A prospective randomized-controlled study to evaluate the effect of a standardized yoga practice on chronic back pain
Background:Chronic low back pain is notoriously difficult to treat and is a primary contributor to lost work days and excessive health expenditures, and whose treatment has, in part, contributed to the opioid crisis. Surgery is only an option in a minority of these patients, usually confined to those with structural instability. Yoga is an ancient modality whose benefits are currently being studied. There is enough data that the most recent ACP guidelines have included yoga as a treatment for chronic back pain, but more data needs to be generated regarding the efficacy of this modality in treating the chronic back pain population.Methods:We will perform a prospective, randomized trial with the hypothesis that yoga is superior (non-inferior) to usual care for chronic back pain. Inclusion criteria will be adult patients who have had chronic back pain (pain above the gluteal cleft of at least 3 months duration). Exclusion criteria will be patients who have an indication for surgery: fracture, infection, scoliosis, or spondylolisthesis. The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs. The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections. Outcome measures will be assessed by VAS, ODI, and SF-36 surveys to be given at 3 months, 6 months, 1 year, and 2 years.
A Prospective Randomized Double-Blind Sham-Controlled Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita System in Subjects with Type 2 Diabetes on Insulin therapy
The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa.The exclusion of the duodenum from the passage of nutrients by surgical diversion appears to result in weight-independent improvements in glycemia associated with a reduction in insulin resistance. This effect is also notable in being almost immediate in its onset (within days) and durable over time (years). The gastrointestinal tract is now recognized to be the largest endocrine organ in the body. It releases gastrointestinal hormones in a finely tuned pattern to help the body achieve glucose homeostasis in the fasting and post-prandial states, with the gastro-intestinal mucosa playing the role as a critical sensing and secreting interface. Bypass of the proximal small bowel appears to modify the secretion of certain key gastrointestinal hormones that in turn lead to improvements in glucose homeostasis. This occurs without calorie malabsorption. Rather, these changes restore the ability of the liver to suppress endogenous glucose production in response to insulin, a physiologic process that is otherwise impaired in diabetes.There are two main theories on how the bypass of the proximal small bowel exerts such a strong anti-diabetic effect, both of which may explain the role of the small bowel in glucose homeostasis.29 First, some believe that the delivery of excess nutrients to the distal small bowel leads to enhanced secretion of GLP-1 (and perhaps additional related insulin-secreting hormones) from the GLP-1-rich entero-endocrine cells of the terminal ileum. Enhanced GLP-1 release into the bloodstream after an ingested meal has a number of beneficial effects on glucose homeostasis30.A second theory is that individuals with Type 2 Diabetes acquire mucosal alterations in their proximal small bowel that contribute to insulin resistance and glucose intolerance and that bypass of this segment is beneficial. Data from rats and humans suggest that prolonged exposure to a Western diet leads to an increase in enteroendocrine cell numbers and a subsequent gastric inhibitory peptide (GIP) after a meal.Other studies have demonstrated hypertrophy of the mucosa of the small bowel in subjects with diabetes.In this way, the insulin resistance of the body may arise from hormones produced by the proximal small bowel as a consequence of these mucosal alterations. The hypothesis is that bypass of the duodenum by nutrients prevents the release of these hormones and therefore immediately leads to an improvement in glucose tolerance after surgery.Moreover, it is now becoming increasingly recognized that the upstream surgical perturbation of the gastrointestinal tract, resulting in the exclusion of the duodenum, does indeed manifest a compelling anti-diabetic effect but the diabetes state of the patient is also a key determinant of outcome. Studies have now reported that the potency of the anti-diabetic effect manifested with metabolic surgery is contingent on or influenced by innate endogenous beta-cell reserve or insulin secretory capacity. In other words, surgery elicits powerful anti-diabetic effects but more notably in the presence of sufficient endogenous beta-cell secretory capacity. This raises important questions concerning a more targeted use of such interventions in individuals that have certain beta-cell reserve characteristics and/or certain companion pharmacological agents that augment beta-cell secretory function (e.g. GLP-1-receptor agonists) to best optimize outcome.A model of type 2 diabetes pathogenesis emerges from these observations. Namely, a life of excess fat and sugar ingestion in genetically prone individuals can lead to changes in the mucosa of the proximal small bowel. These mucosal changes, in turn, are associated with alterations in signals emanating from the proximal gut (including hormone secretion). This altered proximal gut signal exerts