14 results on '"Patel, Raman"'
Search Results
2. Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial.
- Author
-
Uriel N, Jeevanandam V, Imamura T, Onsager D, Song T, Ota T, Juricek C, Combs P, Lammy T, Patel-Raman S, Woolley JR, Sayer G, Milano C, Schroder J, Molina E, Grinstein J, Suarez E, Estep JD, Aggarwal S, Silvestry S, and Raval N
- Subjects
- Aged, Counterpulsation adverse effects, Counterpulsation mortality, Feasibility Studies, Female, Heart Failure diagnosis, Heart Failure mortality, Heart Failure physiopathology, Heart Transplantation, Humans, Male, Middle Aged, Prospective Studies, Prosthesis Design, Recovery of Function, Risk Factors, Stroke mortality, Time Factors, Treatment Outcome, United States, Counterpulsation instrumentation, Exercise Tolerance, Heart Failure therapy, Heart-Assist Devices, Quality of Life
- Abstract
Background: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery., Methods: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial., Results: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support., Conclusions: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.
- Published
- 2020
- Full Text
- View/download PDF
3. The first-in-human experience with a minimally invasive, ambulatory, counterpulsation heart assist system for advanced congestive heart failure.
- Author
-
Jeevanandam V, Song T, Onsager D, Ota T, LaBuhn CJ, Lammy T, Sayer G, Kim G, Patel-Raman S, and Uriel N
- Subjects
- Ambulatory Care, Feasibility Studies, Female, Humans, Male, Middle Aged, Prospective Studies, Severity of Illness Index, Counterpulsation methods, Heart Failure surgery, Heart-Assist Devices
- Abstract
Background: The intravascular ventricular assist system (iVAS) is a new, minimally invasive, ambulatory counterpulsation heart assist system delivered via the subclavian artery and powered by a portable driver. It is designed for recovery, bridge to transplantation (BTT) or for prolonging medical therapy. We report the first-in-human (FIH) experience with iVAS., Methods: This is a prospective, non-randomized single arm, U.S. Food and Drug Administration (FDA)-approved early feasibility trial in patients listed for cardiac transplantation. The primary end-point was survival to transplant or stroke-free survival at 30 days., Results: Fourteen patients were enrolled and 13 (92.8%) were treated with iVAS. At time of implant, the average age was 58 ± 6.7 years; 85% were male; 28% had ischemic cardiomyopathy; and 3 were Interagency Registry for Mechanically Assisted Devices (INTERMACS) Level 2, 9 were Level 3, and 1 was Level 4. The mean left ventricular ejection fraction was 22%, left ventricular internal diameter diastole was 7.13 mm, and 69% had moderate or severe mitral regurgitation. There were no intra-operative complications. Intensive care unit stay after implant was 6 ± 6 days. All patients were transplanted after 32 ± 21 days. There were no deaths or thromboembolic events: 1 patient required escalation of mechanical support, and post-implant complications included pleuritis/pericarditis (n = 1) and neuropathy (n = 2). No intra-operative blood transfusions were required., Conclusions: This study demonstrates a high rate of successful outcomes with an excellent risk-to-benefit profile. This FIH experience reveals that the iVAS can be successfully inserted in a standardized approach, provide hemodynamic support, can be interrupted for short periods, and allows for ambulation. A multicenter trial to investigate effectiveness and safety is warranted., (Copyright © 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
- Full Text
- View/download PDF
4. Beyond the VAD: Human Factors Engineering for Mechanically Assisted Circulation in the 21st Century.
- Author
-
Throckmorton AL, Patel-Raman SM, Fox CS, and Bass EJ
- Subjects
- Animals, Clinical Decision-Making methods, Device Approval, Ergonomics methods, Humans, Precision Medicine methods, Prosthesis Design, Heart-Assist Devices adverse effects
- Abstract
Thousands of ventricular assist devices (VADs) currently provide circulatory support to patients worldwide, and dozens of heart pump designs for adults and pediatric patients are under various stages of development in preparation for translation to clinical use. The successful bench-to-bedside development of a VAD involves a structured evaluation of possible system states, including human interaction with the device and auxiliary component usage in the hospital or home environment. In this study, we review the literature and present the current landscape of preclinical design and assessment, decision support tools and procedures, and patient-centered therapy. Gaps of knowledge are identified. The study findings support the need for more attention to user-centered design approaches for medical devices, such as mechanical circulatory assist systems, that specifically involve detailed qualitative and quantitative assessments of human-device interaction to mitigate risk and failure., (Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)
