Ohio Paid Clinical Trials

This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively. Read Less

The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remodeling following modern therapies for FMR. The prospective study entails aiming to recruit 360 adult patients (ages \>18 years) with EF 10-50% and FMR RF\> 20%, who are clinically referred for CMR evaluation. Patients who enroll in our study will be referred for optimization of mGDMT and will undergo follow-up CMR studies at 6months. NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment will undergo follow-up CMR 6 months from Mitraclip intervention. NICM patients referred for mGDMT optimization, but have persistent or progressive FMR at the time of 6 month follow-up CMR and referred for Mitraclip therapy, will undergo a 2nd follow-up CMR 6 months from Mitraclip therapy. Read Less

DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation. Read Less

The purpose of this study is to determine the impact of pre-operative cryoablation, and immune checkpoint inhibition (ICI) on on 3-year Event Free Survival (EFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy. Read Less

The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA). Read Less

This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block. Read Less

Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients. Read Less

I. Title Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial * Today's Date: September 18, 2023 II. Principal Investigator * Principal Investigator: Christopher D. Riemann, M.D. (Cincinnati Eye Institute) * Email: criemann@cvphealth.com, Phone: 513-708-1979 V. Research Summary Purpose: To evaluate methotrexate for the prevention of PVR after primary rhegmatogenous retinal detachment repair. Methods: Inclusion Criteria: • Any adult patient, age ≥18 years-old, undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash, Ohio who is able to give informed consent. Exclusion Criteria: * Age \<18 years old * Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit. * History of endophthalmitis, ruptured globe or significant trauma in the affected eye * Chronic retinal detachment (symptoms greater than or equal to six weeks) * Any previous previous retinal detachment repair with pars plana vitrectomy, or scleral buckling surgery. Patients having undergone previous pneumatic retinopexy will not be excluded. * Presence of Grade C PVR: full thickness retinal folds or subretinal bands * Patients with contraindications to methotrexate, including breastfeeding, pregnancy, attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate * Patients with diminished mental capacity precluding their ability to give informed consent. Study Design and Randomization This prospective double masked trial will randomize patients into four groups in a 1:1:1:1 fashion. All attending surgeons and patients will be masked to group randomization. Randomization into four groups will occur on the day of surgery by the Cincinnati Eye Institute's pharmacist, Deepali Chachare. Group A will consist of ≥ 150 patients receiving intraoperative infusion with balanced salt solution containing methotrexate (40mg/500mL BSS), and methotrexate intravitreal injections (400mcg/0.05mL) at postoperative weeks 1, 3, 6, and 10. Group B will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion containing methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10. Group C will consist of ≥ 150 patients receiving a balanced salt solution infusion without methotrexate, and methotrexate injections at postoperative weeks 1, 3, 6, and 10. Group D will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion without methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10. Read Less

The most clinically meaningful way to discover new targets of T cells in autoimmune diseases is to study the tissues of patients with active autoimmune disease mediated organ inflammation. These tissues contain both cytotoxic and helper T cells that are driving their disease, and these T cells are being guided by TCRs that recognize tissue-specific targets. By collecting tissue when a patient has active inflammation, it is possible to determine which T cells are activated and undergoing clonal expansion in the patient's diseased organ. TScan has developed a genome-wide, high-throughput technology to determine the natural, physiological target of any TCR (Kula, 2019). The goal of this study is to isolate T cells from inflamed tissues and matched blood samples and/or matched normal tissues (for patients with inflammatory bowel diseases). T cell clones that are expanded in diseased tissues relative to blood or normal tissues will be selected and the targets of their TCRs will be defined using TScan's genome-wide, high-throughput target ID technology. The goal of this study is to discover a collection of peptide targets, along with their associated TCRs to be developed as new tolerogenic therapies for patients with autoimmune diseases. Read Less

This clinical trial compares telephone-based physical activity coaching to self monitored physical activity for improving physical function in older adults who are undergoing surgery for lung cancer and their caregivers. Lung cancer surgery in older adults is associated with functional declines and unique challenges. Performing physical activity around the time of surgery has been shown to improve functional outcomes in patients and exercise programs delivered via telehealth may improve access and convenience for patients and minimize participant burden. Telephone-based physical activity coaching may improve physical functioning for older adults with lung cancer who are undergoing surgery. Read Less

The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug). The main question it aims to answer is: * If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants * If improvement in clinical measures are because of improvement in the anatomic and physiologic traits. Participants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better. Read Less

The study will first determine the optimal dose of inupadenant to be given in combination with carboplatin and pemetrexed to patients that progressed after receiving first line anti-PD(L)1 treatment for locally advanced or metastatic non-small cell lung cancer. The efficacy and safety of the combination is then compared to standard of care carboplatin and pemetrexed in the same populations. Read Less