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Subcutaneous Fat Necrosis

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1001. Aloxi (palonosetron hydrochloride)

apparent in lungs, liver, adrenals and testes and lowest in fat, bone (without marrow) and the medulla (brain). Concentrations generally peaked within two hours, later peaks were observed in skin, testes, liver, stomach, bone and fat. Concentration ratios in the brain peaked at 30 min; chromatographic analysis indicated only palonosetron, no metabolites. The kinetic pattern in the brain mirrored that in plasma, indicating rapid elimination. By 96 hours, concentrations in all tissues, except the eye (...) weights were reduced in males at 120 mg/kg/day. In a one-month rat study changes at 180 mg/kg/day included reduced body weight gain, occasional signs and numerous clinical pathology variations, most of which were within the normal range. Low testis and secondary sex organ weights were associated with degeneration and necrosis of the seminiferous epithelium. Low thymus weights in females associated with lymphoid depletion and high liver weights in both sexes with foamy cytoplasmic swelling

2006 European Medicines Agency - EPARs

1002. Crixivan - indinavir

not associated with drug-induced renal injury. In rats administered very high doses of indinavir, renal tubular necrosis and vacuolation were observed. Serum biochemical, haematological and urinanalytical changes were noted in rats and mice exposed to indinavir concentrations in the clinical range. These changes seem to be of minor toxicological significance. Repeated dose toxicity studies in rats and dogs given indinavir sulphate at doses up to 160 mg/kg/day together with two degradates did not show any (...) studies. Data from 374 subjects was presented, of whom 179 were HIV patients. The vast majority of the subjects included were male (84 %). One study was performed in subjects with mild to moderate hepatic impairment. Indinavir is rapidly absorbed in the fasted state (T max of 0.8 hours) with an absolute bioavailability of approximately 60 % within the dose range of 400 mg to 800 mg. The bioavailability of a single 800 mg dose was approximately 65 %. Administration of a 400 mg dose with a high-fat

2005 European Medicines Agency - EPARs

1003. Consensus recommendations for the diagnosis, treatment and control of Mycobacterium ulcerans infection (Bairnsdale or Buruli ulcer) in Victoria, Australia Full Text available with Trip Pro

. Epidemiology Mycobacterium ulcerans was discovered in 1948 by Australian scientists who were investigating a cluster of patients with unusual skin ulcers in the Bairnsdale region of eastern Victoria. M. ulcerans is related to the causative agents of tuberculosis and leprosy, but is transmitted from the environment rather than from person to person. The major virulence factor is a lipid toxin, mycolactone, which causes necrosis of fat and subcutaneous tissue. M. ulcerans infection is not fatal, but can (...) that undergoes necrosis and evolves to a deeply undermined ulcer. Lesions are usually painless or minimally painful. Less commonly, the initial lesion may resemble a plaque or necrotic patch of skin. Systemic symptoms (fever, malaise) are rare. Fully developed ulcers are characteristically deeply undermined, meaning a probe can be passed easily under the edge into the space left by necrotic liquefied fat tissue. Lesions can occur anywhere and may be multiple, but a single lesion on the leg or arm is most

2007 MJA Clinical Guidelines

1004. Improving outcomes in breast cancer

on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52 705 women with breast cancer and 108, 411 without breast cancer. Lancet 1997;350:1047- 59.14 The risk of breast cancer is affected by lifestyle. Obesity is associated with a two-fold increase in risk among post-menopausal women; this has been linked with high intake of meat and dairy fat, but the precise nature of these relationships are still unclear

2002 National Institute for Health and Clinical Excellence - Clinical Guidelines

1006. Cost-effectiveness of becaplermin for nonhealing neuropathic diabetic foot ulcers

The study population comprised adult patients with diabetes mellitus, Type 1 or Type 2, and a foot ulcer. The foot ulcer had to have been present for at least 8 weeks, be full-thickness (to subcutaneous fat), and be free of local wound infection, cellulites or osteomyelitis. It also had to have been debrided to remove callus, necrotic debris and slough. Setting The setting was the community. The economic study was carried out in Ontario, Canada. Dates to which data relate The dates to which

2003 NHS Economic Evaluation Database.

1007. Clinical practice guidelines for the management of early breast cancer

of invasive cancer after surgical excision of DCIS. In a report of mammographically-detected DCIS, invasive cancer occurred in 13 per cent of women within eight years of complete surgical excision of intermediate to high-grade DCIS. 38 This represents a ten-fold risk compared with recent incidence figures. Although there are no reliable predictors for probability of progression to invasive carcinoma, the risk may be greater when DCIS displays features such as comedo necrosis or high nuclear grade. 39

