University of Kansas Medical Center

This phase I/Ib trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period (recurrent platinum-resistant). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer.

Type: Interventional

Start Date: Jul 2021

open study

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Type: Interventional

Start Date: Nov 2020

open study

This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.

Type: Interventional

Start Date: Jul 2024

open study

The purpose of this study is to learn about the effects of two study medicines (maplirpacept [PF-07901801] and glofitamab) when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that is relapsed or is refractory. Relapsed means has returned after last treatment. Refractory means that it has not responded to last treatment. The two study medicines are given after a single dose of obinutuzumab which is the third study medicine. DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system. It develops when the body makes abnormal B lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections. This study is seeking adult participants who: - Have histologically confirmed diagnosis of DLBCL - Have received at least two first lines of treatment for NHL. - Are unable or unwilling to undergo a stem cell transplant or CAR-T cell therapy. Stem cell transplant is a procedure in which a patient receives healthy blood-forming cells to replace their own stem cells that have been destroyed by treatment. A CAR-T therapy is a type of treatment in which a patient's T cells are changed in the laboratory so they will attack cancer cells. Everyone in this study will receive all three medicines at the study site by intravenous (IV) infusion which is given directly into a vein. The two study medicines (maplirpacept [PF-07901801] and glofitamab) will be given in 21-day cycles. At Cycle 0, participants will receive a single dose of obinutuzumab pre-treatment followed by two step-up doses of glofitamab. The combination of maplirpacept (PF-07901801) with glofitamab full dose will be administered for the first time at Cycle 1 Day 1. Maplirpacept (PF-07901801) will be given weekly for the first three cycles and then every three weeks. Glofitamab will be given every 3 weeks for approximately 9 months. Thereafter participants will continue to receive maplirpacept alone. Maplirpacept (PF-07901801) will be given at different doses to different participants. Everyone taking part will receive the same fixed doses of glofitamab and obinutuzumab studied in patients with DLBCL. The study will compare the experiences of people receiving different doses of maplirpacept (PF-07901801). This will help to determine what dose is safe and effective when given with the other 2 study medicines.

Type: Interventional

Start Date: Aug 2023

open study

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Type: Interventional

Start Date: Jun 2023

open study

This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.

Type: Interventional

Start Date: Jun 2021

open study

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Type: Interventional

Start Date: Dec 2019

open study

The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.

Type: Interventional

Start Date: Feb 2019

open study

The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.

Type: Observational [Patient Registry]

Start Date: Oct 2016

open study

In addition to chronically elevated MSNA, there is a growing recognition that hypertension in states of insulin resistance and obesity may also be attributed to an increased vascular sensitivity to MSNA (1, 2, 13, 36-38). To study this phenomenon, we quantify vascular sensitivity to MSNA using an innovative, moment-to-moment assessment of the blood pressure response following individual bursts of muscle sympathetic nerve activity (MSNA), (10, 11, 34, 37). This approach is termed 'sympathetic-vascular transduction (SVT).' We will examine the hypothesis that SVT is exaggerated in obesity and insulin resistance and is attenuated by suppression of oxidative stress. Oxidative stress is the overabundance of reactive oxygen species and is another hallmark of hypertension, obesity, and insulin resistance. Oxidative stress can be safely reduced via intravenous infusion of ascorbic acid (Vit C) (4, 28). Therefore, we will use a randomized, double-blinded, placebo-controlled approach to test the hypothesis that elevated SVT will be attenuated by suppression of oxidative stress via ascorbic acid I.V. infusion compared with saline I.V. infusion (placebo) in obese adults with insulin resistance. Our study will identify a unique mechanism that can be targeted to reduce the excessively high prevalence of hypertension and risk for CVD in obesity and insulin resistance.

Type: Observational

Start Date: Aug 2022

open study

The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).

Type: Interventional

Start Date: Jul 2024

open study

The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.

Type: Interventional

Start Date: Feb 2023

open study

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.

Type: Interventional

Start Date: May 2018

open study

The goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in HER2-positive breast cancer.

