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Discover 6,120 clinical trials near Florida. Find research studies in your area.
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NCT07172438
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, or non-tobacco/non-menthol-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.
NCT04089358
This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.
NCT04538482
The study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Fecal samples will be collected at multiple time points before, during, and after the dietary intervention and will be analyzed using PCR to amplify the V4 region of the 16S rRNA gene and to sequence bases using the MiSeq platform. Sequenced data will then be analyzed using QIIME. The investigators hypothesize that participants receiving the DASH diet will have a greater increase in alpha diversity and greater changes in abundances of CRC-associated microbes than participants receiving the standard American diet. The investigators will also evaluate functional-level markers including bile acid and short chain fatty acid (SCFA) production and inflammatory markers. If the investigator's hypothesis is supported, they expect to see reduced production of secondary bile acids (e.g., deoxycholic acid), greater SCFA production (e.g, butyrate), and reduction in gut and systemic inflammation (e.g, calprotectin, IL-6) among participants receiving the DASH diet compared to the standard American diet. The investigator's findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across racially diverse populations. These findings can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases like CRC.
NCT06660355
Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.
NCT05235165
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
NCT03067181
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
NCT04335799
The purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. Participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.
NCT04526106
This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 4 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3) and a rollover (Part 4).
NCT01712490
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin \[Adriamycin\], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin \[Adriamycin\],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
NCT06445023
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
NCT06532006
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
NCT06433752
The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting
NCT07001748
This study is being done to answer the following questions: Can we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer. If you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below. If you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen). If you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment. It is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in. Once you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon. There is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called "intra-abdominal adhesions". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help. After you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest/Abdomen/Pelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.
NCT06117774
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
NCT07168915
Researchers are looking for new vaccines to prevent illnesses caused by a type of bacteria called Streptococcus pneumoniae. There are many different types of Streptococcus pneumoniae bacteria, called serotypes. Vaccines contain small parts of certain serotypes. These parts will not cause an infection but help the body create antibodies (proteins) to fight the bacteria. PREVNAR 20™ is a vaccine given to help to prevent disease from Streptococcus pneumoniae bacteria. Researchers designed a new vaccine, V118E, to help prevent disease from Streptococcus pneumoniae bacteria. The goal of this study is to learn how safe V118 formulation E is in Healthy Adults and how well people tolerate it.
NCT05891171
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
NCT06129539
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with central precocious puberty (CPP).
NCT03633708
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
NCT06149559
The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to \<18 years with generalized Myasthenia Gravis (gMG).
NCT04606771
This study will compare the activity of the combination of savolitinib and osimertinib against the combination of savolitinib with placebo to osimertinib in patients with Epidermal Growth Factor Receptor Mutation Positive and MET amplified, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.
