Florida Paid Clinical Trials

Treatment of post-stroke apraxia of speech (AOS) requires frequent and ongoing practice with a speech-language pathologist to facilitate lasting behavioral change, which is costly and, therefore, inaccessible to many patients. Thus, there is a critical need to identify novel, cost-effective ways to supplement speech therapy to increase opportunities for practice and optimize treatment outcomes. Our long-term goal is to develop an effective, home-practice, computer-based, motor imagery protocol Motor Imagery for Treatment Enhancement and Efficacy (MI-TEE) which will serve as an adjunct to routine speech therapy to optimize treatment response in persons with AOS. The overall objectives of this application are to (i) evaluate the acceptability and feasibility of MI-TEE as a home practice program and (ii) determine the efficacy of MI-TEE with speech therapy, compared to speech therapy alone, in improving speech production in people with AOS. Our central hypothesis is that MI-TEE will be an accessible, feasible, and efficacious adjunct to speech therapy. To attain our objectives, the following specific aims will be pursued using two single-subject experimental designs with multiple baselines across participants (n=18): 1) Evaluate the acceptability and feasibility of MI-TEE as an adjunct to speech therapy for the rehabilitation of AOS; and 2) Compare the efficacy of adjunctive MI-TEE plus standard speech therapy to standard speech therapy alone. Under the first aim, observational data, surveys, and semi-structured interviews will be employed to assess the acceptability (perceived satisfaction, appropriateness, and intent to continue use) and feasibility (recruitment, retention, and intervention adherence rates) of MI-TEE. For the second aim, accuracy of articulation for trained words and untrained words (generalization) will be measured pre-treatment, repeatedly during the treatment phase, and post-treatment. Improvements in speech accuracy will be documented using a binary scoring system (correct/incorrect). Multilevel analyses will be used to address rate of acquisition, overall change, and response variation across participants. Read Less

This will be a (2 visit) double-blind, randomized, crossover design clinical study to assess the potential benefits of ER-CAFF versus IR-CAFF by assessing its impact on side effect profiles, mood states, alertness, and cognitive abilities following ingestion after a suboptimal night of sleep. This study will enroll 30 healthy men and women who will be recruited by word of mouth, email contact, and direct contact from the greater Tampa Bay Area. To account for potential dropouts, we aim to enroll approximately 20% over the desired sample size (total of 36 participants). The anticipated study period will last approximately 2 weeks. After initial pre-screening, participants will report to the laboratory on two separate occasions after an overnight fast (10 hours minimum). Participants will be required to have a night of partial sleep deprivation the night before (<5 hours sleep), which will be confirmed by self reported sleep logs and objective multisensor (triaxial accelerometry and cardiac data) wearable devices to accurately measure sleep deficit data. Upon arrival, participants will undergo baseline (BL) testing and then ingest a bolus of one study product with 4-8 ounces of water: 400 mg zümXR extended-release caffeine (ER-CAFF), or 400 mg of immediate-release caffeine anhydrous (IR-CAFF) (2 group, crossover design). Thereafter, participants will undergo subsequent testing sessions at 45, 60, 90, 135, 240, 300, 360, and 420 minutes post-supplementation. After the 4-hour (240 min) measurements, a caffeine-free food bar will be provided. This same food bar will also be offered to participants following the final 7-hour (420 min) measurements. The precise measures and timepoints for the measures are further defined below. There will be a one-week minimum washout period between treatments in the crossover design. Read Less

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol. Read Less

The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS). Read Less

This is a multicenter, Phase 1/2 clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Read Less

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multicountry, multicenter, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of durvalumab-based regimens in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, recurrence-free survival, and time to treatment recurrence). Read Less

This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s. Read Less

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 [NCT05620823] or INCB 54707-302 [NCT05620836]). Read Less

This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing surgery for proven or suspected cancer in the lung. Approximately 100 subjects will be enrolled to ensure at least 86 subjects are evaluable with the option to expand enrollment by protocol amendment if deemed necessary by the DSC to meet primary and/or secondary objectives. Read Less

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: This event-driven study will have variable duration ranging from approximately 27 to 51 months. The study intervention duration will vary ranging from approximately 27 to 51 months. The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. Read Less

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy. Read Less

This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo. Read Less