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192 Clinical Trials near Crystal River, 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 PowerVonoprazan for Eosinophilic Esophagitis
Inverness, Florida
The primary objective of this study is to assess the efficacy of vonoprazan 20 mg once daily (QD) compared to placebo QD in the number of participants with a peak eosinophilic histologic response \<15 eosinophils per high-power field (eos/hpf) after 12 weeks of therapy.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Erosive Esophagitis, Barrett's Esophagus, Crohn's, Others
Must Not Be Taking:PPIs, PCABs, Corticosteroids, Dupilumab
80 Participants Needed
TEV-53408 for Celiac Disease
Inverness, Florida
The primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease.
The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease.
A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease.
The expected trial duration per participant is approximately 86 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Refractory Celiac, Malignancy, Alcohol Abuse, Others
Must Not Be Taking:Antibiotics, Antivirals, Antifungals
48 Participants Needed
AZD0780 for Cardiovascular Disease
Inverness, Florida
This is a Phase II, multi-centre, randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of AZD0780 Dose 1 versus placebo on systolic blood pressure (SBP) at Week 4, as measured by 24-hour ambulatory blood pressure monitoring (ABPM) in participants with ASCVD or risk equivalents and LDL-C ≥ 70 mg/dL, on stable medication.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Not Listed
202 Participants Needed
Lunsekimig for Asthma
Inverness, Florida
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments.
Study details include:
* The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study.
* The investigational treatment duration will be up to approximately 52 weeks.
* The number of visits will be 18.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Severe Lung Diseases, Immunosuppression, Active TB, Others
1000 Participants Needed
Oral Vaccine for COVID-19
Inverness, Florida
The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19).
In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Autoimmune, Immunodeficiency, Cancer, Others
Must Not Be Taking:Antibiotics, Antacids, NSAIDs, Others
10400 Participants Needed
Solrikitug for Eosinophilic Esophagitis
Inverness, Florida
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Crohn's, IBS, Others
Must Be Taking:PPI, STC
157 Participants Needed
Targeted Therapies for Crohn's Disease
Inverness, Florida
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. 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, endoscopies, checking for side effects and completing questionnaires and a daily diary.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Ostomy, Others
Must Not Be Taking:P19 Inhibitors
500 Participants Needed
K-877-ER + CSG452 for NASH
Inverness, Florida
This trial is testing two new experimental drugs used together to treat adults with a serious liver disease. The combination is expected to be more effective than using each drug alone.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Other Liver Diseases, Alcohol Use, Others
228 Participants Needed
Efruxifermin for NASH with Cirrhosis
Inverness, Florida
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Not Listed
182 Participants Needed
Upadacitinib for Crohn's Disease
Inverness, Florida
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Non-compliance, Others
107 Participants Needed
Enlicitide for Kidney Failure
Inverness, Florida
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Renal Artery Stenosis, GI Disease, Others
Must Be Taking:Statins
24 Participants Needed
AZD4954 for Healthy Subjects
Inverness, Florida
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp\[a\]) levels.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Gastrointestinal, Hepatic, Renal, Others
Must Not Be Taking:St John's Wort
120 Participants Needed
Revita DMR for Obesity
Inverness, Florida
Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort. The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses. The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index ("BMI") between 30 and 45 kg/m2 who are not currently on a GLP-1 drug. Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham at 2:1.
Midpoint Analysis of Randomized Cohort:
The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis. These patients are distinct from those included in the pivotal analysis.
Pivotal Analysis of Randomized Cohort:
The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy.
Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease ("CVD") risk factors, body composition and pre-diabetes status. All patients enrolled in the study will receive diet and lifestyle counseling.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 70
Key Eligibility Criteria
Disqualifiers:Diabetes, Pancreatitis, Substance Abuse, Others
Must Be Taking:Tirzepatide
315 Participants Needed
MPK vs NMPK Prosthetics for Above-Knee Amputation
Inverness, Florida
This trial tests advanced artificial knees with built-in computers in above-knee or knee-level amputees who have limited walking ability. The goal is to see if these knees can reduce fear of falling, improve quality of life, and increase participation in activities. These advanced knees are well-established devices that significantly increase patient safety, walking ability, and performance in daily activities.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Upper Limb Involvement, Active Malignancy, Others
107 Participants Needed
CC-93538 for Eosinophilic Esophagitis
Inverness, Florida
Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase.
Participants will be randomized at the beginning of the study into 3 treatment arms:
Placebo for Induction and Maintenance
CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance
CC-93538 360 mg SC once weekly for Induction and Maintenance
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:12 - 75
Key Eligibility Criteria
Disqualifiers:Not Listed
399 Participants Needed
NNC0194-0499 + Semaglutide for Fatty Liver Disease
Inverness, Florida
This trial is testing if combining two medicines, NNC0194-0499 and semaglutide, can reduce liver damage in people with non-alcoholic steatohepatitis (NASH). Semaglutide, already used for diabetes and weight loss, and NNC0194-0499 work differently but may be more effective together. Another combination being tested includes semaglutide and NNC0174-0833. Participants will receive regular injections and undergo liver biopsies to measure the treatment's effectiveness.