- Published
- 2016
- Full Text
- View/download PDF
5. Food and Drug Administration commentary on "a new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves".
- Author
-
Aguel F, Kurtzman SB, Patel-Raman S, Hillebrenner M, and Zuckerman BD
- Subjects
- Humans, Device Approval, Heart Defects, Congenital surgery, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Heart Valves surgery, Marketing of Health Services, United States Food and Drug Administration
- Published
- 2013
- Full Text
- View/download PDF
6. Past, present, and future regulatory aspects of ventricular assist devices.
- Author
-
Patel-Raman SM and Chen EA
- Subjects
- Clinical Trials as Topic, Device Approval legislation & jurisprudence, Evidence-Based Medicine, Government Regulation, Heart-Assist Devices adverse effects, Humans, Patient Selection, Practice Guidelines as Topic, Prosthesis Design, Risk Assessment, Treatment Outcome, United States, United States Food and Drug Administration legislation & jurisprudence, Device Approval standards, Heart Failure therapy, Heart-Assist Devices standards, United States Food and Drug Administration standards
- Abstract
The development of ventricular assist devices (VADs) for the treatment of heart failure has been ongoing since the National Heart Lung and Blood Institute (NHLBI) initiated the artificial heart program in 1964. The primary goal was to develop VADs and total artificial hearts for both temporary (short-term) and long-term use. Due to a small target population and the inability to blind patients and clinicians, the Food and Drug Administration (FDA) has recognized the challenges of conducting trials with these invasive devices. In an effort to address those challenges, FDA has accepted a variety of clinical trial designs to collect the data required to evaluate safety and effectiveness data in different patient groups. This article will provide a detailed discussion of the past, present, and future FDA regulatory considerations for VADs.
- Published
- 2010
- Full Text
- View/download PDF
7. Are cannabis use disorders associated with an earlier age at onset of psychosis? A study in first episode schizophrenia.
- Author
-
Sevy S, Robinson DG, Napolitano B, Patel RC, Gunduz-Bruce H, Miller R, McCormack J, Lorell BS, and Kane J
- Subjects
- Adolescent, Adult, Age of Onset, Antipsychotic Agents therapeutic use, Benzodiazepines therapeutic use, Diagnostic and Statistical Manual of Mental Disorders, Executive Function physiology, Female, Humans, Male, Memory, Short-Term physiology, Neuropsychological Tests, Olanzapine, Outcome Assessment, Health Care, Prospective Studies, Retrospective Studies, Risperidone therapeutic use, Schizophrenia drug therapy, Young Adult, Marijuana Abuse etiology, Schizophrenia complications, Schizophrenia diagnosis, Schizophrenic Psychology
- Abstract
Introduction: The purpose of this study is to determine if an earlier age at onset of positive symptoms in schizophrenia is associated with cannabis use disorders (CUD)., Methods: 49 first-episode schizophrenia subjects with CUD were compared to 51 first-episode schizophrenia subjects with no substance use disorders for demographic and clinical variables. A multivariate logistic regression was performed to determine the joint relationship between variables significantly associated with CUD on univariate testing and ascertain if these variables independently predict CUD. Significance level was set at p<0.05., Results: 74% of CUD subjects had the onset of CUD before the onset of positive symptoms. Compared to non-substance abusing subjects, CUD subjects were predominantly male, younger at study entry, had an earlier age at onset of positive symptoms, less educational attainment, a lower self-socioeconomic status, better premorbid childhood social adjustment, a trend for poorer premorbid childhood academic adjustment, less motor abnormalities but more severe hallucinations and delusions. In the multivariate analysis, only male gender, worse socio-economic status, better premorbid childhood social adjustment, and more severe positive symptoms at study entry were associated with a lifetime history of CUD., Discussion: Although cannabis use precedes the onset of illness in most patients, there was no significant association between onset of illness and CUD that was not accounted for by demographic and clinical variables. Previous studies implicating CUD in the onset of schizophrenia may need to more comprehensively assess the relationship between CUD and schizophrenia, and take into account additional variables that we found associated with CUD., ((c) 2010 Elsevier B.V. All rights reserved.)
- Published
- 2010
- Full Text
- View/download PDF
8. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis.
