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227 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 PowerChemotherapy for Acute Myeloid Leukemia in Young Patients with Down Syndrome
Gainesville, Florida
This trial studies a chemotherapy treatment that adjusts based on how well patients respond initially. It targets younger patients with Down syndrome who have certain types of blood cancer. The treatment aims to effectively kill cancer cells while reducing side effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:91 - 3
Key Eligibility Criteria
Disqualifiers:Promyelocytic Leukemia, Prior Therapy, Others
280 Participants Needed
Chemotherapy and Stem Cell Transplant for Germ Cell Cancer
Gainesville, Florida
This study is evaluating whether a combination of chemotherapy and a stem cell transplant is more effective than chemotherapy alone in treating patients with germ cell tumors.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:14+
Sex:Male
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B, Hepatitis C, Others
Must Not Be Taking:Cytotoxic Drugs, Targeted Therapies
420 Participants Needed
Extracorporeal Photopheresis for Bronchiolitis Obliterans Syndrome
Gainesville, Florida
The primary aims of this study is to determine the efficacy and tolerability of Extracorporeal Photopheresis (ECP) for the treatment of either Refractory Bronchiolitis Obliterans Syndrome (BOS) patients (258 at cessation of enrollment April 7, 2022) or Newly Diagnosed (22 as of enrollment Hold February 2022) Bronchiolitis Obliterans Syndrome patients after lung transplantation. In compliance with the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) decision, the study will collect specified demographic, comorbidity, treatment, and outcome data exclusively for Medicare beneficiaries who are treated with ECP for either refractory or New BOS.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Lupus, Porphyria, Others
Must Not Be Taking:T Lymphocyte Depleting
280 Participants Needed
Radiation vs. Radiation + Lymph Node Dissection for Breast Cancer
Gainesville, Florida
This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Inflammatory Breast Cancer, Other Malignancy, Pregnancy, Others
Must Be Taking:Anti-HER2 Therapy
2012 Participants Needed
Radiation Therapy for Oropharyngeal Cancer
Gainesville, Florida
This randomized phase III trial studies the side effects and how well intensity-modulated proton beam therapy works and compares it to intensity-modulated photon therapy in treating patients with stage III-IVB oropharyngeal cancer. Radiation therapy uses high-energy x-rays, protons, and other types of radiation to kill tumor cells and shrink tumors. It is not yet known whether intensity-modulated proton beam therapy is more effective than intensity-modulated photon therapy in treating oropharyngeal cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Major Cardiac Disease, Others
Must Be Taking:Chemotherapy
440 Participants Needed
Radiation and Temozolomide vs. PCV Chemotherapy for Brain Tumor
Gainesville, Florida
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Nursing, HIV, Active Infection, Others
Must Not Be Taking:Retroviral Therapy
305 Participants Needed
Bupivacaine Injection for Headache
Gainesville, Florida
Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Traumatic Headache, Confusion, Pregnancy, Others
Must Not Be Taking:Anticoagulants
100 Participants Needed
Mirena for Endometrial Hyperplasia
Gainesville, Florida
Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH).
Endometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hormone imbalances in women. Symptoms can include abnormal vaginal bleeding or irregular periods. If this condition is not treated, then it may lead to cancer.
Currently, oral progestins (OP) which are progesterone (female hormone) capsules taken by mouth, are used to treat NAEH. However, there is still a need for other treatments due to unmet needs.
The study treatment, Mirena (also known as BAY 865028), is already available as a type of birth control device. It is inserted into the uterus where it gradually releases progesterone.
In this study, researchers want to find out if Mirena works for women with NAEH. They believe it can help by keeping hormone levels balanced in the body.
The main purpose of this study is to learn how well Mirena works compared to oral in NAEH in women who have started their periods.
For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral progestins.
The study participants will be randomly divided equally into one of two treatment groups. Based on their group, participants will receive Mirena, which is inserted into the uterus at the start of the study, or they will take progestins once daily by mouth for 6 months.
