11 results on '"Harris, John"'
Search Results
2. Impact of satellite clinics on geographic access to assisted reproductive technology services in the United States.
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McGarity, Micajah Z., Herndon, Christopher N., Harris, John A., and Hobbs, Benjamin F.
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HEALTH services accessibility ,CHILDBEARING age ,INFERTILITY ,LOGISTIC regression analysis ,CLINICAL trials ,EVALUATION of medical care ,DESCRIPTIVE statistics ,HUMAN reproductive technology ,GEOGRAPHIC information systems ,HEALTH facilities - Abstract
Background: Many assisted reproductive technology (ART) centers utilize satellite clinics to expand reach and access to clinical services, but their contribution to lowering geographic barriers in access to care has not been examined. This study's purpose is to determine the extent to which satellite clinics impact geographic access to ART and estimate the percentage of reproductive-age women who have geographic access to ART services.Methods: A systematic web-search collected the locations of all main and satellite ART clinics in the United States (US). Driving times were calculated between satellite clinics and main clinics. The percentage of women with geographic access to care was characterized by clinic type using US Census Core Based Statistical Areas (CBSAs). Logistic regression was used to statistically model the presence of main and satellite clinics as a function of CBSA median income and female reproductive-age population.Results: Four hundred sixty-nine main clinics with embryology labs and 583 satellite clinics were found in the US. Practices with satellite clinics tend to perform more ART cycles. Satellite clinics are located on average 66 minutes from their practice's main clinic and 31 minutes from any main clinic. 22% of satellite clinics were in CBSAs without a main clinic. 46 M (72%) US reproductive-age women live in a CBSA with a main clinic, 5.1 M (8%) women live in a CBSA without a main clinic but at least one satellite clinic, and 13 M (20%) women live in an area with no ART clinic of either type. Female reproductive-age population was found to be a more important predictor of clinic presence than median income.Conclusions: The majority of satellite clinics in the US are positioned in relative proximity to a main clinic. 85% of satellite clinics are located closer to the main clinic of other practices than to their own main clinic. Less than a quarter of ART satellite clinics expand geographic access to ART services by being located in areas without a main clinic, and the vast majority of practices with satellite clinics position their satellite clinics close to another practice's main clinic.Trial Registration: Not applicable. [ABSTRACT FROM AUTHOR]- Published
- 2022
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3. Effective Treatments for Patients with Vitiligo.
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Harris, John
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VITILIGO , *CLINICAL trials - Published
- 2023
4. Vitiligo: Mechanistic insights lead to novel treatments.
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Frisoli, Michael L. and Harris, John E.
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Vitiligo is an autoimmune disease of the skin characterized by patchy depigmentation. Current treatments are moderately effective at reversing disease by suppressing autoimmune inflammation in the skin and promoting melanocyte regeneration. Recent basic and translational research studies have significantly improved our understanding of disease pathogenesis, which is now leading to emerging treatment strategies based on targeted therapy. Here we discuss important clinical characteristics of vitiligo, current therapies and their limitations, advances in understanding disease pathogenesis, emerging targeted treatments, and strategies to optimize clinical trials to efficiently and effectively test these new treatments. [ABSTRACT FROM AUTHOR]
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- 2017
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5. How participants in cancer trials are chosen: ethics and conflicting interests.
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Jayson, Gordon and Harris, John
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CLINICAL drug trials , *CLINICAL trials , *CLINICAL medicine research , *DRUG monitoring , *CANCER treatment , *CLINICAL pharmacology - Abstract
The development of new drugs for cancer is extremely complex and expensive, and poses ethical problems. In this article we will review issues in clinical trials for cancer drugs that will cast new light on the doctor-patient relationship and their interaction with industry, the health service, academic and administrative organizations. We show that the Declaration of Helsinki cannot be applied to cancer trials as it is currently written, that patients do not and perhaps cannot give fully informed consent to participate, and that the results of clinical trials do not translate into daily practice in a way that patients might expect. [ABSTRACT FROM AUTHOR]
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- 2006
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6. Nursing intervention after carotid endarterectomy: a randomized trial of Co-ordinated Care Post-Discharge (CCPD).
