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NCT ID: NCT05975437 Enrolling by invitation - Breast Cancer Clinical Trials

Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer

NABOR
Start date: March 6, 2023
Phase:
Study type: Observational [Patient Registry]

Surveillance and aftercare for curatively treated primary breast cancer patients is currently mostly 'one-size-fits-all', but can be personalized based on patients' risk of recurrence (depending on patient-, tumor- and treatment-related characteristics) and their personal needs and preferences. The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) based on individual risks and needs might reduce unnecessary burden to the patient, increase quality of life and lower the costs of follow-up. The NABOR study will examine the effectiveness of personalized follow-up care, consisting of personalized surveillance (PSP) and personalized aftercare plans (PAP) incorporating individual recurrence risks and personal needs of breast cancer patients. The main question it aims to answer is: 'what is the effectiveness of personalized surveillance (PSP) and aftercare plans (PAP), compared to current follow-up care, on cancer worry and self-rated overall quality of life (EQ-VAS)'. Also the effect of PSP and PAP on health-related quality of life (EQ-5D), societal participation, risk perception, patient satisfaction, patients' need for support, shared decision-making, health care costs and resource use, cost-effectiveness, and number and severity of the detected recurrences will be investigated. Next, the uptake and appreciation of the personalized plans and related factors (patient, caregiver, hospital and societal/financial) will be evaluated. Patients participating in the study will have to fill in several questionnaires and give consent for requesting data from the Netherlands Cancer Registry and from their electronic health records (EHR). The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) will be implemented stepwise over a period of nine months in ten participating hospitals. To collect observations of both pre- and post-transition to PSP and PAP, each hospital will include patients during the nine months before and after its transition to personalized care. In the future, the results of this project, i.e. the developed tools, can also be used for personalization of survivorship care for other cancer survivors. More broadly, all findings will be actively shared with interested healthcare professionals and other interested parties in the Netherlands.

NCT ID: NCT05908175 Enrolling by invitation - Clinical trials for Spinal Cord Injuries

FES-assisted Gait Intervention in People With Spinal Cord Injury - Pilot Study

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

A spinal cord injury (SCI) disrupts the communication within the nervous system, leading to limitations in sensorimotor activities such as walking. Regular use of functional electrical stimulation (FES) can result in recovery of voluntary muscle control and muscle strength. Locomotor training with FES may be a promising method to improve gait function. The primary objective of this pilot study is to assess the feasibility and safety of an FES-assisted gait training intervention. Secondary objectives are to assess the effects of an FES-assisted gait training intervention on gait function.

NCT ID: NCT05878054 Enrolling by invitation - Chronic Disease Clinical Trials

Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care

Start date: August 2, 2023
Phase: N/A
Study type: Interventional

Hotspotters are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. Reliable data on (cost-)effective interventions for these patients are scarce. The goal of this study is to assess the cost-effectiveness of pro-active and integrated care. This approach includes: an intake consultation with Positive Health; multidisciplinary meetings with physician, mental healthcare nurse, social worker and the patient; a personalised care plan and proactive care management. We aim to include 200 patients, divided over 20 primary care practices.

NCT ID: NCT05844449 Enrolling by invitation - Cystic Fibrosis Clinical Trials

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

Start date: August 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).

NCT ID: NCT05831839 Enrolling by invitation - COVID-19 Clinical Trials

Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints

CO-TRAINER
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Many post COVID-19 patients suffer from cognitive deficits, even after 1 year after hospitalization. These complaints have a huge impact on psychological well-being and quality of life. In rehabilitation programs in the Netherlands, most interventions are based on physical therapy or learning how to cope with fatigue and low levels of energy. In former studies computerized training of cognition in other populations has been proven to be effective. Knowledge on the effect of computerized training on attention and working memory in patients suffering from COVID-19 is urgently needed, and may contribute to more evidence-based rehabilitation programs for these patients. Therefore the effectiveness of computerized training of attention and working memory in post COVID-19 patients with cognitive complaints will be studied in this study.

NCT ID: NCT05827107 Enrolling by invitation - Clinical trials for Lymphoma, T-Cell, Cutaneous

Skin Barrier and Microbiome of CTCL Patients

Start date: April 3, 2023
Phase:
Study type: Observational

The goal of this study is to investigate the microbiome composition of the nares, non-lesional skin and patches, plaques and tumours in lesional skin of CTCL patients, including all stages of the disease, and to correlate microbiome (including S. aureus presence) and disease severity from CTCL patients.

NCT ID: NCT05825898 Enrolling by invitation - Clinical trials for Tricuspid Regurgitation

Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment

TRIGISTRY
Start date: September 1, 2022
Phase:
Study type: Observational

Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population >75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR. What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.

NCT ID: NCT05818644 Enrolling by invitation - Pediatric ALL Clinical Trials

Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children

HEPATIC
Start date: September 28, 2023
Phase:
Study type: Observational

The goal of this observational study is to investigate the incidence, current management practices, and outcomes in pediatric patients with HAC after liver transplantation. Research question: - What are the overall incidence of HAC and the effectiveness of all treatment strategies for HAC after pediatric LT? - What are the current management practices in the experience of centers, anticoagulant therapy, screening protocol, and assessment criteria for HAC after pediatric LT? The burden of participation is considered to be minimal, and limited to the questionnaires.

NCT ID: NCT05802563 Enrolling by invitation - Atrial Fibrillation Clinical Trials

Machine Learning Enabled Time Series Analysis in Medicine

ME-TIME
Start date: May 24, 2022
Phase:
Study type: Observational

The goal of this observational cohort study is to investigate the potential of fitness trackers in combination with machine learning algorithms to identify cardiovascular disease specific patterns. Two hundred participants will be enrolled: 1. 50 with heart failure 2. 50 with atrial fibrillation 3. 100 (healthy) individuals without the former two conditions All participants are given a Fitbit device and monitored for three months. Researchers will compare differences in heart rate variability patterns between the groups and devise a machine learning algorithm to detect these patterns automatically.

NCT ID: NCT05775354 Enrolling by invitation - Clinical trials for Coronary Artery Disease

Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

RED-LRGP
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized trial is to compare the diagnostic yield of a screen-like early diagnosis strategy to usual primary care to detect coronary artery disease (CAD), atrial fibrillation (AF), heart failure (HF), and/or valvular heart disease (VHD) in community people aged 50-80 years who participate in the Utrecht Health Project. The diagnosis strategy consists of a questionnaire with questions related to symptoms suggestive of CAD, AF or HF, a focused physical examination, laboratory testing, electrocardiography, and echocardiography.