Type: Observational [Patient Registry]

Start Date: Sep 2024

open study

The proposed project will evaluate the musculoskeletal outcomes of quadriceps and hamstring muscle size and function following orthopedic knee surgery involving anterior cruciate ligament (ACL) repair or reconstruction. Currently, the research team collaborates with a team of orthopedic specialists at the University of Kansas Health System and monitor muscle size post-knee repair and follow the standard of care (SOC) practices of the licensed physical therapists (PT). The proposed project will include a randomized clinical trial to observe the muscular outcomes following the current SOC plus supplementation of calcium-β-hydroxy-β-methylbutyrate (caHMB) or placebo. CaHMB has been shown to improve rates of muscle protein synthesis while suppressing muscle protein breakdown in healthy adults. The use of caHMB has also provided evidence of muscular protection from atrophy during prolonged bed rest. This evidence supports the utility in clinically injured athletes that are subjected to disuse atrophy from the inability to bear weight or participate in typical daily physical activity. Additionally, matched for activity-related knee injuries, female athletes are more susceptible to incurring a significant injury due to a variety of genetic, hormonal, biological, anatomical, and biomechanical predispositions. Therefore, the proposed study will recruit approximately 30 females over the age of 18 that have sustained an injury to the ACL and will plan to undergo reconstructive knee surgery involving the ACL. Subjects will be monitored and measured prior to their surgical date (T0), at 2-weeks post operative (T1), and every 6-weeks until they are cleared to return to sport (T2-TRTS). Participants will be randomly assigned 1:1 in a double-blind manner to either an experimental (EXPHMB) or placebo (CONPLA) group. Doses will be provided to the participants in coded containers and will complete their dosing and a record log of intake for the duration of their rehabilitation. Three 3-day food, exercise, and health record logs will be collected to monitor nutritional intake, activity, and menstrual patterns at T0, T3, and TRTS. Participant's assessments will include body composition analysis via bioelectrical impedance analysis for total and segmental muscle and fat mass, skeletal muscle mass, and body fat percent. We will collect ultrasound images of the quadriceps and hamstrings of the operative-involved limb (OPIL) and non-operative limb (NOPL) limbs for muscle cross-sectional area (mCSA), thickness (mT), subcutaneous fat thickness (TFAT), and corrected echo intensity (EICOR) at all time points. Strength and functional assessments will occur upon entrance to the study (T0), and after loaded exercise is indicated by the practitioner (T3-TRTS) to the tolerance of the athlete. These assessments include maximal voluntary isometric contractions (MVIC) for leg extension and leg curl, standing balance tests, single-leg and double-leg jump assessment, and drop landing deviation, all on dual force plates. Data will be analyzed using multiple three-way analyses of variance [surgical leg (OPIL vs. NOPL) x treatment (EXPHMB vs. CONPLA) x time (T0 vs. T1 vs. T2 vs. T3 vs. T4 vs. T5 vs. TRTS) for the dependent variables. Significance is established at p≤0.05 and follow-up ANOVAS, T-tests, and post-hoc analyses will be conducted when significance is present. The evidence from this study will support the practitioners and coaches' abilities to maximize recovery and training outcomes, respectively, in previously injured female athletes.

Type: Interventional

Start Date: May 2023

open study

INSIGHTS is a registry research study that collects key information on medical history for girls and women with Turner syndrome and the clinical care they receive. This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. In addition to learning a lot about the current state of health for individuals with TS, INSIGHTS serves as an infrastructure to conduct future studies are meaningful to patients and their families.

Type: Observational [Patient Registry]

Start Date: May 2020

open study

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Type: Interventional

Start Date: Jul 2020

open study

The investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. It differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. Dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. The investigators hope to see if dry needling also helps enhance balance and walking abilities. This might provide potential improvements inoverall mobility and balance.

Type: Interventional

Start Date: May 2024

open study

The objective is to determine the impact of taking a specialized form of carbohydrate in the immediate preoperative period on metabolic markers, surgical outcomes and patient health. Patients will be randomized to receive a specialized sports drink or a standard sports drink. Patients will have a continuous glucose monitor (CGM) placed on their upper arm to measure glucose throughout surgery and during the post-operative period.

Type: Interventional

Start Date: Nov 2023

open study

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.

Type: Interventional

Start Date: Sep 2023

open study

CureDuchenne link is a data hub comprised of integrated biospecimens, clinical data, and self- and/or caregiver-reported information from participants. Anyone over 4 weeks old who has been diagnosed with DMD or BMD or who is a carrier of DMD or BMD can join. Parents or legal guardians can sign up their child(ren).

Type: Observational [Patient Registry]

Start Date: Jul 2021

open study

Establish a biorepository, clinical data registry, and radiographic image database from individuals who were COVID positive at one time and are being seen for outpatient follow-up or a separate study visit.

Type: Observational [Patient Registry]

Start Date: Feb 2021

open study

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).

Type: Observational

Start Date: Nov 2020

open study

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

Type: Observational [Patient Registry]

Start Date: Apr 2014

open study

This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC. Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.

Type: Interventional

Start Date: Jan 2025

open study