- Author
-
Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M, Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, and Kane S
- Subjects
- Administration, Oral, Adult, Aged, Delayed-Action Preparations, Drug Administration Schedule, Female, Humans, Male, Mesalamine adverse effects, Middle Aged, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Colitis, Ulcerative drug therapy, Mesalamine administration & dosage
- Abstract
Background & Aims: The practice of dosing mesalamines in divided doses for the treatment of ulcerative colitis (UC) began with sulfasalazine and was driven by sulfapyridine toxicity. This convention and the assumption that dosing multiple times a day is necessary to treat UC had not been challenged until recently. This study was conducted to determine the efficacy and safety of once-daily dosing of delayed-release mesalamine (Asacol 400-mg tablets) compared with twice-daily dosing for maintaining remission in UC patients., Methods: A multicenter, randomized, investigator-blinded, 12-month, active-control trial was conducted to assess the noninferiority of delayed-release mesalamine 1.6-2.4 g/day administered once daily compared with twice daily in patients with mild-to-moderate UC currently in clinical remission. The primary end point was maintenance of clinical remission at month 6., Results: A total of 1023 patients were randomized and dosed. The primary objective of noninferiority was met. At month 6, 90.5% of patients receiving once-daily dosing had maintained clinical remission, compared with 91.8% of patients receiving twice-daily dosing (95% confidence interval for twice daily - once daily, -2.3 to 4.9). At month 12, 85.4% of patients receiving once-daily dosing had maintained clinical remission, compared with 85.4% of patients receiving twice-daily dosing (95% confidence interval for twice daily - once daily, -4.6 to 4.7). Both regimens had low rates of withdrawals as a result of adverse events and serious adverse events., Conclusions: Once-daily dosing of delayed-release mesalamine at doses of 1.6-2.4 g/day was shown to be as effective as twice-daily dosing for maintenance of clinical remission in patients with UC., (2010 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2010
- Full Text
- View/download PDF
9. FDA's perspectives on cardiovascular devices.
- Author
-
Chen EA, Patel-Raman SM, O'Callaghan K, and Hillebrenner MG
- Subjects
- Animals, Cardiology legislation & jurisprudence, Clinical Trials as Topic legislation & jurisprudence, Consumer Product Safety legislation & jurisprudence, Cooperative Behavior, Defibrillators, Implantable, Equipment Design, Equipment Safety, Evidence-Based Medicine, Guidelines as Topic, Heart Valve Prosthesis, Heart-Assist Devices, Humans, Interdisciplinary Communication, Pacemaker, Artificial, Product Labeling, Prosthesis Design, Risk Assessment, United States, Cardiology instrumentation, Device Approval legislation & jurisprudence, Government Regulation, Health Policy
- Abstract
The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.
- Published
- 2009
- Full Text
- View/download PDF
10. Lack of an inverse relationship between duration of untreated psychosis and cognitive function in first episode schizophrenia.
- Author
-
Goldberg TE, Burdick KE, McCormack J, Napolitano B, Patel RC, Sevy SM, Goldman R, Lencz T, Malhotra AK, Kane JM, and Robinson DG
- Subjects
- Adolescent, Cognition Disorders diagnosis, Cognition Disorders psychology, Double-Blind Method, Early Diagnosis, Female, Humans, Male, Olanzapine, Prognosis, Psychiatric Status Rating Scales, Psychometrics, Psychotic Disorders diagnosis, Psychotic Disorders psychology, Schizophrenia diagnosis, Young Adult, Antipsychotic Agents therapeutic use, Benzodiazepines therapeutic use, Cognition Disorders drug therapy, Neuropsychological Tests statistics & numerical data, Psychotic Disorders drug therapy, Risperidone therapeutic use, Schizophrenia drug therapy, Schizophrenic Psychology
- Abstract
This study assessed the relationship between duration of untreated psychosis (DUP) and cognitive measures in order to assess if longer DUP was associated with worse performance. One hundred two patients with first episode schizophrenia or schizoaffective disorder were assessed on cognitive measures of speed of processing, episodic memory, executive function, and visual spatial processing at baseline (when patients were drug naive and after 16 weeks of olanzapine or risperidone treatment), so that a change score could be derived. DUP was defined by the emergence of psychiatric symptoms and the emergence of psychotic symptoms. Data were analyzed correlationally, parametrically (after the group was divided into long and short DUP by median split), and by regression. We found that DUP for psychotic symptoms in this group of patients was long, with a median of 46 weeks. Neither correlational, parametric analyses in which DUP served as a class variable, nor multiple regression indicated that longer DUP was associated with worse cognition at baseline or smaller magnitude of improvement in cognition. Our results suggest that while early intervention may be critical for symptom amelioration by shortening DUP, early intervention for treatment of psychiatric symptoms may have little or no impact on cognitive function. Furthermore, assuming that cognition is a core symptom of schizophrenia, the notion that ongoing psychosis is somehow toxic for a variety of information processing domains appears questionable.
