Ohio Paid Clinical Trials

The investigators will develop and pilot test an innovative computer-assisted behavior intervention (CABI) for middle school students with attention-deficit/hyperactivity disorder (ADHD). The CABI will deliver evidence-based behavior interventions for ADHD in a manner that is acceptable to teachers and motivating for students. The key element of the CABI is a serious game that will teach and encourage rehearsal of ADHD coping skills in an engaging game environment. Transfer of those skills to authentic education settings will be facilitated by teacher interventionists in consultation with school or clinical psychologists. The investigators will test the CABI condition (n = 18) against traditional teacher consultation for ADHD (n = 18) on measures of consultation fidelity and student academic and behavioral outcomes. Read Less

The coronavirus (COVID-19) pandemic is a significant psychological stressor that threatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19 and its economic impact, as well as loneliness due to the required social isolation, are driving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll, 45% of respondents reported that the coronavirus has had a negative impact on their mental health. This is reflected in Southeastern Ohio. In data that the investigators collected from 317 Ohio University faculty, staff, and students from late May to early June, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severe levels of depression and 57% reported the COVID-19 outbreak was impacting their sense of social connection much or very much. Despite the significant community need for accessible and affordable care, there are currently no evidence-based interventions for individuals coping poorly with coronavirus-related distress. The investigators have developed a virtual group-based intervention targeting cognitive biases that amplify the experience of stress and anxiety (i.e., amplifying cognitions; Coping with Coronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing this intervention in a scientifically rigorous manner is to refine the manual and procedures and conduct a pilot test of the intervention. Read Less

The goal of the study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that takes into account medical evidence and parent values and preferences). The study will compare two methods to help clinicians facilitate this-a clinician pocket guide and a clinician hydroxyurea shared decision making toolkit-in a group of parents of children ages 0-5 with sickle cell disease. The investigators hope that both methods lead to parents reaching a high-quality, well-informed decision. In addition, the team hopes to demonstrate that parents who experience a shared decision will have lower anxiety and decisional uncertainty. The researchers also expect these parents to be more likely to choose hydroxyurea and that their children will have less pain, fewer hospitalizations, better developmental outcomes, and higher quality of life. The project team hopes to show that the toolkit method is easy for clinicians to use and gives parents the support needed to make an informed decision. Read Less

The primary objective of the Phase 1 part of the study is to determine the recommended dose of APVO436 administered intravenously to patients with AML or MDS. The primary objective of the Phase 1b part of the study is to evaluate the clinical activity of APVO436 in patients with AML or MDS. APVO436 is being studied in this Phase 1b, open-label, multi-center, two-part dose-escalation/dose expansion study to evaluate the safety, pharmacokinetic/pharmacodynamic (PK/PD), and clinical activity of APVO436 in patients with AML and MDS. The study will be conducted in 2 parts. The first part of this Phase 1B study is an open-label, multiple dose ascending dose escalation phase to determine the recommended dose (RP2D) level of APVO436 for future Phase 2 studies. The goal of the dose expansion phase of the study (Part 2) is to (i) evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care and (ii) obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental monotherapy and combination therapy modalities. Study Objectives for Dose Escalation Phase Primary Objectives are to: Determine the RP2D level of APVO436 administered intravenously (IV) in patients with AML or MDS, and Evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care and obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental monotherapy and combination therapy modalities. Secondary Objectives are to: Define the safety profile and immunogenicity of APVO436; to determine the PK/PD of APVO436; to evaluate the clinical activity of APVO436 in AML and MDS patients. Further evaluate the safety profile and immunogenicity of APVO436 and the PK/PD of APVO436 and the relationship between PK/PD and clinical response. Study Objectives for Dose Expansion Phase Primary Objective is to evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care. Secondary Objective is to obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental monotherapy and combination therapy modalities. Read Less

A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours. Read Less

The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy. Read Less

There is a growing interest in the effects of mental health and wellness on orthopedic intervention outcomes, not only in terms of how advances in surgical procedures influence patient outcomes, but also with regard for physician physical and mental well-being. Although total hip arthroplasty (THA) is associated with favorable clinical outcomes as assessed by surgeon evaluation, radiographic analysis and implant longevity, unfavorable long-term pain and quality of life outcomes are consistently observed in upwards of 20% of patients receiving THAs. As such, the need to understand and address the determinants of positive and negative outcomes is of critical importance if the field hopes to continue to advance strategies to improve long-term outcomes for joint replacement. The overarching goal of this application is to assess the benefits of the KINCISE for patient recovery outcomes related to physical and mental well-being. Read Less

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders. Read Less

The Retaining Employment and Talent after Injury/Illness Network (RETAIN) demonstration is a collaborative effort between the U.S. Department of Labor (DOL) and the Social Security Administration (SSA) to improve employment outcomes for individuals who experience injuries or illnesses that put them at risk of exiting the labor force and relying on disability programs and other public supports in the long term. RETAIN projects include a combination of medical provider services, stay-at-work/return-to-work (SAW/RTW) coordination services, and other SAW/RTW services. This evaluation will focus on the Ohio Department of Job and Family Services' implementation of "Ohio RETAIN." The evaluation will document how the project is implemented, describe enrollees, estimate the project's impacts on enrollees' outcomes, and assess whether the benefits outweigh the costs. Read Less

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL. Read Less

Endometriosis is a complex, heterogeneous disease that may present inconsistently across women. Using disease-specific biomarkers and advanced biostatistics, DotLab is developing a biomarker test to confirm the presence of endometriosis.This is a multi-center, prospective, observational, minimal risk study in women undergoing laparoscopy, laparotomy or other pelvic surgical procedure for endometriosis, infertility or another benign gynecological indication. Participants will undergo 2 study visits for collection of blood and saliva and completion of study questionnaires. Read Less

The MIDAS study aims to follow LAM patients who are currently taking, have previously failed or been intolerant of, or may (at some time in the future) take mTOR inhibitors (sirolimus or everolimus) as part of their clinical care. Adult female TSC patients may also enroll, with or without lung cysts. Read Less