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NCT ID: NCT05287737 Enrolling by invitation - Diabetes Mellitus Clinical Trials

Clinical Outcome After Total Pancreatectomy With Islet Autotransplantation

TOPPER
Start date: June 21, 2022
Phase:
Study type: Observational

A total pancreatectomy with islet autotransplantation (TPIAT) can be performed for a number of benign indications, such as chronic pancreatitis. In the current standard of treatment, after non-invasive, endoscopic efforts and other surgical options to relieve the pain, a total pancreatectomy is a last resort option. The pancreas is surgically removed during this procedure. Afterwards, the patient will have diabetes mellitus that is usually difficult to control with dependency on exogenous insulin administration. In TPIAT, a total pancreatectomy is followed by islet isolation from the resected pancreas and autotransplantation of these islets into the liver by means of a transhepatic intraportal islet infusion. Depending on the number and quality of islets, TPIAT may lead to full islet function so that no anti-hyperglycemic therapy is necessary or to partial islet function necessitating anti-hyperglycemic therapy. This can be only oral agents with reasonable islet function or complex insulin regimes with poor islet function. However, even with partial Islet function, glycemic control is easier with a lower risk of hypoglycemic events and diabetes-related complications, and an overall improvement of quality of life. In this cohort, the endocrine function and glycemic variability will be monitored over time (up to 15 years). Additionally, pain scores, pain perception and central sensitization, quality of life, exocrine pancreatic insufficiency and diabetes-related stress will be monitored.

NCT ID: NCT05263362 Enrolling by invitation - Breast Cancer Clinical Trials

An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients (STARLINGS Study)

STARLINGS
Start date: April 11, 2022
Phase:
Study type: Observational

To assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome.

NCT ID: NCT05240742 Enrolling by invitation - COVID-19 Clinical Trials

CORona (COVID-19) Follow Up Study: Epidemiology, Pathophysiology, Prediction, and Communication

CORFU
Start date: October 1, 2021
Phase:
Study type: Observational

The CORFU study, funded by ZonMW, is a prospective, multiple, cohort study with a maximum follow-up of 24 months after COVID-19. Dutch COVID-19 patients from 7 existing prospective cohorts, aiming and designed to conduct COVID-19 research, will be included in this study. The CORFU study has 5 aims, divided into 4 work packages (WPs): 1. To describe the nature, severity, pattern and duration of long COVID complaints up to a maximum of two years after infection and its relationship with quality of life (WP1); 2. To describe the rehabilitation and corresponding activities for the treatment and improvement of complaints and quality of life (WP1); 3. To describe the pathophysiological processes that cause long COVID complaints, and the role of vulnerability/resilience factors (WP2); 4. To develop a prediction model for the persistence of complaints, with distinction between patients with and without pre-existing morbidity (WP3); 5. To develop a patient platform prototype in which patients can digitally consult their answers and compare their answers with reference populations (WP4, in collaboration with the EuroQol foundation). The 7 cohorts participating in the CORFU study are: POPCOrn, COVAS, ELVIS, MaastrICCht, DC&TC, CAPACITY-COVID, and Adelante cohort. (Clinical) baseline and follow-up data has been collected in these cohorts and will be used/aggregated to investigate CORFU study aims. In addition, questionnaires will be send to the (former) patients of the existing cohorts and patients will be asked about several domains such as persisting complaints and quality of life, at several moments, depending on when the patients have experienced COVID-19. Within this study a patient platform prototype will be developed, together with the EuroQol foundation, to be able to inform patients about the individual situation and course of disease.

NCT ID: NCT05212571 Enrolling by invitation - Clinical trials for Complex Regional Pain Syndromes

Long-term Pain Modulation by Intravenous Esketamine in CRPS

KetCRPS-2
Start date: April 19, 2022
Phase: N/A
Study type: Interventional

Intravenous administration of esketamine is an effective recognized therapeutic option in refractory pain in CRPS, which sometimes in at least a part of the patients has a prolonged therapeutic effect. Unfortunately, CRPS literature contains a wide range of ketamine dosing regimens with the result that clinical protocols on dosage and administration are very heterogeneous. The current esketamine regimen in Erasmus MC consists of a 6-day hospital admission for continuous administration. In the Netherlands, both inpatient and outpatient esketamine treatments are offered. Inpatient and outpatient ketamine treatments have never been compared in randomized controlled trials and it is therefore unknown whether these two dosing regimens are equally effective. The primary objective is to demonstrate non-inferiority of experimental esketamine administration of 6x 1 day per 2 weeks (in total 3 months) as compared with standard esketamine administration of 1x 6 consecutive days. The end of study is at 6 months after the start of the study/treatment.

