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Discover 12,796 clinical trials near Florida. Find research studies in your area.
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NCT06795048
This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.
NCT01134614
This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.
NCT07540312
This prospective, interventional trial is intended to determine the safety and effectiveness of the Variable Compression System (VCS) device for Irritable Bowel Syndrome (IBS). This pilot study will enroll 20 subjects who will be required to wear the VCS device for a minimum of 6 hours a day and follow up at 21 days, 8 weeks, and 6 months post-device administration.
NCT06237452
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
NCT04896775
The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.
NCT06649110
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
NCT02890329
This phase I trial studies the side effects and best dose of ipilimumab when given together with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ipilimumab and decitabine may work better in treating patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.
NCT02559778
A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma.
NCT06454240
This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups. The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.
NCT03055338
This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of elpipodect compared with placebo, using Risperidone as an active control. The participants will be adult subjects experiencing an acute episode of schizophrenia, according to the criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each participant. The study will consist of a Screening/tapering period (up to one week long), a 4-week treatment period, and a 14-day follow-up period. The primary objective will be to assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during treatment and post-treatment follow-up. The secondary objective will be to assess the severity of schizophrenia at 4 weeks. The primary hypothesis is that elpipodect is superior to placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of treatment.
NCT06951217
This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.
NCT05934526
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.
NCT04468061
This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
NCT06524414
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine. To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution. The immune response is how the body's cells; tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. This study is seeking participants who are: * male or female infants who are 2 months of age, * infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and, * said to be healthy by the study doctor There are four groups in this study. All participants will be assigned to one of the four groups. All study vaccines will be given as a single shot into the left thigh muscle. Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study. The first 400 participants who enter the study will be assigned to either Group 1 or Group 2. Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2, 4, 6, and 12 to 15 months of age of PG4 mixed in the first solution. The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1. Once 400 participants have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3. Half the participants in Group 3 will receive PG4 in the second solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Groups 3 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. Once the 100 participants have been assigned to Group 3 then 300 new participants will be assigned to Group 4. Half the participants in Group 4 will receive PG4 in the first solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Group 4 will receive 4 doses of a licensed pneumococcal comparator vaccine at 2, 4, 6, and 12 to 15 months of age. Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.
NCT05893862
The primary purpose of this study to evaluate the effect of a supratherapeutic dose of 80 mg elpipodect on the QT interval corrected for heart rate (QTc interval) and to assess the safety and tolerability of multiple once-daily doses of elpipodect in participants with schizophrenia. The effects of 3 treatment sequences 1) elpipodect (48 mg \[Day 1\] and 80 mg \[Day2\]); 2) standard image placebo (Day 1) and moxifloxacin 400 mg (Day 2); and 3) elpipodect placebo (Day 1 and Day 2) were assessed with 5-day washout intervening sequence. Participants received all treatments in a counter-balanced order according to 1 of 6 possible treatment sequences. The primary hypothesis is that the administration of an 80 mg elpipodect dose on Day 2 does not prolong the QTc interval to a clinically significant degree. Specifically, the true mean difference (elpipodect - placebo) in QTc change from baseline is less than 10 milliseconds (msec).
NCT04980482
This is a randomized, open label, multicenter Phase 2 study investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB.
NCT05755386
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.
NCT06023589
To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
NCT06938841
Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising intervention for treatment-resistant depression (TRD), yet substantial uncertainties persist regarding its efficacy as a maintenance treatment. This prospective study seeks to investigate the efficacy of maintenance rTMS in individuals with TRD who have previously responded to an acute course of rTMS. In the R61 phase of the study, we will recruit 75 participants across three study sites, the University of California San Diego, Weill Cornell Medicine, and Australian National University, into a double-blind, three-arm maintenance treatment trial. In this trial, participants will be randomized to receive either standard maintenance rTMS, clustered maintenance rTMS, or sham maintenance rTMS for a duration of 6 months. Our primary aim is to examine the efficacy of maintenance rTMS on sustaining connectivity between the dorsolateral prefrontal cortex (DLPFC) and subgenual cingulate cortex (SGC) measured through concurrent TMS and electroencephalography (TMS-EEG) at baseline and every six weeks throughout the 6-month treatment period. We will also assess changes in depressive symptom severity using clinical scales, including the Montgomery-Asberg Depression Rating Scale (MADRS) as a secondary outcome measure. It is hypothesized that stimulation with clustered maintenance rTMS will demonstrate superiority in sustaining DLPFC-SGC connectivity compared with standard maintenance rTMS and sham maintenance rTMS
NCT06103487
RGX-111-5101 is a long-term follow up study that evaluates the long-term safety and efficacy of RGX-111 in participants who have received RGX-111 (a gene therapy intended to deliver a functional copy of the alpha-L-iduronidase gene (IDUA) to the central nervous system) in a separate parent study.
