Investigating efficacy and safety of adjunctive therapy in Parkinson’s Disease patients
Parkinson’s Disease involves the loss of brain cells that produce dopamine, a messenger that sends information to the parts of the brain that control movement and coordination. Lower than normal levels of dopamine in the brain causes the symptoms of Parkinson’s, including muscle stiffness, resting tremor (uncontrollable shaking), and slowing of movements. Parkinson’s patients may have “on” periods where they are able to control their muscle movement, and “off” times when controlling these movements is harder.
Levodopa is a medication used to help treat Parkinson’s by increasing dopamine levels in the brain. We are looking for participants who have these “on” and “off” periods, and who are on Levodopa and at least one other medication. We are looking at whether adding tozadenant, a drug that hasn’t been approved by the U.S. FDA, will help improve Parkinson’s symptoms.
Recruiting | parkinsons adjunctive therapy | Not Multisite
ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH).
The ENRICH trial will compare the outcomes between early surgical intervention using the
BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical
approach includes a combination of available technologies, including the FDA-cleared NICO
BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot
evacuation. The medically managed cohort will be treated according the Clinical
Standardization Guidelines (CSG) as adapted by Emory University from the 2015 AHA/ASA
Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Clinical efficacy
will be determined by demonstrating a 10% improvement in functional outcome, as determined
by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS).
Data suggests improved mortality rates and potential functional benefits of surgical ICH
evacuation. The methodology proposed for this trial was tested in a preliminary series of 39
patients treated for supratentorial spontaneous ICH and retrospectively reviewed (Labib et
al.). These results were replicated in a single center retrospective series of 18 patients
(Bauer et al.). Despite positive results of both studies and the widely accepted benefit of
the BrainPath Approach (i.e., MIPS) for subcortical lesions, stronger evidence supporting
the use of these techniques in ICH is needed for the technique to become universally
validated.
Recruiting | Subcortical Intracerebral Hemorrhage | Site Unknown
A Phase II trial of sEphB4-HSA in combination with Anti PD1 Antibody Pembrolizumab (MK-3475) for metastatic urothelial cancer refractory to platinum
Patients with the most common type of bladder cancer are initially treated with chemotherapy with regimens that include a platinum agent such as cisplatin or carboplatin. Once the cancer develops resistance the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as pembrolizumab or nivolumab. This study proposes to give pembrolizumab to patients who have had further growth of their cancer after chemotherapy with a platinum agent, according to standard of care, and combine it with an experimental agent, sEphB4-HSA, which may have synergistic effect with pembrolizumab. It is hypothesized that the two drugs, in combination, will be more effective than either drug alone. The sEphB4-HSA was studied in various cancers and was found to be safe with its primary side effect being elevated blood pressure which may require blood pressure medication while receiving the drug. If you, or a loved one, has advanced (metastatic, stage IV, or unresectable) bladder cancer (or urothelial carcinoma) and have been treated with platinum-based chemotherapy in the past, this trial may be a treatment option
Recruiting | Metastatic bladder cancer | Multisite
Spectroscopic detection of colon polyps (Spy Colonic Neoplasia)
The purpose of this study is to determine if colon cancer or precancerous colon polyps can be predicted from examining the lining of the rectum with a special harmless light. If so, primary care physicians will be able to determine from this simple test which of their patients actually needs a colonoscopy instead of referring 100% of their patients simply because they turn 50 years old.
Healthy Minds Volunteer Database
The Healthy Minds Volunteers (http://healthyminds.usc.edu) help research labs at the University of Southern California. These labs are working towards a greater understanding of how aging can affect physical, mental and emotional health. The goal is to learn how we can maintain healthy minds and bodies across our lifespan.
A pilot study of safety and adequacy of pancreatic lesion biopsy (Spy Bite)
The purpose of this study is to determine the safety and effectiveness of an experimental technique to obtain biopsies of pancreatic lesions. This technique uses biopsy forceps, which are small jaw-like devices that open and close, to also obtain tissue samples for examination and diagnosis. The biopsy forceps will pass through the endoscope that is already in place for the endoscopic ultrasound guided fine needle aspiration procedure, and an additional biopsy will be taken. This technique is experimental because biopsy forceps are routinely used in gastrointestinal endoscopy, but are not routinely used to obtain biopsies of the pancreas.
A pilot study of safety and efficacy of spectroscopic diagnosis of pancreatic lesions (Spy Panc)
The objective of this study is to determine if a minimally invasive optical probe can accurately predict a histological diagnosis of dysplastic or malignant tumor cells in solid lesions of the pancreas. If effective, this optical probe would facilitate the detection of malignant and pre-malignant pancreatic lesions. This would lead to more accurate decision-making as to which patients require surgical resection versus patients who should be spared from major surgery.
Assessing brain response to sugar
This study is aimed at understanding brain and hunger responses to different types of sugars and how this influences feeding behavior in lean and obese people.
Mother's Milk Study
The purpose of this study is to examine the effects of human milk oligosaccharides (i.e. HMOs, which are a type of sugar) on infant intestinal bacteria and understand how these sugars influence the growth and development of the child. The ultimate goal of this study is to promote the growth of good bacteria in the infant’s intestine and reduce the growth of harmful bacteria.
Blue Light Cystoscopy With Cysview® Registry
Data will be captured on specific patient types undergoing Blue Light Cystoscopy with Cysview
for known or suspected non-muscle invasive bladder cancer. Specific clinical questions will
be asked.
1. What is the incremental detection rate with Blue Light Cystoscopy with Cysview over
conventional white light cystoscopy in each of the seven (7) patient populations? Does
this translate into lower recurrence/progression rate?
