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Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
University of Alabama at Birmingham
Arthritis Knee
Arthritis Hip
Chronic Pain
The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper
intervention for patients undergoing total knee or hip replacement who are on chronic
opioids before their surgery. The main questions it aims to answer are:
- Is the intervention feasible and acceptable... expand
The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are: - Is the intervention feasible and acceptable to patients? - Does the intervention result in a decrease in opioid dose during the preoperative period? Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary. Type: Interventional Start Date: Jan 2024 |
A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on...
Mineralys Therapeutics Inc.
Hypertension
a Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat (an
aldosterone synthase inhibitor), administered on a background of a standardized
anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or
treatment-resistant hypertension. expand
a Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat (an aldosterone synthase inhibitor), administered on a background of a standardized anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or treatment-resistant hypertension. Type: Interventional Start Date: Mar 2023 |
Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
University of Alabama at Birmingham
Pelvic Organ Prolapse
The purpose of the study is to evaluate the surgical outcomes of injecting platelet-rich
plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse
surgery expand
The purpose of the study is to evaluate the surgical outcomes of injecting platelet-rich plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse surgery Type: Interventional Start Date: Jul 2023 |
The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity...
Boston Children's Hospital
Communication
In 2014, a team of parents, nurses, and physicians created Patient and Family Centered
I-PASS (PFC I-PASS), a bundle of communication interventions to improve the quality of
information exchange between physicians, nurses, and families, and to better integrate
families into all aspects of daily decision... expand
In 2014, a team of parents, nurses, and physicians created Patient and Family Centered I-PASS (PFC I-PASS), a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. PFC I-PASS changed how doctors and nurses talk to patients and families on rounds when they're admitted to the hospital. (Rounds are when a team of doctors visit patients every morning to do a checkup and make a plan for the day.) Rounds used to happen in a way that left out patients and families. Doctors talked at, not with patients, used big words and medical talk, and left nurses out. PFC I-PASS changed rounds by including families and nurses, using simple non-medical words, and talking in an organized way so nothing is left out. When PFC I-PASS was put in place in 7 hospitals, patients had fewer adverse events and better hospital experience. But it didn't focus on how to talk with patients with language barriers. This project builds upon upon PFC I-PASS to make it better and focus on the special needs of patients who speak languages other than English. This new intervention is known as PFC I-PASS+. PFC I-PASS+ includes all parts of PFC I-PASS plus having interpreters on and after rounds and training doctors about communication and cultural humility. The study team will now conduct a stepped-wedge cluster randomized trial to compare the effectiveness of PFC I-PASS+ and PFC I-PASS to usual care at 8 hospitals. Type: Interventional Start Date: Mar 2024 |
Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
University of Alabama at Birmingham
Blood Pressure
Low Back Pain
Hypertension
The purpose of this study in patients undergoing routine care epidural spinal cord
stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in
patients which chronic low back pain and hypertension, 2) whether higher baseline BP
(i.e., hypertension) predicts reductions... expand
The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography). Type: Interventional Start Date: Aug 2022 |
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant...
Arkansas Children's Hospital Research Institute
Hematopoietic Cell Transplant
Solid Organ Transplant
Respiratory Viral Infection
The participants are being asked to take part in this clinical trial, a type of research
study, because the participants are scheduled to receive or have recently received a
hematopoietic cell transplant (HCT) or a solid organ transplant (SOT).
Primary Objective
To determine if pre-transplant... expand
The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: - To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. - To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors . Type: Observational Start Date: Dec 2022 |
Reduced-dose Botox for Urgency Incontinence Among Elder Females
Dartmouth-Hitchcock Medical Center
Overactive Bladder
Urinary Incontinence in Old Age
Urgency Urinary Incontinence
The purpose of this study is to study the treatment of urgency urinary incontinence
(UUI), specifically among women 70 years and older, by comparing reduced versus standard
dose of onabotulinumtoxinA (BTX; trade name BOTOX(c)) injection in the bladder. expand
The purpose of this study is to study the treatment of urgency urinary incontinence (UUI), specifically among women 70 years and older, by comparing reduced versus standard dose of onabotulinumtoxinA (BTX; trade name BOTOX(c)) injection in the bladder. Type: Interventional Start Date: May 2023 |
Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer
Academic and Community Cancer Research United
Stage IB Hepatocellular Carcinoma AJCC v8
Stage II Hepatocellular Carcinoma AJCC v8
Stage III Hepatocellular Carcinoma AJCC v8
Stage IIIA Hepatocellular Carcinoma AJCC v8
This phase II trial tests whether regorafenib and durvalumab work to shrink tumors in
patients with high-risk liver cancer. Regorafenib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal
antibodies, such as durvalumab, may help... expand
This phase II trial tests whether regorafenib and durvalumab work to shrink tumors in patients with high-risk liver cancer. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and durvalumab may work better in treating patients with high-risk liver cancer. Type: Interventional Start Date: Jul 2023 |
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
Ono Pharmaceutical Co. Ltd
Refractory Primary Central Nervous System Lymphoma
Primary CNS Lymphoma
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib
monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in
combination with one of two different high dose methotrexate based regimens
(methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/
vincristine)... expand
This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B) Type: Interventional Start Date: Dec 2021 |
Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
University of Alabama at Birmingham
Brain Injuries, Traumatic
MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for
the monitoring of traumatic intracranial hematomas. expand
MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas. Type: Observational Start Date: Apr 2022 |
Evolutionary Therapy for Rhabdomyosarcoma
H. Lee Moffitt Cancer Center and Research Institute
Rhabdomyosarcoma
This clinical trial will evaluate 4 different strategies of chemotherapy schedules in
newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma.
