The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending thoracic aortic pathologies including type A aortic dissection, who are suitable for endovascular repair with the Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System (or the Valiant PS-IDE Stent Graft).

Type: Interventional

Start Date: Dec 2018

open study

The purpose of this study is to explore the concept that biomarker sensitivity will detect activity in Multiple Sclerosis (MS) subjects and allow appropriate change in treatment to prevent dysfunction.

Type: Interventional

Start Date: Sep 2020

open study

A high prevalence of diabetes has been reported in Qatar with nearly 23% population suffering from the pandemic, thereby increasing the associated healthcare cost. Low compliance with exercise and physical activity in patients with diabetes increases foot risk complications, deteriorates health, and further increases economic costs. This is particularly true among patients with diabetes who are undergoing hemodialysis (HD) process. Exercise interventions have been shown to improve mobility and balance, reduce the incidence of falls, and improve peripheral blood flow, which is essential to reduce foot problems and peripheral arterial disease. However, uptake of exercise programs for individuals who are undergoing HD treatment has been limited. The three main factors limiting uptake and adherence among HD patients are time availability, post-dialysis fatigue, and transportation to exercise programs, which are usually offered in rehabilitation departments or cardiovascular centers but not in nephrology departments or in free-standing dialysis clinics. Many of these patients visit clinics 3 times a week to receive hemodialysis, providing an optimal opportunity for intervention. Thus the investigators are proposing an innovative intervention based on plantar electrical stimulation treatment during HD (3 times per week) to enhance balance and quality of life while reducing the risk of peripheral arterial diseases and diabetic foot ulcers, which are highly prevalent among people with diabetes and chronic kidney disease. This interdisciplinary study is based on preliminary studies, in which the investigators demonstrated that regular plantar electrical stimulation is an effective and practical therapy to enhance motor performance and plantar sensation in patients with diabetes. The scientific premise of the proposed intervention has been also supported by literature as well as three systematic reviews suggesting the effectiveness of electrical stimulation to reduce pain, improve balance, improve skin perfusion, and improve plantar sensation. In the context of this study, the investigators propose to bring an innovative technology based on an FDA-cleared bio-electric stimulation technology (BEST®) microcurrent platform, named Tennant Biomodulator® (Avazzia Inc., Dallas, TX, USA), which is a transcutaneous electrical nerve stimulator (TENS) and has been designed for symptomatic relief and management of chronic pain. However, the system was modified to provide electrical stimulation to the plantar area via two electrodes placed on the hind and forefoot area instead of the leg. The device has a 60-minute run cycle after which it automatically turns off. In the context of a previous study funded by QNRF, the investigators developed and tested 50 electrical stimulation units (which will be used in the context of the study), including 25 active systems and 25 placebo systems. The placebo systems are similar to active systems in the appearance and functioning of lights and indicators. However, they were programmed not to provide any electrical current. In a preliminary study, the proof of concept of this revised technology was tested in the context of enhancing balance and skin perfusion in ambulatory patients with diabetes and peripheral neuropathy. In the context of this study, the investigators plan to translate this technology for routine treatment during HD sessions for patients with diabetes who are undergoing regular HD treatment. Using a double-blinded randomized-controlled model, the investigators will validate the effectiveness of this technology to enhance balance, reduce pain, and improve skin perfusion. One hundred (n=100) HD volunteers with diabetes will be recruited and randomized to either intervention (n=50) or control (CG: n=50) group for the purpose of this study. Plantar electrical stimulation will be provided during HD sessions, 3 times per week and for 12 weeks. Outcomes will be assessed at baseline, 6 weeks, and 12 weeks to examine the effectiveness of the proposed intervention to enhance balance, improve quality of life, and improve lower extremity skin perfusion among HD patients with diabetes. This proposal is in line with Qatar National Priorities Research goals and if successful the result will open new doors to managing diabetes and kidney failure. In a setting where no therapeutic agents or interventions effectively address poor balance and loss of protective sensation among HD patients with diabetes and where affected individuals life with a heightened risk of developing a debilitating foot ulcer and quite possibly a disabling amputation, the potential impact from the plantar electrical stimulation system may offer the potential for significant clinical benefit, with very low risk, and with ease of implementation in routine care application for patients who are undergoing HD treatment.

