Search Clinical Trials
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Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
University of Calgary
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Hemolytic-Uremic Syndrome
The objective of this study is to determine if early high volume intravenous fluid
administration (hyperhydration) may be effective in mitigating or preventing
complications of shiga toxin-producing E. coli (STEC) infection in children and
adolescents when compared with traditional approaches (cons1 expand
The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management). Type: Interventional Start Date: Sep 2022 |
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
Johns Hopkins University
Intracerebral Hemorrhage
This first-in-patient phase 2a pilot study will assess the safety and tolerability of
MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). expand
This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). Type: Interventional Start Date: Oct 2022 |
MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against
a control group of similar patients1 expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
FIT Exercise in 30d of ULLS-induced Muscle Disuse
Lance Bollinger
Muscle Atrophy
Muscle Weakness
This study aims to determine how flywheel-based inertial training (FIT) implemented
according to principles of velocity-based training (VBT) and High-Intensity Interval
Training (HIIT) affects disuse-induced physical de-conditioning including loss of
voluntary muscle strength, aerobic capacity, and1 expand
This study aims to determine how flywheel-based inertial training (FIT) implemented according to principles of velocity-based training (VBT) and High-Intensity Interval Training (HIIT) affects disuse-induced physical de-conditioning including loss of voluntary muscle strength, aerobic capacity, and balance regulation. Type: Interventional Start Date: Oct 2024 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Pat1
Gilead Sciences
Triple Negative Breast Cancer
The goal of this study is to find out if the experimental product, sacituzumab
govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective
and safe compared to the treatment of physician's choice (TPC) which includes either
pembrolizumab or pembrolizumab plus capecitabin1 expand
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment. Type: Interventional Start Date: Dec 2022 |
Citadel Embolization Device Study
Stryker Neurovascular
Unruptured Wide-neck Aneurysms
The purpose of this study is to gather safety and effectiveness data on Stryker
Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the
Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of
wide-neck intracranial aneurysms. expand
The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms. Type: Interventional Start Date: Jul 2019 |
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults Wit1
Perspective Therapeutics
Melanoma (Skin)
Metastatic Melanoma
Melanoma Stage IV
Mucosal Melanoma
Melanoma Stage III
In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an
alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor
(MC1R) is being evaluated as a monotherapy and in combination with Nivolumab in subjects
with unresectable and metastatic mel1 expand
In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with Nivolumab in subjects with unresectable and metastatic melanoma. Type: Interventional Start Date: Jun 2023 |
Lumbar Fusion With Porous Versus Non-Porous Cages
University of Kentucky
Spinal Fusion
Lumbar Fusion
Arthrodesis
Spondylolisthesis
Pseudarthrosis
The objective of this single site, randomized controlled trial is to assess and compare
radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion
procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the
following interventions:
1. Porou1 expand
The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: 1. Porous titanium cages 2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages. Type: Interventional Start Date: Nov 2022 |
Degenerative Cervical Myelopathy Repository
University of Kentucky
Cervical Myelopathy
To create a research repository of patients with known degenerative cervical myelopathy
(DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This
repository will be used to assess functional and/or biological measures that may allow
for improved prediction of symptomatic1 expand
To create a research repository of patients with known degenerative cervical myelopathy (DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with DCM. In addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of DCM. Type: Observational [Patient Registry] Start Date: Jul 2022 |
Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallo1
GOG Foundation
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Stage III Primary Peritoneal Cancer
Stage IV Primary Peritoneal Cancer
Stage III Fallopian Tube Cancer
Patients will be registered prior to, during or at the completion of neoadjuvant
chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1
every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant
chemotherapy will not be eligible for iCRS and wil1 expand
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease). Type: Interventional Start Date: Mar 2024 |
Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Denise Fabian
Uterine Cervix Cancer
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix
cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood
samples are obtained to detect circulating levels of deoxyribonucleotides, human
papillomavirus DNA, and circulating tumor1 expand
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells. Type: Observational Start Date: Jan 2023 |
Hepatitis C Treatment in Probation and Parole Office
Jens Rosenau
Hepatitis C
HCV
This prospective cohort study compares aims to determine the efficacy and effectiveness
of telemedicine-supported on-site linkage to care and treatment in a community probation
and parole office (P&P office) setting and compare the results with a historic control
with referral to care. Research par1 expand
This prospective cohort study compares aims to determine the efficacy and effectiveness of telemedicine-supported on-site linkage to care and treatment in a community probation and parole office (P&P office) setting and compare the results with a historic control with referral to care. Research participants will be followed in the P&P office when they report to their officer during regularly scheduled appointments. Participants will receive treatment without having to travel to a specialist's office. The telemedicine visit will include a consultation with an experienced HCV provider such as a hepatologist or an advanced practice provider and a specialty pharmacist who will educate about and monitor HCV treatment. The UK specialty pharmacy will be available to participants and the HCV management team through a 24-hour support line. Participants will be treated per HCV guidelines and insurance preference. Type: Interventional Start Date: Aug 2022 |
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Mirati Therapeutics Inc.
Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease
This study will evaluate the safety, tolerability, drug levels, molecular effects, and
clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have
a KRAS G12C mutation. expand
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation. Type: Interventional Start Date: Jan 2019 |
Mandibular Advancement Device and Changes in Nocturia
Fernanda Yanez Regonesi
Obstructive Sleep Apnea
Nocturia
OSA
The main purpose of this study is to test is mandibular advacenment device (MAD) use is
associated with reductions in nocturia. expand
The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia. Type: Interventional Start Date: Dec 2023 |
Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice
Joshua A. Lile, Ph.D.