Each participant will be in the study for around 10 months with up to 5 visits to the study clinic/site.
Participants will visit the study clinic:
* once before the treatment starts
* 3 times with a gap of 3 months between the visits during the treatment
* then 1 more time after the treatment ends
During the study, the doctors and their study team will:
* check participant's health by performing tests such as blood and urine tests
* perform vaginal ultrasound and hysteroscopy. Hysteroscopy is a minor surgical procedure where a thin camera will be inserted into the womb to check for any abnormality. Sampling of the endometrial lining (cells in the womb) will be done with a thin tube at the same time.
* take samples of womb (endometrial) lining
* ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:16+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Uterine Anomaly, Pregnancy, Cancer History, Others
Must Be Taking:Progestins
300 Participants Needed
4D-150 + EYLEA for Age-Related Macular Degeneration
Gainesville, Florida
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:50+
Key Eligibility Criteria
Disqualifiers:Retinal Detachment, Glaucoma, Uncontrolled Blood Pressure, Others
400 Participants Needed
Lu AF82422 for Multiple System Atrophy
Gainesville, Florida
The main goal of this trial is to evaluate the efficacy and safety of Lu AF82422 for the treatment of participants with Multiple System Atrophy (MSA).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:40 - 75
Key Eligibility Criteria
Disqualifiers:Previous Lu AF82422, Other CNS Diseases, Others
360 Participants Needed
Lumateperone for Irritability in Autism
Gainesville, Florida
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Rett Syndrome, Fragile X, Others
Must Be Taking:ADHD Medications
174 Participants Needed
Setmelanotide for Obesity
Gainesville, Florida
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:2+
Key Eligibility Criteria
Disqualifiers:Melanoma, Depression, Pregnancy, Others
Must Be Taking:Setmelanotide
30 Participants Needed
ARTIA Reconstructive Tissue Matrix for Breast Reconstruction
Gainesville, Florida
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Uncontrolled Diabetes, Compromised Wound Healing, Others
783 Participants Needed
Sacituzumab Govitecan for Endometrial Cancer
Gainesville, Florida
The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC).
The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Uterine Leiomyosarcoma, Active Second Malignancy, Others
Must Not Be Taking:Trop-2 ADCs
520 Participants Needed
Venetoclax + Obinutuzumab/Acalabrutinib for Chronic Lymphocytic Leukemia
Gainesville, Florida
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed.
Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.
Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Infection, Richter's Transformation, Others
Must Be Taking:Venetoclax
120 Participants Needed
Pegozafermin for Liver Cirrhosis
Gainesville, Florida
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Liver Disorder, Hepatic Decompensation, Hepatocellular Carcinoma, Diabetes, Others
762 Participants Needed
Del-desiran for Myotonic Dystrophy
Gainesville, Florida
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Global Study to Evaluate the Efficacy and Safety of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC 1001) for the Treatment of Myotonic Dystrophy Type 1
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Uncontrolled Diabetes, Heart Failure, Others
Must Not Be Taking:Anti-myotonic Medications
150 Participants Needed
Dato-DXd + Rilvegostomig for Non-Small Cell Lung Cancer
Gainesville, Florida
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Autoimmune Disorders, Severe Diseases, Brain Metastases, Others
675 Participants Needed
Sacituzumab Tirumotecan + Pembrolizumab for Breast Cancer
Gainesville, Florida
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Curative Cancer, Autoimmune Disease, Others
Must Not Be Taking:Steroids
1200 Participants Needed
Efruxifermin for NASH
Gainesville, Florida
This trial is testing a medication called efruxifermin (EFX) to see if it can help people with a specific liver condition called non-cirrhotic NASH/MASH. The patients have significant liver damage but not cirrhosis. EFX aims to improve liver health by reducing swelling and scarring in the liver.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cirrhosis, Type 1 Diabetes, Others
1650 Participants Needed
Why Other Patients Applied
"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
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"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
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
PHMB + Topical Corticosteroids for Acanthamoeba Keratitis
Gainesville, Florida