- Published
- 2009
- Full Text
- View/download PDF
11. Food and Drug Administration's perspectives on pediatric cardiac assist devices.
- Author
-
Chen EA, Patel-Raman SM, Berman MR, and Zuckerman BD
- Subjects
- Child, Clinical Trials as Topic, Humans, United States, Device Approval, Heart-Assist Devices, United States Food and Drug Administration
- Abstract
Dual missions of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) are 1) promoting public health by promptly reviewing and taking appropriate, timely action regarding the marketing of regulated medical devices while at the same time, and 2) protecting public health by ensuring a reasonable assurance of the safety and effectiveness of medical devices deemed appropriate for human use. In the past, clinicians have used cardiac assist devices intended for adults to treat pediatric heart failure patients. However, because of the larger size of the approved devices, many pediatric patients are underserved by this approach. Currently, several cardiac assist devices intended for use in pediatric patients are being developed. FDA believes that clinical data used to support such safety and probable benefit may be derived from a small focused clinical trial in this target population, and developers may want to consider this approach for approval of the humanitarian device exemption application. Pediatric device development is challenging and early communication with FDA to develop an appropriate regulatory and scientific pathway for device submission is advised and warranted. This early interaction can facilitate the development of a small but necessary trial for these life-sustaining pediatric cardiac assist devices.
- Published
- 2008
- Full Text
- View/download PDF
12. Cognitive improvement after treatment with second-generation antipsychotic medications in first-episode schizophrenia: is it a practice effect?
- Author
-
Goldberg TE, Goldman RS, Burdick KE, Malhotra AK, Lencz T, Patel RC, Woerner MG, Schooler NR, Kane JM, and Robinson DG
- Subjects
- Adult, Antipsychotic Agents pharmacology, Benzodiazepines pharmacology, Benzodiazepines therapeutic use, Cognition drug effects, Cognition Disorders diagnosis, Cognition Disorders psychology, Control Groups, Female, Humans, Male, Neuropsychological Tests statistics & numerical data, Olanzapine, Practice, Psychological, Psychiatric Status Rating Scales statistics & numerical data, Research Design standards, Risperidone pharmacology, Risperidone therapeutic use, Schizophrenic Psychology, Treatment Outcome, Antipsychotic Agents therapeutic use, Cognition Disorders drug therapy, Schizophrenia drug therapy
- Abstract
Context: Cognitive impairment in schizophrenia is frequent, involves multiple domains, and is enduring. Numerous recent clinical trials have suggested that second-generation antipsychotic medications significantly enhance cognition in schizophrenia. However, none of these studies included healthy controls undergoing repeated testing to assess the possibility that improvements might reflect simple practice effects., Objective: To report the results on cognition of a randomized comparison of 2 widely prescribed second-generation antipsychotic medications, olanzapine and risperidone, in patients with first-episode schizophrenia and a healthy control group., Design: Randomized clinical trial., Setting: Hospital-based research units. Patients A total of 104 participants with first-episode schizophrenia and 84 healthy controls., Main Outcome Measures: Cognitive assessment of all study participants occurred at baseline, 6 weeks later, and 16 weeks later. Neurocognitive tests included measures of working memory and attention, speed, motor function, episodic memory, and executive function., Results: No differential drug effects were observed. Of 16 cognitive measures, 9 demonstrated improvement over time and only 2 demonstrated greater rates of change than those observed in the healthy control group undergoing repeated assessment. The composite effect size for cognitive change was 0.33 in the healthy control group (attributed to practice) and 0.36 in the patients with first-episode schizophrenia. Improvements in cognition in the first-episode schizophrenia group could not be accounted for by medication dose, demographic variables, or intellectual level., Conclusions: The cognitive improvements observed in the trial were consistent in magnitude with practice effects observed in healthy controls, suggesting that some of the improvements in cognition in the first-episode schizophrenia group may have been due to practice effects (ie, exposure, familiarity, and/or procedural learning). Our results also indicated that differential medication effects on cognition were small. We believe that these findings have important implications for drug discovery and the design of registration trials that attempt to demonstrate cognitive enhancement.
