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NCT ID: NCT06207123 Not yet recruiting - Acute Leukemia Clinical Trials

A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)

Start date: April 1, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to learn more about LP-118 (an experimental drug) and its side effects and decide on acceptable doses. The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib, that is FDA-approved for the treatment of acute lymphoblastic leukemia.

NCT ID: NCT06260891 Not yet recruiting - Sickle Cell Disease Clinical Trials

Zinc Supplementation in Sickle Cell Disease

ZnSCD
Start date: April 1, 2025
Phase: Phase 2
Study type: Interventional

The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-35 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 7 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS.

NCT ID: NCT06352177 Not yet recruiting - Liver Diseases Clinical Trials

Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD

ENLIGHTEN
Start date: April 1, 2025
Phase: N/A
Study type: Interventional

The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH. People who have MASH, the progressive subtype of MASLD, have the highest risk for liver disease progression and poor outcomes, including cirrhosis and hepatocellular carcinoma, and greater overall mortality. Thus, these participants are expected to experience the greatest benefit from treatment. This is a randomized, controlled trial comparing DTx lifestyle intervention in participants with non-cirrhotic MASH to standard clinical care. The study includes a screening period (up to 2 wks.) followed by randomization, 48-wk treatment period and 12-wk follow-up period (total duration up to 62 wks.).

NCT ID: NCT06367738 Not yet recruiting - Aging Clinical Trials

Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults

Start date: April 1, 2025
Phase: Phase 1
Study type: Interventional

We will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults. We will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose. Dose response will be assessed. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. We will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect.

NCT ID: NCT06371768 Not yet recruiting - Breast Cancer Clinical Trials

Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors

AYA STEPS
Start date: April 1, 2025
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care.

NCT ID: NCT06397131 Not yet recruiting - Clinical trials for Macular Telangiectasia Type 2

A Study to Determine the Safety and Efficacy of NT-501 With MHFM

Start date: April 1, 2025
Phase: Phase 3
Study type: Interventional

This study is to determine the long-term levels of CNTF, and the clinical safety and efficacy of the NT-501 implants with the Medica Hollow Fiber Membrane (MHFM) in participants with macular telangiectasia type 2.

NCT ID: NCT06399991 Not yet recruiting - Depression Clinical Trials

Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi

ALIGN
Start date: April 1, 2025
Phase: N/A
Study type: Interventional

The main objective of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health treatment model into multiple medical care settings.

NCT ID: NCT06413979 Not yet recruiting - Clinical trials for Substance Use Disorders

Family Support Protocol for Adolescent Internalizing Disorders

Fam-AID
Start date: April 1, 2025
Phase: N/A
Study type: Interventional

This R34 will develop and test an adjunctive treatment protocol for addressing co-occurring internalizing disorders among adolescents enrolled in usual care for substance use problems. Internalizing disorders (ID), primarily depression and anxiety, are highly prevalent among youth receiving community-based treatment for substance use disorder (SUD). Comorbidity rates range from 30-70% due to the multiple developmental pathways by which adolescent SUD and ID cause and exacerbate one another. Moreover, unresolved ID issues significantly interfere with youth SUD treatment and recovery processes. Yet, the youth SUD clinical workforce is not systematically educated or trained in evidence-based practices for ID; thus, line services for youth SUD do not systematically target ID. The research literature offers a few integrated behavioral models for simultaneously treating both SUD and ID in youth; however, such models feature intensive manualized procedures that have proven cumbersome to scale and deliver in frontline settings. As a result, the clinical workforce, though desiring ID-focused training, currently has inadequate resources for treating ID effectively. A promising solution to diminish this quality gap is developing an adjunctive, modular protocol to augment routine care for comorbid SUD/ID by directly targeting ID as a key treatment goal: Family Support Protocol for Adolescent Internalizing Disorders (Fam-AID). As an adjunctive protocol, Fam-AID will not require clinicians to markedly alter existing base practices for SUD. It will be anchored by three evidence-based foundations for treating co-occurring adolescent ID. First, it prioritizes family engagement in services and family-oriented treatment goals, which have been shown to enhance outcomes for youth SUD and ID alike. Second, it is a modular protocol that features core elements of manualized treatment for ID; core element interventions enhance treatment effectiveness by fostering implementation feasibility and sustainability in usual care. Third, it seeks to reinforce the family safety net to prevent teen self-harm. In accord with these foundations, and pending pilot development, we anticipate that Fam-AID will contain five treatment modules that can be delivered in any sequence to meet client needs: (1) Family Engagement of caregivers and primary supports in treatment planning and services; (2) Relational Reframing of family constraints, resiliencies, and social capital connected to the youth's ID symptoms; (3) Functional Analysis of the youth's ID symptoms and related behaviors; (4) Cognitive-behavioral therapy (CBT) core techniques to address the youth's ID symptoms and functional needs, featuring three transdiagnostic interventions (emotion acceptance, emotional exposure, behavioral activation) to address negative affect and emotional dysregulation underlying both depression and anxiety; and (5) Family Psychoeducation and Safety Planning focused on education about comorbid SUD/ID and prevention of youth self-harm. All interventions featured in each module have strong empirical support. The Fam-AID protocol will contain several innovations intended to boost treatment feasibility and impact for this vulnerable group. Aligned with the core elements strategy, it will be designed for uptake by all motivated clinicians regardless of their clinical orientation and training. It will use evidence-based family engagement techniques to systematically integrate caregivers in the treatment process; typically, families are not centralized in SUD services for youth despite compelling empirical and clinical rationale to do so. It will feature a treatment customization exercise in which clients and therapists collaboratively select CBT techniques to integrate in ongoing treatment based on functional ID assessment. To achieve study aims we will first develop a Fam-AID implementation toolkit during a three-part Pilot Phase at one pilot site: (a) Solicit provider input on Fam-AID components; (b) Create video-based training and fidelity procedures, leveraging the PI's existing online therapist training and consultation resources in core CBT techniques for adolescent SUD, as well as the Co-I's equivalent training resources for adolescent ID; (c) Pilot the toolkit with 4-6 clients. In Years 2-3 we will conduct an Interrupted Time Series Study for N = 60 SUD/ID cases across two sites serving diverse youth: 30 will receive TAU, and then following line staff training, 30 new cases will receive TAU enhanced by adjunctive Fam-AID. Aim 1: Feasibility will examine Fam-AID cases for acceptability via client and therapist interviews and fidelity benchmarks via therapist- and observer-report of module coverage and protocol dose. Aim 2: Outcomes will test TAU vs. TAU + Fam-AID for immediate impact on family member attendance and ultimate impacts on adolescent ID symptoms at 3- and 6-month follow-up.

NCT ID: NCT06426004 Not yet recruiting - Clinical trials for Normal Pressure Hydrocephalus

Addressing Health Disparities in Normal Pressure Hydrocephalus (NPH) in Maryland

NPH
Start date: April 1, 2025
Phase: N/A
Study type: Interventional

The study aims to estimate Normal Pressure Hydrocephalus (NPH) prevalence and evaluate health equity gaps in Baltimore and Maryland based on zip codes and race, with a focus on the Black community. Interventions will include educational elements about NPH and three layers targeting patients, Primary Care Providers, and community health workers to enhance care access. Short-term outcomes will measure referrals to specialists, while long-term outcomes will assess healthcare utilization. The study aims to identify and reduce racial disparities in NPH care access, informing intervention strategies for NPH and other surgical areas.

NCT ID: NCT06447194 Not yet recruiting - Clinical trials for Degenerative Disc Disease

Effect of RECK in Posterior Spinal Fusion

Start date: April 1, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following. Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores. Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay. Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.