Opioid Use Disorder
The objective of this protocol is to use probabilistic choice tasks, reinforcement
learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making
in individuals with opioid use disorder and physical opioid dependence. expand
The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence. Type: Interventional Start Date: May 2024 |
Loupe-Based Intraoperative Fluorescence Imaging
Guoqiang Yu
Glioblastoma Multiforme
Anaplastic Astrocytoma
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary
malignant brain tumors. Survival of patients with these brain tumors is directly related
to the extent of resection. Consequently, a great deal of effort has been directed at
developing techniques and technolo1 expand
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections. This study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope. Type: Observational Start Date: Nov 2017 |
GORE® ENFORM Biomaterial Product Study
W.L.Gore & Associates
Hernia, Ventral
Hernia, Hiatal
Hernia, Diaphragmatic
Incisional Hernia
A prospective, retrospective, non-randomized, multicenter study with two independent
hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal
Hernia Repair). The primary objective of this study is to collect GORE® ENFORM
Biomaterial product commercial-use data on device f1 expand
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance. Type: Interventional Start Date: May 2021 |
Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
Julie Pendergast
Mild Cognitive Impairment
This study will investigate the feasibility of implementing a time-restricted eating
intervention in females with mild cognitive impairment. Targeted therapeutic
interventions that improve cognitive impairment and delay onset of ADRD are particularly
important for females, who have twice the lifeti1 expand
This study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. Targeted therapeutic interventions that improve cognitive impairment and delay onset of ADRD are particularly important for females, who have twice the lifetime risk of developing AD, compared to males. Type: Interventional Start Date: Apr 2024 |
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Wake Forest University Health Sciences
Osteomyelitis Tibia
Tibial Fractures
Open Tibia Fracture
This prospective randomized clinical trial will compare outcomes between patients treated
primarily with a prophylactic antibiotic coated nail and those treated with traditional
standard of care intramedullary (IM) nailing. expand
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing. Type: Interventional Start Date: May 2023 |
Neurobehavioral Mechanisms of Cocaine Choice
Joshua A. Lile, Ph.D.
Cocaine Use Disorder
The objective of this protocol is to use a drug-vs-money choice task, reinforcement
learning modeling and fMRI to determine the neurobehavioral and neurobiological
decision-making "profile" associated with the decision to take cocaine and the reduced
cocaine choice that occurs during behavioral and1 expand
The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning modeling and fMRI to determine the neurobehavioral and neurobiological decision-making "profile" associated with the decision to take cocaine and the reduced cocaine choice that occurs during behavioral and pharmacological interventions. Type: Interventional Start Date: Jan 2021 |
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
Ad scientiam
Myasthenia Gravis
ME&MG is a standalone software (digital solution) running on patients smartphones,
connected to a web portal for physicians. It is intended to be used as an unsupervised
digital self-assessment tool for the monitoring of disabilities in patients living with
MG.
ME&MG contains digital active tests1 expand
ME&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. ME&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction. Type: Interventional Start Date: Jan 2024 |
A mHealth System for Patients With POTS
Jami Warren
POTS - Postural Orthostatic Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3
million Americans. This number will only increase due to the large number of patients
experiencing POTS due to "long COVID." POTS patients experience several symptoms,
including tachycardia, palpitations, dizziness,1 expand
Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3 million Americans. This number will only increase due to the large number of patients experiencing POTS due to "long COVID." POTS patients experience several symptoms, including tachycardia, palpitations, dizziness, and pre-syncope or syncope, among others. POTS can be very debilitating and not only affect patients physically but also emotionally and financially. It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses, stigma, and depression and anxiety. Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers. Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology. The two study aims are: 1) Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients; and 2) Evaluate the usability and feasibility of the mHealth app and study design. To achieve these aims, researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance (MAMMA) and stakeholders (patients, caregivers, and providers) to co-design a mHealth app for POTS patients, including key educational components guided by the IDEA model, an instructional risk communication approach. A group of diagnosis-seeking POTS (n=20) patients will pilot test the app and provide feedback for improvement as well as evaluate its usability. Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes, such as patient experience during visits with physicians, perceived stigma, and time to diagnosis. Type: Interventional Start Date: Feb 2024 |
Impaired Risk Awareness During Intoxication in DUI Offenders
Mark Fillmore
Alcohol Use
This study aims to test the efficacy of experiential-based training to increase DUI
offenders' perceptions or risk associated with alcohol use. expand
This study aims to test the efficacy of experiential-based training to increase DUI offenders' perceptions or risk associated with alcohol use. Type: Interventional Start Date: Feb 2022 |
Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet
Mohamed Bazina
Obstructive Sleep Apnea
Malocclusion
This research aims to provide pediatric patients with polysomnography (a sleep study)
before and after orthodontic treatment to determine if the extraction of upper premolars
for treating excessive overjet results in an increase of the AHI (Apnea Hypopnea Index)
compared to similar patients treated1 expand
This research aims to provide pediatric patients with polysomnography (a sleep study) before and after orthodontic treatment to determine if the extraction of upper premolars for treating excessive overjet results in an increase of the AHI (Apnea Hypopnea Index) compared to similar patients treated without upper premolar extractions. Type: Observational Start Date: Sep 2021 |
Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation
Phillip Gribble
Ankle Sprains
The purpose of this project is to compare a novel sensorimotor ankle rehabilitation
training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care
(SOC) protocol to determine if it is more successful at producing successful one-year
outcomes and lower rates of re-injury and i1 expand
The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower rates of re-injury and improved health. This will address the identified needs for evidence-support and reintegration strategies to improve understanding of the management of patient rehabilitation strategies throughout the rehabilitation process following neuromusculoskeletal injury. The project will validate an innovative rehabilitation approach while providing metrics of success using a variety of clinical and innovative markers. Type: Interventional Start Date: Nov 2019 |
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