Type: Interventional

Start Date: Jun 2018

open study

The Retaining Employment and Talent after Injury/Illness Network (RETAIN) demonstration is a collaborative effort between the U.S. Department of Labor (DOL) and the Social Security Administration (SSA) to improve employment outcomes for individuals who experience injuries or illnesses that put them at risk of exiting the labor force and relying on disability programs and other public supports in the long term. RETAIN projects include a combination of medical provider services, stay-at-work/return-to-work (SAW/RTW) coordination services, and other SAW/RTW services. This evaluation will focus on the Ohio Department of Job and Family Services' implementation of "Ohio RETAIN." The evaluation will document how the project is implemented, describe enrollees, estimate the project's impacts on enrollees' outcomes, and assess whether the benefits outweigh the costs.

Type: Interventional

Start Date: Jan 2022

open study

The Retaining Employment and Talent after Injury/Illness Network (RETAIN) demonstration is a collaborative effort between the U.S. Department of Labor (DOL) and the Social Security Administration (SSA) to improve employment outcomes for individuals who experience injuries or illnesses that put them at risk of exiting the labor force and relying on disability programs and other public supports in the long term. RETAIN projects include a combination of medical provider services, stay-at-work/return-to-work (SAW/RTW) coordination services, and other SAW/RTW services. This evaluation will focus on the Kansas Department of Commerce's implementation of "RETAINWORKS" statewide. The evaluation will document how the project is implemented, describe enrollees, estimate the project's impacts on enrollees' outcomes, and assess whether the benefits outweigh the costs.

Type: Interventional

Start Date: Oct 2021

open study

Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches. Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.

Type: Observational

Start Date: Apr 2020

open study

Coronary angiography and percutaneous coronary intervention (PCI) is often performed in patients with ischemic heart disease. The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. The objectives of this multi-center observational registry are to examine frequency of complications occuring during cardiac catheterization and PCI, examine procedural strategies utilized for complication management, and evaluate the clinical outcomes (both immediate and during follow-up.)

Type: Observational

Start Date: Nov 2020

open study

This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.

Type: Observational

Start Date: Apr 2021

open study

Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears. Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes.

Type: Observational [Patient Registry]

Start Date: Aug 2021

open study

OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.

Type: Interventional

Start Date: Feb 2021

open study

'The reason for doing this research is to better understand hidradenitis suppurativa also known as HS or acne inversa. HS involves skin folds and causes swelling of the skin and surrounding tissues pain and foul-smelling discharges. These changes normally occur in the armpits groin and under the breasts however they can occur anywhere.  'Effective treatment options are lacking. Recently clinical trials conducted by researchers from our lab found Brodalumab was an effective drug for this disease. Common treatments for HS include combinations of antibiotics retinoids and the biologic agent Adalimumab/Humira. Yet as these treatments are frequently unsatisfactory many severe patients eventually undergo extensive surgery to remove areas with active skin lesions. Still even after extensive surgery there may be a relapse of the disease in other areas. There is thus a great need to better understand the disease and the drivers of the inflammation in HS that will allow the develop of new therapeutics in the future.  'To do that we will enroll HS patients with different symptoms and severity levels. We will study their disease with one or more of the following assessment tools: blood testing skin biopsies skin tape-strips clinical assessment ultrasound tissue impedance microbiological sampling and clinical photography-before during and after therapy. However we will not be prescribing medication and will not take over patients' medical care.

