quarantine, such as during the lockdown issued during the COVID-19 outbreak in the Netherlands, may have a large effect on glycemic control in patients with diabetes. In this observational cross sectional study, we aim to assess the impact of long-term self-quarantine on glycemic control, diabetes self-management and distress in patients with type 1 and type 2 diabetes mellitus. A specific subgroup of patients with T1D are those with complicated diabetes who have received a pancreas or islet transplantation and use immunosuppression, having multiple risk factors for severe COVID-19. The impact of lockdown strategies on mental and physical health is expectedly even greater in patients at even higher risk for severe COVID-19. We therefore additionally investigated differences in behavioral, mental and physical implications of a nationwide lockdown on patients with type 1 diabetes with and without islet or pancreas transplantation. Measurements will be performed during the lockdown period. Patients will be asked to perform a fingerprick HbA1c measurement once, sent back to the LUMC by mail. Data from continuous or flash glucose monitoring devices will be collected according to standard clinical practice. Furthermore, patients will be asked to fill out an online questionnaire once on diabetes self-management behavior, well-being and distress, along with questions about health status, level of education, medication use, employment, social situation and the impact of self-quarantine on daily routines. In this questionnaire, we ask patients to compare certain aspects of their life (e.g. anxiety, stress, weight, physical activity, glycemic control) at the time of the lockdown to before the lockdown. Data on demographics, type of diabetes, weight, BMI and HbA1c prior to the COVID-19 outbreak will be derived from the patient's electronic health file.

NCT ID: NCT05954351 Completed - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.

PRoVAcT-COVID
Start date: May 1, 2022
Phase:
Study type: Observational

PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.

NCT ID: NCT05942950 Completed - Clinical trials for Distal Radius Fracture

Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey

SSDART
Start date: June 20, 2023
Phase:
Study type: Observational

The goal of this surgeon survey is to find out if orthopedic and trauma surgeons can predict outcomes in older adults with distal radius fractures. The main questions it aims to answer are: - Can orthopedic and trauma surgeons effectively predict which treatment would benefit a patient the most in terms of good outcome versus poor outcome (based on Δ PRWE) following casting or surgical treatment for displaced intra-articular distal radius fractures? - What are the perspectives of trauma surgeons and orthopedic surgeons on current literature? - What factors direct trauma surgeons and orthopedic surgeons to surgery?

NCT ID: NCT05940753 Completed - Cancer Clinical Trials

Flash Mob Study With Regard to Travel Willingness Among Patients With Cancer

Start date: March 13, 2023
Phase:
Study type: Observational [Patient Registry]

This is a cross-sectional study in the form of a flash mob study, in which an inventory will be made on 13 and 14 March 2023 of the willingness to travel of oncology patients in the participating hospitals. Patients who have an appointment with an internist-oncologist or oncology specialist nurse at the outpatient clinic or by telephone and patients who come to day treatment unit for medical oncology are asked to participate. Willingness to travel is examined by means of a survey, in which a minimal set of categorized patient data (e.g. age, gender, level of education) is collected as part of the survey.

NCT ID: NCT05940337 Completed - Aging Clinical Trials

FIT to Grow Old - Functionality of the Immune System and Healthy Aging

FTGO
Start date: November 11, 2020
Phase:
Study type: Observational

Aging is commonly associated with reduced functionality of the immune system, resulting in a higher prevalence of infectious disease, auto-immune disease, cancer, and lower efficiency of vaccination. Nutritional strategies are increasingly recognized as a method to improve immune functionality, as several nutrients are shown to exert immunomodulatory properties. However, the large variation between individuals with regard to immune responses asks for more personalized approaches. Therefore, this field of research would benefit from a selection of those individuals with immune dysfunction. It is recently shown that immune functionality is largely dependent on intracellular metabolism, leading to the introduction of the new term 'immune cell fitness' which combines the metabolic and functional status of an immune cell. Within this study, we will determine the immune cell fitness of monocytes from healthy young adults and elderly subjects by measuring and integrating a broad range of metabolic and functional immune parameters into an immune cell fitness score. We aim to identify those individuals with immune dysfunction, the unfit. Furthermore, to identify potential nutritional strategies to improve immune cell fitness, we will study the effects of metabolites and nutrients on the immune cell fitness status of monocytes from elderly subjects.