an effect that worsens insulin resistance, could negatively affect insulin secretion and may well drive the pathogenesis of T2D. In this context, duodenal exclusion through surgery or a medical device may reduce the abnormal signal emanating from the proximal gut, and thus improves glucose homeostasis.Duodenal mucosal resurfacing (DMR), using the Revita® System, is designed to mimic the metabolic benefit of the duodenal exclusion component of bariatric surgery, thereby eliciting an insulin-sensitizing effect. Duodenal Mucosal Resurfacing (DMR) consists of a highly controlled mucosal lift and ablation procedure of the post papillary duodenum using the Revita® System over the guided wire placed using a standard endoscope.The Revita® clinical data indicates that DMR exerts insulin-sensitizing like effects as evidenced by a lowering of HOMA-IR40, by an insulin-sensitizing metabolic signature by metabolomics testing (e.g., lowering of a-hydroxybutyrate, diacylglycerol, and peroxidase activity), and by other related insulin-sensitizing biomarker effects (including lowered hepatic transaminases and urinary microalbumin).Unlike bariatric surgery, which involves an anatomical bypass of the duodenum and therefore no exposure of ingested nutrients to the surface of that portion of the GI tract, DMR is designed to ablate and re-epithelialize the duodenal mucosal surface, thus allowing nutrients to be exposed to a newly regrown and normalized local mucosa. This infers that the duodenal mucosa surface is in some way abnormal in insulin resistant T2D subjects and is, therefore, emanating a potential ‘insulin resisting’ effect. This notion is supported by multiple lines of evidence: the duodenum undergoes a maladaptive hypertrophic response when exposed to unhealthy nutrients (i.e., fat, simple sugars); this change appears to be associated with an augmented insulin-resistant signal emanating from this portion of the bowel.This signal appears to be persistent and reversible in T2D, as revealed in post-bariatric surgery: in those individuals in whom metabolic improvement has been established after surgery, the acute re-exposure of the bypassed duodenum to nutrients quickly restores the insulin resistant, hyperglycemic, dysmetabolic condition that had existed pre-surgery ; and ablation technology applied to other tissue surfaces has shown that the natural tissue response to ablation is re-growth of a healthy tissue surface.Taken together, there is a strong rationale that the duodenal mucosa of T2D subjects is abnormal and that subjects would likely reap a metabolic benefit if the local duodenal mucosa is resurfaced through an ablation technique.In addition to the glycemic benefits previously seen, data has also indicated liver benefits after ablating abnormal duodenal mucosa in T2D. The C-20000 study, which did not require a NAFLD diagnosis at baseline, showed that approximately 85% of patients had fatty liver even in the presence of normal liver transaminases, confirming prior evidence of the growing epidemiologic overlap with T2D.Patients with NAFLD (liver MRI-PDFF > 5%)at baseline showed a large magnitude and a clinically meaningful reduction in liver fat content at week 12, confirming earlier findings of reductions in ALT through 2 years. These data provide insight into a potential therapeutic opportunity for DMR to favorably impact both T2D and NAFLD/NASH in a manner that can modify the natural history of these chronic and progressive diseases.
A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
The main purpose of this study is to confirm Prism training can help U.S. Veterans and civilians with post-traumatic stress disorder (PTSD). We will do this by running a large-scale study where some participants get actual neurofeedback treatment and others receive a pretend (sham) treatment.
A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients with End-stage Renal Disease (ESRD)
Each year, only about 27,000 kidney transplants are performed in the United States, leaving over 90,000 people with end stage renal disease (ESRD) waiting for a kidney transplant. Central to the problem of prolonged wait-times is the fact that there are not enough donor organs available for all the ESRD patients who need them. However, over the past 5 years there have been exciting developments in a new type of transplant called kidney xenotransplantation, which may help people with ESRD who are struggling with long wait-times. In kidney xenotransplantation, a kidney from a genetically modified pig is transplanted into a person with ESRD. Special medicines, similar to those used in regular human-to-human transplants, help prevent the body from rejecting the new kidney. These pig kidneys can perform the same important functions as human kidneys, allowing the body to stay balanced and healthy. One big advantage of xenotransplantation is that it can drastically reduce wait-times since there is a more plentiful and easily available supply of pig kidneys compared to human donor kidneys. Patients who have received these pig kidneys have seen encouraging results— all the kidneys have started working right away, and patients have been able to stop dialysis after the transplant. NYU is excited to start a clinical trial, offering this pioneering treatment to ESRD patients who rely on dialysis. If you are interested in learning more about this trial, please reach out to our team for more information.