The participant and their physician will choose from: Arm A) a first strike therapy, Arm
B) a first strike-second strike (maintenance)... expand
This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy. Type: Interventional Start Date: Sep 2020 |
A Peer-Led Intervention to Improve Postpartum Retention in HIV Care
University of Pennsylvania
HIV/AIDS
The purpose of this study is to test the efficacy of a theory-driven peer intervention
for pregnant and postpartum women living HIV. The peer intervention is designed to
increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy
in order to improve retention in care... expand
The purpose of this study is to test the efficacy of a theory-driven peer intervention for pregnant and postpartum women living HIV. The peer intervention is designed to increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy in order to improve retention in care and viral suppression postpartum. The intervention will consist of face-to-face prenatal educational sessions, starting in early third trimester, and postpartum sessions scheduled up to three months postpartum. Type: Interventional Start Date: Mar 2020 |
An Exercise Intervention to Improve Overall Brain Health
University of Alabama at Birmingham
Brain Care Score
Exercise
Hypertension
BMI
The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall
brain health, reduction in blood pressure, and the number of blood vessels in the back of
the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main
question[s] it aims to answer are:... expand
The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall brain health, reduction in blood pressure, and the number of blood vessels in the back of the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main question[s] it aims to answer are: - To test the effect of moderate vs intensive exercise on Brain Care Score outcomes. - To ascertain the differential impact of moderate vs high intensity exercise in reducing hypertension and its downstream effects. Type: Interventional Start Date: Jan 2024 |
Study on Use of Omega-3 Fatty Acids to Improve Outcomes in Individuals With Sickle Cell Disease
University of Alabama at Birmingham
Sickle Cell Disease
Sickle cell disease (SCD) is associated with significant morbidity and mortality. Pain
and many adverse outcomes occurring in sickle cell disease are inflammatory driven.
Recent data has shown that gut dysbiosis is present in individuals with sickle cell
disease. Gut dysbiosis has been linked to inflammation... expand
Sickle cell disease (SCD) is associated with significant morbidity and mortality. Pain and many adverse outcomes occurring in sickle cell disease are inflammatory driven. Recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. Gut dysbiosis has been linked to inflammation in certain diseases. Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with sickle cell disease, but its acceptance is variable. The aim of this study is to determine if a plant-based omega-3-fatty acids will be more acceptable and also improve outcomes in individuals with sickle cell disease Type: Interventional Start Date: Aug 2023 |
Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT
University of Alabama at Birmingham
Orthopedic Disorder
Anterior Cruciate Ligament Injuries
The choice of autograft for ACL reconstruction continues to be debated. To date, there
has only be one completed randomized controlled trial with quad tendon to BTB and the
tendon included a bone plug. There has been no study to date comparing an all soft tissue
quad tendon to patellar tendon in a... expand
The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction. Type: Interventional Start Date: Sep 2023 |
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer...
National Cancer Institute (NCI)
Bladder Adenocarcinoma
Bladder Clear Cell Adenocarcinoma
Bladder Mixed Adenocarcinoma
Bladder Neuroendocrine Carcinoma
Bladder Small Cell Neuroendocrine Carcinoma
This phase II trial studies how well cabozantinib works in combination with nivolumab and
ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from
where it first started (primary site) to other places in the body. Cabozantinib may stop
the growth of tumor cells by blocking... expand
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone. Type: Interventional Start Date: May 2019 |
Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative...