NCT ID: NCT05931978 Completed - Clinical trials for Chronic Kidney Disease stage4

Effect of a CKD Dashboard on Patient Activation and Shared Decision Making

NEFRODASH
Start date: January 4, 2021
Phase: N/A
Study type: Interventional

The goal of this clinical pre-post study is to evaluate the effect of using a CKD dashboard, which visualizes individual patient data in patients with Chronic Kidney Disease stage 3b-4, and is used to structure the conversation during patient-clinician health visits. The main question[s] it aims to answer are: • what is the effect of the dashboard on patient activation levels (or outcomes related to patient activation)? • What is the effect of the dashboard on the conversation during health visits, including Shared Decision Making (SDM), Motivational interviewing (MI) and conversation topics? Participants will receive three surveys and have two routine care follow up consultations with their clinician audio recorded. Researchers will compare the same patients before and after implementation as well as compare them with patients in another hospital where no dashboard is (yet) implemented to see if patient activation levels (and related outcomes) increase, and whether there is an increase in SDM, MI and a difference in conversation topics.

NCT ID: NCT05926518 Completed - Critical Illness Clinical Trials

Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 Patients

NADRO
Start date: November 1, 2020
Phase:
Study type: Observational

Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients. Secondary objectives 1. To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups. 2. To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.

NCT ID: NCT05924685 Completed - Immunosuppression Clinical Trials

PREPARE-iVAC Trial

PREPARE-iVAC
Start date: August 22, 2023
Phase: Phase 4
Study type: Interventional

Objective: To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titer against the Omicron XBB.1.5 strain. Trial design: Multicentre, open-label randomized controlled clinical trial, for a duration of at least 10 weeks with an optional extension to 18 weeks. Trial population: Kidney transplant recipients, 18 years or older, who are at least 6 months after transplantation, with a functioning kidney transplant, using MMF/MPA in combination with at least one other immunosuppressant including a calcineurin inhibitor (CNI), with at least 3 previous COVID-19 vaccinations (=basic COVID-19 immunisation). Interventions: Patients will be randomized into one of two equally sized groups, with either continuation of their current immunosuppressive regimen including MMF/MPA or replacement of MMF/MPA by everolimus during at least six weeks before until four weeks after the last vaccination. Patients will receive a repeated COVID-19 vaccination with the monovalent Omicron XBB.1.5 vaccine, 28 days thereafter they can opt to also receive two herpes zoster vaccinations with the Recombinant Zoster Vaccine (RZV) with an interval between the first and second dose of 28 days. Main trial endpoints: The neutralizing antibody titer against the Omicron XBB.1.5. strain 28 days after monovalent Omicron XBB.1.5 COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus. Secondary trial endpoints: - SARS-CoV-2 specific anti-S1 antibody level at 28 and 56 days after COVID-19 vaccination - Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination - SARS-CoV-2 specific T-cell response 28 days after COVID-19 vaccination - Varicella zoster specific T-cell response 28 days after 2nd herpes zoster vaccination - Safety in terms of incidence of acute rejection, kidney function decline, SAEs, AESIs and solicited local and systemic AEs after COVID-19 and herpes zoster vaccination

NCT ID: NCT05906615 Completed - Pancreatic Cancer Clinical Trials

Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis

LIDOPAN
Start date: January 14, 2021
Phase: Phase 2
Study type: Interventional

Pain is a major clinical problem for many patients with pancreatic cancer and chronic pancreatitis (CP).In pancreatic cancer, nearly 75% of patients suffer from pain at the time of diagnosis, with over 90% of patients in advanced stages. In CP, pain occurs in 80-90% of patients and strongly affects quality of life. For both conditions, the majority of pain is addressed using the WHO analgesic ladder. However, more invasive pain therapies are often necessary. Currently, in several centers in the Netherlands, treatment with IV lidocaine is already used in clinical practice in patients with pancreatic cancer and CP. Based on practical experience, the majority of patients benefit from this therapy, however, its efficacy in terms of duration of pain relief, decrease in pain scores, increase in patient satisfaction and adverse events is unknown. Therefore, the aim of this study is to investigate the efficacy of monitored single intravenous infusion in patients with pancreatic cancer and CP.

NCT ID: NCT05902806 Completed - Clinical trials for Enteral Tube Nutrition

Evaluation of the Gastro-intestinal Tolerance of an Upgraded Composition of an Enteral Tube Feed for Adults

Start date: May 23, 2023
Phase: N/A
Study type: Interventional

This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support.