- Published
- 2007
- Full Text
- View/download PDF
13. Randomized comparison of olanzapine versus risperidone for the treatment of first-episode schizophrenia: 4-month outcomes.
- Author
-
Robinson DG, Woerner MG, Napolitano B, Patel RC, Sevy SM, Gunduz-Bruce H, Soto-Perello JM, Mendelowitz A, Khadivi A, Miller R, McCormack J, Lorell BS, Lesser ML, Schooler NR, and Kane JM
- Subjects
- Adult, Antipsychotic Agents adverse effects, Basal Ganglia Diseases chemically induced, Benzodiazepines adverse effects, Benzodiazepines therapeutic use, Body Mass Index, Female, Follow-Up Studies, Humans, Male, Obesity chemically induced, Olanzapine, Psychotic Disorders drug therapy, Psychotic Disorders psychology, Risperidone adverse effects, Schizophrenic Psychology, Treatment Outcome, Weight Gain drug effects, Antipsychotic Agents therapeutic use, Risperidone therapeutic use, Schizophrenia drug therapy
- Abstract
Objective: The authors compared 4-month treatment outcomes for olanzapine versus risperidone in patients with first-episode schizophrenia spectrum disorders., Method: One hundred twelve subjects (70% male; mean age=23.3 years [SD = 5.1]) with first-episode schizophrenia (75%), schizophreniform disorder (17%), or schizoaffective disorder (8%) were randomly assigned to treatment with olanzapine (2.5-20 mg/day) or risperidone (1-6 mg/day)., Results: Response rates did not significantly differ between olanzapine (43.7%, 95% CI=28.8%-58.6%) and risperidone (54.3%, 95% CI=39.9%-68.7%). Among those responding to treatment, more subjects in the olanzapine group (40.9%, 95% CI=16.8%-65.0%) than in the risperidone group (18.9%, 95% CI=0%-39.2%) had subsequent ratings not meeting response criteria. Negative symptom outcomes and measures of parkinsonism and akathisia did not differ between medications. Extrapyramidal symptom severity scores were 1.4 (95% CI=1.2-1.6) with risperidone and 1.2 (95% CI=1.0-1.4) with olanzapine. Significantly more weight gain occurred with olanzapine than with risperidone: the increase in weight at 4 months relative to baseline weight was 17.3% (95% CI=14.2%-20.5%) with olanzapine and 11.3% (95% CI=8.4%-14.3%) with risperidone. Body mass index at baseline and at 4 months was 24.3 (95% CI=22.8-25.7) versus 28.2 (95% CI=26.7-29.7) with olanzapine and 23.9 (95% CI=22.5-25.3) versus 26.7 (95% CI=25.2-28.2) with risperidone., Conclusions: Clinical outcomes with risperidone were equal to those with olanzapine, and response may be more stable. Olanzapine may have an advantage for motor side effects. Both medications caused substantial rapid weight gain, but weight gain was greater with olanzapine.
- Published
- 2006
- Full Text
- View/download PDF
14. Association between seclusion and restraint and patient-related violence.
- Author
-
Khadivi AN, Patel RC, Atkinson AR, and Levine JM
- Subjects
- Cross-Sectional Studies, Hospitals, Community, Hospitals, Urban, Humans, Incidence, Mental Disorders psychology, New York City epidemiology, Patient Isolation psychology, Restraint, Physical psychology, Safety Management, Self Mutilation epidemiology, Self Mutilation prevention & control, Self Mutilation psychology, Suicide, Attempted psychology, Suicide, Attempted statistics & numerical data, Violence psychology, Violence statistics & numerical data, Mental Disorders epidemiology, Patient Isolation statistics & numerical data, Psychiatric Department, Hospital statistics & numerical data, Restraint, Physical statistics & numerical data, Violence prevention & control
- Abstract
This study assessed the effect of an intervention designed to reduce the use of seclusion and restraint on reported episodes of patient-related violence on an acute inpatient psychiatric service. Results showed a significant decrease in the total number of episodes of seclusion and restraint between the 12 months before and after the intervention. However, the number of episodes of assault on patients and staff increased significantly. Efforts to decrease seclusion and restraint may be accompanied by an increased risk of harm to psychiatric patients and staff, and intensive safety monitoring and staff training should accompany all such efforts.
- Published
- 2004
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.