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Middleton, Sandy, Donnelly, Neil, Harris, John, and Ward, Jeanette
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ENDARTERECTOMY ,NURSING ,CLINICAL trials ,VASCULAR surgery ,ARTERIAL surgery - Abstract
Aim. This paper reports a study evaluating the short-term impact of nursing-led, co-ordinated care after discharge following carotid endarterectomy. Background. Patient education about stroke risk factors, combined systematically with carotid endarterectomy, holds unrealized potential to improve patient outcomes. Nurses are well-placed in the healthcare system to co-ordinate this type of education. Methods. A randomized controlled trial was conducted between October 2001 and October 2002. Patients having carotid endarterectomy ( n = 133) were randomized to either the intervention ( n = 66) or control group ( n = 67). The intervention consisted of telephone liaison with the patient by a Registered Nurse at 2, 6 and 12 weeks following carotid endarterectomy, combined with education about stroke risk factor management and structured liaison with the patient's surgeon and referring general practitioner. While patients allocated to the control group did not receive any postoperative telephone contact directly from the Registered Nurse during the study, their general practitioners received structured postoperative liaison. Results. The co-ordinated care postdischarge intervention had a statistically significant positive effect on patient knowledge of stroke warning signs ( P = 0·002), patient self-reported changes to improve lifestyle ( P = 0·006) and diet modification ( P < 0·001). Statistically significant improvements from baseline to follow-up were detected in both groups for other outcomes. Conclusions. While nursing-led, co-ordinated care after discharge achieves important improvements for short-term outcomes, carotid endarterectomy itself may have been a catalyst for improved patient outcomes. Further research of nursing-led co-ordinated care initiatives for vascular surgery patients is needed. [ABSTRACT FROM AUTHOR]
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- 2005
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7. Comments: to stent or not to stent.
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Harris, John P.
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TREATMENT of carotid artery diseases , *ENDARTERECTOMY , *VASCULAR surgery , *SURGICAL stents , *CLINICAL trials , *SAFETY ,CAROTID artery stenosis - Abstract
The article focuses on the efficacy of carotid endarterectomy (CEA) in carotid artery stenosis as compared to carotid stenting (CAS). It mentions the two trials including the North American Symptomatic Carotid Endarterectomy Trial and Asymptomatic Carotid Atherosclerosis Study which served as historical basis in contrast with the result of CAS. The French endarterectomy versus angioplasty in symptomatic severe carotid stenosis patients found that CAS has higher stroke and death rate than CEA.
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- 2009
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8. A Community-Based Trial of an Online Intimate Partner Violence CME Program
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Short, Lynn M., Surprenant, Zita J., Harris, John M., and Harris, John M Jr
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CONTINUING medical education , *INTIMATE partner violence , *INTERNET , *CLINICAL trials - Abstract
Background: There is a broad need to improve physician continuing medical education (CME) in the management of intimate partner violence (IPV). However, there are only a few examples of successful IPV CME programs, and none of these are suitable for widespread distribution.Design: Randomized controlled trial beginning in September 2003 and ending in November 2004. Data were analyzed in 2005.Setting/participants: Fifty-two primary care physicians in small (fewer than eight physicians), community-based medical offices in Arizona and Missouri.Intervention: Twenty-three physicians completed a minimum of 4 hours of an asynchronous, multi-media, interactive, case-based, online CME program that provided them flexibility in constructing their educational experience ("constructivism"). Control physicians received no CME.Main Outcome Measures: Scores on a standardized self-reported survey, composed of ten scales of IPV knowledge, attitudes, beliefs, and self-reported behaviors (KABB) administered before randomization and repeated at 6 and 12 months following the CME program.Results: Use of the online CME program was associated with a significant improvement in eight of ten KABB outcomes, including physician self-efficacy and reported IPV management practices, over the study period. These measures did not improve in the control group.Conclusions: The Internet-based CME program was clearly effective in improving long-term individual educational outcomes, including self-reported IPV practices. This type of CME may be an effective and less costly alternative to live IPV training sessions and workshops. [ABSTRACT FROM AUTHOR]- Published
- 2006
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9. SUPPLEMENTARY OXYGEN AND WOUND HEALING IN VASCULAR SURGERY: TOO SIMPLE TO BE TRUE?
