Observational Study to Assess the Reliability and Validity of the MLYMT
Recruiting
This is a prospective Multi-Center Observational Study to assess the reliability and validity of the Multi-Luminance Y-Mobility Test (MLYMT). Main Outcome Measures: (i) Performance scores in normal and severely visually impaired subjects with a clinical diagnosis of retinitis pigmentosa (RP) on MLYMT at multiple luminance levels and (ii) reliability and content validity of MLYMT.
Gender:
All
Ages:
18 years and above
Locations: Nanoscope Clinical Site, Miami, Florida +6 locations
Conditions: Retinitis Pigmentosa, Retinal Dystrophy
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-552 Capsules Moves Through the Body of Participants Aged 50 to 90 Years With Mild Alzheimer's Disease
Recruiting
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-552 is in treating sy... Read More
Gender:
All
Ages:
Between 50 years and 90 years
Locations: Vertex Research Group Inc /ID# 248295, Clermont, Florida +11 locations
Conditions: Alzheimer's Disease (AD)
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous RO7121932 in Participants With Multiple Sclerosis.
Recruiting
The primary purpose of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses of RO7121932 in participants with multiple sclerosis (MS)
Gender:
All
Ages:
Between 18 years and 65 years
Locations: University of South Florida, Tampa, Florida +22 locations
Conditions: Multiple Sclerosis
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Recruiting
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the stud... Read More
Gender:
All
Ages:
Between 18 years and 75 years
Locations: Schiff Center for Liver Diseases - University of Miami, Miami, Florida +12 locations
Conditions: Primary Sclerosing Cholangitis
Siplizumab in T1DM
Recruiting
This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0. Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs. Blood samples f... Read More
Gender:
All
Ages:
Between 8 years and 45 years
Locations: University of Florida: Diabetes Center of Excellence, Gainesville, Florida +19 locations
Conditions: Type 1 Diabetes Mellitus
Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers
Recruiting
This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made... Read More
Gender:
Female
Ages:
18 years and above
Locations: University of Florida Health Science Center - Gainesville, Gainesville, Florida +9 locations
Conditions: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Metastatic Endometrial Endometrioid Adenocarcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Stage IV Uterine Corpus Cancer AJCC v8
Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Breast Cancer
Recruiting
The PIK3CA gene is frequently mutated in breast cancer, leading to disease aggressiveness and patient mortality. Alpelisib, a small molecule that inhibits the activity of the PIK3CA gene product PI3Kα, has demonstrated clinical benefit in cancer patients with this gene mutation. However, hyperglycemia, an on-target toxicity associated with alpelisib that leads to hyperinsulinemia, limits the drug's clinical efficacy and induces high grade hyperglycemia in patients with baseline metabolic dysfunc... Read More
Gender:
All
Ages:
18 years and above
Locations: Miami Cancer Institute at Baptist Health, Miami, Florida +5 locations
Conditions: HR+/HER2-negative Breast Cancer, Metastatic Breast Cancer
Study of TTI-101 in Combination for Participants With Metastatic Hormone Receptor (HR)-Positive and Human Epidermal Receptor 2 (HER2)-Negative Breast Cancer
Recruiting
The primary objectives of the Phase 1b part of this study are to evaluate the safety and tolerability of TTI-101 when added to palbociclib and aromatase inhibitor (AI) administered orally to participants with HR-positive HER2-negative palbociclib-resistant breast cancer, and to determine the recommended Phase 2 dose (RP2D) for TTI-101 when added to palbociclib and AI. The primary objective of the Phase 2 part of this study is to evaluate tumor response by Response Evaluation Criteria in Solid T... Read More
Gender:
All
Ages:
18 years and above
Locations: Holy Cross Health Fort Lauderdale - Holy Cross Hospital, Fort Lauderdale, Florida +4 locations
Conditions: Breast Cancer
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
Recruiting
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.
Gender:
All
Ages:
18 years and above
Locations: Crinetics Study Site, Miami, Florida +29 locations
Conditions: Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Syndrome Diarrhea, Carcinoid Intestine Tumor, Carcinoid Tumor of Liver, Carcinoid Tumor of Pancreas
A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy
Recruiting
This trial will study the efficacy and safety of taldefgrobep alfa as an adjunctive therapy for participants who are already taking a stable dose of nusinersen or risdiplam or have a history of onasemnogene abeparvovec-xioi, compared to placebo.
Gender:
All
Ages:
Between 4 years and 21 years
Locations: UF Health, Shands Hospital, Gainesville, Florida +58 locations
Conditions: Spinal Muscular Atrophy, Neuromuscular Diseases, SMA
Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma
Recruiting
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 recept... Read More
Gender:
Female
Ages:
18 years and above
Locations: Florida Cancer Specialists - Sarasota Downtown, Sarasota, Florida +236 locations
Conditions: Endometrial Serous Adenocarcinoma, Uterine Corpus Carcinosarcoma
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
Recruiting
The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.
Gender:
All
Ages:
18 years and above
Locations: Florida Research Institute, Lakewood Ranch, Florida +43 locations
Conditions: NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2