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Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
University of Kansas Medical Center
Pain, Postoperative
Burns
Donor site pain study comparing post-operative donor site pain and opioid consumption
after use of Lidocaine, Liposomal Bupivicaine or regional nerve block for split thickness
skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5
Deep partial or full thickness burn... expand
Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine, Liposomal Bupivicaine or regional nerve block for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds. Type: Interventional Start Date: Mar 2019 |
Fabry Disease Registry & Pregnancy Sub-registry
Genzyme, a Sanofi Company
Fabry Disease
The Fabry Registry is an ongoing, international multi-center, strictly observational
program that tracks the routine clinical outcomes for patients with Fabry disease,
irrespective of treatment status. No experimental intervention is involved; patients in
the Registry undergo clinical assessments... expand
The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The primary objectives of the Registry are: - To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease; - To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; - To characterize and describe the Fabry population as a whole; - To evaluate the long-term safety and effectiveness of Fabrazyme® Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected. Type: Observational [Patient Registry] Start Date: Jul 2001 |
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid...
Ionis Pharmaceuticals, Inc.
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
The purpose of this study is to evaluate the safety and tolerability of extended dosing
with eplontersen in participants with ATTR-CM. expand
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM. Type: Interventional Start Date: Nov 2022 |
A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum...
EpicentRx, Inc.
Carcinoma, Small Cell Lung
This Global Phase 3 study aims to find out whether RRx-001 + platinum chemotherapy is
more effective than platinum chemotherapy alone in 3rd line or beyond small cell cancer. expand
This Global Phase 3 study aims to find out whether RRx-001 + platinum chemotherapy is more effective than platinum chemotherapy alone in 3rd line or beyond small cell cancer. Type: Interventional Start Date: Aug 2022 |
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
Sumitomo Pharma Switzerland GmbH
Prostate Cancer
This is a multi-center, prospective, observational study of patients being treated with
ORGOVYX. The goal of this study is to generate real-world evidence about the safety and
effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and
the clinical course during treatment... expand
This is a multi-center, prospective, observational study of patients being treated with ORGOVYX. The goal of this study is to generate real-world evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX. Type: Observational Start Date: Oct 2022 |
Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment
SWOG Cancer Research Network
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
This clinical trial studies how well an educationally enhanced genomic tumor board (EGTB)
intervention works to increase the number of patients with solid tumors that have come
back (recurrent), do not respond to treatment (refractory), have spread to other parts of
the body (metastatic), or are newly... expand
This clinical trial studies how well an educationally enhanced genomic tumor board (EGTB) intervention works to increase the number of patients with solid tumors that have come back (recurrent), do not respond to treatment (refractory), have spread to other parts of the body (metastatic), or are newly diagnosed and spread to other parts of the body (advanced) who receive genome-informed treatment. Genome-informed treatment refers to treatment based on the information found in genomic tumor test results. This study compares the usual approach to reviewing genomic tumor test results with the approach of having a genomic tumor board (GTB) review the test results. A GTB is team of doctors and scientists that have experience in understanding genomic changes and review genomic tumor test results. The tumor board helps to suggest whether there are other cancer treatment options based on patient genetic test results. The usual approach is to review genomic tumor test results without the GTB being involved. This study may help researchers learn if using a GTB enhances the treatment decision making process within 6 months of joining the study. This study may also help researchers learn if using the GTB increases doctors' understanding of genomic tumor test results and increases doctors' comfort level with genomic tumor tests. Type: Interventional Start Date: Oct 2022 |
Complex Adult Deformity Surgery (CADS)
International Spine Study Group Foundation
Adult Spinal Deformity
Scoliosis
Kyphosis
Sagittal Imbalance
Evaluate surgical treatment outcomes and identify best practice guidelines for complex
adult spinal deformity (ASD) patients, including radiographic and clinical outcomes,
surgical and postoperative complications, risk factors for and revision surgery rates,
and the role of standard work to improve... expand
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications. Type: Observational [Patient Registry] Start Date: Jul 2018 |
Testing Swim Instruction for Autistic Children
University of Kansas Medical Center
Autism
The goal of this clinical trial is to compare the effects of a specialized swimming and
water-safety program (Sensory Enhanced Aquatics) and standard swimming lessons for
autistic children. The main question[s]it aims to answer are:
- Do Sensory Enhanced Aquatics and standard swimming lessons... expand
The goal of this clinical trial is to compare the effects of a specialized swimming and water-safety program (Sensory Enhanced Aquatics) and standard swimming lessons for autistic children. The main question[s]it aims to answer are: - Do Sensory Enhanced Aquatics and standard swimming lessons improve swimming and water-safety skills of autistic children? - Which participant characteristics are associated with the highest post-intervention swim skills and water safety across both groups? Participants will: - Complete questionnaires, motor, and swim tests before the intervention. - participate in 16, 30-minute Sensory Enhanced Aquatics lessons. - Complete a swim test after the intervention. - Complete an interview. Researchers will compare with participation in standard swim lessons to see if which bests teaches swimming and water-safety to autistic children. Type: Interventional Start Date: Apr 2024 |
Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
University of Kansas Medical Center
Smoking Cessation
This study will evaluate the efficacy of extended bupropion(6 months) versus standard
bupropion treatment (7 weeks) among African American daily smokers. expand
This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers. Type: Interventional Start Date: Feb 2023 |
Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA
Geisinger Clinic
Obstructive Sleep Apnea
This study seeks to enhance long-term positive airway pressure (PAP) adherence among
Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will
assess the feasibility of a linguistically and culturally adapted tele-management
intervention (Automated Management, AM) for... expand
This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA. Type: Interventional Start Date: Oct 2023 |
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Jun Zhang, MD, PhD
Lung Cancer
NSCLC
NSCLC Stage IV
To test whether it is feasible to perform the 3D-EX functional predictive response
bioassay in the context of patients with advanced/metastatic NSCLC receiving immune
checkpoint inhibitors in the standard of care clinical setting. expand
To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting. Type: Observational Start Date: Jul 2022 |
Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine
Geistlich Pharma AG
Pancreatic Cancer, Adult
This is a phase 1 first in human, dose escalation trial of GP-2250 administered in
combination with gemcitabine in subjects with advanced pancreatic cancer previously
treated with 5-fluorouracil-based chemotherapy.
