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NCT ID: NCT06461273 Not yet recruiting - Obesity Clinical Trials

Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome

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

The investigators are piloting a 3 month community-based lifestyle medicine program that incorporates experiences and education in urban agriculture, nutrition, culinary arts, and physical fitness to test the hypothesis whether this improves clinical and socio-behavioral outcomes of participants with Cardiovascular Kidney Metabolic (CKM) syndrome (high blood pressure, diabetes, high cholesterol, heart disease, and obesity) in comparison to the current medical care model (usual care) or providing healthy produce (medically tailored groceries).

NCT ID: NCT06461559 Not yet recruiting - Stoma Ileostomy Clinical Trials

Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

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

This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.

NCT ID: NCT06462027 Not yet recruiting - Cardiac Arrest Clinical Trials

Packed Red Blood Cell Transfusion During Cardiac Arrest

Start date: August 1, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this pilot interventional study is to collect preliminary data on administering packed red blood cell (PRBC) during cardiac arrest (CA). The primary objective is to assess the feasibility of PRBC transfusion during cardiac CA to help optimize the methods required to augment cerebral and other vital organ oxygen delivery during cardiopulmonary resuscitation (CPR). The secondary objectives are to assess the effect of PRBC transfusion during prolonged cardiac arrests on cerebral oxygenation, end tidal carbon dioxide (ETCO2), return of spontaneous circulation (ROSC), survival to discharge, biomarkers of neural injury and inflammation, and neurological outcomes at hospital discharge, 30 days post-CA, and 90 days post-CA.

NCT ID: NCT06462937 Not yet recruiting - Exercise Clinical Trials

A Digital Exercise Intervention in Patients With Spondyloarthritis

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

This protocol describes a 6-month randomised, controlled exercise trial in patients with axial spondyloarthritis (axSpA) with re-randomization after 3-months. The primary outcome of the trial (disease activity) will be evaluated at 3-months. The exercise programme on trial comprises high intensity interval training (HIIT), muscular strength exercise and aerobic physical activity sessions of specified duration, frequency, and intensity. It also includes brief knowledge videos to empower the patient. The intervention is remotely delivered by the SPARK application with personalised follow-up including monitoring to ensure exercise progression and adherence to exercise intensity. The SPARK application is built on a platform delivered by ABEL Technologies (trademark) and is customised for patients with axSpA.

NCT ID: NCT06463483 Not yet recruiting - Diabetes Mellitus Clinical Trials

Automated Insulin Delivery in Adults With Advanced Kidney Disease

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

Diabetes is the leading cause of kidney failure in the UK. Many people with diabetes and advanced kidney failure inject themselves with insulin and do finger-prick blood glucose tests. Managing diabetes in people with advanced kidney disease is hard, with fluctuating glucose levels and an increased risk of unsafe low glucose levels. There are currently continuous glucose monitors (CGM), which allow people to monitor glucose without painful fingerprick tests. CGM can be combined with insulin pumps to create automated insulin delivery systems (AID) that deliver insulin automatically to control glucose. AID systems are currently used in people with type 1 diabetes, but they are not used in people with type 2 diabetes. There is little information on how these systems might help people with diabetes and advanced kidney failure and on dialysis. This study will investigate whether automated insulin delivery can improve glucose levels and quality of life in people with diabetes treated with more than one insulin injection with advanced kidney failure and/or undergoing regular dialysis treatment. This study will be a feasibility study conducted in a single centre (Imperial College, London) and be of a cross-over design. The study will aim to complete 12 people. Participants will wear a glucose sensor at the start. In random order, half will start AID followed by the usual treatment, while the other half will start the usual treatment followed by AID treatment. The duration of each treatment stage is eight weeks. The study will last about 22 weeks for each participant. Investigators will compare the glucose levels in the AID group with the usual care group to see if there is a difference. Questionnaires and interviews will help us understand participants' experiences. Investigators will carefully monitor the safety of participants.

NCT ID: NCT06464471 Not yet recruiting - Cancer Clinical Trials

Comprehensive Health Assessment for My Plan: Initial Implementation Study (CHAMP Implementation Study)

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

The current standard preoperative assessment does not consider the needs of older adults undergoing non-oncological surgery. To enhance the treatment decision-making and planning for older adult surgical patients, the British Geriatric Society and the American Society of Colon and Rectal Surgeons recommend the implementation of preoperative GA for all older adults. Geriatric assessment (GA) predicts treatment toxicity and overall mortality in older adults with complex health problems. However, in-person GA may not be feasible in several clinical settings for various reasons, including lack of training, time, or access to advanced geriatric services. These challenges can be minimized through a self-reported online GA that can be completed by patients prior to the participants' medical appointment. In a previous study, the investigators developed a self-reported online GA, known as the Comprehensive Health Assessment for My Cancer treatment Plan (CHAMP), which was used in geriatric oncology to increase accessibility to GA for older adults with cancer. In this study, the aim is to deploy the CHAMP tool to various clinics across 4 institutions and assess feasibility outcomes, as well as the efficacy of the CHAMP tool in the identification of geriatric issues and the development of supportive care.