NCT ID: NCT05197296 Enrolling by invitation - COVID-19 Clinical Trials

Zooming in on Cerebral Abnormalities in Severely Affected COVID-19 Patients

ZoomCOVID
Start date: June 20, 2022
Phase:
Study type: Observational

Brain injury is one of the complications in COVID-19 intensive care unit (ICU) survivors, though the precise underlying mechanism is unclear. It is likely caused by a combination of prolonged hypoxia, a massive systemic inflammatory response, direct infection of the brain and small vessel vasculitis in combination with widespread hypercoagulopathy and thrombosis. Using novel MRI techniques, blood-brain barrier (BBB) permeability, as well as other microstructural and microvascular properties of the brain tissue, will be assessed non-invasively in COVID-19 ICU survivors approximately one year after ICU admission and compared to serial clinical and laboratory measurements of hypercoagulation and inflammation during the (ICU) admission. This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. In addition, neuropsychological tests and an objective smell/taste test will be used to evaluate neuropsychological status and sense of smell/taste. By gaining more insight into the pathogenesis of brain injury, the treatment of COVID-19 patients in the acute phase might be improved.

NCT ID: NCT05128695 Enrolling by invitation - COVID-19 Clinical Trials

Public Health Consequences of Covid-19

Start date: November 17, 2021
Phase:
Study type: Observational

Aim of this observational study is to improve our understanding of the impact of Covid-19 on health. By an online questionnaire at least 60.000 people are invited by email to participate. Invited are those people who tested for Covid-19 at the Public Health Service South Limburg since June 2020. Participants are followed over time (open cohort), to study impact on health, that is physical health, mental health, and social health (longcovid and other conseauences). Also, the socioeconomic impact is studied, as on work and education. And the consequences for health-care consumption; it also includes aspects as coping, stigma and lifestyle. All focused to understand the impact of Covid-19, in relation to health, and to gain information for promoting positive health and improving prevention and care.

NCT ID: NCT05052203 Enrolling by invitation - Sepsis Clinical Trials

Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis

REQOVERY
Start date: September 28, 2021
Phase:
Study type: Observational

Sepsis is a life-threatening dysregulated immune response to infection associated with multi-organ failure and a high mortality rate.While researchers have focused mainly on acute sepsis, post-sepsis care of survivors has long been neglected despite the observation that many sepsis survivors suffer from debilitating post-sepsis syndrome. This syndrome is characterized by frequent hospital readmissions and increased mortality due to persistent immune dysfunction, cardiovascular disease, and cognitive impairment, causing poor quality of life and a substantial burden on the healthcare system. Disconcertingly, the number of sepsis survivors at risk for hospital readmission continues to rise.7 Of the post-sepsis symptoms, post-sepsis immunosuppression is perhaps the most clinically important. While sepsis presents as an initial phase of hyperinflammation (a "cytokine storm"), it is followed by an immunosuppressive phase that is now understood to last weeks to months and predisposes survivors to lethal secondary infections and sepsis recurrence. A third of deaths eight years post-sepsis are caused by recurrent sepsis.We hypothesize that changes in the transcriptome and DNA methylome in immune cells of survivors might be the underlying driver for prolonged immunosuppression, and may also be correlated with long-term morbidity and mortality post-sepsis, as well as other symptoms of post-sepsis syndrome including PTSD and cardiovascular disease.

NCT ID: NCT05041309 Enrolling by invitation - Clinical trials for Solid and Hematological Malignancies

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

NCT ID: NCT04957719 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

SOS-AMI
Start date: August 14, 2021
Phase: Phase 3
Study type: Interventional

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

NCT ID: NCT04905693 Enrolling by invitation - Clinical trials for Idiopathic Pulmonary Fibrosis

Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

TETON-OLE
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.