Prior radiosensitization with gemcitabine, the use of 5-fluorouracil, FOLFIRINOX... expand
This is a phase 1 first in human, dose escalation trial of GP-2250 administered in combination with gemcitabine in subjects with advanced pancreatic cancer previously treated with 5-fluorouracil-based chemotherapy. Prior radiosensitization with gemcitabine, the use of 5-fluorouracil, FOLFIRINOX or Nab-paclitaxel/gemcitabine in the neoadjuvant setting, and prior pancreaticoduodenectomy (Whipple procedure) is allowed. If prior treatment with gemcitabine was at therapeutic doses, a minimum of 3 months must have elapsed since the end of such treatment. As a precursor to 5-FU use of capecitabine-based chemotherapy is also permitted. Type: Interventional Start Date: Jan 2019 |
Multicohort Phase II Trial of sEphB4-HSA+Pembrolizumab in Solid Tumors
University of Southern California
Stage IV Bladder Urothelial Carcinoma
Prostate Cancer
Urothelial Carcinoma
This is a multi-cohort single arm phase II/screening trial of the combination of a fusion
protein that binds EphrinB2 and blocks interaction with cell surface EphB receptors
(sEphB4-HSA) in combination with an anti-PD1 antibody (MK-7435 / Pembrolizumab) for
treatment of patients with specific solid... expand
This is a multi-cohort single arm phase II/screening trial of the combination of a fusion protein that binds EphrinB2 and blocks interaction with cell surface EphB receptors (sEphB4-HSA) in combination with an anti-PD1 antibody (MK-7435 / Pembrolizumab) for treatment of patients with specific solid tumors. There will be four cohorts in this trial: 1. Cohort A, phase II 2nd line trial of sEphB4-HSA and pembrolizumab for platinum refractory metastatic urothelial carcinoma. 2. Cohort B, phase II 3rd line trial of sEphB4-HSA and pembrolizumab for platinum refractory metastatic urothelial carcinoma. 3. Cohort C, phase II neoadjuvant trial of sEphB4-HSA and pembrolizumab for locally advanced muscle invasive urothelial carcinoma. 4. Cohort D, phase II neoadjuvant trial of sEphB4-HSA and pembrolizumab for locally advanced prostate cancer. Type: Interventional Start Date: Nov 2016 |
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
CHDI Foundation, Inc.
Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two
former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North
America and Australasia-while also expanding to include sites in Latin America. More than
30,000 participants have now enrolled into... expand
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more. Type: Observational [Patient Registry] Start Date: Jul 2012 |
IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Duke University
Type B Aortic Dissection
The goal of this clinical trial is to determine whether an upfront invasive strategy of
TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause
death or major aortic complications compared to an upfront conservative strategy of
medical therapy with surveillance for deterioration... expand
The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection. Type: Interventional Start Date: Apr 2024 |
Study of DF1001 in Patients With Advanced Solid Tumors
Dragonfly Therapeutics
Solid Tumor, Adult
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell
activation signals to specific receptors on cancer cells. The study will occur in two
phases. The first phase will be a dose escalation phase, enrolling patients with various
types of solid tumors that express... expand
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy. Type: Interventional Start Date: Nov 2019 |
Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along...