The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:
* Group 1: Topical corticosteroid
* Group 2: Topical placebo
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:8+
Key Eligibility Criteria
Disqualifiers:Interstitial Keratitis, Herpetic Keratitis, Fungal Keratitis, Others
Must Not Be Taking:Systemic Corticosteroids
232 Participants Needed
BGF with Different Propellants for COPD
Gainesville, Florida
The purpose of this study is to demonstrate that the lung function effect from orally inhaled BGF delivered via HFO propellant is equivalent to the lung function effect from orally inhaled BGF delivered via HFA propellant in participants with COPD. The study duration for each participant will be approximately 15 to 16 weeks and consist of:
1. A screening and placebo run-in period of approximately 2 weeks prior to first dosing
2. Three treatment periods of approximately 4 weeks each (one period for each of 3 study interventions)
3. A final safety follow-up visit via telephone contact approximately 1 to 2 weeks after the final dose administration Participants will be provided with rescue SABA (albuterol or salbutamol) to be used as needed throughout the study. Participants will attend in-clinic study visits approximately weekly during the screening/run-in period (Visits 1, 2, and 3), then every 4 weeks (Visits 4, 5, and 6) to receive take-home study treatment, measure their lung function, and assess their health and safety
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:40 - 80
Key Eligibility Criteria
Disqualifiers:Asthma, Tuberculosis, Lung Cancer, Others
Must Be Taking:LABA, LAMA, ICS
255 Participants Needed
Risankizumab for Crohn's Disease
Gainesville, Florida
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.
Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.
Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Indeterminate Colitis, Others
Must Not Be Taking:P19 Inhibitors
276 Participants Needed
MK-7240 for Ulcerative Colitis
Gainesville, Florida
This trial is testing tulisokibart, a new medication, to see if it can help people with moderately to severely active ulcerative colitis. The goal is to determine if tulisokibart can reduce inflammation and heal sores in the colon, leading to fewer symptoms. The study will compare different doses of tulisokibart over several months.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Crohn's Disease, Fulminant Colitis, Cancer, Others
1020 Participants Needed
NMRA-335140 for Depression
Gainesville, Florida
This trial is testing a new medication called NMRA-335140 to see if it helps people with major depressive disorder. It includes participants who have no safety concerns. The medication aims to improve mood by affecting brain chemicals.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Personality Disorder, Bipolar, Schizophrenia, Others
650 Participants Needed
BMS-986278 for Pulmonary Fibrosis
Gainesville, Florida
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:21+
Key Eligibility Criteria
Disqualifiers:Idiopathic Pulmonary Fibrosis, Stroke, Heart Failure, Current Malignancy, Others
Must Not Be Taking:Systemic Corticosteroids
1092 Participants Needed
RBT-1 for Cardiac Surgery Complications
Gainesville, Florida
The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-1 by means of a popPK approach in subjects scheduled to undergo cardiac surgery.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Acute Organ Dysfunction, CKD Dialysis, Cancer, Others
454 Participants Needed
BMS-986278 for Idiopathic Pulmonary Fibrosis
Gainesville, Florida
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Stroke, Heart Failure, Malignancy, Others
Must Be Taking:Pirfenidone, Nintedanib
1185 Participants Needed
The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previous clinical study. No study drug will be administered as part of this study. Pre-infusion baseline will be defined as the timepoint just prior to infusion of delandistrogene moxeparvovec from a previous clinical study. Each participant will be followed for a minimum of 5 years post-infusion of delandistrogene moxeparvovec from a previous clinical study. The duration of participation in this study is dependent on the length of follow-up the participant completed post-infusion of delandistrogene moxeparvovec from a previous clinical study.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Non-disclosure To Physicians, Others
400 Participants Needed
Camizestrant for Breast Cancer
Gainesville, Florida
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Cancer, Heart Failure, Others
Must Not Be Taking:SERDs, Fulvestrant, LHRH Agonists
5500 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 BI 1291583 for Bronchiectasis to the Power online platform.
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