2. How do the six (6) tumor variables used in the European Association of Urology (EAU)
risk tables (primary/secondary, recurrence rate, size, multifocality, grade, and history
of carcinoma in situ (CIS))6 affect this incremental rate?
3. How does an abnormal cytology or positive or negative fluorescent in situ hybridization
(FISH) affect the likelihood that Blue Light Cystoscopy with Cysview will detect more
cancers than white light?
4. What are the performance characteristics of Blue Light Cystoscopy with Cysview within
eight (8) weeks of Bacillus Calmette-Guérin (BCG) with respect to improved tumor
detection and false positive rate compared to conventional white light cystoscopy?
5. What is the incremental Blue Light Cystoscopy with Cysview detection rate over random
bladder biopsies alone in patients being evaluated for routine three month restaging
(group 4) or occult disease (group 5)?
6. What are the performance characteristics of Blue Light Cystoscopy with Cysview after
repeated Blue Light Cystoscopy with Cysview evaluations with respect to improved tumor
detection, false positive rate and safety compared to conventional white light?
7. Does an abnormal urinalysis help identify patients with inflammation more likely to have
false positive Blue Light Cystoscopy with Cysview results?
8. What is the practical learning curve for becoming "proficient" with Blue Light
Cystoscopy with Cysview?
9. What is the overall false positive rate with Blue Light Cystoscopy with Cysview?
10. Can Blue Light Cystoscopy with Cysview make the resection more complete? If yes, is this
due to improved margins and/or additional tumors seen under blue light?
The Blue Light Cystoscopy with Cysview Registry is a web-based program supported by Global
Vision Technologies. Data will be captured longitudinally over five (5) years on patients
from each enrolled site. Each center will enter their respective site's patient data
electronically.
Effects of Oxytocin on Smoking
This study is examining the effects of a hormone called oxytocin on smoking. Oxytocin is a naturally occurring hormone in the brain and throughout the body In this study, oxytocin is experimental and is in the form of a nasal spray. We hope to learn if oxytocin nasal spray will help reduce the urge to smoke.
Project FIRE: Understanding the health effects of wildfires
Wildfire seasons are increasing in length and frequency, putting more people at risk to the effects of wildfire smoke. Project FIRE (Fire Impact REsearch) aims to investigate the acute effects of wildfires on human health. To this end, we have developed a smartphone application (app) that will be made freely available to our study participants. We will use this app to collect data on smoke exposure and health symptoms before, during, and after a wildfire. The findings from this study will help us understand how wildfires affect people’s health so that ultimately, we can better prepare for future wildfires and minimize health risks to communities.
Tracking the Risk for Alzheimer’s Disease using the APT Webstudy
The Alzheimer Prevention Trials (APT) Webstudy is designed to accelerate enrollment into Alzheimer’s clinical trials by identifying and tracking individuals online, who may be at higher risk for developing Alzheimer’s. The Alzheimer’s Association estimates that 5.5 million Americans age 65 and older are currently living with Alzheimer’s dementia. It’s believed these numbers will increase by almost 30% to over 7 million people by 2025, where it’s the only top 10 cause of death that cannot be prevented, cured, or even slowed. The APT Webstudy is open to anyone over the age of 50. The goal of the APT Webstudy is to develop an online group of individuals who will allow their memory and thinking test scores to be tracked over time. Participants will have the opportunity to take online tests to assess their memory and thinking skills, gain access to their scores, and be notified of opportunities for in-person assessments and clinical trials aimed at preventing dementia. These in-person visits will be offered through the closest clinical site to participants.
A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative
study. Subjects who sign informed consent will undergo study-specific screening assessments
within 45 days from the day of informed consent.
Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization
will be stratified by upper arm or forearm placement based on the investigator's
determination of where the study access (SA) should be located. Subjects will be followed to
24 months post SA creation at routine study visits regardless of patency status. After 24
months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up
to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV
subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation
at routine study visits.
Protocol for Immunology Specimen Collection From Cancer Patients, Patients With Hematologic Diagnoses, and Healthy Normal Controls
PRIMARY OBJECTIVES; I. Identify changes in immune system parameters in patients receiving
immunotherapies (including immune checkpoint inhibitors, immunostimulatory/immunomodulatory
agents, cellular therapies, stem cell transplantation) and compare to changes in patients
receiving conventional chemotherapy, targeted-agent therapy, and healthy normal volunteers
using multiparameter flow cytometry, time-of-flight mass cytometry, cytokine quantification,
functional analysis of immune cell subsets isolated via fluorescence activated cell sorting
(FACS), and genetic and proteomic techniques (deoxyribonucleic acid [DNA] sequencing,
ribonucleic acid sequence [RNASeq], reverse transcriptase-polymerase chain reaction [RT-PCR],
Western blot).
SECONDARY OBJECTIVES:
I. Optimize methods for measuring functional status of circulating immune cells and
hematopoietic progenitors (activation, inhibition, cytotoxicity, proliferative capacity).
II. Use genetic and epigenetic techniques to a) study clonal diversity in T cell subsets b)
determine the genetic basis for T cell immune reconstitution following stem cell
transplantation.
OUTLINE:
Patients and healthy normal volunteers undergo collection of peripheral blood samples for
analysis via flow cytometry, RNASeq, immunohistochemistry, cytometry by time of flight
(CyTOF) experiments, cell cultures, and functional studies of immune cell subsets obtained by
FACS. Patients also undergo collection of bone marrow and leukopheresis/leukoreduction
specimens, and single cell suspensions and bulk excised tumor biopsies are obtained from
routine testing for analysis via immunohistochemistry or CyTOF.
After completion of study, patients are followed up for up to 2 years.
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