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NCT ID: NCT06111014 Enrolling by invitation - Clinical trials for Neurodegenerative Diseases

Continuation Study for Latozinemab

Start date: December 8, 2023
Phase: Phase 3
Study type: Interventional

Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

NCT ID: NCT06110234 Recruiting - Healthy Clinical Trials

Efficacy, Transfer, and Neuro-functional Basis of a Memory Training Targeting Episodic Retrieval in Older Adults.

SPECTRA
Start date: September 22, 2023
Phase: N/A
Study type: Interventional

Aging leads to cognitive changes that affect memory, particularly episodic retrieval. These impairments are detrimental to seniors' quality of life. Cognitive trainings are of great interest to the scientific community because they improve cognition in older people, and produce structural and functional changes likely to provide neuroprotection. Identifying the brain changes induced by cognitive training could therefore provide a better understanding of the neuroplastic processes of the aging brain. Some training programs aim to improve key processes underlying cognitive functioning to lead to transfer, but these most often target working memory or processing speed. Our aim is to understand the brain changes associated with a training program targeting episodic retrieval, and likely to engage a core network for memory, including the anterior hippocampus. 60 healthy older adults will be randomly divided into two groups; one receiving a training based on the Episodic Specificity Induction (ESI) - a manipulation based on a well-established police interviewing technique thought to target and facilitate episodic construction; the other receiving a control training consisting of recalling pairs of words and images. Before and after training, behavioural and brain measures will be taken. Behavioural measures will be taken during recall, recognition, and problem solving tasks. These tasks will be completed once in the ESI condition (after one ESI) and once in the NoESI condition (after a general thoughts interview). Measures of brain activation as well as static and dynamic functional connectivity (SFC & DFC) will be taken using magnetic resonance imaging (MRI) during a recognition task. For behavioural measures, higher pre-training performance should be observed in the ESI than in the NoESI condition, and pre-to-post-training improvement should be observed only after the ESI training, especially in the NoESI condition. For brain measures, ESI training should decrease activation of the task network targeted by training, reflecting an increase in efficiency. ESI training should also increase the SFC of the task network and reduce its connectivity with the cognitive control network, suggesting more automated processing. Finally, ESI training should increase DFC by increasing the speed of transition between the networks associated with the two phases of episodic retrieval: the construction phase and the elaboration phase.

NCT ID: NCT06109948 Recruiting - Healthy Clinical Trials

Study to Assess the Safety, Tolerability, PK and PD of ABX1100

Start date: October 19, 2023
Phase: Early Phase 1
Study type: Interventional

Study ABX1100-1001 is a first-in-human (FIH), phase 1 study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) and multiple doses (MD) of ABX1100 administered intravenously to healthy participants. - Part A features a SAD study with a double-blind, placebo-controlled, randomized design in NHVs involving 3 cohorts (A1-A3). This Part also includes a single dose, open-labeled cohort (A4) in NHVs which will commence after cohorts A1-3. - Part B is a MD, double-blind, placebo-controlled, randomized design in NHVs. The MD Part B will commence after completion of Cohorts A1, A2 and A3 in the SAD Part A and SRC review of these 3 cohorts.

NCT ID: NCT06109779 Recruiting - Clinical trials for Biliary Tract Cancer

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Start date: December 4, 2023
Phase: Phase 3
Study type: Interventional

A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.

NCT ID: NCT06109441 Recruiting - Ulcerative Colitis Clinical Trials

Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics

Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, and a Maintenance Phase. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268 followed by weekly doses of ALTB-268 for 12 weeks. Primary efficacy endpoint will be evaluated at week 12. Week 12 dosing will occur during the 40 wks Maintenance Phase. During 40 weeklong maintenance phase SC doses of ALTB-268 will be administered every other week. At week 52, all subjects will have an endoscopy performed and efficacy and safety evaluation will take place.

NCT ID: NCT06108544 Recruiting - Plaque Psoriasis Clinical Trials

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

Start date: November 6, 2023
Phase: Phase 3
Study type: Interventional

The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 weeks.

