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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 tumor... 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 participants... 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 |
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
Woolsey Pharmaceuticals
Amyotrophic Lateral Sclerosis
A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in
Patients with Amyotrophic Lateral Sclerosis (ALS) expand
A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS) Type: Interventional Start Date: Dec 2021 |
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 technologies... 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... 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 lifetime... 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 and... 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 tests... 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 |
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
SI-BONE, Inc.
Sacroiliac Joint Dysfunction
Sacroiliac; Fusion
Sacroiliac Disorder
Sacroiliac Joint Pain
STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant
system. expand
STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. Type: Interventional Start Date: May 2023 |
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,... 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 treated... 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... 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 |
The Effects of Sex Hormones and Alcohol on Sleep
Lauren Whitehurst
Alcohol Use Disorder
Rates of heavy drinking and Alcohol Use Disorder (AUD) are increasing in women, but
research on alcohol-related harms in women - including alcohol's impact on sleep - has
been minimal. Numerous studies in men show that alcohol impairs sleep, and preliminary
evidence suggests that women may be even... expand
Rates of heavy drinking and Alcohol Use Disorder (AUD) are increasing in women, but research on alcohol-related harms in women - including alcohol's impact on sleep - has been minimal. Numerous studies in men show that alcohol impairs sleep, and preliminary evidence suggests that women may be even more sensitive to alcohol-disrupted sleep due to their sex hormones, which fluctuate across both their menstrual cycles and their reproductive lifespans. This study will investigate the influence of sex, menstrual cycle phase, and sex hormones on alcohol-disrupted sleep in adults ages 21-45. Healthy women and men will complete two sets of placebo-controlled lab sessions, during the mid-follicular and late luteal phases of female participants' menstrual cycles. During these sessions, participants will receive a dose of alcohol or a placebo (saline) and they will then be monitored (with polysomnography) while they sleep. At-home sleep and alcohol use will also be measured through actigraphy, daily sleep and wake diaries, and alcohol wrist sensors. Investigators hypothesize that women will show greater disruption of sleep following alcohol use or administration than men, and that alcohol-disrupted sleep will be more pronounced in the late luteal phase compared to the mid-follicular phase. Investigators also expect that estradiol will be negatively associated with alcohol-disrupted sleep, whereas progesterone will be positively associated with alcohol-disrupted sleep. Type: Interventional Start Date: Jan 2024 |
NM Balance Regulation With ULLS and Loss of Sleep
Lance Bollinger
Muscle Weakness
Quadriceps Muscle Atrophy
Sleep Disturbance
The goal of this trial is to learn about how restricted sleep and not bearing weight on
the leg affects muscle strength and posture control. Participants will walk exclusively
on one leg, sleep at differing intervals, and complete posture tests, muscle strength
tests, and muscle imaging. Researchers... expand
The goal of this trial is to learn about how restricted sleep and not bearing weight on the leg affects muscle strength and posture control. Participants will walk exclusively on one leg, sleep at differing intervals, and complete posture tests, muscle strength tests, and muscle imaging. Researchers will compare adequate sleep and restricted sleep to see if muscle strength and posture are affected. Type: Interventional Start Date: Aug 2023 |
Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in...
Ohio State University Comprehensive Cancer Center
Cervical Carcinoma
Human Papillomavirus Infection
This trial studies how well a multilevel human papillomavirus (HPV) self-testing
intervention works in increasing cervical cancer screening among women in Appalachia.
Most cases of cervical cancer occur among unscreened and underscreened women. A
multilevel HPV self-testing intervention may help to... expand
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates. Type: Interventional Start Date: Aug 2021 |
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 |
Mechanisms for Activation of Beige Adipose Tissue in Humans
Philip Kern
PreDiabetes
Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist
marketed for overactive bladder. This trial will assess the effects of mirabegron on
glucose tolerance and adipose tissue in prediabetic patients expand
Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients Type: Interventional Start Date: Dec 2020 |
Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
Rachel Miller
Cancer
This is a substudy (Part 2) of a larger two-part clinical trial including both
observational and therapeutic (interventional) cohorts to assess the progression free
survival ratio of patients treated with a targeted therapy based on genomic analysis
results and recommendation by the Markey Cancer... expand
This is a substudy (Part 2) of a larger two-part clinical trial including both observational and therapeutic (interventional) cohorts to assess the progression free survival ratio of patients treated with a targeted therapy based on genomic analysis results and recommendation by the Markey Cancer Center Molecular Tumor Board (MCC MTB). Type: Interventional Start Date: Apr 2017 |
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 |
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 (conservative... 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 |
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