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NCT ID: NCT06111586 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

FABULINUS
Start date: December 11, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, parallel group, double-blind Phase 2 study that consists of 2 parts. In Part A the safety of the highest dose-level of frexalimab in adults (age range 18-35 y.o.) will be established. In Part B, a dose-finding study (adolescents and young adults, 12-21 y.o.) evaluating the safety and efficacy of 3 age-adjusted dose-levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. The purpose of this study is to determine safety and efficacy of different dose-levels of frexalimab, by assessment of preservation of endogenous insulin secretion in participants with newly diagnosed T1D aged 12 to 21 years compared with placebo on top of standard insulin therapy, and to determine the dose-response relationship and minimal efficacious dose in Part B. Study details include: - Screening period: at least 3 weeks and up to 5 weeks (Up to 11 days may be required to get investigational medicinal product [IMP] on site. Enrollment date of the participant must take into consideration this constraint.) - Double-blind treatment period (104 weeks): -- Main treatment period: 52 weeks -- Blinded extension: 52 weeks - Safety follow-up: 26 weeks (not applicable for participants entering the open-label study) The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.

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: 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.

NCT ID: NCT06106945 Recruiting - Multiple Myeloma Clinical Trials

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

Start date: December 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM.

NCT ID: NCT06106828 Recruiting - Thyroid Eye Disease Clinical Trials

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2)

SatraGO-2
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

NCT ID: NCT06106087 Recruiting - Clinical trials for Frontline Staff Working Within Personal Care Home Facilities

Supporting Healthcare Improvement Through Facilitation & Training

SHIFT
Start date: November 3, 2023
Phase: N/A
Study type: Interventional

SHIFT will support personal care home (PCH) staff to conduct quality improvement (QI) initiatives more purposefully and objectively in their regular care setting in ways that help to sustainably improve the quality of care and/or life of residents.