NCT ID: NCT06465511 Not yet recruiting - Cancer Clinical Trials

Supportive Clinic for Patients Living With Advanced and Metastatic Cancers

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

To conduct a feasibility trial to examine the feasibility and acceptability of conducting a randomized controlled trial that evaluates the effect of the survivorship care intervention on patient-reported outcomes, defined as symptom distress and health-related quality of life.

NCT ID: NCT06466161 Not yet recruiting - Obesity Clinical Trials

Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients

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

The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods. STUDY ENDPOINTS: Primary Outcome Measures: - Agreement between conical and cylindrical cuff systolic blood pressure across groups - Agreement between conical and cylindrical cuff diastolic blood pressure across groups Secondary Outcome Measures: • Agreement between conical and cylindrical cuff mean arterial pressure

NCT ID: NCT06466499 Not yet recruiting - Clinical trials for Posttraumatic Headache

Non-pharmacological Treatment of Patients at Risk of Developing Persistent Posttraumatic Headache

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

The goal of this mixed method study is to test and evaluate the effect of an early interdisciplinary non-pharmacological treatment of patients at risk of developing persistent posttraumatic headache in order to prevent the development of persistent posttraumatic headache and thereby, reduce persistency and improve the quality of life. Furthermore, to gain knowledge on and a deeper understanding of the patients' perspective and experience of the treatment. The project consists of 3 sub studies: 1. A feasibility study; with the purpose of exploring the feasibility of an early non-pharmacological intervention for patients with persistent posttraumatic headache after mild traumatic brain injury. 2. An experimental design; a randomized controlled trial to evaluate the effect of the early non-pharmacological treatment. 3. A qualitative focus group interview study; to get a more nuanced knowledge of patients' experience with the non-pharmacological treatment related to post traumatic headache.

NCT ID: NCT06466512 Not yet recruiting - Newborn Morbidity Clinical Trials

Feasibility of Introducing Midwifery-embodied Community Clinic Model

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

Background (brief): 1. Burden: Maternal and neonatal mortality continue to be a serious public health problem in Bangladesh. Facility-based healthcare services reduce the probability of preventable causes of maternal and neonatal death. Community clinics (CCs) are located closer to the community than other healthcare facilities are. However, only 2.8% of all CCs are ready to provide antenatal care (ANC) and 2.4% of these facilities are ready to provide delivery services. Despite the wide acceptance of midwifery care for ANC and delivery services, they are posted only up to the Upazila Health Complexes and at selected Union Health and Family Welfare Centers. 2. Knowledge gap: There is a dearth of evidence on whether the utilisation of ANC, normal vaginal delivery, and postnatal care (PNC) services can be increased if midwives are assigned to CCs to provide these services. 3. Relevance: Midwives were trained to provide antenatal and postnatal care, conduct normal deliveries, and manage CC-specific pregnancy-related complications. Midwives are posted up to union-level facilities, and the Government of Bangladesh has a strategic plan to enable selective community clinics for normal delivery services in addition to antenatal and postnatal care. Hypothesis (if any): N/A Objectives: This study aims to assess the feasibility, adoption, acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of introducing Midwifery-embodied Community Clinic (MCC) model in selected community clinics of Bangladesh. Methods: We will implement a Midwifery-embodied Community Clinic (MCC) model in two CCs of the Baliakandi sub-district of Rajbari district. Trained midwives will provide ANC, select low-risk pregnant women, conduct their normal deliveries, and provide PNC services in CCs, while the CHCP will provide essential newborn care during NVD. High-risk mothers will be referred to the upper level of healthcare facilities for managment. In addition, counselling services will be provided to mothers by the Health Assistants and Family Welfare Assistants during their domiciliary visits. Transport services using the ambulances of the Upazila Health Complex will be integrated into the model to transport patients to the CCs and upper-level healthcare facilities in case of emergencies. Outcome measures/variables: The outcome measures will be feasibility, adoption, acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of the MCC model.