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EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
James P. Rathmell, MD
Painful Diabetic Neuropathy
The purpose of this study is to investigate the safety and efficacy of the current hard
gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when
administered for 13 weeks. expand
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks. Type: Interventional Start Date: Sep 2022 |
Exercise Plus Duloxetine for Knee Osteoarthritis
University of Maryland, Baltimore
Knee Osteoarthritis
Depression
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of
symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will
receive the receive the treatment protocol, which will first be evaluated in terms of
feasibility and then pilot tested. expand
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will receive the receive the treatment protocol, which will first be evaluated in terms of feasibility and then pilot tested. Type: Interventional Start Date: Oct 2021 |
Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors
University of Maryland, Baltimore
Survivorship
Cancer
Symptoms and Signs
At the end of cancer treatment, many patients are still dealing with symptoms of cancer
and side effects of treatment. Many are also left in a surreal mental state with
uncertainty regarding the future of their health. Survivorship Care Plans are plans that
are provided to individuals at the completion... expand
At the end of cancer treatment, many patients are still dealing with symptoms of cancer and side effects of treatment. Many are also left in a surreal mental state with uncertainty regarding the future of their health. Survivorship Care Plans are plans that are provided to individuals at the completion of cancer treatment (i.e., chemotherapy, surgery, radiation). Survivorship Care Plans describe the details of a person's diagnosis and treatment, as well as provide recommendations for follow-up appointments, referrals, and healthy behaviors to accelerate recovery and prevent recurrence (e.g., diet, exercise, smoking cessation). Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes. Therefore, there is a need to digitize Survivorship Care Plans to improve the accessibility, modifiability, and longevity of the plan. In addition, with current technology, there is an opportunity for Survivorship Care Plans to be linked with mobile devices and activity trackers so that people can track health behaviors and compare them to their clinical goals, enabling people to take charge of their own health. Charles River Analytics developed an app called POSTHOC (POST-treatment Healthcare Outcomes for Cancer survivors) that digitizes the Survivorship Care Plan with goals to integrate it into the digital medical record. Herein, phase I/II feasibility/preliminary efficacy randomized controlled trial is being conducted among 54 patients with cancer who recently completed adjuvant treatment for cancer (e.g., chemotherapy, radiotherapy, surgery) to compare 12 weeks of the POSTHOC app as part of the Survivorship Care Plan vs. the usual care Survivorship Care Plan on total symptom burden. Participants will be randomized 2:1, POSTHOC:usual care. Those randomized to the POSTHOC group will be provided with their Survivorship Care Plan via the app, and will choose to focus on nutrition or exercise for the duration of the study, based on their individual plan and personal preferences. At baseline, 6 weeks, and 12 weeks, patient-reported outcomes will be evaluated including total symptom burden, diet, and physical activity. Extensive quantitative and qualitative feedback will also be collected on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies. Type: Interventional Start Date: Mar 2024 |
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
University of Maryland, Baltimore
Trigeminal Neuralgia
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused
ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a
type of pain involving the face that can be disabling to those it affects. expand
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects. Type: Interventional Start Date: Feb 2021 |
Robot Aided Rehabilitation - Multi-joint Evaluations
University of Maryland, Baltimore
Stroke
Sensory and motor impairments following stroke can lead to substantial disability
involving the arm and hand. The investigator hypothesized that excessive local and
cross-coupled stiffness, diminished individuation and proprioceptive acuity will be
present among multiple degree of freedom in the upper... expand
Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot. Type: Observational Start Date: May 2018 |
Hyperbaric Oxygen Brain Injury Treatment Trial
Hennepin Healthcare Research Institute
Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial. expand
The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Type: Interventional Start Date: Jun 2018 |
Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Standard of Care Treatment...
InSightec
Brain Tumor
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain
barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain
metastases in patients who are undergoing planned pembrolizumab monotherapy. expand
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy. Type: Interventional Start Date: Aug 2022 |
A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed...
Hoffmann-La Roche
Multiple Myeloma
This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in
participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV)
infusion. expand
This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion. Type: Interventional Start Date: Oct 2022 |
The CREST-2 Registry
University of Maryland, Baltimore
Carotid Artery Diseases
The objective of C2R is to promote the rapid initiation and completion of enrollment in
the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with
severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with
carotid artery stenting (CAS) performed... expand
The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists. Interventionists' eligibility will be determined by a multi-specialty Interventional Management Committee (IMC). Patient eligibility will include patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-procedural complications. The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure. The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial. Type: Observational [Patient Registry] Start Date: Feb 2015 |
Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue
University of Maryland, Baltimore
Neoplasms
Blood Cancer
Fatigue
Diet Habit
Survivorship
Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the
type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved
by sleep or rest, and it sometimes can persist for years after a person's cancer was
treated. The fatigue can be so bad... expand
Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated. The fatigue can be so bad that people cannot return to work, hobbies, family roles, or other daily activities, thereby greatly reducing quality of life. The causes of this fatigue are unknown, and we currently do not have anything that can reliably prevent or cure the fatigue. However, there are recent data suggesting that circadian rhythm, or a person's internal body clock, may be disrupted by the cancer experience and contribute to fatigue. Food intake is an external cue that can entrain circadian rhythm. We recently showed that cancer survivors are willing and able to eat all their food within a 10-hour eating window-a practice called time-restricted eating. Herein, we are testing time-restricted eating against a control group (matched for time-, attention, and expectancy) to see if time-restricted eating can indeed alleviate cancer-related fatigue. All participants will be asked to use the myCircadianClock smartphone app to log their food intake and weekly body weight measurements. The participants assigned to the time-restricted eating group will be asked to eat all their food in a 10-hour window during the day. People can choose their start time based on their schedule and preferences, but we ask that the window is the same for the whole study (e.g., 7am-5pm,9:30am-7:30pm). Black coffee and unsweetened tea are allowed before the eating window, and water and medicines are allowed at all times. The participants in the control group will meet with a nutritionist to discuss the American Cancer Society nutrition guidelines in cancer survivorship; they will not be restricted to when they can eat. Participants in both groups will give us valuable information regarding how diet is related to the experience of fatigue. The purpose of this study is to test the effects of a 12-week TRE intervention vs. an unrestricted eating pattern on fatigue, the sustainability of the program at 24 weeks, and the effects of TRE on circadian rhythm and sugar metabolism. Type: Interventional Start Date: Oct 2024 |
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus...