2001 Cancer Australia

1009. Absence of an effect of liposuction on insulin action and risk factors for coronary heart disease. (Abstract)

infusions) as well as levels of inflammatory mediators and other risk factors for coronary heart disease in 15 obese women before and 10 to 12 weeks after abdominal liposuction. Eight of the women had normal glucose tolerance (mean [+/-SD] body-mass index, 35.1+/-2.4), and seven had type 2 diabetes (body-mass index, 39.9+/-5.6).Liposuction decreased the volume of subcutaneous abdominal adipose tissue by 44 percent in the subjects with normal glucose tolerance and 28 percent in those with diabetes; those (...) with normal oral glucose tolerance lost 9.1+/-3.7 kg of fat (18+/-3 percent decrease in total fat, P=0.002), and those with type 2 diabetes lost 10.5+/-3.3 kg of fat (19+/-2 percent decrease in total fat, P<0.001). Liposuction did not significantly alter the insulin sensitivity of muscle, liver, or adipose tissue (assessed by the stimulation of glucose disposal, the suppression of glucose production, and the suppression of lipolysis, respectively); did not significantly alter plasma concentrations of C

2004 NEJM

1010. Impaired mitochondrial activity in the insulin-resistant offspring of patients with type 2 diabetes. Full Text available with Trip Pro

subjects matched for age, height, weight, and physical activity to assess the sensitivity of liver and muscle to insulin. Proton ((1)H) magnetic resonance spectroscopy studies were performed to measure intramyocellular lipid and intrahepatic triglyceride content. Rates of whole-body and subcutaneous fat lipolysis were assessed by measuring the rates of [(2)H(5)]glycerol turnover in combination with microdialysis measurements of glycerol release from subcutaneous fat. We performed (31)P magnetic (...) dysfunction, as reflected by a reduction of approximately 30 percent in mitochondrial phosphorylation (P=0.01 for the comparison with controls), since there were no significant differences in systemic or localized rates of lipolysis or plasma concentrations of tumor necrosis factor alpha, interleukin-6, resistin, or adiponectin.These data support the hypothesis that insulin resistance in the skeletal muscle of insulin-resistant offspring of patients with type 2 diabetes is associated with dysregulation

2004 NEJM

1011. What is the effect of liposuction on CHD risk factors in overweight and/or obese patients?

obese women before and 10 to 12 weeks after abdominal liposuction. Eight of the women had normal glucose tolerance (mean [+/-SD] body-mass index, 35.1+/-2.4), and seven had type 2 diabetes (body-mass index, 39.9+/-5.6). RESULTS: Liposuction decreased the volume of subcutaneous abdominal adipose tissue by 44 percent in the subjects with normal glucose tolerance and 28 percent in those with diabetes; those with normal oral glucose tolerance lost 9.1+/-3.7 kg of fat (18+/-3 percent decrease in total (...) fat, P=0.002), and those with type 2 diabetes lost 10.5+/-3.3 kg of fat (19+/-2 percent decrease in total fat, P Liposuction did not significantly alter the insulin sensitivity of muscle, liver, or adipose tissue (assessed by the stimulation of glucose disposal, the suppression of glucose production, and the suppression of lipolysis, respectively); did not significantly alter plasma concentrations of C-reactive protein, interleukin-6, tumor necrosis factor alpha, and adiponectin; and did

2006 TRIP Answers

1012. Osteogenic Profiling of Tissue From Children With Craniosynostosis

, University of Pittsburgh Study Details Study Description Go to Brief Summary: The primary objectives of this study are to procure human temporalis muscle, subcutaneous adipose (fat), and bone tissue samples from children with craniosynostosis, to grow cells from these tissues in vitro, to evaluate the osteogenic potentials of these cell types. Condition or disease Intervention/treatment Phase Craniosynostosis Other: biopsy Not Applicable Detailed Description: The screening procedures include review (...) 16, 2008 Last Update Posted: October 23, 2018 Last Verified: October 2018 Keywords provided by Joseph Losee, University of Pittsburgh: to procure human temporalis muscle, subcutaneous adipose (fat), and bone tissue samples from children with craniosynostosis, to grow cells from these tissues in vitro to evaluate the osteogenic potentials of these cell types. Additional relevant MeSH terms: Layout table for MeSH terms Craniosynostoses Synostosis Dysostoses Bone Diseases, Developmental Bone

2008 Clinical Trials

1013. Latino Study

microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening). Drug: Ribavirin 1000-1200mg po daily for 48 weeks Drug: Peginterferon alfa-2a 180 micrograms sc (...) /week for 48 weeks Experimental: Non-Latino White Participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks. Drug: Ribavirin 1000-1200mg po daily for 48 weeks Drug: Peginterferon alfa-2a 180 micrograms sc/week

