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RETRO Study (RETrograde Renal Access Outcomes)
University of Kansas Medical Center
Renal Stones
The goal of this observational study is to learn about the benefit of using RetroPerc® in
obtaining renal access for percutaneous nephrolithotomy. The device is already used in
routine clinical practice by urologists around the country.
Participants who are already scheduled to undergo percutaneou1 expand
The goal of this observational study is to learn about the benefit of using RetroPerc® in obtaining renal access for percutaneous nephrolithotomy. The device is already used in routine clinical practice by urologists around the country. Participants who are already scheduled to undergo percutaneous nephrolithotomy as part of their regular care will be asked to participate. Type: Observational Start Date: Dec 2024 |
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
Apreo Health, Inc.
COPD
Emphysema
The objective of this study is to assess the safety and efficacy of Apreo BREATHE system
when used to support native airways and release trapped air in the treatment of adult
COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal
medical treatment. The Apreo BREAT1 expand
The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work? Type: Interventional Start Date: Jul 2025 |
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therap1
Celgene
Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the
investigator's choice of therapy in participants with Metastatic Castration-resistant
Prostate Cancer. expand
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer. Type: Interventional Start Date: Mar 2025 |
A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Biogen
Antibody-mediated Rejection
The main goal of this trial is to evaluate the efficacy of felzartamab compared to
placebo in kidney transplant recipients diagnosed with late active or chronic active AMR. expand
The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR. Type: Interventional Start Date: Dec 2024 |
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/M1
Incyte Corporation
Graft-versus-host Disease (GVHD)
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus
Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in
Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell
Transplantation expand
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation Type: Interventional Start Date: Apr 2025 |
Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LAB1
Regeneron Pharmaceuticals
Asthma
This study is researching a drug called dupilumab. The study is focused on patients who
have uncontrolled asthma. Asthma is a condition where the airways narrow and swell,
making it difficult to breathe. Uncontrolled asthma means that patients are still having
frequent symptoms while taking their c1 expand
This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab Type: Interventional Start Date: Aug 2024 |
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydro1
CereVasc Inc
Normal Pressure Hydrocephalus
Prospective, multi-center, randomized, controlled trial of the eShunt System in the
treatment of patients with normal pressure hydrocephalus. expand
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus. Type: Interventional Start Date: Nov 2024 |
Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
University of Kansas Medical Center
Osteoarthritis, Knee
Diabetes Mellitus, Type 2
A Phase 2 Randomized Study to Evaluate the Effects of triamcinolone acetonide
extended-release (TA-ER; Zilretta) vs. triamcinolone acetonide immediate-release (TA-IR;
Kenalog) on Blood Glucose Levels in Diabetic Subjects with Knee Osteoarthritis. Subjects
should have Type 2 Diabetes Mellitus (T2DM)1 expand
A Phase 2 Randomized Study to Evaluate the Effects of triamcinolone acetonide extended-release (TA-ER; Zilretta) vs. triamcinolone acetonide immediate-release (TA-IR; Kenalog) on Blood Glucose Levels in Diabetic Subjects with Knee Osteoarthritis. Subjects should have Type 2 Diabetes Mellitus (T2DM) with HbA1C ≤9 that is managed without insulin and have been diagnosed with symptomatic unilateral or bilateral osteoarthritis (OA) of the knee, based on clinical and radiological criteria (if bilateral, then a target knee will be selected).Total study duration for individual subject will be about 4 months, which includes 3 weeks of Screening period, 10 days of pretreatment phase, treatment day, and 12 weeks of post-treatment period. Type: Interventional Start Date: Aug 2024 |
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Celldex Therapeutics
Chronic Spontaneous Urticaria
The purpose of this study is to establish the efficacy, safety and tolerability of
barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately
controlled by non-sedating second generation H1-antihistamines in comparison to placebo. expand
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo. Type: Interventional Start Date: Jul 2024 |
Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals Wit1
University of Kansas Medical Center
Multiple Sclerosis
Insomnia
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to
insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated
with reduced cognitive performance, physical function, psychological well-being, quality
of life, and occupational funct1 expand
The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3). Type: Interventional Start Date: Jul 2024 |
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in1
Celgene
Large B-cell Lymphoma
The purpose of this study is to compare the effectiveness and safety of golcadomide in
combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
(R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants
with previously untreated high-risk1 expand
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL). Type: Interventional Start Date: Jun 2024 |
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe C1
Mesoblast, Ltd.
