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226 Clinical Trials near Gainesville, FL
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerBI 456906 for Diabetes and Obesity
Gainesville, Florida
This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate.
The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight.
Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.
The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Gastric Issues, Pancreatitis, Thyroid Cancer, Others
Must Be Taking:Diet, Exercise
756 Participants Needed
Tadalafil for Duchenne Muscular Dystrophy
Gainesville, Florida
This Trial will test if tadalafil can improve blood flow in the leg muscles of boys with DMD and see if it can help slow down the disease progression. Tadalafil is a medication that is approved for the treatment of certain conditions in men.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:7 - 13
Sex:Male
Key Eligibility Criteria
Disqualifiers:Older Than 13, Unstable Medical Problems, Others
Must Not Be Taking:Nitrates, Alpha-blockers, PDE5A Inhibitors
25 Participants Needed
EYE103 for Diabetic Macular Edema
Gainesville, Florida
EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME).
In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Recent Eye Surgery, Others
Must Not Be Taking:Retinal Toxicity Drugs
960 Participants Needed
Low Dose Tamoxifen for Breast Cancer
Gainesville, Florida
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Premenopausal, Endometrial Pathology, Others
Must Be Taking:Endocrine Therapy
1156 Participants Needed
EYP-1901 for Age-Related Macular Degeneration
Gainesville, Florida
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Subfoveal Fibrosis, Atrophy, Scarring, Others
Must Be Taking:Anti-VEGF Injections
400 Participants Needed
Tivozanib + Pembrolizumab for Kidney Cancer
Gainesville, Florida
This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Uncontrolled Hypertension, Cardiac Disease, Others
Must Not Be Taking:Corticosteroids, Immunosuppressive Drugs
1040 Participants Needed
Olaparib +/- Bevacizumab for Ovarian Cancer
Gainesville, Florida
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cardiac Disease, Infection, Others
Must Be Taking:Platinum-based Chemotherapy
880 Participants Needed
Belimumab for Interstitial Lung Disease
Gainesville, Florida
Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Systemic Sclerosis, Rapidly Progressive Disease, Emphysema, Others
Must Be Taking:Standard Therapy
440 Participants Needed
EYE103 for Diabetic Macular Edema
Gainesville, Florida
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cataract Surgery, Others
Must Not Be Taking:Retinal Toxicity Drugs
960 Participants Needed
Optune + Temozolomide + Pembrolizumab for Brain Cancer
Gainesville, Florida
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Pneumonitis, Other Malignancy, Others
Must Be Taking:Temozolomide
741 Participants Needed
Immunotherapy + Chemotherapy for Sarcoma
Gainesville, Florida
This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable UPS or a related poorly differentiated sarcoma live longer without having disease progression.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Interstitial Lung Disease, Others
Must Not Be Taking:Steroids, Anthracyclines
180 Participants Needed
Clofazimine Inhalation for Nontuberculous Mycobacterial Infections
Gainesville, Florida
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cystic Fibrosis, Active Tuberculosis, Others
Must Be Taking:Guideline-based Therapy
234 Participants Needed
Liposomal Curcumin for Kidney Disease
Gainesville, Florida
A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CKD Stages 1-4, Peritoneal Dialysis, Pregnant, Others
30 Participants Needed
Elamipretide for Age-Related Macular Degeneration
Gainesville, Florida
The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55+
Key Eligibility Criteria
Disqualifiers:Diabetic Retinopathy, Organ Transplant, Cancer, Others
Must Not Be Taking:Plaquenil, Tamoxifen, Digoxin, Others
360 Participants Needed
Secukinumab for Polymyalgia Rheumatica
Gainesville, Florida
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50 - 100
Key Eligibility Criteria
Disqualifiers:Chronic Infections, Malignancy, Live Vaccinations, Others
Must Not Be Taking:Prohibited Medications
300 Participants Needed
BI 1015550 for Pulmonary Fibrosis
Gainesville, Florida
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.
Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.
Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Suicidality, Severe Depression, Malignant Neoplasm, Others
Must Be Taking:Nerandomilast
1700 Participants Needed
Dinutuximab + Chemotherapy for High-Risk Neuroblastoma
Gainesville, Florida
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs 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. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:< 30
Key Eligibility Criteria
Disqualifiers:Bone Marrow Failure, Primary Immunodeficiency, Pregnancy, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
478 Participants Needed
AMX0035 for Progressive Supranuclear Palsy
Gainesville, Florida
A35-009 (ORION) is a Phase 2b/3 trial to evaluate the efficacy and safety of AMX0035 in participants with Progressive Supranuclear Palsy (PSP), consisting of randomized, double blind placebo controlled phases, followed by an optional open-label extension phase.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Schizophrenia, Bipolar, Depression, Others
110 Participants Needed
Chemotherapy + Immunotherapy vs. Immunotherapy for Advanced Lung Cancer
Gainesville, Florida
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs 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. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:70+
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Prior Chemotherapy, Others
Must Not Be Taking:Immunosuppressants, Steroids
304 Participants Needed
BI 456906 for Obesity
Gainesville, Florida
This study is open to adults who are at least 18 years old and have
* a body mass index (BMI) of 30 kg/m² or more, or
* a BMI of 27 kg/m² or more and at least one health problem related to their weight.