Type: Observational

open study

The reason for doing this research is to study the nature diagnosis and treatment of individuals affected with the genetic disease Fanconi anemia an inherited disorder that leads to bone marrow failure (aplastic anemia) and cancer development.  In most cases it is a recessive disorder: if both parents carry a defect (mutation) in the same Fanconi anemia gene each of their children has a 25% chance of inheriting the defective gene from both parents.  When this happens the child will have Fanconi anemia.  Patients may have a variety of birth defects and may eventually develop acute myelogenous leukemia (AML) head and neck gynecological and/or gastrointestinal cancer.  The researchers doing the study will collect information about the medical history genetics clinical course blood test results treatment complications and social issues of Fanconi anemia.  Information about relatives of Fanconi anemia patients will also be collected.  A purpose of this project is to develop a detailed listing or `registry' of people who may have Fanconi anemia and their close family members. Tissue samples are collected in a repository in order to study the genotype of the study subjects for geneotype/phenotype correlation and to understand why bone marrow and cancer develop.  Using patient samples we want to understand the disease so we can develop new preventive and treatment strategies.

Type: Observational

open study

The purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device (CF-LVAD) implantation compared to usual care oral vasodilator therapy.

Type: Interventional

Start Date: Nov 2019

open study

feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

Type: Observational

Start Date: Jun 2020

open study

The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to chemotherapy and maybe associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells. Pembrolizumab has been found effective in other types of cancer and has already been approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell killing. There is no control or placebo treatment in this study.

Type: Interventional

Start Date: Sep 2017

open study

The overall objective of the Morehouse Total Cancer Care study is to develop an improved standard of cancer care by facilitating new biomarker and drug target discovery, informatics solutions, clinical trials, and "personalized medicine" for our community oncology partners (i.e., community hospital systems, and other cancer care providers). To bring new translational research to the community, Morehouse School of Medicine has initiated the Total Cancer Care Program (TCCP). The TCCP establishes a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of African American cancer patients, survivors, or those at risk of having cancer. This is not a treatment trial, but a longitudinal study designed to create a centralized cancer biorepository for precision medicine.

Type: Observational [Patient Registry]

Start Date: Apr 2018

open study

Open-label, uncontrolled, phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma

Type: Interventional

Start Date: Aug 2019

open study

This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine

Type: Interventional

Start Date: Oct 2018

open study

Task-dependent upper limb tremor is a disorder that frequently impairs patients' function and quality of life. Few studies exist that quantify the improvements in motor performance and disability with botulinum toxin (injections). The study team aims to perform an exploratory pilot trial using toxin Type A (Dysport) in 25 patients with task-dependent upper limb tremor, to refine quantitative measures of performance using blinded video analysis, demonstrate efficacy and tolerability of injections, and provide power calculations for a potential future multi-centered double blinded clinical trial.

Type: Interventional

Start Date: Dec 2018

open study

Purpose: To compare the radiation exposure in patients during Endoscopic retrograde cholangiopancreatography (ERCP) done by Endoscopists formally trained in judicious use of fluoroscopy versus ERCPs done by Endoscopists without such formal training. Research design: This is an observational study to compare radiation exposure in patients during ERCPs based on formal training. Procedures to be used: None Risks and potential benefits There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future. Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to provide new insights and develop newer guidelines for radiation use in the future.

Type: Observational

Start Date: Nov 2015

open study

Over the past 10 years, electronic cigarettes (e-cigarettes, EC) have been commercialized as a "less harmful" alternative to traditional cigarettes.1,2 However, e-cigarettes are believed to cause pulmonary epithelial, endothelial and vascular dysfunction, and to cause murine phenotypes similar to those of human COPD. Recently, "spiked" vape juice has been linked to severe lung damage. Unfortunately, the effects of e-cigarettes on the human lungs are still poorly understood, especially in healthy young adults. Therefore, establishing the health effects of e-cigarettes in humans is of paramount importance to guide medical and regulatory decision making. Its widespread use and immense popularity among teenagers and young adults have caused major concern given potentially significant addictive and detrimental long-term health effects.

Type: Interventional

Start Date: Nov 2020

open study

Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.

