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Sponsor Condition of Interest |
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Harmony TPV Post-Approval Study
Medtronic Cardiovascular
Congenital Heart Disease
Tetrology of Fallot
RVOT Anomaly
Pulmonary Regurgitation
The purpose of this study is to characterize the functionality of transcatheter
implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by
real-world implanters. expand
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters. Type: Interventional Start Date: Oct 2021 |
Ridge Augmentation Using Allograft Particles Hydrated With or Without Recombinant Human Platelet-Derived...
University of Alabama at Birmingham
Dental Implant
Bone Loss
This study will compare two techniques to achieve increase in ridge dimensions as a
preparation for dental implants using a resorbable barrier membrane and bone particulate
allogenic graft hydrated with saline or a growth factor called Recombinant Human
Platelet-Derived Growth Factor (rhPDGF). expand
This study will compare two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF). Type: Interventional Start Date: Aug 2021 |
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
Eisai Inc.
Epilepsies, Myoclonic
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy
compared to placebo on percent change in frequency of convulsive seizures per 28 days in
participants with Dravet syndrome. expand
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome. Type: Interventional Start Date: Sep 2020 |
Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder...
ECOG-ACRIN Cancer Research Group
Stage II Gallbladder Cancer AJCC v8
Stage IIA Gallbladder Cancer AJCC v8
Stage IIB Gallbladder Cancer AJCC v8
Stage III Gallbladder Cancer AJCC v8
Stage IIIA Gallbladder Cancer AJCC v8
This phase II/III trial compares the effect of adding chemotherapy before and after
surgery versus after surgery alone (usual treatment) in treating patients with stage
II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in
different ways to stop the growth of tumor... expand
This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. 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 chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient's life span compared to the usual approach. Type: Interventional Start Date: Feb 2021 |
Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants &...
Sonya Heltshe
Cystic Fibrosis
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). expand
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 |
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients...
Alliance for Clinical Trials in Oncology
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2 Negative Breast Carcinoma
Hormone Receptor Positive Breast Carcinoma
This phase III trial compares an additional support program (text message reminders
and/or telephone-based counseling) with usual care in making sure breast cancer patients
take their endocrine therapy medication as prescribed (medication adherence). Medication
adherence is how well patients take... expand
This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed. Type: Interventional Start Date: Feb 2021 |
Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess...
AbbVie
Endometriosis
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of
childbearing age. Endometriosis affects daily activities, social relationships, sexuality
and sexual activity, and mental health. This study will evaluate how well elagolix in
combination with combined oral contraceptives... expand
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Aug 2020 |
Exosome Cargo From Preeclampsia Patients
University of Alabama at Birmingham
Preeclampsia
Although extensively studied, the cause of preeclampsia remains uncertain other than it
is thought that the placenta plays a critical role in the development of preeclampsia.
Recent data revealed that exosomes released from the placenta could cause preeclampsia by
transporting specific cargo responsible... expand
Although extensively studied, the cause of preeclampsia remains uncertain other than it is thought that the placenta plays a critical role in the development of preeclampsia. Recent data revealed that exosomes released from the placenta could cause preeclampsia by transporting specific cargo responsible for the pathophysiological changes associated with the systemic disease. By isolating these exosomes from maternal blood and placental tissue in patients diagnosed with preeclampsia and studying their biochemical, cellular and molecular mechanism in an animal model, the investigators hope to elucidate the critical role that exosomal cargo plays in the development of preeclampsia and cardiovascular remodeling. This will be accomplished by obtaining patient samples from volunteers delivering at the Women and Infants Center and taking the samples to the lab for quantification, characterization, and identification of key functional roles through in/ex vivo, in vitro, and profiling studies. The investigators believe this work will be valuable as hope exists to define the functional role exosomes play in the development of preeclampsia that leads to cardiovascular remodeling. Data from this study will shed more light on the functional role of exosomal cargo in normal and pathological pregnancies and point towards novel therapeutic intervention strategies for preeclampsia associated with cardiovascular disease. Type: Observational Start Date: Dec 2019 |
CERENOVUS Neurothrombectomy Devices Registry
Cerenovus, Part of DePuy Synthes Products, Inc.
