Ohio Paid Clinical Trials

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements. Read Less

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. HPV is known to cause a variety of cancers including cervical cancer. Even though there are ways to detect cervical cancer, many individuals are not diagnosed. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. The low screening numbers show more testing needs to be done. Without appropriate screening and care, preventable precancer may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. Information gathered from this study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements. Read Less

Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images. Read Less

The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting. Read Less

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders. Read Less

The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy. Read Less

STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO). Read Less

ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers. ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. It also makes the cancer cells visible to the immune system which will fight the cancer cells. Before ASP1012 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This will help find a suitable dose for future studies and check for potential medical problems from the treatment. In this study, ASP1012 is being tested in humans for the first time. ASP1012 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed. People in this study will be adults whose tumor has either grown outside of the area where it started (locally advanced) or it has spread to other parts of the body (metastatic). They will receive ASP1012. Also, some people will receive ASP1012 with pembrolizumab, an approved medicine. There are 2 main aims of this study. The first is to learn if people with certain solid tumors can tolerate different doses of ASP1012. The second is to find a suitable dose of ASP1012. This study will be in 3 parts. Part 1 is called Dose Escalation. People with locally advanced or metastatic tumors can take part. They will have been previously treated with all available standard cancer therapies. Different small groups of people will receive lower to higher doses of ASP1012. For each dose, any medical problems will be recorded. This will help to find suitable doses of ASP1012 to use in Parts 2 and 3 of the study. The first group will receive the lowest dose of ASP1012. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP1012. The panel will do this for each group until all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3. Part 2 is called Dose Expansion. 3 groups will take part: people with previously-treated melanoma (a type of skin cancer) that have not responded to their treatment (refractory) or their cancer has come back (relapsed), people with newly-diagnosed or untreated melanoma, and people with previously-treated solid tumors. People with previously-treated melanoma will receive ASP1012 at the dose worked out from Part 1. People with previously-treated solid tumors will receive ASP1012 with pembrolizumab. The first few people will receive ASP1012 at a lower dose than the dose worked out from Part 1, to check the safety of the treatments being given together. If there are no safety issues: the next people in the solid tumor group will receive ASP1012 at the dose worked out from Part 1, with pembrolizumab; also people with untreated melanoma will receive ASP1012 at the dose worked out from Part 1, with pembrolizumab. Part 3 is also a Dose Expansion for people with other specific cancers. These are stomach cancer, ovarian cancer, or colorectal cancer. If people with certain tumors respond well in Parts 1 and 2 of the study, other people with this same type of tumor can also take part in Part 3. For all parts of the study, ASP1012 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will start with 3 treatment cycles. People in the study may receive extra treatment cycles, if they respond well to treatment. People with melanoma who are receiving ASP1012 with pembrolizumab will not be offered the extra treatment cycles. People can stop leave the study early if: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment. People will visit the clinic on certain days during their treatment. Some visits will be virtual or by phone. During all clinic visits, the study doctors will check for any medical problems from ASP1012. They will also check vital signs. Vital signs include temperature, pulse, breathing rate, the amount of oxygen in the blood, and blood pressure. At some visits, other checks will also include a medical examination, and an electrocardiogram (ECG) to check the heart rhythm, blood draws and urine samples for testing. A tumor sample, if available, will be taken during the first treatment cycle. People will have imaging scans and have blood draws for testing every 6 weeks during and after treatment. This will stop if they leave the study early. People will visit the clinic within 7 days and 30 days after stopping treatment. At both visits, the study doctors will check for any medical problems from ASP1012. Other checks will include a medical examination, blood draws and urine samples for testing and checking vital signs. An ECG will also be done at the 7-day visit. After the 30-day visit, clinic staff will phone people in the study every 12 weeks to check the condition of their cancer for up to 1 year. Read Less

The primary objective of this phase IIb/III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent. Read Less

The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma. Read Less

LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation. Read Less

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. Read Less