ECOG-ACRIN Cancer Research Group
CD20 Positive
Mantle Cell Lymphoma
This randomized phase III trial studies rituximab after stem cell transplant and to see
how well it works compared with rituximab alone in treating patients with in minimal
residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal
antibodies, such as rituximab, may interfere... expand
This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma. Type: Interventional Start Date: Mar 2018 |
Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study
University of Alabama at Birmingham
Acute Myeloid Leukemia
The purpose of the study is to observe the outcomes of patients with acute myeloid
leukemia who do not receive an immediate second round of chemotherapy after undergoing a
standard mid-induction bone marrow biopsy. expand
The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy. Type: Observational Start Date: May 2024 |
Cord Clamping Among Neonates With Congenital Heart Disease
Carl Backes, MD
Congenital Heart Disease (CHD)
The goal of this clinical trial is to compare 2 different timepoints for clamping the
umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital
heart disease (CHD). The main questions it aims to answer are:
- Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed... expand
The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are: - Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) after birth lead to better health outcomes? - Does DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)? Participants will be asked to do the following: - Participate in either DCC-120 or DCC-30 at birth (randomized assignment). - Complete General Movements Assessment (GMA) at 3-4 months of infant age (postnatal), complete questionnaires / surveys at this time. - Complete questionnaires / surveys at 9-12 months of infant age (postnatal). - Complete Hammersmith Infant Neurological Examination (HINE), Developmental Assessment of Young Children 2 Edition (DAYC-2), and questionnaires / surveys at 22-26 months of infant age (postnatal). - Permit data collection from electronic medical records for both the mother and infant study participants. Investigators will compare DCC-120 vs. DCC-30 to see which approach is more beneficial to both the mother and baby with CHD. Type: Interventional Start Date: Dec 2023 |
Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast...
ECOG-ACRIN Cancer Research Group
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Positive Breast Carcinoma
Invasive Breast Carcinoma
This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG)
positron emission tomography/computed tomography (PET/CT) works in predicting response to
standard of care chemotherapy prior to surgery in patients with HER2-positive stage
IIa-IIIc breast cancer. FDG is a radioactive... expand
This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy. Type: Interventional Start Date: May 2023 |
Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized...
Columbia University
Injection Site Infection
Substance Use Disorders
The goal of this clinical trial is to test the effectiveness of an integrated infectious
disease/substance use disorder (SUD) clinical team intervention approach in patients
hospitalized with severe injection-related infections (SIRI) who use drugs. The main
question this study aims to answer is whether... expand
The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. The main question this study aims to answer is whether this intervention approach will be associated with lower mortality and fewer hospital readmissions. Participants will participate in the integrated SUD/ID care team intervention (SIRI Team). Researchers will compare this intervention to treatment as usual (TUA) to see if there are any differences in health outcomes. Type: Interventional Start Date: Jan 2024 |
Cardiometabolic Health Intervention Using Movement-to-Music Exercise
University of Alabama at Birmingham
Cardiometabolic Risk Factors in Adult Wheelchair Users
The study aims to test the benefits of a 24-week, cardio-emphasized Movement-to-Music
exercise program for reversing cardiometabolic health risk factors compared to
asynchronous, standard exercise programs among 132 adult wheelchair users. The targeted
cardiometabolic health factors are waist circumference,... expand
The study aims to test the benefits of a 24-week, cardio-emphasized Movement-to-Music exercise program for reversing cardiometabolic health risk factors compared to asynchronous, standard exercise programs among 132 adult wheelchair users. The targeted cardiometabolic health factors are waist circumference, triglycerides, "good" cholesterol, glucose, and blood pressure. Additionally, a 12-week follow-up phase (weeks 25-36) is included to see whether the gains are maintained. Type: Interventional Start Date: Sep 2023 |
Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia
Celgene
Leukemia, Myeloid
This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and
preliminary biological and clinical activity of CC-96191 as a single-agent in the setting
of Relapsed or refractory acute myeloid leukemia (R/R AML).
The dose escalation (Part A) of the study will explore escalating... expand
This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D. Type: Interventional Start Date: Jun 2021 |
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma...
Caribou Biosciences, Inc.
Lymphoma, Non-Hodgkin
Relapsed Non Hodgkin Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma
Non Hodgkin Lymphoma
Lymphoma
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. expand
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 |
A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
Fusion Pharmaceuticals Inc.
Pancreatic Ductal Adenocarcinoma (PDAC)
Squamous Cell Carcinoma of Head and Neck
Colorectal Cancer
Gastric Cancer
Ewing Sarcoma
This is a first-in-human Phase 1 clinical trial designed to investigate the safety,
tolerability, pharmacokinetics, and biodistribution of [225Ac]-FPI-2059 and
[111In]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid
tumours. expand
This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of [225Ac]-FPI-2059 and [111In]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours. Type: Interventional Start Date: Feb 2023 |
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