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NCT ID: NCT06170138 Recruiting - Clinical trials for Nicotine Use Disorder

Study to Assess PK, PD, Nicotine Extraction, Palatability, Subjective Effects of Nicotine Pouches - Daily Nicotine Users

Start date: November 24, 2023
Phase: N/A
Study type: Interventional

This is an explorative, open-label, randomised, 3-way cross-over study to assess pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability, nicotine extraction, palatability and subjective effects after single use of nicotine pouches in daily nicotine users.

NCT ID: NCT06169072 Recruiting - Breast Cancer Clinical Trials

Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients

MagSnow2
Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

NCT ID: NCT06169020 Enrolling by invitation - Health Promotion Clinical Trials

Developing Intelligent Wearable Algorithms

DIWAH
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Physical activity (PA) is one of the few behaviors that individuals can change on their own, incurring minimal costs while simultaneously yielding significant health benefits. Over the past decade, new methods have been developed to measure both physical activity and associated health outcomes, such as blood pressure. Notably, there has been an explosive development of so-called wearables, including smartwatches and activity trackers. Wearables are equipped with multiple sensors that measure various aspects of PA, such as steps and heart rate, as well as cardiovascular health indicators like blood pressure and oxygen saturation. Therefore, wearables can be viewed as Swiss army knives with many tools in one instrument. They are highly popular in the fitness industry, but their role in healthcare is appropriately limited. However, most wearables on the market have several disadvantages that make them unsuitable for use, even among healthy individuals. Several studies have revealed that they do not produce reliable or valid data for metrics like pulse, steps, and PA-related energy expenditure. Furthermore, they are primarily designed for the fitness market, not for use within healthcare systems or as support for behavior change, and they have not been transparently evaluated. Additionally, the algorithms translating signals from sensors into interpretable outcomes are often trade secrets. Worse still, they are updated and modified at irregular intervals, making it challenging to compare outcomes over time. Other significant limitations include questionable patient confidentiality, as data is often uploaded to companies' cloud services. While research monitors are more flexible and transparent compared to commercial wearables, they lack essential features for daily use that are crucial in healthcare environments, such as the ability to communicate with the user. Currently, both commercial and research monitors cannot assess PA on an individual level, as they only utilize a limited portion of the rich data collected. Therefore, it is not surprising that their implementation in clinical care remains a challenge. Given the plethora of new products entering the market without documented validity, it is crucial to provide consumers, patients, healthcare professionals, and researchers with a transparent, evidence-based wearable. Against this backdrop, an interdisciplinary research group with the ambitious goal of developing and testing a high-functioning wearable tailored for use in healthcare-an e-physiotherapist (as opposed to commercial wearables targeting the fitness market-an "e-personal trainer") have been formed. In this project, the focus is on measuring PA, blood pressure, and energy consumption, as they represent some of the most significant risk factors for mortality and morbidity, namely inactivity, hypertension, and obesity. The overall goal of this project is to develop and validate AI-based algorithms for individually measuring various aspects of physical activity (PA), heart rate, energy expenditure, and blood pressure in laboratory settings as well as in everyday conditions. These algorithms represent a significant advancement compared to previous methods. In the case of PA metrics from accelerometry, current approaches rely on cut-points (threshold values) to define the intensity of PA. These cut-points are absolute, and individual variations in biology and biomechanics increase the risk of serious misclassification. To estimate intensity using heart rate, it is well-known that both resting heart rate and maximum heart rate are relative, requiring individual calibration for accurate measurements-essential even for accelerometry if one aims to measure PA on an individual level, a step not commonly taken today. Furthermore, heart rate is influenced by factors beyond PA, such as emotions and medication. To address these issues, combining information from accelerometry (biomechanics) and heart rate (physiological response), enhancing the ability to identify individual intensity and energy expenditure of PA. In this project, artificial intelligence (AI) and machine learning (ML) will be employed to analyze the collected data and predict the intensity of PA. If the proposed method demonstrates the ability to measure PA and blood pressure at an individual level, the project will proceed. Our intention is to use AI/ML to combine PA information with blood pressure data, creating a self-learning system capable of suggesting an appropriate dose of PA to optimize blood pressure. This approach has not been studied yet, likely due to the complexity of obtaining and analyzing these data. However, the technology, processing power, and analysis tools are now available, making it timely to investigate its feasibility.

NCT ID: NCT06168539 Recruiting - Clinical trials for Hemodialysis Complication

Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis

Start date: May 11, 2022
Phase: N/A
Study type: Interventional

During hemodialysis (HD) the blood of the patient pass an extracorporeal circuit that contains a dialyzer for rinsing and a venous chamber (air trap) to prevent from air embolism through the return blood into the patient. However, air traps in clinical use have limited capacity to prevent from microemboli of air to enter the return bloodline and deposit as emboli in the body such as lungs, heart and brain. The Investigator developed the air trap Emboless that was patented. In vitro studies showed significantly better reduction of microemboli contaminations than air traps compared to that in clinical use. The present randomized clinical trial compares two different air traps used by the same patients in a cross-over design (as pairs) using the Emboless compared with the Fresenius 4008/5008 (F5008). Chronic HD patients are randomized to perform the first HD with either their standard air trap (F5008) in the venous bloodline tubing or using the Emboless bloodline and vice versa. Each patient was included to make two paired series. A safety committee evaluates if significantly worse outcome appears especially with the Emboless, to stop the study. During HD the microbubbles are counted by a GAMPT ultrasound device using two probes. One probe is set at the inlet side of the air trap and the second at the outlet side. The outlet side represents data of microbubbles in the blood that are entering into the patient. Comparative non-parametric paired analyses are performed between the air traps. Monitoring of the study is performed.