2005 Clinical Trials

1014. Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens

years post-intervention ] Subcutaneous tissue toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity: 0= none; 1= slight induration (fibrosis) and loss of subcutaneous fat; 2= moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction; 3= severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= necrosis Secondary Outcome Measures : Cosmetic effect of PBIC [ Time Frame: up to 5 years post (...) skin folds, pitting edema; 4= ulceration, hemorrhage, necrosis. Late skin toxicities of PBIC [ Time Frame: up to 5 years post-intervention ] Late Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity: 0= none; 1= slight atrophy, pigmentation change, some hair loss; 2= patchy atrophy, moderate telangiectasias, total hair loss; 3= marked atrophy, gross telangiectasias; 4= ulceration Subcutaneous tissue toxicities of PBIC [ Time Frame: up to 5

2008 Clinical Trials

1015. Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers

to a modified Wagner system, which includes wounds involving the epidermis, the dermis, the hypodermis or the subcutaneous fat but not the tendon or joint capsule. The thickness of aforesaid layers wounds be approximately between 0.2 mm and 8 mm and is ranging in size between 3 and 15 cm2 post debridement. An ankle brachial index ≥0.80. The study ulcer should show "infection control" as judged by the investigator The subject should be free of any necrotic or infected soft and bony tissue. Signed informed (...) consent form. Exclusion Criteria: Ulcers caused by venous or arterial insufficiency, osteomyelitis. Poor nutritional status (albumin < 3g/dl), poor diabetic control (HbA1c > 10%), anemia (hemoglobin<10 g/dL), a leukocyte counts < 1,000/cumm. Requiring prostaglandin treatment. Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement. Presence of connective tissue disease

2008 Clinical Trials

1016. Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer

Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan [ Time Frame: Within 1 year of protocol registration ] -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her. Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous (...) Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity [ Time Frame: Within 1 year of protocol registration ] -The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity Secondary Outcome Measures : Incidence and Severity of Cutaneous Toxicity [ Time Frame: Up to 5 years ] Uses RTOG/EORTC Late Radiation Morbidity Scoring Scheme Grade 0 = none

2006 Clinical Trials

1017. BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

plasma concentration versus time data. AUC (TAU) of Tenofovir at Week 4 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ] AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4. Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured (...) by Dual Energy X-ray Absorptiometry (DEXA) at Week 96 [ Time Frame: Baseline (Day 1) and Week 96. ] Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis [ Time Frame: Baseline visit ] 19 genes of interest were selected from previous results or literature, and 34

2006 Clinical Trials

1018. Radiation Therapy, Cyclophosphamide, and Doxorubicin in Treating Women With Stage I or Stage II Breast Cancer Who Have Undergone Surgery

atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= Necrosis Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate (...) : Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation (PBI) and concurrent cyclophosphamide/doxorubicin (AC) chemotherapy. Assess the cosmetic effects of partial breast irradiation/chemotherapy (PBIC) in these patients. Assess the local control rate in patients treated with this regimen. OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3 weeks. Patients also

2006 Clinical Trials

1019. Telmisartan-Induced Reduction in Intra-Myocellular Lipids Trial

) Heart and Stroke Foundation of Canada Medtronic Information provided by: McMaster University Study Details Study Description Go to Brief Summary: The purpose of this study is to determine whether telmisartan and/or a low-glycemic index diet are effective in reducing intra-myocellular lipid (muscle fat) content. Condition or disease Intervention/treatment Phase Metabolic Syndrome X Drug: Telmisartan (Micardis®) vs. Placebo Behavioral: Low-Glycemic Index Diet vs. Control Diet Phase 3 Detailed (...) Description: The metabolic syndrome currently affects over 20% of the adult population in Canada. Patients with abdominal obesity are at markedly increased risk for diabetes and heart disease. Recent studies have shown that decreased sensitivity to insulin (insulin resistance), a hallmark of the metabolic syndrome, is related to increased storage of fat in muscle cells (muscle fat). Several recent studies indicate that blocking the renin-angiotensin system (RAS) may improve insulin sensitivity and prevent

2005 Clinical Trials

1020. Changes in serum levels of E-selectin correlate to improved glycaemic control and reduced obesity in subjects with the metabolic syndrome. (Abstract)

the effect of physical exercise and pravastatin (40 mg daily) on serum levels of CAMs and a possible role of adipose tissue in regulating serum levels of CAMs were investigated.The study was designed as an unmasked randomized 2x2 factorial trial of 12 weeks duration in 32 subjects with the metabolic syndrome. Changes from baseline were studied, and correlations between changes in CAMs, anthropometric measures, regional fat distribution, glycaemic control and the adipocytokine tumour necrosis factor (...) -a (TNF-a) and adiponectin were investigated.No significant changes in CAMs were observed in any of the intervention groups. However, when examining the whole study population regardless of intervention, changes in serum E-selectin were significantly correlated to changes in body mass index (r=0.48, p=0.006), waist circumference (r=0.48, p=0.006), fasting glucose (r=0.43, p=0.02) and HbA1c (r=0.45, p=0.01), but not to changes in visceral fat, subcutaneous fat, TNF-a or adiponectin.Changes in glycaemic

2005 Scandinavian journal of clinical and laboratory investigation Controlled trial quality: uncertain

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