Type: Interventional

Start Date: Oct 2019

open study

This is an expanded access program (EAP) for eligible participants designed to provide access to fedratinib. Expanded access is only available in markets where fedratinib is not yet approved.

Type: Expanded Access

open study

Staphylococcus aureus (SA) is a leading cause of morbidity mortality and as a result it is responsible for a marked economic burden on today's health care system. Infections with SA that are resistant to Methicillin antibiotic (MRSA) are very common and are a major part of this burden. 30% of the population are colonized with S. aureus so at least theoretically their immune system is constantly exposed to the bacteria and expected to induce protective immunity. However at the same time 30% of the population experiencing an infection with S. aureus will be afflicted with recurrent infections with this bacterium and despite previous exposure. Developing a vaccine would be an ideal solution for prevention of these infections. However despite intensive study in the last 3 decades a successful vaccine against S.aureus is still unavailable. For developing and designing an efficient vaccine a better understanding of the immune response to S. aureus is needed..For many yearsthe concept was that B cell responses and antibody production are enough for protection against S.aureus. In recent years direct evidence from KO mice as well as evidence from humans with primary immune deficiency demonstrates that CD4 Th1 and Th17 immune responses are necessary for protection from S. aureus. Nevertheless our recent results demonstrate that the Th1 and Th17 response to the various S. aureus strains varied extensively in response to in-vitro stimulation. Further wide variability was also inspected in IgG expression by proliferating B cells in response to the different strains. We could show that mobile genetic elements carried by phages are responsible for a significant portion of this immune response variability. These findings are bringing up the possibility that the strain specificity is a new factor that might need to be taken into account when we are evaluating protection. At this time point what is not known/understood and what we want to clarify in the current study is:   (i) Whether previous exposure to various strains results in different level of protective memory. (ii) How immune memory induced by exposure to one strain affect the ability to respond to other strains of S. aureus.

Type: Observational

open study

Ribonucleic acid (RNA) is a biomolecule with a variety of function within living cells. It is biochemically very similar to deoxyribonucleic acid (DNA) the biomolecule encoding the genetic information. In contrast to DNA however RNA is less stable and easily degraded by ubiquitiously present enzymes (RNases or more generally nucleases). There is a high nuclease activity in extracellular fluids (biofluids) so that extracellular RNA are commonly viewed as being rapidly degraded and useless for diagnostic applications. But recent research inlcuding in our laboratory showed that at least certain RNA classes are to a certain degree protected from degradation. This is particularly true for miRNAs. We and others have shown that they can be reliably measured in the blood circulation and that a characteristic and robust miRNA signature exists for selected diseases or in pregnancy. However there is very limited data on the biogenesis or the clearance of RNA containing complexes circulating micro RNAs (miRNAs) and almost no data about confounding factors during the sample preparation. Our data on archived clinical samples and publications by other groups indicate that the extracellular RNA content is strongly influenced by blood cell damage variables during samples procurement sample handling as well as by different RNA isolation methods. The use of assays based on distinct technologies and the lack of standardization and precise quantification additionally makes it very hard to compare available results. In this study which follows our pilot study on exRNA isolation for biomarker discovery (IRB KAK-839) we want to identify confounders in sample handling and quantification that can critically influence the circulating RNA profile. In addition we aim to explore techniques for enrichment or concentration of certain RNA classes including but not limited to messenger RNAs (mRNAs) that can be linked to physiological and pathophysiological states. While our focus of this study is on RNA retrieval an characterization a second goal is to direct method development towards optionally extracting extracellular DNA from the same sample after extraction of the RNA an opportinity that discovered unexpectedly when developing our own RNA extraction method. To ensure proper blood collection we will use blood from a cohort of healthy volunteers prepared with different types of anticoagulant and treated with different enzymes and additives after collection. Blood from this cohort will be used for method development in this study and and for quality control purposes in this study and in other studies of extracellular RNA and DNA conducted in this group.

Type: Observational

open study