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Harris, John P.
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OXYGEN , *POSTOPERATIVE period , *SURGICAL site infections , *CLINICAL trials , *RISK assessment - Abstract
The article discusses issues concerning efficacy of supplementary oxygen in the postoperative phase. The role of supplementary oxygen and the risk of surgical site infection (SSI) has been a considerable controversy, it has conflicting results from the published controlled trials. Grief and his colleagues has found out that providing 80% oxygen throughout surgery and for 2 h postoperatively decreased infection risk by half compared with patients who were given 30% oxygen.
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- 2007
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10. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo.
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Rosmarin, David, Passeron, Thierry, Pandya, Amit G., Grimes, Pearl, Harris, John E., Desai, Seemal R., Lebwohl, Mark, Ruer-Mulard, Mireille, Seneschal, Julien, Wolkerstorfer, Albert, Kornacki, Deanna, Kang Sun, Butler, Kathleen, Ezzedine, Khaled, Sun, Kang, and TRuE-V Study Group
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CLINICAL trials , *ACNE , *HETEROCYCLIC compounds , *ORGANIC compounds , *JANUS kinases , *TREATMENT effectiveness , *RANDOMIZED controlled trials , *ITCHING , *BLIND experiment , *CUTANEOUS therapeutics , *STATISTICAL sampling , *VITILIGO - Abstract
Background: Vitiligo is a chronic autoimmune disease that causes skin depigmentation. A cream formulation of ruxolitinib (an inhibitor of Janus kinase 1 and 2) resulted in repigmentation in a phase 2 trial involving adults with vitiligo.Methods: We conducted two phase 3, double-blind, vehicle-controlled trials (Topical Ruxolitinib Evaluation in Vitiligo Study 1 [TRuE-V1] and 2 [TRuE-V2]) in North America and Europe that involved patients 12 years of age or older who had nonsegmental vitiligo with depigmentation covering 10% or less of total body-surface area. Patients were randomly assigned in a 2:1 ratio to apply 1.5% ruxolitinib cream or vehicle control twice daily for 24 weeks to all vitiligo areas on the face and body, after which all patients could apply 1.5% ruxolitinib cream through week 52. The primary end point was a decrease (improvement) of at least 75% from baseline in the facial Vitiligo Area Scoring Index (F-VASI; range, 0 to 3, with higher scores indicating a greater area of facial depigmentation), or F-VASI75 response, at week 24. There were five key secondary end points, including improved responses on the Vitiligo Noticeability Scale.Results: A total of 674 patients were enrolled, 330 in TRuE-V1 and 344 in TRuE-V2. In TRuE-V1, the percentage of patients with an F-VASI75 response at week 24 was 29.8% in the ruxolitinib-cream group and 7.4% in the vehicle group (relative risk, 4.0; 95% confidence interval [CI], 1.9 to 8.4; P<0.001). In TRuE-V2, the percentages were 30.9% and 11.4%, respectively (relative risk, 2.7; 95% CI, 1.5 to 4.9; P<0.001). The results for key secondary end points showed superiority of ruxolitinib cream over vehicle control. Among patients who applied ruxolitinib cream throughout 52 weeks, adverse events occurred in 54.8% in TRuE-V1 and 62.3% in TRuE-V2; the most common adverse events were application-site acne (6.3% and 6.6%, respectively), nasopharyngitis (5.4% and 6.1%), and application-site pruritus (5.4% and 5.3%).Conclusions: In two phase 3 trials, application of ruxolitinib cream resulted in greater repigmentation of vitiligo lesions than vehicle control through 52 weeks, but it was associated with acne and pruritus at the application site. Larger and longer trials are required to determine the effect and safety of ruxolitinib cream in patients with vitiligo. (Funded by Incyte; TRuE-V1 and TRuE-V2 ClinicalTrials.gov numbers, NCT04052425 and NCT04057573.). [ABSTRACT FROM AUTHOR]- Published
- 2022
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11. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial.