A Randomized Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study
This study is being conducted in Aortic Stenosis patients who have undergone successful TAVR with a balloon expandable heart valve who also have coronary artery disease (CAD) or narrowing of the heart arteries.The study will compare:1. opening all suitable stenosis or blockages with an additional procedure (either during the same hospitalization as the TAVR or as a separate procedure) called percutaneous coronary intervention (PCI). This procedure opens or widens the stenosis with a stent thereby allowing blood to flow to the heart muscle. This procedure will happen within 45 days of your TAVR procedure. You will also receive optimal medical therapy.OR2. treating these additional stenosis or blockages with medication only and not opening them with an additional PCI procedure.
A Randomized controlled study of a health literacy-informed technology-based approach to support safe medication use by parents after discharge of infants from the neonatal intensive care unit
This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 425 subjects will be recruited across two sites over preparatory phases and two primary study phases. Subjects will be assigned to 1 of 3 intervention groups: usual care, HELPix (health literacy-informed written materials and verbal counseling in addition to usual care), or HELPix + TECH (a health literacy-informed web application in addition to HELPix and usual care). Phase A is a pilot study, in which 120 parents will be enrolled at Bellevue Hospital and randomly assigned to usual care or HELPix + TECH. Phase B will take place at both Bellevue and Elmhurst Hospitals, and 225 subjects will be randomly assigned to usual care, HELPix, or HELPix + TECH. Parents will be screened and recruited, written informed consent will be obtained, and a brief survey will be administered on the day of the child’s expected discharge from the neonatal intensive care unit Subjects will then receive usual care followed by the intervention if randomized to one of those groups (Visit 1, Day 0). Medication knowledge, dosing, and adherence will be assessed in-person at a subsequent follow-up visit (Visit 2, Day ~1-7). Adverse events will be assessed via phone call (Visit 3, Day ~30-45). Additional data will be assessed using a chart review. There will be a preparatory phase before each of the 2 phases. For the preparatory phase before Phase A: 10 cognitive interviews will be conducted to assess parent comprehension/ acceptability of HELPix followed by 20 parent interviews focused on HELPix app usability.For the preparatory phase before Phase B: 12 cognitive interviews will be conducted to assess parent comprehension/ acceptability of HELPix. In addition to the cognitive interviews, 3 rounds of feedback with 6 parents per round will be conducted to iteratively refine the HELPix digital app. Once adapted, 20 parents will be asked about HELPix app usability.
A RANDOMIZED CONTROLLED TRIAL OF MAGNESIUM SULFATE AS AN ADJUNCTIVE ANALGESIC IN PROSTATE SURGERY
We will randomize prostate surgery patients to receive magnesium sulfate or not in the context of a standardized anesthetic. Postoperative pain scores and analgesic dose will be measured, in addition to the presence of shivering, quantitative neuromuscular blockade monitoring, drugs administered during anesthesia, and postoperative disposition (home or admission to hospital). We anticipate 110 subjects will give us 90% power to detect a 2 point difference in a 10 point pain score 30 minutes after awakening.
A randomized double-blind double-dummy parallel-group study comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis followed by extended treatment with open-label remibrutinib
The purpose of this research study is to compare remibrutinib and teriflunomide safety and efficacy in patients with relapsing forms of Multiple Sclerosis (RMS).
A Randomized Double-Blind Placebo-Controlled Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)
The purpose of this study is to evaluate the safety and efficacy of multiple doses of AP01 compared with placebo (a study treatment containing no active ingredients), over 52 weeks in participants with Progressive Pulmonary Fibrosis (PPF). During the study, you will continue your current PPF treatment regimen; the study drug will be added to your current treatment regimen.
A Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiranin the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease with METAVIR Stage F2 to F4 Fibrosis
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of fazirsiran (TAK-999, previously called ARO-AAT) in the treatment of subjects aged 12 to 75 years (inclusive) with AATD-LD moderate to advanced fibrosis and compensated cirrhosis.The study will enroll subjects with PiZZ AATD-LD with METAVIR stage F2, F3, or F4 liver fibrosis. Approximately 126 up to 140 subjects are planned to be randomized 1:1 to receive either placebo or fazirsiran administered subcutaneously (SC). Subject randomization will be stratified according to METAVIR stage (F2 or F3 vs F4). The F4cc population will be capped at 25% of the total subjects with the remaining 75% being comprised of F2 and F3 subjects.