University of Kansas Medical Center

The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.

Type: Observational

Start Date: Jul 2025

open study

This study aims to assess the levels of phosphorylated alpha-synuclein (P-SYN) in patients with Parkinson's disease and REM Behavior Disorder using a minimally invasive skin punch biopsy. It seeks to understand the natural progression of P-SYN deposition over time to explore the potential of P-SYN quantification as a biomarker for disease progression.

Type: Observational

Start Date: Dec 2024

open study

The ASPIRE trial is a 52 week randomized, double-blind, placebo-controlled, parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of orally administered buloxibutid, either on top of stable IPF therapy or as monotherapy, are assessed in participants with IPF. Trial website: www.aspire-ipf.com

Type: Interventional

Start Date: Dec 2024

open study

The goal of this community-engaged research is two-fold. The first goal is to gather stakeholder feedback to inform a school-based community health worker intervention with youth with poor school attendance and an enhanced usual care condition. The second goal is to evaluate the feasibility of implementing the school-based community health worker intervention and enhanced usual care approach within rural schools. The main question it aims to answer is whether it is feasibile to recruit children with poor school attendance and their families to the intervention, to complete the trauma-informed intervention, and to complete the associated study measures of meeting social determinants of health/mental health needs, school-based health center utilization, and behavioral helath symptoms. At least 38 rural students in grades 6-12 with poor school attendance and their parents/guardians will meet with the school-based community health worker for support around social determinants of health needs that may be barriers to attendance. Researchers will also assess the feasibility of recruiting at least 10 rural students and their parents/guardians to complete the study measures in an enhanced usual care condition in which the school-based health center without a school-based community health worker is reminded of the availability of an online social services directory.

Type: Interventional

Start Date: Aug 2025

open study

To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.

Type: Interventional

Start Date: Oct 2024

open study

This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.

Type: Observational

Start Date: Jan 2025

open study

This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infection. There are several types of lymphoma. This study will enroll people who have classical Hodgkin lymphoma (cHL), peripheral T cell lymphoma (PTCL), or diffuse large B cell lymphoma (DLBCL). This clinical trial uses a drug called PF-08046044/SGN-35C . The study drug is in testing and has not been approved for sale. This is the first time SGN -35C will be used in people. This study will test the safety of SGN-35C in participants with lymphoma. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. This study will have three parts. Parts A and B of the study will find out the best dose and dosing schedule for SGN-35C. Part C will use the dose found in parts A and B to find out how safe SGN-35C is and if it works to treat select lymphomas.

Type: Interventional

Start Date: May 2024

open study

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

Type: Interventional

Start Date: Sep 2023

open study

This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the standard of care.

Type: Interventional

Start Date: Mar 2023

open study

This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.

Type: Interventional

Start Date: Jun 2021

open study

This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan 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. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.

Type: Interventional

Start Date: Jun 2021

open study

This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have seven groups or "parts." - Part A will find out how much SEA-CD70 should be given to participants - Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS. - Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML. - Part D will find out how much SEA-CD70 with azacitidine should be given to participants - Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML that has not been treated. - Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML. - Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.

Type: Interventional

Start Date: Aug 2020

open study

The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.

Type: Interventional

Start Date: Feb 2025

open study

The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).

Type: Interventional

Start Date: Jan 2025

open study

Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program

Type: Observational

Start Date: Jun 2025

open study

The goal of this observational study is to evaluate intravenous lidocaine efficacy and safety in treating headache following non-traumatic subarachnoid hemorrhage. Through this prospective analysis, the investigators hope to: 1. show that intravenous lidocaine infusion causes a clinically significant reduction in pain scores in patients with moderate/severe headache pain following non-traumatic subarachnoid hemorrhage; 2. show that intravenous lidocaine infusion is safe in treating headache following non-traumatic subarachnoid hemorrhage; 3. and report vasospasm prevalence in the cohort. Participants will receive lidocaine infusion as treatment for non-traumatic subarachnoid hemorrhage headache and provide pain scores (on a numeric pain scale) every two hours the patients are awake for a maximum of seven days. Monitoring for vasospasm will occur as part of the patients regular medical care.

Type: Observational [Patient Registry]

Start Date: Jan 2025

open study

The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.

Type: Interventional

Start Date: Jan 2025

open study

This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Type: Interventional

Start Date: Sep 2024

open study

This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424 or 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

Type: Interventional

Start Date: Sep 2024

open study

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.

Type: Interventional

Start Date: Oct 2024

open study

This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.

Type: Interventional

Start Date: Dec 2024

open study

Many hospitals and outpatient clinics often refer people who smoke to quitlines and provide prescriptions for smoking cessation medications, but patients rarely fully engage in counseling or use their cessation medications. This is a single-arm, open-label pilot study to provide feasibility metrics for a text-based contingency management (CM) intervention to increase engagement in smoking cessation treatment. All participants (N=20) will be referred to a state quitline and will receive a prescription for medication plus 12 weeks of a text-based CM intervention to increase engagement in quitline calls and varenicline utilization. The engagement of participants in quitline counseling will be tracked for 6 weeks and medication utilization for 12 weeks post-enrollment. The investigators will use mixed-methods to collect implementation and acceptability data to inform changes to the text-based contingency management (CM) intervention.

Type: Interventional

Start Date: Sep 2024

open study

Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

Type: Interventional

Start Date: Oct 2024

open study

The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).

Type: Interventional

Start Date: Aug 2024

open study

The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. The primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (aromatase inhibitor (AI) or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors. Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing).

Type: Interventional

Start Date: Oct 2024

open study