NCT ID: NCT06167616 Completed - Type 2 Diabetes Clinical Trials

Infections and Latent Autoimmune Diabetes in Adults

LADA
Start date: September 1, 2010
Phase:
Study type: Observational [Patient Registry]

Infections are proposed risk factors for type 1 diabetes in children. The investigators will examine whether a diagnosis of infectious disease also confers an increased risk of latent autoimmune diabetes in adults.

NCT ID: NCT06167018 Completed - Clinical trials for Irritable Bowel Syndrome

Nurse-administered, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS).

Start date: September 2005
Phase:
Study type: Observational

Adult IBS patients with symptoms refractory to standard medical treatment received nurse-administered, gut-directed hypnotherapy. The primary outcome measure was change in gastro-intestinal symptom severity.

NCT ID: NCT06166199 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Effects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus

SLE-HIIT
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the safety and effects of high-intensity interval training (HIIT) combined with resistance training in patients with systemic lupus erythematosus

NCT ID: NCT06165185 Completed - Clinical trials for Excess Intake of Macronutrients

Water and Coffee Intervention in Humans

Start date: January 1, 2011
Phase: N/A
Study type: Interventional

39 healthy subjects without medication (except oral contraceptives) aged 20-70 years are recruited via advertisements or through telephone contacts with individuals that had previously participated in population-based cohort studies in Malmö. All subjects are exposed to three different intervention procedures; water and coffee loads (acutely and chronically), or no change from usual fluid intake (as a time-control), respectively in randomized order. The daily intake of coffee or water will amount to 3 L of water and 1 L of coffee, respectively for one week each. The three interventions (water, coffee and control), are separated by three weeks of normal fluid intake as a wash-out period. By testing if simple life style interventions, i.e., increased water or coffee intake, may affect vasopressin secretion, evaluated as copeptin, we will increase the knowledge as to whether such life style induced changes of copeptin may in turn lead to effects on glucose tolerance as well as on other cardiometabolic risk factors previously shown to be associated with high copeptin level. Thus, the study will lead to further understanding about vasopressin and copeptin release and how life style manipulation of the vasopressin system may influence glucose metabolism and other cardiometabolic risk factors in healthy individuals.

NCT ID: NCT06163339 Not yet recruiting - Mental Health Issue Clinical Trials

Evaluation of the Cultural Formulation Interview (CFI)

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

Studies show that the mental health of children may have deteriorated in recent decades. In Sweden, several national initiatives have been implemented to develop and strengthen interventions for children's mental health. One of these initiatives involves enhancing the first line of primary care for children with mental health issues, whose mission is to provide early intervention, i.e., support for mild to moderate mental health problems. The responsibility for children with moderate to severe mental health issues lies with child and adolescent psychiatry. Research indicates that children with a migration background, to a lesser extent than native-born children, have contact with both the first line of mental health care and child and adolescent psychiatry. There is also research showing that when newly arrived individuals do seek care, they may receive poorer quality care than others and, for example, may be misunderstood. From the perspective of equal healthcare, this is a significant shortcoming. In our study, the investigators address differences between healthcare providers and families based on cultural factors as a possible reason for the lack of equality in healthcare. In the study, the investigators aim to evaluate whether the Cultural Formulation Interview (CFI) improves the connection between healthcare providers and families and increases the family's involvement in treatment, ultimately leading to better mental health for the child. The method can be said to aim at enhancing the assessment, compliance, and treatment that are currently available within healthcare.

NCT ID: NCT06163261 Recruiting - Clinical trials for Non-functioning Pituitary Adenoma

Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma

Start date: February 27, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about physical activity's effect on health in people who have had surgery of a non-functioning pituitary adenoma. The main questions it aims to answer are: - Do physical activity increase quality of life? - Do physical activity increase general health, cardiovascular fitness, self-efficacy and muscle strength and reduce fatigue and cardiovascular risk profile? Participants will at the start of the the study, at 6 months follow up and 12 months follow up: - Fill out health surveys - Perform a cycling test, hand strength test, chair stand test and wear and accelerometer for a week - Undergo a dual energy X-ray absorptiometry to measure muscle and fat mass - Leave blood samples Researchers will compare those who are randomized to the intervention and see a physiotherapist to get an individualized and person-centred prescription of physical activity plan and those who are randomized not to be in the intervention to see if physical activity increases quality of life and general health.¨.