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
698 Participants Needed
Sacituzumab Govitecan for Breast Cancer
Brooksville, Florida
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Active Second Malignancy, Serious Infection, Hepatitis B/C, Others
Must Be Taking:Antiretroviral Therapy
654 Participants Needed
Giredestrant + Everolimus for Advanced or Metastatic Breast Cancer
Brooksville, Florida
This trial is testing if a combination of giredestrant and everolimus works better than other hormone treatments plus everolimus in patients with advanced breast cancer who have already tried other treatments. The drugs work by blocking estrogen receptors and a growth pathway in cancer cells. Everolimus has been shown to improve outcomes in breast cancer patients when combined with hormonal treatments.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Chemotherapy, CNS Metastases, Cardiac Disease, Others
Must Be Taking:LHRH Agonists
373 Participants Needed
Tafasitamab + Lenalidomide + Rituximab for Follicular & Marginal Zone Lymphoma
Weeki Wachee, Florida
This trial is testing if adding two drugs, tafasitamab and lenalidomide, to an existing treatment (rituximab) is more effective than just adding one drug (lenalidomide) for patients with certain types of lymphoma that have returned or not responded to treatment. The drugs aim to better target and destroy cancer cells while boosting the body's immune response against the cancer. Lenalidomide has shown activity in various lymphoma subtypes, including diffuse large B-cell lymphoma, and is often combined with rituximab for enhanced efficacy.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Non-hematologic Malignancy, Others
Must Be Taking:Rituximab
654 Participants Needed
Rilzabrutinib for Immune Thrombocytopenia
Weeki Wachee, Florida
This trial tests rilzabrutinib, a drug that may help people with chronic ITP who have very low platelet counts. The drug works by blocking a substance that causes the immune system to destroy platelets. Participants will take the drug for several months to see if it helps increase their platelet levels.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:10+
Key Eligibility Criteria
Disqualifiers:Secondary ITP, Pregnancy, Malignancy, Others
Must Not Be Taking:Immunosuppressants, Rituximab, BTK Inhibitors
232 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 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
"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
"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
Intra-arterial vs. IV Chemotherapy for Pancreatic Cancer
Weeki Wachee, Florida
This trial tests different ways to treat advanced pancreatic cancer that can't be removed by surgery. It uses a combination of chemotherapy drugs and radiation, then compares direct artery chemotherapy to other treatments.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Active Malignancy, HIV, Others
Must Be Taking:Gemcitabine, Nab-paclitaxel
190 Participants Needed
RVT-3101 for Crohn's Disease
Brooksville, Florida
This trial is testing a new medication called RVT-3101 in adults with moderate to severe Crohn's disease. The goal is to see if it can reduce inflammation and improve symptoms by calming the immune system.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Short Gut, Others
21 Participants Needed
AVM0703 for Lymphoma
Weeki Wachee, Florida
This is an open-label, Phase 1/2 study designed to characterize the safety, tolerability, Pharmacokinetics(PK), and preliminary antitumor activity of AVM0703 administered as a single intravenous (IV) infusion to patients with lymphoid malignancies.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12 - 95
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Diabetes, Infections, Others
Must Not Be Taking:Antidepressants
144 Participants Needed
Telisotuzumab Vedotin for Lung Cancer
Brooksville, Florida
This trial tests telisotuzumab vedotin, a treatment that targets and kills cancer cells, in NSCLC patients with high c-Met levels. It aims to find the best patient group for this therapy and evaluate its safety and effectiveness. Telisotuzumab vedotin is a specialized treatment targeting c-Met-overexpressing tumor cells, and it has been evaluated in various studies for its safety and efficacy in treating advanced solid tumors, including non-small cell lung cancer.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Radiation Therapy, Adenosquamous Histology, ILD, Others
Must Not Be Taking:Live Vaccines, Systemic Steroids
270 Participants Needed
RVT-3101 for Crohn's Disease
Brooksville, Florida
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Short Gut Syndrome, Ostomy, Bowel Resection, Others
20 Participants Needed
INSPIRE Stewardship Bundle for Skin and Soft Tissue Infections
Brooksville, Florida
This trial tests a computer system that helps doctors choose the right antibiotics for adults with skin infections by predicting if the infection will resist common treatments.
No Placebo Group
Trial Details
Trial Status:Completed
Trial Phase:Unphased
Key Eligibility Criteria
Must Be Taking:Extended-spectrum Antibiotics
118562 Participants Needed
INSPIRE Stewardship Bundle for Abdominal Infections
Brooksville, Florida
This trial tests a computer system that helps doctors choose the best antibiotics for non-critically ill adults with abdominal infections. The system shows how likely it is that an infection is resistant to common antibiotics. This aims to improve treatment decisions and outcomes for these patients.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, Intensive Care, Others
Must Be Taking:Extended-spectrum Antibiotics
102 Participants Needed
ABX464 for Ulcerative Colitis
Brooksville, Florida
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Age:16+
Key Eligibility Criteria
Disqualifiers:Proctitis, Sclerosing Cholangitis, Hepatitis, Others
Must Not Be Taking:Antidiarrheals, Probiotics
612 Participants Needed
Lebrikizumab for Eczema
Brooksville, Florida
This trial will test the safety and effectiveness of lebrikizumab in people with severe eczema who have already tried another treatment called Dupilumab. Lebrikizumab aims to reduce skin inflammation by blocking a protein that causes it.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:12+
Key Eligibility Criteria
Disqualifiers:Not Listed
120 Participants Needed
Orelabrutinib for B-Cell Malignancies
Weeki Wachee, Florida
This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
81 Participants Needed
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