People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate.
The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 2 Diabetes, Heart Failure, Others
Must Not Be Taking:Obesity Medications, Glucose-lowering Agents
727 Participants Needed
Why Other Patients Applied
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
Nectero EAST System for Abdominal Aortic Aneurysm
Gainesville, Florida
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:21 - 85
Key Eligibility Criteria
Disqualifiers:Cardiac Conditions, Recent Surgery, Stroke, Others
400 Participants Needed
Blood Test and Immunotherapy for Bladder Cancer
Gainesville, Florida
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disease, Hepatitis, Myocarditis, Others
Must Be Taking:Immunotherapy
992 Participants Needed
Efgartigimod SC for Myositis
Gainesville, Florida
This trial aims to check the safety and effectiveness of an injectable medication called efgartigimod PH20 SC in adults with muscle inflammation who participated in an earlier phase. The medication works by reducing harmful proteins that cause muscle problems.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Major Surgery, Malignancy, Myositis, Others
240 Participants Needed
Udenafil for Single Ventricle Heart Disease
Gainesville, Florida
This trial tests udenafil, a medication that improves blood flow, on adolescents who have had heart surgery (Fontan procedure). It works by relaxing blood vessels to help them exercise better.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 18
Key Eligibility Criteria
Disqualifiers:Heart Failure, Liver Cirrhosis, Others
Must Be Taking:Antiplatelet, Anticoagulant
436 Participants Needed
Gene Therapy for Duchenne Muscular Dystrophy
Gainesville, Florida
The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study. Participants will be in the study for approximately 128 weeks. All participants will have the opportunity to receive intravenous (IV) delandistrogene moxeparvovec in either Part 1 or Part 2.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Gene Therapy, Investigational Medication, Others
Must Be Taking:Corticosteroids
148 Participants Needed
Belimumab for Systemic Sclerosis Interstitial Lung Disease
Gainesville, Florida
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Pulmonary Hypertension, SSc Renal Crisis, Others
Must Be Taking:Mycophenolate, Methotrexate, Azathioprine
300 Participants Needed
Smartwatch-Guided DOAC Therapy for Atrial Fibrillation
Gainesville, Florida
This trial tests whether taking blood-thinning medication continuously or only when a smart watch detects an irregular heartbeat is better for adults with a history of irregular heartbeats and moderate stroke risk.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:22 - 85
Key Eligibility Criteria
Disqualifiers:Valvular AF, Pregnancy, Hypertrophic Cardiomyopathy, Others
Must Be Taking:DOACs
5350 Participants Needed
Ribitol for Limb-Girdle Muscular Dystrophy
Gainesville, Florida
This trial will test the safety and effectiveness of BBP-418 in patients aged 12 to 60 who have a specific type of muscular dystrophy called LGMD2I/R9. The goal is to see if this new treatment can help improve their condition over several months.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:12 - 60
Key Eligibility Criteria
Disqualifiers:Renal Impairment, Pregnancy, Suicidal Ideation, Others
Must Not Be Taking:Ribose, Sugar Alcohols, Corticosteroids, Others
81 Participants Needed
Setmelanotide for Hypothalamic Obesity
Gainesville, Florida
This trial tests if Setmelanotide, an injection, can help reduce weight and hunger in patients aged 4 and older with acquired Hypothalamic Obesity. The medication works by targeting brain pathways that control hunger and energy use. Setmelanotide has been approved for treating obesity in rare genetic conditions and is being developed for other obesity-related disorders.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:4+
Key Eligibility Criteria
Disqualifiers:Prader-Willi, ROHHADNET, Severe Psychiatric, Others
120 Participants Needed
Cabozantinib + Chemotherapy for Bone Cancer
Gainesville, Florida
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors which block protein signals affecting new blood vessel formation and the ability to activate growth signaling pathways. This may help slow the growth of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:< 40
Key Eligibility Criteria
Disqualifiers:CNS Metastases, GI Disorders, Hypertension, Others
Must Not Be Taking:Anticonvulsants, Anticoagulants, CYP3A4 Drugs
1122 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do clinical trials in Gainesville, FL pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in Gainesville, FL work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in Gainesville, FL 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Gainesville, FL is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Gainesville, FL several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in Gainesville, FL?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in Gainesville, FL?
Most recently, we added Xenon for Out-of-Hospital Cardiac Arrest, Mirena for Endometrial Hyperplasia and Bupivacaine Injection for Headache to the Power online platform.
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