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NCT ID: NCT05224258 Active, not recruiting - Type 1 Diabetes Clinical Trials

Evaluation of the MiniMedâ„¢ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®

Start date: March 17, 2022
Phase: N/A
Study type: Interventional

This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.

NCT ID: NCT05224141 Active, not recruiting - Clinical trials for Small Cell Lung Carcinoma

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

NCT ID: NCT05221281 Active, not recruiting - Ulcerative Colitis Clinical Trials

Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care

Start date: February 25, 2022
Phase: N/A
Study type: Interventional

Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program. Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.

NCT ID: NCT05218499 Active, not recruiting - Clinical trials for Liposarcoma, Dedifferentiated

Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

Start date: March 25, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05217927 Active, not recruiting - Migraine Clinical Trials

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Start date: March 4, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

NCT ID: NCT05217667 Active, not recruiting - Clinical trials for Homozygous Familial Hypercholesterolemia

Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH)

Gateway
Start date: April 22, 2022
Phase: Phase 2
Study type: Interventional

Participants with documented homozygous familial hypercholesterolemia (HoFH) who have provided informed consent will receive 2 open-label doses of ARO-ANG3 and be evaluated for safety and efficacy parameters through 36 weeks. Participants who complete the first 36 week treatment period may opt to continue in an additional 24-month extension period during which they will receive up to 8 doses open-label doses of ARO-ANG3.

NCT ID: NCT05216835 Active, not recruiting - Clinical trials for Relapsed or Refractory Classical Hodgkin Lymphoma

Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Start date: March 18, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).

NCT ID: NCT05216250 Active, not recruiting - Clinical trials for Upper Limb Essential Tremor (UL ET)

Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

Start date: April 12, 2022
Phase: Phase 2
Study type: Interventional

Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated. BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America. Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05211960 Active, not recruiting - Mental Disorder Clinical Trials

Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

Start date: January 24, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a mindfulness-based meditation app provided to outpatients (or community participants) who are waitlisted for standard psychological care for mental health or substance use concerns.

NCT ID: NCT05211778 Active, not recruiting - Clinical trials for Head and Neck Cancer

Digital Patient Education Platform in Head and Neck Cancer

Start date: January 8, 2019
Phase: N/A
Study type: Interventional

Head and neck cancer is a disease that has a particular propensity for treatment-related morbidity. It is hypothesized that patients who are more involved in their care in hospital and who are actively provided with more treatment-related education may report increased satisfaction and have improved overall outcomes. The investigators aim to determine whether delivery of patient-centred education in a multimedia format via a digital platform has an impact on overall satisfaction and perceived quality of medical care.