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NCT ID: NCT05565092 Active, not recruiting - Clinical trials for Sickle Cell Disease (SCD)

Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of ALXN1820 in Adult Participants With Sickle Cell Disease

PHOENIX
Start date: February 22, 2023
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of ALXN1820 SC (subcutaneous) in participants with SCD (Sickle Cell Disease).

NCT ID: NCT05564533 Active, not recruiting - Depression Clinical Trials

Heart-Smile Training Intensive Introduction Program

HST-IIP
Start date: February 9, 2023
Phase: N/A
Study type: Interventional

Heart-Smile Training (HST) is a compassion and loving-kindness-based intensive introduction program consisting of a 3-day retreat, 4-weeks of weekly 2 hour meetings, and a 1-day final retreat. This study is a randomized controlled trial study to evaluate the effectiveness of Heart-Smile Training as compared to the passive control group on measures of neural, physiological, and clinically-relevant outcomes among individuals with symptoms of depression. Participants will be randomized to either the HST group or a waitlist control group. Both groups will complete assessments before and after HST including electroencephalography (EEG), electrocardiogram (EKG), electrodermal activity tests, and self-report surveys. All study activities except surveys will be conducted in person.

NCT ID: NCT05564481 Active, not recruiting - Type 1 Diabetes Clinical Trials

Research on Optimizing the Use of Technology With Education

ROUTE-T1D
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and sustain use of CGM. The proposed study will conduct a feasibility trial of a behavioral intervention designed to optimize use of CGM in adolescents specifically targeting underrepresented populations in diabetes technology research.

NCT ID: NCT05564039 Active, not recruiting - Type 2 Diabetes Clinical Trials

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

SURPASS-SWITCH
Start date: November 30, 2022
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide compared to increasing the dulaglutide dose in adults with type 2 diabetes.

NCT ID: NCT05563857 Active, not recruiting - Depression Clinical Trials

Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Start date: October 19, 2022
Phase: N/A
Study type: Interventional

US residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.

NCT ID: NCT05562934 Active, not recruiting - Clinical trials for Resistant Hypertension

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.

Start date: November 8, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC) injections, compared to placebo. Since all study participants will be patients with rHTN, all study treatments will be given on top of maximally tolerated background antihypertensive therapy recommended by international guidelines for treatment of HTN (i.e., a thiazide or a thiazide-like diuretic, an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), and a long-acting dihydropyridine calcium channel blocker (CCB).

NCT ID: NCT05562830 Active, not recruiting - Clinical trials for Urothelial Carcinoma

A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

Start date: November 16, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.

NCT ID: NCT05562349 Active, not recruiting - Cocaine Dependence Clinical Trials

Clavulanic Acid for the Treatment of Cocaine Use Disorder

Start date: May 3, 2023
Phase: Phase 2
Study type: Interventional

A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)

NCT ID: NCT05561933 Active, not recruiting - Depression Clinical Trials

Scaling Well-Being for Educators During COVID-19

Start date: October 21, 2022
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of Jefferson County Public Schools (JCPS) in Louisville, KY. The study will enroll 1300 JCPS employees. After completing the baseline assessment, participants will be randomly assigned to the intervention (i.e., the Healthy Minds Program App) or to a "Choice" control condition. HMP assigned participants will receive instructions and support in downloading and activating the app. Choice assigned participants will receive a list of resources that are focused on the science of well-being and happiness consisting of TED talk videos and books. 10 copies of each suggested book will be available for participants to check out. TED talk video links will be provided and are free to watch. Each week during the 4-week intervention period, participants in both conditions will complete the same weekly set of measures. Within two-weeks following the end of the intervention period, all participants will complete the post-test assessment. Approximately five to six months following post-test, participants will complete the follow-up assessment. In addition to study team collected data, the research team will receive from the district multiple years of student records (e.g., standardized assessments, attendance, disciplinary referrals) linked to teachers (teachers only, not other categories of employees who choose to participate). The researchers predict that participants assigned to the intervention will demonstrate significantly reduced anxiety and depressive symptoms and significantly improved well-being after the intervention, and these improvements will persist at the follow-up (primary outcomes). It is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes. In addition, the investigators predict that intervention period improvements on well-being skills assessed weekly will mediate long-term improvements on primary outcomes.

NCT ID: NCT05560867 Active, not recruiting - Hemiparesis Clinical Trials

Neural Mechanisms of Motor Recovery With Technology Assisted Training

Start date: December 14, 2022
Phase: N/A
Study type: Interventional

Stroke is a leading cause of disability that often impairs arm function and activities of daily living. The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke. However many studies have shown that patients in the later stages post-stroke can still continue to benefit from rehabilitation. Technology-assisted therapy may offer a means to efficiently provide ongoing therapies to patients in the later stages (>6 months) post-stroke. This study will determine which patients are best able to benefit from this therapy approach, and will also expand our knowledge of which brain structures need to be intact for patients to benefit from technology-assisted training. The results of this study will help to improve rehabilitation and quality of life for disabled Americans.