Novartis Pharmaceuticals
Systemic Lupus Erythematosus
The trial will evaluate efficacy, safety and tolerability of ianalumab compared to
placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC)
treatment in participants with active systemic lupus erythematosus (SLE). expand
The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE). Type: Interventional Start Date: Apr 2023 |
The Effects of Fluoxetine and/or DHEA
University of Maryland, Baltimore
Type 1 Diabetes Mellitus
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine
(Prozac), an antidepressant often used to treat depression, stimulates the participant's
body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a
hormone, dehydroepiandrosterone (DHEA), stimulates... expand
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study. Type: Interventional Start Date: Dec 2017 |
Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications...
European Foundation for Study of Chronic Liver Failure
Liver Diseases
Liver Cirrhosis
Acute-On-Chronic Liver Failure
Liver Transplant; Complications
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider
liver transplantation as an option, even if controversial. In sicker recipients, LT
results in immediate survival, but poor medium-term survival rates in some studies. The
scarcity of deceased donors obliges to... expand
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor. Type: Observational Start Date: Jul 2021 |
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
Memo Therapeutics AG
BK Viremia; BKV DNAemia
The purpose of this study is to evaluate the safety, tolerability, and efficacy of
AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney
transplant recipients. This study has an operationally seamless phase II/III design. The
phase II part will evaluate the safety of... expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes. After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and if clinically indicated. Type: Interventional Start Date: Apr 2023 |
ICG Fluorescence Imaging in Post-traumatic Infection
Dartmouth-Hitchcock Medical Center
Trauma Injury
The focus of this prospective observational study is to (1) establish the range and
variation associated with bone/soft tissue perfusion in fracture patients, using ICG
fluorescence imaging; (2) examine the relationship between perfusion and complications
such as surgical site infection (SSI), persistent... expand
The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications. Type: Observational [Patient Registry] Start Date: Sep 2020 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
Stroke
CPAP
The purpose of this study is to determine whether treatment of obstructive sleep apnea
(OSA) with positive airway pressure starting shortly after acute ischemic stroke (1)
reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke outcomes... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
University of Miami
Hypoplastic Left Heart Syndrome
The objectives of this pilot study are to evaluate the feasibility and safety of
intramyocardial injection of autologous c-kit+ cells during the Stage II BDCPA operation
and to observe effects on clinical outcome including right ventricular myocardial
function, severity of tricuspid regurgitation,... expand
The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II BDCPA operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of tricuspid regurgitation, incidence of serious adverse events, re-hospitalizations, changes in health status, the need for transplantation, or mortality. Type: Interventional Start Date: Oct 2019 |
Gastroschisis Outcomes of Delivery (GOOD) Study
Medical College of Wisconsin
Gastroschisis
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35
6/7 weeks in stable patients with gastroschisis is superior to observation and expectant
management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we
will complete a randomized, prospective,... expand
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Type: Interventional Start Date: Feb 2018 |
Robot Aided Rehabilitation - Intervention
University of Maryland, Baltimore
Stroke
Sensorimotor impairments following stroke often involve complex pathological changes
across multiple joints and multiple degrees of freedom of the arm and hand, thereby
rendering them difficult to diagnose and treat. The objective of this study is to
evaluate multi-joint neuromechanical impairments... expand
Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training. Type: Interventional Start Date: Oct 2018 |
Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence
University of Maryland, College Park
Substance-Related Disorders
Opioid Medication Assisted Treatment
Opioid Use Disorder
Opioid Use
Opioid Addiction
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led,
brief, behavioral intervention to improve adherence to medication for opioid use disorder
(MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in
Baltimore, Maryland. The intervention... expand
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months. Type: Interventional Start Date: Apr 2022 |
Systemic Hypothermia in Acute Cervical Spinal Cord Injury
University of Miami
Spinal Cord Injury, Acute
This study is a prospective multi-center trial designed to determine the safety profile
and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to
C8) Spinal Cord Injury (SCI). expand
This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI). Type: Interventional Start Date: Aug 2017 |
DMID 21-0041; Influenza CVD 59000
University of Maryland, Baltimore
Influenza
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to
implement interventions which are known to reduce inhalation (airborne) transmission, so
that the contribution of transmission by route of aerosols for influenza may be
identified. expand
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified. Type: Interventional Start Date: Feb 2023 |
Subscap Reverse Shoulder Arthroplasty
University of Maryland, Baltimore
Shoulder Injuries
Rotator Cuff Injuries
The subscapularis is part of the rotator cuff and is release as part of a reverse
shoulder replacement. The decision to repair this tendon is controversial. This research
is being done to help determine if rotator cuff repair improves or hinders shoulder
replacement. A worrisome but rare complication... expand
The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary. Type: Interventional Start Date: Nov 2022 |