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Rosmarin, David, Pandya, Amit G, Lebwohl, Mark, Grimes, Pearl, Hamzavi, Iltefat, Gottlieb, Alice B, Butler, Kathleen, Kuo, Fiona, Sun, Kang, Ji, Tao, Howell, Michael D, and Harris, John E
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VITILIGO , *SUBDURAL hematoma , *BODY surface area , *OINTMENTS , *RUXOLITINIB , *RESEARCH , *CLINICAL trials , *HETEROCYCLIC compounds , *RESEARCH methodology , *CASE-control method , *EVALUATION research , *MEDICAL cooperation , *TREATMENT effectiveness , *COMPARATIVE studies , *RANDOMIZED controlled trials , *BLIND experiment - Abstract
Background: Vitiligo is a chronic autoimmune disease resulting in skin depigmentation and reduced quality of life. There is no approved treatment for vitiligo repigmentation and current off-label therapies have limited efficacy, emphasising the need for improved treatment options. We investigated the therapeutic potential of ruxolitinib cream in patients with vitiligo and report the efficacy and safety results up to 52 weeks of double-blind treatment.Methods: We did a multicentre, randomised, double-blind, phase 2 study for adult patients with vitiligo in 26 US hospitals and medical centres in 18 states. Patients with depigmentation of 0·5% or more of their facial body surface area (BSA) and 3% or more of their non-facial BSA were randomly assigned (1:1:1:1:1) by use of an interactive response technology system to receive ruxolitinib cream (1·5% twice daily, 1·5% once daily, 0·5% once daily, or 0·15% once daily) or vehicle (control group) twice daily on lesions constituting 20% or less of their total BSA for 24 weeks. Patients in the control group in addition to patients in the 0·15% once daily group who did not show a 25% or higher improvement from baseline in facial Vitiligo Area Scoring Index (F-VASI) at week 24 were re-randomised to one of three higher ruxolitinib cream doses (0·5% once daily, 1·5% once daily, 1·5% twice daily). Patients in the 0·5% once daily, 1·5% once daily, or 1·5% twice daily groups remained at their original dose up to week 52. Patients, investigators, and the study sponsor (except members of the interim analysis and primary endpoint analysis data monitoring teams) remained masked to treatment assignment throughout the study. The primary endpoint was the proportion of patients achieving a 50% or higher improvement from baseline in F-VASI (F-VASI50) at week 24, assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT03099304.Findings: Between June 7, 2017, and March 21, 2018, 205 patients were screened for eligibility, 48 were excluded and 157 patients (mean age, 48·3 years [SD 12·9]; 73 [46%] male and 84 [54%] female) were randomly assigned to either an intervention group or the control group. 32 (20%) of 157 were assigned to the control group, 31 (20%) to the 0·15% once daily group, 31 (20%) to the 0·5% once daily group, 30 (19%) to the 1·5% once daily group, and 33 (21%) to the 1·5% twice daily group. F-VASI50 at week 24 was reached by significantly more patients given ruxolitinib cream at 1·5% twice daily (15 [45%] of 33) and 1·5% once daily (15 [50%] of 30) than were treated with vehicle (one [3%] of 32). Four patients had serious treatment-emergent adverse events (one patient in the 1·5% twice daily group developed subdural haematoma; one patient in the 1·5% once daily group had a seizure; one patient in the 0·5% once daily group had coronary artery occlusion; and one patient in the 0·5% once daily group had oesophageal achalasia), all of which were unrelated to study treatment. Application site pruritus was the most common treatment-related adverse event among patients given ruxolitinib cream (one [3%] of 33 in the 1·5% twice daily group; three [10%] of 30 in the 1·5% once daily group; three [10%] of 31 in the 0·5% once daily group; and six [19%] of 31 in the 0·15% once daily group)with three [9%] of 32 patients showing application site pruritis in the control group. Acne was noted as a treatment-related adverse event in 13 (10%) of 125 patients who received ruxolitinib cream and one (3%) of 32 patients who received vehicle cream. All treatment-related adverse events were mild or moderate in severity and similar across treatment groups.Interpretation: Treatment with ruxolitinib cream was associated with substantial repigmentation of vitiligo lesions up to 52 weeks of treatment, and all doses were well tolerated. These data suggest that ruxolitinib cream might be an effective treatment option for patients with vitiligo.Funding: Incyte. [ABSTRACT FROM AUTHOR]- Published
- 2020
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