San Diego, CA Paid Clinical Trials

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature. Read Less

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond. Read Less

Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat children who have hearing loss due to changes in the otoferlin gene. The purpose of this study is to: * Learn about the safety of DB-OTO * Determine how well DB-OTO is tolerated (does not cause ongoing discomfort) * Evaluate the efficacy of DB-OTO (how well DB-OTO works) Read Less

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives include assessing the impact of pitolisant on: Irritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech Read Less

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus. The study will consist of 3 periods: Period 1: eligible participants will be randomized 1:1 to IMVT-1402 or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 SC QW for 26 weeks. Read Less

The investigators cancer rehabilitation/recovery program, Strong Survivor, has been designed to be delivered digitally, and while there are many such programs currently available on the internet, especially in the time of COVID-19, the novel feature of this program is the delivery of semi-individualized instruction in real time within a small group setting. The program was designed with physician input and by exercise physiologists and a Doctor of Physical Therapy candidate, all with extensive training in both group and individualized exercise for geriatric and cancer survivor populations. Strong Survivor is 16-week iterative curricular program with three core components: aerobic fitness, balance and mobility, and muscular strength and power. Classes will be held twice per week. The first 4 classes will be deployed in a small class of up to 5 people (first 2 weeks), then one class per week with the small class and one class per week is with a larger class of up to 15 people (weeks 3 and 4). The program is then continued for 12 additional weeks in a larger class using principles and exercises specifically trained during the small group classes. All the exercises offered over the course of the intervention are appropriate for the target population and are standardized so all participants receive the same basic instruction, but level of difficulty is scaled to participant experience, capability, and musculoskeletal limitations. Participants will need to have a minimal adequate space and technology to accommodate this instructional method. Specifically, they will require an internet connected device with a camera that is at least 7 inches square. (tablet size or larger). Additionally, participants' will need to have adequate space to both set up a computer/camera and move around. The minimal acceptable space for this is 6+ feet with an unobstructed view (from a table for instance) of a 2 x 2 open space. All study participants will complete a clinic visit before they join the classes and after the last class to evaluate cardiorespiratory fitness, strength, balance and posture and answer questionnaires about quality of life and system usability. Read Less

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder. Read Less

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors. Read Less

This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting Read Less

This is a phase 2 study to test the hypothesis that venetoclax in combination with standard chemotherapy will be tolerable and active in pediatric patients with newly diagnosed acute myeloid leukemia (AML). Primary Objectives: * Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML * Estimate the proportion of patients who become minimal residual disease (MRD) negative by flow cytometry after one course of venetoclax-based induction therapy Secondary Objectives: - Estimate the rates of complete remission (CR), event-free survival (EFS), and overall survival (OS) in pediatric patients who receive venetoclax-based chemotherapy Read Less

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5). Read Less

This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin (Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia (B-ALL). Some patients with newly diagnosed ALL maintain low levels of MRD, despite achieving complete remission with less than 5% blasts in the bone marrow. Others experience re-emergence of low level MRD or increasing levels of MRD on therapy or post-transplant. New approaches are needed to achieve undetectable MRD in these high-risk patients. Inotuzumab ozogamicin is an antibody-drug conjugate composed of a humanized IgG subtype 4 monoclonal CD22-targeted antibody linked to calicheamicin, a potent anti-tumor antibiotic. CD22 is expressed in more than 90% of patients with B-cell ALL, making it an attractive target in this patient population. Inotuzumab ozogamicin has demonstrated exceptional activity in adults with relapsed or refractory B-ALL. Primary Objective * Assess the efficacy of inotuzumab ozogamicin in patients with MRD positive CD22+ B-ALL with 0.1 - 4.99% blasts in bone marrow. Secondary Objectives * Study the safety of inotuzumab ozogamicin when used in patients with MRD - positive CD22+ B-ALL with \< 5 % blasts in bone marrow. * Estimate the incidence, severity, and outcome of hepatotoxicity and sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) in patients during inotuzumab ozogamicin and following subsequent treatment, including hematopoietic stem cell transplant (HSCT). Read Less