University of Kansas Medical Center
Non Small Cell Lung Cancer Stage
The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions
(2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance
durvalumab will improve locoregional control at 18 months by 10% compared to
standard-fractionated chemo-IMRT/durvalumab. A modest... expand
The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance durvalumab will improve locoregional control at 18 months by 10% compared to standard-fractionated chemo-IMRT/durvalumab. A modest improvement in locoregional control (LRC) was selected as a target which could merit further study of this hypofractionated IMRT regimen in a Phase III trial Type: Interventional Start Date: Feb 2022 |
Chronic Pain, Opioid Use, and Epidermal Nerve Fiber Density
University of Kansas Medical Center
Chronic Pain
Opioid Use
Nerve Disorders
This pilot study is being performed to examine whether epidermal axons are altered in
patients taking opioid therapy for chronic non-cancer pain, and if epidermal axonal
changes predict heightened pain sensitivity. expand
This pilot study is being performed to examine whether epidermal axons are altered in patients taking opioid therapy for chronic non-cancer pain, and if epidermal axonal changes predict heightened pain sensitivity. Type: Observational Start Date: Dec 2020 |
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
MedtronicNeuro
Epilepsy
The purpose of this post-approval study is to further evaluate the long-term safety and
effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly
implanted participants through 3 years of follow-up. expand
The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up. Type: Interventional Start Date: Mar 2020 |
Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
SWOG Cancer Research Network
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy
without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage
triple negative breast cancer. Paclitaxel is in a class of medications called
anti-microtubule agents. It stops cancer cells... expand
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer. Type: Interventional Start Date: Sep 2023 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
The primary aim is to test whether abatacept, as compared to placebo, is associated with
a reduction in major adverse cardiac events (MACE) among participants hospitalized with
myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE,
is a composite of first occurrence... expand
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Type: Interventional Start Date: Jun 2022 |
Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
University of Kansas Medical Center
NSCLC Stage IV
NSCLC, Recurrent
The purpose of this study is to see if adding pirfenidone to atezolizumab will increase
anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small
cell lung cancer participants. expand
The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung cancer participants. Type: Interventional Start Date: May 2022 |
Efficacy of Point Of Service Testing in MBC
University of Kansas Medical Center
Metastatic Cancer
Breast Cancer
This study will assess the efficacy of an innovative point of service cancer genetics
counseling delivery model for metastatic breast cancer (MBC) patients whom have received
a referral for hereditary cancer genetic counseling and testing. expand
This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing. Type: Interventional Start Date: Jun 2019 |
Functional Fitness for Overweight or Obese Adults With Mobility Disabilities
University of Kansas
Mobility Limitation
Overweight or Obesity
Physical Disability
Over 64 million people in the U.S. have a permanent disability, with mobility-related
disability (MRD) representing the most prevalent disability type (13.7%). Adults with MRD
are 66% more likely to be overweight or obese than their non-disabled peers. Exercise in
adults with MRD is important for... expand
Over 64 million people in the U.S. have a permanent disability, with mobility-related disability (MRD) representing the most prevalent disability type (13.7%). Adults with MRD are 66% more likely to be overweight or obese than their non-disabled peers. Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension, hyperlipidemia, insulin processing/sensitivity, etc. However, over half (57%) of adults with MRD do not exercise, while 22% engage in exercise of insufficient duration or intensity to obtain health benefits. Adults with MRD face numerous barriers to participation in community-based exercise, and exercise is frequently limited to short-term referrals for outpatient physical and/or occupational therapy. High-intensity functional training (HIFT) represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions, in addition to improving physical function and aspects of psychosocial health for people with disabilities. Preliminary evidence supports the effectiveness of HIFT to improve body composition, cardiovascular and muscular fitness, insulin processing and insulin sensitivity in non-disabled adults who are overweight/obese. To date, no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweight/obese adults with MRD. Thus, the proposed study will implement a 6-mo. pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention (60 min sessions/3 days/wk.) in 25 adults with MRD and overweight/obesity. This study will address the following aims: Aim 1: Evaluate the intervention feasibility based on participant recruitment, session attendance, retention, outcome assessment completion, and the results of semi-structured exit interviews to obtain information regarding experience and overall satisfaction with the intervention. Aim 2: Evaluate changes (baseline - 6 mos.) in weight and fat-mass/fat-free mass, and components of the metabolic syndrome (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose). Type: Interventional Start Date: Apr 2023 |
A Post-market Clinical Study to Evaluate the Safety and Performance of the Carbon Fibre Reinforced Polyetheretherketone...
Invibio Ltd
Hallux Rigidus
The clinical study involves the routine treatment of skeletally mature patients who have
been diagnosed with hallux rigidus (stiffness of the first metatarso-phalangeal joint in
the foot due to arthritis and degeneration of cartilage).
It follows standard practice surgery to treat this condition.... expand
The clinical study involves the routine treatment of skeletally mature patients who have been diagnosed with hallux rigidus (stiffness of the first metatarso-phalangeal joint in the foot due to arthritis and degeneration of cartilage). It follows standard practice surgery to treat this condition. This type of degenerative arthritis affects the joint of the big toe (hallux) which is attached to the foot. Taking part in this research will involve collecting data of the surgery to remove damaged cartilage and fix the two bones together with screws and a plate (called the CoLink® PCR MTP Plate). Type: Observational Start Date: Mar 2023 |
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