NCT ID: NCT06108427 Not yet recruiting - Clinical trials for Primary Aldosteronism

REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study

RETAME-PA
Start date: March 2024
Phase: N/A
Study type: Interventional

High blood pressure, or hypertension, can be caused by a condition called Primary Aldosteronism (PA), where the body produces too much of a hormone called aldosterone. People with PA have a higher risk of heart problems compared to those with regular high blood pressure. To treat PA, some patients need to take medicine called mineralocorticoid receptor antagonists (MRA) for the rest of their lives. While treatment with MRA is effective, it can have side effects like high levels of potassium in the blood, breast enlargement in men, menstrual problems in women, and reduced sex drive. Finding the right dose of MRA for each patient can be tricky. Recent observations suggest that when a hormone called renin goes up during MRA treatment, it might be a good sign. This is because renin is higher when the action of aldosterone is well blocked. But it's not certain if this happens because of the patient's unique characteristics or if it can truly be a way to know if the treatment is working. This study aims to find out if guiding MRA treatment with renin levels leads to more patients having unsuppressed renin levels compared to the standard of care. This is a multicentric pragmatic clinical trial. Patients with a new diagnosis of PA and low renin levels will be asked if there are willing to participate. Those with recent use of MRA, known MRA intolerance, severe kidney problems, or have high potassium levels will not be able to participate. Participants will be randomized into two groups: one group will have their MRA treatment adjusted based on renin levels (the "renin-guided" group), and the other group won't have renin levels checked during treatment (the "renin-blinded" group). Both groups will aim to have their blood pressure under control and potassium levels in the normal range. The main outcome is the proportion in each group with unsuppressed renin levels after 12 months. Other outcomes will be tested, such as changes in renin levels, how well the treatment works, and any safety concerns (like potassium levels, kidney function, side effects, and blood pressure changes). Different groups of patients will also be looked at separately, like men and women, different ages, races, and initial renin levels, to see if the approach works better for some people. This study will help find a safe and effective way to treat PA with MRA. Choosing the right dose of MRA is important to adequately block aldosterone but also to avoid side effects.

NCT ID: NCT06108388 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Functional Investigation of Endothelial Function and Regenerative Cell Exhaustion

FIERCE
Start date: November 2023
Phase:
Study type: Observational

FIERCE is an observational cross-sectional study. Approximately 90 individuals living with type 2 diabetes (T2D) and/or individuals living without diabetes will be randomized (2:1). The primary objective of this trial is to determine if there are differences in the content and function of circulating vascular regenerative (VR) progenitor cell subsets isolated from individuals living with T2D versus individuals not living with T2D. The main question this study aims to answer is: Does T2D compromise or enhance VR cell functionality? Each participant will be asked to provide a single blood sample. Blood samples will be processed to enumerate the number of vessel-repairing cells and determine the functionality of the different subtypes of vessel-repairing cells.

NCT ID: NCT06107868 Active, not recruiting - Metastatic Cancer Clinical Trials

Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer

GyneRep
Start date: March 20, 2024
Phase: Phase 1
Study type: Interventional

This is a phase 1 study to evaluate investigational drug RP-6306 in combination with carboplatin and paclitaxel in patients with TP53 mutated ovarian or uterine cancer. The dose escalation part of the study will determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) and schedule of RP-6306 in combination with carboplatin and paclitaxel and the dose expansion will further assess the safety and tolerability as well as determine the preliminary efficacy of RP-6306 in combination with carboplatin and paclitaxel.

NCT ID: NCT06107699 Recruiting - Aging Clinical Trials

The CHARM Study-Coordinating Transitions From Hospital for Older Adults With Fractures

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Background: Fall-related injuries like fractures are on the rise among older adults in New Brunswick. These injuries can lead to hospitalization and adverse health effects. Moreover, transitions from acute care can be complicated and overwhelming, especially for patients and their families. Researching patient navigators as a means of enhancing inpatient care, while also ensuring successful transitions in care for patients, may have positive impacts and help older adults successfully age in place. Objective: This study seeks to investigate the effects of having support from patient navigators in helping older adults admitted to the Orthopedic Unit with a fracture. Specifically, the objectives are to investigate whether there are differences between patients with patient navigators and those patients receiving standard of care, regarding: the length of stay in acute care; healthcare utilization post-discharge; patient and family experience and satisfaction with care; and, healthcare provider experiences working with patient navigators. Methods: This study uses a mixed-method concurrent embedded design, in which the quantitative randomized control trial has an embedded qualitative component. Potential Benefits/Risks: This study is considered low risk. Potential benefits of this study include a better understanding of the impact of support from a patient navigator on inpatient care and patient transitions. This information will be used to inform the development of practical recommendations for policymakers and clinicians on how to enhance inpatient acute care and successful transitions for older adults.