Cerebral Stroke
A post-market registry evaluating the EmboTrap® Revascularization Device, CERENOVUS Large
Bore Catheter/ EMBOVAC™ Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter in
acute ischemic stroke patients with confirmed intracranial vessel occlusion. expand
A post-market registry evaluating the EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC™ Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter in acute ischemic stroke patients with confirmed intracranial vessel occlusion. Type: Observational Start Date: Sep 2018 |
Liver X Receptor (LXR) as a Novel Therapeutic Target in Diabetic Retinopathy (DR)
University of Alabama at Birmingham
Diabetic Retinopathy
Results from large clinical trials demonstrate a strong association between lipid
abnormalities and progression of the most common microvascular complication, diabetic
retinopathy (DR). We found that activation of a master regulator of cholesterol
metabolism, the nuclear hormone receptors liver X... expand
Results from large clinical trials demonstrate a strong association between lipid abnormalities and progression of the most common microvascular complication, diabetic retinopathy (DR). We found that activation of a master regulator of cholesterol metabolism, the nuclear hormone receptors liver X receptors (LXRα/LXRβ), prevents DR in rodent models. In this application, we seek to understand the mechanisms responsible for the beneficial effects of LXR agonists on retina and on bone marrow (BM) to preserve the function of reparative cells while reducing inflammatory cell. Type: Observational Start Date: Jan 2018 |
Dose-Escalation Study of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R...
Genentech, Inc.
Multiple Myeloma
This is a phase I, multicenter, open-label, dose-escalation study of cevostamab
administered as a single agent by IV infusion to participants with relapsed or refractory
multiple myeloma (R/R MM). expand
This is a phase I, multicenter, open-label, dose-escalation study of cevostamab administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM). Type: Interventional Start Date: Sep 2017 |
Blue Light Cystoscopy With Cysview® Registry
Photocure
Bladder Cancer
Registry study to gather more information on the current use of Blue Light Cystoscopy
with Cysview (BLCC) in urologists' practices. expand
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 |
Advancing Transplantation Outcomes in Children
National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant
This is a pediatric kidney transplant study comparing the safety and efficacy of an
immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate
Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups
within 24 hours following the transplant procedure.... expand
This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months. Type: Interventional Start Date: May 2024 |
Lupus Landmark Study: A Prospective Registry and Biorepository
Lupus Research Alliance
Systemic Lupus Erythematosus (SLE)
Lupus Nephritis
Neuropsychiatric Systemic Lupus Erythematosus
The purpose of the registry and biorepository is to provide a mechanism to store clinical
data, linked biospecimens and molecular data to support the conduct of future research on
Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN). expand
The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN). Type: Observational [Patient Registry] Start Date: Jun 2023 |
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 |
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ...
In8bio Inc.
Glioblastoma
This multicenter, Phase 1b/2 study is being conducted to determine if the experimental
cell therapy is safe, tolerable and can delay the return of cancer in patients with a
newly diagnosed or recurrent glioblastoma multiforme (GBM) in combination with standard
chemotherapy treatment temozolomide (TMZ).... expand
This multicenter, Phase 1b/2 study is being conducted to determine if the experimental cell therapy is safe, tolerable and can delay the return of cancer in patients with a newly diagnosed or recurrent glioblastoma multiforme (GBM) in combination with standard chemotherapy treatment temozolomide (TMZ). If there is a 25% or greater improvement in survival in this study then the therapy should be studied further. Type: Interventional Start Date: Sep 2023 |
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced...
Karyopharm Therapeutics Inc
Endometrial Cancer
The purpose of this study is to evaluate the efficacy and safety of selinexor as a
maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have
achieved a partial response (PR) or complete response (CR) (per Response Evaluation
Criteria in Solid Tumors version 1.1 [RECIST v 1.1])... expand
The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo. Type: Interventional Start Date: Apr 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 |
Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With AKT Mutations, A ComboMATCH...
National Cancer Institute (NCI)
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm
This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy
(paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be
removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally
advanced) or from where it first started... expand
This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy (paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced) or from where it first started (primary site) to other places in the body (metastatic), and has an AKT genetic change. Chemotherapy drugs, such as paclitaxel, 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. Targeted therapy, such as Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of ipatasertib to paclitaxel in solid tumors with an AKT genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus ipatasertib will shrink this type of cancer or stop its growth. Type: Interventional Start Date: Sep 2023 |
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant...
St. Jude Children's Research Hospital
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 |
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