Degenerative Disc Disease
The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA
compared to control in reducing low back pain at 12 months post-treatment and safety of a
single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc
compared to control through 12 months pos1 expand
The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment. Type: Interventional Start Date: Jul 2024 |
A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous I1
Sanofi
Chronic Inflammatory Demyelinating Polyneuropathy
The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult
participants with CIDP who are receiving maintenance treatment with IVIg. The study
duration will be for a maximum of 109 weeks including screening, treatment phases, and
follow-up. expand
The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. Type: Interventional Start Date: Aug 2024 |
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy f1
Jazz Pharmaceuticals
Biliary Tract Cancer
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus
CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death
protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or
Pembrolizumab, where approved under local reg1 expand
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. Type: Interventional Start Date: Jul 2024 |
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
GB002, Inc.
Pulmonary Arterial Hypertension
This open-label extension study will evaluate the long-term safety, tolerability and
efficacy of orally inhaled seralutinib in subjects who have completed a previous
seralutinib study expand
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study Type: Interventional Start Date: Sep 2024 |
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advance1
Regeneron Pharmaceuticals
Melanoma
This study is researching an experimental drug called fianlimab (also known as REGN3767),
combined with another medication called cemiplimab (also known as REGN2810), called
"study drugs". The study is focused on patients with a type of skin cancer known as
melanoma. The aim of the study is to see1 expand
This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. The study is looking at several other research questions, including: - What side effects may happen from taking the study drugs. - How much study drug is in the blood at different times. - Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: Sep 2024 |
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Sclerosis
Myasthenia Gravis
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug
levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS),
Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG). expand
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG). Type: Interventional Start Date: Mar 2024 |
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sc1
Sanofi
Multiple Sclerosis
The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People1 expand
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 12 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Pati1
Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination
with standard of care anti-cancer drugs is more effective than standard of care in
participants with untreated advanced NSCLC. NSCLC must have a change in a gene called
KRAS G12C. Study participation, including f1 expand
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing. Type: Interventional Start Date: Dec 2023 |
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301
Immunocore Ltd
Advanced Melanoma
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab
compared to standard nivolumab regimens in HLA-A*02:01-positive participants with
previously untreated advanced melanoma. expand
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma. Type: Interventional Start Date: Jun 2024 |
Changes in Resting Metabolic Rate Following Orthopedic Surgery
University of Kansas Medical Center
Metabolism; Disorder, Postprocedural
Resting Metabolic Rate
Post Operative Nutrition
This project is intended to determine the magnitude and duration of RMR changes in
patients receiving orthopedic surgery. The result will help to guide postoperative
nutrition recommendations in patients receiving orthopedic surgery. expand
This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery. Type: Observational Start Date: Oct 2023 |
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Takeda
Ulcerative Colitis
The main aim of this study is to learn about the effect of treatment with vedolizumab IV
(vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative
colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the
double treatment.
All participants w1 expand
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab. Type: Interventional Start Date: Jun 2024 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progr1
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Pos1
Novartis Pharmaceuticals
Oligometastatic Prostate Cancer (OMPC)
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu)
vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer
(OMPC) progressing after definitive therapy to their primary tumor. The data generated
from this study will provide evidence for t1 expand
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT). Type: Interventional Start Date: Mar 2024 |
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and G1
Novartis Pharmaceuticals
Breast Cancer
The purpose of this trial is to estimate the recommended dose (RD) of [177Lu]Lu-NeoB in
combination with ribociclib and fulvestrant in participants with estrogen receptor (ER)
positive (ER+), human epidermal growth factor receptor-2 (HER2) negative (HER2-) and
gastrin releasing peptide receptor (GR1 expand
The purpose of this trial is to estimate the recommended dose (RD) of [177Lu]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor-2 (HER2) negative (HER2-) and gastrin releasing peptide receptor (GRPR) positive (GRPR+) advanced breast cancer experiencing early relapse from (neo)adjuvant endocrine therapy or who have progressed on endocrine therapy in combination with a CDK4/6 inhibitor for advanced disease. Type: Interventional Start Date: Nov 2023 |
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