UK Center for Clinical and Translational Science

This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed stage IIb-IV Non-Small Cell Lung Cancer (NSCLC) and are planning to undergo treatment for their cancer.

Type: Interventional

Start Date: Apr 2022

open study

This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.

Type: Interventional

Start Date: Sep 2022

open study

The goal of this study is to develop and pilot test an intervention, entitled Health is Wealth: A Cervical Health Program, designed to promote screening and reduce perceived barriers to Cervical Cancer (CC) screening. Aim 1: Examine general awareness and cultural factors (fatalism, religiosity/spirituality, temporal orientation, medical mistrust, and acculturation) related to cancer control and prevention among African Americans (AA) and Sub Saharan African (SAI) Immigrants. Aim 2: Examine the socioecological barriers and facilitators to CC screening and self-sampling to inform tailoring of an evidenced based cervical health program to promote CC screening. Aim 3: Assess feasibility, acceptability, and preliminary efficacy in a pilot test of the Health is Wealth: A Cervical Health Program among 30 AA and 30 SAI women using quasi-experimental design. This study will take place in 2 phases.

Type: Interventional

Start Date: Jan 2023

open study

This trial will evaluate whether the immune-sensitizing effects of immunotherapy (Pembrolizumab) and radiation with or without a PARP-inhibitor (Olaparib) will increase the effects of immunotherapy in men with high-risk localized prostate cancer.

Type: Interventional

Start Date: Jul 2023

open study

Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct administration of heated intra-peritoneal (IP) chemotherapy (HIPEC) to the affected peritoneal surfaces, has been shown to be an effective treatment option that extends overall survival among certain cases of peritoneal carcinomatosis. IP chemotherapy allows delivery of a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic residual disease while systemic exposure remains limited. Additionally, hyperthermia is known to enhance the cytotoxicity of several agents (including Mitomycin C) and improves the depth of peritoneal penetration. This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C. The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity, compared with the HIPEC flat dosing approach in patients undergoing CRS/HIPEC.

Type: Interventional

Start Date: Jun 2021

open study

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.

Type: Interventional

Start Date: May 2021

open study

Fetal complete (i.e., third degree, 3°) atrioventricular block (AVB), identified in the 2nd trimester of pregnancy in an otherwise normally developing heart, is almost universally associated with maternal anti-Ro autoantibodies and results in death in a fifth of cases. To date treatment of 3° AVB has been ineffective in restoring normal rhythm (NR) which may be because current surveillance is limited to once- weekly fetal echocardiograms. It is hypothesized that there may be a vital transition period of several hours in which incomplete block (2° AVB) may be successfully treated avoiding fully advanced irreversible 3° AVB. To optimize the likelihood of timely detection of the transition period this study comprises three steps: 1) to risk stratify for high titer anti-Ro antibodies, which are necessary but not sufficient to develop fetal AVB; 2) to empower mothers to identify 2° AVB by using fetal heart rate and rhythm monitoring (FHRM) at home, and 3) to rapidly treat mothers who detect an abnormality by monitoring with an urgent echocardiogram that confirms 2° AVB with the hope of reversing 2° AVB before it becomes permanent (3° AVB). In addition, it will be determined if FHRM reduces the need for weekly echoes. Although mothers with low titer anti-Ro will not be continued in Step 2 and therefore not followed by FHRM, birth ECGs will be collected to confirm that low titer antibodies do not confer risk. It is anticipated that this study will provide an evidenced based surveillance strategy for those mothers at high risk of having a child with 3° AVB.

Type: Interventional

Start Date: Aug 2020

open study

The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are: Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management? If effective, which facets of the peer model are most effective? Peer coaches will Undergo peer coach training. Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting. Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups.

Type: Interventional

Start Date: Feb 2024

open study

Appalachian Kentuckians in Martin and Letcher Counties are grappling with a health-threatening drinking water crisis arising from exposures to disinfection by-products (DBPs). DBPs include trihalomethanes (THMs), haloacetic acids (HAAs), chlorate, and other compounds that have been associated with a variety of adverse health effects, including increased risk of bladder cancer and cardiovascular birth defects. This study implements a multi-stakeholder, multi-method approach to improve understanding of, characterize spatial and temporal variations in, and reduce exposure to DBPs in these Appalachian Kentucky counties.

Type: Interventional

Start Date: Feb 2022

open study

This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstruction patients with concomitant meniscal injuries as this group is at greatest risk of rapid PTOA progression. Patients will randomly be assigned to receive oral montelukast (10 mg) versus placebo daily for 6 months after surgery.

Type: Interventional

Start Date: Feb 2021

open study

This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.

Type: Interventional

Start Date: Jun 2020

open study

The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.

Type: Interventional

Start Date: Feb 2024

open study

This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).

Type: Interventional

Start Date: Feb 2023

open study

Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.

Type: Interventional

Start Date: Mar 2024

open study

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.

Type: Interventional

Start Date: Mar 2019

open study

The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.

Type: Interventional

Start Date: Jul 2022

open study

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

Type: Interventional

Start Date: Aug 2021

open study

The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.

Type: Interventional

Start Date: May 2021

open study

The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Type: Interventional

Start Date: Feb 2021

open study